Pest Control Products (Registration) Regulations, Legal Notice no. 130 of 2024

NATI ONAL COUNCI L FOR L AW REPORTI NG L i : l i b r a r y 2 22 5SPE C I A L I SSU E 6th August, 2024Kenya Gazette Supplement No. 155 (Legislative Supplement No. 61) L eg a l N o t ic e N o . 130 T H E PE ST CONT ROL PROD U CT S A CT (Cap . 346; THE PEST CONTROL PRODUCTS (REGISTRATION) REG UL A T I ON S, 2024 A RR A N GEM ENT OF REGU L A T IO N S Regulation 1— C i ta t i o n . 2—Interpretation. 3—Object of the Regulations. 4—General requirements on registration of pest control products. 5—Application for registration of a conventional pest co n tr o l products. 6—Application for registration of a biopesticide or biocontro l agent . 7—Application for registration of a generic pest control product or equivalent. 8—Application for registration of a spray adjuvant. 9—Application for registration of a pest control product f o r u se i n paint for in-can and film preservatives. 10—Application for registration of a plant growth regulator. 11 — Ef fi cacy trial s. 12—Waiver of data requirements. 13—Registration of a parallel pest control product. 14 —L abel ex tension . 15—Application by non-residents. 16—Change of trade name. 17—Technical information required. 18— Confi dential B usiness I nform ation . 19—Submission of samples. 20 —D enaturation . .L igo/ . , ' J 4h ' NATIONAL COUNCIL FOR LAW REPORTING eh LIBRARY SPECIAL ISSUE 2225 Kenya Gazette Supplement No. 155 6th August, 2024 — (Legislative Supplement No. 61) LEGAL NOTICE NO. 130 THE PEST CONTROL PRODUCTS ACT (Cap. 346) THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 2024 ARRANGEMENT OF REGULATIONS Regulation 1 —Citation. 2— Interpretation. 3—Object of the Regulations. 4—General requirements on registration of pest control products. 5—Application for registration of a conventional pest control products. a Tq cio} 11QS4 6— Application for registration of a biopesticide or biocontrol agent. 7— Application for registration of a generic pest control product or equivalent. 8— Application for registration of a spray adjuvant. 9— Application for registration of a pest control product for use in paint for in-can and film preservatives. 10— Application for registration of a plant growth regulator. 11—Efficacy trials. 12— Waiver of data requirements. 13—Registration of a parallel pest contro] product. 14— Label extension. 15— Application by non-residents. 16—Change of trade name. 17—Technical information required. 18—Confidential Business Information. * 19—Submission of samples. 20—Denaturation. Kenya Subsidiary Legislation, 20242 2 2 6 21 — Fees for application for registration. 22—Termination of registration process. 23—Issuance of certificate of registration. 24—Notice to holder of certificate of registration 24—Duration and renewal of certif icate of registration. 25—Temporary registration. 26—Emergency Registration. 27—Registration of pest control Products for export and re-exports. 28— Risk assessment 29—Sources of registered pest control products. 30—Exemption from registration. 31 —Refusal to register pest control product . 32—Suspension of certificate of registration. 33—Revocation of certifi cate of registration. 34—Notice to holder of certifi cate of registration. 35—A ppeals. 36—Register of Pest Control Products. 37 — R eco rd s . 38—General Penalty. 39 —Revocation . SC H E D U L E S : F i r st Sc hed u le : — Forms and Requirements Second Schedule: —Items Exempted from Registration 2226 Kenya Subsidiary Legislation, 2024 21—Fees for application for registration. 22— Termination of registration process. 23—Issuance of certificate of registration. 24 —Notice to holder of certificate of registration 24— Duration and renewal of certificate of registration. 25— Temporary registration. 26— Emergency Registration. 27—Registration of pest control Products for export and re-exports. 28— Risk assessment 29—Sources of registered pest control products. 30— Exemption from registration. 31—Refusal to register pest control product. ’ 32—Suspension of certificate of registration. 33— Revocation of certificate of registration. 34— Notice to holder of certificate of registration. 35— Appeals. 36—Register of Pest Control Products. 37—Records. | 38— General Penalty. 39— Revocation. SCHEDULES: — First Schedule: — Forms and Requirements Second Schedule: —Items Exempted from Registration 2 2 27Kenya Subsidiary Legislation, 2024 T H E PE ST C O N T R O L PR O D U C T S A C T (Cap . 346) IN EX ERCISE of the powers conferred by sect ion 15 of t he Pest Control Products Act , the Cabinet Secretary for Agriculture and L ivestock Development, af ter consultation with the Pest C o n t ro l Products Board, makes the following Regulations— THE PEST CONTROL PRODUCTS (REGISTRATION) REG UL A T I ON S, 2024 1. These Regulations may be cited as the Pest Control P r o d uc ts Citation. (Registration) Regulations, 2024. 2. In these Regulations, unless the context otherwise requires— “adjuvant” means a compound or substance that enhances o r modif ies or is intended to enhance or modify the physical o r ch em i c al characteristics of a pest control product to which i t i s added ; “banned pest control product” means a pest control product where all uses have been prohibited by the Board through a regulatory act ion ; Interpre tation. “biochemical pesticide” means a pest control product w ho se active ingredient constitutes a chemical derived from naturally occurring plant, animal or other organism intended to co n t r o l invertebrate pests; “ conf idential business inf ormat ion” means i nf orm ation t h at d i sc lo ses the — t Ki r , - . r . r : (a) manufacturing or quality control processes and 5 -b atc h analysis; (b) methods for testing and measuring the quantity o f deliberately added inert ingredients and impurities; and (c) identity or percentage quantity of deliberately add ed i ner t ingredients in the technical grade or formulated product; (r ‘conventional pest control product” means a synthetic c h em i c al pesticides; “designated competent persons” means a person or an i nst i t u t io n that has been off icially recognized by the Board as having the capacity and competence to undertake biological eff icacy trials, physicochemical studies, toxicological , ecotoxicological and r esi d ue studies; “ device” means any article, instrument , apparatus, co n t r i v an ce o r gadget that by itself or in conj unction with a pest control product is used as a means to control pests directly or indirectly; “experimental permit” means a permit issued by the B o ar d f o r small quantity of a pest control product imported or produced locally for purposes of research, efficacy trials and other studies prior to consideration for registration; % 2227 Kenya Subsidiary Legislation, 2024 THE PEST CONTROL PRODUCTS ACT (Cap. 346) ; IN EXERCISE of the powers conferred by section 15 of the Pest Control Products Act, the Cabinet Secretary for Agriculture and Livestock Development, after consultation with the Pest Control . Products Board, makes the following Regulations — THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 2024 1. These Regulations may be cited as the Pest Control Products (Registration) Regulations, 2024. 2. In these Regulations, unless the context otherwise requires— “adjuvant” means a compound or substance that enhances or modifies or is intended to enhance or modify the physical or chemical characteristics of a pest control product to which it is added; “banned pest control product” means .a pest control product where all uses have been prohibited by the Board through a regulatory action; “biochemical pesticide” means a pest control product whose . active ingredient constitutes a chemical derived from naturally occurring plant, animal or other organism intendéd to control invertebrate pests; 7 ° “confidential business information” means information that. discloses the — (a) manufacturing or quality control processes and 5-batch analysis; (b) methods for testing and measuring the quantity of deliberately added inert ingredients and impurities; and (c) identity or percentage quantity of deliberately added inert ingredients in the technical grade or formulated product; “conventional pest control product” means a synthetic chemical pesticides; “designated competent persons” means a person or an institution that has been officially recognized by the Board as having the capacity and competence to undertake biological efficacy trials, physicochemical studies, toxicological, ecotoxicological and residue studies; “device” means any article, instrument, apparatus, contrivance or gadget that by itself or in conjunction with a pest control product is used as a means to control pests directly or indirectly; “experimental permit” means a permit issued by the Board for small quantity of a pest control product imported or produced locally for purposes of research, efficacy trials and other studies prior to consideration for registration; Citation. Interpretation. o Tee rane IKenya Subsidiary Legislation, 20242 22 8 “ local agent” means a person or company that has been appointed to act on behalf of a registrant in accordance with regulation 11(2); “ macrobial biopesticide” means a pest control product o f naturally occurri ng macro-organisms or macro-biological agents such as predators, parasitoids, entomopathogenic nematodes, or genetically modified living macro- organism, intended for the control o f invertebrate pests, weeds, pathogens of crops and pests of public health and to which effects of the pest control products or active agent are attri buted ; “ m ax i m um r esi d u e l i m i t ” m ean s th e m ax i m u m c o nc en tr at io n o f a residue that is legal ly permitted or recognized as acceptable in or on a food, agri cultural commodity or feedstuf f ; ‘microbial biopesticide‘ means a pest control product of naturally occurri ng micro-organisms or microbiological agents such as viruses and ri ckettsia, bacteri a, protozoa, fungi, or genetical ly modif ied l iving micro-organism, intended for the control of invertebrate pests, weeds, pathogens of crops and pests of public health and to w h ic h eff ects of the pest control products or active agent are attr ibuted ; “national collection number” means the unique code given to a culture or an isolate by the National Museums of Kenya or any other institution recognized by the Board; “ paral lel registration” means a registration of a trade n am e b ased on a registered product from the same manufacturer and so u r ce an d with authorization from the registrant; and “ registrant” means the owner of technical information su b m i t ted for the purposes of registration of a pest control product or person authori zed in wri ting by such owner. 3. (1) The object of these Regulations is to provide a f r am ew or k Obj ect of the Regulations.for the registration of pest control products. (2) Without prej udice to the general ity of sub-regulation ( 1) , the obj ect of these Regulations is to provide for the— (a) procedures, requirements and condi tions for the registration of pest control products; and (b) ri sk assessment and evaluation of pest control products. 4. (1) A person who intends to register a pest control product shall apply to the Board using the respective application f o rm set o u t i n the F i r st Sc h ed u l e . G eneral requirements on registration of pest control products. (2) An appl ication under sub-regulation ( 1) shal l — (a) be submitted in tri pl icate; (b) comply with the requirements set out in the First Schedule; (c) contai n a check l i st and an i ndex to ensure that the applicant has suppl ied the relevant data required in the First Schedule; (d) include a certificate of registration from,‘the country of origin, where the product is sourced outside Kenya; and 2228 Kenya Subsidiary Legislation, 2024 “local agent” means a person or company that has been appointed to act on behalf of a registrant in accordance with regulation 11(2); “macrobial biopesticide” means a pest control product of naturally occurring macro-organisms or macro-biological agents such as predators, parasitoids, entomopathogenic nematodes, or genetically modified living macro- organism, intended for the control of invertebrate pests, weeds, pathogens of crops and pests of public health and to which effects of the pest control products or active agent are attributed; “maximum residue limit” means the maximum concentration of a residue that is legally permitted or recognized as acceptable in or on a food, agricultural commodity or feedstuff; “microbial biopesticide” means a pest control product of naturally occurring micro-organisms or microbiological agents such as viruses and rickettsia, bacteria, protozoa, fungi, or genetically modified living micro-organism, intended for the control of invertebrate pests, weeds, pathogens of crops and pests of public health and to which effects of the pest control products or active agent are attributed; “national collection number” means the unique code given to a culture or an isolate by the National Museums of Kenya or any other institution recognized by the Board; “parallel registration” means a registration of a trade name based on a registered product from the same manufacturer and source and with authorization from the registrant; and “registrant” means the owner of technical information submitted for the purposes of registration of a pest control product or person authorized in writing by such owner. 3. (1) The object of these Regulations is to provide a framework for the registration of pest control products. (2) Without prejudice to the generality of sub-regulation (1), the object of these Regulations is to provide for the— (a) procedures, requirements and conditions for the registration of pest control products; and (b) risk assessment and evaluation of pest control products. 4. (1) A person who intends to register a pest control product shall apply to the Board using the respective application form set out in the First Schedule. (2) An application under sub-regulation (1) shall— (a) be submitted in triplicate; (b) comply with the requirements set out in the First Schedule; (c) contain a checklist and an index to ensure that the applicant has supplied the relevant data required in the First Schedule; (d) include a certificate of registration from. ‘the country of origin, where the product is sourced outside Kenya; and Object of the Regulations. General requirements on registration of pest control products. Kenya Subsidiary Legislation, 2024 22 2 9 I (e) be accompanied by a copy of the label for the pest co n tr o l product and the proposed trade name of the product. (3) Where a pest control product is sourced from a non-English speaking country, the applicant shall provide a translated copy of the certif icate of registration. (4) Where an applicant who intends to register a pest co n tr o l product is sourced from a non-English speaking country su b m i t s wrongly translated registration certificate under sub-regulation (3) , the appl icant shal l be required to— (a) submit a new appl ication; (b) pay a resubmission fee; and (c) conduct another efficacy trial for the pest control product . (5) An applicant who intends to import into or export o u t o f Kenya live organisms shall provide to the Board proof of compl iance with any other written law governing such organisms. (6) An applicant who intends to introduce genetically m o d i f i ed organisms and living modified organisms as microbial biopesticides shall provide to the Board proof of compliance with any other written laws governing such organisms or requisite approvals f r o m the re lev an t government agency . 5. (1) A person who intends to register a conventional pest Application for registration of a conventional pest control products. control product shall apply to the Board in Form A 1 as set o u t i n t h e F i r st Sc hed u l e . (2) The application under sub-regulation (1) shall b e accompanied by a copy of the summary dossier in the m an ner set o u t i n Form B as set out in the F i rst Schedule . 6. (1) A person who intends to register a biopesticide o r a biocontrol agent shall apply to the Board in Form A2 as set o u t i n t he F i r st Sch ed u l e . (2) For purposes of sub-regulation (1), the applicant shal l — (a) provide information in support of the request for registration, both publ ished and unpubl ished, fully cited, in the f o rm o f a summary data sheet in Form A2 set out in the First Schedule; * Application for registration of a biopesticide or biocontrol agent . and (b) attach a copy of the summary dossier for biochemical pest control products in Form B3 as set out the First Schedule. (3) An applicant intending to introduce a microbial o r m ac r o b i al biopesticide shall — (a) submit evidence of collection and culture reference n u m b er where culture is deposited; (b) provide a sample of the technical grade of the biopesticide’s active agent to the Board; w s Kenya Subsidiary Legislation, 2024 (e) be accompanied by a copy of the label for the pest control product and the proposed trade name of the product. (3) Where a pest control product is sourced from a non-English speaking country, the applicant shall provide a translated copy of the certificate of registration. (4) Where an applicant who intends to register a pest control product is sourced from a non-English speaking country submits wrongly translated registration certificate under sub-regulation (3), the applicant shall be required to— (a) submit a new application; (b) pay a resubmission fee; and (c) conduct another efficacy trial for the pest control product. (5) An applicant who intends to import into or export out of Kenya live organisms shall provide to the Board proof of compliance with any other written law governing such organisms. (6) An applicant who intends to introduce genetically modified organisms and living modified organisms as microbial biopesticides shall provide to the Board proof of compliance with any other written laws governing such organisms or requisite approvals from the relevant government agency. 5. (1) A person who intends to register a conventional pest control product shall apply to the Board in Form A1 as set out in the First Schedule. (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in the manner set out in Form B as set out in the First Schedule. 6. (1) A person who intends to register a biopesticide or a biocontrol agent shall apply to the Board in Form A2 as set out in the First Schedule. (2) For purposes of sub-regulation (1), the applicant shall — (a) provide information in support of the request for registration, both published and unpublished, fully cited, in the form of a summary data sheet in Form A2 set out in the First Schedule; and (b) attach a copy of the summary dossier for biochemical pest control products in Form B3 as set out the First Schedule. (3) An applicant intending to introduce a microbial or macrobial biopesticide shall — (a) submit evidence of collection and culture reference number where culture is deposited; . (b) provide a sample of the technical grade of the biopesticide’s active agent to the Board; 2229 Application for registration of a conventional pest control products. Application for registration of a biopesticide or biocontrol agent. Kenya Subsidiary Legislation, 20242 2 3 0 (c) submit a copy of a summary dossier— (i) for microbial pest control products, in Form B1 a s se t out in the First Schedule; or (ii) for macrobial pest control products, in Form B2 a s se t out i n the F i rst Schedule. 7. A person who intends to register a generic pest co n t ro l product equivalent to a registered pest control product shal l apply to the Board in Form A3 as set in the First Schedule. A pplication for registration of a generic pest control product or equivalent . Small pack labels display panel . 8. (1) A person who intends to register a spray adjuvant shal l apply to the Board in Form A4 as set out in the First Sch ed u le . (2) The application under sub-regulation (1) shall b e accompanied by a copy of the summary dossier in Form B 4 as set o u t i n the Fi rst Schedule . 9. (1) A person who intends to register a pest control product for use in paint for in-can and film preservatives shall apply to the Board in Form A5 as set out in the First Schedule. A ppl ication for registration for use in paint for in can and f i l m preservatives. (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in Form B 5 as set o u t i n the F i rst Schedule. 10. (1) A person who intends to register a plant growth regulator and post-harvest product for f lowers and ornamentals sh al l m ak e application to the Board in Form A 6 set out in the First Schedule . (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in Form B 6 set o u t i n the F i rst Schedule. 11. (1) For purposes of regulations 5, 6, 7, 8, 9 and 10 , local efficacy trials shall be conducted following the requirements generating and reporting of pest control products for plants and the national efficacy trial requirements for public health products, respectively . (2) Ef ficacy and other pre-registration trials shall b e co nd u c ted in a recognized institution approved in accordance w ith the techni cal criteria for designating efficacy trial centres as provided for in the First Schedule. A pplication for registration of a plant growth regulator . a n 4 Eff icacy trials. o n (3) For purposes of regulations 5, 6, 7, 8, 9 and 10 (a) local efficacy data shall be generated in accordance w i th t he data extrapolation requirements set out in the First Schedule; (b) residue data for edible crops shall be generated and submitted in accordance with the requirements for the conduct of supervised pesticide residue field trials o n c r o p s as set out in the First Schedule; and (c) residue data for edible crops shall be submitted, or generated for an individual crop or indicator crop in accordance w i th 2230 Kenya Subsidiary Legislation, 2024 (c) submit a copy of a summary dossier— (i) for microbial pest control products, in Form BI as set out in the First Schedule; or (ii) for macrobial pest control products, in Form B2 as set out in the First Schedule. 7. A person who intends to register a generic pest control product equivalent to a registered pest control product shall apply to the Board in Form A3 as set in the First Schedule. 8. (1) A person who intends to register a spray adjuvant shall apply to the Board in Form A4 as set out in the First Schedule. (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in Form B4 as set out in the First Schedule. 9. C()A person who intends to register a pest control product for use in paint for in-can and film preservatives shall apply to the Board in Form AS as set out in the First Schedule. (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in Form B5 as set out in the First Schedule. 10. (1) A person who intends to register a plant growth regulator and post-harvest product for flowers and ornamentals shall make an application to the Board in Form A6 set out in the First Schedule. (2) The application under sub-regulation (1) shall be accompanied by a copy of the summary dossier in Form B6 set out in the First Schedule. 11. (1) For purposes of regulations 5, 6, 7, 8, 9 and 10, local efficacy trials shall be conducted following the requirements on generating and reporting of pest control products for plants and the national efficacy trial requirements for public health products, respectively, ‘ (2) Efficacy and other pre-registration trials shall be conducted in a recognized institution approved in accordance with the technical criteria for designating efficacy trial centres as provided for in the First Schedule. (3) For purposes of regulations 5,6, 7,8, 9 and 10— (a) local efficacy data shall be generated in accordance with the data extrapolation requirements set out in the First Schedule; (b) residue data for edible crops shall be generated and submitted in accordance with the requirements for the conduct of supervised pesticide residue field trials on crops as set out in the First Schedule; and (c) residue data for edible crops shall. be submitted or generated for an individual crop or indicator crop in accordance with Application for registration of a generic pest control product or equivalent. Small pack labels display panel. Application for registration for use in paint for in can and film preservatives. Application for registration of a plant growth regulator. Efficacy trials. 22 3 1Kenya Subsidiary Legislation, 2024 the data extrapolation requirements as set out in the F i r st Sch ed u l e . 12. (1) A person may apply to the Board for determination o f t h e technical equivalence of the active ingredient in the pest control product in Form A3 as set out in the First Schedule. (2) Where the Board determines that the active ingredient o f th e pest control product under sub-regulation (1) is equivalent t o an ac t i v e ingredient of a pest control product registered in ac co r d an ce w i th th ese Regulations, the Board may waive any of the data requirements f o r t h e active ingredient and register the pest control product upon submission of data for the formulated pest control product . 13. (1) The Board shall register a parallel pest control product where the appl icant— (a) submits to the Board an application in Form A7 as set ou t i n the Fi rst Schedule; (b) pays the prescribed fee; (c) provides a letter of access from the registrant; (d) provides a letter of no objection from the local agent; and (e) uses the approved label of the original registered pest control product and only changes the trade name of the product. (2) The Board shall not require a new dossier for the registration of a parallel pest control product. (3) The Board shall register a parallel pest control product if the W ai v er o f data requirements. Registration of a parallel pest control product. ( - : (a) original registered product and the parallel pest c o n tr o l product originate from the same source; and (b) number of the registered parallel pest control product does not exceed fi ve parallel pest control products in respect t o one original pest control product . (4) The Board shall , upon registration of a parallel pest control product, issue the applicant with a Parallel Registration C er t i fi c ate . (5) The registration number of the certifi cate issued u n der su b regulation (4) shall be linked to the original registered pest control product by indicating the original registered product n u m b er o n th e Paral lel Registration Certifi cate. (6) A parallel pest control product registered under t h i s regulation shall be exempt from local effi cacy trials w h er e the i n ten d ed use is identical to that of the original registered pest control product. (7) Where the use of a parallel pest control product i s d i f f er en t from that of the original registered pest control product, effi cacy trials shal l be conducted . (8) A person shall not use the registration requirements o f a paral lel pest control product to' register another pest control product . i £ ; dl Kenya Subsidiary Legislation, 2024 2231 the data extrapolation requirements as set out in the First Schedule. 12. (1) A person may apply to the Board for determination of the technical equivalence of the active ingredient in the pest control product in Form A3 as set out in the First Schedule. (2) Where the Board determines that the active ingredient of the pest control product under sub-regulation (1) is equivalent to an active ingredient of a pest control product registered in accordance with these Regulations, the Board may waive any of the data requirements for the active ingredient and register the pest control product upon submission of data for the formulated pest control product. 13. (1) The Board shall register a parallel pest control product where the applicant— (a) submits to the Board an application in Form A7 as set out in the First Schedule; (b) pays the prescribed fee; (c) provides a letter of access from the registrant; (d) provides a letter of no objection from the local agent; and (e) uses the approved label of the original registered pest control product and only changes the trade name of the product. (2) The Board shall not require a new dossier for the registration of a parallel pest control product. (3) The Board shall register a parallel pest control product if the (a) original registered product and the parallel pest control product originate from the same source; and (b) number of the registered parallel pest control product does not exceed five parallel pest control products in respect to one original pest control product. (4) The Board shall, upon registration of a parallel pest control product, issue the applicant with a Parallel Registration Certificate. (5) The registration number of the certificate issued under sub regulation (4) shall be linked to the original registered pest control product by indicating the original registered product number on the Parallel Registration Certificate. (6) A parallel pest control product registered under this regulation shall be exempt from local efficacy trials where the intended use is identical to that of the original registered pest control product. (7) Where the use of a parallel pest control product is different “ Waiver of data requirements. Registration of a parallel pest control product. 29997 BB from that of the original registered pest control product, efficacy trials ~~ shall be conducted. (8) A person shall not use the registration requirements of a parallel pest control product to tegister another pest control product. Kenya Subsidiary Legislation, 20242 2 32 (9) The use for which an original pest control product i s registered may change without affecting the parallel registration and may transfer access of the original dossier. 14. The Board may extend the use of a registered pest control Experi mental product through a label extension where the applicant shal l subm it — successful two-season efficacy trial data on the respective area of use including crop or pest combination in accordance with the efficacy requirements set out in the First Schedule; (b) residue data based on the Good Agriculture Practice i n t he efficacy trial, if the new use is on edible crops in ac co r d anc e with the residue requirements set out in the First Schedule; (c) a copy of the previously approved label ; (d) a revised commercial label with the proposed new u se s , rates, pre-harvest interval and re-entry interval and th e fi n al commercial version label ; and proposed maximum residue limits and pre- harvest intervals for edible commodities and re-entry interval for greenhouse l abel . (a) (e) u s e . 15 . (1) For purposes of these Regulations, a person not resident Application by in Kenya who intends to register a pest control product under these non-re sidents. Regulations shall appoint a local agent for purposes of registration of the pest control product. (2) A local agent appointed under sub-regulation (1) sh al l — (a) be a permanent resident of Kenya; (b) possess at least an undergraduate degree in chemistry, c r o p protection, toxicology, environmental science or any o th er relevant science; (c) engage a person with technical expertise in pesticide management where the local agent does not have expertise i n pesticide management; (d) facilitate registration, renewal and payment, importation, exportation, and product stewardship; and (e) be the contact person to whom any notice or correspondence relating to the pest control product may be sent. (3) Despite sub-regulation (2)(c), the Board may directly en g ag e with the registrant, manufacturer, exporter or formulator of a pest control product on matters relating to the product. (4) The applicant under this regulation shall deposit w i th t he Board a binding agreement with a clear duration of c o n tr ac t en ter ed into with the agent appointed under sub-regulation ( 1) . (5) The Board may consider the terms of the agreement deposited under sub-regulation (4) and any other relevant do c u m en ts make a determination under these Regulations. t o 2232 Kenya Subsidiary Legislation, 2024 (9) The use for which an original pest control product is registered may change without affecting the parallel registration and may transfer access of the original dossier. 14. The Board may extend the use of a registered pest control product through a label extension where the applicant shall submit — (a) (b) (c) (d) (e) 15. successful two-season efficacy trial data on the respective area of use including crop or pest combination in accordance with the efficacy requirements set out in the First Schedule; residue data based on the Good Agriculture Practice in the efficacy trial, if the new use is on edible crops in accordance with the residue requirements set out in the First Schedule; a copy of the previously approved label; a revised commercial label with the proposed new uses, rates, pre-harvest interval and re-entry interval and the final commercial version label; and proposed maximum residue limits and pre- harvest intervals for edible commodities and re-entry interval for greenhouse use. (1) For purposes of these Regulations, a person not resident in Kenya who intends to register a pest control product under these Regulations shall appoint a local agent for purposes of registration of the pest control product. (2) (a) (b) (c) @ (e) (3) with the t A local agent appointed under sub-regulation (1) shall— be a permanent resident of Kenya; possess at least an undergraduate degree in chemistry, crop protection, toxicology, environmental science or any other relevant science; engage a person with technical expertise in pesticide management where the local agent does not have expertise in pesticide management; facilitate registration, renewal and payment, importation, exportation, and product stewardship; and be the contact person to whom any notice or correspondence relating to the pest control product may be sent. Despite sub-regulation (2)(c), the Board may directly engage registrant, manufacturer, exporter or formulator of a pest control product on matters relating to the product. (4) The applicant under this regulation shall deposit with the Board a binding agreement with a clear duration of contract entered into with the agent appointed under sub-regulation (1). (5) The Board may consider the terms of the agreement deposited under sub-regulation (4) and any other relevant documents to make a determination under these Regulations. Experimental label. Application by non-residents. 2 2 3 3Kenya Subsidiary Legislation, 2024 (6) The applicant under this regulation shall submit to th e B o ar d an appl ication for registration of a local agent in F o r m C l as set o u t i n the F i r st Sc hed u l e . (7) Where there is a change in appointment of the local agent , the applicant shall submit to the Board an application for registration of a change of agent in Form C2 as set out in the First Sc hed u le . (8) Where the registrant or local agent intends to ter m i nate o r replace the agency agreement, either party shall issue a si x m o n th notice to the other party and the Board. (9) A person who fails to comply with the provisions o f th i s regulation commits an offence. 16. A person who intends to change the trade name of a pest control product submitted under regulation 4(2)(e) shal l apply to the B oard in Form C 3 as set out i n the F i rst Schedule 17. (1) A person who intends to introduce a pest control product for efficacy testing and other trials in Kenya shall su b m i t t o t he B o ar d the requisite information including regulatory data and c o n f i d en t i al b u si ness i n f o r m at i o n . (2) The Board shall evaluate the data provided under sub regulation (1) and if satisfied that the application merits approval , issue a Pest Control Experimental Permit to the applicant. (3) The Pest Control Experimental Permit shall be in F o rm D as set o u t i n th e F i r st Sch ed u le . (4) The Board shall provide the applicant, with information relating to existing designated competent persons in t he f iel d o f t r i a l o r study whom the applicant may work with. (5) When the efficacy trials or other studies have b een completed, the designated competent persons shall submit reports thereon to the B oard . 18. (1) An application for registration of a pest control product under these Regulations shall be accompanied by detailed co n f i den t i al business information as prescribed in Form El as set out in the Fi rst Sc hed u l e . Change of tra de n a m e . T ec hn i cal i nf o rm at io n required . ( C onf ident i al busi ness i nf o rm at io n . (2) The applicant shall ensure that confidential business information is packaged and submitted to the Board i n a seal ed envelope or f ile, separate from any other regulatory data, and clearly m ark ed as “ Conf ident ial B usiness I nf orm at ion” . (3) A local agent submitting the confidential business information to the Board shall sign the confidential d ec l ar at io n set o u t in Form E2 as set out i n the F i rst Schedule at the time of submitting the do ssier . (4) An officer of the Board receiving confidential b u si ness inf orm ation shal l record the conf ident ial busi ness i n f o rm at i o n d ata submitted in Form El as set oiit in the First Schedule. at ] Kenya Subsidiary Legislation, 2024 2233 (6) The applicant under this regulation shall submit to the Board an application for registration of a local agent in Form C1 as set out in the First Schedule. (7) Where there is a change in appointment of the local agent, the applicant shall submit to the Board an application for registration of a change of agent in Form C2 as set out in the First Schedule. (8) Where the registrant or local agent intends to terminate or replace the agency agreement, either party shall issue a six month notice to the other party and the Board. (9) A person who fails to comply with the provisions of this regulation commits an offence. 16. A person who intends to change the trade name of a pest control product submitted under regulation 4(2)(e) shall apply to the Board in Form C3 as set out in the First Schedule 17. (1) A person who intends to introduce a pest control product for efficacy testing and other trials in Kenya shall submit to the Board the requisite information including regulatory data and confidential business information. (2) The Board shall evaluate the data provided under sub regulation (1) and if satisfied that the application merits approval, issue a Pest Control Experimental Permit to the applicant. (3) The Pest Control Experimental Permit shall be in Form D as set out in the First Schedule. (4) The Board shall provide the applicant, with information relating to existing designated competent persons in the field of trial or study whom the applicant may work with. (5) When the efficacy trials or other studies have been completed, the designated competent persons shall submit reports thereon to the Board. 18. (1) An application for registration of a pest control product under these Regulations shall be accompanied by detailed confidential business information as prescribed in Form E1 as set out in the First Schedule. (2) The applicant shall ensure that confidential business information is packaged and submitted to the Board in a sealed envelope or file, separate from any other regulatory data, and clearly marked as “Confidential Business Information”. (3) A local agent submitting the confidential business information to the Board shall sign the confidential declaration set out in Form E2 as set out in the First Schedule at the time of submitting the dossier. (4) An officer of the Board receiving confidential business information shall record the confidential business information data submitted in Form E1 as set out in the First Schedule. Change of trade name. Technical information required. Confidential business information. toby Kenya Subsidiary Legislation, 20242 2 34 (5) The confidential business information data shall n o t b e copied by any person unless authorised by the Board. (6) The Board shall store the confidential business inf orm ation in a secure place and such information may only be accessed by a person authorised by the Board in that regard. (7) An authorisation by the Board to make copies of c o n f i d en t i al business information shal l contain the— (a) name of the recipient of the copy; (b) intended purpose for which the copy is to be used; an d (c) manner in which the copy is to be disposed of after u s e . (8) Save as provided in these Regulations, no person sh al l disclose confidential business information obtained un d er th ese Regulations. (9) A person may be required to reveal confi dential b u si ness information to the Board, judicial hearings or in findings of f act i ssued by the Board, formulas of products, even if confidential, to car ry out other f unctions of the Board. (10) The Board, the applicant and the local agent shall protect confi dential business information obtained under these Regulations and shal l not disclose such information. (11) The requirements for protection of confi dential b u si ness information shall be as set out in Form El of the First Sc hed u l e . (12) A person who discloses confi dential business information contrary to this regulation commits an off ence. 19. (1) An applicant shall, when requested to do so by the Submission of Board, provide— samples. (a) a sample of the pest control product; (b) a sample of the technical grade of the pest control product active ingredient; (c) a sample of the analytical standard of pest control product active ingredient; and (d) any other sample as may be required by the Board. (2) The samples under sub-regulation (1) shall be submitted t o the Board in Form F as set out in the First Schedule. 20. Where the physical properties of a pest control product such that the presence of the pest control product may not be recognized when it is used, and is likely to expose a person or domestic animal to a severe health risk, the pest control product sh al l b e denatured by means of colour, odour or such other means as the B o ar d may approve to provide signal or warning of its presence. 21. An applicant shall pay the prescribed fees for the registration of a pest control product. ar e Denaturation. Fees f or application for registration. 2234 Kenya Subsidiary Legislation, 2024 (5) The confidential business information data shail not be copied by any person unless authorised by the Board. (6) The Board shall store the confidential business information in a secure place and such information may only be accessed by a person authorised by the Board in that regard. (7) An authorisation by the Board to make copies of confidential business information shall contain the — (a) name of the recipient of the copy; (b) intended purpose for which the copy is to be used; and (c) manner in which the copy is to be disposed of after use. (8) Save as provided in these Regulations, no person shall disclose confidential business information obtained under these Regulations. (9) A person may be required to reveal confidential business information to the Board, judicial hearings or in findings of fact issued by the Board, formulas of products, even if confidential, to carry out other functions of the Board. (10) The Board, the applicant and the local agent shall protect confidential business information obtained under these Regulations and shall not disclose such information. (11) The requirements for protection of confidential business information shall be as set out in Form E1 of the First Schedule. (12) A person who discloses confidential business information contrary to this regulation commits an offence. 19. (1) An applicant shall, when requested to do so by the Board, provide— (a) a sample of the pest control product; (b) a sample of the technical grade of the pest control product active ingredient, : (c) a sample of the analytical standard of pest control product active ingredient; and (d) any other sample as may be required by the Board. (2) The samples under sub-regulation (1) shall be submitted to the Board in Form F as set out in the First Schedule. 20. Where the physical properties of a pest control product are such that the presence of the pest control product may not be recognized when it is used, and is likely to expose a person or domestic animal to a severe health risk, the pest control product shall be denatured by means of colour, odour or such other means as the Board may approve to provide signal or warning of its presence. 21. An applicant shall pay the prescribed fees for the registration of a pest control product. Submission of samples. Denaturation. Fees for application for registration. 2 2 35Kenya Subsidiary Legislation, 2024 Rev ocat i on . Sub-Leg.22. The Board may terminate the process of registration of a pest control product at any stage where— (a) new information has become available that indicates t h at th e product is unsafe to human health and environment; o r (b) the use of the active ingredient has been withdrawn f o r u se or banned from use in Kenya or globally. 23. (1) The Board shall , if satisfied with the quality, safety , efficacy and economic value of a pest control product, i ssue notification of approval of registration of the pest control product . (2) Upon receipt of the notice under sub-regulation (1), the applicant shall, within ninety days from the date of receipt of the no t i ce — I ssu an ce of cert i fi c ate o f registration. a (a) submit a sample of the pest control product; (b) submit the final commercial label for the pest co n tr o l product; (c) pay the prescribed registration fee; and (d) fulfil any other condition imposed by the Board. (3) An applicant who fails to meet the timeline set o u t i n sub regulation (2) shall be liable to a penalty as prescribed by the Board. (4) Where the applicant meets the conditions set out i n su b regulation (2), the Board shall register the pest control product and issue a certificate of registration in Form G as set out i n the Fi rst Sc hed u l e . (5) Where the Board is not satisfied with the safety, eff icacy , quality or economic value of the pest control product, the Board may defer the registration of the pest control product and comm unicate the reasons for the deferment to the applicant, in writing. (6) Where the Board is satisfied that the reasons for d ef er m en t of registration under sub-regulation (5) have been addressed by the applicant, the Board shall approve the application and i ssu e a notif ication in writing. (7) A person to whom a certificate of registration h as b een issued shall not transfer the certif icate to any other person without the approval of the Board. (8) The approval of the Board shall be endorsed on t h e Certificate of Registration. . (0.) j -n g n ! s v i i 24. (1) A certificate of registration issued under these Regulations shall, unless suspended or revoked, be valid for a period of five years from the date of issue and may thereafter be renewed for a registration, period not exceeding three years at any one time. (2) An applicant shall pay the prescribed fee for the renew al of a certificate of registration and the application for renew al shal l be accompanied by three copies , of the current label for the pest control product . ' ? ■ Kenya Subsidiary Legislation, 2024 2235 22. The Board may terminate the process of registration of a pest control product at any stage where — (a) new information has become available that indicates that the product is unsafe to human health and environment; or (b) the use of the active ingredient has been withdrawn for use or banned from use in Kenya or globally. 23. (1) The Board shall, if satisfied with the quality, safety, efficacy and economic value of a pest control product, issue a notification of approval of registration of the pest control product. , (2) Upon receipt of the notice under sub-regulation (1), the applicant shall, within ninety days from the date of receipt of the notice— (a) submit a sample of the pest control product, (b) submit the final commercial label for the pest control product; : (c) pay the prescribed registration fee; and (d) fulfil any other condition imposed by the Board. (3) An applicant who fails to meet the timeline set out in sub regulation (2) shall be liable to a penalty as prescribed by the Board. (4) Where the applicant meets the conditions set out in sub regulation (2), the Board shall register the pest control product and. issue a certificate of registration in Form G as set out in the First Schedule. (5) Where the Board is not satisfied with the safety, efficacy, quality or economic value of the pest control product,.the Board may defer the registration of the pest control product and communicate the reasons for the deferment to the applicant, in writing. (6) Where the Board is satisfied that the reasons for deferment of registration under sub-regulation (5) have been addressed by the applicant, the Board shall approve the application and issue a notification in writing. (7) A person to whom a certificate of registration has been issued shall not transfer the certificate to any other person without the approval of the Board. (8) The approval of the Board shall be endorsed on the Certificate of Registration. 24. (1) A certificate of registration issued under these Regulations shall, unless suspended or revoked, be valid for a period of five years from the date of issue and may thereafter be renewed for a period not exceeding three years at any one time. (2) An applicant shall pay the prescribed fee for the renewal of a certificate of registration and the application for renewal shall be accompanied by three copies,of the current label for the pest control product. Revocation. Sub-Leg. Issuance of certificate of registration. + (a) merge avis Duration and renewal of certificate of registration. Kenya Subsidiary Legislation, 20242 2 3 6 (3) A holder of a certificate of registration who does not apply for renewal within three months after expiry of the val idity period of the certificate shall pay a penalty as prescribed under the Regulations m ade under the A ct . (4) A holder of a certificate of registration who does not apply for renewal within six months after expiry of the validity period shall have the pest control product removed from the list of registered products and from the distribution chain. (5) A holder of a certificate of registration issued u nd er th ese Regulations shall give a notice to the Board in writing at least three months before the expiry of the registration, of any intention to keep the product registration in abeyance for a period not exceeding f ive years and the notice shal l — (a) give reasons for temporary withdrawal; and (b) show the record of all quantities of the pest control product stock, manufactured and sold by the holder of certificate of registration in the preceding two years. (6) The Board shall consider the notification under sub regulation (5) and if satisfied with the reasons for temporary withdrawal, the Board shall suspend the registration of the pest control product for a period not exceeding five years. (7) A person whose certificate of registration has expired shal l give a notice to the Board in writing of any intention to reintroduce the product for registration and the notice shall — (a) give reasons for reintroduction; (b) be accompanied by a fee for the renewal of a certificate o f registration which fee shall include the fees payable f o r t h e period that the product was in abeyance had the certificate o f registration been renewed; and (c) be accompanied by three copies of the label that c o n f o r m s with these Regulations. (8) A holder of a certificate of registration who does not apply for renewal within five years in accordance with sub-regulation (2) sh al l — i n (a) have the registration cancelled; (b) submit a fresh application; and (c) supply any further information which may be requested by the Board in writing. 25. (1) The Board may, on payment of the prescribed f ee, register a pest control product for a period of one year where the applicant agrees to produce additional scientific or t ec h n i c al information in relation to the use for which the pest control product is to be so l d . Temporary registration. 2236 Kenya Subsidiary Legislation, 2024 (3) A holder of a certificate of registration who does not apply for renewal within three months after expiry of the validity period of the certificate shall pay a penalty as prescribed under the Regulations made under the Act. (4) A holder of a certificate of registration who does not apply for renewal within six months after expiry of the validity period shall have the pest control product removed from the list of registered products and from the distribution chain. (5) A holder of a certificate of registration issued under these Regulations shall give a notice to the Board in writing at least three months before the expiry of the registration, of any intention to keep the product registration in abeyance for a period not exceeding five years and the notice shall— (a) give reasons for temporary withdrawal; and (b) show the record of all quantities of the pest control product in stock, manufactured and sold by the holder of certificate of registration in the preceding two years. (6) The Board shall consider the notification under sub regulation (5) and if satisfied with the reasons for temporary withdrawal, the Board shall suspend the registration of the pest control product for a period not exceeding five years. (7) A person whose certificate of registration has expired shall give a notice to the Board in writing of any intention to reintroduce the product for registration and the notice shall — (a) give reasons for reintroduction; (b) be accompanied by a fee for the renewal of a certificate of registration which fee shall include the fees payable for the period that the product was in abeyance had the certificate of registration been renewed; and (c) be accompanied by three copies of the label that conforms with these Regulations. (8) A holder of a certificate of registration who does not apply for renewal within five years in accordance with sub-regulation (2) shall — (a) have the registration cancelled; (b) submit a fresh application; and (c) supply any further information which may be requested by the Board in writing. 25. (1) The Board may, on payment of the prescribed fee, register a pest control product for a period of one year where the applicant agrees to produce additional scientific or technical information in relation to the use for which the pest control product is to be sold. Temporary registration. Kenya Subsidiary Legislation, 2024 22 37 (2) The terms and conditions specif ied by the Board u n der su b regulation (1) shall be contained in the temporary c er t i f i c ate o f registration. (3) The temporary registration of the pest control product issued under this regulation may be renewed for a maximum period of two y ear s . 26. ( 1) The Board may register a pest control product f o r managing invasive and exotic pests for a period of one year where there is local ized, conf ined or nationwide invasion, or infection, o r a n emergency situation that can potential ly af fect plants or publ ic health. (2) A person who wishes to apply for an emergency use registration under sub-regulation (1) shal l submit the following d o c u m en ts to th e B o ar d — (a) a duly f i l led appl ication form; (b) proof of payment for the application of emergency u s e appl ication; (c) supporting technical data on pest control product; (d) a pest control product label ; (e) proof of registration of the pest control product i n ano ther country ; and (f) any other additional information that the Board may , in writing, request for . (3) The requirements for emergency registration of pest control products for use in plants or publ ic health shal l be as speci f ied in Form H as set o u t i n th e F i r st Sc hed u l e . (4) A pest control product registered under this regulation sh al l only be sold for emergency control of infestations that are seriously detrimental to public health, animals, crops, agricultural produce or n atu r al resou r ces . (5) The Board may cancel an emergency use registration w h ere the registrant contravenes the registration conditions of the pest control product . Emergency Registration. ; V 27. The Board may , upon payment of the prescribed fee, register a pest control product for export or re-export if the safety data sheet and certif icate of analysis provided by the applicant meets the requirement prescribed by the Board. 2 8 . T he B o ar d sh al l c o n du c t a h azar d and r i sk assessm en t o n a pest control product and where appl icable provide mitigation m e a s u r e s o n th e asso c i ated h az ard o r r i sk . 29. (1) Where a certif icate of registration for a pest c o n tr o l product is issued under these Regulations, the product sh al l b e o b tai ned f rom the declared source at the time of registration. Registrati on of pest control Products f or export and re ex ports. R i sk assessm ent . Sources o f registered pest control products. Kenya Subsidiary Legislation, 2024 2237 (2) The terms and conditions specified by the Board under sub regulation (1) shall be contained in the temporary certificate of registration. (3) The temporary registration of the pest control product issued under this regulation may be renewed for a maximum period of two years. 26. (1) The Board may register a pest control product for managing invasive and exotic pests for a period of one year where there is localized, confined or nationwide invasion, or infection, or an emergency situation that can potentially affect plants or public health. (2) A person who wishes to apply for an emergency use registration under sub-regulation (1) shall submit the following documents to the Board — ; (a) aduly filled application form; (b) proof of payment for the application of emergency use application; (c) supporting technical data on pest control product; (d) a pest control product label, (e) proof of registration of the pest control product in another country; and 4 (f) any other additional information that the Board may, in writing, request for. (3) The requirements for emergency registration of pest control products for use in plants or public health shall be as specified in Form H as set out in the First Schedule. (4) A pest control product registered under this regulation shall only be sold for emergency control of infestations that are seriously detrimental to public health, animals, crops, agricultural produce or natural resources. (5) The Board may cancel an emergency use registration where the registrant contravenes the registration conditions of the pest control product. 27. The Board may, upon payment of the prescribed fee, register a pest control product for export or re-export if the safety data sheet and certificate of analysis provided by the applicant meets the requirement prescribed by the Board. 28. The Board shall conduct a hazard and risk assessment on a pest control product and where applicable provide mitigation measures on the associated hazard or risk. 29. (1) Where a certificate of registration for a pest control product is issued under these Regulations, the product shall be obtained from the declared source at the time of registration. Emergency Registration. Registration of pest control Products for export and re exports. Risk assessment. Sources of registered pest control products. Kenya Subsidiary Legislation, 20242 2 3 8 (2) An application for change of source or additional so ur ce f o r the product shal l be submitted to the Board in Form I as set o u t i n th e F i r st Sc hed u le . 30. A pest control product shall be exempt from registration under these Regulations if the pest control product i s — (a) for use by a person for research purposes on the approval of the B oard ; Exemption from registration. (b) a classical biological control agent for release by an authorized Government agency; or (c) a type or kind set out in the Second Schedule and m eet s th e condi t ions relevant to that substance as set out in t h e Sec o nd Sc hed u le . 31. The Board may lefuse to register a pest control product Refusal to register pest control product . w here the (a) application for registration or the label for the pest contro l product does not comply with the provisions of the A c t an d these Regulations; (b) information provided to the Board by the applicant i s insufficient to enable the pest control product to be assessed or evaluated ; (c) applicant fails to establish that the pest control product has merit or value for the purpose claimed when the pest co n tro l product is used in accordance with its label directions; o r use of the pest control product would lead to an unacceptable r i sk o r h ar m to — things on or in relation to which the pest control product in intended to be used; or (ii) public health, plants, animals or the environment. (1) The Board may suspend a certif icate of registration issued under these Regulations where— (a) the quality of the product does not meet the specifications declared during the registration process; or (b) the registrant has not renewed the certif icate of registration for the pest product. (2) The suspension of a registration certif icate under sub regulation (1) shall not exceed a period of six months. 33. (1) The Board may revoke a certificate of registration i ssu ed under these Regulations where — (a) the information provided in the application for registration w as f alse; (b) new scientif ic information has become avai lable t o t he B o ard which indicates that pest control product is unsafe o r dangerous to use according to label instructions; (d) (i ) 3 2 . Suspension of cert i f ic ate o f registration. R ev ocat ion o f cer t i fi cate o f registration. 2238 Kenya Subsidiary Legislation, 2024 (2) An application for change of source or additional source for the product shall be submitted to the Board in Form J as set out in the First Schedule. 30. A pest control product shall be exempt from registration under these Regulations if the pest control product is— (a) for use by a person for research purposes on the approval of the Board; : (b) a classical biological control agent for release by an authorized Government agency; or (c) a type or kind set out in the Second Schedule and meets the conditions relevant to that substance as set out in the Second Schedule. 31. The Board may refuse to register a pest control product where the — (a) application for registration or the label for the pest control product does not comply with the provisions of the Act and these Regulations; (b) information provided to the Board by the applicant is insufficient to enable the pest control product to be assessed or evaluated; (c) applicant fails to establish that the pest contro! product has merit or value for the purpose claimed when the pest control product is used in accordance with its label directions; or (d) use of the pest control product would lead to an unacceptable risk or harm to— (i) things on or in relation to which the pest control product in intended to be used; or (ii) public health, plants, animals or the environment. 32. (1) The Board may suspend a certificate of registration issued under these Regulations where— (a) the quality of the product does not meet the specifications declared during the registration process; or (b) the registrant has not renewed the certificate of registration for the pest product. (2) The suspension of a registration certificate under sub regulation (1) shall not exceed a period of six months. 33. (1) The Board may revoke a certificate of registration issued under these Regulations where — (a) the information provided in the application for registration was false; (b) new scientific information has become available to the Board which indicates that pest contro! product is unsafe or dangerous to use according to label instructions; Exemption from registration. Refusal to register pest control product. Suspension of certificate of registration. | . Revocation of certificate of registration. 2 23 9Kenya Subsidiary Legislation, 2024 (c) new information has become available to the Board indicating that the pest control product is sourced f r o m a manufacturer, formulator or any facility other than t h at specified in the application form and dossier for registration for the respective pest control product or sources au th o r i sed by the Board; (d) the principal or registrant withdraws the technical support to the local agent or distributor on the basis of which a pest control product was registered, in writing; or (e) the timeframe of six months under suspension in regulation 32 has lapsed and no corrective action has been undertaken by the principal or registrant. (2) The Board shall revoke the parallel registration of a pest control product when the registrant withdraws the letter o f access . (3) The Board shall cancel the registration of a parallel pest control product where the registrant of an original pest control product requests, in writing, the cancellation the registration of the pest control product . N oti ce to ho lder o f cer t i fi cate o f registration. 34 . W h er e the B o ar d — (a) refuses to register a pest control product; or (b) intends to revoke the certificate of registration, the Board shall issue the applicant or the holder of t he C er t i f i c ate of Registration, as the case may be, with a notice through any recognized means of communication, notifying the applicant o r h o l der of the refusal or revocation and the reasons thereof . 35. An applicant or holder of a Certificate of Registration w h o has received a notice under regulation 34 may, within thirty days from the date of receipt of the notice, appeal to the Cabinet Secretary . 36. The Board shall maintain an up-to-date database o f t he registered pest control products. 37. A holder of a certificate of registration issued u nd er t hese Regulations shall keep a record of all the quantities of the pest control products stored, manufactured or sold by the holder and that record sh al l Appeals. Register of Pest C ontro l Pr od ucts. R ecord s. (a) be maintained for f ive years from the time the rec o r d i s m ade; and (b) be availed to the Board at such times and in much m a n n e r a s the Board may require. 38. A person who contravenes these Regulations commits a n offence and shall be liable upon conviction to the penalties specif ied under section 12A of the A ct . General penalty. R ev oc at i on . Sub . Leg . 39. The Pest Control Products (Registration) Regulations a r e r ev o k ed . Kenya Subsidiary Legislation, 2024 2239 (c) new information has become available to the Board indicating that the pest control product is sourced from a manufacturer, formulator or any facility other than that specified in the application form and dossier for registration for the respective pest control product or sources authorised by the Board; (d) the principal or registrant withdraws the technical support to the local agent or distributor on the basis of which a pest control product was registered, in writing; or (e) the timeframe of six months under suspension in regulation 32 has lapsed and no corrective action has been undertaken by the principal or registrant. (2) The Board shall revoke the parallel registration of a pest control product when the registrant withdraws the letter of access. (3) The Board shall cancel the registration of a parallel pest control product where the registrant of an original pest control product requests, in writing, the cancellation the registration of the pest control product. 34. Where the Board— (a) refuses to register a pest control product; or (b) intends to revoke the certificate of registration, the Board shall issue the applicant or the holder of the Certificate of Registration, as the case may be, with a notice through any recognized means of communication, notifying the applicant or holder of the refusal or revocation and the reasons thereof. 35. An applicant or holder of a Certificate of Registration who has received a notice under regulation 34 may, within thirty days from. the date of receipt of the notice, appeal to the Cabinet Secretary. 36. The Board shall maintain an up-to-date database of the registered pest control products. 37. A holder of a certificate of registration issued under these Regulations shall keep a record of all the quantities of the pest control products stored, manufactured or sold by the holder and that record shall— (a) be maintained for five years from the time the record is made; and (b) be availed to the Board at such times and in much manner as the Board may require. 38. A person who contravenes these Regulations commits an offence and shall be liable upon conviction to the penalties specified under section 12A of the Act. 39. The Pest Control Products (Registration) Regulations are revoked. Notice to holder of certificate of registration. Appeals. Register of Pest Control Products. Records. General penalty. Revocation. Sub. Leg. Kenya Subsidiary Legislation, 20242 24 0 SC H E D U L E S THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 20 24 H R ST SC H E D U L E F O R M S F O R M A I (r 5(l ) T H E PEST CON T ROL PR OD U CT S B O A R D A PPL I CA T I ON FOR T H E REGI ST RA T ION OF CON V EN T I ON A L CH EM I CA L PE ST I C I D E S Data Requirements I n t r o d u c t i o n Data requirements are listed in two parts: Part I for data required on the active ingredient(s); and Part II for data required on the formulated product. If the product contains more than one active ingredient a separate dossier for part I should be submitted for each active ingredient. Part III of the requirements contains the application form for registration of a conventional chemical pesticide. The data requirements below are structured as follows: N u m ber = Data point number. Applicants should follow the numbering in these requirements when constituting their d o ssier . Description of the data or study required The pesticide use patterns for which the data are required ■ A l l : a l l u ses • Food uses: use of the pesticide on human food, or w h en food may be exposed to the pesticide (e.g. crops, stored products, l ivestock) ■ Feed uses: use of the pesticide on animal feed, or w hen feed may be exposed to the pesticide (e.g. grazing land, fodder, feed crops) ■ Outdoor uses: all outdoor uses of the pesticide (e.g. terrestrial f ields, aquatic use (e.g. irrigated rice), forestry , gardens) ■ Indoor uses: all indoor uses of the pesticide (e.g. glasshouse, store) R = always required; CR = conditionally required (conditions are specified in the remarks column) D ata = Use pattern = C o n d i t i o n s = 2240 Kenya Subsidiary Legislation, 2024 SCHEDULES THE PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 2024 FIRST SCHEDULE FORMS FORM Al (r 5(1) THE PEST CONTROL PRODUCTS BOARD APPLICATION FOR THE REGISTRATION OF CONVENTIONAL CHEMICAL PESTICIDES Data Requirements INTRODUCTION Data requirements are listed in two parts: Part I for data required on the active ingredient(s); and Part II for data required on the formulated product. If the product contains more than one active ingredient a separate dossier for part I should be submitted for each active ingredient. Part III of the requirements contains the application form for registration of a conventional chemical pesticide. The data requirements below are structured as follows: Number = Data point number. Applicants should follow the numbering in these requirements when constituting their dossier. Data = Description of the data or study required Use pattern = The pesticide use patterns for which the data are required « All: all uses * Food uses: use of the pesticide on human food, or when food may be exposed to the pesticide (e.g. crops, stored products, livestock) * Feed uses: use of the pesticide on animal feed, or when feed may be exposed to the pesticide (e.g. grazing land, fodder, feed crops) " Outdoor uses: all outdoor uses of the pesticide (e.g. terrestrial fields, aquatic use (e.g. irrigated rice), forestry, gardens) " Indoor uses: all indoor uses of the pesticide (e.g. glasshouse, store) Conditions = R = always required; CR = conditionally required (conditions are specified in the remarks column) Kenya Subsidiary Legislation, 2024 • 2 24 1 Details about the studies to be conducted, conditions u n der which these are required, etc. Endpoint of study = The resulting value(s) or outconi e(s) of a study . These are specif ied when relevant The level of detail of the information or data to be provided is specif ied, when needed: • endpoint = R em ar k s = L ev el o f d etai l = only the endpoint(s) of the study needs to be provided; a summary of the study needs to be provided, describing - as a minimum the ti tle page, signed declaration page, m ater i al s o b serv at io n s an d o u tc o m es o f th e study , the endpoint(s) of the study the full report of the study needs to be provided. In ALL CASES, the source/reference of the data or study should be provided, as well as the method used to generate the data. Internationally accepted testing methods should be used, whenever possible (e.g. OECD , CIPAC, A STM , EC) List of abbreviations A D I ■ su m m ar y = and m ethods, m ain ■ repor t = Acceptable Dai ly Intake active ingredient Acceptable Operator Exposure Level A c u te R ef er ence D o se body weight C hem i c al A b st r ac t s Ser v ice C o n f i d en t i al B u si n ess I n f o r m at i o n Col laborative International Pesticides Analytical Counci l Conditional ly required Half -life (dissipation) Half -life (degradation) Good Agricultural Practice Good L aboratory Practice International Standards Organization International Union of Pure and Appl ied Chemistry Octanol-water partition coeff icient Adsoption coeff icient (organic carbon) Adsoption coeff icient (organic matter) a .i . A O E L A R f D b w C A S C B I C I P A C C R D T 5 0 DegTso G A P G L P I SO l U PA C K„w Koc K o m Kenya Subsidiary Legislation, 2024 *2241 Remarks = Details about the studies to be conducted, conditions under which these are required, etc. Endpoint of study = The resulting value(s) or outcome(s) of a study. These are specified when relevant Level of detail = The level of detail of the information or data to be provided is specified, when needed: * endpoint = summary = report = only the endpoint(s) of the study needs to be provided; a summary of the study needs to be provided, describing — as a minimum — the title page, signed declaration page, materials and methods, main observations and outcomes of the study, the endpoint(s) of the study the full report of the study needs to be provided. In ALL CASES, the source/reference of the data or study should be provided, as well as the method used to generate the data. Internationally accepted testing methods should be used, whenever possible (e.g. OECD, CIPAC, ASTM, EC) List of abbreviations ADI Acceptable Daily Intake ai. active ingredient AOEL Acceptable Operator Exposure Level ARfD Acute Reference Dose bw body weight CAS Chemical Abstracts Service CBI Confidential Business Information CIPAC Collaborative International Pesticides Analytical Council CR Conditionally required DT 55 Half-life (dissipation) DegT 5 Half-life (degradation) GAP Good Agricultural Practice GLP Good Laboratory Practice ISO International Standards Organization IUPAC International Union of Pure and Applied Chemistry Kw Octanol-water partition coefficient K,, Adsoption coefficient (organic carbon) Adsoption coefficient (organic matter) Kenya Subsidiary Legislation, 2024224 2 L D M ed i an l eth al d o se50 L C M edi an lethal concentration M ax i m u m R esi d ue L i m i t N o Observed A dverse Ef f ect L evel N o Observed Ef f ect Concentration P asc al A cid di ssociation constant 50 M R L N O A E L N O E C P a pK, R Required 2242 Kenya Subsidiary Legislation, 2024 LDs Median lethal dose LCs Median lethal concentration MRL Maximum Residue Limit NOAEL No Observed Adverse Effect Level NOEC No Observed Effect Concentration Pa Pascal pK, Acid dissociation constant R Required Kenya Subsidiary Legislation, 2024 2 24 3 D a t a T o B e Pr o v i d ed o n T h e A c t i v e I n g r e d ie n t U se p atter n Endpoint of study Level of d eta i l D a ta R em a r k sC o n d i t i o n s 1 D e s i g n a t io n / I d e n t i t y I . l C o m m o n (ISO) of the active ingredient (a.i .) A l l R According to the I n te rn at io nal Organization for Stand ar d i zat io n (I SO ) com mon n a m e , proposed ISO c o m m o n n a m e n a m e o r 1 .2 Appl icant name an d add r ess A l l R To be provided t heo n application form 1 .3 N am e and ad d ress o f m an u f ac tu r er o f t h e a .i . A l l R 1 .4 N am e and add r ess A l l R o f to l l m anuf acturer qf the a.i . ( i .e . secondary contract manufacturer) (if appl icable) 1 .5 N am e and ad d ress of manufacturing plant(s) of the a.i . A l l R 1 .6 M an u f ac tu rer o r development code o f t he a .i . A l l R 1 .7 M e t h o d s m an u f ac tu r e (synthesis pathway) , including starting m ater ial s, pathways, by products, impurities o f A l l R T o be tr eated as C o n f iden t i a l B u siness I n f o r m at i o n (CB I ) Summary 1 .8 Purity of the active ingredient A l l R M i n i m u m content of pure active ingredient i n t he tec h n i c al m ate r i al u sed f o r production of In g/kg Kenya Subsidiary Legislation, 2024 2243 DATA TO BE PROVIDED ON THE ACTIVE INGREDIENT Data Use Conditions Remarks Endpoint of Level of pattern study detail 1 DESIGNATION / IDENTITY 1.1 |Common name] All R According to the (ISO) of the active International ingredient (a.i.) Organization for Standardization (iSO) common name, or proposed JSO common name 1.2 |Applicant name/ All R |To be provided and address on the {application torm 1.3 )Name and address| All R of manufacturer of the a.i. 1.4 |Name and address} All R of toll manufacturer of the al. (ie. secondary contract manufacturer) (if applicable) 1.5 |Name and address} All R of manufacturing plant(s) of the ai. | 1.6 |Manufacturer or| All R development code of the a.i. 1.7 |Methods of} All R To be treated as Summary manufacture Confidential (synthesis Business pathway), Information including starting (CBI) materials, pathways, by products, impurities 1.8 |Purity of the active} All R Minimum In g/kg ingredient content of pure active ingredient in the technical material used for production of Kenya Subsidiary Legislation, 20242 24 4 U se p atter n Endpoint of study Level of d eta i l D a ta R em a r k sC o n d i t i o n s the pesticide 1 .9 Identity , content, str uc tu r al f o rm u l a i somers, impuri ties, and ad d i t i v es A l l R I f t he ac t i v e ingredient is a m i x tu re o f i somers, the r at i o o f t he c o n te n t i so m er s sho u l d be specif ied M i n i m u m and m ax i m u m content in g/kg of each impurity and add i t i v e In g/kg o f o f T o be treated as CB I ; relevant impurities wil l b en o t co n sid ered as C B I 1 .10 B atc h analysis A l l R A t l east f i v e analytical prof i les of representative batch es f r o m c u r r e n t i nd u str i al sc al e production of t he a .i . need s to be provided. They should i nc l ud e the content (in g/kg) of pure a.i ., impuri ties, add i t i v es an d o ther components, as appropriate. Representative batches shal l , i n principle, be w i th i n the l ast f ive years of m anuf ac tu re . A ll components pr esen t A nalytical prof i les. C o n ten t s i n g/kg Report d ata S i n 2244 Kenya Subsidiary Legislation, 2024 Use . Endpoint of Level of Data pattern Conditions Remarks study detail the pesticide 1.9 Identity, content,} All R if the active In glkg structural formula ingredient is a of isomers, mixture of impurities, and isomers, the additives ratio of the content of isomers should be specified Minimum — and maximum content in g/kg of each impurity and additive To be treated as CBI; relevant impurities will not be considered as CBI 1.10 |Batch analysis} All R |At least five; Analytical {Report data analytical profiles. profiles of . representative Contents m batches from Bik current industrial scale production of the ai. needs to be provided. They should include the content (in g/kg) of pure aii., impurities, additives and other components, as appropriate. Representative batches shall, in principle, be within the last five years of manufacture. All components present in 2 24 5Kenya Subsidiary Legislation, 2024 Level of detai l Endpoint of study U se Remar ksCond itionsD a ta p atter n quantities of 1 g/kg or more sh o u l d analysed and the total of al l components sh ou l d ac c ou n t f or at l east 980 g/kg of the m ater i al analysed. b e T o be treated as C B I According to the I nternati onal U nion of Pure and Appl ied Chemistry (l UPAC) RA l lChemical name (l UPAC) 1 .1 1 RA l l1.12 Chemical group A l l RStructural f ormula1.13 RA l lEmpirical formula1 .14 Name of patent holder ; expiry date of patent RA l l1 .15 P aten t statu s RA l l1.16 M olecular m ass C h em i c al A b st r ac t s Service (CAS) RA l lCA S N umber , CI PA C number 1 .17 an d Coll aborative I n ter n at io n al Pest i c i des A nalytical C o u nc i l (CIPAC) numbers of the a.i ., where they ex i st Ph y sic a l an d Chemic a l Pr o per t ies2 EndpointSol id, l iquid etc.RA l lPhysical state2 .1 EndpointRA l l2 .2 C o l o u r Kenya Subsidiary Legislation, 2024 2245 Data Use pattern Conditions Remarks Endpoint of study Level of detail quantities of 1 g/kg or more should be analysed and the total of all components should account for at least 980 g/kg of the material analysed. To be treated as CBI 1.11 Chemical (IUPAC) name All According to the International Union of Pure and Applied Chemistry (IUPAC) 1.12 Chemical group All 1.13 Structural formula All 1.14 Empirical formula All 1.15 Patent status All A) wm ) A we Name of patent holder; expiry date of patent 1.16 Molecular mass All nw 1.17 CAS Number, CIPAC number All Chemical Abstracts Service and Collaborative International Pesticides Analytical Council (CIPAC) numbers of the a.i., where they exist (CAS) PHYSICAL AND CHEMICAL PROPERTIES 2.1 Physical state All R Solid, liquid etc. Endpoint 2.2 Colour All R Endpoint Kenya Subsidiary Legislation, 20242 24 6 U se p a tter n Endpoint of study Level of d eta i l D a ta Rema r ksCond it ions 2 .3 O d o u r A l l R Endpoint 2 .4 Density A l l R A t 20 ° C Endpoint 2 .5 Vapour pressure A l l R A t 20 or 25 °C . I n Pa Endpoint 2.6 Volatility A l l R I f the a.i . is a solid or liquid, the volatility (Henry ’s law constant) of the puri f ied needs to be determ ined or c al cu l ated . I n P a X X Endpoint 1m o l a . i 2 .7 Solubility in water A l l R At 20 °C, in neu tr al r an ge . If the pKa (acid di ssociation constant) betw een 2 and w a t e r solubility also needs to be determ ined i n the acidic range (pH 4- 5) and in alk al i ne range (pH 9 g/L Endpoint pH I S d 12 , t he 10) . If the solubility in w ater cannot deter m i ned due to instability of the a.i ., this sh ou l d j ustif ied. be be 2 .8 Solubility organic solvents A l l R Prov ide for r el ev an t so l v en t s . Temperature should be specif ied. m g/L Endpoint 2 .9 N -octanol/ w ater partition coef ficient (K„.., or A l l R A t 20 or 25 °C Endpoint 2246 Kenya Subsidiary Legislation, 2024 j { Data Use pattern Conditions Remarks Endpoint of study Level of detail 2.3 Odour All R Endpoint 2.4 Density All At 20 °C Endpoint 2.5 Vapour pressure All At 20 or 25 °C. In Pa Endpoint 2.6 Volatility All R R R If the ai. is a solid or liquid, the - volatility (Henry’s law constant) of the purified a. needs to be determined or calculated. In Pa x m? x mot! Endpoint 2.7 Solubility in water All G in pH At 20 °C, neutral range. If the pK, (acid dissociation constant) is between 2 and 12, water solubility also needs to be determined in the acidic range (pH 4-5) and in the alkaline range (pH 9 10). If the solubility in water cannot be determined due to instability of the a.i., this should be justified. g/L Endpoint 2.8 Solubility organic solvents in All Provide for relevant solvents. Temperature should specified. be g/L Endpoint 29 N-octanol/water partition coefficient (K,, or All. At 20 or 25 °C Endpoint 2 24 7Kenya Subsidiary Legislation, 2024 Level of deta i l Endpoint of study Use Rema r ksCond itionsD a ta p atter n log P„w) EndpointI n ' CA l l R2.10 Boiling point EndpointI n ^CRA l l2.11 M elting point EndpointI n XA l l RDecomposition temperature 2 .12 EndpointA l l R2.13 Stabil ity in water EndpointRA l lStability in organic sol vents used i n f ormulat ion 2 .14 EndpointRA l lThermal stabil ity , identity of b reak d o w n product 2 .15 EndpointRA l l2.16 Flammabil ity EndpointI f the a.i . as m anuf actured has a melting point below 40 RA l l2.17 R ash point ° C EndpointRA l lExplosive properties 2 .18 EndpointRA l lOxidizing properties 2 .19 EndpointU ltrav iolet/v isib le (UVA ÎS), i nf rared (I R) nu c l ear magnetic r e so n a n c e (N M R) m a s s (M S) A l l R2.20 Absorption spectra and spectra EndpointA l l RReactivity towards container materi al 2 .2 1 A n a l y t ic a l M et h o d s3 Summary o r F u l l m eth o d Prov ide methodsRM ethods f or analysis of the active substance as manuf actured A l l3 .1 thef o r determ ination of : pure active substance in the a .i .as (to be determ ine Kenya Subsidiary Legislation, 2024 2247 Use 7 Endpoint of | Level of Data pattern Conditions Remarks study detail log Pow) 2.10 |Boiling point All R In°C Endpoint 2.11 [Melting point All R In °C Endpoint 2.12 |Decomposition All R In°C |Endpoint temperature 2.13 |Stability in water All R Endpoint 2.14 |Stability in organic] All R Endpoint solvents used in formulation 2.15 (Thermal stability,| All R Endpoint , identity . of breakdown product {2.16 [Flammability All R Endpoint .| 2.17 |Flash point All R jIf the ai. as Endpoint manufactured has a melting point’ below 40 °C 2.18 |Explosive All R Endpoint properties 2.19 |Oxidizing All R Endpoint properties 2.20 |Absorption spectra} All R |Ultraviolet/visib Endpoint le (UV/VIS), infrared (IR), |nuclear magnetic resonance (NMR) and mass spectra (MS) 2.21 |Reactivity towards} Ail R Endpoint container material 3 ANALYTICAL METHODS 3.1 |Methods for; All R {Provide methods Summary analysis of the for the or Full active substance as determination method manufactured of: pure active (to b substance in the det - a.i.as : etermine Kenya Subsidiary Legislation, 20242 24 8 U se Endpoint of study Level of deta i l D a ta Cond i tions R ema r k s p atter n m an u f ac tu r ed signif icant and rel ev an t impuri ties and additives (such as stabil isers) in the a.i . as manuf actured . Refer to CI PA C methods, where appl icable d by the n at i o n al authority) 3 .2 A nalytical methods f or the determ inati on of resi dues to enable compliance with M R L s determ ine dislodgeable r esi d ues F o o d R F or al l components of the residue d efi n i t i on u s e s N o n f o o d u s e s C R If dislodgeable residues need to be determ ined (e.g. for ri sk assessm en t o f harvesting) o r t o 3 .3 Description of m eth o d s analysis in the envi ronment of the parent compound and metabol i tes of toxicological , ecotoxicological or en v i r o n m en ta l c o n c e r n A l l C R F or f o r environmental components (soil , water , organisms ...) , relevant , depending on the proposed use pattern of the product a s 4 - T o x i c o l o g y 1 ' ■ 4 .1 Toxicological reference values A l l R Acceptable Dailyi ntake (ADI ) A cute Reference Dose (ARfD) Acceptable Operator Exposure Level (A OEL) Specify source. mg a.i ./kg body weight Summary 2248 Kenya Subsidiary Legislation, 2024 Data nanern Conditions Remarks aioe of “ane of manufactured d by the Lignificant and national relevant authority) impurities and dditives (such S stabilisers) in he ai. as manufactured. Refer to CIPAC methods, where applicable 3.2 |Analytical Food R |For all methods for the] uses components of determination of the residue residues to enable definition compliance with MRLs or to| Non- CR {If dislodgeable determine food residues need to dislodgeable uses be determined residues .\(e.g. for risk assessment of harvesting) 3.3 |Description off All CR |For methods for environmental analysis in the components environment of the (soil, water, parent compound organisms ...), and metabolites of as relevant, toxicological, depending on ecotoxicological or the proposed use environmental pattern of the concern product 4. | . TOXICOLOGY ss Ree ee 4.1 |Toxicological All R cceptable mg ai/kg |Summary reference values DailyIntake body weight (ADD Acute Reference Dose (ARfD) Acceptable Operator Exposure Level (AOEL) Specify source. 2 2 4 9Kenya Subsidiary Legislation, 2024 Level of d eta i l Endpoint of study U se p atter n Remar ksCond i tionsD a ta SummaryLD50 (mg a.i ./kg bw) Not required if test m ateri al i s a gas or a highly volatile l iquid. Study normal ly conducted in rat . RA l l4.2 Acute oral toxicity SummaryLD50 (mg a.i ./kg bw) Not required if test m ater ial i s a gas or a highly volatile l iquid. Not required if the test m ateri al is corrosive to skin or has a pH of < 2 or > 11.5 . Study normally conducted in rat , rabbit or guinea derm al A l l R4 .3 A c u te toxicity p i g SummaryLC50 (mg a.i ./L ) Required if the product consists of , or under condit ions of use w i l l resul t in, a respirable material (e.g. gas, vapour , aer o so l particulate) . Study normally conducted in rat . RA l l4.4 Inhalation toxicity o r Categories for erythema/esch ar f orm ation , o ed em a f orm ation , i nf lam -m at ion , reversibility of sk in lesions SumimaryNot required if test materi al i s a gas or a highly volatile l iquid . Not required if the test mater ial i s corrosive to skin or has a pH of < 2 or > 11.5 . Study normally conducted i n rabbi t ; al ternati vel y . RA l l4 .5 Sk in ir r i tation Kenya Subsidiary Legislation, 2024 2249 Data Use pattern Conditions Endpoint of Remarks study Level of detail 4.2 Acute oral toxicity All R Not required if] LDs. (mg test material is a] a.i/kg bw) gas or a highly volatile liquid. Study normally conducted in rat. Summary 43 toxicity Acute dermal All Not required if} LDs. (mg test material is a] a.i/kg bw) gas or a highly volatile liquid. Not required if the test material is corrosive to skin or has a pH of <2o0r> 1155. Study normally conducted in rat, rabbit or guinea pig Summary 44 Inhalation toxicity All Required if the] LCs. (mg product consists a.i/L) of, or under conditions of use will result in, a respirable material (e.g. gas, vapour, aerosol | or particulate). Study normally conducted in rat. Summary 45 Skin irritation All Not required if| Categories for Summary test material is a|erythema/esch gas or a highly] ar formation, volatile liquid. oedema . .,| formation, Not required if the test material is corrosive ' to skin or has a pH of <2 or> 11.5. Study normally conducted in rabbit; skin lesions alternatively, inflam-mation, reversibility of Kenya Subsidiary Legislation, 20242 2 50 U se p a tter n Endpoint of study Level of deta i l D a ta R em a r ksCondi ti ons stud i es w i t h sk i n di sk s of the rat or h u m an sk i n models can be u sed 4 .6 Eye irri tation A l l R Not required if the test materi al is corrosive to skin or has a pH of < 2 or > 11.5 . Study normally c ond u cted i n rabbi t ; alternatively, c o rn eas f ro m cattle eyes, or chicken eyes can be u sed . Categori es for co r neal opacity , iri tis, conj uctival r ed ness o r o ed em a (chemosis), reversibil ity of eye lesions Summary 4 .7 Sk in sensi t izat ion A l l R Not required if the test m ateri al i s corrosi ve to skin or has a pH of < 2 or > 11.5 . Required i f repeated dermal ex p o su re l ikely to Occur under condi tions o f u se . Conventi onal study normally conducted i n guinea local lymph node assay (LENA ) in mice C onvent ional test : sk i n reaction (e.g. ery thema) L E N A : proli feration Summary o f lymphocytes in the lymph n o des I S p i g ; 4 .8 Sub-chronic oral toxicity (90 day) A l l R Study normally conducted in rat . NOAEE (mg a.i ./kg bw/day) Summary A dd i t io n al studies i n a non rodent species, th ougho r d er m al inhal ati on ex p o sur e , m ay o r 2250 Kenya Subsidiary Legislation, 2024 Data pattern Conditions Remarks ain of anit studies with skin disks of the rat or human skin models can be used 4.6 |Eye irritation All R |Not required if| Categories for Summary the test material corneal is corrosive to opacity, iritis, skin or has a pH} conjuctival of <2or>11.5.| redness or oedema Study normally (chemosis), coneucted m reversibility of oe eye lesions alternatively, corneas from cattle eyes, or chicken eyes can be used. 4.7 |Skin sensitization | All R |Not required if] Conventional Summary ! the test material) test: skin is corrosive to] reaction (e.g. skin or has a pH} erythema) of <2 or> 11.5. LLNA: Required if} proliferation repeated dermal of exposure is} lymphocytes likely to occur| in the lymph under conditions nodes of use. Conventional study normally conducted in guinea pig; local lymph node assay (LLNA) in mice 4.8 |Sub-chronic oral] All R - |Study normally} NOAEL (mg |Summary toxicity (90 day) conducted in rat. a.i/kg Additional bwiday) studies in a non rodent species, or through dermal or inhalation exposure, may 2 2 5 1Kenya Subsidiary Legislation, 2024 Level of deta i l Endpoint of study U se p atter n Remar ksCond itionsD a ta be required by the registration authori ty NOAEL (mg a.i ./kg bw/day) SummaryStudy normally co n d uc ted i n r at . F o o d Ro r alC h r o n i c toxicity 4 .9 u s e s b eM ay combined w i th t h e carcinogenicity study . Required if oral exposure could o c c u r . C RN o n f o od u s e s SummaryNOAEL (mg a.i ./kg bw/day) Study normally conducted in r o den t species, rat and m o u s e . Required if : the use of the pesticide likely to result in significant human exposure o v e r considerabl e portion of the human l ifespan w h i c h signi f icant in term s of ei ther f requency , d u r a t i o n magnitude of exposure; or the use requires m ax i m u m resi due l im i t or an exemption f r o m requirement of a m ax i m u m residue l im i t ; or ac t i v e C RA l lCarcinogenicity4 .10 t w o I S a I S o r a th e th e ingredient, metabol i te. ■ .iT Kenya Subsidiary Legislation, 2024 2251 Use . Endpoint of | Level of Data pattern Conditions Remarks study detail be required by the registration authority 49 |Chronic oral} Food R {Study normally) NOAEL (mg |Summary toxicity uses conducted in rat. ai/kg May be bw/day) combined with the carcinogenicity ’ jstudy. Non- CR {Required if oral food exposure could uses occur. 4.10 |Carcinogenicity All CR |Study normally) NOAEL (mg |Summary conducted in ai/kg two rodent] bw/day) species, rat and mouse. Required if: the use of the pesticide is likely to result in human exposure over a considerable portion of the human lifespan which is exposure, or the use requires a maximum an from exemption the maximum residue limit; or the ingredient, active metabolite, significant significant in terms of either frequency, duration or magnitude of residue limit or requirement of a Kenya Subsidiary Legislation, 20242 2 52 U se p a tter n Endpoint of study Level of d eta i l D a ta Cond it ions R em a r k s degradate, impurity (a) is structural ly related to a recognized carcinogen, or c a u s e s o r (b) mutagenic ef f ec t s demonstrated by i n v it ro or i n vivo testing, or (c) produces a morphologic effect in any o rg an hyperplasia, metaplasia) in sub -c h r o n i c a s (e.g. studies that may l ead t o a neoplastic change. 4 .1 1 A c u te neurotoxicity A l l R Study normally conducted in rat . NOAEL (mg a.i ./kg bw/day) Summary 4 .12 Su b -ch r o n i c neurotoxicity (90 days) A l l R Study normally co nd uc ted i n r at . May be adapted t o b e c o m b i ned w ith the sub chronic oral toxicity study NOAEL (mg a.i ./kg bw/day) Summary 4 .13 Delayed neurotoxicity following acute ex p o su re A l l C R Required if the pesticide is an organophosphor u s su b stan ce o r is structurally rel ated to other substances that m ay cause the delayed neurotoxicity . Study normally conducted in h en . T o x i c r esp o n se , including mortality Summary 2252 Kenya Subsidiary Legislation, 2024 Data Use pattern Conditions Remarks Endpoint of study Level of detail degradate, or impurity (a) is structurally related to a recognized carcinogen, or (b) causes mutagenic effects as demonstrated by in vitro or in vivo testing, or (c) produces a morphologic effect in organ hyperplasia, metaplasia) sub-chronic studies that may lead to a neoplastic change. any (e.g. in 4.11 Acute neurotoxicity All Study normally conducted in rat. NOAEL (mg a.i/kg bw/day) Summary 4.12 Sub-chronic neurotoxicity (90 days) All Study normally conducted in rat. May be adapted to be combined with the sub chronic oral toxicity study NOAEL (mg ai/kg bw/day) Summary 4.13 Delayed neurotoxicity following exposure acute All CR Required if the pesticide is an organophosphor us substance or is structurally related to other substances that may cause the delayed neurotoxicity. Study normally conducted in hen. Toxic response, including mortality Summary 2 25 3Kenya Subsidiary Legislation, 2024 Endpoint of study Level of d eta i l U se p a tter n R em a r k sD a ta Cond it ions SummaryStudy normal ly co nd u cted two species: rat and r ab b i t . NOAEL (mg a.i ./kg bw/day) Teratogenicity F o od u s e s R4 .14 m C R Required if use of the pesticide is likely to resul t in signif icant human exposure over a portion of t h e h u m an l i fespan in terms of f requency , magnitude or d ur at io n o f ex po su r e . N o n f oo d u s e s SummaryStudy normally co nd uc ted i n NOAEL (mg a.i ./kg bw/day) Reproduction toxicity (two generation study) F o o d R4 .15 u s e s r a t s Required if use of the pesticide is l ikely to result in signif icant human exposure over a portion of h u m an l ifespan in terms of f requency , magnitude or d u r at io n ex p o su re . C RN o n f o o d u s e s t he o f SummaryB o th i n v i t r o and i n v i v o cytogent ics stu d ies required. A t a m inimum , initial battery of mutagenicity t e st s possible conf irmatory testing n eed ed . / A l l R4 .16 M utagenicity Genotoxicity a r e a n w i th I S Study normal ly co nd uc ted i n SummaryF o o d u s e s R4 .17 M etab o l i sm A bsorption, distri bution . r a t s Kenya Subsidiary Legislation, 2024 2253 Data Use pattern Conditions Remarks Endpoint of study Level of detail 4.14 Teratogenicity Food uses R Study normally conducted in two species: rat and rabbit. Non food uses ‘CR Required if use of the pesticide is likely to result in significant human exposure over a portion of the human lifespan in terms of frequency, magnitude — or duration of exposure. NOAEL (mg ai/kg » bw/day) 4 Summary 4.15 Reproduction toxicity generation study) (two Food uses Study normally conducted in rats Non food uses CR Required if use of the pesticide is likely to result in significant human exposure over a portion of the human lifespan in terms of frequency, magnitude or duration of exposure. NOAEL (mg a.i/kg bw/day) Summary 4.16 Mutagenicity Genotoxicity / All vitro vivo Both in and = in cytogentics studies are required. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing needed. iS Summary 4.17 Metabolism Absorption, distribution, Food uses Study normally conducted in rats Summary Kenya Subsidiary Legislation, 20242254 Use Endpoint of study Level of d eta i l D a t a R em a r k sCond iti ons p a tter n excretion and m etab o l i sm mamm al s, w i th special reference to di f ferences between laboratory ani mal s humans, kinetics, acc u m u l at i o n an d hal f - l ives N o n f o od C R Required when c hr o n i c carcinogenicity stu d ies reco m m end ed . M ay r eco m m en ded i f signif icant ad v er se ef f ec ts ar e seen i n av ai l ab le toxicology stud ies an d these ef f ec ts c an b e f u r ther elucidated by m etab o l i sm stu d i es . o r u s e s a r e an d b e 4 .18 Other studies A l l C R As required by the registration authori ty Summary 5 E c o t o x i c o l o g y S.l B i rds toxicity oral Outdoor u s e s R Studies should be co n du c ted o n tw o r el ev an t species: passerine species and e i th er w ater f o w l species or one terr est r i al b i r d species. Generally not required for pesticide products in the form of a gas, a highly volatile liquid, a highly reactive sol id , or highly LD50 (mg a.i ./kg bw) NOAEL (mg a.i ./kg bw/day) Summary o n e o n e I a c o r r o s i v e m ater i al . products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material. 2254 Kenya Subsidiary Legislation, 2024 Use 7 Endpoint of | Level of . Data pattern Conditions Remarks study detail jexcretion = and metabolism with Non- CR |Required when special reference food chronic or to differences} USeS carcinogenicity between laboratory studies are animals and recommended. humans, kinetics, May d ae jaccumulation and recommended 1 half-lives significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism studies. 4.18 |Other studies All CR |As required by Summary . the registration authority 5 ECOTOXICOLOGY ~ 5.1 |Birds - oraljOutdoor| R [Studies should] LD..(mg [Summary toxicity uses. be conducted on} a.i/kg bw) two relevant Species: one NOAEM- (mg passerine bwid 8 species and w/day) either one ’ waterfowl i species or one terrestrial bird ; species. Generally not required for pesticide Kenya Subsidiary Legislation, 2024 2 2 5 5 Endpoint of study Level of d eta i l U se R em a r k sD a ta Cond iti ons p a tter n I nd o o r u s e s C R Required ex p o su re birds may occur (e.g. open-sided greenhouses) W ater f o w l o r ter restr i al b ir d species preferred. i f o f a r e NOAEL (mg a.i ./kg bw/day) SummaryO u tdo o r u s e s R Stu d i es sh o u l d be co n d u cted o n tw o re l ev an t species: w ater f o w l an d terrestri al bi rd species preferred. General ly not required for pesticide products in the form of a gas, a highly volati le l iquid, a highly reactive sol id , or highly 5 .2 B i r d s reproduction toxicity a r e a c o r r o s i v e m ater i al . Not required for i nd o o r u ses . LCjo (mg a.i ./L ) Summ^Stu d i es sh o u l d b e co n d u cted o n tw o r e lev an t fi sh species. If the pesticide i s t o b e u sed i n coastal areas, d ata o n o n e m ar i ne/estu ar i ne fi sh species should be provided. 5 .3 F i sh toxicity O u td o or u s e s Ra c u t e J Required exposure of w aterw ays m ay (e.g. i fI n d o or C R u s e s o c c u r Kenya Subsidiary Legislation, 2024 2255” Data Use pattern Conditions Remarks Endpoint of study Level of detail Indoor uses CR Required if exposure of birds may occur (e.g. open-sided greenhouses) Waterfowl or terrestrial © bird species are preferred. 5.2 Birds — reproduction toxicity Outdoor uses Studies should be conducted on two relevant species: waterfowl and terrestrial bird species are preferred. Generally not required for pesticide products in the form of a gas, al highly volatile liquid, a highly reactive solid, or a highly corrosive material. Not required for). indoor uses. NOAEL (mg ai/kg bw/day) Summary 5.3 Fish — toxicity acute Outdoor uses Studies should be conducted on two relevant fish species. If the pesticide is to be used in coastal areas, data on one marine/estuarine fish species should be provided. Indoor uses CR Required if exposure of waterways may occur (e.g. LC. (mg ai/L) Summary : Kenya Subsidiary Legislation, 202422 5 6 U se p a tter n Endpoint of study Level of deta i l D a ta R em a r k sCond itions drainage of co n tam i n ated irrigation water f r o m greenhouses) Stu d i es sh o u l d be c o nd uc ted o n one f ish species. 5 .4 Fish - early-life stage O u td o o r u s e s R Stud ies sh o u l d b e co nd u cted o n o n e r el ev an t f i sh species. NOEC (mg a.i ./L ) Summary If the pesticide i s t o b e u sed i n coastal areas, d ata o n o n e add i t i o nal m ar i ne/estu ar i ne speciesf i sh sh o u l d provided. b e Not required for i n do o r u ses . 5 .5 Fish - life-cycle Outdoor u s e s C R Required if the pesticide is to be appl ied to water , an d the r esu l t s of the early-life stag e i nd i c ate that f i sh ar e sen si t i v e to the pesticide. Not required for i nd o o r u ses. NOEC (mg a.i ./L ) Summary t e s t t e st 5 .6 F i sh bioconcentration O u td o or u s e s C R Required if log > 3 and the pesticide stab l e i n w ater (i .e. < 90% loss by hydrolysis in 24 hours) B C F Summary I S 5 .7 Daphnia - acute toxicity O u td o o r u s e s R If the pesticide i s t o b e u sed i n coastal areas, data o n o ne LC50 (mg a.i ./L ) Summary 2256 Kenya Subsidiary Legislation, 2024 Data Use pattern Conditions Remarks Endpoint of study Level of detail drainage of contaminated irrigation water from greenhouses) Studies should be conducted on one fish species. 5.4 Fish —- early-life stage Outdoor uses Studies should be conducted on one relevant fish species. If the pesticide is to be used in coastal areas, data on one additional marine/estuarine fish species should be provided. Not required for indoor uses. NOEC (mg a.i/L) Summary 5.5 Fish — life-cycle test Outdoor uses CR Required if the pesticide is to be applied to water, and the results of the early-life stage test indicate that fish are sensitive to the pesticide. Not required for indoor uses. NOEC (mg a.i/L) Summary 5.6 Fish bioconcentration Outdoor uses CR * [pesticide Required if log K,,, > 3 and the is stable in water (i.e. < 90% loss by hydrolysis in 24 hours) BCF Summary 5.7 Daphnia - acute toxicity — Outdoor uses If the pesticide is to be used in coastal ‘areas, data on one LCs. (mg a.i/L) Summary Kenya Subsidiary Legislation, 2024 2 2 57 U se Endpoint of study Level of d eta i l D a ta R em a r k sC o n d i t i o n s p atter n add i t i o nal m ari n e/estu ari n e i nv ert eb r ate species should be provided. I n do o r u s e s C R Required if exposure of w aterw ays may (e.g. drainage of co n t am i n ated irrigation water f ro m greenhouses) o c c u r l i f e If the pesticide i s to b e u sed i n coastal areas, data o n o ne ad d i t i o n al m ar i n e/est u ar i n e i nv ert eb r ate species should be provided. Not required for i nd o o r u ses . NOEC (mg a.i ./L ) Summary5 .8 Daphnia cycle study O u td o or u s e s R NOEC (mg a.i ./L ) Summary5 .9 A lgae O u tdo or u s e s R Stud ies sho u l d b e c o nd uc ted o n one species of green algae. F o r phytotoxicants (e.g. herbicides), a second algal species, from a d i f f er en t tax o n o m i c group, should be t ested . C R Required exposure of w aterw ays may o c c u r drainage of c o n tam i n ated irrigation water f r o m greenhouses) i fI n d oo r u s e s (e.g. Kenya Subsidiary Legislation, 2024 2257 Data Use pattern Conditions Remarks Endpoint of study Level of detail additional Marine/estuarine invertebrate species should be provided. Indoor uses CR Required if exposure of waterways may occur (e.g. drainage of contaminated irrigation water from greenhouses) 3.8 Daphnia — cycle study life Outdoor uses If the pesticide is to be used in coastal areas, data on one additional marine/estuarine invertebrate species should be provided. Not required for indoor uses. NOEC (mg ai/L) Summary 5.9 Algae Outdoor uses Studies should be conducted on one species of green algae. For phytotoxicants (e.g. herbicides), a second algal species, from a different taxonomic group, should be tested. Indoor uses CR Required if| exposure of waterways may occur (e.g. drainage of contaminated irrigation water from greenhouses) NOEC (mg ai/L) Summary Kenya Subsidiary Legislation, 20242 2 5 8 Endpoint of study Level of d e ta i l U se p atter n D a ta R em a r k sCondi tions 5 .10 Honey bees ac u te o r al an d contact toxicity O u td o o r u s e s R LD50 (|Xg a.i ./bee) Summary I nd o o r u s e s C R Required exposure of bees may occur (e.g. open-sided greenhouses, i nd o o r pol lination by bumblebees) i f 5 .1 1 Honey bee toxicity of residues on fol iage O u td o o r u s e s C R Required if RT25 (hours) a c u t e c o n t a c t LD50 is < 11 pg/bee Summary 5 .12 Bee brood-feeding t e st s O utd o o r u s e s C R Required for pesticides that m ay sub l eth al ef f ec t s on growth or development NOEC (mg a.i ./kg food) Summary h av e 5 .13 Non-target terr estr i al arthropods O u td o or u ses and greenho u s e s D ata o n re l ev an t predators, parasitoids and o ther b enef i c i al s are required if the pesticide is i n tend ed to b e u sed I ntegrated Pest M anagement (I PM ) . C R Depends on Summary t e st m 5 .14 O u tdo or u se s , except aquatic u s e s E ar th w o r m s R Stu d i es o n o ther soil organisms may be required, in particular if the pesticide is i n ten d ed to b e u sed i n sem i ar i d co n d i t io n s NOEC (mg a.i A g soil ) Summary 5 .15. Soi l .. . organisms O u td o or u se s , except aquatic u s e s R NOEC (mg a.i .A g.soil ) Summarym i c r o uses 2258 Kenya Subsidiary Legislation, 2024 Data pattern Conditions Remarks in of ‘evel of .5.10 |Honey bees -|Outdoor|; R LDoo (ug Summary acute oral and] uses a.i/bee) contact toxicity Indoor CR [Required if uses exposure of bees may occur (e.g. open-sided greenhouses, indoor pollination by bumblebees) 5.11 ]/Honey bee -|Outdoor}] CR [Required if|RT,, (hours) |Summary toxicity of residues| uses acute — contact on foliage LD, is < 11 Lg/bee 5.12 |Bee brood-feeding) Outdoor} CR [Required for/NOEC (mg |Summary tests uses pesticides thatla.i/kg food) may have sublethal effects on growth or a development 5.13 |Non-target Outdoor} CR |Data on relevant|Depends on {Summary terrestrial uses and predators, test arthropods greenho parasitoids and uses other beneficials are required if the pesticide is intended to be used in Integrated Pest Management (IPM). 5.14 |Earthworms Outdoor R jStudies on other[NOEC (mg [Summary uses, soil organisms|a.i/kg soil) except may be required, aquatic in particular if uses the pesticide is intended to be used in semi arid conditions 5.15.|Soil.. . micro-| Outdoor| R NOEC (mg = |Summary organisms uses, a.i/kg soil) except aquatic Kenya Subsidiary Legislati on, 2024 2259 U se p a tter n Endpoint of study Level ofD a ta R em a r ksCond itions detai l 5 .16 Terrestri al plants screening data O utd o o r u s e s R Screening data c an b e u sed to sh o w th at t he pesticide does h av e Summaiy n o t her b i c i d al plant growth regulatory activi ty . Screening sho u l d be d o ne o n at l east 6 plant species fr om 6 di f ferent f am i l i es o r 5 .17 Terrestri al plants toxicity tests O utdo o r u s e s C R Toxicity tests on terrestri al plants are required if the pesticide has h er b i c i d al plant growth regulatory activity . Stu d i es vegetative Vigour and seedl ing em er g ence sh ou l d c o nd uc ted ERjo (g a.i yha) Summary o r o n b e 5 .18 O ther stu d i es A l l C R O ther ecotoxicological stu d i es sem i - f i e ld studies, m icro /mesocosms) may be required (e.g., •- ,( i by t he registration authori ty 6 B eh a v i o u r I n E n v i r o n m en t 6 .1 Behaviour , ways of degradation, degradation products in soil : Kenya Subsidiary Legislation, 2024 2259 Data Use pattern Conditions Remarks Endpoint of study Level of detail 5.16 Terrestrial plants — screening data Outdoor uses R Screening data can be used to show that the pesticide does not have herbicidal or plant gtowth regulatory activity. Screening should be done on at least 6 plant species from 6 different families Summary 5.17 Terrestrial plants — toxicity tests Outdoor uses CR Toxicity tests on terrestrial plants are required if the pesticide has herbicidal or plant growth regulatory activity. Studies vegetative vigour seedling emergence should conducted on and bel’ ER,, (g aiJha) Summary 5.18 Other studies All CR Other ecotoxicological studies (e.g., semi-field studies, micro /mesocosms) may be required by the registration authority BEHAVIOUR IN ENVIRONMENT 6.1 Behaviour, ways of degradation, degradation products in soil: Kenya Subsidiary Legislation, 20242 2 6 0 IU se p a tter n Endpoint of study Level of d eta i l D a ta R em a r k sC o n d i t i o n s 6 .1 .1 Behaviour, ways of degradation, degradation products in soi l aer o b i c O u td o o r R Required, unless ex po sur e aero b i c so i l s i s unlikely to occur (e.g. t r e a t m e n t stored products) So i l degradation pathways (schematic), maj or metabol ites, DegTjo (days) Summary and o f greenho u s e u s e s i nd o o r o f 6 .1 .2 Behaviour , ways of degradation, degradation products in soi l an aer ob i c O u td o o r u s e s R Required, unless it is unli kely that pesticide wil l be exposed t o an aer o b ic so i l co nd i t i o n s So i l Summary degradation pathways (schematic), maj or metabol i tes, DegTjo (days) t he 6 .1 .3 M obi l ity adsorption/desorpt i o n stud i es o f th e O u tdo o r R Required, unless exposure of soils is unl ikely to (e.g. i nd o o r t r eatm en t sto red K„c, K „, Summary and greenho u s e u s e sa . i . o c c u r o f products) 6 .1 .4 M obi l ity adsorption/desorpt i o n stud ies o f t he m etabo l i tes O utd o o r R Required m etab o l i tes ac c o u n t m o re th an 5 % o f ac t i v e ingredient in the soil degradation stu d i es i f Koc. K Summaryo m and greenho u s e u s e s f o r t he 6 .2 Behaviour, ways of degradation, degradation products in water : 6 .2 .1 Hydrolysis O u tdo o r R M aj or metabol i tes, DegTjo (days) Summary and greenho u s e u s e s 6 .2 .2 Photolysis O u td o o r u s e s R M aj or metabol ites, DegTso (days) Summary 6 .2 .3 W ater - sed i m en t stud i es O u td o o r u s e s R M aj or metabol i tes, DegTso (days) , DTjo (days) Summary 2260: Kenya Subsidiary Legislation, 2024 Data pattern Conditions Remarks oh of ‘evel of 6.1.1|Behaviour, ways} Outdoor R — /Required, unless/Soil Summary of degradation,| and exposure of|degradation degradation greenho aerobic soils is|pathways products in soil —| use uses unlikely to occur|(schematic), aerobic (e.g. indoor|major treatment of|metabolites, stored products) |DegT 5, (days) 6.1.2|/Behaviour, ways! Outdoor R Required, unless|Soil Summary of degradation,| uses it is unlikely that/degradation degradation the pesticide|pathways products in soil — will be exposed|(schematic), anaerobic to anaerobic soil|major conditions metabolites, DegT sy (days) 6.1.3 Mobility —| Outdoor R Required, unless/K,., K,, Summary adsorption/desorpt | and exposure of soils ion studies of the] greenho is unlikely to ai. use uses occur (e.g. ; indoor treatment of stored products) 6.1.4|Mobility —| Outdoor R Required if]Kocs Kom Summary adsorption/desorpt | and metabolites ion studies of the} greenho account for metabolites use uses more than 5% of the active ingredient in the soil degradation studies 6.2 |Behaviour, ways of degradation, degradation products in water: 6.2.1 |Hydrolysis Outdoor R Major Summary and metabolites, greenho DegT 55 (days) use uses 6.2.2|Photolysis Outdoor R Major Summary uses metabolites, DegTs, (days) 6.2.3; Water-sediment Outdoor R Major Summary studies uses metabolites, DegT so (days), DT (days) 2 2 6 1Kenya Subsidiary Legislation, 2024 Endpoint of study Level of d eta i l U se R em a r k sD a ta Condi t ions p atter n I Required for fumigants and other vol ati le products A l l C R6 .3 Behaviour , ways of degradation, degradation products in air M o d e o f A c t i o n7 EndpointA l l RF u nct i o n herbi cide , insecticide) (e.g.7 .1 SummaryM o d e o f ac t i o n o f ac t i v e A l l R7 .2 th e ingredient 8 R es id u e s SummaryStorage stability of resi du es F o od u s e s R8 .1 M etabo l i sm and beh av i o u r o f r esi d ues 8 .2 Summaryrequired g reen I nc l u d e sch em at i c diagramme of th e m etab o l i c R A l soand F o o d u s e s 8 .2 .1 N atu r e chemical identity o f t h e r esi d ue i n plants, including major metabolites f o r to b acc o . Depending on the level of pathways residues found plants on the green tobacco , ad d i t i o nal d ata (crops, stored products) i n may be required o n c u red o r d r i ed t ob acc o and pyrolysis products. SummaryRequired i f the pesticide use i s directly appl ied t o l i v esto ck . Required pesticide r esid u es present in or on l i v esto ck f eed i tem s intentional ly ad d ed dri nk ing-w ater . I n c l u d e sc hem at i c diagramme of the m etab o l i c pathways in an i m al s and C R8 .2 .2 N atu r e chemical identity o f t he r esid u e i n F o o d u se (animal s) animal products, including maj or m et ab o l i t es i f a r e o r t o Kenya Subsidiary Legislation, 2024 2261 Data attern Conditions Remarks aed of revel of 6.3 |Behaviour, ways} All CR {Required — for of degradation, fumigants and degradation other volatile products in air products 7 MODE OF ACTION 7.1 |Function (e.g.| All R Endpoint herbicide, insecticide) 7.2 |Mode of action of All R Summary the active ingredient 8 RESIDUES 8.1 |Storage stability of} Food R Summary residues uses 8.2 |Metabolism and behaviour of |residues 8.2.1 Nature and) Food R {Also required|Include Summary chemical identity} uses for green|schematic of the residue in tobacco. diagramme of! plants, including (crops, Depending on|the metabolic : P stored . major metabolites the level of|pathways in products) residues found|plants on the green tobacco, additional data may be required on cured or |dried — tobacco and pyrolysis products. 8.2.2 |Nature and|Food use} CR |Required if the|/Include Summary chemical identity} (animals) pesticide use is/schematic of the residue in , directly applied|diagramme of animal products, to livestock. the metabolic includin, major . .-[pathways in metabolites Required if onimmals. pesticide residues are present in or on livestock feed items or intentionally added to drinking-water, Kenya Subsidiary Legislation, 20242 2 6 2 U s e p atter n Endpoint of study Level of d eta i l D a ta R em a r k sCond itions u n l ess l i v esto ck m etab o l i sm stu d i es i n d i c ate negl igible t r an sf er o f t he pesticide r esi d u es o f c o n c e r n t i ssues, m i lk and eggs from animals exposed at t he m ax i m u m expected level . t o 8 .2 .3 N atu r e chemical identity o f th e r esi d u e i n f ish, maj or metabol ites and Aquatic f o o d u se R Required if the pesticide appl ied directly w a t e r i nhabi ted , or to be inhabited, by fi sh that may be caught h ar v ested h u m an consumption. I nc l ud e sch em at i c diagramme of th e m et ab o l i c pathways in an i m al s Summary i s including t o o r f o r 8 .3 R esi du e t r i al s Residue trials in Kenya are required, unless: A Codex M RL has been established, and the proposed GAP of the . pesticide to be registered is similar to the Codex GAP (i .e. ±25% of the reference GAP), and no specifi c dietary concerns exist; o r An MRL has been established by the EU , the USA , Austral ia, New Zealand, Japan, Canada or Brazil , and the proposed GAP of the pesticide to be registered is similar to the reference GA P, and no specifi c dietary concerns exist. o r If residue data extrapolation is possible base on Codex crop grouping. Residue tr i als conducted in other countries may be submitted, i f 2262 Kenya Subsidiary Legislation, 2024 . Data Use e pattern Remarks Conditions Endpoint of Study Level of detail unless livestock metabolism studies indicate negligible transfer of the pesticide residues concern to tissues, milk and eggs from animals exposed at the maximum expected level. of 8.2.3 Nature chemical fish, major metabolites and identity of the residue in including Aquatic food use Required if the pesticide is applied directly to water inhabited, or to be inhabited, by fish that may be caught or harvested for human consumption. Include schematic diagramme of the metabolic pathways in animals Summary 8.3 Residue trials Residue trials in are required, unless: A. Codex MRL has been established, and the proposed GAP of the pesticide to be registered is similar to the Codex GAP (ic. +25% of the reference GAP), and no specific dietary. concerns exist; Kenya or An MRL has been established by the EU, the USA, Australia, New Zealand, Japan, Canada or Brazil, and the proposed GAP of the pesticide to be registered is similar to the reference GAP, and no specific dietary concerns exist. or If residue data extrapolation is possible base on Codex crop grouping. Residue trials conducted in other countries may be submitted, if 2 26 3Kenya Subsidiary Legislation, 2024 Level of deta i l Endpoint of study U se Rema r ksD a ta Cond i ti ons p atter n conducted under comparable agronomic crop/pesticide combinations and following a similar GAP. Such studies should be conducted by GL P cert if ied insti tutions and follow international ly accepted requirements. For f urther detail s on the number and design of residue trials, the applicant should refer to the Requirements for the Conduct of Supervised Residue Field Trials on Crops f o rpractices SummaryAlso required if i n d o o r co u l d r esu l t i n pesticide r esi d ues i n o r o n f ood or f eed . RResidue tr i al s f or crops or plant product used as fo o d o r f eed o n w h i ch proposed or fr om w h i c h fr om soi l can be taken up (crop f ield trials) F o o d u se (crops) 8 .3 .1 u s e F u l l reports f o r t r i a l s co n d u ctedu s e I S r esi d u es SummaryRequired if a pesticide is to be appl ied directly l ivestock , to l i v esto ck premises, to l i v esto ck drink ing-water , or to crops used f o r l i v esto ck f eed . I f the resul ts of the plant m etab o l i sm study show dif fering metabol i tes i n plants and animal s, ad d i t i o n al l i v esto ck m etab o l i sm study involving L ivestock feeding studies on the nature of the r esi d ue l i v esto ck F eed u se C R8 .3 .2 F u l l reports f o r t r i al s c o n du cted t om a n Kenya Subsidiary Legislation, 2024 2263 Use . Endpoint of | Level of Data pattern Conditions Remarks study detail conducted under comparable agronomic practices for crop/pesticide combinations and following a similar GAP. Such studies should be conducted by GLP certified institutions and follow internationally accepted requirements. For further details on the number and design of residue trials, the applicant should refer to the Requirements for the Conduct of Supervised Residue Field Trials on Crops 8.3.1|Residue trials for/Food use| R |Also required if Summary crops or plant} (crops) indoor use Full product used as could result in food or feed on pesticide reports which use ~ is residues in or on for trials proposed or from food or feed. ; conducted which residues from soil can be taken up (crop field trials) 8.3.2\Livestock feeding|Feed use! CR Required if a Summary studies on the pesticide is to Full nature of the be applied residue in directly to nanan livestock livestock; to or trials livestock conducted premises, to , livestock drinking-water, or to crops used for livestock feed. If the results of the plant metabolism study show differing metabolites in plants and animals, an additional . livestock a metabolism study involving Kenya Subsidiary Legislation, 20242 2 64 U se p atter n Endpoint of study Level of d eta i l D a ta R em a r k sCond i t ions dosing with the plant ni etabol ite(s) may also be needed . 8 .3 .3 E f f ec t s i nd u stri al processing and/or ho u seh o l d preparation on the n atu re o f t he residue, d i st ri b u t i o n o f th e residue, resi d u e lev e l s o f F o o d C R Required if residues could potentially c o n c e n t r a t e duri ng processing thus requiri ng the estab l i shm en t o f a separate M RL higher than that o f t he r aw agri cultural commodity . Summary an d f eed F u l l u s e . reports f o r t ri a l s co nd uc ted and 8 .3 .4 R esi d ues succeeding crop (rotational crops) F o o d C R Required if it is reasonably f oreseeable that a f ood or f eed c o u l d Summarym an d f eed F u l l u s e . repor ts f o r t ri al s co n du c ted cro p subsequently be planted on the site of pesticide appl ication aft er h ar v est o r f ai lure of the treated crop. Not required for pesticide uses in permanent food cr op s v ari o u s crops, vines) or semi -permanent cr op s asp ar ag u s , pineapples) or for greenhouse crops if the su b st r ate replaced. (e.g. t r e e (e.g. I S 8 .4 N at i o n al regional residue def ini t ion and F o o d an d f eed R Required if use co u ld r esu l t i n pesticide Summaryo r 2264 Kenya Subsidiary Legislation, 2024 Data Use . pattern Conditions Remarks Endpoint of study Level of detail dosing with the plant metabolite(s) may also be needed. 8.3.3 Effects industrial processing and/or household preparation on the nature of the residue, distribution of the residue, and residue levels of| Food and feed use. CR if could Required residues potentially concentrate during processing thus requiring the establishment of a separate MRL higher than that of the raw agricultural commodity. Summary Full reports for trials conducted 8.3.4 Residues in succeeding crop (rotational crops) Food and feed use. CR Required if it is reasonably foreseeable that a food or feed crop could subsequently be planted on the site of pesticide application after harvest or failure of the treated crop. Not required for pesticide uses in permanent food crops (e.g. various tree crops, vines) or semi-permanent crops (e.g. asparagus, pineapples) or for greenhouse crops if the substrate is replaced. Summary Full reports for trials conducted 8.4 National regional definition or residue and Food and feed Required if use could result in pesticide Summary 2 2 6 5Kenya Subsidiary Legislation, 2024 Level of de ta i l Endpoint of study U se p atter n R em a r ksD a ta Cond iti ons resid ues i n o r o n f o o d o r f eed . (ifM R L established) , or proposed national residue def ini t ion an d M R L . (inch associated GAP) u s e SummaryRequired if use could resul t in pesticide residues in or on f ood or f eed . RResidue def ini t ion and M RL by the C o d ex Alimentarius (if establ ished) and by other relevant authorities (e.g. European Union, US-EPA , countries to w hich treated com modi ties are likely to be exported), (incl . associated GAP) F o o d8 .5 an d f eed u s e SummaryRequired if use could resul t in pesticide residues i n or on f ood or feed . RF o odProposed harvest interval s, withholding periods in case of post-harvest use. 8 .6 p r e and f eed u s e Kenya Subsidiary Legislation, 2024 2265 Use , Endpoint of | Level of Data pattern Conditions Remarks study detail MRL Cif] use residues in or on established), or food or feed. proposed national residue definition and MRL. (incl. associated GAP) 8.5 |Residue definition) Food R {Required if use Summary and MRL by the| and feed’ could result in Codex use pesticide Alimentarius (if residues in or on established) and food or feed. by other relevant authorities (e.g. European Union, US-EPA, countries to which treated commodities are likely to be exported). (incl. associated GAP) 8.6 |Proposed pre-| Food R {Required if use Summary harvest intervals,| and feed could result in withholding use pesticide periods in case of residues in or on post-harvest use. food or feed. Kenya Subsidiary Legislati on, 20242 2 6 6 II . Dat a To Be Pr ov ided On The For mul at ed Pr oduct For terminology and the list of abbreviations, see the Part I - Active Ingredient D a ta U se p atter n C o nd i t i on s R ema r ks Endpoint Level of d eta i l 1 I d en t i t y 1 .1 T r ad e commercial or brand nam e A l l R T rade name of the pesticide product should be unique in Kenya; identical t r ade n am es f o r the d i f ferent products are not al l o w ed . o r 1.2(a) Type and code of fo rmulation A l l R According to the latest Catalogue of pesticide form ulation types international coding system of CropL ife I n ter n at i o n al an d 1.2(b) Type Registration Appl ied for . o f T ic k a s Necessary Full Registration Temporaiy Registration 2266 Kenya Subsidiary Legislation, 2024 II]. DATA TO BE PROVIDED ON THE FORMULATED PRODUCT For terminology and the list of abbreviations, see the Part I — Active Ingredient be unique in Kenya; identical trade names for the different products are not Data Use Conditions Remarks Endpoint | Level of pattern detail 1 IDENTITY 1.1 |Trade or All R Trade name of commercial or the pesticide brand name product should allowed. 1.2(a) |Type and code All R According to the of formulation latest Catalogue of pesticide] . formulation types and international coding system of CropLife International 1.2(b) [Type of Registration Applied for. Tick as Necessary Full Registration ‘Temporary Registration 2 26 7Kenya Subsidiary Legislation, 2024 Complete recipe T o b e t r eated as C o n f i d en t i al B u si ness I n f o rm at i o n (CBI ) A l l R1 .3 D et ai led quantitative and qual itative i n f o r m at i o n o n the composition o f th e f ormul ation , including: c o n ten t o f t ec h n i c al ac t i v e sub stan ce and f o rm u l an t s cer t i f i ed l i m i t s o f eac h compound sal t , ester , an i o n cation present f o r eac h act i v e sub st anc e f o r eac h f orm ulant , or component of f o r m u l an ts : chem i c al n a m e , st r u c t u r e o r str u c tu r al formula, CA S o r C I PA C numbers, trade nam e, specification o r o f formulat ion , f u nc t i o n o f each f o rm u l an t description of f o r m u l at i o n process and d i scu ssi o n o f t he f o rm at i o n of impurities o f toxicological c o n c e r n Kenya Subsidiary Legislation, 2024 2267 1.3 |Detailed All R To be treated as Complete quantitative and Confidential recipe qualitative Business information on Information the composition (CBI) of the formulation, including: —content of technical active substance and formulants —certified limits of each compound —salt, ester, anion or cation present for each active © substance ~for each formulant, or component of formulants: chemical name, structure or structural formula, CAS or CIPAC numbers, trade name, specification of formulation, function of each formulant —description of formulation process and discussion of the formation of impurities of toxicological concem Kenya Subsidiary Legislation, 20242 2 6 8 1 .4 C er t i f i c ate o f analysis A l l R C er t i f i c ate sh o u l d b e f ro m a GLP laboratory C o n tac t d etai l s of the laboratory sho u l d b e provided 2 Ph y sic a l A n d Ch emic a l Pr o per t ies 2 .1 Physical state/ f o r m u l at i o n type A l l R Sol id , liquid etc . Endpoint 2 .2 C o l o u r A l l R Endpoint 2 .3 O do u r A l l R Endpoint 2 .4 Storage stability A l l R I nd i c ate th e stabil ity of the preparation after storing at 54°C for 14 days. Other durations and /o r o ther temperatures (e.g. 8 weeks at 40°C , 18 w eek s at 30°C) i f the preparation is t her m o sen si t i v e . Endpoint( s) 2 .5 Shel f - l i f e A l l R T he she l f - l i f e o f the product at r o o m temperatures (30°C) is given in years if it is m or e th an t w o Endpoint years and in m o n th s i f i t i s l ess th an tw o T hey ear s , appropriate temperature speci f ications must be given. 2 .6 Relative density A l l C R Required for l iquids Endpoint 2 .7 Bulk density A l l C R Required for sol ids, af ter compression Endpoint 2268 Kenya Subsidiary Legislation, 2024 1.4 | Certificate of All R Certificate analysis should be from a GLP laboratory Contact details of the laboratory should be provided 2 PHYSICAL AND CHEMICAL PROPERTIES 2.1 {Physical All R Solid, liquid etc. Endpoint state/formulation type 2.2 |Colour All R Endpoint 2.3 {Odour All 7 Endpoint 2.4 |Storage stability All R Indicate the Endpoint( stability of the s) preparation after storing at 54°C for 14. days. Other durations and/or other temperatures (e.g. 8 weeks at 40°C, 18 weeks at 30°C) if the preparation is thermo sensitive. 2.5 |Shelf-life All R The shelf-life of Endpoint the product at room temperatures (30°C) is given in years if it is more than two years and in months if it is less than two years. The appropriate temperature specifications must be given. 2.6 {Relative density All ~ CR Required for Endpoint liquids 2.7 {Bulk density All CR Required for Endpoint solids, after compression 2 26 9Kenya Subsidiary Legislation, 2024 Endpoint2 .8 Flammabil ity A l l R Endpoint2 .9 Flash point A l l R Indicate types of pesticides that the product is incompatible with. Explain the h az ar d s ad v er se ef f ec t s Summary2 .10 Compatibil ity/in compatibil ity w i th o ther pesticides A l l R o r SummarySt ate th e ef f ec t of pH on stabi l ity and ef f ec t i v eness . 2 .1 1 pH range A l l R Required for products to be d i l u ted i n w ater Endpoint2 .12 pH of 1% aqueous dilution A l l R EndpointI nd i c ate m ater i al s t h at can be damaged by oxidizing properties of the f o r m u l at i o n . 2 .13 Oxidizing properties A l l R Specify ef fect on containers, equipment , skin EndpointC or r o si v eness A l l R2 .14 e t c . t h e EndpointA l l R I nd ic ate m ax i m u m w ater c o n ten t w h en i t h as an i n f l uence on the qual ity of the product 2 .15 W ater co n ten t Required for w a t e r so l u b l e f o r m u l at io n s . EndpointDegree of d i sso l u t i o n and /o r so l u t i o n stabili ty A l l C R2 .16 Required for so l i d f o r m u l at i o n s to be dispersed or d i sso l v ed w a t e r . EndpointWettabil ity A l l C R2 .17 m Kenya Subsidiary Legislation, 2024 2269 2.8 |Flammability All R Endpoint 2.9 |Flash point All R Endpoint 2.10 |Compatibility/in All R Indicate types of Summary compatibility pesticides that with other the product is pesticides incompatible with. Explain the hazards or adverse effects 2.11 |pH range All R State the effect Summary of pH on stability and effectiveness. . 2.12 |pH of 1% All R Required for Endpoint aqueous dilution products to be diluted in water 2.13 |Oxidizing All R Indicate Endpoint properties materials that can be damaged by oxidizing properties of the formulation. 2.14 |Corrosiveness All R Specify effect on Endpoint containers, equipment, skin etc. 2.15 |Water content All R Indicate the Endpoint maximum water content when it has an influence on the quality of the product 2.16 |Degree of All CR Required for Endpoint dissolution water soluble and/or solution formulations. stability os 2.17 |Wettability All CR Required for Endpoint solid formulations ‘to be dispersed 'or dissolved ‘in water. Kenya Subsidiary Legislation, 20242270 2 .18 Per si sten t foaming A l l C R Required for f o r m u l at i o n s i n ten ded f o r d i l u t i o n w i t h w ater b ef o r e u se . Endpoint 2 .19 Particle si ze A l l C R Required for f o r m u l at i o n s containing particles Endpoint 2 .20 N o m i nal si ze r an ge A l l C R Required for granular f o r m u l at i o n s Endpoint 2 .2 1 D u st i n ess A l l C R Required for granular f o r m u l at i o n s Endpoint 2 .22 A ttr i t ion r esi stanc e & tablet integrity A l l C R Required for granular and tab l et f o r m u l at i o n s Endpoint 2 .2 3 Suspensibility A l l C R Required for w et tab le powders (WP) , suspension c o n c e n t r a t e s (SC), f lowable c on cen tr ate f o r seed t r eatm en t (FS) which are di luted f or use , capsule suspensions (CS), dispersible granules (WG) w a t e r Endpoint w a t e r and dispersible tablets (WT) 2 .24 Dispersibility and spontaneity of dispersion A l l C R Required for suspension c o n c e n t r a t e s (SC), aqueous capsule suspensions (CS) and water dispersible granules (WG) Endpoint 2270 Kenya Subsidiary Legislation, 2024 2.18 {Persistent All CR |Required for Endpoint foaming formulations intended for dilution with water before use. 2.19 |Particle size All CR {Required for, Endpoint formulations . containing particles 2.20 {Nominal size All CR Required for Endpoint range granular formulations 2.21 jDustiness All CR {Required for Endpoint granular formulations 2.22 {Attrition All CR |Required for Endpoint ‘resistance & granular and tablet integrity tablet formulations 2.23 {Suspensibility All CR |Required for Endpoint wettable powders (WP), suspension concentrates (SC), flowable concentrate for seed treatment (FS) which are diluted for use, capsule suspensions (CS), water dispersible i granules (WG) and water : dispersible tablets (WT) 2.24 {Dispersibility All CR {Required for Endpoint Jand spontaneity suspension of dispersion concentrates (SC), aqueous capsule suspensions (CS) and water dispersible granules (WG) 2 27 1Kenya Subsidiary Legislation, 2024 Endpoint2 .25 W et siev e test A l l C R Required for w ett ab l e powders (WP); suspension c o n c e n t r a t e s including those seed tr eatm en t and oil -based (SC, FS and OD); water dispersible granules (WG) w a t e r f o r an d dispersible powder for slurry seed treatment (W S) ; aqueous capsule suspensions (CS); dispersible c o n c e n t r a t e s (DC); su sp o emulsions (SE); w ater - so l ub l e and dispersible tablets (ST and W T ) ; em u l si f i ab l e granules and powders (EG and EP) an d Required for powders and granules i n tend ed f o r d i r ec t appl ication and s e e d t r e a t m e n t Endpoint2 .2 6 Dry sieve test A l l C R I Required for em u l si f i ab l e c o n c e n t r a t e s (EC), em ulsions, oi l in water (EW ) Endpoint2 .27 E m u l si o n stabil ity A l l C R an d m i cr o em u l si o n s (M E) Kenya Subsidiary Legislation, 2024 2271 2.25 |Wet sieve test All CR |Required for Endpoint wettable powders (WP); suspension concentrates including those for seed treatment and oil-based (SC, FS and OD); water dispersible granules (WG) and water dispersible powder for slurry seed treatment (WS) ; aqueous capsule suspensions (CS); dispersible concentrates (DC); suspo emulsions (SE); water-soluble and dispersible tablets (ST and WT); and emulsifiable granules and powders (EG and EP) 2.26 |Dry sieve test All CR ~ |Required for Endpoint powders and granules intended for direct ; application and | seed treatment 2.27 |Emulsion All CR Required for Endpoint stability emulsifiable . concentrates (EC), emulsions, oil in water (EW) and microemulsions (ME) Kenya Subsidiary Legislation, 20242 2 72 2 .2 8 Required for water dispersible granules (WG) , w ater so l u b l e granules (SG) , granules (GR) an d em u l si f i ab l e granules (EG) EndpointFlowabi lity A l l C R 2 .29 Pourabi lity Required for suspension c o n c e n t r a t e s (SC, FS and OD) , aqueous capsule EndpointA l l C R su sp en si o n s (CS), su sp o emulsions (SE) o i l - i n - w ater emulsions (EW) and simi larly v i sco u s f orm ulations, but may also be appl ied f o rm u l at i o n s i n solution , such as so l u b l e c o n c e n t r a t e s (SL ) em u l si f i ab l e t o and c o n c e n t r a t e s (EC) Endpoint2 .30 Dispersion stabil ity A l l C R Required f or suspo-emulsions (SE), em u l si f i ab l e granules (EG), em u l si f i ab l e powders (EP), dispersible c o n c e n t r a t e s (DC) and oil b ased suspension c o n c e n t r a t e s (OD) ■' Vi l i 2272 Kenya Subsidiary Legislation, 2024 2.28 Flowability All CR Required for water dispersible granules (WG), water soluble granules (SG), granules (GR) and emulsifiable granules (EG) Endpoint 2.29 Pourability All CR Required for suspension concentrates (SC, FS and OD), aqueous capsule suspensions (CS), suspo emulsions (SE) oil-in-water emulsions (EW) and similarly viscous formulations, but may also be applied to formulations in solution, such as soluble concentrates (SL) and emulsifiable concentrates (EC) Endpoint Dispersion stability All CR Required for suspo-emulsions (SE), emulsifiable granules (EG), emulsifiable powders (EP), dispersible concentrates (DC) and oil based suspension concentrates (OD) Endpoint Kenya Subsidiary Legislation, 2024 2 27 3 2 .3 1 M iscibi lity with hydrocarbon oi l A l l C R Required for any f o r m u l at i o n i n ten ded to b e d i l u ted w i th o i l before use (e.g. OL ) Endpoint 2 .32 Volati l ity A l l C R Required for u l t r a- l o w volume l iquids (UL ) Endpoint 2 .3 3 Viscosity A l l C R Required for f o rm u l at i o n s t o be used at very l o w v o l u m e Endpoint 2 .34 A d h esi o n to seed s A l l Required for seed treatm en t f o rm u l at i o n s C R Endpoint 2 .35 D i sso l u t i o n o f w ater so l u b l e bags A l l C R Required for f o r m u l at i o n s packaged w ater so l u b l e bags Endpoint m 3 M et h o d s o f A n a l y si s 3 .1 M eth o d s o f analysis A l l R A nalytical m eth o d s f o r th e d eterm i n at i o n o f ac t i v e Summary o r F u l l m eth o d the (dependin g on the p r esenc e o f a pesticide analytical laboratory i n t he country ) ingredient, impurities of toxicological c o nc er n and f o rm u l an t s i n th e f o rm u l ated product . R ef er to C I PA C methods, w here appl icable 4 T o x i c o l o g y 4 .1 A cu te o r al toxicity Not required if the product is a gas or a highly volati le liquid. A l l R LDjo (mg a.i ./kg Suiiunary bw) Kenya Subsidiary Legislation, 2024 2273 2.31 |Miscibility with All CR {Required for any Endpoint hydrocarbon oil formulation intended to be diluted with oil before use (e.g. OL) 2.32 {Volatility All CR Required for Endpoint ultra-low volume liquids (UL) 2.33 |Viscosity All CR Required for Endpoint formulations to ‘tbe used at very low volume 2.34 |Adhesion to All CR |Required for Endpoint seeds seed treatment formulations 2.35 |Dissolution of All CR |Required for Endpoint water soluble formulations bags packaged “in water soluble bags 3 METHODS OF ANALYSIS 3.1 |Methods of All R Analytical Summary analysis methods for the or Full determination of method the active : ingredient, (dependin impurities of g on the toxicological Presence concern and ofa . formulants in the pesticide formulated labs iyical aboratory product . in the Refer to CIPAC country) methods, where applicable 4 TOXICOLOGY 4.1 |Acute oral All R Not required ifj/LD.) (mg /Summary toxicity the product is aja.i/kg gas or a highly/bw) volatile liquid. Kenya Subsidiary Legislation, 202422 74 4 .2 A cu te d er m al toxicity A l l R Not required if LD50 (mg the product is a a.i .̂ g gas or a highly bw) volatile liquid. Summary N ot r eco m m end ed i f t he t est m ater i al i s c o r r o si v e to sk in or has a pH o f < 2 or > 1 1 .5 . 4 .3 I nh al at i o n toxicity A l l Required if the product consists of , or under co nd i t i o n s o f u se w i l l resul t in , a respirable material (e.g. g as , v ap ou r , aero so l particulate) . R LC50 (mg a.i ./L ) Summary o r 4 .4 Sk i n i r r i tat i o n A l l R Not required if the product is co rr o si v e to sk i n or has a pH of < 2 o r > 1 1 .5 . Categorie Summary f o rs erythema/ esc h ar f orm ation , o edem a f orm ation , i n f lam mation , r ev er si b i l i ty of skin l esi o n s i : 4 .5 Eye irri tation A l l R Not required if the product is a gas or a highly volatile liquid. Not required if the product is c o r r o si v e to sk i n or has a pH of < 2 o r > 1 1 .5 . Categorie Summary f o rs co r neal opacity , i r i t is, conj uctiva 1 r ed ness o r o ed em a (chemosis ) , r ev er si b i l i ty of eye l esi o n s 2274 Kenya Subsidiary Legislation, 2024 42 Acute dermal toxicity All R Not required if the product is a gas or a highly volatile liquid. Not recommended if the test material is corrosive to skin or has a pH of <2or>11.5. LDso (mg ai/kg bw) Summary 43 Inhalation toxicity All Required if the product consists of, or under conditions of use will result in, a respirable material (e.g. gas, vapour, aerosol or particulate). LCs (mg ai/L) Summary 44 Skin irritation All Not required if the product is corrosive to skin or has a pH of < 2or>1155. Categorie s for erythema/ eschar formation, oedema formation, inflam mation, reversibili ty of skin lesions Summary Eye irritation All Not required if the product is a gas or a highly volatile liquid. Not required if the product is corrosive to skin or has a pH of < 2or> 11.5. Categorie s for corneal opacity, iritis, conjuctiva 1 redness or oedema (chemosis )s reversibili ty of eye lesions Summary Kenya Subsidiary Legislation, 2024 2 27 5 Not required if Conventio the product is nal test: co r r o si v e to sk i n Or has a pH of < 2 o r > 1 1 .5 . Required repeated dermal LLNA : exposure is proliferati l ikely under on of co nd i t i o n s u s e . Summary4 .6 Sk i n sen si t i zat i o n A l l R sk i n r eact io n (e.g. erythema)i f of lymphocy t es i n th e lymph no d es 4 .7 D er m al absorption. A l l C R D er m al absorption data Summary o f th e formulation may be provided w hen der m al exposure is a signifl cant exposure route, and def aul t absorption v al u es r esu l t i n no acceptable r i sk . A d d i t i o nal toxicological stu d i es w i t h t he f o r m u l ated product may be required by the registration authority . Summary4 .8 Other toxicity stud ies A l l C R ! E f f i c a c y5 F u l l5 .1 Eff icacy data, demonstrating eff icacy for the crops/pests for w h i c h registration has been requested A l l R Eff icacy requirements sh o u l d b e u sed repor t a Kenya Subsidiary Legislation, 2024 2275 46 {Skin All R Not required if|Conventio/Summary sensitization the product isjnal test:| — corrosive to skin|skin or has a pH of <jreaction 2or> 115. (e.g. Required if erythema) repeated dermal/LLNA: exposure is|proliferati likely under|on of conditions — of|lymphocy use. tes in the lymph . nodes 4.7 |Dermal All CR {Dermal Summary absorption. absorption data of the formulation may be provided when dermal exposure is a significant exposure route, and default absorption values result in no acceptable risk. 4.8 |Other toxicity All CR Additional Summary studies toxicological studies with the formulated product may be required by the registration authority. EFFICACY 5.1 jEfficacy data, All R Efficacy Full demonstrating requirements report efficacy for the should be used crops/pests for which a registration has been requested Kenya Subsidiary Legislation, 20242 2 76 5 .2 A d v er se ef f ec t s (e.g. phytotoxicity , ef f ec t s succeeding or adj acent crops, development of resistance) A l l O b ser v at i o ns to be i nc lu d ed i n the eff icacy tr ials under 5 .1, w hen ev er possible. Specify any c o n t r ai nd i c at i o n s with respect to follow-up crops, adj acent crops R F u l l report o n e t c 5 .3 G o od Agricul tural Practices (GAP) tab l e f o r al l uses/crops/pests f o r w h i c h a registration has been requested, including: A l l O E C D f o r m at f o r G A P table, or si m i l ar . R U se T ab l e 5 .3 .1 Crop/area of use T he c o m m o n name of the crop o n w h ic h th e product is aimed at sh o u l d b e clearly specif ied. W h en product is not aimed at a crop, i nd i c ate areas of use, e .g . l ivestock , publ ic heal th , h ar v est t h e the post 5 .3 .2 Target organism The target organisms sh o u l d b e identif ied by c o m m o n and sc i en t i f i c n am e . 2276 Kenya Subsidiary Legislation, 2024 5.2 -|Adverse effects All R Observations to Full (e.g. be included in report phytotoxicity, the efficacy effects on trials under 5.1, succeeding or whenever adjacent crops, possible. development of . resistance) Specify any contraindications with respect to follow-up crops, adjacent crops etc 5.3. |Good All R Use OECD Table Agricultural format for GAP Practices (GAP) table, or similar. table for all uses/crops/pests for which a registration has been requested, including: 5.3.1 |Crop/area of use The common name of the crop on which the product is aimed at should be clearly specified. When the product is not aimed at a crop, indicate the areas of use, e.g. livestock, public health, post harvest 5.3.2 |Target organism The target organisms should be identified by common and scientific name. Kenya Subsidiary Legislation, 2024 2 27 7 N atu re o f ef f ec t s of the pesticide sh ou l d specif ied; e.g. contact action , w hether active ingredient i s t r an s- l o c ated i n si d e organism, etc.) 5 .3 .3 N atu r e o f ef f ec t s on the target organisms b e I the th e T he r ate o f appl ication must b e i nd i c ated o n the b asi s area tr eated volume used e.g. 1/ha, g/ha, 1/m̂ 5.3.4 Application rate o r e t c . Specify the m i n i m u m an d m ax i m um n um ber o f t reatments per y ear o r p er growing season Appl ication frequency 5 .3 .5 Specify methods(s) of application of the product that t h e5 .3 .6 M eth od application o f n a r e r eco m m en ded to b e u sed Specify the stage of the crop or target organism w h ic h appl ication must b e m ade o f5 .3 .7 Stage t r e a t m e n t a t M i n im u m t i m e need ed b etw een th e l ast t r eatm en t and harvest , re entry l ivestock , entry of w orkers, etc . 5 .3 .8 P re -h ar v est i n te r v al waiting period o r o f Kenya Subsidiary Legislation, 2024 2277 5.3.3 Nature of effects on the target organisms Nature of effects of the pesticide should be specified; e.g. contact action, whether the active ingredient is trans-located inside the organism, etc.) 5.3.4 Application rate The rate of application must be indicated on the basis area treated or volume used e.g. Wha, g/ha, W/m? etc. 5.3.5 |Application Specify the frequency minimum and maximum number of| treatments per year or per growing season 5.3.6 |Method of Specify the application methods(s) of application of the product that are recommended to be used 5.3.7 |Stage of ' {Specify the stage treatment of the crop or target organism at which application must be made 5.3.8 |Pre-harvest Minimum time interval or waiting period needed between the last treatment and harvest, re entry of livestock, entry of workers, etc. Kenya Subsidiary Legislation, 20242 2 7 8 5 .4 Data on effi cacy , as w el l as o n ef f ec t s b enefi c i al organisms, of the u se o f th e pesticide within I P M / I V M A l l C R Required in case a c l ai m o f compatibi l ity w i th i n I PM / I V M i s m ad e F u l l repor t o n 6 O t h e r In f o r m a t io n 6 .1 M aterial Safety D ata Sheet (M SDS) A l l R 6 .2 H az ar d c l assi fi c at i o n (WHO) A l l R Pr o v i d e the h azar d c l assi f i c at i o n o f th e f o r m u l ated product according to the W H O c l assi f i c at i o n o f pesticides by h az ar d 6 .3 H az ar d c l assi fi c at i o n (GHS) A l l R Pro v i de th e complete hazard c l assi f i c at io n o f t he f o r m u l ated product according to the Global ly H ar m o n i zed System of c l assi f i c at io n and labell ing of c hem i c al s (GH S) . T hi s i nc l u des physical hazards, h eal th h az ar d s ♦ and en v i r o nm ental hazards, as far they product triggers a hazard c l assi fi c at io n 2278 Kenya Subsidiary Legislation, 2024 5.4 |Data on efficacy, All CR Required in case Full as well as on a claim of report effects on compatibility beneficial within IPM/IVM organisms, of the is made use of the pesticide within IPM/IVM 6 OTHER INFORMATION 6.1 |Material Safety All R Data Sheet (MSDS) 6.2 {Hazard All R Provide the classification hazard (WHO) classification of the formulated product according to the WHO classification of pesticides by hazard 6.3 |Hazard All R Provide the classification complete hazard (GHS) classification of the formulated product according to the Globally Harmonized System of classification and labelling of chemicals (GHS). This includes physical hazards, health hazards and environmental hazards, as far they product triggers a hazard classification Kenya Subsidiary Legislation, 2024 2 27 9 A l l I nc l ud e i n f o r m at i o n o n t reatm en t o f poisoning and antidotes (if relevant) 6 .4 Emergency m easur es i n c ase of exposure or poisoning R A l l R I n c l u d e d ec o n tam i n at i o n procedures and neutral izing chemicals (if relevant), and i n f o r m at i o n o f c o m b u st i o n products likely to be generated i n c ase o f f i r e 6 .5 Emergency m easu r es i n c ase of spillage or f ire o f A l l R6 .6 Type packaging, pack size(s) and (in )compatibil ity w i th th e f o r m u l at i o n P ro ced u r es f o r cleaning appl ication equipment A l l R6 .7 R Statem en t o f risks arising f r o m r ec o m m end ed methods, and precautions and handl ing procedures to m i n i m i ze th o se ri sks, including: storage; transport ; protective clothing; procedures to m i n i m i ze generation of w a s t e 6 .8 R i sk statem en ts A l l and theprecautionary st a t e m e n t s I Kenya Subsidiary Legislation, 2024 2279 6.4 |Emergency All R - {Include measures in case information on of exposure or treatment of poisoning poisoning and antidotes (if; relevant) 6.5 |Emergency All R Include measures in case decontamination of spillage or fire procedures and neutralizing chemicals (if| relevant), and information of] combustion products likely to be generated in case of fire 6.6 |Type of All R packaging, pack size(s) and (in )compatibility with the formulation 6.7 |Procedures for All R cleaning application equipment 6.8 |Risk statements All R Statement of] and precautionary statements risks arising from the recommended methods, and precautions and handling — procedures to minimize those risks, including: storage; transport; protective clothing; procedures to minimize generation of waste Kenya Subsidiary Legislation, 20242 2 80 6 .9 Pyrolytic b eh av i o u r A l l R Pyrolytic b eh av i ou r o f t he ac t i v e su b stan ce u nder co n t ro l l ed c o nd i t i o n s at 80 0 “C , and the c o n t e n t polyhalogenated dibenzo-p d i o x i n s i n t he products pyrolysis o f o f 6 .10 Disposal procedures for the pesticide A l l R Pr o v i d e r eal i st i c safe disposal m eth o d o f t he product 6 .1 1 Proposed label A l l R Pr o v i d e r eal i st i c m o ck up of the proposed label , as required by respective m em ber state pesticide laws. a 2280 Kenya Subsidiary Legislation, 2024 6.9 Pyrolytic behaviour All R Pyrolytic behaviour of the active substance under controlled conditions at 800 °C, and the content of| polyhalogenated dibenzo-p dioxins in the products of pyrolysis 6.10 Disposal procedures for the pesticide All Provide realistic safe disposal method of the product 6.11 Proposed label All Provide a realistic mock up of the proposed label, as required by respective member state pesticide laws. 2 2 8 1Kenya Subsidiary Legislation, 2024 P ro v i d e complete list of registrations of th e f o rm u l ated product in other co u n tr i es . Specify w h i c h u ses th e product has been registered, w el l as n at i o n al regional Registration of the product in o th er c o u n t r i es A l l R6 .12 a f o r a s o r registration n u m b er s and expiry dates. I nd ic ate w h eth er the product is registered in the country f o r m u l at i o n an d/ o r manufacture; if the product is registered, indicate why this i s t he c ase . o f n o t Kenya Subsidiary Legislation, 2024 2281 6.12 Registration of the product in other countries All R Provide a complete list of registrations of the formulated product in other countries. Specify for which uses the product has been registered, as well as national or regional registration numbers and expiry dates. Indicate whether the product is registered in the country of formulation and/or manufacture; if the product is not registered, indicate why this is the case. Kenya Subsidiary Legislation, 202422 82 7 D ec l a r a t i o n For and on behal f of I hereby certify that the above mentioned information, as well as the data provided in the technical dossier , in support of this application are true, correct and complete. Name in f ull (pr int) Signature Of f icial title D a te Off icial stamp of applicant!company 8 Fo r o f f ic ia l u se Appl ication No: .. . Reception date: . .. F ees r ecei v ed : Y es N o r l ■ 2282 Kenya Subsidiary Legislation, 2024 7 DECLARATION For and on behalf of ................0000c0008 I hereby certify that the above mentioned information, as well as the data provided in the technical dossier, in| support of this application are true, correct and complete. Name in full (print) Signature CEO e eer meme en rer ener ereenas ees eee are serene see eee eneenes Bee serene renee e ner ennseunanebeserese Official title Date Official stamp of applicant/company 8 FOR OFFICIAL USE Application No: ... Reception date: ... an Fees received: Yes No tel. 2 2 83Kenya Subsidiary Legislation, 2024 SU M M A R Y D O SSI E R (r .5(2)F o r m b PE ST C ON T R OL PR O D U CT S B O A R D P.O. BOX 13794-00800 , NA IROBI , W A IY A K I W A Y T el 020 4446 115 or 020 4450242 Fax 020 4449072 E-MAIL; info@ pcpb .go .ke/md@pcpb .go .ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ Summary of the data submitted to the PCPB f or registration of a Conventional Pest C o n t r o l P r od u c t . P A R T I T r ad e N am e T he N ame and A ddress of F o rm u l ato r Common Name of the active ingredient(s), and concentration Source(s) of a.i .(s) Source(s) of formulation(s) C hem ic al N am e Formulation type Proposed Uses ... Packaging/Containers (Material size Registrant (Name, Address, Status Agents/Distributors in Kenya Premises (L icense No., Date of issue Kenya Subsidiary Legislation, 2024 2283 SUMMARY DOSSIER FORM B (r.5(2) PEST CONTROL PRODUCTS BOARD P.O. BOX 13794-00800, NAIROBI, WAIYAKI WAY Tel 020 4446115 or 020 4450242 Fax 020 4449072 E-MAIL: info@pcpb.go.ke/md@ pcpb.go.ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ Summary of the data submitted to the PCPB for registration of a Conventional Pest Control Product. PARTI The Name and Address of Formulator.. ere re rrr rrr rr rr rr rrr rrr tr trrrrrrrrrritrrrrrrirrrrririr it rrr iririiiiiir ie Source(s) Of .1.(S) ...cccscccscssccsesesscscesnecsecssesecesceessssssescescesseseseeseeesseeeneeseseeteseesseenaesessoneneaseeas Source(s) of formulation(S) ......ccccseesesseesescsesesensssensesteeneeseseeneneensnseasseeesnenssaseseenennenens pees Chemical Name seccsssuesssuccesavecesnesssacessseeees seuensncnccccccccacacasesnseseseseseseneresevaneusucanaegseseseecaseenesesers Formulation type ........eescsssssssssssssssssseesssssenenseecsenesssasscaesenseesessensensnsnssgesesssenssssssneseeney errr rrr rr rrr rr rrr rrrrrrrrrrrrrrrrirrrrrrtrrrrrrrtitrrriririiititiriiiiiriiiiir a) Kenya Subsidiary Legislation, 20242 2 84 PA R T I I C h em i st r y D a t a (a) Physical /Chemical Properties of the a.i (b) Physical/Chemical properties of the technical grade m ater ial (c) Composition of the technical product (purity%, nature and content of impur ties, i somers, by-products) (d) Physical/Chemical Properties of the Formulated Pr o d u c t (e) Composition of the Formulated Product (f) Method of analysis for determination of the a.i . in technical and formulated products P A R T I I I Biol ogical (ef f icacy ) Dat a (a) Summarize the efficacy trial including the testing institution, number of seasons, period of testing (b) Target Pest(s), Diseases(s), Host(s). Complete the eff icacy GA P table below accordance with local efficacy data i n 2284 Kenya Subsidiary Legislation, 2024 (a) (b) (c) (d) (e) (f) PART II CHEMISTRY DATA Physical /Chemical Properties of the 2.1 ...0..cccccecccsccsesesssessseecscsessessteseeerels Composition of the technical product (purity%, nature and content of impur isomers, by-products) PART III BIOLOGICAL(EFFICACY) DATA Summarize the efficacy trial including the testing institution, number of seasons, Period of testing. ........ 0... ccc ce cceceescucecescuscuceeaverececueasaseeseteatenens (b) Target Pest(s), Diseases(s), Host(s). Complete the efficacy GAP table below, in accordance with local efficacy data Kenya Subsidiary Legislation, 2024 2 2 85 GAP Table for Eff icacy I 3 5 6 7 8 10 12 134 I I 14 Use Crop and Fungic ide / H er b ic id e Pests A ppl ication A ppl ication rate P H I R em ar k s :o r Group of pests co nt ro l led /o r (days) N o . / Insect icide si t uat i o n /O t her s (specify) Method T iming M ax . M i n . o f a .i max . rate per hL per appl . L . g/kg product / a.i/haa) W ater (crop (additional ly / K ind / n um ber o f in ter v a l betw een appl icat io L / dest i nat io Growth appl ication stage of s crop & s e a s o n h a H am in/ development al stages of the pest or n a) max . m i n . - m a x purpose of crop) n s a) per use b) max . to ta l r ate r a t e m a x . per pest b) per crop appl . per c ro p o r s e a so n Group, w here o r s e a s o n b) max . to ta l necessary [e.g . larvae adults] ) r a t e per crop/ s e a so n Indicator e.g . I nd ica to r Fungicide pest(s) : Fo l ia r Upon 1 - 2 per 7 days 1.6 kg 1.6 - 60 01 2.0 kg 14 in f estat seaso n 2g 100 0 L dayscro p : sp ray 4.0 kg 3 .2 kg i o n (e.g . e .g . Tomato) Phytophthor ainf estans (late bl ight) 2 T o be F Phytophthor Fol iar ainf estans{ \Q. spray Upon 1 - 2 pel 7 days 2.0 kg 1.6 kg 1.6 60 0 14 extrapolat ed to : i n f estat season 2g 1000 L days 3.2 kg4 .0 kg te blight i o n Po tat o Kenya Subsidiary Legislation, 2024 2285 GAP Table for Efficacy 1 3 4 5 6 7 8 10 1 12 13 14 UselCrop and |Fungicide [Pests or Application Application rate PHI | Remarks: /Herbicide|Group of /or (days) No. /Insecticide |pests situation /Others |controlled —|Method|Timing |Max. Min. L. g/kg g/kg |Water (crop (specify) |(additionally}/ Kind |/ number oflinterval [product ja.i/naa) jof a.iJL/ destinatio Growthlapplication [between [ha max. ratelper hL Hamin/ a A development stage offs lapplicatio per appl. a) max min. --jmax purpose of lal stages off crop & ns a) per use rate |b) max|max. crop) ithe pest of| season per total rate pest b) per crop} appl. |per crop or season Group, or season b) max where total necessary rate fe.g. larvae per ladults]) crop/ season 1 [Indicator |e.g. Indicator [Foliar [Upon |] ~ 2 pen? days |20kg {1.6kg- [16 4600 +14 crop: Fungicide |pest(s): spray |infestat |season 2. 1000 L jdays P gicide |p pray song [2ke g y ion (e.g. e.g. ‘ Tomato) Phytophthor lainfestans (late blight) 2 {To belF Phytophthor |Foliar Upon |i ~ 2. per|7 days 20kg |l.6kg |i6 ~600 -14 lextrapolat lainfestans(lalspray jinfestat|season 2: 1000 L |days p if pry 40kg |3.2kg 8 y led to: te blight ion Potato Kenya Subsidiary Legislation, 20242 2 86 (c) Complete the crop safety GAP table below: Crop safety assessment results 3 6 8 10 11 12 13 141 7 R e m ar k sUse* Rormulatio Crop N o . n deta i l s in d/ o r (a j / L or li tuati on ICg and [crop ror m u l at i o dest i nat i 1 type) OT / Appl ication Cro p re spo n se j u r po se jf crop) Method/ Timing/ Growing Number Interval Product g/kg Kind Growth conditions of of rate/ ha a.i/ha stage of (e.g. applicat applicat arotected ions per ions se a s o n g/kg of Watei a.i . per L/ha i L cr o p mi n . ~ v s . m a x . outdoor) .6 - 2g S00 -1 Represe ntat i v e co m m od Fol iar R oweri ng spr ay 3 7 days 2.0 kg 4.0 kg 1.6 kg 3.2 kg 100 0 L ity : [e.g .To mato) ^ 1 ̂ 2286 Kenya Subsidiary Legislation, 2024 (c) Complete the crop safety GAP table below: Crop safety assessment results 1 3 6 7 8 10 11 12 13 14 Use-iFormulatio(Crop Application Crop Remarks No. fn details and/or response (a.i/Lor fituation g and crop ‘ormulatio Mestinati mtype) pn/ urpose pf crop) Method / Timing/ {Growing Pambey Interval [Product loike lp/kg of [Water] {Kind Growth conditionslof of Irate/ ha a.i/ha jai. per [L/ha Stage of e.g. applicat japplicat IhL crop protected fions perfions min. vs. season butdoor) max i eprese [Foliar [Flowering 3 7 days ROkg 1.6kg |1.6—2g(600 — tative spray 4.0 k: B 2 k; 1000 ommod axe “ne \5 ty: e.g.To ato) Kenya Subsidiary Legislation, 2024 2 2 87 d) Recommendations for use in Kenya e) Recommendations for use by authorized bodies outside Kenya PA R T I V Toxicological data a) Acute Toxicological Data of the active ingredient(s) b) Acute toxicity data of the formulated product:.. c) Short term toxicity studies d) Other toxicological studies; 1) Reproduction studies 2) Teratological studies 3) Neurotoxicity studies 4) M utagenecity studies 5) Long term toxicity/carcinogenicity studies Kenya Subsidiary Legislation, 2024 2287 d) Recommendations for use in Kenya e) Recommendations for use by authorized bodies outside Kenya .............cssccscscsresssseees PART IV Toxicological data a) Acute Toxicological Data of the active ingredient(s) d) Other toxicological studies: 1) Reproduction studies ...........ccccesesseerees pacecanessseneseeseseseeesseceseceuscesnsesnesenseesuecesteneneeesees Pee eee rr eee rere erie eeerer cere rere terre rere re rt errrrererercrrerer terete rrererrrrrrirrrrrrriritrrrrttiriry Kenya Subsidiary Legislation, 20242 2 8 8 6) Accumulation of compound in tissues 7) M etabol ic studies 8) Effects on l ivestock , poultry 9) Toxicity Data on impuri ties 10) Toxicity Data on metabol ites 11) Human toxicology and medical aspects: l )Hazards to humans 2) Symptoms of poisoning * 3) Antidote 4 ) T reatment 5) First A id M easures 6) Safety Precautions/Restrictions 2288 Kenya Subsidiary Legislation, 2024 6) Accumulation of compound in tissues niet esetesescceseneers 11) Human toxicology and medical aspects: 1)Hazards to humans ..............ceseeecceseeeccccueececceeeeseeueusessescecssresesecsubeeesseesses Kenya Subsidiary Legislation, 2024 2 2 89 PA R T V - R E SI D U E D A T A a) Pri ncipal Residues b) Disappearance and fate of residues c) M ethod(s) of analysis (crops, soil , water , feedstuffs etc.) d) Summary of results of supervised residue trials (Complete the GAP table for residues below . Use a dif ferent table for each crop group l isted in the eff icacy GAP table) Kenya Subsidiary Legislation, 2024 2289 PART V —- RESIDUE DATA eee eee ee eee ee ee ee ee eee ee ee ee ines d) Summary of results of supervised residue trials (Complete the GAP table for residues below. Use a different table for each crop group listed in the efficacy GAP table) Kenya Subsidiary Legislation, 20242 2 9 0 G A P tab l e f o r r esi d ues 12 13 143 6 7 8 10 111 2 4 Application R esu l C o dexUse/ Country F o r m u l at i o n d eta i l s (a.i/L or Kg and f o r m u l a t i o n type) Crop an d/ o r si t uat i o n (crop dest i n at i o n / p u rp o se of crop) PH [ /E UN o . t s (days) (mg (days af ter M R L a.i/kg ) lastl appl ic ation) M eth od / K i nd T i m i n N u m ber I n ter v al Pro g/kg g/kg W ater L /h amo f o f d u ct a .i /h o fg / G r o w t applicat ions per s e a s o n applicat i o n s i n /r a t e a . i . h / h a p er m a x hLstage of cr o p m i n . m a x 1.6 60 0 - 14 1000 L days Represe n tat i v e c o m m o dity: (e.g. T o m ato F o l i ar sp r ay F lo w e ring 3 7 days 2 .0 1 .61 kg kg - 2g 4 .0 3 .2 kg kg ) T r i al 1 T r i al 2 « T ri al 3 T ri al 4 2290 Kenya Subsidiary Legislation, 2024 GAP table for residues 1 2 3 4 6 7 8 10 11 | 12 B 14 Use/|Country|Formul |Crop Application PHI ResuljCodex No. ation |and/or { |ts |/BU details |situatio (days)l(mg |MRL (a.i/L or|n (crop (days ai/kg Kg and |destinat after |) formulajion / last tion — [purpose applic type) |of crop). | YPe. P ation) Method |Timin |Number|Interval |Pro |g/kg |g/kg| Water /Kind |g/ — jof of ductla.i/h of |L/ham Growtlapplicat|applicat|rate}a —fa.i. in / h ions perjions /ha per |max stage |season hL of crop min max 1 Represe|Foliar |Flowe|3 Tdays |2.0 {1.6 |1.6 |600- 114 Ntative |spray jring kg |kg |-—2g!1000 Lidays commo 4.0 |3.2 dity: kg |kg (e.g. Tomato ) Trial 1 Trial 2 Trial 3 Trial 4 Kenya Subsidiary Legislation, 2024 22 9 1 PA R T V I Environment and wildlif e hazards a) Degradation and mobi li ty studies (soil ,water , air) b) Toxicity to birds c) Toxicity to f ish d) Toxici ty to honeybees/benef icial insects e) Toxici ty to earthworms, other soi l invertebrates f ) Changes in soi l ecology PA R T V I I Information on Approvals/Registrations in other countries PA R T V I I I D r af t o f l o c al l abe l PA R T I X Brief prepared by: Signature: Off icial stamp D ate PA R T X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration R easo n s: D ate Kenya Subsidiary Legislation, 2024 2291 PART VI Environment and wildlife hazards a) Degradation and mobility studies (soil,water, air) .............ccccecsecstececesceeuseecesees b) Toxicity to Birds 2.0... eee e cee c scence ec ee dee nen eee eesteeeeeaseeseesesesaensensanenssenss C) TOXICity to fish... cece cee ecn eee ee nen eee cee eneeereseeaeneneeeneeseesecesesaeaeseaeees d) Toxicity to honeybees/beneficial insects ............ Lee ceeeeeeeeeeeeeeeessereaeseesseseneesens e) Toxicity to earthworms, other soil invertebrates ...........:.ccccecscesereseeeenenreeeen wane f) Changes in soil ecology........ccccscesecsessessecesseseeecercuevareecesvsavsneseeateass se eeeee PART VII Information on Approvals/Registrations in other COUNTIES ............s:ccceeseeeceesenee sence PART vil Draft of local label PART IX Brief prepared DY?......... ccs ce cee cec ec ec ee eee eee ne nen eu sees eeeeeneneneseseeaeeesiensaessseneseeeaee SUQMACUIC. occ cece cece eee ee eee eee cena ee eea senate ee eeeeneeeaeeeetenseeneeeeeneeeneeeneneneas Official stamp Date... .cc cece cece cece ee nen re eee nee nee e enna Bene HOA EEE O EE EE EE AE AEE EE EEE AG ERED EEE EGER EEE EE SEES PART X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration Reasons: Kenya Subsidiary Legislation, 20242 2 92 I (r 6(l ) (2) i a) REQUIREMENTS FOR THE REGISTRATION OF BIOPESTICIDES A N D B I O C O N T R O L A G E N T S F O R PL A N T PR O T E C T I O N A B B R E V I A T I O N S F ORM A 2 B C F C A S CFU - . C R I SPR D N A B i o C o nc en t r at io n F acto r C h em i c al A b str ac t s Ser v ice Colony Forming Unit Clustered regularly interspaced short palindromic repeats Deoxyribonucleic acid European Commission Food and A griculture Organization of the United Nation Genetical ly modif ied organisms G r anu l o si s v i r u s International Centre of Insect Physiology and Ecology Integrated Pest M anagement I n ter nat io na l P l an t P ro tec t i o n C o n v en t i o n The International Organization for Standardization International Standards for Phytosanitary M easures I nternational U ni t : a standardised measure of dosage f or B t product The International Union of Pure and Appl ied Chemistry ‘No observable effect level ’ in testing toxici ty and o th er u nd esi red ef f ec t s of a pesticide. Nuclear Polyhedrosis V irus Organisation for economic cooperation and development Polyhedral Occlusion Body R i bo n uc l ei c A c i d straight chain lepidopteran pheromones Technical grade active ingredient . Word Health Organization E C F A O G M O s G V I C I P E « I PM I PPC I SO - « I SPM l U l U PA C N O E L N P V O E C D PO B R N A SC L P s T G A I : W H O 2292 Kenya Subsidiary Legislation, 2024 Form A2 (r6(1)(2)(a) REQUIREMENTS FOR THE REGISTRATION OF BIOPESTICIDES AND BCF CAS CFU-. CRISPR DNA EC FAO GMOs GV ICIPE IPM IPPC ISO ISPM IU TUPAC NOEL NPV OECD POB RNA SCLPs TGAI: WHO BIOCONTROL AGENTS FOR PLANT PROTECTION ABBREVIATIONS Bio Concentration Factor Chemical Abstracts Service Colony Forming Unit Clustered regularly interspaced short palindromic repeats Deoxyribonucleic acid , European Commission Food and Agriculture Organization of the United Nation Genetically modified organisms Granulosis virus International Centre of Insect Physiology and Ecology Integrated Pest Management International Plant Protection Convention The International Organization for Standardization International Standards for Phytosanitary Measures International Unit: a standardised measure of doSage for Bt product The International Union of Pure and Applied Chemistry ‘No observable effect level’ in testing toxicity and other undesired effects of a pesticide. . Nuclear Polyhedrosis Virus Organisation for economic cooperation and development Polyhedral Occlusion Body Ribonucleic Acid straight chain lepidopteran pheromones Technical grade active ingredient. Word Health Organization 2 2 9 3Kenya Subsidiary Legislation, 2024 1 . I n t r o d u c t i o n Kenya needs to intensify agricultural production to ensure achievement of food securi ty and increased incomes through trade of agricultural produce that is necessary to support their economies. Currently, plant protection is heavily dependent on the use of conventional pesticides whose excessive use may adversely impact human health and environment. The development and use of alternative plant protection approaches such as Biopesticides is recommended to augment existing Integrated Pest M anagement (IPM ) system. Biopesticides are a potential tool in integrated pest management as they generally pose minimal health or environment risk and can have good compatibility with many benef i cial invertebrates used in IPM . The registration of biopesticides and biocontrol agents should take into account the special biological properties of the natural agents and requires expertise in microbial ecology, bacteriology, virology and protozoology in order to understand the biology of the particular agents and evaluate key issues of safety and environmental impact . 1 .1 . O b j e c t i v e s These requirements aim at providing data requirements, evaluations and decision making with regard to registration of Biopesticides and biocontrol agents in order to provide an acceptable level of protection for human and animal health and the env i ronment . 1.1.1. Ov er a l l O bj ec t iv e Provide farmers with a sustainable access to safer and effective biopesticides and Biocontrol agents for pest control . G e n e r a l Pr o v i s i o n s 1.2.1. PCPB shal l ensure that all new Biopesticides and biocontrol agents or new uses of existing products are subjected to a thorough efficacy evaluation before they are authorized for any use. 1.2.2. All efficacy trials involving Biopesticides and biocontrol agents shall be approved by PCPB . 1.2.3. Applicants intending to register Biopesticides or biocontrol agents shall ensure the protocols are compiled with. 1.2.4. The cost of conducting efficacy trials of biopesticides or biocontrol agents authorized by the regulatory authority will be incurred by the appl icant . 1.2.5. All applicants intending to import/export live organisms into or out of tthe country should seek clearance from the National Plant Protection Organizati on. Sc o pe These Requirements covers: (i) Microorganisms (bacteria, fungi, viruses, protozoa) (ii) Macro-organisms (Predators and Parasitoids, insects and m i tes) (iii) Biochemical pesticides (Botanicals and Semiochemicals). These requirements shall not cover biochemical pesticides and any other products that may pose adverse effects on human, non-target organisms and environment. Therefore, in this case, such products shall not be considered as bio pesticides and shall a 1 .2 . 1 .3 . Kenya Subsidiary Legislation, 2024 2293 1. INTRODUCTION Kenya needs to intensify agricultural production to ensure achievement of food security and increased incomes through trade of agricultural produce that is necessary to support their economies. Currently, plant protection is heavily dependent on the use of conventional pesticides whose excessive use may adversely impact human health and environment. The development and use of alternative plant protection approaches such as Biopesticides is recommended to augment existing Integrated Pest Management (IPM) system. Biopesticides are a potential tool in integrated pest management as they generally pose minimal health or environment risk and can have good compatibility with many beneficial invertebrates used in IPM. The registration of biopesticides and biocontrol agents should take into account the special biological properties of the natural agents and requires expertise in microbial ecology, bacteriology, virology and protozoology in order to understand the biology of the particular agents and evaluate key issues of safety and environmental impact. 1.1. OBJECTIVES These requirements aim at providing data requirements, evaluations and decision making with regard to registration of Biopesticides and biocontrol agents in order to provide an acceptable level of protection for human and animal health and the environment. 1.1.1. OVERALL OBJECTIVE Provide farmers with a sustainable access to safer and effective biopesticides and Biocontrol agents for pest control. 1.2. GENERAL PROVISIONS 1.2.1. PCPB shall ensure that all new Biopesticides and biocontrol agents or new uses of existing products are subjected to a thorough efficacy evaluation before they are authorized for any use. 1.2.2. Allefficacy trials involving Biopesticides and biocontrol agents shall be approved by PCPB. 1.2.3. Applicants intending to register Biopesticides or biocontrol agents shall ensure the protocols are compiled with. 1.2.4. The cost of conducting efficacy trials of biopesticides or biocontrol agents authorized by the regulatory authority will be incurred by the applicant. 1.2.5. All applicants intending to import/export live organisms into or out of tthe country should seek clearance from the National Plant Protection Organization. 1.3. SCOPE These Requirements covers: (i) Microorganisms (bacteria, fungi, viruses, protozoa) (ii) Macro-organisms (Predators and Parasitoids, insects and mites) (iii) Biochemical pesticides (Botanicals and Semiochemicals). These requirements shall not cover biochemical pesticides and any other products that may pose adverse effects on human, non-target organisms and environment. Therefore, in this case, such products shall not be considered as bio pesticides and shall Kenya Subsidiary Legislation, 20242 2 94 be evaluated as conventional pesticides. In some cases, waivers will be granted where there is sufficient evidence that there are no safety c o n c e r n s . Microbial, macrobial , botanical and semiochemical bio pesticides derived from based on genetically modified organisms (GMOs) and pest control agents based “RNA interference” technology or on “clustered regularly interspaced short palindromic repeats (CRISPR)” or other gene editing techniques and microbial agents for control of vertebrate pests e.g rodents are not covered. 2 .0 D ef in i t io n s Active agent: A living component in a bio pesticide to which pest control activity is o r o n at tr i b u ted . Active ingredient: The biologically active part of the bio pesticide such microbials or phytochemicals, extracted with solvent c hem i c al s . Acute dermal LD50: A statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified c o n d i t i o n s . a s Acute inhalation LC50: A statistically derived estimate of the inhaled concentrati on of a substance that would cause 50 percent mortality to the test population under specif ied conditions. Acute oral LD50: A statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified c o n d i t i o n s . Antagonism: refers to the action of any organisms that suppress or interfere the normal igrm th and activity of a plant pathogen, such as the main parts of bacteria or fungi . n - . . - ! Baculoviruses: a member of a family of DNA viruses infecting only invertebrate animals. Somefshave a very specific insect host, and may be used in biological pest co n t ro l . A Bioassay: Procedure or method of testing potency of a substance by its effect l iving cells or tissues. Biocontrol: A pest control strategy that uses living natural enemies, antagonists competitors of the organism;being protected and other self-replicating biotic entities. Biological control agent: A natural enemy, antagonist or competitor , and other sel f ;tepj:iqatjng biotic entity used for pest management. Biopesticide: A generic term generally applied to a substance derived from nature, suchras a microorganism or botanical or semiochemical that may be formulated and applied in a manner similar to a conventional chemical pesticide and that is normally used for short-term pest control . Botanical : Natural (unmodified) plant extracts. Botanical pesticides: Formulations of pesticides that originate from plants phytochemicals and eliciting toxic effects on insects an d m i tes . Colony Forming Unit: An estimate of viable bacterial or fungal cel ls. o n o r a s 2294 Kenya Subsidiary Legislation, 2024 be evaluated as conventional pesticides. In some cases, waivers will be granted where there is sufficient evidence that there are no safety concerns. Microbial, macrobial, botanical and semiochemical bio pesticides derived from or based on genetically modified organisms (GMOs) and pest control agents based on “RNA interference” technology or on “clustered regularly interspaced short palindromic repeats (CRISPR)” or other gene editing techniques and microbial agents for control of vertebrate pests e.g rodents are not covered. 2.0 DEFINITIONS Active agent: A living component in a bio pesticide to which pest control activity is attributed. Active ingredient: The biologically active part of the bio pesticide such as microbials or phytochemicals, extracted with solvent chemicals. Acute dermal LDSO: A statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test population under specified conditions. Acute inhalation LCS0: A statistically derived estimate of the inhaled concentration of a substance that would cause 50 percent mortality to the test population under specified conditions. Acute oral LDS50: A statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test population under specified conditions. Antagonism: refers to the action of any organisms that suppress or interfere the normal jgrowth and activity of.a plant pathogen, such as the main parts. of bacteria or fungi. Me oN Baculoviruses: a member of a family of DNA viruses infecting only invertebrate animals. Somexhave a very specific insect host,.and may be used in biological pest control. - Be Bioassay: Procedure or method of testing potency of a substance by its effect on living cells or tissues. Biocontrol: A pest control strategy that uses living natural enemies, antagonists or competitors of the organism-being protected and other self-replicating biotic entities. Biological control agent: A natural enemy, antagonist or competitor, and other self feplicating biotic entity used for pest management. Biopesticide: A generic term generally applied to a substance derived from nature, such:as a microorganism or botanical or semiochemical that may be formulated and applied in a manner similar to a conventional chemical pesticide and that is normally used for short-term pest control. Botanical: Natural (unmodified) plant extracts. Botanical pesticides: Formulations of pesticides that originate from plants as phytochemicals and eliciting toxic effects on insects and mites. Colony Forming Unit: An estimate of viable bacterial -or fungal cells. 2 2 9 5Kenya Subsidiary Legislation, 2024 Efficacy (of a biological control agent): The ability to cause a statistically significant reduction with regard to the number of pest organisms, direct and indirect crop damage, or yield loss. Endotoxin; a toxin present inside a bacterial cell that is released w hen i t disintegrates. Entomopathogenic: is the ability to act as a parasite of insects and ki l ls or seriously d i sab l es t h em . Entomotoxic: Any substance that is toxic to insects Environmental Fate: The destiny of pesticides after release i nto the env i ronment . Formulated product: The pesticide active ingredient(s) and other components, in the form in which it is packaged and sold. Formulation: means the combination of various ingredients designed to render the product useful and effective for the purpose claimed; the form of the biopesticides ready to use products) as purchased by users. Human health exposure: Degree of likelihood that one or more exposures to a biopesticides may have damaged or will damage the health of the exposed person(s). Immunology assay: biochemical test that measures the presence of concentration or a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes). Inert ingredient: means any substance (or group of structurally similar substances if .ogmn/ Infectivity: The ability of a microorganism to invatle aft d persist in avviable state or to multiply within or on an organism, with or without di sease mani festation . Integrated Pest Management (IPM): The careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep biopesticides and other i nterventions to level s that are economically j ustifi ed and reduce or minimize r i sk s to hum an and anim al heal th and/or the env ironment . M acrobials: A n invertebrate natural enemy used for pest management . designated by Generalist. ■ 3 f Macroorganisms: Are organisms large enough to be seen by the normal unaided human eye. Metabolites: are breakdown products that form when a biopesticide is usbd)in '̂4he environment and mixes with air , water , soil or l iving organisms. f Microbial: relating to or characteristic of a microorganism, especially a bacterium causing disease or fermentation. Microorganism; Living organism (such as a bacteria, fungi , viruses) too small to be seen with naked eye but visible under a microscope. M ode of action: it describes a functional or anatomical change, at the cellular level , resulting from the exposure of a living organism to a su b stan ce . Monophagous: An organism that att acks only one host species and- is species specifi c. Kenya Subsidiary Legislation, 2024 2295 Efficacy (of a biological control agent): The ability to cause a Statistically significant reduction with regard to the number of pest organisms, direct and indirect crop damage, or yield loss. Endotoxin: a toxin present inside a bacterial cell that is released when it disintegrates. Entomopathogenic: is the ability to act as a parasite of insects and kills or seriously disables them. Entomotoxic: Any substance that is toxic to insects Environmental Fate: The destiny of pesticides after release into the environment. Formulated product: The pesticide active ingredient(s) and other components, in the form in which it is packaged and sold. Formulation: means the combination of various ingredients designed to render the product useful and effective for the purpose claimed; the form of the biopesticides ready to use products) as purchased by users. Human health exposure: Degree of likelihood that one or more exposures to a biopesticides may have damaged or will damage the health of the exposed person(s). Immunology assay: biochemical test that measures the presence of concentration or a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes). Inert ingredient: means any substance (or group of structurally similar substances if designated by Generalist. 6F jogetti? Infectivity: The ability of a microorganism to invade arid persist in avviable state or to multiply within or on an organism, with or without disease manifestation. Integrated Pest Management (IPM): The careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep biopesticides and other interventions to levels that are economically justified and reduce or minimize risks to human and animal health and/or the environment. Macrobials: An invertebrate natural enemy used for pest management. Macroorganisms: Are organisms large enough to be seen by the normal unaided human eye. Metabolites: are breakdown products that form when a biopesticide is usedtb itn the environment and mixes with air, water, soil-or living organisms. F i Microbial: relating to or characteristic of a microorganism, especially a bacterium causing disease or fermentation. Microorganism: Living organism (such as a bacteria, fungi, viruses) too small to be seen with naked eye but visible under a microscope. Mode of action: it describes a functional or anatomical change, at the-cellular level, a resulting from the exposure of a living organism to a substance. en Monophagous: An organism that attacks only one host species and/is species specific. Kenya Subsidiary Legislation, 20242 2 9 6 Non-target organism: Living organisms other than the one against which the biopesticide is applied. Oligophagous: An organism that attacks a limited group o f r el ated h o st s . Parasite: An organism which lives on or in a larger organism, feeding upon it. Parasitoid: An insect parasitic only in its immature stages, ki ll ing its host in the process of its development, and free living as an adult. Pathogenicity: The ability of a microorganism to inflict inj ury and damaging the host af ter i nf ect ion . Polyphagous: An organism that attacks a wide range of hosts f rom di f ferent su b f am i l ies . Predator: A natural enemy that preys and feeds on other animal organisms, more than one of which are killed during its lifetime. Regulatory authority: The government agency or agencies responsible for the registration and management of pesticides/biopesticides for manufacturing, distribution, stock and sale in Kenya. Residue: means any specified substances in or on food, agricul tural commodities or animal feed resulting from the use of a pesticide. Semiochemicals: Substances or mixtures of substances emitted by plants, animals, and other organisms that evoke a behavioural or physiological response in other individuals of the same or other species. Shelf life: the length of'l ime in the approved label f or w hich a f ormul ated biopesticide remains stable and f it for use. Technical grade: The technical material used to manufacture the biopesticide product . 3 .0 Ca t eg o r ies OF B io pest ic id es For the purpose of these requirements, biopesticides fall into three categories: i . Microbial pesticides (Babteria, fungi, viruses) ii . Biochemical pesticides (Botanicals and Semiochemicals) iii . Macroorganisms (Predators and Parasitoids) 3.1. Major registration categories of Biopesticides and biocontrol agents In the following sections the data requirements for each category of Biopesticides and biocontrol agents are described. The data requirements will apply equally whether the appl ication is for: 3.1.1. Experimental use permit: means status granted (bearing experimental Permit number) allowing experimental use prior to submitting appl ication for full registration. 3.1.2. Full registration: Granted when all registration requirements have been met and the registration authority has granted approval for Biopesticides and biocontrol agents according to the conditions laid down in the certificate of registration. 2296 Kenya Subsidiary Legislation, 2024 Non-target organism: Living organisms other than the one against which the biopesticide is applied. Oligophagous: An organism that attacks a limited group of related hosts. Parasite: An organism which lives on or in a larger organism, feeding upon it. Parasitoid: An insect parasitic only in its immature stages, killing its host in the process of its development, and free living as an adult. Pathogenicity: The ability of a microorganism to inflict injury and damaging the host after infection. Polyphagous: An organism that attacks a wide range of hosts from different subfamilies. Predator: A natural enemy that preys and feeds on other animal organisms, more than one of which are killed during its lifetime. Regulatory authority: The government agency or agencies responsible for the registration and management of pesticides/biopesticides for manufacturing, distribution, stock and sale in Kenya. Residue: means any specified substances in or on food, agricultural commodities or animal feed resulting from the use of a pesticide. Semiochemicals: Substances or mixtures of substances emitted by plants, animals, and other organisms that evoke a behavioural or physiological response in other individuals of the same or other species. Shelf life: the length of‘time in the approved label for which a formulated biopesticide remains stable and fit for use. Technical grade: The technical material used to manufacture the biopesticide product. 3.0 CATEGORIES OF BIOPESTICIDES For the purpose of these requirements, biopesticides fall into three categories: i. Microbial pesticides (Bacteria, fungi, viruses) ii. Biochemical pesticides (Botanicals and Semiochemicals) iii. Macroorganisms (Predators and Parasitoids) 3.1. Major registration categories of Biopesticides and biocontrol agents In the following sections the data requirements for each category of Biopesticides and biocontrol agents are described. The data requirements will apply equally whether the application is for: 3.1.1. Experimental use permit: means status granted (bearing experimental Permit number) allowing experimental use prior to submitting application for full registration. 3.1.2. Full registration: Granted when all registration requirements have been met and the registration authority has granted approval for Biopesticides and biocontrol agents according to the conditions laid down in the certificate of registration. Bop a fs 2 29 7Kenya Subsidiary Legislation, 2024 3.1.3. Temporary/Emergency registration: means registration status granted to a microbial biopesticide (with temporary registration number) after pre-submission consultation and approval has been given for full submission, but not al lowing the Biopesticides and biocontrol agents to be used. 3.1.4. Provisional registration: means registration status granted to Biopesticides and biocontrol agents (bearing provisional registration number) pending supply of further data required by the registration authority. (Black , 2013) . 3 .2 . M ic r o bia l Pest ic id es Microbial pesticides are microorganisms that produce a pesticidal effect. They have pesticidal modes of action that often include competition or inhibi tion, toxici ty and even use of the target pest as a growth substrate. Microbial pesticides can control many different kinds of pests, although each separate active agent is relatively specific for its target pest (s) . 3.2.1. Data requirements for microbial pesticides registration 3.2.1. Biological and Chemical Characteristics Microbial biopesticide products covered under this guidel ine shall meet the criteria summ ari zed in T able 1. 3.2.1.1 Systematic name The systematic names, consisting of genus and species names, of microbial shal l be given, (example: Bacillus thuringiensis, Trichoderma han ianum) . 3.2.1.2 Strain or isolate of microbials The strain or isolate of microbial shal l be stated clearly. (Example: Bacillus thuringiensis subsp. kurstaki, strain ABTS-351; Metarhizium Anisopliae I CIPE 69 strain) 3.2.1.3. Source or origin, host range, and mode of act i o n The source or origin of microbial shall be indicated including country, where its isolated from, ecological habitat. The host range of microbial should be clearly indicated. Reports from any reliable and reputable publication journal are accepted. The mode of action of microbial should be indicated clearly (example: infection of target , competitive or antagonistic behaviour, etc). 3.2.1.4. Biological properties History and geographical distribution of active agent L ife cycle M ode of action Relationship to known plant animal or human pathogens Host range Dispersal Colonizing ability Information on production of metabolites Genetic stabil ity i Tf i -J' l OU i ••i l Kenya Subsidiary Legislation, 2024 2297 3.1.3. Temporary/Emergency registration: means registration status granted to a microbial biopesticide (with temporary registration number) after pre-submission consultation and approval has been given for full submission, but not allowing the Biopesticides and biocontrol agents to be used. 3.1.4. Provisional registration: means registration status granted to Biopesticides and biocontrol agents (bearing provisional registration number) pending supply of further data required by the registration authority. (Black, 2013). 3.2. MICROBIAL PESTICIDES Microbial pesticides are microorganisms that produce a pesticidal effect. They have pesticidal modes of action that often include competition or inhibition, toxicity and even use of the target pest as a growth substrate. Microbial pesticides can control many different kinds of pests, although each separate active agent is relatively specific for its target pest (s). 3.2.1. Data requirements for microbial pesticides registration 3.2.1. Biological and Chemical Characteristics Microbial biopesticide products covered under this guideline shall meet the criteria summarized in Table 1. 3.2.1.1 Systematic name The systematic names, consisting of genus and species names, of microbia! shall be given. (example: Bacillus thuringiensis, Trichoderma harzianum). ote 3.2.1.2 Strain or isolate of microbials ae iS OL The strain or isolate of microbial shall be stated clearly. (Example: Bacillus thuringiensis subsp. kurstaki, strain ABTS-351; Metarhizium Anisopliae ICIPE 69 strain) 3.2.1.3. Source or origin, host range, and mode of action The source or origin of microbial shall be indicated including country, where its isolated from, ecological habitat. The host range of microbial should be clearly indicated. Reports from any reliable and reputable publication journal are accepted. The mode of action of microbial should be indicated clearly (example: infection of target, competitive or antagonistic behaviour, etc). 3.2.1.4. Biological properties anh ot History and geographical distribution of active agent al Life cycle Mode of action Relationship to known plant animal or human pathogens Host range. . Dispersal Colonizing ability Information on production of metabolites Genetic stability Kenya Subsidiary Legislation, 20242 2 9 8 3.2.1.5. Specifi cation of active agent (Technical grade) and Composition of the product Specifi cation of the active agent shall include names, and am ount af the active agent , concentration and contaminants. M icrobial active agent needs to be specifi ed in relevant unit of activity. The example unit of activity for each m icrobial are as f o l low s: (a) Entomotoxic bacteria in endotoxin content (lU/mg or ml); (b) Baculoviruses (Nuclear Polyhedrosis Virus (NPV) and Granulosi s v i rus (GV)) in viral unit (Polyhedral Occlusion Body (POB)/capsul co u n t/ m l mg); (c) Entomopathogenic fungi and antagonistic bacteria (Colony Forming Unit (cfu)/g or ml) product. The Composition of active and inert ingredients in % w/w and purpose in f ormulation shal l be stated . 3.2.1.6 Impurities and contaminants The technical grade and formulation product shall be free from biological contaminants especially plant, human and animal pathogenic contam inants such Salmonella typhi. Salmonella paratyphi A, B, and C, Salmonella sendai . Salmonella cholera-suis. Shigella dysenteriae, Escherichia coli and Vibr io choler ae. The technical grade shall be free from the contaminants. (Other microbial contam inants should not exceed 1 x 10'' count/ml or g of formulation (FAO, 2012, 2018) . The microbial contaminants shall be determined throughout the process of production. The method used shall be meri tioned and theiresultraittached in product speci fi cation sheet . 3.2.1.7. Physical chemical properties of formulated product Physical chemical properties Specifi cation of the product include appearance, physical state, colour, pH, persistent foaming, solubility or suspendabi li ty , particle size, viscosity (liquids) and density. Type and test method used shall be indicated clearly. 3.2.1.8. Production process and quality control The production process shall be stated clearly; (a) The name and address of the production plant shall be provided (b) Flowchart of the production process shall be submitted with the application ari j tii iij A ll raw materials used shal l be stated, (c) The quality control procedure shall be described 3.2.15 ; Test procedure and criteria for identifi cation Test procedure and cri teria for identifi cation for each m icrobial shal l be stated clearly. The robust methods of bioassays and identifi cation shal l be used : o r a s a) Entomotoxic bacteria; immunology assays: Elisa/Dot B l o t assay test or potency of product by bioassay method (LC50) on target larvae (Trichoplusia „ nilHelocoverpa armigera) and potency against a reference using artifi cial diet or leaf disc method or in the water for mosquito larvae. b) Baculoviruses; biological assay for determining the L C 50/L D 50 of the formulation. Bioassay for Nuclear Polyhedrosis Virus (NPV) by the diet surface contamination method and Granulosis, virus (GV) using bioassay against Chilo infuscatellus, Plutella xylostella ovAcheae j anata. 2298 Kenya Subsidiary Legislation, 2024 3.2.1.5. Specification of active agent (Technical grade) and Composition of the product Specification of the active agent shall include names, and amount af the active agent, concentration and contaminants. Microbial active agent needs to be specified in relevant unit of activity. The example unit of activity for each microbial are as follows: (a) Entomotoxic bacteria in endotoxin content ([U/mg or ml); (b) Baculoviruses (Nuclear Polyhedrosis Virus (NPV) and Granulosis virus (GV)) in viral unit (Polyhedral Occlusion Body (POB)/capsul count/ml or mg); (c) Entomopathogenic fungi and antagonistic bacteria (Colony Forming Unit (cfu)/g or ml) product. The Composition of active and inert ingredients in % w/w and purpose in formulation shall be stated. 3.2.1.6 Impurities and contaminants The technical grade and formulation product shall be free from biological contaminants especially plant, human and animal pathogenic contaminants such as Salmonella typhi, Salmonella paratyphi A, B, and C, Salmonella sendai, Salmonella cholera-suis, Shigella dysenteriae, Escherichia coli and Vibrio cholerae. The technical grade shall be free from the contaminants. (Other microbial contaminants should not exceed 1 x 10* count/ml or g of formulation (FAO, 2012, 2018). The microbial contaminants shall be determined throughout the process of production. The method used shall be mentioned and the:result attached in product specification sheet. 3.2.1.7. Physical chemical properties of formulated product Physical chemical properties Specification of the product include appearance, physical state, colour, pH, persistent foaming, solubility or suspendability, particle size, viscosity (liquids) and density. Type and test method used shall be indicated clearly. 3.2.1.8. Production process and quality control The production process shall be stated clearly; (a) The name and address of the production plant shall be provided (b) Flowchart of the production process shall be submitted with the application. ort igi; All raw materials used shall be stated. (c) The quality control procedure shall be described 3.2.1.9: Test procedure and criteria for identification Test procedure and criteria for identification for each microbial shall be stated clearly. The robust methods of bioassays and identification shall be used: a) Entomotoxic bacteria; immunology assays: Elisa/Dot Blot assay test or potency of product by bioassay method (LC50) on target larvae (Trichoplusia .ni/Helocoverpa armigera) and potency against a reference using artificial diet ,or leaf disc method or in the water for mosquito larvae. b) Baculoviruses; biological assay for determining the LC50/LDS50 of the formulation. Bioassay for Nuclear Polyhedrosis Virus (NPV) by the diet surface contamination method and Granulosis, virus (GV) using bioassay against Chilo infuscatellus, Plutella xylostella or Acheae Janata, 22 9 9Kenya Subsidiary Legislation, 2024 c) Entomopathogenic fungi ; pathogenicity test on a relevant insect and bioassay procedure shall be provided Test procedure other than the above may also be used f or considerat ion . The identification and bioassay shall be carried out in a laboratory accredited and/or recognized by the regulatory authority 3 .2 .1.10 . Shel f l i fe cl aim Applicants shall provide storage stability studies and shelf life in the proposed packaging to support specific shelf life claim 3.2.1.11. Quality verif ication report The verification report from a laboratory accredited and/or recognized by the regulatory authority shall be provided to confirm that the content of active agent is the same as the composition declared. 3.2.1.12. Bioeff icacy The recommended product use on crops shall be obtained f rom local bioeff icacy trials. Efficacy trials shall be carried out in accordance with the requirements for evaluating and reporting the efficacy of pest control products for plants. 3.2.1.13. Laboratory studies Additional laboratory study reports may be submitted depending ion proposediuses. 3.2.1.14. Packaging and labelling 3.2.1.14.1. Packaging material The type of packing material used shall be stated. The packaging material shal l maintain the quality, integrity and the properties of the product without leakages. 3.2.1.14.2. Labels and leaflets ,, A draft label shal l be submitted to the PCPB for evaluation. 3.2.1.14.3. Infectivity and pathogenicity or toxicity to t est an i m al s Toxicological data may be waived where there is sufficient ev idence that the product is safe. This would be based on results of medical survei l l ance , actual studies or published data. Where no evidence is provided or where thefC; is insufficient evidence, toxicological studies have to be conducted as indicated under T IER 1 in the first instance. TIER 2 is applied when, in the absence of ev idence of pathogenicity, either toxicity of infectivity is observed i n T I E R 1 . TIER 3 is applied when there are issues of known or suspected subchronic toxicity and human pathogenicity and tests for effects following long-term exposure and particular adverse effects of intra-cellular parasites of mammalian cel ls. Report on infectivity and pathogenicity or toxicity on test animals for the technical ifi a'tffi al of the microbial shall be submitted to PCPB . Acute studies (six pack for formulated product shal l be submi tted to PCPB 3.2.1.15. Human health hazafd/assessment , environmental f ate an d ef f ec t s •yj fc i -. . . Kenya Subsidiary Legislation, 2024 2299 c) Entomopathogenic fungi; pathogenicity test on a relevant insect and bioassay procedure shall be provided Test procedure other than the above may also be used for consideration. The identification and bioassay shall be carried out in a laboratory accredited and/or recognized by the regulatory authority 3.2.1.10. Shelf life claim : Applicants shall provide storage stability studies and shelf life in the proposed packaging to support specific shelf life claim 3.2.1.11. Quality verification report The verification report from a laboratory accredited and/or recognized by the regulatory authority shall be provided to confirm that the content of active agent is the same as the composition declared. 3.2.1.12. Bioefficacy The recommended product use on crops shall be obtained from local bioefficacy trials. Efficacy trials shall be carried out in accordance with the requirements for evaluating and reporting the efficacy of pest control products for plants. 3.2.1.13. Laboratory studies bdo abhhan, Additional laboratory study reports may be submitted depending:on proposedvuses. 3.2.1.14. Packaging and labelling hy ae" 3.2.1.14.1. Packaging material The type of packing material used shall be stated. The packaging material shall maintain the quality, integrity and the properties of the product without leakages. 3.2.1.14.2. Labels and leaflets 4, A draft label shall be submitted to the PCPB for evaluation. 3.2.1.14.3. Infectivity and pathogenicity or toxicity to test animals Toxicological data may be waived where there is sufficient evidence that the product is safe. This would be based on results of medical surveillance, actual ;- (5) studies or published data. Where no evidence is provided or where there: is insufficient evidence, toxicological studies have to be conducted as indicated under TIER 1 in the first instance. TIER 2 is applied when, in the absence of evidence of pathogenicity, either toxicity of infectivity is observed in TIER 1. TIER 3 is applied when there are issues of known or suspected subchronic toxicity and human pathogenicity and tests for effects following long-term exposure and particular adverse effects of intra-cellular parasites of mammalian ‘cells. Report on infectivity and pathogenicity or toxicity on test animals for the technical material of the microbial shall be submitted to PCPB. Acute studies (six pack for formulated product shall be submitted to PCPB . ade Pda 3.2.1.15. Human health hazard/assessment, environmental fate’ and effects: € Kenya Subsidiary Legislation, 20242 3 0 0 3 .2 .1.15 .1. H um an heal th hazard Data on animal tests are required to facilitate risk assessment . Specif ic studies the active agent and formulated product as indicated in the summary of data requirements for microbial registration shall be submitted. Peer reviewed Reports from scientif ic journals on human health based on the active agent may be submitted where there is sufficient evidence that the active agent is safe and has been in use for many years. 3.2.1.15.2. Ecotoxicological and Environmental fate Waivers may be granted on presentation of evidence that exposure to the particular non target organisms wi l l not occur , or where effects of exposure are already documented. TIER 1 studies should report any observed pathogenicity/infectivity to the test species. TIER 2 studies are required on representative non target species if acute studies indicate that adverse effects will occur during routine appl ication. Data on the effect on birds, aquatic organisms, algae and bees shal l be submi tted f or evaluati on . D ata on the fate and behavior of the microbials in the environment shal l be provided. 3 .2 .1.15 .3 . Residues Data shall be submitted if microbes are suspected to produce any residue of concern on food or feed items. Inert ingredients used in formulated products must not produce residues of concern on food or feed items. Where appl icable, residue data shall be provided as per the PCPB requirements for the conduct of supervised residue f ield t r i a l s . Table 1: Summary of data requirements for the registration o f m i c r o b i al o n N o . Status of data requirements A c t i v e F o rm u l at i o n F o r m u l ated product agent (A .A .) Type of Registration Applied for. Tick as Necessary Full Registration R R Temporary Registration A : Biological and Chemical Characteristics 1 Systematic name R 2 Strain or isol ate of m i crobi al s R 3 ! Common name (if available) Source or origin (country, where its isolated from, ecological habitat) Physical chemical properties of the product physical co l o u r R 4 - R 5 R pH persistent foaming suspendabil i ty particle size viscosi ty 2300 Kenya Subsidiary Legislation, 2024 3.2.1.15.1. Human health hazard Data on animal tests are required to facilitate risk assessment. Specific studies on the active agent and formulated product as indicated in the summary of data requirements for microbial registration shall be submitted. Peer reviewed Reports from scientific journals on human health based on the active agent may be submitted where there is sufficient evidence that the active agent is safe and has been in use for many years. 3.2.1.15.2. Ecotoxicological and Environmental fate Waivers may be granted on presentation of evidence that exposure to the particular non target organisms will not occur, or where effects of exposure are already documented. TIER 1 studies should report any observed pathogenicity/infectivity to the test species. TIER 2 studies are required on representative non target species if acute studies indicate that adverse effects will occur during routine application. Data on the effect on birds, aquatic organisms, algae and bees shall be submitted for evaluation. Data on the fate and behavior of the microbials in the environment shall be provided. 3.2.1.15.3. Residues Data shall be submitted if microbes are suspected to produce any residue of concern on food or feed items. Inert ingredients used in formulated products must not produce residues of concern on food or feed items. Where applicable, residue data shall be provided as per the PCPB requirements for the conduct of supervised residue field trials. Table 1: Summary of data requirements for the registration of microbial No. | Status of data requirements Active | Formulation agent Formulated (A.A.) product Type of Registration Applied for. Tick as Necessary R R Full Registration Temporary Registration Biological and Chemical Characteristics Systematic name Common name (if available) A: 1 2 Strain or isolate of microbials 3 4 A A A Aw ‘Source or origin (country, where its isolated from, ecological habitat) 5 Physical chemical properties of the product R physical colour pH persistent foaming * suspendability particle size viscosity Kenya Subsidiary Legislation, 2024 2 30 1 density test m eth o d 6 Biological properties R History and geographical distribut ion of active agent L ife cycle M o d e o f ac t io n Relationship to known plant animal or human pathogens Host range Dispersal Colonizing abi l ity Information on production of m etabo l i tes Genetic stability 7 Composition of the product R R i l L . 8 Production process and quality control N am e an d ad dr ess o f m an u f ac t ur er N am e and add r ess o f F o r m u lato r f lowchart of production process R R 'I / ■I ’. l : 9 T est Pr oced ure and c r i ter i a f o r i d en t i f i c at i o n R 10 Impuri ties and contaminants R 11 Sh el f l i f e c l ai m R 12 Quality Verif ication report R B . B ioef f icacy t 13 Field eff icacy studies on proposed use R 14 Laboratory studies for Bioassays C R C. Packaging and L abell ing 15 Packaging material R 16 L abel s an d l eaf let s R D . Human Health, Infectivity and Pathogenicity or Toxici ty t o test an i m al s 17 Infectivity and pathogenicity T I E R 1 S tud ies R M ed i c al su r v e i l l ance d ata f o r Kenya Subsidiary Legislation, 2024 2301 density test method 6 | Biological properties R History and geographical distribution of active agent Life cycle Mode of action Relationship to known plant animal or human pathogens Host range Dispersal Colonizing ability Information on production of metabolites Genetic stability 7 | Composition of the product R R 8 | Production process and quality control — R R. ~ . Name and address of manufacturer vue Name and address of Formulator flowchart of production process 9 | Test Procedure and criteria for identification R 10 | Impurities and contaminants R 11 | Shelf life claim R 12 | Quality Verification report R B. Bioefficacy 13 | Field efficacy studies on proposed use R 14 | Laboratory studies for Bioassays CR C. Packaging and Labelling 15 | Packaging material R 16 | Labels and leaflets R D. Human Health, Infectivity and Pathogenicity or Toxicity to test animals 17 | Infectivity and pathogenicity R TIER 1 Studies Medical surveillance data for Kenya Subsidiary Legislation, 20242 3 0 2 manufacturing plants and Agricul tural workers (Such as occurrence of hypersensitivity/allergies) Acute Oral LD50 mg/kg LC50 (rat/rabbit) A c u te der m al Inhalation LC50 mg/4 hours (rat/rabbit) D er m al i r r i t at i o n Eye irritation Sk i n sen si t az i t i o n Intra-peritoneal (Fungi and protozoa)/Intravenous (others) inj ection for infectivity T I E R 2 Stud i es Subchronic toxicity 28 day NOEL mg/kg/day T I E R 3 S tud i es Chronic toxicity/Carcinogenicity NOEL mg/kg/day..(mouse/rat) Neurotoxicity NOEL mg/kg/day Teratogenicity NOEL mg/kg/day Reproduction (rat/rabbit) M utagenicity RAcute Toxicity studies Acute Oral LD50 mg/kg LC50 (rat/ rabbi t) A cu te d er m al Inhalation LC50 mg/4 hours (rat/ rabbi t) D er m al i r r i t at i o n Eye irritation Sk i n sen si t i zat i o n E. Ecotoxicology and Environmental Fate R18 Ecotoxicology fate TIER 1 (Acute studies) Birds (2 species) Aquatic organisms (2 species) 2302 Kenya Subsidiary Legislation, 2024 manufacturing plants and Agricultural workers (Such as occurrence of hypersensitivity/allergies) Acute Oral LD.) mg/kg LCs (rat/rabbit) Acute dermal Inhalation LC.) mg/4 hours (rat/rabbit) Dermal irritation Eye irritation Skin sensitazition Intra-peritoneal (Fungi and protozoa)/Intravenous (others) injection for infectivity TIER 2 Studies Subchronic toxicity 28 day NOEL mg/kg/day TIER 3 Studies Chronic toxicity/Carcinogenicity NOEL mg/kg/day (mouse/rat) Neurotoxicity NOEL mg/kg/day Teratogenicity NOEL mg/kg/day Reproduction (rat/rabbit) Mutagenicity Acute Toxicity studies Acute Oral LD50 mg/kg LC50 (rat/rabbit) Acute dermal Inhalation LC50 mg/4 hours (rat/rabbit) Dermal irritation Eye irritation Skin sensitization E. Ecotoxicology and Environmental Fate 18 Ecotoxicology fate TIER | (Acute studies) Birds (2 species) Aquatic organisms (2 species) Kenya Subsidiary Legislation, 2024 2 30 3 Aquatic invertebrates A lgae B ees Representative natural enemies E ar th w o r m s Soil Micro organisms Representative non target plant T I E R 2 Birds (1 specie) Reproduction and NOEL Aquatic organisms (2 species) Reproduction, BCF & NOEL Environmental fate - Behaviour in the soi l , surface & ground water Persistence of active agent. Mobility ofactive agent. Major metabolites where appropriate ‘ ' / I F . R esi d ue 19 R esi d u e d ata C R 20 . Clearance from National Plant Protection Organization (NPPO) authorizing import or export. R R 2 1. Procedure f or destruction and decontamination R Abbreviation: R= required CR=Conditionally Required Kenya Subsidiary Legislation, 2024 2303 Aquatic invertebrates Algae Bees Representative natural enemies Earthworms Soil Micro organisms Representative non target plant TIER 2 Birds (1 specie) Reproduction and NOEL Aquatic organisms (2 species) Reproduction, BCF & NOEL Environmental fate — Behaviour in the soil, surface & ground water Persistence of active agent, Mobility ofactive agent, Major metabolites where appropriate — F. Residue 19 | Residue data CR 20. | Clearance from National Plant Protection Organization | R R : (NPPO) authorizing import or export. "21. | Procedure for destruction and decontamination R Abbreviation: R= required CR=Conditionally Required Kenya Subsidiary Legislation, 20242 3 04 3 .3 . B i o c h e m ic a l Pe st i c i d e s Biochemical pesticides means a pest control product whose active ingredient derived from naturally occurring plants, animals, or other organisms intended to control plant pests. For the purpose of these requirements. Biochemical pesticides include B otanical s and Semiochem ical s. 3 .3 .1 . B o t a n ic a l / P l a n t E x t r a c t s B otanical acti ve substance; I t consists of one or more components found in plants and obtained by subjecting plants or parts of plants of the same species to a process such as pressing, milling, crushing, distillation and/or other methods of ex tract ions. Botanical products covered under this guideline shall meet the cri teri a sum m ari zed i n T ab l e 2 . 3.3.2. Data requirements for registration of botanical/plant e x t r ac t 3 .3 .2 .1 . N o m en c l atu r e The systematic and common names the plant shall be provided. The active ingredient (s) of the plant extracts shall be provided i f av ai l ab l e . 3.3.2.2. Source or origin The source or origin of botanical/plant extract shall be indicated including country , where i ts extracted from, plant part , and ecological habitat . The applicant shall provide infoffi i&tion on registration status of the product in the country of origin. .-.i i n ;, : 3.3.2.3 ŝsPhysical chemical properties of active ingredient and formulated product . Information of Color , physical state, odour , storage stabi l ity , corrosion characteri stics, UV-light absorption, water solubi lity and vapor pressure for the plant extracts and formulated products shal l be submitted. The specif ication of the technical grade and the formulated product shall conform to, FAO specif ications whenever such specifi cations are available. 3.3.2.4. Composition of the product Composition of active and inert in % w/w or w/v and purpose in formulation shall be provided. If available, the following information shal l be submitted : l U PA C and CA S chemical names and numbers, and structural f orm ula. 3.3.2.5. M anufacturing process The Extraction process shall be stated clearly and the following information shall be provided; a) The name and address of the manufacturing plant , b) A description of the quality control procedures and equipment shall be provided to assure consistency of the composition of substance produced, c) Information on substances used in the manufacturing process (example: identity of any extraction solvent, enzymes, stabilizers such as ant iox idants) , and any special precautions such as control of light, humidity and temperature, d) Flowchart of the process of extraction of active ingredient and the manufacture of formulated product shal l be submitted. 2304 Kenya Subsidiary Legislation, 2024 3.3. BIOCHEMICAL PESTICIDES Biochemical pesticides means a pest control product whose active ingredient derived from naturally occurring plants, animals, or other organisms intended to control plant pests. For the purpose of these requirements, Biochemical pesticides include Botanicals and Semiochemicals. 3.3.1. BOTANICAL/ PLANT EXTRACTS Botanical active substance: It consists of one or more components found in plants and obtained by subjecting plants or parts of plants of the same species to a process such as pressing, milling, crushing, distillation and/or other methods of extractions. Botanical products covered under this guideline shall meet the criteria summarized in Table 2. 3.3.2. Data requirements for registration of botanical/plant extract 3.3.2.1. Nomenclature The systematic and common names the plant shall be provided. The active ingredient (s) of the plant extracts shall be provided if available. 3.3.2.2. Source or origin The source or origin of botanical/plant extract shall be indicated including country, where its extracted from, plant part, and ecological habitat. The applicant shall provide infotihation on registration status of the product in the country of origin. ab ties: Hop He 3.3.2.3<Physical chemical properties of active ingredient and formulated product. Information of Color, physical state, odour, storage stability, corrosion characteristics, UV-light absorption, water solubility and vapor pressure for the plant extracts and formulated products shall be submitted. The specification of the technical grade and the formulated product shall conform to, FAO specifications whenever such specifications are available. 3.3.2.4. Composition of the product Composition of active and inert in % w/w or w/v and purpose in formulation shall be provided. If available, the following information shall be submitted: TUPAC and CAS chemical names and numbers, and structural formula. 3.3.2.5. Manufacturing process The Extraction process shall be stated clearly and the following information shall be provided; a) The name and address of the manufacturing plant. b) A description of the quality control procedures and equipment shall be provided to assure consistency of the composition of substance produced. Information on substances used in the manufacturing process (example: identity of any extraction solvent, enzymes, stabilizers such as antioxidants), and any special precautions such as control of light, humidity and temperature. d) Flowchart of the process of extraction of active ingredient and the manufacture of formulated product shall be submitted. Kenya Subsidiary Legislation, 2024 2 30 5 3.3.2.6. Test procedures and criteria for identification The applicant shall provide test procedures for the plant extracts and or a validated analytical method for the active ingredients. 3)3 .2.1. Impuri ties The applicant shall provide information on the identity and quantity of the impurities in the plant extracts. 3.3.2.8. Storage stability The applicant shall specify the shelf life of the products based on test conducted under the following conditions: FAO Accelerated Storage Test Procedures is performed at 54 ± 2 ° C f o r 14 days or at 45 ± 2 °C for 6 weeks or at 40 ± 2 °C for 8 w eek s or at 35 ± 2 “ C for 12 weeks or at 30 ± 2 °G for 18 weeks when applicable. Two- Year Storage Stability (Ambient testing) to demonstrate the storage stability of a formulation under true storage conditions usual ly over a period of 2 years. The test shall be conducted at ambient temperature or , 20 “ C , 25 °C or 30 “C dependent on the f inal area of use. The packaging used in the study shall be based upon that in which the product i s so l d . Verif ication report a) b) c) 3 .3 .2 .9 . The applicant shall provide a verification report base of) a five batch analysiSrjpf .the plant extracts and formulated products to ensure that content of active ingredient is the same as in composition declared. A report from own or third party independent laboratory is accepted. 3 .3 .2 .10 . Packaging and labelling 3.3.2.10.1. Packaging material The type of packing material used shall be stated. The packaging material shall maintain the quality, integrity and the properties of the product without leakages. 3 .3 .2 .10 .2 . L abel s and leaf lets A draf t l abel shal l be subm itted to PCPB f or evaluation . H uman heal th hazard/assessment , env i ronm ental f ate and ef f ec t s 3 .3 .2 .11 .1 . H u m an heal th h azar d Data on animal tests are required to facil itate risk assessment . Specif ic studies on the active ingredient and formulated product for registration of botanical products shall be submitted. Peer reviewed reports from scientif ic j ournals o n h u m an heal th b ased o n th e plant extract or active ingredient may be submitted w here there i s suf f ic ient ev idence that the plant extract or active ingredient is safe and has been in use for many years. 3.3.2.11.2. Ecotoxicological and Environmental fate Waivers may be granted on presentation of sufficient evidence that exposure to the particular non target organisms will not occur, or where effects of exposure are already documented. TIER 1 studies should report any acute effects on non-target species. TIER 3 .3 .2 .1 1 . Kenya Subsidiary Legislation, 2024 2305 3.3.2.6. Test procedures and criteria for identification The applicant shall provide test procedures for the plant extracts and or a validated analytical method for the active ingredients. : 3.3.2.7. Impurities The applicant shall provide information on the identity and quantity of the impurities in the plant extracts. 3.3.2.8. Storage stability The applicant shall specify the shelf life of the products based on test conducted under the following conditions: a) FAO Accelerated Storage Test Procedures is performed at 54 + 2 °C for 14 days or at 45 + 2 °C for 6 weeks or at 40 + 2 °C for 8 weeks or at 35 + 2 °C for 12 weeks or at 30 + 2 °C for 18 weeks when applicable. b) Two- Year Storage Stability (Ambient testing) to demonstrate the storage stability of a formulation under true storage conditions usually over a period of 2 years. The test shall be conducted at ambient temperature or, 20 °C, 25 °C or 30 °C dependent on the final area of use. c) The packaging used in the study shall be based upon that in which the product is sold. 3.3.2.9. Verification report The applicant shall provide a verification report base on a five batch analysis,of the plant extracts and formulated products to ensure that content of active ingredient i is the same as in composition declared. A + Teport from own or third party indepérident laboratory is accepted. 3.3.2.10. Packaging and labelling ’ 3.3.2.10.1. Packaging material The type of packing material used shall be stated. The packaging material shall maintain the quality, integrity and the properties of the product without leakages. 3.3.2.10.2. Labels and leaflets A draft label shall be submitted to PCPB for evaluation. 3.3.2.11. Human health hazard/assessment, environmental fate and effects 3.3.2.11.1. Human health hazard OEE Data on animal tests are required to facilitate risk assessment. Specific studies on the active ingredient and formulated product for registration of botanical products shall be submitted. Peer reviewed reports from scientific journals on human health based on the plant extract or active ingredient may be submitted where there is sufficient evidence that the plant extract or active ingredient is safe and has been in use for many years. 3.3.2.11.2. Ecotoxicological and Environmental fate Waivers may be granted on presentation of sufficient evidence that exposure to the particular non target organisms will not occur, or where effects of exposure are already documented. TIER 1 studies should report any acute effects on non-target species. TIER Mu Kenya Subsidiary Legislation, 20242 30 6 studies are required on non-target species if acute studies i ndicate that adverse effects will occur during routine application. Data on the eff ect on birds, aquatic organisms, algae and bees shal l be subm itted for evaluation. Data on the fate and behavior of the plant extracts and the active ingredient in the environment shall be provided. 3.3.2' 11.3. Ef ficacy and laboratory studies Efficacy data requirements for botanical/plant extract are sim i l ar to those f or conventional agriculture products. Required field and laboratory studies will depend on purpose of uses. 3 .3 .2 .11.4 . Residues 2 Data shall be submitt ed if plant extracts are suspected to produce any residue of on food or feed items. Inert ingredients used in formulated products must notc o n c e r n produce residues of concern on food or feed items. Where applicable, residue data shall be provided as per the PCPB requirements for the conduct of supervised residue fi eld t r i al s . Table 2: Summary of data requirements for registration of botanicals A ctive agent F o rm u l at i o nStatus of data requirementsN o . (A .I .) RRType of Registration Applied for. Tick as Necessary Full Registration Temporary Registration Physical and Chemical CharacteristicsA : RSystematic name1 RCommon name (if avai lable)2 RSource or origin3 R RSpecifi cation of the product physical state co l o u r O d o u r Storage stability Corrosi on characteri stics UV-light absorption Water pressure V apor pressure 4 RRComposition of the product5 R RManufacturing process and quality control6 2306 Kenya Subsidiary Legislation, 2024 2 studies are required on non-target species if acute studies indicate that adverse effects will occur during routine application. Data on the effect on birds, aquatic organisms, algae and bees shall be submitted for evaluation. Data on the fate and behavior of the plant extracts and the active ingredient in the environment shall be provided. 3.3.2.11.3. Efficacy and laboratory studies Efficacy data requirements for botanical/plant extract are similar to those for conventional agriculture products. Required field and laboratory studies will depend on purpose of uses. 3.3.2.11.4. Residues Data shall be submitted if plant extracts are suspected to produce any residue of concern on food or feed items. Inert ingredients used in formulated products must not produce residues of concern on food or feed items. Where applicable, residue data shall be provided as per the PCPB requirements for the conduct of supervised residue field trials. Table 2: Summary of data requirements for registration of botanicals Active agent ‘No. Status of data requirements (AL) Formulation Type of Registration Applied for. Tick as Necessary R- R Full Registration Temporary Registration A: Physical and Chemical Characteristics Systematic name ‘Common name (if available) Source or origin BA YT G O ] N T = a wR ) Ww Bw Specification of the product physical state colour Odour Storage stability Corrosion characteristics UV-light absorption Water pressure Vapor pressure 5 ‘Composition of the product . R R 6 Manufacturing process and quality control R . R Kenya Subsidiary Legislation, 2024 2 30 7 manuf acturer name and address flowchart of manufacturing process Test Procedure and cri ter ia f or identi f ication R R 8 Impurities R Verif ication report R R 10 Packaging and labelling R B . Toxicology Evaluation TI E R 1 Stu d i es R Acute Oral LD50 mg/kg LC50 (rat/rabbit) A c u te derm al Inhalation LC50 mg/4 hours (rat/rabbit) D erm al i r r i tat i o n Eye irri tation Sk in sensitazi t ion TI E R 2 Stud i es Subchronic toxicity 28 day NOEL mg/kg/day i i T I E R 3 S tu d i es m r o o n ’ Chronic toxicity/Carcinogenicity NOEL mg/kg/day (mouse/rat) Neurotoxicity NOEL mg/kg/day Teratogenicity NOEL mg/kg/day Reproduction (rat/rabbit) M utagenici ty Acute Toxici ty studies R Acute Oral LD50 mg/kg LC50 (rat/rabbit) A c u te der m al Inhalation LC50 mg/4 hours (rat/rabbit) D er m al i r r i tat io n Eye irritation Sk i n sen si t i zat i on I 13 Ecotoxicology and Environmental Fate ■ j . .R Ecotoxicology fate Kenya Subsidiary Legislation, 2024 2307 manufacturer name and address flowchart of manufacturing process Test Procedure and criteria for identification Impurities x Verification report 10 Packaging and labelling B. Toxicology Evaluation 11 TIER 1 Studies Acute Oral LDs5y) mg/kg LC. (rat/rabbit) Acute dermal Inhalation LCs, mg/4 hours (rat/rabbit) Dermal irritation Eye irritation Skin sensitazition TIER 2 Studies Subchronic toxicity 28 day NOEL mg/kg/day TIER 3 Studies Chronic toxicity/Carcinogenicity NOEL mg/kg/day (mouse/rat) Neurotoxicity NOEL mg/kg/day Teratogenicity NOEL mg/kg/day Reproduction (rat/rabbit) Mutagenicity godt it WSIOdH 12 Acute Toxicity studies Acute Oral LDS0 mg/kg LC50 (rat/rabbit) Acute dermal Inhalation LCSO mg/4 hours (rat/rabbit) Dermal irritation Eye irritation Skin sensitization 13 Ecotoxicology and Environmental Fate Ecotoxicology fate Kenya Subsidiary Legislation, 20242 3 0 8 TIER 1 (Acute studies) Birds (2 species) Aquatic organisms (2 species) Aquatic invertebrates A lgae B ees Representative natural enemies E ar th w o r m s Soil M icro organisms Representative non target plant I T I E R 2 Birds (1 specie) Reproduction and NOEL Aquatic organisms (2 species) Reproduction, BCE & NOEL REnvironmental fate - Behaviour in the soi l , surface & ground water Persistence of active agent . M obility ofact ive agent . Major metabolites where appropriate C. Eff icacy R14 Field and laboratory study D . R esid ue C R15 Resi d ue d ata CR = Conditionally RequiredA bbreviations: R = Required 2308 Kenya Subsidiary Legislation, 2024 TIER 1 (Acute studies) Birds (2 species) Aquatic organisms (2 species) Aquatic invertebrates Algae Bees Representative natural enemies Earthworms Soil Micro organisms Representative non target plant TIER 2 Birds (1 specie) Reproduction and NOEL Aquatic organisms (2 species) Reproduction, BCF & NOEL Environmental fate — Behaviour in the soil, surface & R lground water Persistence of active agent, Mobility ofactive agent, Major metabolites where appropriate C. Efficacy 14 [Field and laboratory study D. Residue 15 Residue data | CR | Abbreviations: R = Required CR = Conditionally Required 2 30 9Kenya Subsidiary Legislation, 2024 3 .4 . SEM IOCHEM ICA L S Semiochemicals are active substances used in plant protection and publ ic health products and have a non-toxic, target specific, mode o f ac t i o n and ar e o f n at u r al occurrence. They are general ly effective at very low rates, of ten comparable to levels that occur naturally. They may be volatile and can dissipate and/or degrade rapidly in the environment. These chemicals pose low risk to human h eal th and the env i ro n m ent . Different types of semiochemicals are: Allelochemicals produced by individuals of one species that modify the behaviour of individuals of a dif ferent species (i .e. an interspecif ic effect) . They include allomones (emitting species benefits), kairomones (receiving species benefits) and synomones (both species benefit). Pheromones produced by individuals of a species that modify the behaviour of other individuals of the same species (i .e. an intraspecif ic effect) . Straight-chained lepidopteran pheromones (SCLPs) are a group of pheromones consisting of unbranched aliphatics having a chain of 9 to 18 carbons, containing up to three double bonds, ending in an alcohol, acetate or aldehyde functional group. 3.4.2. Data requirements for registration of Semiochemicals Common name proposed/accepted by ISO or others standard o f i n ter n at i o n al organizations, (if any) Trade name or manuf acturer ’ s code number The composition of the semiochemical and its formulated products Chem ical and technical i nf orm at ion of the semiochem ical s and i t s i n tend ed u se (Pheromones, mating disruption or kairomones) . Production process and quality control Content (%) and nature of components included in the f o r m u l at i o n and ap pear ance . Analytical method for active ingredient Validated laboratory report of f ive batch analysis Information about packaging and labeling Peer reviewed reports from the scientif ic journal may be accepted. On case by case basis other information may be required by the regulatory authority . Disclaimer: The above requirements shall be applicable only for a pure formulation of a semiochem ical . W here a sem iochem ical i s com bined w i th ; a 1. n . 111. 1 . 1 . V . V . V I . V l l . V l l l . I X . X . X I . in a formulation, the requirements for the(a) a conventional insecticide registration for conventional pesticides shall be required. (b) a microbial in a formulation the requirements for the registration for semiochemical and microbials shall be required. Table 3: Summary of data requirements for registration o f Sem i o ch em i c al s (Pheromones, disrupting hormones and other semiochemicals) Kenya Subsidiary Legislation, 2024 2309 3.4. SEMIOCHEMICALS Semiochemicals are active substances used in plant protection and public health products and have a non-toxic, target specific, mode of action and are of natural occurrence. They are generally effective at very low rates, often comparable to levels that occur naturally. They may be volatile and can dissipate and/or degrade rapidly in the environment. These chemicals pose low risk to human health and the environment. Different types of semiochemicals are: i. Allelochemicals produced by individuals of one species that modify the behaviour of individuals of a different species (i.e. an interspecific effect). They include allomones (emitting species benefits), kairomones (receiving species benefits) and synomones (both species benefit). ii. | Pheromones produced by individuals of a species that modify the behaviour of other individuals of the same species (i.e. an intraspecific effect). ili. Straight-chained lepidopteran pheromones (SCLPs) are a group of pheromones consisting of unbranched aliphatics having a chain of 9 to 18 carbons, containing up to three double bonds, ending in an alcohol, acetate or aldehyde functional group. 3.4.2. Data requirements for registration of Semiochemicals i. Common name proposed/accepted by ISO or others standard of international organizations, (if any) ii. Trade name or manufacturer’s code number iii. | The composition of the semiochemical and its formulated products iv. Chemical and technical information of the semiochemicals and its intended use (Pheromones, mating disruption or kairomones). v. Production process and quality control vi. Content (%) and nature of components included in the formulation and appearance. . vil. Analytical method for active ingredient Vill. Validated laboratory report of five batch analysis ix. Information about packaging and labeling X. Peer reviewed reports from the scientific journal may be accepted. xi. On case by case basis other information may be required by the regulatory authority. Disclaimer: The above requirements shall be applicable only for a pure formulation of a semiochemical. Where a semiochemical is combined with; (a) a conventional insecticide in a formulation, the requirements for the registration for conventional pesticides shall be required. (b) a microbial in a formulation the requirements for the registration for semiochemical and microbials shall be required. Table 3: Summary of data requirements for registration of Semiochemicals (Pheromones, disrupting hormones and other semiochemicals) Kenya Subsidiary Legislation, 20242 3 10 N o . Status of data requirements A .I . F o r m u l at i o n A : Physical and Chemical Characteri stics 1 Systematic name R 2 Common name (if available) R 3 T r ade n am e R 4 Chem ical and technical i nf orm ation R R 5 Source or origin R 6 Physical properties: (Specification of the product) Colour , R R odour , physical state, stability (temperature, metals), solubi lity in water and other solvents UV/visible absorption Volatility (Henry’s law constant) Octanol/water partition coefficient Submission of analytical standards (samples). Corrosion char acteri st ics Water pressure Vapor pressure 7 Composition of the product g/kg or g/L of TG A I g/kg or g/L of all ingredients exceeding Ig/kg Content (%) and nature of components Production process and quality control Description of starting materials, production process and potential impuri ties manuf acturer name and address flowchart of manufacturing process R R 8 R 9 R R 10 T est Procedure and cri teria f or identi f ication Identity by spectral confirmation, including one oi more of U V /I R/ NM R/M S. R R 1 1 Impuri ties R Analytical method for active ingredient Analytical data and methodology (including spectral confirmation of identity) R Analytical methodology and data for impurities of toxicological concern. 12 Validated laboratory report of five batch analysis R R 2310 Kenya Subsidiary Legislation, 2024 No. | Status of data requirements All. Formulation A: Physical and Chemical Characteristics Systematic name Common name (if available) Trade name Chemical and technical information Source or origin D I M A B l Q i r f e Physical properties: (Specification of the product) Colour, odour, physical state, stability (temperature, metals). solubility in water and other solvents UV/visible absorption Volatility (Henry’s law constant) Octanol/water partition coefficient Submission of analytical standards (samples). Corrosion characteristics Water pressure Vapor pressure R A I A Composition of the product g/kg or g/L of TGAI g/kg or g/L of all ingredients exceeding 1 g/kg ios ] Content (%) and nature of components Production process.and quality control Description of starting materials, production process and potential impurities manufacturer name and address flowchart of manufacturing process 10 Test Procedure and criteria for identification Identity by spectral confirmation, including one or more of UV/IR/NMR/MS.. 11 Impurities Analytical method for active ingredient Analytical data and methodology (including spectral confirmation of identity) Analytical methodology and data for impurities of toxicological concern. 12 Validated laboratory report of five batch analysis 2 3 1 1Kenya Subsidiary Legislation, 2024 R13 [Packaging and labeling C. Eff icacy RField and laboratory study Eff icacy Summary 14 Description of pest problem and AI ’s mode of action (May be addressed by qualitative description). Efficacy trials of product, used as directed on label , including reportin Sustainability considerations (compatibility with integrated pest management; contribution to risk reduction)g of adverse effects to site (e.g., phytotoxicity) (May be addressed by qualitative description). D . R esi d ue C RResidue data and Analytical method for residues.15 CR = Conditionally RequiredAbbreviations: R = Required J J : . ‘ y , ' O i T ' J Kenya Subsidiary Legislation, 2024 2311 13 |Packaging and labeling R C. Efficacy 14 Field and laboratory study R Efficacy Summary Description of pest problem and AI’s mode of action! (May be addressed by qualitative description). Efficacy trials of product, used as directed on label, including reportin Sustainability considerations (compatibility with| integrated pest management; contribution to risk reduction)g of adverse effects to site (eg., phytotoxicity) (May be addressed by qualitative description). D. Residue 15 | Residue data and Analytical method for residues. CR Abbreviations: R = Required CR = Conditionally Required Da: a Ot Kenya Subsidiary Legislation, 20242 3 12 3 .5 . M a c r o b i a l s These requirements cover registration of : (i) predators (i i) parasitoids 3.5.1. Required information on predators and parasitoids (a) The following information shall be required by the regulatory authority for the registration of predators and parasitoids: (b) Taxonomic identity along with classification (e.g. phylum, class, order, family , genus, species), including common names and history of any recorded name change; with accession number of voucher specimen deposited in recognized m u seu m o r c u l t u r e c o l l ec t io n . (c) Information on physical characteristics: morphology, appearance, sexual dimorphism, height, length, weight and size, winged/wingless, (d) Bionomics and lifecycle of the organism, including behavioural characteri stics such as predator/prey relationships, life history and l ife cycle information; for example, mode of reproduction, seasonal pattern of reproduction; reproductive potential (number of eggs, young, generations), and longevity , (e) Information on the efficacy is important to prevent the i ntroduct ion and release of ineffective biocontrol agents. A biological control agent is considered effective if it can cause a statistically signif icant red u ct io n o f at l east 10 percent in the number of pest organisms, of direct and indirect crop damage, or of yield loss. All relevant information to j udge the eff icacy of a biocontrol ageht shall be provided. Summary of the information on crop, against pest, and conditions the agent is shown to be effective, the role and strength of the agent would be in IPM programmes, (f) Host range. Available information on host/prey range of biocontrol agents shall be provided. Monophagous and oligophagous biocontrol agents are expected to pose no or very limited potential risks to non-target organisms, whereas polyphagous biocontrol agents may affect them directly and indirectly . (g) Intra-guild predation. Provide avai lable information on negative intraguild predation effects for specific or related natural enemy species, or determine from the biology of the natural enemy whether negative effe cts are l ikely .g fn o j ri >S I yjjjCh) Information on competition and displacement sh al l be su m m i ted to th e regulatory authority . (i) Potential for hybridisation with indigenous strains or biotypes. Provide available information on hybridisation of the natural enemy with indigenous strains or biotypes of the same or very closely related natural enemy species, (j ) Effects on plants: Effects of natural enemy on plants shall be provided if the biological control agent is potentially a facultative herbi vore and i f there i s a potential for phytotoxic effects, (k) Available information on the potential for establishment and dispersal shal l be provided. 2312 Kenya Subsidiary Legislation, 2024 3.5. MACROBIALS These requirements cover registration of: (i) predators (ii) parasitoids 3.5.1. Required information on predators and parasitoids (a) (b) (c) (d) (e) (f) (g) EHiate . 3 The following information shall be required by the regulatory authority for the registration of predators and parasitoids: Taxonomic. identity along with classification (e.g. phylum, class, order, family, genus, species), including common names and history of any recorded name change; with accession number of voucher specimen deposited in recognized museum or culture collection. Information on physical characteristics: morphology, appearance, sexual dimorphism, height, length, weight and size, winged/wingless. Bionomics and lifecycle of the organism, including behavioural characteristics such as predator/prey relationships, life history and life cycle information; for example, mode of reproduction, seasonal pattern of reproduction; reproductive potential (number of eggs, young, generations), and longevity. Information on the efficacy is important to prevent the introduction and release of ineffective biocontrol agents. A biological control agent is considered effective if it can cause a statistically significant reduction of at least 10 percent in the number of pest organisms, of direct and indirect crop damage, or of yield loss. All relevant information to judge the efficacy of a biocontrol agent shall be provided. Summary of the information on crop, against pest, and conditions the agent is shown to be effective, the role and strength of the agent would be in IPM programmes. Host range. Available information on host/prey range of biocontrol agents shall be provided. Monophagous and oligophagous biocontrol agents are expected to pose no or very limited potential risks to non-target organisms, whereas polyphagous biocontrol agents may affect them directly and indirectly. Intra-guild predation. Provide available information on negative intraguild predation effects for specific or related natural enemy species, or determine from the biology of the natural enemy whether negative effects are likely. NH bubi vor ‘tovs ,(h) (i) 0) (k) Information on competition and displacement shall be summited to the regulatory authority. Potential for hybridisation with indigenous strains or biotypes. Provide available information on hybridisation of the natural enemy with indigenous strains or biotypes of the same or very closely related natural enemy species. Effects on plants: Effects of natural enemy on plants shall be provided if the biological control agent is potentially a facultative herbivore and if there is a potential for phytotoxic effects. Available information on the potential for establishment and dispersal shall be provided. Ls teegnedy « hytets 2 3 13Kenya Subsidiary Legislation, 2024 Potent ial f or establ ishment . I n case of m ovement of biological control agents from one area to another, it is important to know if the agent can be established. If the agent cannot be established, less information may be required. Key factors that need to be considered include: — abiotic factors: The matching of climates of the area of origin and area of r el ease . — biotic factors: availability of non-target species suitable for reproduction, temporal and/or spatial matching of non-target organisms and biocontrol agent , diapause capabilities, dry season survival ; and combined biotic and abiot ic factors: availability of other resources for survival and reproduction. Potential for dispersal: The probability of a temporal and spatial encounter between the biological control agent and non-target species to determine the potential for dispersal of the biocontrol agent. (1) Available information on possible indirect effects - report of any known indirect effects or discuss potential indirect effects on individual species and/or ecosy stem , (m) Available information on environmental benefits - i n f o r m at i o n o n th e benefi cal ef fects of release of biological control agents compared to current or alternative pest management methods. Information for assessment of any potential environmental risks, (n) Information for assessment of efficacy of biological'control agent '- q ! 'V ' Methods for the evaluation of quality and purity (qual ify control) of biological control agents. Benef its of use of biological control agents. Summary of assessment of efficacy, (o) For native or established natural enemies and on biological control agents, long use, substantially reduced information requirements may be appropriate (p) Assessment of safety and effects on human health ' Safety and effects on human health in manufacturing, market handling, and storage in commercial warehouses and farms as wel l as appl ication in farms shall be provided to the regulatory authority. Peer reviewed report from the scientif ic j ournals may be accepted, (q) Packaging and labelling Packaging material The type of packing material used shall be stated. The packaging material shall maintain the quality, integrity and the properties of the product without leakages. L abel s and l eaf l ets A draft label shal l be submitted to PCPB for evaluation. i ' j Kenya Subsidiary Legislation, 2024 2313 Potential for establishment. In case of movement of biological control agents from one area to another, it is important to know if the agent can be established. If the agent cannot be established, less information may be required. Key factors that need to be considered include: — abiotic factors: The matching of climates of the area of origin and area of release. — biotic factors: availability of non-target species suitable for reproduction, temporal and/or spatial matching of non-target organisms and biocontrol agent, diapause capabilities, dry season survival; and combined biotic and abiotic factors: availability of other resources for survival and reproduction. Potential for dispersal: The probability of a temporal and spatial encounter between the biological control agent and non-target species to determine the potential for dispersal of the biocontrol agent. (1) Available information on possible indirect effects — report of any known indirect effects or discuss potential indirect effects on individual species and/or ecosystem. (m) Available information on environmental benefits — information on the benefical effects of release of biological control agents compared to current or alternative pest management methods. Information for assessment of any potential environmental risks. oils 5 (n) Information for assessment of efficacy of bidlogical'control agent'~< L. f ter Methods for the evaluation of quality and purity (quality control) of biological control agents. Benefits of use of biological control agents. Summary of assessment of efficacy. . (o) For native or established natural enemies and on biological control agents, long use, substantially reduced information requirements may be appropriate (p) Assessment of safety and effects on human health * Safety and effects on human health in manufacturing, market handling, and storage in commercial warehouses and farms as well as application in farms shall be provided to the regulatory authority. Peer reviewed report from the scientific journals fray be accepted. (q) Packaging and labelling Packaging material The type of packing material used shall be stated. The packaging material shall maintain the quality, integrity and the properties of the product without leakages. ‘ Labels and leaflets A draft label shall be submitted to PCPB for evaluation. Kenya Subsidiary Legislation, 20242 3 14 3.5.2. Data requirements for registration of macrobial pest control products The dossier accompanying the application must provide f ul l detai l s of the i nform ation requested in this list. If the product contains more than one active agent, a separate dossier for each active agent should be provided. Table 4: Summary of data requirements for registration o f a M ac r o b i al s Pest control product (a) Designation / identity N O . STATUS OF DATA REQUIREMENTS A c t i v e agent F or m u l ated product C o m m o n n am e R 1.2 Full taxonomic name including isolate, strain subspecies (where appropriate) Ro r Ful l taxonom ic classi f icat ion R M ethods of identi f ication and enumeration R R Manufacturer or Development Code R 1.6 Source, Name ari d Address of manufacturer /formulator and address and location of manufacturing plants. XK 'n Methods of producition, substrates and quality control R R R R 1.8 Collection and culture reference number where cul ture i s deposited. R 1.9 Formulation type and Code R 1 .10 Source and specifications for components included in t h e f o r m u l at io n R L jl .l l Evidence of registration/approval in other countries R 1.12 Validated laboratory report of five batch analysis R R C . Ef ficacy ^ Efficacy Summary of Field and laboratory study1 .13 R (b). biological/physical properties of the macrobial agents N O . Status of data requirements A c t i v e agent F or m u l ated product 2 .1 History of the macro-organism and its uses. Natural occurrence and geographical distribution R 2 .2 Description of the target organism(s) and mode of ac t i o n R 2314 Kenya Subsidiary Legislation, 2024 3.5.2. Data requirements for registration of macrobial pest control products The dossier accompanying the application must provide full details of the’ information requested in this list. If the product contains more than one active agent, a separate dossier for each active agent should be provided. Table 4: Summary of data requirements for registration of a Macrobials Pest control product (a) Designation / identity action NO. STATUS OF DATA REQUIREMENTS Active | Formulated agent product Common name R 1.2 |Full taxonomic name including isolate, strain or R subspecies (where appropriate) Full taxonomic classification R Methods of identification and enumeration R R Manufacturer or Development Code R 1.6 |Source, Name arid Address of manufacturer /formulator R R and address and location of manufacturing plants. eit Methods of production, substrates and quality control R R 1.8 |Collection and culture reference number where culture is] R deposited. 1.9 |Formulation type and Code R. 1.10 |Source and specifications for components included in the R : formulation 11 Evidence of registration/approval in other countries R 1.12 |Validated laboratory report of five batch analysis R R C. Efficacy 1.13 | ” Efficacy Summary of Field and laboratory study R (b). biological/physical properties of the macrobial agents NO. {Status of data requirements Active | Formulated agent product 2.1 |History of the macro-organism and its uses. Natural R occurrence and geographical distribution 2.2 |Description of the target organism(s) and mode of R 2 3 15Kenya Subsidiary Legislation, 2024 RHost specificity range and effects on species other t h an the target harmful organism 2 .3 RDevelopment stages/life cycle of the macro-organism2 .4 RInvasiveness, dispersal and colonisation ability2 .5 Effect of environmental parameters on stability and survival (UV, temperature, soil pH, humidity, etc.) o f macrobial agents R2 .6 RRelationships to known plant, animal or human parasites/pests and any known hyper parasite of m ac ro b i al 2 .7 RGenetic stability of macrobial agent2 .8 C RInformation on the production of metabolites (relevant to entomopathogenic nematodes) 2 .9 RBiological function in the control of insects, mites, ticks, nematodes, weeds, mol luscs, etc 2 .10 RInformation on the occurrence or potential development of resistance of the target organism(s) and resistance management strategy . 2 .11 Methods to prevent loss of predation or parasitic properties of the seed stock of the macro-organism R2 .12 ' b o ,d f !; ' o i Recommended methods and precautions concerning handling, storage, or transport R2 .13 RRProcedures f or destruct ion or decontamination2 .14 RPhysical state (solid, liquid etc)2 .15 R2 .16 C o l o u r RStorage stability in proposed packaging2 .17 i RSh el f l i f e2 .18 ■n RWater content (Humidity)2 .20 FRType and size of packaging2 .2 1 £ 1. 1 Rlabeling2 .2 2 r ;,-; ’ ! ' o o i Kenya Subsidiary Legislation, 2024 2315 2.3 |Host specificity range and effects on species other than) R {the target harmful organism 2.4 |Development stages/life cycle of the macro-organism R 2.5 |Invasiveness, dispersal and colonisation ability R 2.6 |Effect of environmental parameters on stability and R survival (UV, temperature, soil pH, humidity, etc.) of macrobial agents 2.7 |Relationships to known plant, animal or human R parasites/pests and any known hyper parasite of macrobial 2.8 |Genetic stability of macrobial agent R 2.9- [Information on the production of metabolites (relevant | CR to entomopathogenic nematodes) 2.10 [Biological function in the control of insects, mites, R ticks, nematodes, weeds, molluscs, etc 2.11 [Information on the occurrence or potential R development of resistance of the target organism(s) and resistance management strategy. 2.12 |Methods to prevent loss of predation or parasitic R properties of the seed stock of the macro-organism . . die votes vbarloby 2.13 {Recommended methods and precautions concerning —~ R — handling, storage, or transport ; 2.14 {Procedures for destruction or decontamination R R 2.15 |Physical state (solid, liquid etc) R 2.16 |Colour R 2.17 |Storage stability in proposed packaging R 2.18 |Shelflife vi R 2.20 |Water content (Humidity) R{7 2.21 |Type and size of packaging RT €h1 2.22 |labeling RR recoil Kenya Subsidiary Legislation, 20242 3 16 (c) Biosafety Hazard data may be waived where there is suff icient ev i d enc e t hat t here are no safety concerns. This would be based on results of medical survei l lance and publ ished d ata N O . Status of data requirements A c t i v e agent F or m u l ated product 3 .1 Medical surveillance data for manufacturing plant and agricultural workers (such as occurrence of hypersensitivity / allergies) R R 3 .2 Discussion of the effects of repeated human ex p o su re R R (d) Environmental safety Waivers may be granted on presentation of evidence that exposure to the particular non-target organism wil l not occur, or where effects of exposure are already documented. N O . Status of data requirements Active agent Formulated product 4 .1 Aquatic organisms C R 4 .2 Aquatic invertebrate C R 4 .3 B ees C R 4 .4 Representati ve natural enemies C R 4 .5 Persistence of active agent (days) R 4 .6 M obi li ty of active agent R Abbreviations: R = Required CR = Conditional ly Required R e f e r en c e s Black, R. (2013). A guide to the development of regulatory f ramew ork s f or microbial biopesticides in Sub-Saharan A frica. FAO. (2012) . GUIDANCE FOR HARM ONIZING PESTICIDE REG U L A T OR Y M A N A GEM ENT I N SO U T H EA ST A SI A . E lectr onic Publ ishing Pol icy and Suppor t Branch Communication D i v i si o n . (2018). International code of conduct on pesticide m a na g em en t : requirements f or the registration of microbial , botanical a nd semiochemical pest control agents f or plant protection and publ ic health uses: Food & Agriculture Org. https://croplif e-r9qnrxt3qxgj ra4.netdna-ssl .eom/wp-content/upload s/2 0 1 7/0 4 / T ec h n i ca l ALonograph 4 . F A O . Pest control products board (2003). Application for the registration of a microbial pest control product, Form A2 PCPB, Nairobi , Kenya 2316 Kenya Subsidiary Legislation, 2024 (c) Biosafety Hazard data may be waived where there is sufficient evidence that there are no safety concerns. This would be based on results of medical surveillance and published data NO. |Status of data requirements Active Formulated agent product 3.1 |Medical surveillance data for manufacturing plant R R and agricultural workers (such as occurrence of hypersensitivity / allergies) 3.2 |Discussion of the effects of repeated human R R exposure (d) Environmental safety Waivers may be granted on presentation.of evidence that exposure to the particular non-target organism will not occur, or where effects of exposure are already documented. NO. |Status of data requirements Active agent] Formulated product 4.1 {Aquatic organisms CR 4.2 |Aquatic invertebrate CR 4.3 |Bees CR 4.4 |Representative natural enemies CR 4.5 |Persistence of active agent (days) R 4.6 |Mobility of active agent R Abbreviations: R = Required CR = Conditionally Required 4. REFERENCES Black, R. (2013). A guide to the development of regulatory frameworks for microbial biopesticides in Sub-Saharan Africa. FAO. (2012). GUIDANCE FOR HARMONIZING PESTICIDE REGULATORY MANAGEMENT IN SOUTHEAST ASIA. Electronic Publishing Policy and Support Branch Communication Division. FAO. (2018). International code of conduct on pesticide management: requirements for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses: Food & Agriculture Org. hitps://croplife-r9qnrxt3qxgjra4 netdna-ssl.com/wp-content/uploads/2017/04/Technical Monograph Pest control products board (2003). Application for the registration of a microbial pest control product, Form A2 PCPB, Nairobi, Kenya Kenya Subsidiary Legislation, 2024 2 3 ] 7 'f aA F o r m a 2 A PPENDIX 1: Appl ication Form for the Registration of a Biopesticide Product Information for appl icants 1. The appl icant is the natural or legal person that manufactures the pest control product and/or places it on the market. After approval of the registration, the appl icant wi ll become the registration holder of the product. 2. The appl icant shall be a legal entity in Kenya or be represented by a local agent who is a permanent resident in Kenya and duly recognized by PCPB. 3. The appl ication form shal l be completed by a person duly authorized by the appl icant . 4. The appl ication shal l be submitted in tripl icate to PC P B 5. Every application must be accompanied by: (a) proof of payment of the appl ication fee as prescribed by the national pesticide registration authority ; (b) three (3) copies of the draft label t f C •■i '/ i (c) three (3) copies of the technical dossier as per the data reguirements detai led in L ist I (act ive ingredient) and L ist I I (formulated product) . 6 . The applicant may be required to submit: (a) Registration authorization letter: In case the appl icant is not the owner of the TGAI/product, provide a letter in which the owner of the TGAI/product authorizes the applicant to apply for registration; sample of the pest control product , for bio eff icacy trial purposes; (c) a sample of the pest control product for residue trial purposes (where appl icable); (d) a sample of the technical grade of its active ingredient(s)/ agent(s); (e) a sample of the analytical standard of its act ive ingredient(s) (A pplicable for only B iochemicals); any other sample as may be required by the pesticide registration authority (b) A >{ (f ) Kenya Subsidiary Legislation, 2024 2317 FORM A2 APPENDIX 1: Application Form for the Registration of a Biopesticide Product Information for applicants 1. The applicant is the natural or legal person that manufactures the pest control product and/or places it on the market. After approval of the registration, the applicant will become the registration holder of the product. 2. The applicant shall be a legal entity in Kenya or be represented by a local agent who is a permanent resident in Kenya and duly recognized by PCPB. 3. The application form shall be completed by a person duly authorized by the applicant. 4. The application shal] be submitted in triplicate to PCPB 5, Every application must be accompanied by: (a) proof of payment of the application fee as prescribed by the national pesticide registration authority; (b) three (3) copies of the draft label ier wie? ty “aay rab SS (c) three (3) copies of the technical dossier as per the data requirements detailed in List I (active ingredient) and List II (formulated product). 6. The applicant may be required to submit: (a) Registration authorization letter: In case the applicant is not the owner of the TGAI/product, provide a letter in which the owner of the TGAI/product authorizes the applicant to apply for registration; (b) sample of the pest control product, for bio efficacy trial purposes; (c) a sample of the pest control product for residue trial purposes (where applicable); (d) asample of the technical grade of its active ingredient(s)/ agent(s); (e) asample of the analytical standard of its active ingredient(s) (Applicable for only Biochemicals); (f) any other sample as may be required by the pesticide registration authority Kenya Subsidiary Legislation, 20242 3 18 PR O D U C T1 Product name (brand name)1 .1 Type of formulation (CropL ife code) 1 .2 1 .3 Active ingredient(s)/Agent (s) (common name) A ctive ingredient/Agent (s) concentrat ion(s) 1 .4 Patent status and expiry date (if applicable) 1 .5 Quick Response (QR) code (if avai lable) 1 .6 2 A P PL I C A N T 2 .1 A ppl icant name (corporate name of company) f o r m u l ato rm anu f ac tu r er o ther : . . . . 2 .2 Stat us Business registration number2 .3 2 .4 Physical address 2 .5 Po stal ad d ress 4 3 0 Telephone number .2 .6 2 .7 E -m ai l add r ess 2 .8 W eb si t e Contact person at appl icant c o m p an y 2 .9 2 .10 Contact person telephone number 3 L O C A L A G E N T 3 .1 L ocal agent name (corporate name of company) (if dif ferent from appl icant) formulator importer distributor o ther : . . . . Stat u sB.2 Business registration number3-.3 3 .4 Physical address Po stal ad d ress3 .5 3 .6 Telephone number E -m ai l ad dr ess3 .7 3 .8 Contact person at local agent Contact person telephone number3 .9 i \ ' - • r / 2318 Kenya Subsidiary Legislation, 2024 1 PRODUCT 1.1 {Product name (brand name) Type of formulation (CropLife code) Active ingredient(s)/Agent (s) (common name) Active ingredient/Agent (s) concentration(s) Patent status and expiry date (if applicable) Quick Response (QR) code (if available) APPLICANT Applicant name (corporate name of company) Status manufacturer other: .... formulator Business registration number Physical address Postal address .|Tefephone number. Tey E-mail address Web site Contact person at applicant company Contact person telephone number LOCAL AGENT Local agent name (corporate name of company) (if different from applicant) Status formulator importer other: .... distributor Business registration number Physical address Postal address Telephone number E-mail address Contact person at local agent Contact person telephone number Kenya Subsidiary Legislation, 2024 2 3 19 4 PU RPO SE OF A PPL I CA T I ON A New pest control product containing a new active ingredient (a.i .)/A gent New pest control product containing an active ingredient/Agent already registered in the country New source of active ingredient/Agent and/or formulation of an existing registration Amendment or extension to an existing registration B C D E Registration transfer (between registrants) F Other (specify): 5 I N T E N D E D U SE 5 .1 Function/category of product (more functions/categories possible) I n sect i c i d e Fungicide H er b i c i d e A c ar i c i de R od en t i c i d e M o l l u sc i c i de B acter i c i de D ef o l i an t Plant growth regulator Sem i o C hem i c al Other (specify): .. . 5 .2 Type of use (more types possible) Agriculture Veterinary P ub l i c heal th H o u seh o l d Forestry I n d u str i al I , ■ T ' Other (speci fy): 5 .3 Category of Biopesticide M i cr o b i al M acr o b i al B o tan i c al s Sem i o ch em i c al s 5 .4 Target pest(s)/di sease(s) and crop(s)Mse(s) 1 2 3 6 H A Z A RD CL A SSI FI CA T I ON (FOR BIOCHEM ICALS) 6 .1 W H O H azar d C l ass o f the formulated product C l ass l a C l ass I b C l ass I I C l ass I I I C l ass U 6 .2 GHS classif ication of the formulated product (list all classif iable hazards) Physical hazards H eal th hazards E n v i r o n m en tal h az ar d s D e c l ar a t i o n For and on behalf of as wel l as the data provided in the technical dossier , in suppor t of this application I hereby certif y that the above mentioned inf ormation. Kenya Subsidiary Legislation, 2024 2319 4 |PURPOSE OF APPLICATION A | New pest control product containing a new active ingredient (a.i.)/Agent B | New pest control product containing an active ingredient/Agent already registered in the country C | New source of active ingredient/Agent and/or formulation of an existing registration D | Amendment or extension to an existing registration E | Registration transfer (between registrants) F | Other (specify): 5 INTENDED USE 5.1 {Function/category of product Insecticide Fungicide Herbicide voit categories Acaricide | Rodenticide | Molluscicide Bactericide Defoliant Plant growth regulator Semio Chemical Other (specify): | i . 5.2 |Type of use (more types possible) | Agriculture Veterinary Public health Household Forestry Industrial .. Other (specify):|... nS 5.3 {Category of Biopesticide Microbial Macrobial Botanicals Semio chemicals 5.4 Target pest(s)/disease(s) and 1 crop(s)/use(s) 6 |HAZARD CLASSIFICATION (FOR BIOCHEMICALS) 6.1 |WHO Hazard Class of the Class Ia Class Ib Class II formulated product Class Ill Class U 6.2 GHS classification of the formulated product (list all classifiable hazards) Physical hazards Health hazards Environmental hazards DECLARATION For and on behalf of .......... hereby certify that the above mentioned information, as well as the data provided in the technical dossier, in support of this application Kenya Subsidiary Legislation, 20242 32 0 are true, cor rect and complete. Name in f ull (pr int) Signature D a teOff icial title Of f icial stamp of appl icant!company 8 F o r O f f i c i al U se R em a r k s :Appl ication No: . . . Reception date: . .. F ees r ecei ved : Yes N o Amount paid: Approved Rej ected Pending Status of appl ication: 2320 Kenya Subsidiary Legislation, 2024 are true, correct and complete. PreeTeITTTTIrirTeee rr ceeer eee ee sire Official title Official stamp of applicant/company FOR OFFICIAL USE Application No: ... ‘|Remarks: Reception date: cee Lan nennnnenennnsersecenacanancnscenenccegeeaenaaeeeneeeeeeeaees Fees received: Yes No [7 vvrrrmmemmmmnneneren a ae Status of application: Approved Rejected Pending Kenya Subsidiary Legislation, 2024 2 32 1 Complete the GAP Table for Efficacy Appendix xxx G A P tab le f o r GAP rev . 1, d ate : Pr o d uct n am e Active ingredient(s) K u v u 80 W P M anc o zeb Formulation type: WP Cone, of a.i : 800g/Kg Appl icant: XYZ A grochemicals ) ' . Kenya Subsidiary Legislation, 2024 2321 Complete the GAP Table for Efficacy Appendix xxx GAP table for GAP rev. 1, date: Product name ‘Kuvu 80WP Formulation type: WP Active ingredient(s) Mancozeb Conc. of a.i: 800g/Kg Applicant: XYZ Agrochemicals Kenya Subsidiary Legislation, 20242 32 2 12 13 141 18 105 6 71 3 4 P H I R e m ar k s :Application rateApplicationUse/ Crop N o . and/ Fungicid e/H erb ic i d e/ I n sec t i c i d e / O t h P e st s o r (days)g/kg of a.i . per W ater L /haL g/kgTiming / G row th stage of crop & s e a s o n M ax . numbe M i n . i nterv al between applicati M et h Group a.i/haproducod /o r m i n / m axof h Lr of t / hasi tu at K ind a) m ax . rate per appl . b) max . total rate pests control e r s applies t ions i o n a) m m . -(specify)(crop desti n at i o o n s m a x .m a x .led per r a t e (additi onally: develo pmenta 1 stages of the pest or crop o r s e a s o n pe r n / appl . per croppurp b) o r s e a s o n o s e m a x .of totalcrop/ r a teg r o w pe rth pest crop/se a s o n h ab i t at e .g i ndo Group, w h e re n e c e s s o r o r outd ary [e.g. larv ae , adults] oo r) ) 160 - 600 - 1000 L 14 days2.0 kg 1.6 kg 4.0 kg 3.2 kg Ind icat Fol ia Upon infestati 1 - 2 7 days1 Indie e.g. ator Fungicid or crop : e 200gr pe r pest(s): spray on s e a s o n (e.g. T o m e .g . Phytop hthotai n f esta n s(l ate blight) ato) 600 - 1000 L 14 day s.6 kg 16 0 -F o l i a Upon i n f est at i 1 - 2 7 days 2.0 kg 4.0 kg 2 T o F Phytop h t h o r a i nfestan s( late blight 200gb e pe rr 3.2 kg e x t r a polat sp r ay o n s e a s o n ed t o : P o t at o 2322 Kenya Subsidiary Legislation, 2024 1 3 4 5 6 7 8 10 11 12 13 14 Use/iCrop|Fungicid | Pests Application Application rate PHI |Remarks: No. |and/ ne Meth|Timing/|Max. [Min. |L [g/kg [g/kg of [Water L/ha | (days) or |, © nsect/GrouP |44/ |Growth |numbe interval producja.i/ha jai. per : . Jicide/Oth| of ; min / max situad Kind|stage of jrof —|between |t/ha hL ion |*S Pests crop & |applicalapplicati |. a) max. . (specify) |control . a) rate per |min. (crop season |tions |ons : led max. {appl. max. desti per rate natio (additi crop or b) max. per n/ onally: season appl total rate purp develo PP’. per crop ose pmental b) or season] of I stages, max. crop/ of the total grow pest or rate th pest per i crop/ habit Group, ‘op/se at ¢.g where ason indo necess or or ary outd leg. oor) larvae, adults] ) 1 |Indicje.g. Indicat|Folia}Upon |1-2 |7days |20kg|1.6kg |160- |600-1000L) 14 days ator |Fungicid jor C infestati| per 4.0kg |3.2kg 200g crop:|e pest(s):|sprayjon season (e.g. e.g. Tom Phytop ato) hthorai nfestan s(late blight) 2 |To |F Phytop|Folia}Upon |1—2 |7 days 2.0kg |16kg |160- |600-1000L) 14 days be hthorai|r infestati}per 4.0 kg [3.2 kg 200g extra nfestan|spray|on season polat s(late ed blight to: Potat ° Kenya Subsidiary Legislation, 2024 2 3 2 3 F O R M B 3 ( r . 6 (2)(b) PE ST C ON T R O L PR O D U C T S B O A R D P.O. BOX 13794-00800, NAIROBI , WAIYAKI WA Y T el ; 254-020 4446 115/4450242 Fax : 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@pcpb.go.ke WEBSITE ADDRESS: https://wwvv.pcpb.go.ke/ Summar y Of The Dat a Submit t ed To The Boar d For Regist r at ion O f A B io c hemic a l Pest Co n t r o l Pr o d u c t . PA R T I T r ad e N am e T he N ame and A ddress of manuf acturer , /'’HI, ' • i T ,;c T he N ame and A ddress of Formulator , ■' i Common Name of the active ingredient(s) Concentration of active ingredient(s) Source of active ingredient(s) C h em i c al N am e i -i Form ulation type I Proposed Uses Packaging/Containers (M aterial size) Registrant (Name, Address, Status) Agents/Distributors in Kenya Premises (Reg.No. Date of issue) Kenya Subsidiary Legislation, 2024 2323 FORM B3 (r.6 (2)(b) PEST CONTROL PRODUCTS BOARD P.O. BOX 13794-00800, NAIROBI, WAIYAKI WAY Tel: 254-020 44461 15/4450242 Fax: 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@pcpb.go.ke WEBSITE ADDRESS: https://www.pcepb.go.ke/ SUMMARY OF THE DATA SUBMITTED TO THE BOARD FOR REGISTRATION OF A BIOCHEMICAL PEST CONTROL PRODUCT. PART I Common Name of the active ingredient(s).......0..0.0...0.cccccccescecceceucecceucececcuseuscess Concentration of active ingredient(s)...............c..c.cccccceceeuececeecucuseueueecsrtsctececuees Source of active ingredient(s)..............cccccccscececucuseesevcecuceavecseaeeesueeueuseecuseseess Chemical Name..............00c0.cccceeevcceccecuceeececcseveecvereseash dicccececeevecessesevueeesees Packaging/Containers (Material size)..............0.0ccccceceeccccu cece ccacaececucesensucancesesss Registrant (Name, Address, Status)...........0...ccccsccceccuceeccuseeasecsneucustcevucecerereeees Agents/Distributors in Kenya..... 0.00... ccc ccc ccc ccc ceecueeeeussuseceusueceneuccueateveueusvevasavens Premises (Reg.No. Date of issue)......... 000... ccccc cece eecce ccc vecceccauseucrevtaesesertraneeness Kenya Subsidiary Legislation, 20242 324 P A R T I I C H E M I ST R Y D A T A Physical /Chemical Properties of the a.i(a) Physical/Chemical properties of the technical grade m ater i al(b) Composition of the technical product (purity%, nature and content of impurities, isomers, by-products - other details should be provided in the dossier ) (c) Physical/Chemical Properties of the Formulated Product(d) Composition of the Formulated Product ( Concentration of a.i . in the f ormulat ion , other details should be provided in the dossier) (e) Method of analysis for determination of the a.i . in technical and formulated products(f) PA R T I I I Biological (eff icacy) Data a) Target Pest(s), Diseases(s), Host(s) b) M ode of action c) Method, Rate, Frequency of application.... d) Recommendations for use in Kenya e) Recommendations for use by authorized bodies outside Kenya 2324 Kenya Subsidiary Legislation, 2024 PART I CHEMISTRY DATA (a) Physical /Chemical Properties of the a.............. cies eee e ec ce eee ence tenet ner e ee ctees (b) Physical/Chemical properties of the technical grade material................::secseeeees (c) Composition of the technical product (purity%, nature and content of impurities, isomers, by-products — other details should be provided in the dossier) (e) Composition of the Formulated Product ( Concentration of a.i. in the formulation. other details should be provided in the COSsier) .........:ccsesesetseeeereeeeeenecnereeeeeeseerseneeenaes (f) Method of analysis for determination of the a.i. in technical and formulated products PART HI Biological (efficacy) Data a) Target Pest(s), Diseases(s), HOSt(S). .........cccceeeee ene ne ener eee eee nee ene ene ena d) Recommendations for use in Kenya 1.0.0.0... cece erence eee ener nen e eens e) Recommendations for use by authorized bodies outside Kenya..........---..sceeeeeee ees Kenya Subsidiary Legislation, 2024 2 32 5 P A R T I V Toxicological data a) Acute Toxicological Data of the active ingredient(s) 9 b) Acute toxicity data of the formulated product: c) Short term toxicity studies d) Other toxicological studies: 1) Reproduction studies 2) Teratological studies 3) Neurotoxicity studies 4) Mutagenecity studies 5) Long term toxicity/carcinogenicity studies 6) Accumulation of compound in tissues 7) M etabolic studies, 8) Effects on l ivestock , poultry 9) Toxicity Data on impurities 10) Toxicity Data on metabol ites 11) Human toxicology and medical aspects: (a) Hazards to humans (b) Symptoms of poisoning Kenya Subsidiary Legislation, 2024 2325 PART IV Toxicological data a) Acute Toxicological Data of the active ingredient(s) d) Other toxicological studies: 1) Reproduction studies .............cccccceecee cee eee ee ee nec ee eee nee seen eens nen eee eee eenecnee ene ts 2) Teratological studies............:.ccceceeeneeceene ene ee en ee nena enone tener eee eee eee eaeneneee eee aes Rem ee eee nee eee eee mee eee EO ARETE HEMET ROE SE ESTER EDEL ODED OSHS OHESES SREB ED EDF SDE SHEESH HOH OHSS HED ELE HES ERE OEE 11) Human toxicology and medical aspects: (a) Hazards to humans....... nea eeesececeeeeeseceeeeeeteneneens dee ten eee ten eeeeneaneeeeseereees (b) Symptoms of pOisONning............. cc ccc eec eee ec ee ee ene ne nee eeee ee ee tence cena es nee eee es Kenya Subsidiary Legislation, 20242 32 6 (c) Antidote (d) Treatment (e) First A id M easures (f ) Safety Precautions/Restrictions P A R T V - R E SI D U E D A T A a) Principal Residues b) Disappearance and fate of residues c) M ethod(s) of analysis (crops, soi l , water , feedstuffs etc.) PA R T V I Environment and wildl if e hazards a) Degradation and mobility studies (soil ,water, air) b) Toxicity to birds c)Toxicity to f ish d)Toxici ty to honeybeeŝ enef lcial insects e) Toxicity to earthworms, other soil invertebrates f) Changes in soil ecology PA R T V I I Information on Approvals/Registrations in other countries (A ttach copies of certif icates) PA R T V I I I D raf t of l ocal label PA R T I X Brief prepared by Signature 2326 Kenya Subsidiary Legislation, 2024 (C) Artidote...... 0... ccc cccc ccc ec ese cceceneneeeecasceenceueuaeueeseeeeusesseasunecseveneveacs (d) Treatment ..............cccceceececeececeeeceeeeeeeesersesere Lace eeneeecneceeeeeseeeeeseees (e) First Aid Measures..............ccccceccccscesececceeeeerteteneeseesentessucuucuuerensees (f) Safety Precautions/Restrictions..............ccscccecceesecesceetescucucuesscuseeeeses PART V —- RESIDUE DATA @) Principal Residues...........0....cccseceesececsscnececeecaeeeeeseeeeseeneessaesesaeaseeeeseuneens b) Disappearance and fate of residues................0cccecceeeceeeeeeceeceeeeeeeeeeeceneneseneees c) Method(s) of analysis (crops, soil, water, feedstuffs etc.).............cccccssecceveneceeeees PART VI Environment and wildlife hazards a) Degradation and mobility studies (SOi] Water, AIL) ...... 0... cece cece ccc edeccenenecncewevess SE ee MONIC Fh ocettnnninnnnninnnnnnnnnnnnnnnne A)Toxicity to honeybeeshbenefica inst. vvessvnvnvnvininvinnnnee e) Toxicity to earthworms, other sol iverEbIMES. nesses Changes in s0i €c0108Y eee vnsettntttnntitnninnnnnnnnie ee Pee eee nee nea e ete EEE RENTS NEE EUS EOE EAE SEO DEO EGE OEOESEE EE EO EEE EEE AGE REE EE SEE EEE SEEDS Information on Approvals/Registrations in other countries (Attach copies of certificates) Brief prepared by......... 0.0... cee cceceecseceeneeceecsece ees eee sence eee seg euseeecenseeeueaesarsaeenss Sigmature......... 0c. ccecccsescsecsecascceccereseeceeenseeeeeeseeeeecseeeseeeeerseestasssuesuteuneaneees Kenya Subsidiary Legislation, 2024 2 3 2 7 Off icial stamp D ate P A R T X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration R easo n s: D ate o * ' ' t i S. . / T P.A q Kenya Subsidiary Legislation, 2024 2327 PERE REP Ere Sree reer ee eee er errere reece rer rerrrrerrrrrre reer reer err errr eres esse crac e re cece eee eee eee PTEPETEVEPETESESESESECEOS ECCS eee eee eee Tee See err eee CEES Peer eer reer e ree eee eee eee cere eee eee eee cree sy 4 THAW a t “ote” Kenya Subsidiary Legislati on, 20242 3 2 8 F o r m B I (r6(3)(c)(i)) P E ST C O N T R O L PR O D U C T S B O A R D P.O. BOX 13794-00800, NAIROBI , WAIYAK I WA Y T el ; 254-020 4446 115/4450242 Fax : 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@pcpb.go.ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ SU M M A R Y OF T H E D A T A SU B M I TT ED TO T H E PCPB FOR RE GI STR A T I ON O F A M I CR OB I A L PE ST CON T ROL PROD U CT . PA R T I T r ad e N am e , N ame of the m anuf acturer and dddress T he N ame and A ddress of Form ulator Common Name of the active Agent (s) Concentration of active ingredient(s) Source of active ingredient(s) Scientific name of the microbial Agent Formulation type Proposed Uses Packaging/Containers (M aterial size) Agents/Distributors in Kenya, Premises (Reg.No. Date of issue) 2328 Kenya Subsidiary Legislation, 2024 ForM BI ; (r6(3)(c)(i)) PEST CONTROL PRODUCTS BOARD P.O. BOX 13794-00800, NAIROBI, WAIYAKI WAY Tel: 254-020 44461 15/4450242 Fax: 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@pcpb.go.ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ SUMMARY OF THE DATA SUBMITTED TO THE PCPB FOR REGISTRATION OF A MICROBIAL PEST CONTROL PRODUCT. Trade Name......c.ccccceccccscessccsccescesccessscseesecueceseesacecseceuetatsssecaseesessteeesecseens Name of the manufacturer and dddress..............cccscceccacceeeeeesesereseeceeseusussussesanens The Name and Address of Formulator cena eek eee canoe nea eee n eee ee eee ses ees ea eeee eee eeeereaseeeses Common Name of the active Agent (S) .............ccsscceesseeeeeereeeceteseeseesenecestaceeceess Concentration of active ingredient(s) ............... Vente nee ene eae eeeseceeneeusecueesausesensesesess Source of active ingredient(s) .............ccccececssssevevcecccescesececcececsesucaesceescseseceneees Scientific name of the microbial Agent.................... Agents/Distributors in Kenya......... 0.0... scceeceseceecueceeceuseuceesescascsssaseeccneeessaseuess Premises (Reg.No. Date of issue) .............ccccccecceececescccesceseceeescescccrsceceesesseneens HOP. Kenya Subsidiary Legislation, 2024 2 3 29 P A R T I I Ph y sic a l /Chemic a l Pr oper t y Of T he A c t iv e A g en t (a) Physical /Chemical Propert ies of the active agent (b) Physical/Chemical propert ies of the technical grade material add (incase dif ferent f rom point a) above) (c) Composition of the technical product (purity %, nature and content of impuri ties/ contaminants, by-products - other details should be provided in the dossier) (d) Physical/Chemical Propert ies of the Formulated Pr od uc t (e) Concentration of active agents, in the formulation. (Other detai ls should be provided in the dossier) ' (f ) M ethod of Identif ication, Enumeration and Bioassay «13 't o■M t. PA R T I I I B io l o g ic a l Pr o per t ies o f t he M ic r o o g an i sm Origin of microorganisms and its uses Effect in the non-target organisms Life cycle of the microorganisms Infectivity (plants and animals) Dispersal and colonization Effect of environmental parameters (UV , temperature, soil pH , humidity , nutrition requirements, etc.) on stability and survival Relationships to known plant, animal or human pathogens Genetic stability and factors affecting it(potential mutant) Information on the production of metabolites (especially toxins) Show antibiotics and other anti-microbial propert ies (a) (b) (c) (d) iqof -l (e) (f ) (g) (h) (i ) a) Kenya Subsidiary Legislation, 2024 2329 PART II PHYSICAL/CHEMICAL PROPERTY OF THE ACTIVE AGENT (a) . Physical /Chemical Properties of the active agent............:..cteeceeceecnenneer ere nenes (b) Physical/Chemical properties of the technical grade material add (incase different from point a) ADOVE) 22.0.2... ee ee eect cen ence ence nee e ene Eee eee EEE EERE EEEE EEE eEH EEE Eee eet ees (c) Composition of the technical product (purity%, nature and content of impurities/ contaminants, by-products — other details should be provided in the dossier) (d) Physical/Chemical Properties of the Formulated Product PTT rTrrer rrr rrr rrr rr errrrrrr rr er rrr rr rrrr rrr err rrr ere rrr err rr rere ries reese eee eee eee (e) Concentration of active agents. in the formulation. (Other details should be provided in the dossier) ..............cccessce ee eeeeensensesen eet ens eases le ceeene tee neneneeeseeuens ait t ; “ PART II BIOLOGICAL PROPERTIES OF THE MICROOGANISM (a) Origin of microorganisms and its USES..............6ceeceeeeeeeeeeeen eens veceenaeseens (b) Effect in the non-target organisms.. 7 be eeeeseenes . beece ee ten eee eeeeeeeee eee nseaeeseeee . (c) Life cycle of the microorganisMS...............csccceserseneneee nee nen sence neeee eee as (d) Infectivity (plants and animals)................0.ccceeeeeeeeececececne rec sueueeceees me (e) Dispersal and colomization............::.:eecescneneeceeeeeeeeseeca se eaeeenerenees a0 (f) Effect of environmental parameters (UV, temperatute, soil pH, humidity, nutrition requirements, etc.) on stability and survival (g) Relationships to known plant, animal or human pathogens.............. se eeeeeeees (h) Genetic stability and factors affecting it(potential mutant)..............-..---e.eee (i) Information on the production of metabolites (especially toxins) ..............6+ (j) Show antibiotics and other anti-microbial properties...............5s:.s:eeeeeee eens Kenya Subsidiary Legislation, 20242 3 30 PA R T I V Biol og ical (ef f ic acy ) Dat a (a) Target Pest(s) , Diseases(s) , Host(s) (b) Mode of action of the microorganism Method, Rate, Frequency of application Recommendations for use in Kenya Recommendations for use by authorized bodies outside Kenya. (c) (d) (e) PA R T Y T o x ic o l o g ic a l da t a (a) Acute Toxicological/Infectivity Data of the active agent(s) (b) Acute toxicity data of the formulated product: (c) Short term toxicity studieŝ îf there is concern under T ier 1 studies) (d) Other toxicological studies(if concerns on Tier 1 and 2) ( 1) Reproduction studies (2) Teratological studies (3) Neurotoxicity studies (4) Long term toxicity/carcinogenicity studies, 6) Metabolic studies (if microorganism organism is known to produce metabol ites) (7) Effects on livestock, poultry (if exposure is expected) 2330 Kenya Subsidiary Legislation, 2024 PART IV BIOLOGICAL (EFFICACY) DATA (a) Target Pest(s), Diseases(s), Host(s)............ccccccesececccsscsceeecrecs sete eeeeeeeeesenenees : (b) Mode of action of the microorganism ................cccccesseceeceecscessevecaceccesenscneaes (c) Method, Rate, Frequency of application..............cccsccsecssstesceeeuesencesestenseuceuees (d) Recommendations for use in Kenya ................cccccscecessscsceccscuseeeuccecasansnenees (e) Recommendations for use by authorized bodies outside Kenya..................00c.0.005 PART V TOXICOLOGICAL DATA (a) Acute Toxicological/Infectivity Data of the active agent(s) COMO e ee errr arse rae nee esa sar ees e re eee eae eee sEe een OE TEESE SEE EEE E EE EEE HOS ESH OOS EEE EOE OED ESSE EEE EOE HOE DOE ED ee ee ee ee ee ee ee ee ee eee eee re ee ee ee ri i rnin i ee ee ee ee eee ee eee eee ee ee ee ee eee rr ean ee ee ae a re ee ee a i ee ee ee ee ee ee ee ee ee eee res eee eee eee eee ee ee eee ee ee eee ee ee arn Ue ee ee ee aa a res (7) Effects on livestock, poultry (if exposure is expected) ete des eee eeneeecneeneseeeeetoeetanes 2 3 3 1Kenya Subsidiary Legislation, 2024 (8) Toxicity information on impurities/contaminants if pathogenic signif icant (9) Toxicity Data on metabolites (if applicable) (10) Human toxicology and medical aspects: (a) Hazards to humans (b) Symptoms of poisoning or allergic reactions (c) A ntidote (d) Treatment (e) First A id M easures (f) Safety Precautions/Restrictions PA R T V I R e s i d u e D a t a (Data is required if the microorganism produces metabolites) (a) Principal Residues (a) Disappearance and fate of residues, (c) Method(s) of analysis (crops, soil , water, feedstuffs etc.) P A R T V I I E n v i r o n m en t a n d w i l d l i f e h a z a r d s Degradation and mobility studies (soil , water, air) Toxicity to birds Toxicity to fi sh Effects on aquatic invertebrates Toxicity to honeybees/benefi cial insects Toxicity to earthworms, other soil invertebrates Effect on other soi l microorganisms (bat -Jic : • (£) (a) (b) (c) (d) (e) (f ) (g) Kenya Subsidiary Legislation, 2024 2331 TTT ree rT eer ere ere ere eee eee eee eee ee eee CeCe eee Ter eee eee eee eee eee eee eS eee eee eee ee eee eee (9) Toxicity Data on metabolites (if applicable) ...............ccceecceeseceeeseeeeeeeeenenenees (10) Human toxicology and medical aspects: (b) (d) (g) (a) Hazards to humans..............ccseceeeeneeeeeeseeveeees evcesesacssesesevsessessvscuesen (b) Symptoms of poisoning or allergic reactionS...............:.ccceenesererteeeneeeeeees Coa 20166 (0) (ne (G) Treatment ..........cccccccecenc eect eee cence nee e eee eee nee ne nee n eee eet ee eee ee snes eee eeen es (e) First Aid Measures............ cscs ceecee eee eeeeee eee e ee een eens ene nen eee en eran een en ene (f) Safety Precautions/Restrictions.............cccscececne see eeeeeeeeeeeneneneneeeeneenees PART VI RESIDUE DATA (Data is required if the microorganism produces metabolites) Principal Residues..............ccecececec cee eeneesenenen sees Seve eneceeeeuseeeesestoccoccceeeetens PART VII ENVIRONMENT AND WILDLIFE HAZARDS LM (€) Degradation and mobility studies (soil, water, air) ..........:.ccecee ee eeeeeeeeeneen eee neees TOXICILY tO DIFdS....... cece ee ee erence eee e eee een ee eee e ae eet eee seer ee eeeaee a sees TOXicity to fish... 0... eee cee cece sete ne cece ester eee eee eee en eens eee tee eee tee eenenee creases Effects on aquatic invertebrates.............cccec cee eee eee eeeeeen en een enna eneeeen ene seee ean ens Toxicity to honeybees/beneficial insects.............:.cseseeeeeeeneeeeeeeoees veeseneseseueees Toxicity to earthworms, other soil invertebrates.............cccccseeeesceceeceveceeneesees Effect on other soil mMicroorganisMS..............ccceeeceeescncee ee neneeeeneereneeeneneeaees J. (betuecqr: Kenya Subsidiary Legislation, 20242 3 32 PA R T V I I I (a) Information on Approvals by local phytosanitary au th o r i t i es . . (b) Registrations in other countries (Attach copies of certif icates) (b) Information on approval by national bio-safety B o ar d i f G M O ’ s PA R T IX Draft of local label (as per Legal Notice No.89/1984). PA R T X Brief prepared by Signature Off icial stamp ... . D ate PA R T X I Decision of the PCPB Technical and registration Committee Recommended/Not Recommended for registration R easo n s: D ate 2332 Kenya Subsidiary Legislation, 2024 PART VIII (a) Information on Approvals by local phytosanitary authorities..................0cc0cceeee0e (b) Registrations in other countries (Attach copies of certificates) PART IX Draft of local label (as per Legal Notice No.89/1984). PART X Brief prepared DY............... ee eeceeec eee eceeeeeeeeeesseeneseeaseenenesaseessucescesseeeerensenss Signature...........ccce eee ee POON ee ene EERE EE EE EERE RE EE ERODE EEE EEE EERE EES EO EEE EE Official stamp ...........eeeecee cece teeeeeenees tena aesaeeaae nee eeeeeeteneoseceeeeceaneeaeeaaaeeeeeeeess Date... 0... ccc secs cece neces ceeeenceuecseceneeeae eee ececnesanesaeeseseescseetaecteessasesssuenssnscaucs PART XI Decision of the PCPB Technical and registration Committee Recommended/Not Recommended for registration Reasons: Kenya Subsidiary Legislation, 2024 2333; ̂ F o r m B 2 (r .6 (3)(c)i i i-) ■: .. I P E ST C O N T R O L P R O D U C T S B O A R D P.O. BOX 13794-00800, NAIROBI , WAIY AKI WA Y T el : 254-020 4446 115/4450242 Fax : 254-020 4449072; E-M A IL : md@pcpb.go.ke WEBSITE ADDRESS: https://wwvv.pcpb.go.ke/ Su mma r y o f T h e D a t a Su bmit t ed t o T h e Pc pb Eo r Reg ist r a t io n o f A M a c r o b i a l Pe st C o n t r o l Pr o d u ct . 1 c , f . - r •fev/ . f' PA R T I T r ad e N am e Collection Number (National museum of Kenya) T he N am e and A d d r ess o f F o r m u l ato r Common Name of the active agent(s) Description of unit Counts of active agent(s) per unit Source of act ive agent Scientif ic name of the agent i . n r Form of presentation (stage of development , carrier m ater ial Proposed Uses ( I• C t. Packaging/Containers (M aterial ,size) ■>.L L 3-i 'T • » s Registrant (Name, Address, Status) ■■fl-, . / ( 2 ; A gents/Distributors in Kenya Premises (Reg.No. Date of issue) Kenya Subsidiary Legislation, 2024 2333; ¢ Ste ei ee orm Bo | 6 NCH.» PEST CONTROL PRODUCTS BOARD. .. ou Atle P.O. BOX 13794-00800, NAIROBI, WAIYAKI WAY |. os uti: Tel: 254-020 44461 15/4450242 Fax: 254-020 4449072: ik. aires E-MAIL: md@pcpb.go.ke WEBSITE ADDRESS: https://www.pcpb.go kel SUMMARY OF THE DATA SUBMITTED TO THE PCPB FOR REGISTRATION oF PA MACROBIAL, PEST CONTROL PRODUCT. PART | eo Oe C6 ET 9 Collection Number (National museum of Kenya).... : Sore steeeeees eeees The Name and Address of Formulator................ veceee *eeceeeuae . ve Common Name of the active agent(s) Description of unit Counts of active agent(s) per unit .......... Leen Se Source of active agent ............0...064. FeSO SEES SESS SEESSS Scientific name of the agent...............ccccceeeeeee ee eneeees eee ees better pedeee te nep ite geek eompe i pies ere scnieng crag es cies sean esate By Form of presentation (stage of development, carrier material.......... tees prtnstreetses agrees, Proposed Uses.......... cc cicecec cece cece eect e neta nee ee nea scene ete teteaee scenes een ene ea ea se i . Kenya Subsidiary Legislation, 20242 3 34 P A R T I I B I O L O G I C A L D A T A (a) Description of the agent as presented (stage, colour) (b) Taxonomy (c) Descriptive identification of the agent (d) Natural occurrence and geographical distribution (e) Host specificity range and effects on non-target species.. .(including invasiveness, dispersal , colonization ability) (f) Development stages/life cycle (g) Genetic stability , (h) Stability in proposed packaging (i) Method of quantification P A R T I I I E m c A CY D a t a (a) Target Pest(s), Diseases(s), Host(s) b) M ode of action b) Method, Rate, Frequency of appl ication C) Recommendations for use in Kenya d) Recommendations for use by authorized bodies outside Kenya. P A R T I V B i o sa f et y d a t a (a) Bio-Surveillance data available (b) Relationships to known plant , animals or human parasites (c) Hazards to humans. (d) Safety precautions/Restrictions (e) Recommended methods and precautions concerning handl ing, storage, or storage (f) Procedures for destruction (g) Measures in case of an accident PA R T V I E n v i r o n m en t a l D a t a (a) Eff ects of environmental parameters on stabil ity and survival (UV , temperature, soi l , pH, Humidity, etc) 2334 Kenya Subsidiary Legislation, 2024 PART II BIOLOGICAL DATA (a) Description of the agent as presented (stage, colour) (b) Taxonomy (c) Descriptive identification of the agent ‘(d) Natural occurrence and geographical distribution..... (e) Host specificity range and effects on non-target species...(including invasiveness, dispersal, colonization ability) (f) Development stages/life cycle (2) Genetic stability. (h) Stability in proposed packaging (i) Method of quantification | PART III EFFICACY DATA (a) Target Pest(s), Diseases(s), HOSt(S). 0... .ceccecccsceeeee nee cct eae eneeeeseneenaeenseseeerecs b) Mode Of action. ............ ccc cccec ene nencec eect et eeeeee ene en sees ens ee ease ens esneeeeaeereceeeneetes b) Method, Rate, Frequency of application..............ccceceesec eee scne ee eens essen nese enenes c) Recommendations for use in Kemya ...........c ccc cc cscs eee eenenceteeecnce cen neeenneeeeseens “d) Recommendations for use by authorized bodies outside Kenya.................:.00000e PART IV BIOSAFETY DATA (a) Bio-Surveillance data available .................:ceseeeeeeee voce sees eceeeeeeesssnesetnenenenes (b) Relationships to known plant, animals or human parasites...................s:cceeeeeee sees (c). Hazards to humans..:.......0...0..0cccceecsecececceccesseeceeeseereusececeatusscaesaeeeaeeeeees (d) Safety precautions/RestrictionS...................cccceeeeecneeee eee ee eee eeeseeeeeeneeeeeeeeia es (e) Recommended methods and precautions concerning handling, storage, or storage PUUeVEPPOPUCeLEre Tee Eereere rere reer rrr rer ee rere rerrererre etree verre rire rer ere ee eee eee PART VI ENVIRONMENTAL DATA (a) Effects of environmental parameters on stability and survival (UV, temperature, soil, PH, Humidity, etc) 20.0.2... cece ee cet nee en eee eeen cece en ee eee e rete ene ee ence nee a ee nea ees Kenya Subsidiary Legislation, 2024 2 3 35 PA R T V I I (a) Clearance by Phytosanitary Board (b) Registrations in other countries (Attach copies of certifi cates) PA R T V I I I D r af t o f l o c al l ab el PA R T I X Brief prepared by Signature Offi cial stamp .... D ate P A R T X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration R easo n s: — ■tf ' -to i -' r t m o : * T • D ate d (b) cT (a) Kenya Subsidiary Legislation, 2024 2335 PART VII (a) Clearance by Phytosanitary Board (b) Registrations in other countries (Attach copies of certificates) PART VIII Draft of local label PART IX . Brief prepared by.......... 0... cceceeccsecneeeeeseceeeeeeeeceessenesaseesuesesseusenereeres deeeeeees SiQMAture... 2... eeeec sec scaeceeeee cee eeeseeteseusuenseneeneens sesesssesesscanchasseseassaces Official stamp ............ccccccsececeeecneceeesseeeseeeeuceeseseecaeeseeeeseeaceusessueenseneneeaes Date... .. ccc ceecccccc eee teecuecneeeeeececeeeeseeeseeseu eee eeee scene sea eseuseneetsusuassseneucuaceaeeess PART X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration “ww . been 0 Reasons: — ee tot STORE Dat... ccceeecececececee cee ececeeeeceesaeacenesaceceuneusaseaeeeeseeussecsctetensueecsuseetaseeeens ay & (b) oF (a) ys Kenya Subsidiary Legislation, 20242 3 36 PE ST CO N T ROL PR OD U CT S A CT (r 7, 12(1)F o r m A 3 A ppl ic a t io n Fo r T h e Reg i st r a t io n Of A Pest Co nt r o l Pr oduct (Gener ic ) I n tr o d u c t i o n These requirements are for registration of identical products that are manufactured af ter the expiry of the patent of an original/proprietary registered product. These identical products are generally referred to as generics and w i l l i nclude conventional and biochemical pesticides. A pre-registration consultation between the applicant and the registration Board is strongly recommended. T R A D E N A M E : Information for Appl icants 1. The application form must be completed by a duly authorized person. 2. The application must be submitted in triplicate t o : The M anaging Director/Secretary Pest Control Products Board (PCPB) P..O . B o x 137 94 - 0 0 80 0 N ai r o b i . E-mail address: info@pcpb.go.ke.ke/md@pcpb.go.ke T el : 254 - 020 - 802 1846/7/8 Fax : 254- 020 - 802 1865 Website: https://www .pcpb.go.ke/ 3. Every application must be accompanied by: (a) application fee as prescribed (Registration fee is payable upon approval by the Board), (b) 3 copies of the draft label as per PCPB requirements. 4. The appl icant may be required to submit: (a) a sample of the pest control product; .. .(b) a sample of the technical grade of its active ingredient; (c) a sample of the laboratory standard of its active ingredient; (d) any other sample as may be required by the Board. 5. List I and II are supplied as a check list and an index to ensure that the applicant has provided the relevant data. 6. The application must be accompanied by a technical dossier as per PCPB data requirements (Lists I and II). 7. An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control Pr o d uc ts B o ar d . 2336 Kenya Subsidiary Legislation, 2024 PEST CONTROL PRODUCTS ACT ForM A3 (r7, 12(1) APPLICATION FOR THE REGISTRATION OF A PEST CONTROL PRODUCT (GENERIC) Introduction These requirements are for registration of identical products that are manufactured after the expiry of the patent of an original/proprietary registered product. These identical products are generally referred to as generics and will include conventional and biochemical pesticides. A pre-registration consultation between the applicant and the registration Board is strongly recommended. TRADE NAME ...........ccccecec ccc ee cence eee nee ne ee ene Ae EEE een EE EEE HEGRE EER EE AEE EEE EEE EGE Information for Applicants 1. The application form must be completed by a duly authorized person. 2. The application must be submitted in triplicate to: The Managing Director/Secretary Pest Control Products Board (PCPB) P.O. Box 13794 - 00800 Nairobi. E-mail address: info@ pcpb.go.ke.ke/md@pcpb.go.ke Tel: 254— 020 — 8021846/7/8 Fax: 254- 020- 8021865 Website: https://www.pcpb.go.ke/ . 3. Every application must be accompanied by: (a) application fee as prescribed (Registration fee is payable upon approval by the Board). (b) 3 copies of the draft label as per PCPB requirements. 4. The applicant may be required to submit: (a) asample of the pest control product; ...(b) asample of the technical grade of its active ingredient; (c) asample of the laboratory standard of its active ingredient; : (d) any other sample as may be required by the Board. 5. List I and II are supplied as a check list and an index to ensure that the applicant has provided the relevant data. 6. The application must be accompanied by a technical dossier as per PCPB data requirements (Lists I and II). 7. An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control Products Board. Kenya Subsidiary Legislation, 2024 2 3 37 Pur po se o f A ppl ic a t ion (tick/j i l l as appropr iate) (a) Pest control product containing a generic active ingredient (i) Date of expiry of patent (ii) Name of former patent holder (b) Pest control product where source of active and/or f o r m u l at i o n is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e.g inerts, source of technical material e.t .c) (e). Type of Registration Applied for. Tick as Necessary Full Registration Temporary Registration (f) Other (Explain) • i . (g) W ill the product be marketed under own label? If no specify Y es N o Proposed date of marketing I ' . Kenya Subsidiary Legislation, 2024 2337 PURPOSE OF APPLICATION (tick/fill as appropriate) (a) Pest control product containing a generic active ingredient (i) Date of expiry of patent.......... Lene ba ve eae senses eae eeeeeeeeeeeeas ee ee ene eee es (ii) Name of former patent holder...........0...0....ccecece cues Leese teeeeeeeeees (b) Pest control product where source of active and/or formulation is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e.g inerts, source of technical material e.t.c) (e). Type of Registration Applied for. Tick as Necessary Full Registration Temporary Registration Oe : (f) Other (Explain) a (g) Will the product be marketed under own label? Yes No — If no specify............ eevee Ve keenceeeececeneeseeaeaeeceeseseneenes PPPS EESESEESESEEESE Proposed date of marketing.................cccccce ccc ccececese cues ec cesses seuaseseueueges a. ft Kenya Subsidiary Legislation, 20242 3 3 8 1 . A ppl i c a n t 1 .1 I d en t i f i c at i o n Name of applicant/Corporate name of company Business Registration No.: Name of registration holder 1.2 Status: (manufacturer / f ormulator/ other) 1.3 Physical Address 1 .4 Po stal A d d ress: 1.5 Telephone: (and area code) 1.6 Fax : (and area code) 1.7 e -M ai l : 2. Name of local agent in country: (if dif ferent fr om registration holder) Business Registration No.: 2.1 Status: (Importer/formulator/distributor) 2.2 I^ ^ al Address ̂ rjj 2 .3 P o stal A d dr ess: x i t j 2.4 Telephone:(and area code) 2.5 Fax:(and area code) 2 .6 e - m ai l : 3 Pr o d u c t T r ad e n am e : T r ad e m ar k :3.1 Designation (Description of product) T r ade m ar k h o l d er : .2 Function of product: (eg. Insecticide, herbicide !tC.) 3.3 Intended use: (Publ ic health, industrial , agriculture, forestry , etc. 3.4 A ppl ication for (a) Single crop/pest combination (b) Mul tiple uses (using the extrapolation tool) (c) I f YES under (b) above, refer to the crop grouping and data extrapolation requirements to identify the relevant indicator pest and crop for effi cacy . N OY es N oY es :l ;c. f f f 2338 Kenya Subsidiary Legislation, 2024 1. APPLICANT 1.1 Identification Name of applicant/Corporate name of company Business Registration No.: Name of registration holder 1.2 Status: (manufacturer / formulator/ other) 1.3 Physical Address 1.4 Postal Address: 1.5 Telephone: (and area code) 1.6 Fax: (and area code) 1.7 e-Mail: 2. Name of local agent in country: (if different from registration holder) Business Registration No.: 2.1 Status: (Importer/formulator/distributor) 2.2 Physical Address 44; 15°. 2.3 Postal Address: *!*5 2.4 Telephone:(and area code) 2.5 Fax:(and area code) identify the relevant indicator pest and crop for grouping and data extrapolation requirements to) °. bo rire efficacy. oa fT 2.6 e-mail: , 3. PRODUCT Trade name: 3.1 Designation (Description of product) Trade mark: Trade mark holder: .2 Function of product: (eg. Insecticide, herbicide etc.) 3.3 Intended use: (Public health, industrial, agriculture, forestry, etc. 3.4 Application for Yes NO (a) Single crop/pest combination (b).. Multiple uses (using the extrapolation tool) (c) If YES under (b) above, refer to the crop Yes No Kenya Subsidiary Legislation, 2024 2 3 39 Indicator pest (Common and sc i en t i fi c name) I ndicator c ro p (Common and 3.5 Indicator pest(s) 3.6 Indicator host crop (s) scienti fi c name) Pest (Common and sc ien t i fi c name) Crop (Common an d scienti fi c name) 3.7 Requested extrapolation pests and crops 3.8 Method, dosage rates and appl ication: frequency of Complete the GAP Ttible" for Ef fi cacy Appendix xxx 7 Crop L ife IntefnationaKCLI*) Code (if avai lable) 3.9 Type of formulation: (eg. EC, WP, etc.) Y es N o 3.10 a) Is the product registered in country of m an u f ac tu r e? If no, give reasons 1 Y es N ob) Is the product registered in the country of f o r m u l at i o n ? If no, give reasons ■ I . 3.11 Proof of registration in SEARCH** country/ies: (names) I -j 3 .12 Proof of registration in other*countries. Kenya Subsidiary Legislation, 2024 2339 Indicator pest | Indicator (Common and | crop scientific (Common name) and 3.5 Indicator pest(s) scientific 3.6 Indicator host crop (s) name) Pest Crop (Common and | (Common scientific and name) scientific name) 3.7 Requested extrapolation pests and crops 3.8 Method, dosage rates and frequency of, Complete the GAP Table for b) Is the product registered in the country of formulation? eee rere cescesece application: Efficacy Appendix xxx 7" Crop Life : 3.9 Type of formulation: (eg. EC, WP, etc.) International(CLI ) ~ |Code (if available) Yes No 3.10 a) Is the product registered in country of| one manufacture? If no, give reasons ......... Heme ewe n ero ereenensenteserereane No} 3.11 Proof of registration in SEARCH** country/ies: (names) lye 3.12 Proof of registration in othér,countries. i Kenya Subsidiary Legislation, 202423'40 3.13 Customs Tarif f Code: (Brussels Tarrif N omenclature) 4 COM POSITION OF A CTIVE INGREDIENT (S) (Technical grade) (Information ^ on a.i may be attached in sealed envelope) M i n i m u mM an uf act u r er : (Name and address) a.i . Range' Active ingredient(s): , (Common name/s) a .i . % % purity r ' 5 . F o r m u l a t i o n 5.1 Formulator: (Name) P o sta l A d d ress : Phy sical address: 5 .2 I n ter nal c o de : 5.3 Corhposition (Information on composition may be attached in sealed envelope) g/Kg RangeIngredients and Function: g/L I . '. I f 6. TOX ICOLOGY (formulated product) Inhalation LCjo (mg/L/4 hour) A c u te O r al (LDjo mg/Kg) A c u te D er m al6 .1 R at : (LDjo mg/Kg) ExperimentalExperimentalExperimental Sk i n i r r i t at i o n Eye irr itation6 .2 R abbi t : N o ne M i l d M o der ate Sev er e • ■ M i l d M o der ate Sev ere6.3 Skin Sensi tization in guinea pig: (tick) N o ne I I I T ab le VI b I Il a6 .4 ■ 2340-- Kenya Subsidiary Legislation, 2024 B.13 Customs: Tariff Code: Nomenclature) % (Brussels Tarrif 14 COMPOSITION OF ACTIVE INGREDIENT (S) (Technical grade) (Information * on a.i may be attached in sealed envelope) oo. . Manufacturer: | Minimum |. : Active ingredient(s): : a.i. Range : (Name and a. % (Common name/s) address) % purity nee 5. FORMULATION 15.1. Formulator: (Name) ’ Postal Address: Physical address: 5.2, Internal code: re - 2 53 Composition (Information on composition may be attached in sealed envelope) g/L Ingredients and Function: g/Kg Range . to gt . COREE [6.. TOXICOLOGY (formulated product) {6.1 Rat: Acute Oral Acute Dermal Inhalation LC.) (mg/L/4 (LD, mg/Kg) (LDzy mg/Kg) hour) Experimental |Experimental Experimental 6.2 Rabbit: Skin irritation |Eye irritation None Mild Moderate Severe -' 63 Skin Sensitization in guinea pig: (tick) None Mild Moderate Severe 64 ° Ta Ib I Il Table V Kenya Subsidiary Legislation, 2024 2 34 1 6.5 Summary of other mammalian toxicological studies: eg. L ivestock, wildlife, poultry , pets 7 Summary of environmental ef fects 7 .1 Toxici ty to bees: 7.2 Toxici ty to fi sh and other aquatic o r g an i sm s: 7.3 Toxicity to birds: 7.4 Toxicity to earthworms and soil micro-organisms:I 7.5 Toxicity to other non-target organisms: 7 .6 Persi stence in env i ronment : 7.7 Other effects: Specify 8 . Pa c k a g in g 8.1 Packaging material / container: 8.2 Pack size(s): 8.3 Disposal of empty container(s): 9. Ot her Spec if ic Requir ement s 9.1 Operator exposure 9 .1.1 Dermal absorption. 9.1.2 L ikely operator exposure under f ield conditions 9.2 Available toxicological data relating to other ingredients in formulation (non-active additives in formulation). 10 . D ec l a r a t i o n F o r an d o n b eh al f o f I hereby certif y that the above mentioned information and data provided in support ol this appl ication are to the best of my knowledge true, correct and complete. Name in ful l {pr inted) Signature Kenya Subsidiary Legislation, 2024 2341 6.5 Summary of other mammalian toxicological studies: eg. Livestock, wildlife, poultry, pets, 7 Summary of environmental effects 7.1 Toxicity to bees: ‘7.2 Toxicity to fish and other aquatic organisms: 7.3 Toxicity to birds: 7.4 Toxicity to earthworms and soil micro-organisms: 7.5 Toxicity to other non-target organisms: 7.6 Persistence in environment: 7.7 Other effects: Specify 8. PACKAGING 8.1 Packaging material / container: 8.2 Pack size(s): 8.3 Disposal of empty container(s): 9. OTHER SPECIFIC REQUIREMENTS 9.1 Operator exposure 9.1.1 Dermal absorption. 9.1.2 Likely operator exposure under field conditions 9.2 Available toxicological data relating to other ingredients in formulation (non-active additives in formulation). 10. DECLARATION For and on behalf of 2.0.2.0... ccc cee cece ec eee cece ee ec eee ee eee essen eee nen eae eeneneaeeeenens viewed I hereby certify that the above mentioned information and data provided in support off this application are to the best of my knowledge true, correct and complete. Name in full (printed) Signature Kenya Subsidiary Legislation, 20242 34 2 D a teOf f icial Ti tle F o r O f r c ia l U se R em ar k s Of f icial Stamp of Appl icant / Company Signed: D a te : NOTE: The format of this appl ication is recognized by all SEARCH countries. 2342 Kenya Subsidiary Legislation, 2024 Official Title Date FOR OFFICIAL USE Remarks Official Stamp of Applicant / Company Signed: Date NOTE: The format of this application is recognized by all SEARCH countries. Kenya Subsidiary Legislation, 2024 2 34 3 Fo r m A 3 , L i st I A c t iv e I n g r ed ien t : D o ssier In d ex The dossier accompanying the application must provide full details (as applicable) of the information requested in this list. I .e., details of the methods used, results of toxicological and ecotoxicological studies, methods of analysis, etc. Appl icants are advised to use CIPAC methods for physical and chemical properties. Numbering used in the dossier must correspond to that used in the application fo rm. I f the product contains more than one active ingredient, compile a separate dossier for each active ingredient . A n nex N o . i n d o ssi er i f study included Offi ci al use only A CTIVE INGREDIENT (a.i ) 1. D esig n a t io n /I d en t it y o f a.i . 1.1 Common name (ISO) 1.2 Manufacturer or Development code 1.3 Source, N ame and A ddress ol m anuf acturer and address and l ocation of manufacturing plants. 1.4 Methods of manufacture (synthesis Pathways) to include relevant impuri ties impuri ties, water content & insolubles may be sent direct to PCPB . manufacturingi .e . 1.5 Specifications of purity supported by random ” 5” batch analysis from GLP certif ied laboratory . 1.6 Active ingredient content supported by random “ 5” batch analysis from GLP certif ied laboratory . 1.7 Chemical name (l UPAC) 1.8 Chemical group 1 .9 S tr uc tu ral f o r m u l a 1.10 Empirical formula 1 .1 1 M o l ecu l ar m ass 1 .12 C A S N u m b er 1.13 Expiry of patent Kenya Subsidiary Legislation, 2024 2343 ForM A3, LIST I ACTIVE INGREDIENT: DOSSIER INDEX The dossier accompanying the application must provide full details (as applicable) of the information requested in this list. I.e., details of the methods used, results of toxicological and ecotoxicological studies, methods of analysis, etc. Applicants are advised to use CIPAC methods for physical and chemical properties. Numbering used in the dossier must correspond to that used in the application form. If the product contains more than one active ingredient, compile a separate dossier for each active ingredient. Annex No. in dossier if | Official use ACTIVE INGREDIENT (a.i) study included only 1. DESIGNATION/IDENTITY OF a.i. 1.1 Common name (ISO) 1.2 Manufacturer or Development code 1.3 Source, Name and Address of manufacturer and address and location of manufacturing plants. 1.4 Methods of manufacture (synthesis Pathways) to include relevant impurities ie. manufacturing impurities, water content &insolubles| may be sent direct to PCPB. 1.5 Specifications of purity supported by random ”5” batch analysis from GLP certified laboratory. 1.6 Active ingredient content supported by random “5” batch analysis from GLP certified laboratory. 1.7 Chemical name (IUPAC) 1.8 Chemical group 1.9 Structural formula 1.10 Empirical formula 1.11 Molecular mass 1.12 CAS Number 1.13 Expiry of patent Kenya Subsidiary Legislation, 20242 34 4 2 . Ph y s i c a l A n d C h em i c a l Pr o per t ie s The applicant must provide original information specif ic to the generic product (technical grade) 2.1 Physical state 2 .2 C o l o u r 2 .3 O d o ur 2.4 Density at 20°C 2.5 Vapour pressure at 20/25“C 2.6 Volatil ity ®C2.7 Hydrolysis DTjo Days pH 2.8 Photolysis Jc2.9 Solubil ity in water pH 2.10 Solubi l ity in organic solvents 2.11 n-octanoi/water partition coefficient 2.12 Boiling point “C 2.13 Melting point “C 2.14 Decomposition temperature °C 2.15 M ethod of Analysis and Impurities 2.16 Stabi l ity in water , hydrolysis rate, effect of light , identity of breakdown products 2.17 Stability in organic solvents used in formulation 2.18 Stabil ity in air ; effect of light , identity of b r eak do w n Pr o du ct s 2.19 Thermal stabi lty , identity of breakdown products. 2-3.0 Flammabi l ity 2.21 Flash point 2.22 Explosive properties 2.23 Oxidizing properties 2.24 Absorption spectra - UVA îsible, infra-red, IM R , M S 2.25 Reactivity towards container material 2.26 Technical Equivalence (if appl icable) 1 3. Technical equivalence - refer to dossier index 2344 Kenya Subsidiary Legislation, 2024 2. PHYSICAL AND CHEMICAL PROPERTIES The applicant must provide original information specific to the generic product (technical grade) 2.1. Physical state 2.2 Colour 2.3. Odour 24 Density at 20°C 2.5 Vapour pressure at 20/25°C 2.6 Volatility 2.7 Hydrolysis DT. ..... Days ...... Vonnee pH 2.8 Photolysis 2.9 Solubility in water ............. OC eeeeeeees pH 2.10 Solubility in organic solvents 2.11 n-octanol/water partition coefficient 2.12 Boiling point °C 2.13 Melting point °C 2.14 Decomposition temperature °C 2.15 Method of Analysis and Impurities 2.16 Stability in water, hydrolysis rate, effect of light, identity of breakdown products 2.17 Stability in organic solvents used in formulation 2.18 Stability in air; effect of light, identity of breakdown Products 219 Thermal stabilty, identity of breakdown products. 2:20 Flammability 2.21 Flash point 2.22 Explosive properties 2.23 Oxidizing properties 2.24 Absorption spectra — UV/Visible, infra-red, IMR, MS 2.25 Réactivity towards container material 2.26 Technical Equivalence (if applicable) 1 . . ws 3. Technical equivalence — refer to dossier-index Kenya Subsidiary Legislation, 2024 2 34 5 T O X I C O L O G Y Where technical equivalence is proven, provide studies from 3.1 to 3.3 specif ic to the technical grade material . Information required from 3.4 to 6.4 may be sourced from published literature. Where technical equivalence is not proven then al l the studies specif ic to the , technical grade material f rom 3.1 to 6.4 must be provided. Where an impuri ty is present at a concentration greater than I g/K g or is known or suspected to be of toxicological signif icance then its toxicological prof ile must be su b m i t t ed . 3 .1 A D I 3.2 Acute oral LDjo mg/Kg rat/rabbit 3.3 Acute dermal LD50 mg/Kg (rat) 3.4 Inhalation LC50 mg/L hour (rat) 3.5 Skin irritation (rabbit) 3.6 Eye irritation (rabbit) 3.7 Skin sensi tization (guinea pig) 3.8 Reproduction (specify species) 3.9 Subchronic toxici ty 90 day NOEL mg/Kg/day j Q I-n s - i n r •, t 3.10 Chronic toxicity NOEL mg./Kg/day 3.11 Carcinogenicity (life time) NOEL mg/K g/day 3.12 Neurotoxicity NOEL mg/Kg/day 3.13 Teratogenicity NOEL mg/Kg/day 3.14 M utagenicity /Genotoxicity 3.15 M etabolism (rat) 3 .16 Other studies 4 . A C T I V E I N G R E D I E N T E C O -T O X I C O L O G Y A n nex N o . i n d o ssier O f f i c i al u se only(Active ingredient - technical grade if study included 4.1 Birds (2 species) LD50 mg/K g N O E L Reproduction Kenya Subsidiary Legislation, 2024 2345 TOXICOLOGY Where technical equivalence is proven, provide studies from 3.1 to 3.3 specific to the technical grade material. Information required from 3.4 to 6.4 may be sourced from published literature. Where technical equivalence is not proven then all the studies specific to the. technical grade material from 3.1 to 6.4 must be provided. Where an impurity is present at a concentration greater than 1g/Kg or is known or suspected to be of toxicological significance then its toxicological profile must be submitted. 3.1 ADI 3.2 Acute oral LD.) mg/Kg rat/rabbit 3.3 Acute dermal LD,, mg/Kg (rat) 3.4 Inhalation LCs) mg/L hour (rat) 3.5 Skin irritation (rabbit) 3.6 Eye irritation (rabbit) 3.7 Skin sensitization (guinea pig) 3.8 Reproduction (specify species) 3.9 Subchronic toxicity 90 day NOEL B19 ai iP xt mg/Kg/day oe 3.10 Chronic toxicity NOEL mg./Kg/day 3.11 Carcinogenicity (life time) NOEL mg/Kg/day - 3.12 Neurotoxicity NOEL mg/Kg/day 3.13 Teratogenicity NOEL mg/Kg/day 3.14 Mutagenicity /Genotoxicity 3.15 Metabolism (rat) 7 3.16 Other studies pores 4. ACTIVE INGREDIENT ECO-TOXICOLOGY Annex No. in dossier Official use (Active ingredient — technical grade if study included only 4.1 Birds (2 species) LD5) mg/Kg NOEL Reproduction : Kenya Subsidiary Legislation, 20242 34 6 LD50 mg/K g N O E L Reproduction 4.2 Fish (2 species) LD50 mg/K g N O E L Reproduction B C F LD50 mg/K g N O E L Reproduction B C F 4.3 Daphnia LC50 mg/L N O E L 4 .4 Algae EC50 mg/L (96 hours) 4 .5 B ees L D 50 i g/bee 4 .6 E ar th w or m s LC50 mg/K g 4.7 Soi l micro-organisms ■5 . B e h a v i o u r in E n v i r o n m en t S.l Behaviour , ways of degradation, degradation products i n so i l : 5.1.1 M aj or metabolites 5.1.2 DTsoCdays) 5.1.3 M obil ity of a.i . 5.1.4 Adsorption / desorption 5.1.5 M obi li ty of metabol ites 5 .2 Behaviour , ways of degradation, degradation products i n w ater 5.2.1 M aj or M etabol ites 2346 Kenya Subsidiary Legislation, 2024 LD., mg/Kg NOEL Reproduction 4.2 Fish (2 species) LD., mg/Kg NOEL Reproduction BCF LD. mg/Kg NOEL Reproduction BCF 43 Daphnia LC.) mg/L NOEL ASA Algae EC.) mg/L (96 hours) 45 Bees * LDso i g/bee 4.6 Earthworms LC.) mg/Kg 4.7 Soil micro-organisms 5. BEHAVIOUR IN ENVIRONMENT 5.1Behaviour, ways of degradation, degradation products in soil: 5.1.1 Major metabolites 5.1.2 DT x (days) 5.1.3. Mobility of ai. 5.1.4 Adsorption / desorption 5.1.5 Mobility of metabolites 5.2. Behaviour, ways of degradation, degradation products in water 5.2.1 Major Metabolites Kenya Subsidiary Legislation, 2024 2 34 7 5.2.2 DT50 (days) 5 .2 .3 Sur f ace w ater 5 .2 .4 G r o u n d w ater 5 .3 Behaviour, ways of degradation, degradation products i n ai r . R ate and r o u te o f degradation in air (for fumigants and other volatile products) . 6 . R E SI D U E S 6.1 M aj or metabolites 6 .2 M et ab o l i sm 6 .3 B eh av i o u r o f r esi d u es 6.4 M RL codex or other certi f ied sources 6.5 Method of residue analysis 7 . M o d e OF A c t i o n 8. Ot h er Spec if ic Req u ir emen t s 8 .1 R esi d ue d ata f r o m a G L P cer t i f i ed laboratory . ()C 8.2 Proposed i nterval s, withholding Periods in case of post h arv est u se . pre-harvest 8 .3 Effect on taint , odour , taste, or other qual ity aspects due to residues in or on fresh or processed products. 8.4 Effects on industrial processing and/oi household preparation on the nature and magnitude of residues. : . 1 8.5 Residue data in succeeding or rotational crops where presence ol residues might be expected. . c . : L ?. . KJ tS I .i t . Kenya Subsidiary Legislation, 2024 2347 5.2.2 DT, (days) 5.2.3 Surface water 5.2.4 Ground water 5.3. Behaviour, ways of degradation, degradation products in air. Rate and route of degradation in air (for fumigants and other volatile products). 6. RESIDUES 6.1 Major metabolites 6.2 Metabolism 6.3 Behaviour of residues 6.4 MRL codex or other certified sources 6.5 Method of residue analysis (7. MODE OF ACTION 8. OTHER SPECIFIC REQUIREMENTS 8.1 Residue data from a GLP certified ee 2 ee ened tate laboratory. o ver 8.2 Proposed pre-harvest intervals J withholding Periods in case of post harvest use. 8.3 Effect on taint, odour, taste, or other quality aspects due to residues in or on fresh or processed products. ~ ~ a 8.4 Effects on industrial processing and/or household preparation on the nature and magnitude of residues. 8.5 Residue data in succeeding of rotational crops where presence of . Le residues might be expected. = Kenya Subsidiary Legislation, 20242 34 8 Fo r m A 3 , L i st I I F o r m u l a t e d Pr o d u c t : D o s si e r I n d ex The dossier accompanying the form should provide more d et ai l s o f t he i n f o r m at io n requested in this list. Applicants are advised to use C o l l ab o r at i v e I n tern at i o n al Pest i c i d es Analytical Council (CIPAC) methods for Physical/Chemical properties. Summaries of the methods used and the results of toxicological an d ecotoxicological studies, methods of analysis etc. should be given. Numbering used in the dossier must correspond with t h at u sed i n F o r m A 3 . F o r m u l a t e d P r o d u c t A n nex N o . i n d o ssier if study included O f f i c i al u se only 1 . P H Y SI C A L A N D C H E M I C A L PR O PE R T I E S 1.1 Source, Name and A ddress ol f o r m u l ato r and ad d ress an d l o c at i o n o f formulation plant . 1.2 Source, M SDS and specif ications foi components included in the f o r m u l at i o n 1.3 Physical state / formulation type 1 .4 C o lo u r 1 .5 O d o u r 1.6 Ef fects of l ight , air , temperature, water o n tec h n i c al ch ar acter i st i c s o f th e f o rm u l at io n 1.7 Storage stabi lity in proposed packaging 1 .8 Sh el f l i f e 1.9 D ensi ty 1.10 Bulk density 1.11 Flammabil ity 1.12 Flash point 1.13 Explosivity 1.14 In-compatibility with other pest control P r o d u ct s 1.15 pH 1.16 pH of 1% aqueous dilution 1.17 Oxidizing properties 1 .18 C o r r o si v en ess 1 .19 W ater c o n ten t 2348 Kenya Subsidiary Legislation, 2024 Form A3, LIsT II FORMULATED PRODUCT: DOSSIER INDEX The dossier accompanying the form should provide more details of the information requested in this list. Applicants are advised to use Collaborative International Pesticides Analytical Council (CIPAC) methods for Physical/Chemical properties. Summaries of the methods used and the results of toxicological and ecotoxicological studies, methods of analysis etc. should be given. , Numbering used in the dossier must correspond with that used in Form A3. FORMULATED PRODUCT 1. PHYSICAL AND CHEMICAL) Annex No. in dossier Official use PROPERTIES if study included only 1.1 Source, Name and Address of formulator and address and location of formulation plant. 1.2. Source, MSDS and specifications for components included in the formulation 1.3. Physical state / formulation type 14 Colour 1.5 Odour 1.6 Effects of light, air, temperature, water on technical characteristics of the formulation | 1.7 Storage stability in proposed packaging 1.8 Shelf life 1.9 Density 1.10 Bulk density 1.11 Flammability 1.12 Flash point 1.13 Explosivity 1.14 In-compatibility with other pest contro] Products 1.15 pH 1.16 pH of 1% aqueous dilution 1.17 Oxidizing properties 1.18 Corrosiveness 1.19 Water content Kenya Subsidiary Legislation, 2024 2 34 9 1.20 Wettabi li ty 1.21 Solubil ity in water 1.22 Persistent foaming 1.2 3 P ar t i c le si ze 1.24 Suspensibility / emulsifiability 1.25 Emulsion stabi lity 1.26 Volati li ty 1.27 V iscosi ty 1 .2 8 W et siev e test 1.29 Dry sieve test 1.30 M ethods of A nalysis 1.31 Detailed composition supported by analytical evidence from GLP certif ied laboratory 1.32 Other properties (where applicable) 2 . T o x i c o l o g y 2 .1 Rat Acute oral LD50 mg/Kg 2.2 Acute dermal LD50 mg/Kg 2.3 Inhalation LC50 mg/L / 4hours 2 .4 R ab b i t Sk i n i rr i t at i o n 2.5 Eye irri tation 2.6 Skin Sensitization in guinea pig or Local lymph node assay (LENA ) t- r. 2 .7 W H O c l assi f i c at i o n 2 .8 O th er stud ies 1 Detailed studies in 2.1 to 2.6 MUST be original and specif ic to the formulation. The studies should be conducted in GL P cer ti f ied laboratories. A n n ex N o . i n d o ssi er i f study included Of f icial use only 3 . Emer g en c y Pr o c ed u r es in Ca se o f A c c id en t a l Ex po su r e o r P o i s o n in g 3.1 Symptoms of human poisoning 3 .2 M o d e o f ac t i o n i n m an 3 .3 F i r st ai d t reatm en t 3 .4 Sk i n c o n tac t Kenya Subsidiary Legislation, 2024 2349 1.20 Wettability 1.21 Solubility in water 1.22 Persistent foaming 1.23 Particle size 1.24 Suspensibility / emulsifiability 1.25 Emulsion stability 1.26 Volatility 1.27 Viscosity 1.28 Wet sieve test 1.29 Dry sieve test 1.30 Methods of Analysis 1.31 Detailed composition supported laboratory analytical evidence from GLP certified] by 1.32 Other properties (where applicable) 2. TOXICOLOGY 2.1 Rat Acute oral LD,) mg/Kg 2.2 Acute dermal LD,) mg/Kg 2.3 Inhalation LC,, mg/L / 4hours 2.4 Rabbit Skin irritation 2.5 Eye irritation Local lymph node assay (LLNA) 2.6 Skin Sensitization in guinea pig on (2.7 WHO classification 2.8 Other studies aan Detailed studies in 2.1 to 2.6 MUST be original and specific to the formulation. The ‘ studies should be conducted in GLP certified laboratories. Annex No. in dossier if, study included Official use only 3. EMERGENCY PROCEDURES IN CASE OF ACCIDENTAL EXPOSURE OR POISONING 3.1 Symptoms of human poisoning 3.2 Mode of action in man 3.3 First aid treatment 3.4 Skin contact Kenya Subsidiary Legislation, 20242350 3.5 Eye contact 3 .6 I n h al at i o n 3.7 Ingestion 3 .8 A n t i d o te 3.9 Note to physician 4. Emer g en c y Pr o c ed ur es in Ca se o f Fir e/Spil l a g e 4.1 Fire-fi ghting measures 4.2 Procedures in case of spi l lage 5. Bioef f icacyAJses (New label claims with this application) A nnex N o . in dossier if study included Off icial use only 5.1 Crop/publ ic health etc 5.2 Target organism 5 .3 R ate 5.4 Stage of treatment 5.5 D irections f or use 5.6 Residue data and pre-harvest interval ; Refer to section 6 in the requirements 5.7 Provide Effi cacy data fr om similar c l i m at ic zo nes 5.8 Phytotoxicity/Crop safety Refer to section 5.7 in the guidel ine 5 .9 C o n tr ai nd ic at i o n s M inimum Label Requir ement s - See PCPB label requirements (provided separately). 6 . 7. Ot her Spec ih c Requir ement s M edical surveillance, on manufacturing plant personnel7.1 7.2 Health records of occupationally exposed personnel , - industry , agriculture, forestry etc. 7.3 Proposed packaging Type of packaging in which the product is imported 2350 Kenya Subsidiary Legislation, 2024 3.5 Eye contact 3.6 Inhalation 3.7 Ingestion B.8 Antidote B.9 Note to physician 4. EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE 4.1 Fire-fighting measures 4.2 Procedures in case of spillage 5. BIOEFFICACY/USES (New label claims with this application) Annex No. in dossier if t udy included Official use only 5.1 Crop/public health etc 2 Target organism §.3 Rate 5.4 Stage of treatment 5.5 Directions for use 5.6 Residue data and pre-harvest interval; Refer to section 6 in the requirements 5.7 Provide Efficacy data from similar climatic zones 5.8 Phytotoxicity/Crop safety ‘Refer to section 5.7 in the guideline 5.9 Contraindications 6. MINIMUM LABEL REQUIREMENTS —See PCPB label requirements (provided separately). 7. OTHER SPECIFIC REQUIREMENTS 7.1 Medical surveillance, on manufacturing plant personnel 7.2 Health records of occupationally exposed personnel, - industry, agriculture, forestry etc. 7.3 Proposed packaging Type of packaging in which the product is imported Kenya Subsidiary Legislation, 2024 2 3 5 1 Type of packaging for distribution in Kenya Packaging material Sizes of individual packaging 7.4 Procedures of destruct ion and decontamination of pest control product and its packaging Possibi l ity of neutral ization Controlled discharge Control led incineration Water purif ication Procedures of cleaning application equipment Recom mended m ethods and precautions concerning handling, storage, display or transport . . iC'HS] ’ 3 1 0 I .d-- .4 q a a Kenya Subsidiary Legislation, 2024 2351 Type of packaging for distribution in Kenya Packaging material Sizes of individual packaging 7.4 Procedures of destruction and decontamination of pest control product and its packaging Possibility of neutralization Controlled discharge Controlled incineration Water purification Procedures of cleaning application equipment Recommended methods and precautions concerning handling, storage, display or transport. SIG) lB agbies! , Agel Kenya Subsidiary Legislation, 20242 3 52 T H E PEST CON T ROL PROD U CT S A CT (r 8(l )F o r m A 4 Appl icat ion For The Regist r at ion Of A Pest Cont r ol Pr oduct (Spr ay A d ju v an t ) A Spray adjuvant: Is a compound or substance that enhances or modi f ies or i s intended to enhance or modify the physical or chemical characteristics of a pest control product to which it is added. T R A D E N A M E : Information for Appl icants 1. The application form must be completed by a duly authorized person. 2. The application must be submitted in triplicate t o : The M anaging Director/Secretary Pest Control Products Board (PCPB) " ■ P .O . B ox 13794 - 00800 N airobi . E-mail address: inf o@pcpb.gokelmd@pcpb.go.ke T el : 254 - 020 - 802 1846/7/8 Fax : 254 - 020 - 802 1865 Website :https:l lwww .pcpb .go .ke! 3. Every application must be accompanied by: — (a) application fee as prescribed (Registration fee is payable upon approval by the B o ar d , (b) copies of the draft label as per PCPB requirements. 4. The applicant may be required to submit: — (a) a sample of the pest control product; (b) a sample of the laboratory standard of its active ingredient ; (c) any other sample as may be required by the Board. 5. List I is supplied as a check list and an index to ensure that the applicant has provided t h e r el ev an t d ata . 6. The application must be accompanied by a technical dossier as per PCPB data requirements (Dossier index). 7. An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control P ro d u c t s B o ar d . 2352 Kenya Subsidiary Legislation, 2024 THE PEST CONTROL PRODUCTS ACT Form A4 (r 8(1) APPLICATION FOR THE REGISTRATION OF A PEST CONTROL PRODUCT (SPRAY ADJUVANT) A Spray adjuvant: Is a compound or substance that enhances or modifies or is intended to enhance or modify the physical or chemical characteristics of a pest control product to which it is added. Information for Applicants 1. The application form must be completed by a duly authorized person. 2. The application must be submitted in triplicate to: The Managing Director/Secretary Pest Control Products Board (PCPB) —“P.O, Box 13794 - 00800 Nairobi. E-mail address: info@ pcpb.go .ke/md@ pcpb.go.ke Tel: 254 — 020 — 8021846/7/8 Fax: 254 — 020 — 8021865 Website:hitps://www pcpb.go.ke/ 3. Every application must be accompanied by: — (a) application fee as prescribed (Registration fee is payable upon approval by the Board. (b) copies of the draft label as per PCPB requirements. 4. The applicant may be required to submit: — (a) asample of the pest control product; (b) asample of the laboratory standard of its active ingredient; (c) any other sample as may be required by the Board. 5. List I is supplied as a check list and an index to ensure that the applicant has provided the relevant data. 6. The application must be accompanied by a technical dossier as per PCPB data requirements (Dossier index). 7. An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control Products Board. Kenya Subsidiary Legislation, 2024 2 35 3 Pur pose of Appl icat ion (tick as appropriate) (a) A pest control product which is an adjuvant (b) Pest control product where source of active and/or formulation is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e) Type of Registration Applied for. (Tick as Necessary) Ful l Registration Temporary Registration (f) Other (Explain) '' >:t )F !Will the product be marketed under own label? Y es N o If No specify Proposed date of marketing ..s ad'C . i : > 'A l( ' ) \ Kenya Subsidiary Legislation, 2024 2353 PURPOSE OF APPLICATION (tick as appropriate) (a) A pest control product which is an adjuvant [] (b) Pest control product where source of active and/or formulation [] is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e) Type of Registration Applied for. (Tick as Necessary) Full Registration [] Temporary Registration [J (£) Other (Explain) ...ceccescsesccsssssscssesssssesssesesssesscsusesessecsecsussessesesssssvesscsessuncnessessessessucsucens od PF Will the product be marketed under own label? Yes No If No specify.......c.ccccccseseeeeees soos cceeeessnnnseesessueessessniseeeennniepecetinstessnsnesen Proposed date of marketing..............:c:ccccseseesesssssssneeceeeeeceeeeesaeseaseseeececeseees 6 dt £9) 8 Pome Ya Kenya Subsidiary Legislation, 20242 3 54 ' 1 . A ppl i c a n t 1.1 I dent if ication Name of applicant/Corporate Name of company Business Registration No.: Name of registration holder 1.14 Status: (manuf acturer / f ormulator/ other) 1.15 Physical Address 1.16 Postal A ddress: 1.17 Telephone:(and area code) 1.18 Fax: (and area code) 1 .19 E -M ai l : Name of local agent in country : (if dif ferent from registration holder) 2 . Business Registration No.: 3d . Status: (Importer/formulator/distributor) 3.2 Physical Address 2 ri </ . n a P o sta l A d d ress: 3.4 Telephone: (and area code) Fax: (and area code)3 .5 3 .6 E-m ai l : ̂3 . Pr o d uc t 3.1 Designation (Description of product) T r ade n am e : T r ade m ark : T r ade m ar k h o l d er : 3.̂ 1—Spray adjuvant function: (wetter, surf actant , etc) 3.3 Intended use: (Publ ic health, industrial , agriculture, forestry, etc. N O.Y es3.4 Application for (a) Single crop/Pest combination (b) Multiple uses (using the extrapolation tool) (c) I f Y ES under (b) above, refer to the crop grouping and data extrapolation requirements to identify the relevant indicator pest ari d crop for efficacy. N oY es t f . ̂ 11 y - . 2354° Kenya Subsidiary Legislation, 2024 1. APPLICANT 1.1. Identification Name of applicant/Corporate Name of company Business Registration No.: Name of registration holder 1.14 Status: (manufacturer / formulator/ other) 1.15 Physical Address 1.16 Postal Address: 1.17 Telephone:(and area code) 1:18 Fax: (and area code) 1.19 E-Mail: 2. Name of local agent in country: (if different from registration holder) Business Registration No.: 3.1 . Status: (Importer/formulator/distributor) 3.2 Physical Address an, no Postal Address: 3.4 Telephone: (and area code) 3.5 Fax: (and area code) 3.6 E-mail: ‘.3. PRODUCT 3.1 Designation (Description of product) Trade name: Trade mark: Trade mark holder: 3:2.—Spray adjuvant function: (wetter, surfactant, etc) 3.3 Intended use: (Public health, industrial, agriculture, forestry, etc. 3.4 Application for (a) Single crop/Pest combination (b) Multiple uses (using the extrapolation tool) (c) If YES under (b) above, refer.to the crop grouping and data extrapolation requirements to identify the relevant indicator pest and crop for efficacy. Yes Yes NO No Kenya Subsidiary Legislation, 2024 2 35 5 3.5 Target use e .g product and crop/animal 3.6 Indicator pest (s) 3.7 Indicator host crop (s) Indicator pest (Common and scientifi c name) Indicator crop (Common and Scientifi c name) 3.8 Requested extrapolation pests and crops Pest (Common an d sc i en t i fi c name) Crop (Common and Scientifi c name) 3.9 Method, dosage rates and frequency of application: Complete the GAP Table for Effi cacy Appendix xxx 3.10 Type of formulation; (e.g. EC, WP, CropL ife I n ter n at i o n al (CLI '*) Code (if avai lable) etc .) 3.11 a) Is the product registered in country of manuf acture? Y es N o I f no, give reasons ) A b) is the product registered in the country of formulation? Y es N o I f no, give reasons 5 * *3.12 Registration in SEARCH Country/ies; (names) 3.13 Proof of existing registration in other country(ies) . i 3 .14 C ustom s T ari f f Code: (Brussels Tarrif Nomenclature) .a . 4 * CLI - CropLife International formerly Global Crop Protection Federation (GCPR SEARCH: Southern and Eastern Afri can Regulatory Committee on H an honi sat ion of Pesticide Registration 5 * * Kenya Subsidiary Legislation, 2024 2355 3.6 Indicator pest (s) 3.7 Indicator host crop (s) 3.5 Target use e.g product and crop/animal Indicator pest (Common and scientific name) Indicator crop (Common and Scientific name) 3.8 Requested extrapolation pests and crops Pest (Common and scientific name) Crop (Common and Scientific name) 3.9 Method, dosage rates and frequency of|Complete the GAP Table for Efficacy application: Appendix xxx 3.10 Type of formulation: (e.g. EC, WP, CropLife etc.) International (CLI) Code (if available) 3.11 a) Is the product registered in country of manufacture? Yes No If no, give reasons nok, . van b) is the product registered in the country of formulation? Yes [| No If no, give reasons 3.12 Registration in SEARCH?” Country/ies: (names) 3.13 Proof of existing registration in other country(ies) 3.14 Customs Tariff Code: (Brussels Tarrif Nomenclature) Et Ni ib as t ig ““CLI- CropLife International formerly Global Crop Protection Federation (GCPF) 5** Pesticide Registration — - = SEARCH: Southern and Eastern African Regulatory Committee’ on n Harmonisation of Kenya Subsidiary Legislation, 20242 3 56 4, ' Spr ay Adjuvant For mul a (attach conf idential formula) Active ingredient(s): (Common name/s) Spray adj uvant f u nc t io n PercentageM anu f ac tu r er : (Name and address) 5 . F o r m u l a t i o n 5.1 Formulator : (Name) IP o stal A d d r ess: Physical address: 5 .2 I nternal code: 5.3 Composition (Information on composition formula may be attached in sealed R angeg/K ge!LI ngredients * SEARCH - Southern and Eastern Af rican Regulation Committee on Harmonisation of Pesticide Registration 6. • TOXICOLOGY (f ormulated product) Inhalation LC50 (mg/l/hour)A c u te D er m alA c u te O r al (LD50 mg/kg) 6 .1 R at : (LD50 mg/kg) ExperimentalExperimentalExperimental C alc u l atedC al c u latedC al c u l ated( Eye irritationSk i n i rr i t at i o n6 .2 R abb i t : N o ne M i l d M o d er ate Sev er e Sev er eM o d er ateM i l dN o ne6 .3 Sk in Sensi tizat ion in Guinea pig: (tick) 6 .4 W H O I I II II bl a C l assi f f i c at i o n : 6.5 Summary of other toxicological studies: eg. wildlife, poultry , pets 2356 Kenya Subsidiary Legislation, 2024 ‘4. ° SPRAY ADJUVANT FORMULA (attach confidential formula) ') Active ingredient(s): (Common name/s) Manufacturer: (Name and address) Spray adjuvant — | Percentage function 5.. FORMULATION 5.1 Formulator: (Name) Postal Address: Physical address: ‘| 5.2 Internal code: 153° Composition (Information on composition formula may be attached in sealed Ingredients g/L g/Kg Range * SEARCH — Southern and Eastern African Regulation Committee on Harmonisation of Pesticide Registration 6. - TOXICOLOGY (formulated product) Guinea pig: (tick) 6.1 Rat: Acute Oral Acute Dermal Inhalation LCs, (mg/I/hour) (LDso mg/kg) (LDso mg/kg) Experimental Experimental Experimental Calculated Calculated Calculated 6.2 Rabbit: | Skin irritation Eye irritation None Mild Moderate Severe 6.3 Skin Sensitization in None Mild Moderate Severe LI LJ 6.4 WHO Classiffication: la Ib [ ] I Il 6.5 Summary of other toxicological studies: eg. wildlife, poultry, pets Kenya Subsidiary Legislation, 2024 2 3 5 7 7. Summar y of envir onment al ef f ect s {where applicable e.g. sensi tive areas) 7.1 Toxicity to bees: 7.2 Toxici ty to fi sh and other aquatic organisms: 7.3 Toxicity to birds: 7.4 Toxicity to earthworms and soil micro-organisms: 7.5 Toxicity to other non-target organisms: 7 .6 Persi stence i n env i ronment : 7.7 Other effects: Specify 8 Pa c k a g in g 8.1 Packaging material / container : 8.2 Pack size(s): 8.3 Disposal of empty container(s): 9. Ot her Spec if ic Requir ement s 9 .1 Operator exposure 9.1.1 Dermal absorption. 9.1.2 Likely operator exposure under fi eld conditions 9 .2 Available toxicological data relating to other ingredients i n formulation (non active additives in formulation) . * Kenya Subsidiary Legislation, 2024 2357 SUMMARY OF ENVIRONMENTAL EFFECTS (where applicable e.g. sensitive areas) Toxicity to bees: Toxicity to fish and other aquatic organisms: Toxicity to birds: Toxicity to earthworms and soil micro-organisms: Toxicity to other non-target organisms: Persistence in environment: Other effects: Specify................... PACKAGING Packaging material / container: Pack size(s): Disposal of empty container(s): OTHER SPECIFIC REQUIREMENTS Operator exposure Dermal absorption. Likely operator exposure under field conditions Available toxicological data relating to other ingredients in formulation (non active additives in formulation). Kenya Subsidiary Legislation, 20242 3 5 8 10 . D ec l a r a t i o n For and on behal f of I hereby certify that the above mentioned information and data provided in support of this application are to the best of my knowledge true, correct and complete. SignatureName in f ull (pr inted) D a teOff icial Ti tle F o r O f f i c ia l U se Rem ar k s Offi cial Stamp of Appl icant / Company Signed: D a te . FORM U L A T ED PR OD U CT/ SPRA Y A D JU V A N T : D OSSI ER IN D EX The dossier accompanying the form should provide more d etai l s o f th e i n f o r m at i o n requested in this list. Applicants are advised to use Col l aborat ive I nternational Pestici des Analytical Council Limited (CIPAC) methods for Physical/Chemical properties. Summaries of the methods used and the results of toxicological and methods of analysis 'etc. should be given. Numbering used in the dossier must correspond with that used in F o r m A 4 . f FO RM U L A T ED PROD U CT/Spray ad juvant Off icial use onlyA n n ex N o . i n d o ssier1 . P h y s i c a l AN D C h e m i c a l Pr o pe r t i e s if study included 1.1 Source, Name and A ddress of form ulatoi and ad d ress and location of form ulat ion plant . 1.2 Source, M SDS and specifications components included i n the f o r m u l at i o n f o i 1.3 Physical state / formulation type 1 .4 C o l o u r 2358 Kenya Subsidiary Legislation, 2024 10. “DECLARATION For and on behalf of application are to the best of my knowledge It hereby certify that the above mentioned information and data provided in support of this true, correct and complete. i Name in full (printed) Signature Official Title Date FOR OFFICIAL USE Remarks Official Stamp of Applicant / Company ~ Signed Date , FORMULATED PRODUCT/ SPRAY ADJUVANT: DOSSIER INDEX The dossier accompanying the form should provide more details of the information requested in this list. Applicants are advised to use Collaborative International Pesticides Analytical Council Limited (CIPAC) methods for Physical/Chemical properties. Summaries of the methods used and the results of toxicological and methods of analysis ‘etc. should be given. Numbering used in the dossier must correspond with that used in Form A4. FORMULATED PRODUCT Spray adjuvant 1. PHYSICAL AND Annex No. in dossier Official use only CHEMICAL PROPERTIES if study included 1.1 Source, Name and Address of formulator and address and location of formulation! plant. 1.2 Source, MSDS and specifications for components included! in the formulation 1.3 Physical state / formulation type 1.4 Colour Kenya Subsidiary Legislation, 2024 2 35 9 1 .5 O do u r 1.6 Ef fects of l ight , air , temperature, w ater on tech n i c al c h ar ac ter i st i c s o f t h e f o r m u l at i o n 1.7 Storage stabil ity in proposed packaging 1 .8 Shel f l i f e 1.9 Density 1.10 Bulk density 1.11 Flammabi lity 1.12 Flash point 1.13 Explosiv i ty 1.14 Incompatibil ity with other pest control Pr o d u ct s 1.15 pH 1.16 pH of 1% aqueous d i l u t io n 1.17 Oxidizing properties 1 .18 C o rr o si v eness 1 .19 W ater co n ten t 1.20 W ettabi l i ty 1.21 Solubi lity in water 1.22 Persistent foaming 1 .2 3 P ar t i c l e si ze 1.24 Suspensibi lity / emulsifi abil ity 1.25 Emulsion stabi li ty 1.26 Volatil ity 1.27 V iscosity 1.28 Surface tension (where appl icable) ■' ■' I 1 .2 9 A d hesi o n 1.30 M ethods of Analysis 1.31 Detailed composition supported analytical f r o m . , .. ’1 . 1 by HO ev i d enc e c er t i f i ed l . \ l aboratory 1 .3 2 O ther properties (where appl icable e.g penetration) <u ., A n nex N o . i n d o ssi er if study included ';\ 7 , Official use 'qnl^2 . T o x i c o l o g y 2 .1 Acute oral LDjo mg/K g (Rat) Kenya Subsidiary Legislation, 2024 2359 15 Odour 1.6 Effects of light, air, temperature, water on! technical characteristics of the’ formulation 1.7 Storage stability in proposed packaging 1.8 Shelf life 1.9 Density 1.10 Bulk density 1.11 Flammability 1.12 Flash point 1.13 Explosivity 1.14 Incompatibility with other pest control Products 5 pH 1 6 pH of 1% aqueous) dilution 1.17 Oxidizing properties 1.18 Corrosiveness 1.19 Water content 1.20 Wettability 1.21 Solubility in water 1.22 Persistent foaming 1.23 Particle size 1.24 Suspensibility / emulsifiability 1.25 Emulsion stability 1.26 Volatility 1.27 Viscosity 1.28 Surface tension (where applicable) 1.29 Adhesion 1.30 Methods of Analysis 1.31 Detailed composition! supported by analytical evidence from certified| laboratory 1.32 Other properties (where applicable e.g penetration) shbeay TOXICOLOGY Annex No. in dossier if study included Official use only 2.1 Acute oral LD.) mg/Kg (Rat) Kenya Subsidiary Legislation, 20242 3 6 0 2 .2 A c u te d er m al L D mg/Kg 5 C 2.3 Inhalation LCjo mg/L / 4 h o ur s 2.4 Skin irri tation (Rabbit) 2.5 Eye irri tation 2 .6 Sk i n Sen si t i z at i o n i n guinea pig or Local lymph node assay (L L N A ) 2 .7 W H O c l assi f i c at i o n 2 .8 O th er stud i es Detai led studies in 2.1 to 2.6 M UST be original and specif ic to the formulation. T he studies should be conducted in GL P certi f ied l aborator ies. 3 . Emer g en c y Pr o c edu r es in c a se o f A c c id ent a l Ex po sur e o r Po i so n i n g A nn ex N o . i n d o ssi er i f study included Official use only 3.1 Symptoms of human poisoning 3 .2 M o de o f ac t i o n i n m am 3 .3 F i r st ai d t r eatm en t 3 .4 Sk i n c o n tac t 3 .5 Eye contact 3 .6 I n h al at i o n 3.7 Ingestion f 3 .8 A n t i d o te 3.9 Note to physician 4 . E m e r g en c y Pr o c ed u r e s i n c a se o f F ir e /Spi l l a g e 4 .1 F i re f ighti ng measures 4 .2 Pr o ced ur es i n c ase o f (Spil lage 5 . B l OEFn CA CY A JSES A n nex N o . i n do ssier i f Study included Off icial use onlySpr a y A d j u v a n t 5 .1 Pr o d u ct and Crop/public health etc 5.2 Spray adj uvant f u nc t i o n 5.3 Adj uvant Rates 5.4 Spray carrier 2360 Kenya Subsidiary Legislation, 2024 2.2 Acute dermal LDgg mg/Kg 2.3 Inhalation LCs) mg/L 4hours 2.4 Skin irritation (Rabbit) 2.5 Eye irritation 2.6 Skin Sensitization in| guinea pig or Local lymph node assay (LLNA) 2.7 WHO classification 2.8 Other studies Detailed studies in 2.1 to 2.6 MUST be original and specific to the formulation. The studies should be conducted in GLP certified laboratories. 3. | EMERGENCY PROCEDURES IN CASE OF ACCIDENTAL EXPOSURE OR POISONING Annex No. in dossier if study included Official use only 3.1 Symptoms of human poisoning . [3.2 “Mode of action in man] 3.3 ~First-aid treatment 13.4 Skin-contact 3.5 Eye contact 3.6 Inhalation 3.7 Ingestion 3.8 Antidote 3.9 Note to physician 4. EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE 4.1 Fire fighting measures 42 Procedures in case of ‘pillage 5. BIOEFFICACY/USES SPRAY ADJUVANT Annex No. in dossier if Official use only study included 5.1 Product and Crop/public health etc 5.2 Spray adjuvant function : 5.3 Adjuvant Rates 5.4 Spray carrier Kenya Subsidiary Legislation, 2024 2 36 1 5.5 Stage of treatment 5 .6 D irect ions f or use 5.7 Residue data and pre har v est i n ter v al R ef er t o sec t i o n 8 i n the requirements 5.8 Provide Efficacy data f rom si m i lar cl imatic z o n e s 5.9 Phytotoxicity/ Crop safety Refer to section 5.7 in the guideline 6. Minimum Label Requir ement s - See PCPB label requirements (provided separately) . 7 . B eh a v io ur in En v i r o nmen t Where used in environmentally sensitive areas e.g aquatic systems, information on environmental impact potential should be submitted. 7.1 Behav iour , way s of degr adat ion , degr adat ion pr oduct s i n s o i l : 7.1.1 M aj or metabol ites 7 .1.2 D T ,n (day s) 7.1.3M obi lity of a.i . 7.1.4 Adsorption / desorption 7.1.5 M obi l ity of metabol ites 7.2 Behaviour, ways of degradation, degradation products i n w ater 7.2.1 M aj or M etabolites 7 .2 .2 D T ,o (day s) 7 .2 .3 Su r f ace w ater 7 .2 .4 G r o u nd w ater 7.3 Behaviour , ways of degradation, degradation products i n ai r . R ate and r o u te o f degradation in air (for fumigants and other volatile products) . 8. Residues (where applicable in food crops/animal s) 8.1 M a jor metabolites 8 .2 M etab o l i sm 8 .3 B eh av i o u r o f r esi d ues 8 .4 M RL codex or other certi f ied sources 8.5 M ethod of residue analysis 8 .6 Residue data f rom a GL P certi f ied laboratory . Kenya Subsidiary Legislation, 2024 2361 . 5.5 Stage of treatment 5.6 Directions for use 5.7. Residue data and pre harvest interval Refer to section 8 in the requirements 5.8 Provide Efficacy dat from similar climatic zones 5.9 Phytotoxicity/ Crop safety Refer to section 5.7 in the guideline 6. MINIMUM LABEL REQUIREMENTS —See PCPB label requirements (provided separately). , 7. BEHAVIOUR IN ENVIRONMENT Where used in environmentally sensitive areas e.g aquatic systems, information on environmental impact potential should be submitted. 7.1 BEHAVIOUR, WAYS OF DEGRADATION, DEGRADATION PRODUCTS IN SOIL: 7.1.1 Major metabolites 2 = 7.1.2DT 5 (days) et 7.1.3 Mobility of a.i. 7.1.4 Adsorption / desorption wn PRION '|7.1.5 Mobility of metabolites 7.2 Behaviour, ways of degradation, degradation products in water 7.2.1 Major Metabolites 7.2.2 DT 59 (days) | 7.2.3 Surface water 7.2.4Ground water = 7.3. Behaviour, ways of degradation, degradation products in air. Rate and route of | degradation in air (for fumigants and other volatile products). 8. | RESIDUES (where applicable in food crops/animals) 8.1 Major metabolites 8.2 Metabolism 8.3 Behaviour of residues 8.4 MRL codex or other certified sources 8.5 Method of residue analysis 8.6 Residue data from a GLP certified laboratory. Kenya Subsidiary Legislation, 20242 3 62 i n ter v al s8.7 Proposed pre-harvest /withholding periods in case of post h ar v est u se . 8 .8 Ef fect on tai nt , odour , taste, or other quality aspects due to residues in or on fresh or processed products. 8.9 Effects on industrial processing and/or household preparation on the nature and magnitude of residues. 8.10 Residue data in succeeding or rotational crops where presence of residues might be expected. 9 M o d e OF A c t i o n 2362 Kenya Subsidiary Legislation, 2024 8.7 Proposed pre-harvest interval /withholding periods in case of post harvest use. 8.8 Effect on taint, odour, taste, or other quality aspects due to residues in or on fresh or processed products. 8.9 Effects on industrial processing and/or household preparation on the nature and magnitude of residues. 8.10 Residue data in succeeding or rotational crops where presence of residues might be expected. [9 MODE OF ACTION Kenya Subsidiary Legislation, 2024 2 36 3 F o r m B 4 (r .8 (2) PE ST C ON T R O L PR OD U CT S B O A R D P.O. BOX 13794-00800, NA IROBI , WAIYA KI WA Y T el : 254-020 4446 115/4450242 Fax : 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@pcpb.go.ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ Summar y of The Dat a Submit t ed To The Boar d For Regist r a t ion o f A Semi oc hemic a l Pest Co n t r o l Pr o d uc t P A R T I 1 . T r ad e N am e T he N ame and A ddress of Form ulator Common Name of the active ingredient(s) Concentration of active ingredient(s) Source of a.i . (natural or synthetic) Name and Location of producer ofa.i C h em ic al N am e Formulation type A sso c i ated D ev i ce Proposed Uses 2 . 3 . 4 . 5 . 6 . 7 . 8a . 8b . 9 . 10 . Packaging/Containers (M aterial , size) 1 1 . Registrant (Name, Address,) 12 . Agent/Distributors in Kenya 13 . Premises (Registration No. Date of issue:) PA R T I I C h e m i st r y D a t a 14 a) Physical/Chemical properties of the technical grade material b) Composition of the technical product (purity %, natures and identity of impurities — other detai ls should be provided in the dossier) . c) Physical/Chemical Properties of the Formulated Product Kenya Subsidiary Legislation, 2024 2363 Form B4 (r.8 (2) PEST CONTROL PRODUCTS BOARD P.O. BOX 13794-00800, NAIROBI, WAIYAKI WAY Tel: 254-020 44461 15/4450242 Fax: 254-020 4449072 E-MAIL: info@pcpb.go.ke/md@ pcpb.go ke WEBSITE ADDRESS: https://www.pcpb.go.ke/ SUMMARY OF THE DATA SUBMITTED TO THE BOARD FOR REGISTRATION OF A SEMIOCHEMICAL PEST CONTROL PRODUCT PARTI V. Trade Name............cccecceccececeeseenctncecceccuseescsuesececessvececusenseensnssauensusaeas 2. The Name and Address of Formulator...............0c.ccccccscccescvenecusscescsceseuensesaes 3. Common Name of the active ingredient(s)..............c.cccsccsecececcccncuscsecccecncesaees 4. Concentration of active ingredient(S)..............c.cccececaccvcecececcecenesssacacecaveeeteees 5. Source of a.i. (natural or synthetic).............ccccsccscscccccscecacceuecscrenscusecscususecens 6. Name and Location of producer Of€.i.............c.ccssecesccvecesersccuusecsccnesenseaeececs 7. Chemical Name.............ccccccceccccccceeeeesscsesucecesesseeececeevencnensaseeesusuensetenees 8a. Formulation type.............. beceeecaeecevseescessseaeecescesesseeceesevessssesereeverseaaaeess Bb. Associated Device.......... cc cecccececsccses sense ueuteusecsseseeecucuenecesacsensuseseneeecsnans 9. Proposed Uses........... eee ee eee ee nee RE eee nee EERE DEES COED EEO EHO Dea HEE EEE EE GEESE EO EES 10. Packaging/Containers (Material, size)...............cccccccececsscceccececccerecscecaceceeasnss 11. Registrant (Name, Address,)...............ccccececcecsccneecsesscescseseusencuceeseaeanensueass 12. Agent/Distributors in Kemya.............cccccccsccececseeceeceesaesueeueseueucssseuseseenecens 13. Premises (Registration No. Date of issue:)............cccceecececececececececucesecesececesaas PART II CHEMISTRY DATA 14 a) Physical/Chemical properties of the technical grade material..................c.c0cce0e b) Composition of the technical product (purity %, natures and identity of impurities — other details should be provided in the dossier). c) Physical/Chemical Properties of the Formulated Product Kenya Subsidiary Legislation, 20242 3 64 Composition of the Formulated Product (Concentration of a.i . in the formulation . Other details should be provided in the dossier) d) Method of analysis for determination of the a.i . in technical and formulated products (State al l the methods for dif ferent components) e) PA R T I I I B i o l o g i c a l E f f ic a c y D a t a Target Pest(s), Host(s)a) b) M o d e o f ac t io n M ethod, Rate, Frequency of appl icationc) Recommendations from local biological ef f icacy trials for use in Kenyad) Recommendations for use by authorized bodies outside Kenyae) PA R T I V T o x i c o l o g i c a l D a t a Technical gr ade act iv e ingr edient (s) TIER I Requirements: Acute Toxicological Data of the Technical grade active ingredient(s) Straight-Chain Lepidopteran Pheromones (SCLPs) are exempt from all toxicological data requirements. The following studies are required for no n - SC L P s A) a) A c u te o r al L D A c u te d er m al L D 50 I n h al at io n L C 5 0 50 b) Short term toxici ty studies c) M utagenecity studies TIER II Requirements: (Information is required if concerns are triggered by TIER I studies. 1) Reproduction studies 2) Teratological studies 3) Neurotoxicity studies 2364 Kenya Subsidiary Legislation, 2024 d) Composition of the Formulated Product (Concentration of a.i. in the formulation. Other details should be provided in the dossier)...............:ecseeeeeeeeeeeeeenerseenee ees e) Method of analysis for determination of the a.i. in technical and formulated products (State all the methods for different components) PART IE BIOLOGICAL EFFICACY DATA a) Target Pest(s), Host(s). .........cccsccece cece seen cee eee renee enero eee tenn e en ene ne Eee Ee EE Ee ee b) Mode of action............ ce seeee ee Serer EET I OSSD EEEISO ISOS TET SSIES SOTSOTCESOOSIONS c) Method, Rate, Frequency of application..............ccccccecee ee eceeeeeeee nen eneenetenenerens d) Recommendations from local biological efficacy trials for use in Kenya e) Recommendations for use by authorized bodies outside Kenya .............:::seeeeee eens PART IV TOXICOLOGICAL DATA ett A) TECHNICAL GRADE ACTIVE INGREDIENT(S) TIER I Requirements: a) Acute Toxicological Data of the Technical grade active ingredient(s) Straight-Chain Lepidopteran Pheromones (SCLPs) are exempt from all toxicological data requirements. The following studies are required for non- SCLPs Acute oral LDyo......... ccc cee cc ence cence eee bene nee e tent eee nee eee Eee ees eE Tee e ne eee ben EEE Ene ES tae Acute dermal LDS0......... 0.0... ccc ccc c cee ee ene ene nee eee een e ee nen DEE DEERE EERE EEE ERE E EEE EE EERE EE Inhalation Lop ...... cece cece eee tee een ne eee een eee teen Eee EEE EEE EEE EOE EE EEE EHTEL ts c) Mutagenecity studies TIER II Requirements: (Information is required if concerns are triggered by TIER I studies. 1) Reproduction studies .............cccec ccc cc cece cence nee eee reer e nen erence Ere Re rere o eta é Kenya Subsidiary Legislation, 2024 2 3 6 5 4) Additional mutagenicity studies 5) Carcinogenicity studies 6) Chronic toxici ty 7) Hypersensitivity/allergies in human or any other human exposure data 8) M etab o l i c stu d ies B ) Acut e Tox icit y Dat a of The For mul at ed Pr oduct : SCLPs are exempt provided the co-formulants are not of toxicological concern (MSDS must be provided). The Acute toxicity studies wi ll be provided for non-SCLPs if any of the co-formulants are of toxicological concern. PA R T Y Emer gency Pr ocedur es in Case of Accident a l Exposur e o r Po i so n i n g a) Hazards to humans . b) Symptoms of poisoning c) A nt i d o te d) T reatm en t F i r st A i d M easur ese) f) Safety Precaut ions/Restrictions i r / ri 8 <■() ■ P A R T V I E c o -T o x i c o l o g y Toxicity to birds (Required if the product could be ingested by birds, e.g. a granular formulation) a) b) Toxicity to fish (Required if product is applied by air, or directly to water or at a rate exceeding natural background levels) Freshwater invertebrates (Required if product is applied by aircraft , or directly to water or at a rate exceeding natural background levels c) Kenya Subsidiary Legislation, 2024 2365 4) 5) 6) 7) 8) B) ACUTE TOXICITY DATA OF THE FORMULATED PRODUCT: SCLPs are exempt provided the co-formulants are not of toxicological concern (MSDS must be provided). The Acute toxicity studies will be provided for non-SCLPs if any of the co-formulants are of toxicological concern. a) b) a) b) c) PART V EMERGENCY PROCEDURES IN CASE OF ACCIDENTAL EXPOSURE OR POISONING Hazards to humans... 0.0.0. ccc cee cccce cee eee eeu ceuceceuceueectsaesneenenenss eeeeeeee een eee, Symptoms Of poisoning........ 6c. cceccceec cece ececeeeeeesesuueccsvanseccuneeersrteceeaueceeeas ANtidOte... 0... ie cece cee eee nee es cee esse seueescacsaeseuveaeseuetssetaceseesentenees Treatment... 0... cece eee eee cece ce eee sete esen ere teseseceeeessttrestuecrnsea lies First Aid Measures....... 00.00. .e ccc ccccecee cee cee ce seu ctu see secrete seateceuceserseessubensees Safety Precautions/Restrictions.......0..00.c0.ccccesceccecenseuceecessuesceeneunees ode, a PART VI ECO-TOXICOLOGY Toxicity to birds (Required if the product could be ingested by birds, e.g. a granular formulation) 00.00.00. cece cee cc eccecesse cee cescecuesauceaesaeesaeeusutiesesvisscuscunrenes Toxicity to fish (Required if product is applied by air, or directly to water or at a rate exceeding natural background levels) .........0.....cccccccccuscesceccuceuceccuccuscecueceuses Freshwater invertebrates (Required if product is applied by aircraft, or directly to water or at a rate exceeding natural background levels ..............0...c.esececeseeeeeees Kenya Subsidiary Legislation, 20242 36 6 d) Algae (Waived for products in affixed dispensers and if exposure is unlikely to exceed natural background levels) e) Toxicity to bees (Information/discussion, to address w h eth er beh av i o uOr o r reproduction would be affected, is required if exposure is likely to exceed natural background levels) f) Toxicity to earthworms (Required if product is applied to soi l and can accumulate in if exposure exceeds natural background levels)soil . Required P A R T V l l Information on Approvals/Registrations in other countries (A ttach copies of certif icates) PA R T V I I I D r af t o f l o c al l ab el P A R T I X Brief prepared by Signature Of fi cial stamp ... . D ate . PART X (For Of h cial Use Onl y ) Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration R easo n s: D ate •C t i' 2366 Kenya Subsidiary Legislation, 2024 d) Algae (Waived for products in affixed dispensers and if exposure is unlikely to exceed natural background levels) .......:0:cccceeceee eee eee eee eee nee nee nec ese nen ene eens nega eee eee teehee Oe ea eee nee renee OER HEHE EEE TERETE EHH MEE EEE H ER BOOTHE REESE HHH DERE ES HOS AEE THERE EES EY e) Toxicity to bees (Information/discussion, to address whether behaviouOr or reproduction would be affected, is required if exposure is likely to exceed natural background levels) ..........ccsccseceeece eee ae ee tee eee e een teen n eae renee eeene ee nee ean eea eens f) Toxicity to earthworms (Required if product is applied to soil and can accumulate in soil. Required if exposure exceeds natural background levels) PART VII Information on Approvals/Registrations in other countries (Attach copies of COTEFICALES) Loe cece cece eee eee ee EE REE EEE E EE EE EEE ADEE EE EE EERE EELS TENE EE EEE EEE EL EEE EES PART VIII Draft of local label ..........ccccecceeceee ee ee eee eee eee eee eens nee ee eee nent eee eene ee eennee ean ene aes ee OE, . PART IX Brief prepared Dy..........cccccccs eee eee cece a eenen eee eee nE Eee ere OnE E EER EEE EET EEE RETR EEE EEO ES SS Tet) OES SEE OOEOOESEOOOOOOOOOOO Official stamp ............sccccccsee eee cece eee e eee ee nee TEA EE EEO EEE EES DEES EE Een EEE EE TEESE EE Ee eS 1 ORES TOTES EOEESOO SOS S PART X (FOR OFFICIAL USE ONLY) Decision of the PCPB registration Sub-Committee | Recommended/Not Recommended for registration REASONS: ....cccccccccccece cee cev coc eae eens tees eens eee e eee e eee eee seee Bese Ee Eee EEO E EE REESE ESSE SEE E BEER EES Kenya Subsidiary Legislation, 2024 2 36 7 PEST CONTROL PRODUCTS ACT F o r m a s (r .m APPLICATION FOR THE REGISTRATION OF A PEST CONTROL PROD U CT FOR USE IN PAINT FOR IN-CAN AND FILM PRESERVATIVES I n f o r ma t io n f o r A ppl ic a nt s 1 . The application form must be completed by a duly authorized p er so n . The application must be submitted in triplicate to:2 . The Secretary, Pest Control Products Board (PCPB) P.O. Box 13794- 00800 Nairobi , E-mail address: -info@pcpb.go.ke/md@pcpb.go.ke Tel .254-2-8021846/7/8, Fax 254-2-802 1865 Every application must be accompanied by: (a) Application fee as prescribed (Registration fee is payable upon approval by the B o ar d . 3 . • bai aq;. (b) copies of the draft label as per PCPB requirements. The applicant may be required to submit: (a) a sample of the pest control product; (b) a sample of the technical grade of its active ingredient; (c) a sample of the laboratory standard of its active ingredient; (d) any other sample as may be required by the Board. List I and II are supplied as a check list and an index to ensure that the applicant has provided the relevant data. u. The application must be accompanied by a technical dossier as per PCPB data • requirements (Lists I and II attached). An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control P ro d u c t s B o ar d . T r a d e N a m e 4 . 5 . 6 . 7 . Kenya Subsidiary Legislation, 2024 2367 PEST CONTROL PRODUCTS ACT | FORM A5 (r.9(1) APPLICATION FOR THE REGISTRATION OF A PEST CONTROL PRODUCT FOR ° USE IN PAINT FOR IN-CAN AND FILM PRESERVATIVES INFORMATION FOR APPLICANTS 1. 2. The application form must be completed by a duly authorized person. The application must be submitted in triplicate to: The Secretary, Pest Control Products Board (PCPB) P.O. Box 13794—00800 Nairobi, E-mail address: -info@pcpb.go.ke/md@ pcpb.go.ke Tel.254-2-8021846/7/8, Fax 254-2-8021865 Every application must be:accompanied by: Board. (b) copies of the draft label as per PCPB requirements. (a) Application fee as prescribed (Registration fee is payable upon approval by the . bais¢:. The applicant may be required to submit: (a) asample of the pest control product; (b) a sample of the technical grade of its active ingredient; (c) asample of the laboratory standard of its active ingredient; abate (d) any other sample as may be required by the Board. Cc List I and II are supplied as a check list and an index to ensure that the applicant has provided the relevant data. ea The application must be accompanied by a technical dossier as per PCPB data :- 8G requirements (Lists I and II attached). An applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control Products Board. Kenya Subsidiary Legislation, 20242 3 6 8 Pur pose of Appl icat ion (tick as appropriate) (a) Pest control product containing a new active ingredient (b) Pest control product where source of active and/or formulation is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e) Type of Registration Applied for. Tick as Necessary Ful l Registration Temporary Registration (f ) Other (Explain) Will the product be marketed under own label? N oY es If No specify Proposed date of marketing 1 . A ppl i c a n t 1 .1 I d en t i f i c at io n Name of applieant / Corporate name of c o m p an y Business Reg No.: Name of registration holder Name of local agent in country : {if dif ferent f rom registration holder) 1.14 Status: (Importer/formulator/distributor) Business Registration No.: 1.15 Physical Address 1.16 Postal A ddress: 1.17 Telephone: {and area code) 2368 Kenya Subsidiary Legislation, 2024 PURPOSE OF APPLICATION (tick as appropriate) (a) Pest control product containing a new active ingredient (b) Pest control product where source of active and/or formulation is not identical to that of a registered product (c) Registration transfer (d) Amendments to existing registration (e) Type of Registration Applied for. Tick as Necessary Full Registration LI Temporary Registration LJ (f) Other (Explain) Will the product be marketed under own label? Yes No If No specify...........cccceseeeeeeeeee nee eee tense cues Lecce ceeeeeceaeeeseeeecereneee veneeenes a Proposed date of marketing .............:::::cseeeeeereeeees veveeesesueaeesssseseneeeseeeseeeeees 1. APPLICANT 1.1 Identification Name of applicant / Corporate name of company Business Reg No.: Name of registration holder Name of local agent in country: (if different from registration holder) 1.14 Status: (Importer/formulator/distributor) Business Registration No.: 1.15 Physical Address 1.16 Postal Address: 1.17 Telephone: (and area code) Kenya Subsidiary Legislation, 2024 23 6 9 1.18 Fax: (and area code) 1.19 e-M ai l : 2 . Pr o d uc t T r ade n am e : 2.1 Designation (Description of product) T r ade m ar k : T rade m ark holder : 2.2. Function of product: (eg. Insecticide, herbicide etc.) 2.3 Intended use: (Public health, industrial , agriculture, forestry, etc. 2.4 Target pest(s) and host(s) 2.5 Method, dosage rates and frequency of application: Crop L ife l ntemational(CL I * ) Code (if available) 2.6 Type of formulation: (eg. EC, WP, etc.) 2.7 a) Is the product registered in country of manuf acture? Y es N o If Yes, attach a copy of certificate. If ■ ihoKj no , ,g i v e reaso n s b ' Y es N o b) Is the product registered in the country of f o r m u l at i o n ? .If Yes, attach a copy of certificate. If no, give reasons 2.8 Registration in SEARCH* country/ies: (names) 2.9 Existing registration No(s) and country(s). • -' O 2 .10 Custom s T ar i f f C o d e : (Brussels Tarrif Nomenclature) 3. Composit ion Of Act ive Ingredient (S) (Technical grade) (Inf ormation may be attached in sealed envelope) o n a . i 5 ; Active ingredient(s): (Common name/s) M anuf acturer : (Name and address) M i nim um a.i .% purity a.i . Range % Kenya Subsidiary Legislation, 2024 2369 1.18 Fax: (and area code) 1.19 e-Mail: 2. PRODUCT Trade name: 2.1 Designation (Description of product) Trade mark: Trade mark holder: 2.2. Function of product: (eg. Insecticide, herbicide etc.) 2.3 Intended use: (Public health, industrial, agriculture, forestry, etc. 2.4 Target pest(s) and host(s) 2.5 Method, dosage rates and frequency of application: manufacture? b) Is the product registered in the country of formulation? . Crop Life 2.6 Type of formulation: (eg. EC, WP, etc.) International(CLI*) Code (if available) 2.7 a) Is the product registered in country of Yes No If Yes, attach a copy of certificate, If no, give reasons eS TSees Yes [| Jbotg No If Yes, attach a copy of certificate, If no, give reasons 2.8 Registration in SEARCH* country/ies: (names) 2.9 Existing registration No(s) and country(s). 2.10 Customs Tariff Code: (Brussels Tarrif Nomenclature) may be attached in sealed envelope) 3. | COMPOSITION OF ACTIVE INGREDIENT(S) (Technical grade) (Information onal Active ingredient(s): Manufacturer: (Common name/s) (Name and address) Minimum a.i.% © purity ai. Range % Kenya Subsidiary Legislation, 20242 37 0 4 . F o r m u l a t i o n 4.1 Formulator: (Name) Postal A ddress: Physical address: 4 .2 I nternal code: 4.3 Composition (Information on composition may be attached in sealed envelope) Ingredients and F u nc t i o n : Rangeg/kg * Formerly GCPF * SEARCH — Southern and Eastern African Regulation Committee on Harmonisation of Pesticide Registration 5. Toxicol ogy (formulated product) A cute D ermal (LD50 mg/kg) I nhal at ion L C (mg/l/hour) Acute Oral (LD50 mg/kg) 50 5 .1 R at : ExperimentalExperimentalExperimental CalculatedCal cul atedCalculated ' Eye irritationSk in i rr i tation5.2 R abbi t : N o ne M i l d M o der ate 4Sev er e Sev ereM o der ateM i l d5.3 Sk in Sensitization in guinea pig: (tick) N o ne I I II II bl a5 .4 W H O classi f f ication : 5.5. Summary of other toxicological studies: eg. wildlife, poultry , pets 5.6 Summar y of Env ir onment al Ef f ect s Toxicity to bees:5 .6 .1 5.6.2 Toxicity to f ish and other aquatic organisms: 5.6.3 Toxicity to birds: 5.6.4 Toxicity to earthworms and soil micro organisms: 5.6.5 Toxicity to other non-target organisms: 2370 Kenya Subsidiary Legislation, 2024 4. FORMULATION 4.1 Formulator: (Name) Postal Address: Physical address: 4.2 Internal code: 43 Composition (Information on composition may be attached in sealed envelope) Ingredients and Function: g/l gike Range * Formerly GCPF * SEARCH — Southern and Eastern African Regulation Committee on Harmonisation of Pesticide Registration . 5. TOXICOLOGY (formulated product) Acute Oral (LD59 Acute Dermal Inhalation LCs 5.1 Rat: /k /Uh mg/kg) (LD, mg/kg) (mg/l/hour) Experimental Experimental Experimental Calculated *~ Calculated Calculated 5.2 Rabbit: Skin irritation Eye irritation None Mild Moderate | . Severe . 5.3 Skin Sensitization in guinea | None [] Mild [| Moderate [] Severe| | pig: (tick) 5.4 WHO la Ib ri il classiffication: 5.5. Summary of other toxicological studies: eg. wildlife, poultry, pets 5.6 SUMMARY OF ENVIRONMENTAL EFFECTS 5.6.1 Toxicity to bees: 5.6.2 Toxicity to fish and other aquatic organisms: — 5.6.3 Toxicity to birds: 5.6.4 Toxicity to earthworms and soil micro organisms: co 5.6.5 Toxicity to other non-target organisms: Kenya Subsidiary Legislation, 2024 2 3 7 1 5.6.6 Persistence in environment: 5.6.7 Other effects: Specify Pa c k a g in g 6 .1 Packaging material / container: 6 .2 Pack size(s): 6.3 Disposal of empty container(s): Ot her Specihc Requir ement s 7.1 Operator exposure (a). Dermal absorption. (b). Likely operator exposure under f ield conditions (c) Available toxicological data relating to other ingredients in formulation (non-active additives in formulation). D ec l a r a t i o n For and on behal f of I hereby certify that the above mentioned information and data provided in support of this application are to the best of my knowledge true, correct and complete. ' ‘ :l i d ' Name in full (pr inted) Signatur e Offi cial Title D a te Fo r Of f ic ia l U se R em ar k s Offi cial Stamp of Applicant / Company Signed: ■ b ate: NOTE: The f ormat of this application is recognized by al l SEARCH countr ies. Kenya Subsidiary Legislation, 2024 2371 5.6.6 Persistence in environment: 5.6.7 Other effects: Specify (6 | PACKAGING 6.1 Packaging material / container: 6.2 Pack size(s): 6.3 Disposal of empty container(s): 7 OTHER SPECIFIC REQUIREMENTS 7.1 Operator exposure (a). Dermal absorption. (b). Likely operator exposure under field conditions (c) Available toxicological data relating to other ingredients in formulation (non-active additives in formulation). 8 DECLARATION For and on behalf Of ........... 0c cccccssssccccecseccscescesetettetttssssteussssuasseseeeeeceeceeeces I hereby certify that the above mentioned information and data provided in support of this application are to the best of my knowledge true, correct and complete. ~ 1 tide Name in full (printed) . Signature Official Title [te . - see eeevessecneaeeecee FOR OFFICIAL USE Remarks ee BB Official Stamp of Applicant / Company ee ne NOTE: The format of this application is recognized by all SEARCH countries. Kenya Subsidiary Legislation, 20242 3 72 FORM A 5 , L IST I ACTIVE INGREDIENT; DOSSIER INDEX The dossier accompanying the application must provide full details (as applicable) of the information requested in this list, i .e., details of the methods used, results of toxicological and ecotoxicological studies, methods of analysis, etc. Applicants are advised to use CIPAC methods for physical and chemical properties. Numbering used in the dossier must correspond to that used in the application form. If the product contains more than one active ingredient , compile a separate dossier for each active ingredient . I O f f ic i al u se only A nnex N o . in dossier i f study includedACTIVE INGREDIENT (a.i) D esig n a t io n /I d en t it y Of a.i .I . 1.1 Common name (ISO) 1.2 M anufacturer or Development code 1.3 Source, Name and Address of manufacturer and address and location of manufactur ing plants. 1.4 M ethods of manufacture (synthesis pathways), may be sent direct to PCPB 1.5 Chemical name (l UPAC) 1.6 Chemical group 1.7 Structural f ormula 1.8 Empirical formula 1 .9 P aten t statu s I s the a.i . under patent? W ho is patent holder Expiry date 1 .10 M o l ec u l ar m ass 1 .10 C A S N u m b er 2 . Phy sic a l an d Ch emic a l Pr o per t ies 2.1 Physical state 2 .2 C o l o u r 2 .3 O d o u r 2.4 Density at 20°C 2372 Kenya Subsidiary Legislation, 2024 ForM AS, List! ACTIVE INGREDIENT: DOSSIER INDEX The dossier accompanying the application must provide full details (as applicable) of the information requested in this list. ie., details of the methods used, results of toxicological and ecotoxicological studies, methods of analysis, etc. Applicants are advised to use CIPAC methods for physical and chemical properties. Numbering used in the dossier must correspond to that used in the application form. If the product contains more than one active ingredient, compile a separate dossier for each active ingredient. ACTIVE INGREDIENT (a.i) anny | in dossier if Tey use |1. - DESIGNATION/IDENTITY OF a.i. 1.1 Common name (ISO) “11.2 "Manufacturer or Development code 1.3 Source, Name and Address of manufacturer and address and location of manufacturing plants. 1.4 Methods of manufacture (synthesis . pathways), may be sent direct to PCPB. 1.5 Chemical name IUPAC) ‘41.6 Chemical group 1.7. Structural formula 1.8 Empirical formula 1.9 Patent status Is the a.i. under patent? Who is patent holder Expiry date 1.10 Molecular mass 1.10 CAS Number 2. PHYSICAL AND CHEMICAL PROPERTIES 2.1 Physical state 2.2 Colour 2.3. Odour 2.4 Density at 20°C Kenya Subsidiary Legislation, 2024 2 37 3 2.5 V apour pressure at 20/25‘’C 2.6 Volati l ity 02.7 Hydrolysis DT50 C pHDays 2.8 Photolysis ."C2.9 Solubility in water pH 2.10 Solubility in organic solvents 2.11 n-octanol/water partition coeff icient 2.12 Boiling point “C 2.13 Melting point ®C 2.14 Decomposition temperature ®C 2.15 M ethod of A nalysis and Impurities 2.16 Stabi l ity in water , hydrolysis rate, effect of light, identity of breakdown products 2.17 Stabi l ity in organic solvents used in f o r m u l at i o n 2.18 Stabi lity in air ; effect of l ight , identity of b reak d o w n Pr o d u ct s 2.19 Thermal stabi lty , identity of breakdown product . 2.20 Flammabi lity 2.21 Flash point 2.22 Explosive properties 2.23 Oxidizing properties A nn ex N o . i n dossier i f study i nc l ud ed O f f i c i al u se only A c t i v e I n g r e d i en t 2.24 Absorption spectra - UV/V isible, infra-red, N M R M S 2.25 Reactivity towards container material 3 . T o x ic o l o g y 3.1 Acute oral LD50 mg/kg rat/rabbit 3.2 Acute dermal LD50 mg/kg (rat) 3.3 Inhalation LC50 mg/1 hour (rat) 3.4 Skin irritation (rabbit) 3.5 Eye irritation (rabbit) Kenya Subsidiary Legislation, 2024 2373 2.5 Vapour pressure at 20/25°C 2.6 Volatility 2.7 Hydrolysis DT. ..... Days ...... C.. pH 2.8 Photolysis 2.9 Solubility in water ............. Vonnne pH 2.10 Solubility in organic solvents 2.11 n-octanol/water partition coefficient 2.12 Boiling point °C 2.13 Melting point °C 2.14 Decomposition temperature °C 2.15 Method of Analysis and Impurities 2.16 Stability in water, hydrolysis rate, effect of light, identity of breakdown products 2.17 Stability in organic solvents used in formulation 2.18 Stability in air; effect of light, identity of breakdown Products 2.19 Thermal stabilty, identity of breakdown product. 2.20 Flammability 2.21 Flash point 2.22 Explosive properties 2.23 Oxidizing properties Annex No. in ACTIVE INGREDIENT dossier if study Official use . only included 2.24 Absorption spectra — UV/Visible, infra-red, NMR MS 2.25 Reactivity towards container material 3. TOXICOLOGY 3.1 Acute oral LD. mg/kg rat/rabbit 3.2 Acute dermal LD.y mg/kg (rat) 3.3. Inhalation LC.) mg/l hour (rat) 3.4 Skin irritation (rabbit) 3.5 Eye irritation (rabbit) Kenya Subsidiary Legislation, 20242 3 74 3.6 Skin sensitisation (guinea pig) 3.7 Reproduction (specify species) 3.8 Subchronic toxicity 90 day NOEL mg/kg/day 3.9 Chronic toxicity NOEL mg./kg/day 3.10 Carcinogenicity (l ife time) NOEL mg/kg/day 3.11 Neurotoxicity NOEL mg/kg/day 3.12 Teratogenicity NOEL mg/kg/day 3.13 M utagenicity /Genotoxicity 3.14 M etabol ism (rat) 3 .15 O th er stud i es Notes:- For long term studies individual studies or publ ished l iterature may be acceptable. 4 . A c t i v e I n g r e d ie n t E C O -T O X I C O L O G Y (Active ingredient - technical grade 4.1 Birds (2 species) A n n ex N o . i n d o ssi er i f study included LDso mg/kg N O E L O f f i c i al u se only LD,,n mg/kg N O E L Reproduction LD.sn mg/kg N O E L 4.2 Fish (2 species) f ' LD?o mg/kg N O E L j . Reproduction B C F 4.3 Daphnia LC,n mg/1 • r i ■ N O E L i4 .4 A lgae LC50 mg/1 N O E L 4 ^5 - - B ees LD,ni g/bee N O E L 4 .6 E ar th w o rm s LC,n mg/kg 4.7 Soi l micro-organisms 5 . B e h a v i o u r i n E n v i r o n m e n t 5.1 Behaviour , ways of degradation, degradation products i n so i l : 5.11 M aj or metabol ites 5.12 DT50 (days) 2374 Kenya Subsidiary Legislation, 2024 3.6 Skin sensitisation (guinea pig) 3.7 Reproduction (specify species) 3.8 Subchronic toxicity 90 day NOEL mg/kg/day 3.9 Chronic toxicity NOEL mg./kg/day 3.10 Carcinogenicity (life time) NOEL mg/kg/day 3.11 Neurotoxicity NOEL mg/kg/day 3.12 Teratogenicity NOEL mg/kg/day 3.13 Mutagenicity /Genotoxicity 3.14 Metabolism (rat) 3.15 Other studies Notes:- For long term studies individual studies or published literature may be acceptable. 4. ACTIVE INGREDIENT ECO-TOXICOLOGY (Active ingredient — technical grade Annex No. in dossier if study included Official use only 4.1 Birds (2 species) LD mg/kg NOEL LD; mg/kg NOEL Reproduction 4.2 Fish (2 species) i , LD. mg/kg NOEL LD mg/kg NOEL Reproduction BCF 4.3 Daphnia ‘FTE LC. mg/l NOEL i4.4 Algae H LC, mg/l NOEL '4-5-- Bees LD.oi g/bee NOEL 4.6 Earthworms LCsy mg/kg 4.7 Soil micro-organisms 5. BEHAVIOUR IN ENVIRONMENT 5.1 Behaviour, ways of degradation, degradation products in soil: 5.11 “Major metabolites 5.12 DT 5 (days) Kenya Subsidiary Legislation, 2024 2 37 5 5.13 M obil ity of a.i . 5.14 Adsorption / desorption 5.15 M obil ity of metabol ites A n n ex N o . i n d o ssi er if study included. F o r o f f i c i al u se only . 5 .2 Behaviour, ways of degradation, degradation products i n w ater 5.21 M aj or M etabolites 5.22 DT50 (days) 5 .2 3 Sur f ace 5 .24 G r o u nd 5 .3 Behaviour, ways of degradation, degradation products i n ai r . R ate and r ou te o f degradation in air (for fumigants and other volatile products) . 6 . M o d e OF A c t i o n Fo r m B 6 , L I ST I I F O R M U L A T E D PR O D U C T : D O SSI E R I N D E X The dossier accompanying the form should provide more d etai l s o f t h e i n f o r m at i o n requested in this l ist . Applicants are advised to use C I P A C m eth o d s f o r Physical/Chemical properties. Summaries of the methods u sed an d th e r esu l t s o f toxicological and ecotoxicological studies, methods of analysis etc. should be given. Numbering used in the dossier must correspond with t h at u sed i n F o r m A 5 . F o r m u l a t ed Pr o d u c t 1 . P h y si c a l a n d C h em i c a l Pr o pe r t i e s A n n e x N o . in D o s si e r IF St u d y I n c l u d e d O f f i c i a l U se O n l y 1.1 Source, N ame and A ddress of f o r m u l ato r and ad d ress and l o c at i o n o t f orm ulation pl ant . 1.2 Source and specif ications for components included in the formulation 1.3 Physical state / formulation type 1 .4 C o l ou r 1 .5 O do u r 1.6 Ef fects of l ight, air , temperature, water o n tec h n i c al c h ar ac ter i st i c s o f t he f o rm u l at i o n 1.7 Storage stabil ity in proposed packaging 1 .8 She l f l i f e 1.9 Density 1.10 Bulk density Kenya Subsidiary Legislation, 2024 2375 5.13. Mobility of a.i. 5.14 Adsorption / desorption 5.15 Mobility of metabolites . Annex No. in dossier | For official use if study included. only. 5.2. Behaviour, ways of degradation, degradation products in water 5.21 Major Metabolites 5.22 DT 5 (days) 5.23 Surface 5.24 Ground degradation in air (for fumigants and other volatile products). 5.3. Behaviour, ways of degradation, degradation products in air. Rate and route of 6. MODE OF ACTION Form B6, LIST II FORMULATED PRODUCT: DOSSIER INDEX The dossier accompanying the form should provide more details of the information requested in this list. Applicants ,are advised to use CIPAC methods for Physical/Chemical properties. Summaries of the methods used and the results of toxicological and ecotoxicological studies, methods of analysis etc. should be given. Numbering used in the dossier must correspond with that used in Form AS. t FORMULATED PRODUCT 1. PHYSICAL AND CHEMICAL PROPERTIES | ANNEX No. IN DOSSIER | OFFICIAL USE IF STUDY INCLUDED ONLY 1.1 Source, Name and Address of formulator and address and location of formulation plant. AB iawn 1.2 Source and specifications for] components included in the formulation 7 1.3. Physical state / formulation type 1.4 Colour 1.5 Odour 1.6 Effects of light, air, temperature, water on technical characteristics of the formulation 1.7 Storage stability in proposed packaging 1.8 Shelf life 1.9 Density Cee 1.10 Bulk density Kenya Subsidiary Legislation, 20242 3 7 6 1.11 Flammabi lity 1.12 Flash point 1.13 Explosivi ty 1.14 In-compatibi l ity with other pest control Pr o du c ts 1.15 pH 1.16 pH of 1 % aqueous di lution 1.17 Oxidizing properties 1 .18 C o rr o si v eness 1 .19 W ater co n ten t 1.20 Wettabi l ity 1.21 Solubi li ty in water 1.22 Persistent foaming 1 .2 3 P ar t i c l e si ze 1.24 Suspensibi li ty / emulsif iabil ity 1.25 Emulsion stabi lity 1.26 Volati lity 1.27 V i scosi ty 1.28 Other properties (w here appl icable) 1.29 M ethods of Analysis T o x i c o l o g y : Food grade & Generally Regarded as Safe (GRA S) data w aivers adm i ssible; Publ ished l i terature/studies should be submitted ; but w here th ere ar e co f o r m u l an ts o f toxicological concern the toxicological studies for the end use product should be provided. For non-food grade and Non GRA S Toxicological studies should be provided. O m c iAL U se O n l y 2 . T o x i c o l o g y A n n e x N o . in D o ss i e r IF St u d y I n c l u d ed 2.1 Rat Acute oral LD n̂ mg/kg 2.2 Acute dermal LD,o mg/kg 2.3 Inhalation LD,n mg/1/hour 2 .4 R ab b i t Sk i n i r r i t at i o n 2.5 Eye irritation 2.6 Sensitisation in guinea pig 2 .7 W H O c l assi f i c at i o n 2 .8 O th er stud ies A n n e x N o . in D o ss ie r O ph c ia l U se O n l y [F St u d y I n c l u d e d 3 . E m er g en c y Pr o c e d u r e s i n C a se o f A c c i d e n t a l E x po su r e o r Po i so n i n g 3.1 Symptoms of human poisoning 3 .2 M o de o f ac t i o n i n m an 3 .3 F i r st ai d t r eatm en t 3 .4 Sk i n c o n tac t 3.5 Eye contact 3 .6 I n h al at i o n 2376 Kenya Subsidiary Legislation, 2024 1.11 Flammability 1.12 Flash point 1.13 Explosivity 1.14 In-compatibility with other pest contro] Products 1.15 pH 1.16 pH of 1% aqueous dilution 1.17 Oxidizing properties 1.18 Corrosiveness 1.19 Water content 1.20 Wettability 1.21 Solubility in water 1.22 Persistent foaming 1.23 Particle size 1.24 Suspensibility / emulsifiability 1.25 Emulsion stability 1.26 Volatility 1.27 Viscosity 1.28 Other properties (where applicable) 1.29 Methods of Analysis TOXICOLOGY: Food grade & Generally Regarded as Safe (GRAS) data waivers admissible; Published literature/studies should be submitted; but where there are coformulants of toxicological concern the toxicological studies for the end use product should be provided. For non-food grade and Non GRAS Toxicological studies should be provided. 2. TOXICOLOGY ANNEX NO. IN DOSSIER | OFFICIAL USE IF STUDY INCLUDED ONLY 2.1 Rat Acute oral LD.) mg/kg 2.2 Acute dermal LD., mg/kg 2.3 Inhalation LD., mg/l /hour 2.4 Rabbit Skin irritation 2.) Eye irritation 2.6 Sensitisation in guinea pig 2.7 WHO classification 2.8 Other studies (ANNEX NO. IN DOSSIER OFFICIAL USE ONLY IF STUDY INCLUDED 3. | EMERGENCY PROCEDURES IN CASE OF ACCIDENTAL EXPOSURE OR POISONING 3.1 Symptoms of human poisoning 3.2 Mode.of action in man 3.3 First aid treatment 3.4 Skin contact 3.5 Eye contact 3.6 Inhalation Kenya Subsidiary Legislation, 2024 2 37 7 3.7 Ingestion 3 .8 A n t i d o te 3.9 Note to physician 4 . E m e r g e n c y Pr o c e d u r e s i n C a se O f R r e / Spi l l a g e 4.1 Fire-f ighting measures 4.2 Procedures in case of spi llage 5. Uses (New label claims with this appl ication) A n nex N o . i n do ssier Off icial use onlyF o r m u l a t e d Pr o d u c t i f study incl uded 5 .1 ar ea o f u se 5.2 Target organism 5.3 D osage 5.4 Stage of treatment 5 .5 D i r ec t i o n s f o r u se 5 .8 C o n t r ai nd i c at i o n s M inimum Label Requir ement s - See PCPB label requirements (provided separately) . 6 . 7 . Ot her SPECin c Req u ir emen t s 7.1 M edical surveillance, on manufacturing plant personnel 7.2 Health records of occupationally exposed personnel , - industry ..etc . i J 'J l i r . I 7.3 Proposed packaging. Type of packaging in which the product is imported. Type of packaging for distribution in Kenya. Packaging material . Sizes of individual packaging 7.4 Procedures of destruct ion and decontamination of pest control product and its packaging. Possibil ity of neutral ization. Controlled discharge. C o nt r o l l ed i nc i ner at i o n . W ater purif ication. Procedures of cleaning appl ication Equipment . R eco m m ended m eth o d s and precautions concerning handling, storage, display or transport . ■ T.r: ) Kenya Subsidiary Legislation, 2024 2377 3.7 Ingestion 3.8 Antidote 3.9 Note to physician 4. EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE Fire-fighting measures Procedures in case of spillage USsEs (New label claims with this application) Water purification. Procedures of cleaning application Equipment. Recommended methods and precautions concerning handling, storage, display or transport. 5. Annex No. in dossier 7 FORMULATED PRODUCT if study included Official use only 5.1 area of use 5.2 Target organism 5.3 Dosage 5.4 Stage of treatment 5.5 Directions for use 5.8 Contraindications 6. | MINIMUM LABEL REQUIREMENTS —See PCPB label requirements (provided separately). 7. OTHER SPECIFIC REQUIREMENTS 7.1 Medical surveillance, on manufacturing plant personnel 7.2 Health records of occupationally exposed personnel, - industry. etc. . 7.3 Proposed packaging. Ne oe ry ’ dyOr Type of packaging in which the a a product is imported. : Type of packaging for distribution in Kenya. Packaging material. Sizes of individual packaging 7.4 Procedures of destruction and decontamination of pest control i" product and its packaging. Possibility of neutralization. Controlled discharge. ee Controlled incineration. » Be Kenya Subsidiary Legislation, 20242 3 7 8 F o r m B 6 (r .l 0 (2) P E ST C O N T R O L P R O D U C T S B O A R D P .O . B ox 13794 - 00800 , N airobi E-mail address: info@pcpb.go.ke/md@pcpb.go.ke T el : 254- 020 - 802 1846/7/ 8 Fax : 254 - 020 - 802 1865 W E B SIT E A D D R E SS : https://www .pcpb .go .ke/ Summar y o f T he D a t a Submit t ed To The B o a r d f o r Reg i st r a t io n o f P l a n t Gr o w t h Reg ul a t o r s an d Po st H a r v est Pr o d u c t s Fo r Fl o w er s a n d O r n a m e n t a l s PA R T I 1 . T r ad e N am e 2 . T he N am e and A ddress of Form ulator , 3 . Common Name of the active ingredient(s) Concentration of active ingredient(s) Name & Location of manufacturer of technical grade active ingredient , C h em ic al N am e Formulation type Proposed Uses 4 . 5 . 7 . 8 . 9 . 10 . Packaging/Containers (M aterial , size) 11 . Registrant (Name, Address, Status) Agents/Distributors in Kenya12 . 13 . Premises (RegJ^o. Date of issue) PA R T I I C H E M I ST R Y D A T A 14 . Physical /Chemical Properties of the a.i 2378 Kenya Subsidiary Legislation, 2024 FORM B6 (r.J0 (2) PEST CONTROL PRODUCTS BOARD 14. P.O. Box 13794 — 00800, Nairobi E-mail address: info@pcpb.go.ke/md@ pcpb.go.ke Tel: 254- 020 — 8021846/7/8 Fax: 254- 020- 8021865 WEBSITE ADDRESS: https://www pcpb.go.ke/ SUMMARY OF THE DATA SUBMITTED TO THE BOARD FOR REGISTRATION OF PLANT GROWTH REGULATORS AND POST HARVEST PRODUCTS FOR FLOWERS AND ORNAMENTALS ee eee ee eee eee ee ee eee ee ee ee ee eee eee ee ee eee eee rere eee ere Sere er eT ee ey . Common Name of the active ingredient(s)..............c.cccceeececscscsceeusuceveuseevuseres . Concentration of active ingredient(s)......... ac eeneneceeeenaeeseeenees tote ee enee eee eeeeneeres . Name & Location of manufacturer of technical grade active ingredient.................. » Chemical Name............::ccccseesceeeeceeeereuecneeceseeceneeeee seas seeaueeeaaeseeeaeeaa nese . Formulation type........53....cceccesceeeeneeeees Lele e eee ne cee eee ee ene eeseeee ten eee ene e ones ees » Proposed USes........ccce cece cee ce sence eee ee ee nee ease ee eee ene eee eee nee eee eee ene teeeaeseees acess CeCe Pee eee eee eee ee eee ee eee ee ee eee eee eee eee ee ee ee cee Cee eC eee eee eee eT eee eee ees . Registrant (Name, Address, Status).............:.cccccecsecesceseuscseesceeceuucustucescusess . Agents/Distributors in Kenya.............. Ssesssesecesecsseuesecesseeassesaucalecstevenseesaes PART II CHEMISTRY DATA Physical /Chemical Properties of the a.i.............cccceceecececeececeeseeueceeaenseesenenes ee ee ee ee ee ee rr ee ee ee re i es Kenya Subsidiary Legislation, 2024 2 37 9 (b) Physical/Chemical propert ies of the technical grade m ater i al (c) Composition of the technical product (purity %, natures and identity of impurities — other details should be provided in the dossier) (d) Physical/Chemical Propert ies of the Formulated Pr o d uc t (e) Composition of the Formulated Product (Concentration o f a .i . i n th e f o r m u l at i o n , other detai ls should be provided in the dossier) (f) M ethod of analysis for determination of the a.i . in technical and formulated products (State al l the methods for dif ferent components) PA R T I I I ..j . n m o '., 7 I J0 Biological (eff icacy) Data (a) A rea of use/Target Organism (if any), f lower type(s). f i a a r rr ' (b) M ode of action (c M ethod, Rate, Frequency of appl ication* . (d) Recommendations for use in Kenya (e) Recommendations for use by authorized bodies outside Kenya, . 11 •; \ .£ 1 P A R T I V Toxicological data Food grade & General ly Regarded as Saf e (GRAS) data waiver s admissib le; include summar ies f rom Published li terature or studies. For non f ood grade and Non GRAS provide acute toxicological study summar ies. For long term study summar ies f rom peer reviewed l iterature sh o u ld b e i n c l ud ed (a) Acute Toxicological Data of the active ingredient(s) s s (b) Acute toxicity data of the formulated product:.. ‘Kenya Subsidiary Legislation, 2024 2379 (c) Composition of the technical product (purity %, natures and identity of impurities — other details should be provided in the dossier) (e) Composition of the Formulated Product (Concentration of a.i. in the formulation. other details should be provided in the dossier)................:ccsceeeececeecnsncncneeeeues (f) Method of analysis for determination of the a.i. in technical and formulated products (State all the methods for different components) ..............0csscssersteneeeeeeeenseseeees PART III . . WYO oa. is SEMION Biological (efficacy) Data . . gone (a) Area of use/Target Organism (if any), flower type(s). (b) Mode of action........ . ui (c Method, Rate, Frequency of application................0.e:eeeeeeeeee pre eeeeseseecenesenenenes (d) Recommendations for use in Kenya ................cscec cee eeneee eee see see eeeeeeeeeren eases (e}) Recommendations for use by authorized bodies outside Kenya.................ceceeeeeens yA PART IV es | Toxicological data Food grade & Generally Regarded as Safe (GRAS) data waivers admissible; include summaries from Published literature or studies. For non food grade and Non GRAS provide acute toxicological study summaries. For long term study summaries from peer reviewed literature should be included (a) Acute Toxicological Data of the active ingredient(s) Seer eee eee eee eee eee eee eee eee eee eee eee rey Pee eee eee ee eee eT Dae are Wieenes . ya (b) Acute toxicity data of the formulated product:.. Kenya Subsidiary Legislation, 20242 3 80 (c) Short term toxicity studies (d) Other toxicological studies; ( 1) Reproduction studies (2) Teratological studies, (3) Neurotoxicity studies (4) M utagenecity studies (5) Long term toxicity/carcinogenicity studies (6) Accumulation of compound in tissues 7) M etabol ic studies (8) Effects on l ivestock , poultry (9) Toxicity Data on impurities 10) T ox ic i ty D ata on metabol ites ( 11) Human toxicology and medical aspects: (i) Hazards to humans (i i) Symptoms of poisoning (i ii) A ntidote (iv) Treatment (v) First A id M easures (vi) Safety Precautions/Restrictions 2380 Kenya Subsidiary Legislation, 2024 (d) Other toxicological studies: (1) Reproduction studies ....... 0.0... .c cc ccsc cee cence eee nee e cence eee e eee e cee neneteeneeeeeass Per ere rere rer ererrererererrerereerrcrercrererere ree cerer rere rrrererrrrve reer reer ee rrrer er creer rer ere ri etree reese erererrrer reer etre rests a 1) Human toxicology and medical aspects: @ Hazards to humans ............ccccsscsssesceseeeseeseesseessesseesnesseees (ii) Symptoms of poisoning 0.0... eeseseecereceeteeeeseeaeeeees (HT) ANtidote oo. ecesccseeseseesssetessesssresessasesesessescsensssseaeeneees (9V) Treatment oo... ccc eeeececesesesssececesscseseseesesteeeceeseeteteueeeseesees (v) First Aid Measures ...............008 secevevenesceenseeceeeaeenaeeeseeenees (vi) Safety Precautions/Restrictions.............:ceeeeeeeeeeeeeees a Kenya Subsidiary Legislation, 2024 2 3 8 1 PA R T V : En v i r o n men t a nd w i l d l i f e ha z a r d s Summar ies f rom publ ished l iterature or studies should be incl uded to addr ess individual r equi r ements (a) Degradation and mobility studies (soil , water, air) (b) Toxicity to birds .. (c) Toxicity to f ish (d) Toxicity to honeybees/benef icial insects (e) Toxici ty to earthworms, other soil invertebrates (f) Changes in soil ecology PA R T V I Information on Approvals/ Registrations in other countries {attach copy of certifi cate of Registration) i io ds ) : PA R T V I I D r af t o f l o c al l abel . M PA R T V I I I Brief prepared by Signature Off icial stamp D ate ( l i , PA R T I X Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration R easo n s: — D ate . Kenya Subsidiary Legislation, 2024 2381 PART V: ENVIRONMENT AND WILDLIFE HAZARDS Summaries from published literature or studies should be included to address individual requirements (a) Degradation and mobility studies (soil, water, air) .....cccccccccecscescecceccecceseeceeecsccaseasesses PART VI Information on Approvals/ Registrations in other countries (attach copy of certificate of Registration) ; PART VII Draft of local label . PART VIII Brief prepared Dy....... 0... e cece cee ne ce ence ete c nee eee ed ee bc nea ea et See eed bab tnEbEE EES SIQMAUIe. 0. ccc een ener e Ene E eee EEA SOE EES Ea ed EE Stati bta ea EE RSE SSE SEE OEGS Official stamp ....0......0ccccccccecceeeevecseecevecsurseeecereessseeeeeseceetsrtteesseseeeeees (hy Date... cence cent nee e ee een rene n tne EE EEE DERG cE peed tee bed aed eg eveebebereseneaeneeteas PART IX Decision of the PCPB registration Sub-Committee Recommended/Not Recommended for registration Reasons: — Kenya Subsidiary Legislation, 20242 3 82 F o r m a ? A PPL I CA T I ON FORM FOR T H E REGI ST R A T I ON OF PA R A L L EL PEST C O N T R O L PR O D U C T I n f o r m a t i o n f o r a ppl i c a n t s 1. The application form shall be completed by a person duly authorized by the applicant, and submitted to The Chief Executive Officer, PC PB . 2. The applicant shall be required to: — (a) Pay the prescribed fee; (b) Provide an original letter of access from the registrant; (c) Provide an original letter of no obj ection from the local agent; (d) Use approved label of the original registered product and only changes the trade name to prepare a product label , (e) Provide three (3) copies of the Proposed label (f ) Conduct eff icacy trials where the proposed use of a paral lel pest control product is-dif ferent from-that of-the original registered pest control product , '.■l o'ft i b ■' '0 k >\ o 'j (g) Provide any other information as may be required by the Board 1 Pr o po s ed Pr o d u c t Proposed Product name (brand name)1 .1 O r i g in a l Pr o d u c t D e t a i l s2 Original Product Brand Name- 2 .1 Type of formulation (Crop Life codê )2 .2 A ctive ingredient(s)/Agent (s) (common name)2 .3 Active ingredient/A gent (s) concentration(s)^ ;4 :Name of M anufacturer , Physical address. Email atldress and Telephone I' ti a Name of Formulator , Physical address. Emai l address and Telephone2 .6 Registrant, Physical address. Email address and Telephone2 .7 Local agent . Physical address. Email address and Telephone 2 .8 A ppl ic a n t3 . 7 2382 Kenya Subsidiary Legislation, 2024 FORM A7 | (r13(1) APPLICATION FORM FOR THE REGISTRATION OF PARALLEL PEST CONTROL PRODUCT INFORMATION FOR APPLICANTS 1. The application form shall be completed by a person duly authorized by the applicant. and submitted to The Chief Executive Officer, PCPB. ; 2. The applicant shall be required to: — (a) Pay the prescribed fee; (b) Provide an original letter of access from the registrant, (c) Provide an original letter of no objection from the local agent; (d) Use approved label of the original registered product and only changes the trade name to prepare a product label. (e) Provide three (3) copies of the Proposed label (f) Conduct efficacy trials where the proposed use of a parallel pest control product is.different from-that of-the original registered pest control product. wrath 3 rafter. 9o9 (g) Provide any other information as may be required by the Board 1 PROPOSED PRODUCT 1.1 | Proposed Product name (brand name) 2, | ORIGINAL PRODUCT DETAILS |-2.1 Original Product Brand Name 2.2 | Type of formulation (Crop Life code’) 2.3 | Active ingredient(s)/Agent (s) (common name) 4-4~--Active ingredient/Agent (s) concentration(s) 7 ‘Name of Manufacturer, Physical address, Email | address and Telephone Name of Formulator, Physical address, Email address and Telephone Registrant, Physical address, Email address and Telephone Local agent, Physical address, Email address 28 and Telephone 3. | APPLICANT Kenya Subsidiary Legislation, 2024 2 3 8 3 Applicant name (corporate name of company)3 .1 M anuf acturer Formul ator D i str i bu to r Status in Kenya3 .2 O ther : . . . . PCPB Prem i se L icense N umber and date of i ssu e3 .3 Business Registration Number3 .4 Physical Address3 .5 Po stal A d d r ess3 .6 Telephone Number3 .7 E -m ai l A d d ress3 .8 W eb si t e3 .9 3.10 Contact person at applicant company Contact person telephone number3 .1 1 L o c a l A g en t Of T h e Or ig in a l Reg i st er ed Pr o d u c t3 P u r po se O f A ppl i c a t io n4 Application for Parallel registration of a pest control product for the same uses as the original registeredA ■f> ■/ ' Application for Parallel registration of a pest control product for different uses from the Original registered product ̂ ! ‘ B Other (speci fy);C 5 Int en d ed U se I n sec t i c i d e Fungicide H er b i c i d e M i t i c i de R o den t i c i d e M o l l u sc i c i d e Function/Category of product (more functions/ categories possible) Plant growth regulator B acter i c i d e D ef o l i an t 5 .1 Sem i o C hem i c al / f . .VOther (specify): Pu b l i c h eal t hAgriculture Veterinary Type of use (more types possible)5 .2 H o u seho l d Forestry I n d u str i al Other (specify): .. . Target pest(s)/ disease(s) and crop(s)/ use(s) (if dif ferent from the registered uses of the original product) 5 .4 1 ' .- fi 2 3 4 Kenya Subsidiary Legislation, 2024 2383 Applicant name (corporate name of company) Status in Kenya Manufacturer — Distributor Formulator Other: .... PCPB Premise License Number and date of issue 3.4 | Business Registration Number 3.5 | Physical Address 3.6 | Postal Address 3.7 | Telephone Number 3.8 | E-mail Address 3.9 | Web site 3.10| Contact person at applicant company 3.11] Contact person telephone number 3 | LOCAL AGENT OF THE ORIGINAL REGISTERED PRODUCT 4 {PURPOSE OF APPLICATION: Application for Parallel registration of a pest control product for the same uses A as the original registered. , hol Application for Parallel registration of a pest ‘control product for different uses B from the Original registered product ‘ iverss Cc Other (specify): 5 |INTENDED USE Insecticide | Fungicide| Herbicide Miticide Rodenticide | Molluscicide Function/Category of produc Bactericide Defoliant Plant growth : 5.1 | (more functions/ categories| regulator possible) Semio ; Chemical aaa Other (specify): ............ cc ccc cee ne ee - jenenee Agriculture] Veterinary | Public health 5.2 | Type of use (more types possible)| Household Forestry Industrial Other (specify): bes Target pest(s)/ disease(s) and 54 crop(s)/ use(s) (if different from 1 4 | the registered uses of the original |! | essere seveenernenenene product) an 2 | ceecseccsceesescessencencnsesasescseesnscossaseccesscopertensssasencs 3 | ceeseecesseccesesececcnsesscsssnsesessesstsesensssessecescenesesance 4 | eeeesecsececescenecnensesnseneeessesssenseesssssessesessesaacenss Kenya Subsidiary Legislation, 20242 3 84 . D ec l a r a t i o n For and on behal f of I hereby certify that the above mentioned information, as well as the data provided in the technical dossier, in support of this application are true, correct and complete. SignatureName in f ul l (pr int) D a teOffi cial title Offi cial stamp of appl icant!company 8 F o r O f f i c i a l U se R em ar k s :Appl ication No: Reception date: F ees r ec ei v ed : Y es N d ' A mount paid: Approved Rej ected Pending Status of application: 2384. Kenya Subsidiary Legislation, 2024 DECLARATION For and on behalf of I hereby certify that the above mentioned information, as well as the data provided in the technical dossier, in support of this application are true, correct and complete. eer ee ee ee ee ee Official title Official stamp of applicant/company 8 |FOR OFFICIAL USE Application No: .........cccecceeeceeeeecenes Remarks: Reception date: ............ccccee eee eeeeeeneee cecuetecsentrecevensuseceevsceeesestseeeeseaneses Feesreceived: Yes NO’ ds eneccnccuccveceveuceeeeeceneeeeeeens eee erneneeee ees Amount paid: Cs evs ene v este eannneeeeeeetetenraeeeeeetereraetaeecey ‘|Status of application: Approved Rejected Pending Kenya Subsidiary Legislation, 2024 2 3 85 F o r m C l (r .l 5 (6) A PPL I CA T I ON FOR R EGI STRA T I ON A S A L OCA L A GEN T I n f o r ma t io n f o r A ppl ic an t s “Agent” means a person or company who has/that has been appointed to act on behalf of a registrant in accordance with regulation 4(2) of the Pest Control Products (Registration) Regulations. The application form must be completed by a duly authorized p er so n . The appl ication must be submitted to: 1 . 2 . 3 . The M anaging Director/ Secretary Pest Control Products Board (PCPB) P .O . B o x 137 94 - 0 0 80 0 N ai ro b i . E -m ai l ad d ress: info @ pcpb .go .ke/md @ pcpb .go .ke T el : 254 - 020 - 8021846/7/8 Fax : 254 - 020 - 802 1865 W eb si te : . https://www.pcpb.go .ke/. Every application must be accompanied by: — (a) An original letter from the registrant, (b) A binding agreement entered between the registrant and the agent , Pr o d u c t D e t a i l s (a) Trade Name (b) Name of M anufacturer (c) Name of Formulator (d) Name of Registrant (e) Name of Agent (f) Period for which agent has been appointed ■ i t '. ”. f 4 . Signature of appl icant (local agent) D a te Signature of Registrant D a te Off icial Stamps of Applicant and Registrant Kenya Subsidiary Legislation, 2024 2385 ForM Cl (r.15 (6) APPLICATION FOR REGISTRATION AS A LOCAL AGENT INFORMATION FOR APPLICANTS 1. “Agent” means a person or company who has/that has been appointed to act on behalf of a registrant in accordance with regulation 4(2) of the Pest Control Products (Registration) Regulations. The application form must be completed by.a duly authorized person. 3. The application must be submitted to: The Managing Director/ Secretary Pest Control Products Board (PCPB) P.O. Box 13794 — 00800 Nairobi. E-mail address: info @ pcpb.go.ke/md@pcpb.go.ke Tel: 254— 020 — 8021846/7/8 Fax: 254— 020— 8021865 Website: . ; https://www.pepb.gokef; 3 4. Every application must be accompanied by: ~ oe (a) An original letter from the registrant, (b) A binding agreement entered between the registrant and the agent, PRODUCT DETAILS (a) Trade Name...............ccccecccecccceeccceuccesseecveuceeeeceeseeenesaeaeueeeeceueaenesenaeacges (b) Name of Manufacturer...............ccccccccceccucuceessesevecsusuaesteneeeeeceneneceauatecceens (c) Name of Formulator............ 0.0... ccccecesececceececcecevecseveceuaeeeuceseaceegeusaesentaeas (d) Name of Registrant... 0... ...c.ccccccccccccecneneeseeese eee easeessseecesueceauessssenenensgenss (e) Name of Agent..............cccccceccnceescacneeeeeecacssucuecsvecneuesueseacusenvaveeeeseereaees (f) Period for which agent has been appointed................0.ccccccccecaeseescuseceseueesees Official Stamps of Applicant and Registrant Kenya Subsidiary Legislation, 20242 3 86 ' (r .l 5 (7)F o r m C 2 A PPL I CA T I ON FOR C H A N G E OF A GEN C Y I n f o r m a t i o n f o r A ppl i c a n t s Agent” means a person or company who has/that has been appointed to act on behalf of a registrant in accordance with regulation 4(2) of the Pest Control Products (Registration) Regulations. The application form must be completed by a duly authorized p er so n . The application must be submitted to: 1 . i t 2 . 3 . The M anaging Director/Secretary Pest Control Products Board (PCPB) P .O . B ox 13794 - 00800 N ai robi E -m ai l ad d ress: info@pcpb.go.ke/md@pcpb.go.ke T el : 254- 020 - 802 1846/7/8 Fax : 254 - 020 - 802 1865 Website: — https://www.pcpb.go.ke/ 4. Every application must be accompanied by: — (a) An original letter from the registrant, (b) A binding agreement entered between the registrant and the agent , (c) An original letter of no objection from the former agent , (d) Application fee of KSH. 20,000 per product (change of agency fee is payable upon approval by PCPB after meeting the other requirements), (e) A copy of the draft label as per PCPB requirements, (f) Proof of licensing of the new agent by PCPB. Pr o d u c t D e t a i l s T r ad e n am e Registration Number (If registered) N am e of M anuf acturer N am e o f f o r m u l ato r Period of which agent has been appointed Name of Registrant r - ' Status of registration D ateSignature Of ficial Stamp Name of former agent . Signature i . D ate 2386 ' Kenya Subsidiary Legislation, 2024 FORM C2 (r.15 (7) APPLICATION FOR CHANGE OF AGENCY INFORMATION FOR APPLICANTS 1. “Agent” means a person or company who has/that has been appointed to act on behalf of a registrant in accordance with regulation 4(2) of the Pest Control Products (Registration) Regulations. The application form must be completed by a duly authorized person. The application must be submitted to: The Managing Director/Secretary Pest Control Products Board (PCPB) P.O. Box 13794 — 00800 Nairobi E-mail address: info@ pcpb.go.ke/md@pcpb.go.ke Tel: 254-020 — 8021846/7/8 Fax: 254— 020— 8021865 Website: — https://www pepb go.ke/ 4. Every application must be accompanied by: — (a) An original letter from the registrant, (b) A binding agreement entered between the registrant and the agent, (c) An original letter of no objection from the former agent, (d) Application fee of KSh. 20,000 per product (change of agency fee is payable upon approval by PCPB after meeting the other requirements), r-~(e) A copy of the draft label as per PCPB requirements, . (f) Proof of licensing of the new agent by PCPB. PRODUCT DETAILS Name of Manufacturer.............0.cccccecccentec rere eee een ee eee eee e seen enna eae ee eee eeneneee eee es Name of formulator Leen e eee nek ee ELDER EEE EEE E EN EEE EEE C EE EEE EE ADE EE DEED SES SEEE EE EEE EERE ER ER EEE EE ERE Period of which agent has been appointed..............ccccsecesee ee eeeeneeeeenen enero enna ee cee ae Name of Registrant................cccee sence eee c eens ene ee enn e ence nee eee een eee EEE OEE EES Signature ...... seb eeeteeeenes sen eenees Date ........cccsceeteee sentence reas stecne a neereaaeeeecoesanaes Official Stamp Name of former agent...............0scececc scene eee eee eee ee eee e en EE Een EE EEO DER eA ee OREO D tee EE Signature ............cccccecceeeeceeeeeeeeeeseee ean ereanees Date... ooo oeeeeeeeecseeseceeseneeeeeeeeeeees Kenya Subsidiary Legislation, 2024 23 87 Off icial Stamp. Name of new agent Signature Off icial Stamp F o r o f f i c ia l u se o n l y Please check whether the following documents have been provided: Reg ist r a t io n D epa r t men t : 1. Has an original letter from the registrant been provided? Yes ■D ate ] No 2. Has an original letter of no objection from the former agent been provided? ] Y es N o 3. Has the applicant attached a copy of the draft label? Yes I I I n spe c t i o n D epa r t m en t : 4. Is the applicant licensed as a pesticide dealer/agent with PCPB in the current year? □N o Y es N o 5. I f yes indicate licence No A c c o u n t s : 6. Has the applicant paid the change of agency fee. ' ) o r ' 1 i 'qqn \ T 't ^ Y es N o , Indicate Receipt Number 7. Has the applicant paid the dealers/agency license f ee? Y es Indicate Receipt Number D ate N o ,<9 D ate R ecom m ended N o t R ecom m ended N ot N o t R ecom m ended R ecom m endedR ecom m ended R ecom m ended an sb m ' i D ate . . . . D a t e D ate 'j f Registration Off icer Inspector A ccountant Approved by Managing Director P est C o n t r o l P r od uc ts B o a r d D a te ' I ' I rwr i ; Changes effected by (IT Officer) D ate Kenya Subsidiary Legislation, 2024 2387 Official Stamp. Name Of new agent............ 00. ccc seeceescuceeueceeceeceseesscseuseecussueeesenenteeseavees SIQMALUIE .0. eee eee eene eee eees Date... cece ceccc enc tececteeeseeeeessaeeeeeaeess Official Stamp FOR OFFICIAL USE ONLY Please check whether the following documents have been provided: REGISTRATION DEPARTMENT: 1. Has an original letter from the registrant been provided? Yes CLC ] No [ ] 2. Has an original letter of no objection from the former agent been provided? Yes cr] No Cc] 3. Has the applicant attached a copy of the draft label? Yes LJ No CD] INSPECTION DEPARTMENT: 4. Is the applicant licensed as a pesticide dealer/agent with PCPB in the current year? YES... eee or ; 5. If yes indicate licence No. ..............00085 ACCOUNTS: ve . ; dor et dane GQ v's 6. Has the applicant paid the change of agency fee. wyt ie YES... eee eens | re Indicate Receipt Number..................cc.ec000ee Date...............0085 7. Has the applicant paid the dealers/agency license fee? Yes...... leet eeeees No........04. Indicate Receipt Number................ccccccecceeeeeeeeseusesaseeens Date...............600. Recommended Not Recommended Not Recommended Not Recommended Recommended Recommended att ebsTy Date... 0 cece ccc ees | DE: Date.......... 0c cece gee eeenee yiteii2zio9s F OF Registration Officer Inspector Accountant Approved by Managing Director Date. °°"! Pest Control Products Board Emeen Changes effected by (IT Officer) r we eeee ee ea ceases eee nena Date .........0.... : ce eeeeee Kenya Subsidiary Legislation, 20242 3 8 8 i r l 6)F O R M C 3 T H E PEST CON T ROL PR OD U CT S A CT Appl icat ion For Change Of Tr ade Name For A Pest Cont r ol Pr o d u c t I n f o r m a t i o n f o r A ppl i c a n t s The application form must be completed by a duly authorized person/A gent The application must be submitted to: 1 . E2 . The M anaging Director , Pest Control Products B oard (PCPB ) P.O . B ox 13794 - 00800 N airobi . E - m ai l ad d ress : info @ pcpb .go .ke/md @ pcpb .go .ke T el : 254 - 020 - 4446 115/4450242 Fax : 254 - 020 - 4449072 . 3. Every application must be accompanied by: — (a) An original consent letter from the manufacturer/principal (b) A copy of the draft label as per PCPB requirements, (c) Proof of licensing as a dealer with Pest Control Products by PCPB 4. The applicant shall be required to submit a sample of the pest control product; 5. The applicant may be required to submit: (e) A sample of the technical grade of its active ingredient; (f) A sample of the laboratory standard of its active ingredient; (g) Any other information as may be required by the B o ard . 6. Evidence from Kenya Intel lectual Property Institute (K IPI) that the new trade name i s av ai l ab le f o r u se . Pr o d u c t D e t a i l s C ur ren t T r ad e N am e Proposed Trade Name Reason for change Stage of registration (i) Registered (indicate registration No.) (Trade name to be in use 6 (six) months af ter approval to al low exhaust ion of o ld stock ) (ii) Undergoing trials (State institution carrying out tr ials and permit No.) (i ii) Other (indicate) 2388 Kenya Subsidiary Legislation, 2024 FORM C3 (r16) THE PEST CONTROL PRODUCTS ACT APPLICATION FOR CHANGE OF TRADE NAME FOR A PEST CONTROL PRODUCT INFORMATION FOR APPLICANTS 1. The application form must be completed by a duly authorized person/Agent 2. The application must be submitted to: The Managing Director, Pest Contro! Products Board (PCPB) P.O. Box 13794— 00800 Nairobi. E-mail address: info@ pcpb.go.ke/md@ pcpb.go.ke Tel: 254— 020 - 4446115/4450242 Fax: 254— 020— 4449072. 3. Every application must be accompanied by: — (a) An original consent letter from the manufacturer/principal (b) A copy of the draft label as per PCPB requirements, (c) Proof of licensing as a dealer with Pest Control Products by PCPB The applicant shall be required to submit a sample of the pest control product; 5. The applicant may be required to submit: (e) A sample of the technical grade of its active ingredient; (f) A sample of the laboratory standard of its active ingredient; (g) Any other information as may be required by the Board. 6. Evidence from Kenya Intellectual Property Institute (KIPI) that the new trade name is available for use. PRODUCT DETAILS Current Trade Name .......ccccccececeeesrereeeneeesteeeseeeeesenesssccrseeseseessacseeseciaeerseeenneesiensnaseriatenaeenses Proposed Trade Name oo... cece ccessss esse eneceenecenecneceenerscneerenesneneetasserssssesneecsenssseseenesaeaeees Reason for Change .....ccccceeseseesseeceereseseescseseasesseessesesseaseesessessneeseseesnenerssensenesienepreeeesesniass Stage of registration (i) Registered (indicate registration NO.)...........:.ceceeeeee nent enter nent eens eet nen eas (Trade name to be in use 6 (six) months after approval to allow exhaustion of old stock) (ii) Undergoing trials (State institution carrying out trials and permit No.) (iii) Other (indicate) Kenya Subsidiary Legislation, 2024 2 3 89 N am e o f M anu f ac tu r er Name of Registrant (Proprietary owner of Technical information) Name of agent Signature of appl icant D ate Offi cial Stamp of Applicant / Company F o r o f f i c i a l u se o n l y Please check whether the fol lowing documents have been provided: Registration Department: 8. Has an original letter from the registrant been provided? Yes 9. Has the applicant attached a copy of the draft label? 10. Has K IPI conf irmed avai labi l ity of new trade name? 11. Has the applicant submitted a sample of the pest control product? Yes [ | No| I I n spec t i o n D epa r t m en t : 12. Is the applicant l icensed as a pesticide dealer/agent with PCP̂ i n the current year? ] If yes indicate licence No ] N o Y es No □ □ No □ □Yes □ □ Y es . N o . . . A cc o u n ts : 13. Has the applicant paid the dealers/agency license fee? Yes..[ Indicate Receipt Number 14. Departmental recommendations □□ No... D atei N o t N o t R ec o m m e n d e d N o t R ec o m m e n d e d R e c o m m e n d e d R ec o m m e n d e dR ec o m m e n d e d R ec o m m en d e d D ateD ateD a t e Registration Offi cer A c co un ta n tI nsp ector 15. Recommendation of the Technical and Registration C o m m i t tee o f t he B o ar d Recommended [ 16. Decision by the Board of M anagement Not Approved 17. Changes effected on List of Products and data base by (IT Off icer) N o t R ec o m m en d ed D ate ] D ateA pproved D a teSignature Kenya Subsidiary Legislation, 2024 2389 BEV oat 9) 0246) Signature of applicant ...............cseeeeee || Official Stamp of Applicant / Company FOR OFFICIAL USE ONLY Please check whether the following documents have been provided: Registration Department: ; 8. Has an original letter from the registrant been provided? Yes LC] No L ] 9. Has the applicant attached a copy of the draft label? Yes [ ] No [ ] 10. Has KIPI confirmed availability of new trade name? Yes [ ] No [J 11. Has the applicant submitted a sample of the pest control product? Yes [—] No[ ] INSPECTION DEPARTMENT: 12. Is the applicant licensed as a pesticide dealer/agent with PCPB in the current year? Yes [] . No... [J If yes indicate licence No...............0068 eerrerreveey Accounts: © 13. Has the applicant paid the dealers/agency license fee? Yes.[. ] No... ( ] Indicate Receipt Numbet............ 0.0. cccccce cee ceecee ere eeeeeeeeeeeeese Date.............000085 14. Departmental recommendations NoT RECOMMENDED Nor NoT : RECOMMENDED RECOMMENDED], RECOMMENDED RECOMMENDED RECOMMENDED IDate..... 0... ececeeeeeeeecee eee eee Date... 1... cece eeeeee nee eeeeee Date... ...ccece ec ee eee eens Registration Officer Inspector Accountant 15. Recommendation of the Technical and Registration Committee of the Board Recommended [ ] NotRecommended [ ] Date..........00.. 16. Decision by the Board of Management Approved ‘| Not Approved [ ] Date.......ccccccceeeeeeneee 17. Changes effected on List of Products and data base by (IT Officer) SUQNAIULE . occ cece cence eee eee ee sen eenc eee rnees | OT ee rrr Kenya Subsidiary Legislation, 20242 3 9 0 (r .l 7 (3)f o r m d PE ST C O N T R O L P R O D U C T S B O A R D T H E PE ST CON TROL PROD U CT S A CT C A P 346 E X PE R I M E N T A L PE R M I T D ate Accredited testing institution A d d r ess T e l : E m ai l : Per mit Fo r Ef h c a c y T r ia l s Of N ew Pest Co n t r o l Pr o d uc t s This is to inform you that your organization has been identif ied to carry out ef f icacy trials of the newly introduced pest control product (s) as i nd i c ated b el o w : Pest C o n tr o l Product(s) (Trade name) C o m m o n n am e and co ncen t r at i o n o f a .i Crop(s)/Commo dity (ies)/ Use(s) Target Pest(s) d b a rn ? You are required to inform the Pest Control Products B o ar d th e c o m m enc em ent o f the experiment/efficacy trials and submit to the Board progress reports. The trials should be carried out using the Pest Control Products Board approved trial protocol . At the conclusion of the experiment/efficacy trials, a confi dential report on the performance of the product and recommendafions for its use should be submitted to the Board quoting t h e ab o v e r ef er en ce and d ate . ' ' It will be appreciated if ‘trials are Completed as soon as possible. Local agent wil l provide you with the required materials and fi nancial r eso u r ces f o r th e t r i al s . A l l companies must apply f or an impor t l icense f or the tr ial sample which should be submitted directly to the Board f or onward transmission to th e r esea r c h er s . T h e t r ia l samples should neither be sold nor used elsewhere without Board f rom PCPB. Local agent is advised to l iaise closely with you and PCPB to ensure that the tests are,x arried out in accordance with the approved trial protocol . C h i e f E x e c u t iv e O f f i c e r / Sec r e t a r y cc. Local agent A d dr ess Note:—All applicants are expected to submit the Pre-harvest interval (PHI ) and Max imum Residue Levels (MRLs) f or all edible crops. d ; i & ' . ■ . ■y n -i Kv i i , ■i o i Js u v ;.5 ‘ 2390 Kenya Subsidiary Legislation, 2024 ForM D | (r.17 (3) PEST CONTROL PRODUCTS BOARD THE PEST CONTROL PRODUCTS ACT CAP 346 EXPERIMENTAL PERMIT Accredited testing institution Address 0 2) Email: .............ecceceeneeeeeeees PERMIT FOR EFFICACY TRIALS OF NEW PEST CONTROL PRODUCTS This is to inform you that your organization has been identified to carry out efficacy trials of the newly introduced pest control product (s) as indicated below: Pest Control Common name and Crop(s)/Commo Product(s) (Trade | concentration of a.i . PA . Target Pest(s) dity (ies)/ Use(s) name) ccd bor. wile.» DI You are required to inform the Pest Control Products Board the commencement of the experiment/efficacy trials and submit to the Board progress reports. The trials should be carried out using the Pest Control Products Board approved trial protocol. At the conclusion of the experiment/efficacy trials, a coifidential report on the performance of the product and recommendations for its use should be submitted to the Board quoting the above reference and date. “It will be appreciated if'trials are completed as soon as possible. Local agent will provide you with the required materials and financial resources for the trials. All companies must apply for an import license for the trial sample which should be submitted directly to the Board for onward transmission to the researchers. The trial samples, should neither be sold nor used elsewhere without Board from PCPB. Local agent is advised to liaise closely with you and PCPB to ensure that the tests are,carried out in accordance with the approved trial protocol. CHIEF EXECUTIVE OFFICER /SECRETARY cc. Local agent Address Note:—All applicants are expected to submit the Pre-harvest interval (PHI) and Maximum Residue Levels (MRLs) for all edible crops. Hie gy , ; Re . Cuan pa. : ‘ sg dsdy tak ty Kenya Subsidiary Legislation, 2024 2 39 1 (r l 8( l )(4)(l l )F o r m E l PEST CON T ROL PRO D U CT S B OA R D Requir ement s For The Pr ot ect ion Of Conh oent ial Business I n f o r m a t i o n Submit t ed Fo r Pest ic id e Reg ist r a t io n A c t ion s In K en y a I n t r o d u c t i o n In submitting data or information required by the Board for the initial registration or experimental use permit or a temporary/emergency registration or a provisional registration of a pesticide product or any other related regulatory action thereof , applicants (registrants) may claim certain data or i n f o rm at i o n as ‘ C o n f i den t i al B u si ness Information’ or CBI . This wil l eventual ly facil itate trade in Kenya These Requirements define what constitutes CBI , list the requirements and procedures for submission and designation of CBI , and describe the responsibi l ities of the Appl icant and the Board to protect CBI from unlawful or unintended d i sc l o su r e . Definition and Scope of Confidential Business Information The following data or information required by the Board and shal l be claimedj by the applicant (registrant) as CBI: 1. Information that discloses the identity or percentage quantity of deliberately added inert ingredients in the technical grade of the active ingredient or in the formulated products (except those considered to have health and envirpnmental rist s/concems). For example, specifications of the'technical grade (active, ingredient) , composition of the product formulation, the process of formation of impuri ties. 2. Information that discloses the processes of manufacturing or the formulation process, quality control and testing of batch analysis of a pesticide product . For example, the m eth o d o f m anu f ac tu r e . 3. Commercial or fi nancial information relating to trade secrets, production, distribution, sales, inventories or other privi leged trade information provided fdMhfe'' purposes of registration. l 4 . There are several other data requirements that do not constitute CBI . For example, the molecular formula of the active ingredient , the ch ar ac ter i zat i o n o r su m m ar i es o f publicly-available risk evaluations where the risk assessment has been conducted by a governmental organization. 5. As a general rule, CBI shall not be disclosed to the publ ic. 6. In exceptional cases such as in the public interest, the Board may disclose CBI to Board Committees or in Court Proceedings/Legal Hearings in compliance with other legal authorities or when public health or environmental safety is at risk leading to cancellation or suspension hearings. 7 . For a more detai led l i st of w hat consti tutes CB I , see F i r st Sc hed u l e F o r m A . Kenya Subsidiary Legislation, 2024 2391 FoRM El a (r 18(1)(4)(11) PEST CONTROL PRODUCTS BOARD REQUIREMENTS FOR THE PROTECTION OF CONFIDENTIAL BUSINESS INFORMATION SUBMITTED FOR PESTICIDE REGISTRATION ACTIONS IN KENYA INTRODUCTION In submitting data or information required by the Board for the initial registration or experimental use permit or a temporary/emergency registration or a provisional registration of a pesticide product or any other related regulatory action thereof, applicants (registrants) may claim certain data or information as ‘Confidential Business Information’ or CBI. This will eventually facilitate trade in Kenya These Requirements define what constitutes CBI, list the requirements and procedures for submission and designation of CBI, and describe the responsibilities of the Applicant and the Board to protect CBI from unlawful or unintended disclosure. Definition and Scope of Confidential Business Information The following data or information required by the Board and shall be claimed by the applicant (registrant) as CBI: 1. Information that discloses the identity or percentage quantity of deliberately added inert ingredients in the technical grade of the active ingredient or in the formulated products (except those considered to have health and environmental risks/concerns). For example, specifications of the’ technical grade (active ingredient), composition of the product formulation, the process of formation of impurities. ~ 2. Information that discloses the processes of manufacturing or the formulation process, quality control and testing of batch analysis of a pesticide product. For example, the method of manufacture. w 3. Commercial or financial information relating to trade secrets, production, distribution, sales, inventories or other privileged trade information provided fof ‘the: purposes of registration. j the molecular formula of the active ingredient, the characterization or summaries of publicly-available risk evaluations where the risk assessment has been conducted by a governmental organization. 5. Asa general rule, CBI shall not be disclosed to the public. 6. In exceptional cases such as in the public interest, the Board may disclosé*CBI to Board Committees or in Court Proceedings/Legal Hearings in compliance with other legal authorities or when public health or environmental safety is at risk leading to cancellation or suspension hearings. 7. Fora more detailed list of what constitutes CBI, see First Schedule Form A. Kenya Subsidiary Legislation, 20242 3 92 G en e r a l P r o c ed u r e s The Board and the appl icant (registrant) , and their local representatives shal l implement measures to protect CBI . Responsibi li ties of the A ppl icant (Registrant) or its local representative shal l be to: 1 . E n sur e th at al l C B I i s su b m i t ted to th e B o ar d i n a secure manner and by a responsible person, authorized by the applicant . 2. Submit the CBI in a separate sealed envelope or a separate electronic storage device clearly marked or identi f ied as “ CONFIDENTIAL BUSINESS I N F O R M A T I O N .” 3. Provide j ustif ication at the time of submission why additional information may be c l ai m ed as C B I . I n su ch c ase a Ju st i f i c at i o n f o r A d d i t i o n al CBI Protection) may be required to be submitted. R e spo n s i b i l i t i e s o f t h e B o a r d sh a l l b e t o : 1. Designate the regulatory off icials that wil l receive, rev iew , record and store CB I submitted by the appl icant (registrant). 2. Establish mechanisms for regular training (minimum of one per year) of the designated regulatory off icials in the PCPB Protection of CBI Requirements and its implementation. 3. Institute adequate measures to protect CBI , such as the reception place, the secure storage area (off ice), and l imiting the access to CBI to only authorized personnel . 4 . Ensure that the storage area is secured with access to only authorized personnel and contains a locked storage unit (e.g . locked cabinet , or a separate laptop or computer). 5. M aintain a record in the form of a log, that indicates the name of appl icant , date of reception, dates of any internal disclosures, the person o r c o m m i t t ee t o w h o m disclosure was made, and a description of the information d i sc l o sed . 6. Designate a regulatory off icer who shall receive the CB I , record the l i st of CB I data or information, and store the CBI in the secure storage area and the secure storage u n i t . 7. A l low only access to authori zed and trained persons, is Rev iew and val idate the inform ation submitted as CBI and may ask for additional ; clarifi cation from the applicant to make the determination w h eth er su c h i n f o r m at i o n c o n st i t u tes C B I . 9 . M ak e an o f f i c i al n o t i f i c at i on o f C B I deter m i n at io n to the applicant by certi fi ed mai l , return receipt requested, or by personal delivery . Where there is no response of this of f ic ial noti f ication , the determ ination of the CB I sh al l su f fi ce as t he o f fi c i al r eco r d o f w h at c o n st i t u tes C B I . 10. Inform the applicant of disclosure and justifi cation f o r d i sc l o su r e i n c ases w hen PCPB may be required to disclose CBI by Board Committees o r i n C o ur t Proceedings/Legal Hearings. 11. Not copy any information submitted and marked by the appl icant as CBI unless authorized by the Board. The authorization to make copies of CBI must contain the fol lowing information: I 2392 Kenya Subsidiary Legislation, 2024 GENERAL PROCEDURES The Board and the applicant (registrant), and their local representatives shall implement measures to protect CBI. Responsibilities of the Applicant (Registrant) or its local representative shall be to: 1. Ensure that all CBI is submitted to the Board in a secure manner and by a responsible person, authorized by the applicant. Submit the CBI in a separate sealed envelope or a separate electronic storage device clearly marked or identified as “CONFIDENTIAL BUSINESS INFORMATION.” Provide justification at the time of submission why additional information may be claimed as CBI. In such case a Justification for Additional CBI Protection) may be required to be submitted. RESPONSIBILITIES OF THE BOARD SHALL BE TO: 1. 7. Designate the regulatory officials that will receive, review, record and store CBI submitted by the applicant (registrant). Establish mechanisms for regular training (minimum of one per year) of the designated regulatory officials in the PCPB Protection of CBI Requirements and its implementation. Institute adequate measures to protect CBI, such as the reception place, the secure storage area (office), and-limiting the access to CBI to only authorized personnel. Ensure that the storage area is secured with access to only authorized personnel and contains a locked storage unit (e.g. locked cabinet, or a separate laptop or computer). Maintain a record in the form of a log, that indicates the name of applicant, date of reception, dates of any internal disclosures, the person or committee to whom disclosure was made, and a description of the information disclosed. Designate a regulatory officer who shall receive the CBI, record the list of CBI data or information, and store the CBI in the secure storage area and the secure storage unit. Allow only access to authorized and trained persons. 8.-Review and validate the information submitted as CBI and may ask for additional | 9. 10. 11. ‘clarification from the applicant to make the determination whether such information constitutes CBI. Make an official notification of CBI determination to the applicant by certified mail, return receipt requested, or by personal delivery. Where there is no response of this official notification, the determination of the CBI shall suffice as the official record of what constitutes CBI. Inform the applicant of disclosure and justification for disclosure in cases when PCPB. may be required to disclose CBI by Board Committees or in Court Proceedings/Legal Hearings. Not copy any information submitted and marked by the applicant as CBI unless authorized by the Board. The authorization to make copies of CBI must contain the following information: ae Kenya Subsidiary Legislation, 2024 2393 The name of the recipient of the copy . The intended purpose for which the copy is to be used. The manner in which the copy is to be disposed of af ter u s e . 12. Not disclose CBI in its custody or submitted by the appl icant , to other pesticide applicants or other local representatives. 13. Not disclose CBI to a similar authority in a different region or country or j urisdiction for the purposes of facilitating registration for a pesticide product , unless the appl icant has consented in writing, in advance, to su c h d i sc l o su r e . 14. Implement a suff iciently deterrent penalty or f ine system applicable to regulators or other , third parties who intentional ly and unlawfully disclose CBI for personal fi nancial or other gains in accordance with their national laws and regulations. D i spu t e R e so l u t i o n I n the event of an unauthori zed d i sclosure of CB I , PC P B sh al l c o nd u c t an i n tern al investigation to determine the facts of the unauthori zed disclosure, to assess culpabil ity for such disclosure, and serve as the basis for any penalty or f ine for such disclosure to be assessed under the applicable national law(s) . C o n f i d en t i a l B u s in e s s I n f o r m a t i o n Su b m i ss i o n /R e c e i pt F o r m Pr o v i ded R em ar k s Y es N o Method of manufacture (e.g synthesis pathway) I a Ci i r .t i Specifi cations of the technical grade (active ingredient) 2 3 Composition of the formulation Method of analysis for impuri ties 4 i ( i ‘5-batch’ analysis; including chromatographs 5 • ( 6 A ny other information .; t j D ate r ecei v ed T r ad e n am e o f t h e Pr o d u ct Active ingredient(s) Registrant / ' r M anufacturer(s) of active ingredient F o r m u l ato r Kenya Subsidiary Legislation, 2024 2393 The name of the recipient of the copy. The intended purpose for which the copy is to be used. The manner in which the copy is to be disposed of after use. 12. Not disclose CBI in its custody or submitted by the applicant, to other pesticide applicants or other local representatives. 13. Not disclose CBI to a similar authority in a different region or country or jurisdiction for the purposes of facilitating registration for a pesticide product, unless the applicant has consented in writing, in advance, to such disclosure. 14. Implement a sufficiently deterrent penalty or fine system applicable to regulators or other, third parties who intentionally and unlawfully disclose CBI for personal financial or other gains in accordance with their national laws and regulations. DISPUTE RESOLUTION In the event of an unauthorized disclosure of CBI, PCPB shall conduct an internal investigation to determine the facts of the unauthorized disclosure, to assess culpability for such disclosure, and serve as the basis for any penalty or fine for such disclosure to be assessed under the applicable national law(s). CONFIDENTIAL BUSINESS INFORMATION SUBMISSION/RECEIPT FORM Provided Remarks Yes , No Method of manufacture (e.g, . 1 : Biles synthesis pathway) . 2 Specifications of the technical grade (active ingredient) 3 |Composition of the formulation a 4 Method of analysis for impurities tk “ 5 ‘5-batch’ analysis; including chromatographs “4 6 {Any other information 4 Date received Trade name of the Product Active ingredient(s) Registrant Manufacturer(s) of active ingredient Formulator 1 Kenya Subsidiary Legislation, 20242 3 94 Export er Local agent Submitted by (Full Name and signature)* Received by: Off icer’s name and signature Handed over to the Head of depart ment. Signature: * Conf idential business inf ormation received as it is subj ect to technical evaluation F o r m E 2 (r .l 8 {3) C ONH OENTIAL IT Y D ECLARA TION I f r o m , .{company of local agent, representative) declare that I shall maintain confidentiality of all Confidential Business information (CBI) as provided f or under the Pest Contro l Products Act and Regulations made thereunder . Signature Name of agent/representative Designation D ate 2394 Kenya Subsidiary Legislation, 2024 Exporter Local agent Submitted by (Full Name and signature)* Received by: Officer’s name and signature Handed over to the Head of department. Signature: * Confidential business information received as it is subject to technical evaluation Form E2 (r.18 (3) Done ceeneee cee ecececteeeeneeeeneceagag enenseteeeeaues FTOM. 0... eee cece cence teen eee ed (company oflocal agent, representative) declare that I shall maintain confidentiality of all Confidential Business information (CBI) as provided for under the Pest Control Products Act and Regulations made thereunder. SUMMA)... cece ete cee ec ecee ese eeneasenes Name of agent/representative Designation Kenya Subsidiary Legislation, 2024 2 3 9 5 i r .l 9 (3)F O R M F T H E PE ST C O N T R O L PR O D U C T S A C T C A P 34 6 Submission of Sampl e (S) f or Ef f icacy Test ing This form should be f i l led in duplicate: Part I and II to be filled by the Applicant I ) Pr oduct Det a il s T r ade n am e Formulation type Active ingredient (s) C o ncen tr at i o n o f ac t i v e ingredient(s) Quantity of sample (L iters or grams), Number of packages REF: (Permit No. and date) Name of Appl icant (Local agent) I I ) Su bmissio n d et a i l s Submitted by: N am e I l l ) D el iv er y d et a i l s Received on behalf of PCPB by: N am e Institution(s) of destination M eans of del ivery : A . PC PB PERSONNEL Name of Person del ivering Date of del ivery Received by Signature Off icial stamp B . C o u r i e r Se r v i c e Name of company Contact person t . D ateSignature :(J. . .D ateSignature Kenya Subsidiary Legislation, 2024 2395 FORM F (r.19 (3) THE PEST CONTROL PRODUCTS ACT CAP 346 SUBMISSION OF SAMPLE (S) FOR EFFICACY TESTING This form should be filled in duplicate: Part I and II to be filled by the Applicant 1) PRODUCT DETAILS Trade Mame.........cccccceec cece cece cere teen been enna e eee ee eRe ORE E EEE EEE EE HEEL EEE EEE E EEE ERE CEE EEE EEE Formulation type............ccccec cee ce ee ee cen eee een nee ener e eee eee nee ne nee Den ERE EMRE EE EE EEE EERE EEE EE Active ingredient (S) .........sssccseceseentecneeensen tener eee eee neeeneeeeeeneean senses eeea neue enenes Concentration of active IngredieNt(S)..........cc cece cece ee eee ee certs ee ne ee neee eee nea ene neneee anes Quantity of sample (Liters OF graMs)............c cece eee eee enna tenet eee ee eee ene ene EE ere Number of packages.............ccececcc cee eee eee eee eee ee nee ee een eee EEO EG EEE Gee eee R et ee ates Eee REF: (Permit No. and date)......... ccc ccc cceee eee eee eee cect eee ee ene ee enen ee ene nesses eee anes neeenes Name of Applicant (Local agent)...............cccceeese eee es NN eee ene eee eee nen ee NUEVOS eee (9 witoer Lean Up II) SUBMISSION DETAILS ‘sitet. Submitted by: IID) DELIVERY DETAILS Received on behalf of PCPB by: Institution(s) Of destination............. cece eee e eee re ee ence ence enseeeeeeen eee enseeen eee eeeeenees eens Means of delivery: . A. PCPB PERSONNEL Name of Person delivering............0..:ceceseeeceenereneeenensereseneesecessneeneuraceneneseneneees Date of delivery... .....c ccc cece cece cece nee n ence ene enero ene n eee e eee eeeee ne ene ee eene tense ene een ene ss RECEIVE DY... eee cee cece ence een eee ee seen ene Ee Un EEE EE EEE RAGED EGEEE EERE EERE E RES EO EEE EERE EE ESSE SSF U (Senne Official stamp..........cccee cee ec cence ee eese ee ences nee te ene MAGEE EE EA EERE EERE E EERE EEE EEE EE EERE STEED B. COURIER SERVICE Name Of COMPANY............cccecee ee ee eee e nee eee EOE nO REE EEE ESE REESE OEE DHEA EEO TEE EOE SEER EOE E EOS COntact PETSOM........ cece cee cence eee eee een een eee EEE EERE SEEDED AE EEE EEE IEE DEES EO EO EEE CEE EOE EEE Kenya Subsidiary Legislation, 20242 3 9 6 Charges (A ttach receipt) Date of del ivery Of ficial stamp Receiving Institution . .. . Date of receipt Person receiving Signature Of f icial Stamp D a te 2396 Kenya Subsidiary Legislation, 2024 Charges (Attach receipt)...........cccece cece ee eec eee ee eee ne nene eee ne een eee es eee tense nena ee teen ees Date of delivery....0..0..0.cecccceeeees bee be scene nena eben bee aes ee beeen eee e eee e eee e nese eee enee eae Official stamp............ ccc cece ee cence et eee eee cee ee cee e eee a seen eee eee ee ee eee ne aes en eneeneaeeeeaeaes Receiving Institution ......... 00... cece cee ececeeceeeeete ee ee eee eeneeeseceeeeeeaeeeeeeeseeetsneeen sees Date of reCeipt...... 0.0... cece cee ccncne nee enee eects eee eeneneenecneeeeseeeeeeaseeeeeeeeeeenseeeenen sees POLSON TECEIVING......... ccc cee eee reece eee ecn ea eene nen eneneeeneeeseseeenseseeeseeeeneeeneeseseeeees SEQNQALUTE 0... eee eee eee nee nenneneesenseneees | Or er 0} CLIN (01) ee Kenya Subsidiary Legislation, 2024 2 39 7 F O R M G (r . 23(4) PEST C ON T ROL PROD U CT S B OA RD (Statutory Organization of Government of Kenya) T H E PEST CON T ROL PR OD U CT S A CT Cer t i f ic a t e o f Reg i st r a t io n o f a Pest Co n t r o l Pr o d uc t N um ber It is hereby certif ied that the pest control product described herein has been registered under the Pest Control Product Act and is subject to c o nd i t i o n s i nd i c ated Approved common name Trade name under which marketed in Kenya 1 . 2 . 4 . Active ingredient(s) . 4 . Eo r m u l at i o n Condition(s) under which pest control product is registered5 . 6 . Registration No Registration in the name of7 . S A d dr ess E m a i l A d ress T e l . N o .: 8. Date of registration 9. Expiry date of registration C h i e f E x ec u t iv e O f f i c e r P est C o n t r o l P r o d uc ts B o a r d Kenya Subsidiary Legislation, 2024 2397 FORM G 7 | (r.23(4) PEST CONTROL PRODUCTS BOARD (Statutory Organization of Government of Kenya) THE PEST CONTROL PRODUCTS ACT CERTIFICATE OF REGISTRATION OF A PEST CONTROL PRODUCT Number .................eceee ues It is hereby certified that the pest control product described herein has been registered under the Pest Control Product Act and is subject to conditions indicated 1. Approved common name 00.00.00... 0ee ccc cec cee ceceeeee eeu ceeseseueseesuecnesieensaeeceraneass 2. Trade name under which marketed in Kenya ...............ccc0cccccescuccecsessustenseneeees 4. Active ingredient(S) .......... ccc cecccsccececceececueecevevevensuesaearaeeeeseeetsnanecensns 4. Formulation 0.0.0... cc cece cec cece ee eeaees ese eseeeeseussnteteeesausansrteueeneeueuses 5. Condition(s) under which pest control product is registered ..............0....cceceeee eee 6. Registration No. 2.2... cc cece cece es eee eee eese eee eresucuesecussteneeesneaeeeereenanss 7. Registration in the name Of ..........0.. ccc ccc ccc cee cec cc seee cee veceueveveneueucesauaensanaes FaNS (0b) Email Adress...... 0.0.0 .ecece cc eceeences en euen ens Tel. NOs ccc cecene eee rena en neaeee 8. Date of registration 0.00.0... ccc ccc cce cesses ee eee eeeeeeuesseuceusarsecutieeaeapansars 9. Expiry date of registration 2.00.0... 00... cece ccc ccc eee nee ees tee sess eeu se seu seesncutetcneeens CHIEF EXECUTIVE OFFICER Pest Control Products Board Kenya Subsidiary Legislation, 20242 3 9 8 {r .26(3)F o r m H PE ST C O N T R O L P R O D U C T S B O A R D PE ST C O N T R O L PR O D U C T S A C T Requir ement s f or Appr ov ing Emer gency Uses of Pest Cont r ol P r o d u c t s f o r M a n a g i n g A g r i c u l t u r a l a n d Pu b l i c H e a l t h Pe st s in K e n y a Pr e a m b l e These requirements shal l be used to address the regulatory approach for approving pest control products in Kenya in the event of pest emergency situations where: A n invasive or exotic pest has been properly identif ied. No specif ic pest control products are registered for control l ing the pest em erg enc y . Registered pest control products are no longer effective for control ling the pest emergency; and There is valid scientif ic information of the potential economic damage to agricul tural product ion and publ ic health , .lilduq' ! . -gfi 1l : s'n L O 'I N.TRODUCTION , The transboundary movement of agricul tural pests and resurgence of existing (endemic) agricul tural and public health pests are occurring with increased frequency due to several interacting forces, such as globalization, expansion and intensi f ication of agricultural production, emergence of pest resistance to common pest control measures, and cl imate change. Invasive pests typical ly invade new ecosystems without the specif ic natural predators that keep them in check in their native environment. Unimpeded increase in invasive pest populationŝ ,pause signif icant economic losses and crop damage until ef fective integrated pest control measures are developed, adopted, and deployed. '{!!f;iln§,ipce early 2016, Kenya has been confronted by severe infestations of invasive agricultural pests such as, the Fall A rmyworm {Spodoptera f rugiperda) . Drosophi la Suzukii , Golden apple snails, the A frican desert locust {Schistocerca gregaria) among others, which have posed signif icant economic damage to key agricultural crops and publ ic health. W hether an invasive or an outbreak of a pest occurs, its unabated control poses special problems for farmers and pest control regulators. The A frican desert locust i s an example of a devastating transboundary , endemic, and recurring agricultural pest . A gronomic (development of pest resistance to intensive use of registered pest control products and envi ronmental f ac to r s ar e k no w n to c reate conditions‘that enable endemic pests to become more damaging and virulent over time. These scenarios j ustif y the need for an effective regulatory instrument capable of responding to pest emergency situations to minimize the potential economic damage to agricultural production and publ ic health. 3398 Kenya Subsidiary Legislation, 2024 FORM H (r.26(3) PEST CONTROL PRODUCTS BOARD PEST CONTROL PRODUCTS ACT REQUIREMENTS FOR APPROVING EMERGENCY USES OF PEST CONTROL PRODUCTS FOR MANAGING AGRICULTURAL AND PUBLIC HEALTH PESTS IN KENYA PREAMBLE These requirements shall be used to address the regulatory approach for approving pest control products in Kenya in the event of pest emergency situations where: An invasive or exotic pest has been properly identified. No specific pest control products are registered for controlling the pest emergency. Registered pest control products are no longer effective for controlling the pest emergency; and There is valid scientific information of the potential economic damage to , agricultural production and public health. viidugy: . ap ie tO 1:0 ‘INTRODUCTION , The transboundary movement of agricultural pests and resurgence of existing (endemic) agricultural and public health pests are occurring with increased frequency due to several interacting forces, such as globalization, expansion and intensification of agricultural production, emergence of pest resistance to common pest control measures, and climate change. Invasive pests typically’ invade new ecosystems without the specific natural predators that keep them in check in their native environment. Unimpeded increase in invasive pest populations cause significant economic losses and crop damage until effective integrated pest control measures are developed, adopted, and deployed. yvlsiingince early 2016, Kenya has been confronted by severe infestations of invasive agricultural pests such as, the Fall Armyworm (Spodoptera frugiperda), Drosophila Suzukii, Golden apple snails, the African desert locust (Schistocerca gregaria) among othérs, which have posed significant economic damage to key agricultural crops and public health. Whether an invasive or an outbreak of a pest occurs, its unabated control poses special problems for farmers and pest control regulators. The African desert locust is an example of a devastating transboundary, endemic, and recurring agricultural pest. Agronomic (development of pest resistance to intensive use of registered pest control products and environmental factors are known to create conditions ‘that enable endemic pests to become more damaging and virulent over time. These scenarios justify the need for an effective regulatory instrument capable of responding to pest emergency situations to m:nimize the potential economic damage to agricultural production and public health. Kenya Subsidiary Legislation, 2024 2 39 9 2 .0 O b j e c t i v e s To facilitate PCPB to expedite approval of pest control products during emergency situations for purpose of mitigating the impact of pest emergency situations. 3.0 Scope OF The Requir ement s The requirements laid out in this document shal l be used to regulate the approval of plant and public health pest control products in Kenya in a pest emergency si tuation. 4 .0 Pr o c e s s O f A ppr o v in g P e st C o n t r o l P r o d u c t s F o r E m er g en c y U se s 4.1 Identifi cation of the pest threat (pest emergency) The relevant agency shal l be required to identify and r eco m m en d to th e m i n i ster to declare a pest as an emergency pest by : ' (a) Acquiring scientif ically val idated information on taxonom ic identi f ication , or genotyping, or breeding/cul tivation, (b) Understanding the nature of the pest threat and determining the potential to affect an agricultural production and public health , (c) Estimating the potential crop losses in tonnage or fi nancial terms, or the serious threat to food securi ty or ri sk to public health i f the pest emergency remains unchal lenged or uncontrolled. 4.2 Determination of potential or actual ‘Signifi cant Yield Loss’ and ‘Signifi cant Economic Impact ’ n o . 11 A key factor to properly classify an invasive or critical agricultural/publ ic health pest as a pest emergency is the determination of what constitutes a ‘signif icant ’ yield loss and a ‘signif icant ’ economic impact to be caused by the said pest . This wil l be determined by the relevant government agencies in agriculture (for agricultural pests) and public health (for publ ic health pests) . 4 .3 Scenarios of a Pesticide Emergency Use Situation The requirements shall be appl icable where there is: (a) Localized or conf ined invasion/infection- for pest emergency situations that potentially affect agricultural production and public heal th i n a co n fi ned ar ea and that can be managed local ly , (b) Nationwide invasion/ infection - for pest emergency situations that potentially affect all agricultural areas and (c) Regional crisis - for agricultural pest emergencies that potential ly aff ect neighboring countries. 4.4 Process of Approval of a Pesticide Emergency Use Registration 4.4.1 Of fi cial declaration of a pest emergency and the need f or the emergency use registration of a pest control product(s) If the criteria in 4.3 above are met, the responsible i n st i tu t i o n sh al l i n c o n su l t at i o n s with other relevant government departments and agencies off icial ly declare a pest emergency and the need for the emergency use of a pest control product . Kenya Subsidiary Legislation, 2024 2399 2.0 OBJECTIVES To facilitate PCPB to expedite approval of pest control products during emergency situations for purpose of mitigating the impact of pest emergency situations. 3.0 SCOPE OF THE REQUIREMENTS The requirements laid out in this document shall be used to regulate the approval of plant and public health pest control products in Kenya in a pest emergency situation. 4.0 PROCESS OF APPROVING PEST CONTROL PRODUCTS FOR EMERGENCY USES 4.1 Identification of the pest threat (pest emergency) The relevant agency shall be required to identify and recommend to the minister to declare a pest as an emergency pest by: ‘* (a) Acquiring scientifically validated information on taxonomic identification, or ’ genotyping, or breeding/cultivation. (b) ‘Understanding the nature of the pest threat and determining the potential to affect an agricultural production and public health. (c) Estimating the potential crop losses in tonnage or financial terms, or the serious threat to food security or risk to public health if the pest emergency remains unchallenged or uncontrolled. 4.2 Determination of potential or actual ‘Significant Yield Loss’ and ‘Significant Economic Impact’ . AG . yo, A key factor to properly classify an invasive or critical agricultural/public health pest as a pest emergency is the determination of what constitutes a ‘significant’ yield loss and a ‘significant’ economic impact to be caused by the said pest. This will be determined by the relevant government agencies in agriculture (for agricultural pests) and public health (for public health pests). 4.3 Scenarios of a Pesticide Emergency Use Situation The requirements shall be applicable where there is: (a) Localized or confined invasion/infection- for pest emergency situations that potentially affect agricultural production and public health in a confined area and that can be managed locally, (b) Nationwide invasion/ infection — for pest emergency situations that potentially affect all agricultural areas and aie (c) Regional crisis — for agricultural pest emergencies that potentially affect neighboring countries. 44 Process of Approval of a Pesticide Emergency Use Registration 4.4.1 Official declaration of a pest emergency and the need for the emergency use registration of a pest control product(s) ‘If the criteria in 4.3 above are met, the responsible institution shall in consultations with other relevant government departments and agencies officially declare a pest emergency and the need for the emergency use of a pest control product. 1 Gio: Kenya Subsidiary Legislation, 202424 0 0 4.4.2 Notifi cation of a pest emergency Once, the need for an emergency use registration of a pest control product is declared, the Pest Control Products Board wi l l prepare an o f f i c i al n o t i f i c at i o n o f an emergency pest situation which shal l include information o n : The nature of the pest emergency . The affected crops and farmers, area or publ ic health . Determination that no registered pest control products are avai l able . The extent of the potential yield losses, economic impact, and risks to public heal th , and The need to mitigate the pest emergency . In preparing the notification, the PCPB shall solicit comments and the engagement with and the cooperation of appropriate stakeholders (e.g., farmer groups, government agencies, pesticide industry , international organizations, any other relevant stakeholders) to identi fy candidate pest control products. The off icial notif ication shall be publ ished on the PCPB website and/or any other avai lable means of communication to inform registration holders and other key stakeholders of the need to cooperate and participate in identifying and applying for emergency use registration for pest control products to manage the pest emergency si t u at i o n . 4.43 Identifi cation of candidate pest control products f or the management of the p est emergency The PCPB shal l engage local representatives of the registered pesticides or the pesticide industry to col lectively identif y those pest control products that are potential candidates for emergency use registration to manage the pest emergency based on: (i) Demonstrated eff icacy and safety of registered pest control products for biologically simi lar pests in the affected agricul tural crop or public health in Kenya, (ii) Demonstrated eff icacy and safety of pest control products on the pest in the same or similar agricultural crops and publ ic health i n o th er c o u n tr i es w i th establ ished pesticide regulatory systems,, (Demonstrated ef fi cacy on the pest f rom other countr ies means inf ormation extrapolated f rom scientifi cally verifi ed ef fi cacy data f rom other countr ies) . (ii i) Priority shall be given to: Effective and safe product formulations containing active ingredients (conventional chemicals or biopesticides) already approved f o r u se i n recognized regulatory j urisdiction with strong pesticide regulatory framework . Effective biocontrol product or conventional chemicals already approved for use in Kenya, In the event , that a new unregistered active ingredient or formulated product or ' biocontrol product is identified as needed, the applicant shal l be required to provide evidence through scientif ic data that the pest control products are effective and wil l not cause unacceptable adverse ef fects o n h u m an heal th and the env i r o nm ent . , § n i m f5v. 2400 Kenya Subsidiary Legislation, 2024 4.4.2 Notification of a pest emergency Once, the need for an emergency use registration of a pest control product is declared, the Pest Control Products Board will prepare an official notification of an emergency pest situation which shall include information on: The nature of the pest emergency, The affected crops and farmers, area or public health, Determination that no registered pest contro] products are available, The extent of the potential yield losses, economic impact, and risks to public health, and The need to mitigate the pest emergency. In preparing the notification, the PCPB shall solicit comments and the engagement with and the cooperation of appropriate stakeholders (e.g., farmer groups, government agencies, pesticide industry, international organizations, any other relevant stakeholders) to identify candidate pest control products. The official notification shall be published on the PCPB website and/or any other available means of communication to inform registration holders and other key stakeholders of the need to cooperate and participate in identifying and applying for emergency use registration for pest control products to manage the pest emergency situation. ' 4.43 Identification of candidate pest control products for the management of the pest emergency The PCPB shall engage local representatives of the registered pesticides or the pesticide industry to collectively identify those pest control products that are potential candidates for emergency use registration to manage the pest emergency based on: (i) Demonstrated efficacy and safety of registered pest control products for biologically similar pests in the affected agricultural crop or public health in Kenya, (ii) Demonstrated efficacy and safety of pest control products on the pest in the same or similar agricultural crops and public health in other countries with established pesticide regulatory systems, (Demonstrated efficacy on the pest .oiat . from other countries means information extrapolated from scientifically sgriminy. verified efficacy data from other countries). (iii) Priority shall be given to: Effective and ‘safe product formulations containing active ingredients (conventional chemicals or biopesticides) already approved for use in recognized regulatory jurisdiction with strong pesticide regulatory framework, Effective biocontrol product or conventional chemicals already approved for use in Kenya, In the event, that a new unregistered active ingredient or formulated product or bidcontrol product is identified as needed, the applicant shall be required to provide evidence through scientific data that the pest control products are effective and will not cause unacceptable adverse effects on human health and the environment. 1% Kenya Subsidiary Legislation, 2024 240 1 Upon approval of a pesticide emergency use and where the use is on a food crop, the applicant shall be required to provide scientif ic evidence that the potential residues on food do not pose an unreasonable adverse dietary risk. 4.4.4 Application f or a pest control products emergency use registration PCPB may prior to arrival of an invasive pest of concern app r o v e em er genc y registration of pest control products once by evaluating data on pest monitoring and early pest warning system from responsible national and international organization in consul tation w i th relevant stakeholders. Once a pest control product candidate (s) is/are identified, the local representative of an existing approved pesticide or the company that owns an unregistered pest control product candidate must formally apply for an emergency use registration to the PCPB , with the following documentation: (i) A completed Emergency use appl ication form available f rom the PCPB websi te https://w w w .Dcpb .go .ke (ii) Proof of payment of applicable fees for application of an emergency use registration as determined by the Board from time to t i m e , (iii) Supporting technical data on the pest control product: Physical/chemical properties. Toxicity (human health, environmental fate and ecotoxicological) . Eff icacy , Potential residues on affected agricultural crops, evidence of,-Testablished pesticide maximum residue limits (M RLs) for the active ingredient in/on affected crops (e.g.. Codex Alimentarius or established M R L s f r o m o th er countries w here the M RL s were establ i shed under scienti f ic cri teria) . And for biopesticides, evidence of MRLs exemptions. A supplemental label , specific to address the pest emergency use situation. The supplemental label shall clearly state that the pest control product can only be used for the pest emergency. The supplemental label sh al l h av e an expiration date of one year from the product approval date. The supplemental label shall also contain basic label information (such as, product composition, registrant information, directions for use. Date of manufacture, expiry date, batch number, declaration of the shelf l ife, health and environmental warning, proper product disposal , product warranty , f irst aid statement , etc .) . For an unregistered pest control product, proof of registration details and technical information from any foreign country where such a product may already be registered (i f appl icable). For an unregistered pest control product, a plan for managing unused stocks of the product at the end of pest emergency. Any additional and pertinent information, such as letters from grower associations or other government agencies in support of the appl ication. 4.4.5 Granting a pest control products emergency use registration. After a thorough evaluation of the pest control product emergency use application, the PCPB shall grant a pesticide emergency use registration if the appl ication meets the Kenya Subsidiary Legislation, 2024 2401 Upon approval of a pesticide emergency use and where the use is on a food crop, the applicant shall be required to provide scientific evidence that the potential residues on food do not pose an unreasonable adverse dietary risk. 444 Application for a pest control products emergency use registration PCPB may prior to arrival of an invasive pest of concern approve emergency registration of pest control products once by evaluating data on pest monitoring and early pest warning system from responsible national and international organization in consultation with relevant stakeholders. Once a pest control product candidate (s) is/are identified, the local representative of an existing approved pesticide or the company that owns an unregistered pest control product candidate must formally apply for an emergency use registration to the PCPB, with the following documentation: (i) A completed Emergency use application form available from the PCPB website https://www.pcpb.go.ke (ii) Proof of payment of applicable fees for application of an emergency use registration as determined by the Board from time to time. (iii) Supporting technical data on the pest control product: ’ Physical/chemical properties, Toxicity (human health, environmental fate and ecotoxicological), Efficacy, Potential residues on affected agricultural crops, evidence of,:established pesticide maximum residue limits (MRLs) for the active ingredient in/on affected crops (e.g., Codex Alimentarius or established MRLs from other countries where the MRLs were established under scientific criteria). And for biopesticides, evidence of MRLs exemptions. HOG A supplemental label, specific to address the pest emergency use situation. The supplemental label shall clearly state that the pest control product can only be used for the pest emergency. The supplemental label shall have an expiration date of one year from the product approval date. The supplemental label shall also contain basic label information (such as, product composition, registrant information, directions for use, Date of manufacture, expiry date, batch number, declaration of the shelf life, health and environmental warning, proper product disposal, product warranty, first aid statement, etc.). For an unregistered pest control product, proof of registration details and technical information from any foreign country where such a product may already be registered (if applicable). For an unregistered pest control product, a plan for managing unused stocks of the product at the end of pest emergency. Any additional and pertinent information, such as letters from grower associations or other government agencies in support of the application. 4.4.5 Granting a pest control products emergency use registration. After a thorough evaluation of the pest control product emergency use application, the PCPB shall grant a pesticide emergency use registration if the application meets the Kenya Subsidiary Legislation, 20242 4 0 2 minimum requirements. The pesticide emergency use registration sh al l b e f o r a 12 month period. This can be renewed once, if the pest emergency continues and no o th er ef f ec t i v e integrated pest control measure exists, or no duly registered pesticide has been approved for controll ing the pest . Once an emergency use registration has been granted the second time, the local representative of the pesticide emergency use registration sh al l c o m m i t t o sub m i t d ata to fulfill all the requirements for a formal registration of the product . 4.4.6 Additional requirements f or approved pest control product emergency uses. In approving the pest control product emergency use, the holder of the registration shall commit to submit an annual report to the PCPB detail ing: The quantity of products that were imported, produced and or sold to users. Actual f ield information on product performance as c l ai m ed i n t h e appl ication for the pest emergency . Information that the use of the product has not resulted i n u n du e r i sk s to h u m an heal t h and th e en v i r o nm en t . Evidence that residues on treated food crops do not ex ceed the m ax i m u m residue limits for the active ingredient(s); and At any time during the pest emergency situation, should th e l o cal representative of the pest control product emergency use appl icant become aware of problems with the efficacy, exceedance of m ax i m u m resi d ue l i m i t s or undue ri sk to hum an heal th and the env i ronment ; the holder of the pest control product emergency use registration shall immediately i n f o r m the PCPB in writing of such situations upon which the PCPB sh al l i n st i t u te appropriate remedial action. 4.5 Cancellation of emergency use registration The PCPB shall cause cancel lation of an emergency use registration when it is establ ished beyond reasonable doubt that there was a co n tr av en t io n i n o ne o r m o re conditions for granting the said approval . 2402 Kenya Subsidiary Legislation, 2024 minimum requirements. The pesticide emergency use registration shall be for a 12 month period. This can be renewed once, if the pest emergency continues and no other effective integrated pest control measure exists, or no duly registered pesticide has been approved for controlling the pest. Once an emergency use registration has been granted the second time, the local representative of the pesticide emergency use registration shall commit to submit data to fulfill all the requirements for a formal registration of the product. 4.4.6 Additional requirements for approved pest control product emergency uses. In approving the pest control product emergency use, the holder of the registration shall commit to submit an annual report to the PCPB detailing: The quantity of products that were imported, produced and or sold to users, Actual field information on product performance as claimed in the application for the pest emergency, Information that the use of the product has not resulted in undue risks to human health and the environment. Evidence that residues on treated food crops do not exceed the maximum residue limits for the active ingredient(s); and At any time during the pest emergency situation, should the local representative of the pest control product emergency use applicant become aware of problems with the efficacy, exceedance of maximum residue limits or undue risk to human health and the environment; the holder of the pest control product emergency use registration shall immediately inform the PCPB in writing of such situations upon which the PCPB shall institute appropriate remedial action. 4.5 Cancellation of emergency use registration The PCPB shall cause cancellation of an emergency use registration when it is established beyond reasonable doubt that there was a contravention in one or more conditions for granting the said approval. Kenya Subsidiary Legislation, 2024 24 0 3 Figure 1; Flowchart for the process of approving a Pest Control product emergency Use !St y ^peciê fdemity affe a r e a Post S itua ti o n devek^ in (he Kenya Ye s i hre ai O fl ic ia) Declai ation an d O ffic ial Noti f ica tion o f a Pcs( Emergency (̂ sify the / Situation ̂ a\ Pest Gntergency ̂ s. Situati on / N o E( / ■No emergency itse registrati on rerjuired co ntro l w it h registered V Identification and StHecti on of Pest conti d product (PCP) Ctet fl idate (this process may follow submission of ot̂ licaiion for emotgerKy use No PCPregistered or rerj fstered PCP are ine ffec tiv e Applicati on for Enfergency Use Sub missio n of Required Data ' , i 7 £ I ' ) Post approval monitori ng & report ing (lata Approve emergency a ut ho riz a tio n submitted adequate 0 Deny emergent̂ authori zation ■i .r 1 Kenya Subsidiary Legislation, 2024 2403 Figure 1: Flowchart for the process of approving a Pest Post Situation develops in the Kenya Declaration and Official a Pest 7 Notfication of a Situation Past Emergency control with registered No emergency use regi c required Ne , [ identification and Selection of Pest cesegisieed POP contro! product (PCP) Candidate are ineffective (this process may follow submission ot application for emergency use Control product emergency Use No omen Application for Emergency Use r Submission of Requited Data 48 at iy data Approve Post approval submitted ne v monitoring & adequate authorization Feporting Deny emergency authorization © Kenya Subsidiary Legislation, 202424 04 (r29(2)F o r m I PE ST C O N T R O L PR O D U C T S B O A R D C H A N G E O F SO U R C E PR O D U C T I N F O R M A T I O N 1. T r ad e N am e; Common name of active ingredient(s) and Concentration: PCPB Registration No: Technical Grade Active Ingredient (Current source) N am e o f basic m an u f ac tu re r : Physical Location of basic manufacturer: A d d ress : 2 . I3 . 4 . (a) (b) (c) (i ) Postal Address: (ii) Telephone No: (i ii) E-M ail ( iv) Fax N o : (v) Street/Road: (d) Speci f ications (Certif icate of composit ion) (e) Relationships with Registrant , if dif ferent Technical Grade Active Ingredient (New source) (a) Name of basic manufacturer; (b) Physical Location of basic manufacturer:. .. . (c) Address: 5 . (i) Postal Address: (i i) Telephone No: ( ii i) E-M ail Address: (iv) Fax No: (v) Street/Road: Specif ications (with analytical proof-5 batch analysis) Relationships with Registrant , if dif ferent (d) (e) I 2404 Kenya Subsidiary Legislation, 2024 Form I (r29(2) PEST CONTROL PRODUCTS BOARD CHANGE OF SOURCE PRODUCT INFORMATION bh w n igo ] OQ la* w 2] o ga e. ft = . 3 Z ° (c) Address: (d) Specifications (Certificate of composition) (e) Relationships with Registrant, if different 5. Technical Grade Active Ingredient (New source) (c) Address: (d) Specifications (with analytical proof-5 batch analysis) (e) Relationships with Registrant, if different 240 5Kenya Subsidiary Legislation, 2024 6 . Formul ated Product N am e o f F o rm u l ato r : Physical Location;. .. A dd r ess (a) (b) (c) (i ) Postal Address: (ii ) Telephone No: (ii i ) Fax No: (iv) E-M ail Address: (v) Street/Road: Composit ion (with analytical proof) Relationship with the registrant Reason for change of manufacturer/Formulator. Fill separate f orm f or each basic manuf acturer/f ormulator, if more than one. (d) (e) I 7 . N B : Kenya Subsidiary Legislation, 2024 2405 6. Formulated Product (a) (b) (c) Address (i) Postal Address: ..........c.cccccc ccs eseeee eee e eee e eee eenaeeneneenene serene (ii) Telephone No? ........... ccc e cece cence ee cen eee nen ene een eee eeeeeeeene nes (iv) E-Mail Address: ..............cceceeeceeeeeeeeeee ene eeneeaneaneeeeeene ens (V) Street/Road: ..........ce ce cecc ee ec ee ee eee cer eee nenc ene eneeeee eee rersneees COMPOSITION (with analytical proof) Relationship with the registrant Reason for change of manufacturer/Formulator. : Fill separate form for each basic manufacturer/formulator, if more than one. Kenya Subsidiary Legislation, 202424 0 6 r6(l ) REQUIREM ENTS FOR EV ALUATING AND REPORTING THE EFFICACY OF PE ST CON T ROL PROD U CT S FOR Pr o c ed u r es Fo r Ev a l u a t in g & Repo r t in g T he Ef f ic a c y O f Pest Co n t r o l Pr od uc t s Fo r Pl an t s 1 . I n t r o d u c t i o n Effi cacy evaluation of a pest control product is important b ec au se i t en ab les t he registration authori ties to evaluate the benefi ts to be gained from new pest control products or new uses of existing pest control products to weigh their benef its against potential hazards due to their introduction. Reports of effi cacy trials in the region are not uniform. These requirements have been developed for trial managers carrying out the eff icacy trials with a view to harmonizing the procedure of conducting and reporting of eff icacy trials. This wi ll improve the evaluation process for the registration of new pest control products in the region. All trials must be authorized by the Board. The trial manager is obl iged to l iaise closely ̂ ith the Board4hrpuĝ ut the trial period. 2' ̂ ‘^Cj 'ener a l Pr ov isions The Board shall ensure that all new pest control products or new uses of existing pest control products are subjected to a thorough efficacy evaluation before they are authorized for any use. All ef fi cacy trials involving pesticides shall be approved by the Board. 2.1 Samples of the pest control product must be sent to the Board for forwarding to the testing institution. 2.2 (a) All trials must be carried out by institutions and/ o r i nd i v i d u al s ac cr ed i t ed by the Board. ■̂^^ .The criteria for accreditation shall be clearly indicated to guarantee standards of 20OfiJ tri als 2.3 Applicant intending to register product(s) in Kenya sh al l en su r e t hat a c o m m o n crop/ pest specifi c study plan is developed in line with this guideline and the ef fi cacy trial protocol approved by the Board in consultation with the testing institutions. The applicant shall ensure the study plans are compl ied with. 2.4 The effi cacy test report should be submitted in hard (duplicate) and soft copies to the Board, with a copy to the applicant. 2.5 The cost of trial authorized by the Board will be incurred by the applicant 2.6 Where the provisions of the European ,and Mediterranean P l an t Pr o tec t i o n Organization (EPPO) requirements conflict ̂with these requirements, the provision of these guideline shall prevail. ' * 2406 Kenya Subsidiary Legislation, 2024 r6(1) REQUIREMENTS FOR EVALUATING AND REPORTING THE EFFICACY OF PEST CONTROL PRODUCTS FOR PROCEDURES FOR EVALUATING & REPORTING THE EFFICACY OF PEST CONTROL PRODUCTS FOR PLANTS 1. INTRODUCTION Efficacy evaluation of a pest control product is important because it enables the registration authorities to evaluate the benefits to be gained from new pest control products or new uses of existing pest control products to weigh their benefits against potential hazards due to their introduction. Reports of efficacy trials in the region are not uniform. These requirements have been developed for trial managers carrying out the efficacy trials with a view to harmonizing the procedure of conducting and reporting of efficacy trials. This will improve the evaluation process for the registration of new pest control products in the region. All trials must be authorized by the Board. The trial manager is obliged to liaise closely with the Board,throughout the trial period. 1; . ° 2'"4 GENERAL PROVISIONS The Board shall ensure that all new pest control products or new uses of existing pest control products are subjected t to a thorough efficacy evaluation before they are authorized for any use. wo All efficacy trials involving pesticides shall be approved by the Board. 2.1 Samples of the pest control product must be sent to the Board for forwarding to the testing institution. 2.2 (a) All trials must be carried out by institutions and/or individuals accredited by the Board. S00 The criteria for accreditation shall be clearly indicated to guarantee standards of Seon efficacy trials. 2.3 Applicant intending to register product(s) in Kenya shall ensure that a common crop/ pest specific study plan is developed in line with this guideline and the efficacy trial protocol approved by the Board in consultation with the testing institutions. The applicant shall ensure the study plans are complied with. 2.4 The efficacy test report should be submitted in hard (duplicate) and soft copies to the Board, with a copy to the applicant. . 2.5 The cost of trial authorized by the Board will be incurred by the applicant 2.6 Where the provisions of the European and, Mediterranean Plant Protection Organization (EPPO) requirements conflict. ,with these requirements, the provision of these guideline shall prevail. 240 7Kenya Subsidiary Legislation, 2024 3 Sc o pe The procedures laid out in this document shall be applied to, pest control products used to control harmful organisms (insects, pathogens, weeds etc.) on plants, plant products, products applied to soil and regulated articles. The procedures shall also be applied to plant growth regulators. This guideline covers all plants. 4 C o n d u c t in g e f f i c a c y t r ia l s The procedures outl ined below shall be employed when setting up ef ficacy trials. Obj ectives of the trials The pest control product to be evaluated and the target crop/plant, the target pest(s) and other obj ectives must be stated clearly. 5 M a t e r i a l s a n d M et h o d s The trial manager should refer to this guideline when conducting efficacy trials. If details are not available, internationally acceptable requirements should be used, e.g. the EPPO standards that are freely available on the EPPO w eb si te (http:llarchives.eppo.intlEPPOStandardslefl icacy.htm) 5 .2 .1 . T r i a l si te sel ec t i on The sites should be as uniform as possible and representative o f t he c o nd i t i o n s where commercial use is anticipated. Sites with irregular so i l c o n d i t i o n s sho u l d be avoided or experiments should be designed to accommodate th e m i n o r d i ff er en ces. The disease, insects, weeds, etc. which forms the object of the efficacy '̂ ridl Should occur in a uniform pattern over the site or should be expected to becom̂ uniformly present during the trial period. Before trials are carried out, it is important to assess the i n f estat i o n l ev e l s . When selecting a site, the history of the site should be co n si d er ed su ch as th e preceding crop situation and previous infestations. A single preceding crop, on which only uniform treatments were applied, should have been grown over the whole area of the si te. . . As a general rule, sites at field edges, or near ditches, trees, hedges or other obstacles should be avoided, as they are subj ect to interfering “ edge” eff ects from those o b stac l es . The experiment should be sited away from the edges of a normal commercial crop. If the crop has to be treated with a pest control product which may interfere witli those under study in the experiment, then a sufficient margin of untreated crop should be left in the immediate vicinity of the experiment. If the trial consists of repeated blocks which fol low each other in ft e direction of dri l l ing, spraying or other treatments of the crop, i t may be helpful to have a gap between the blocks to allow for turning on and off the supply of the pest control product, and as well to align the apparatus with the next plot or sub-plot . 5 .2 .2. Tr ials on plants grown under protection ’ ' Efficacy trials on plants grown under protection should be conducted under conditions comparable to those used in practice. If products with high vapor pressure, fumigants, aerosols or fogs are testejd, separate glasshouses or glasshouse compartments sh o u l d b e u sed f o r each t reat m en t . , Kenya Subsidiary Legislation, 2024 2407 3 SCOPE The procedures laid out in this document shall be applied to, pest control products used to control harmful organisms (insects, pathogens, weeds etc.) on plants, plant products, products applied to soil and regulated articles. The procedures shall also be applied to plant growth regulators. This guideline covers all plants. 4 CONDUCTING EFFICACY TRIALS The procedures outlined below shall be employed when setting up efficacy trials. Objectives of the trials The pest control product to be evaluated and the target crop/plant, the target pest(s) and other objectives must be stated clearly. 5 MATERIALS AND METHODS The trial manager should refer to this guideline when conducting efficacy trials. If details are not available, internationally acceptable requirements should be used, e.g. the EPPO standards that are freely available on the EPPO website (hitp:/larchives.eppo .int/EPPOStandards/efficacy.htm) 5.2.1. Trial site selection The sites should be as uniform as possible and representative of the conditions . where commercial use is anticipated. Sites with irregular soil conditions should be avoided or experiments should be designed to accommodate the minor differences. The disease, insects, weeds, etc. which forms the objjéct of:the efficacy ttidl should occur in a uniform pattern over the site or should be expected to become uniformly present during the trial period. Before trials are carried out, it is important to assess the infestation levels. When selecting a site, the history of the site should be considered such as the preceding crop situation and previous infestations. A single preceding crop, on which only uniform treatments were applied, should have been grown over the whole area of the site. As a general rule, sites at field edges, or near ditches, trees, hedges or other obstacles should be avoided, as they are subject to interfering * “edge” effects from those obstacles. The experiment should be sited away from the edges of a normal commercial crop. If the crop has to be treated with a pest control product which may interfere with those under study in the experiment, then a sufficient margin of untreated crop should be left in the immediate vicinity of the experiment. If the trial consists of repeated blocks which follow each other in the direction of drilling, spraying or other treatments of the crop, it may be helpful to have a gap between the blocks to allow for turning on and off the supply of the pest control product, and as well to align the apparatus with the next plot or sub-plot. 5.2.2. Trials on plants grown under protection Efficacy trials on plants grown under protection should be conducted “under conditions comparable to those used in practice. If products with high vapor pressure, fumigants, aerosols or fogs are tested, separate glasshouses or glasshouse compartments should be used for each treatment. | ' Kenya Subsidiary Legislation, 202424 0 8 5.23 Post harvest pest control products Post-harvest products should be tested in the laboratory (bioassay) and fi eld faci l ities that simulates supply chain/storage conditions. L aboratory tests should be based on reference or known test population of the appropriate pest . Storage duration of the grain before application (or in the case of fresh produce, cold storage conditions) should be specifi ed to establish if there is a relationship between time in storage and prevalence in pest population/disease severi ty/incidence, and subsequent inf luence to the trial . 5 .2.4. Tr ial lay-out The design of a trial intended for eff icacy evaluation should permit a statistical evaluation. It should however be simple and compatible with the immediate obj ective of th e test . A randomized complete block design is usually adequate. A very unique design may be used with prior approval by the Board. 5.2.5. The non-treated control p lot It is a requirement to include non-treated control plots in effi cacy trials. It is important to note that in some situations, the layout of non-treated plots within the randomized blocks may give rise to disadvantages d ue to ex ten si v e i n ter f eren ce between non-treated and treated plots. Examples are effi cacy trials for fungicides with “preventive” action on susceptible cultivars of potatoes, or apples for the control of late blight ’and apple scab, respectively. In order to avoid heavy losses in both the current and subsequent crops, it may sometimes be necessary to discard the non-treated plots from the experiment shortly after the occurrence of the d i sease b ec o m es o b v i o u s . T h e i n i t i a l non-treated plots should be sprayed, taking due care to avoid dri f t into treated plots. Alternatively, excluded controls, i .e. control plots l o c ated o u tsi d e the t r i al ar ea b u t i n an area where conditions are comparable to the trial area, c an b e u sed w her e i n ter f er ence with treated plots is expected. Excluded controls provide information on the level of pest i nf estat ion but cannot be incl uded in the stati stical analysis. 5.2.6. Choice of ref erence product The reference product is sometimes referred to as a standard or positive control . The reference product must have been registered and in use in the country where test is being done for use on the pest and target crop, where possible, the positive control should have'v'the same mode of action as the test product. The reference product should preferably be a product registered in Kenya. In case no product is registered with the same active ingredient or a simi lar mode of action, the trial manager should liaise with the Board for guidance. 5.2.7. Plot size and shape This should be determined by the crop-pest combination in question. In narrow row (broadcast sown) crops, minimum net plot size (the part of the plot used for assessment and harvest) should be between 10 and 20 m̂ depending on plant density . Higher density allows for smaller plot size). In row crops net plot size should be two (2) to four (4) rows of 8-10 m depending on plant density. In tree crop tr ial s, i t is desirable to have 4-6 trees per net plot to allow for variability between trees. The minimum plot size in uniform vegetable or f lower crops may be smal ler , i f internal i n ter f er en ces c an b e av o i d ed . T h e 2408 Kenya Subsidiary Legislation, 2024 5.2.3 Post harvest pest control products Post-harvest products should be tested in the laboratory (bioassay) and field facilities that simulates supply chain/storage conditions. Laboratory tests should be based on reference or known test population of the appropriate pest. Storage duration of the grain before application (or in the case of fresh produce, cold storage conditions) should be specified to establish if there is a relationship between time in storage and prevalence in pest population/disease severity/incidence, and subsequent influence to the trial. 5.2.4. Trial lay-out The design of a trial intended for efficacy evaluation should permit a statistical evaluation. It should however be simple and compatible with the immediate objective of the test. A randomized complete’ block design is usually adequate. A very unique design may be used with prior approval by the Board. 5.2.5. The non-treated control plot It is a requirement to include non-treated control plots in efficacy trials. It is important to note that in some situations, the layout of non-treated plots within the randomized blocks may give rise to disadvantages due to extensive interference between non-treated and treated plots. Examples are efficacy trials for fungicides with “preventive” action on susceptible cultivars of potatoes, or apples for the control of late blight'and ‘apple scab, respectively. In order to avoid heavy losses in both the current and subsequéiit' crops, it may sometimes be necessary to discard the non-treated plots from the experiment shortly after the occurrence of the disease becomes obvious. The initial non-treated plots should be sprayed, taking due care to avoid drift into treated plots. Alternatively, excluded controls, i.e. control plots located outside the trial area but in an area where conditions are comparable to the trial area, can be used where interference with treated plots is expected. Excluded controls provide information on the level of pest infestation but cannot be included in the statistical analysis. 5.2.6. Choice of reference product : The reference product is sometimes referred to as a standard or positive control. The reference product must have been registered and in use in the country where test is being done for use on the pest and target crop, where possible, the positive control should haVvethe same mode of action as the test product. The reference product should preferably be a product registered in Kenya. In case no product is registered with the same active ingredient or a similar mode of action, the trial manager should liaise with the Board for guidance. 5.2.7. Plot size and shape This should be determined by the crop-pest combination in question. In narrow row (broadcast sown) crops, minimum net plot size (the part of the plot used for assessment and harvest) should be between 10 and 20 m? depending on plant density. Higher density allows for‘smaller plot size). In row crops net plot size should be two (2) to four (4) rows of 8-10 m depending on plant density. In tree crop trials, it is desirable to have 4-6 trees per net plot to allow for variability between trees. The minimum plot size in uniform vegetable or flower crops may be smaller, if internal interferences can be avoided. The 24 0 9Kenya Subsidiary Legislation, 2024 plot size should be sufficiently large to allow application of treatments, sampl ing and evaluation of the crop yield at harvest . In some situations, the plot size and separation distance may be required to be larger in order to reduce interferences between treatments e.g. trials on pheromones. 5.2.8. Number of treatments Efficacy trials on the new product should have a maximum o f f i v e t r eatm en t s distr i buted as f ol low s: m anuf acturer recommended rate; rates slightly higher than recommended and slightly lower than recommended for the new product; reference standard at the registered rate; and untreated control . (Lower and higher treatment should not be more than 25% vari ation above or below the m anuf actures' recom mended rate) . There may be exceptional circumstances where more than f ive treatments may be required, such as where the test product has more than one active ingredient with dif ferent modes of action and > 1 positive control may be necessary . 5.2.9 Number of rep lications This will be determined by the likely magnitude of experimental variance and the number of treatments. T he few er the treatments, the more the repl ications needed to give an acceptable estimate of variance and to give the necessary degrees of freedom. Four to f ive replications are usually sufficient to give a reasonable estimate of the vari at ion . 5.2.10. Number of seasons (a) Where an applicant submits an application to the Board for registration of a product not registered in Kenya according to this guideline, the product shall be subjected to two (2) successful cropping ..ŝ sons; trials at twpf.sites in different agro-ecological zones. Where a commercial crop is only gro^ n.in one agro-ecological zone, data from that one zone will su f f i ce , (b) Where an application is for a label extension two seaso n ’ s t r i a l sh al l be c o n d uc ted (c) The above conditions for label extension apply to specific crop and pest combinations but may be adopted in the context of crop grouping and data extrapolation 5.2.11. Application of the pest control products The type of equipment used should be stated. It should, as much as possible, be similar to that currently used in practice, and should give an even distribution of the pest control product over the plot. Other relevant information such as type of nozzles; operating pressure in kilopascal (Kpa) should be provided. The type (foliar, soil incorporated, seed dressing .etc.) , method of appl ication (e.g. drench, spray, etc.), time, dosage and frequency of the pest control products appl ication will be as recommended by the applicant and they should be rec o rd ed . W h ere d ev i at io n s occur, records should be maintained. Precautions should be taken to ensure m i nimum interference with the adjacent plots (avoid drift). 5.2.72 Other pest control products used Information on other pest control products used in the trial plots should be provided by the scientist involved in the trial . . r r ' i Kenya Subsidiary Legislation, 2024 2409 plot size should be sufficiently large to allow application of treatments, sampling and evaluation of the crop yield at harvest. In some situations, the plot size and separation distance may be required to be larger in order to reduce interferences between treatments e.g. trials on pheromones. 5.2.8. Number of treatments Efficacy trials on the new product should have a maximum of five treatments distributed as follows: manufacturer recommended rate; rates slightly higher than recommended and slightly lower than recommended for the new product; reference standard at the registered rate; and untreated control. (Lower and higher treatment should not be more than 25% variation above or below the manufactures” recommended rate). There may be exceptional circumstances where more than five treatments may be required, such as where the test product has more than one active ingredient with different modes of action and >1 positive control may be necessary. 5.2.9 Number of replications This will be determined by the likely magnitude of experimental variance and the number of treatments. The fewer the treatments, the more the replications needed to give an acceptable estimate of variance and to give the necessary degrees of freedom. Four to five replications are usually sufficient to give a reasonable estimate of the variation. 5.2.10. Number of seasons (a) Where an applicant submits an application to the Board for registration of a product not registered in Kenya according to this guideline, the product shall be subjected to two (2) successful cropping .seasons, trials at two,,sites in different agro-ecological zones. Where a commercial crop is only grown.in one agro-ecological zone, data from that one zone will suffice. . (b) Where an application is for a label extension two season’s trial shall be conducted (c) The above conditions for label extension apply to specific crop and pest combinations but may be adopted in the context of crop grouping and data extrapolation 5.2.11. Application of the pest control products The type of equipment used ‘should be stated. It should, as much as possible, be similar to that currently used in practice, and should give an even distribution of the pest control product over the plot. Other relevant information such as type of nozzles; operating pressure in kilopascal (Kpa) should be provided. 3 The type (foliar, soil incorporated, seed dressing.etc.), method of application (e.g. drench, spray, etc.), time, dosage and frequency of the pest control products application will be as recommended by the applicant and they should be recorded. Where deviations occur, records should be maintained. Precautions should be taken to ensure minimum interference with the adjacent plots (avoid drift). 5.2.12 Other pest control products used Information on other pest control products used in the trial plots should be provided by the scientist involved in the trial. ye cist | Kenya Subsidiary Legislation, 20242 4 10 5.2.13 Growth stage of the crop and variety used The growth stage of the crop at the time of application sh o u ld b e i nd ic ated . T h e l ast application (pre-harvest interval) should be linked with harvesting time. The variety of the crop in use should be specified. The most susceptible variety should be considered for the worst case scenario, among the available commercial v ar i et ies . 5.2.14 Meteorological and edaphic data Before, during and after the time of application, precipitation (type and daily amount of rainfall in mm), temperature (daily average, maximum and minimum in “C), insolation should be recorded on the f ield trial site or obtained from a nearby meteorological station. Extreme weather conditions such as severe and prolonged drought , storms, hail , etc, which are likely to influence the effect of the product(s) should also be recorded. For pest control products applied to the soil , soil organic matter , texture and moisture should be recorded. For plants grown under protected environment (glass houses) or grains stored in fumigation sheets or silos, temperature and humidity should be recorded throughout the trial period. 5.2.15 Assessment of ef f icacy and yield A n assessment of the level of infestation/ infect ion should always be made prior to treatment . T he number of assessments af ter treatment depends on the type of the plant, pest and the growth stage of the plant. Assessment should always be made in the net plot. Objective methods of assessment such as counting, weighing, measuring should be used rather than subj ective methods such as visual assessment except for diseases where severity, or incidence is the commonly agreed method of assessment . Parameters that demonstrate direct effects should be measured e.g. disease severity. Where internationally acceptable assessment methods exist, they should be adopted. Time of assessment and sampl ing method should be recorded. Yield data should be recorded in all the efficacy trials. However , in some crops l ike pineapples and sugarcane, yield data may be waived due to duration of the cropping s e a s o n . Raw data and analyzed data should be maintained by the testing institutions and should be readily available to the regulatory authority whenever required. 5.2.16 Phyto-toxicity and other side eff ects The type and extent of phyto-toxicity should be described and, where appropriate, j -eqorded according to a recognized scale. Any detrimental ef fects on w i ldl i fe and/ or j jgOgSc.ial organisms shall also be recorded. For high value crops such as roses and other tfl awers, varietal phytotoxicity tests should be carried out on a number of representative v ar i et i es . For herbicide and plant growth regulators, data should always be provided from trials on crops/plants where double of the normal dose is applied-. 5 .2.17 Residual ef fects The effect of the pest control product on subsequent crop should be documented. This is particularly important for herbicides. Information on effects on succeeding crops may be obtained from trials conducted outside Kenya, including published data. For further information on the assessment of the risk of effects on succeeding crops consult PCPB testing protocol and/or EPPO Standard on Effects on succeeding crops. These data are not required for perennial crops such as sugarcane, pineapple, coffee, etc. 2410 Kenya Subsidiary Legislation, 2024 5.2.13 Growth stage of the crop and variety used The growth stage of the crop at the time of application should be indicated. The last application (pre-harvest interval) should be linked with harvesting time. The variety of the crop in use should be specified. The most susceptible variety should be considered for the worst case scenario, among the available commercial varieties. 3.2.14 Meteorological and edaphic data Before, during and after the time of application, precipitation (type and daily amount of rainfall in mm), temperature (daily average, maximum and minimum in °C), insolation should be recorded on the field trial site or obtained from a nearby meteorological station. Extreme weather conditions such as severe and prolonged drought, storms, hail, etc, which are likely to influence the effect of the product(s) should also be recorded. For pest control products applied to the soil, soil organic matter, texture and moisture should be recorded. For plants grown under protected environment (glass houses) or grains stored in fumigation sheets or silos, temperature and humidity should be recorded throughout the trial period. 5.2.15 Assessment of efficacy and yield An assessment of the level of infestation/infection should always be made prior to treatment. The number of assessments after treatment depends on the type of the plant, pest and the growth stage of the plant. Assessment should always be made in the net plot. Objective methods of assessment such as counting, weighing, measuring should be used rather than subjective methods such as visual assessment except for diseases where severity..or incidence is the commonly agreed method of assessment. Parameters that demonstrate direct effects should be measured e.g. disease severity. Where internationally acceptable assessment methods exist, they should be adopted. Time of assessment and sampling method should be recorded. Yield data should be recorded in all the efficacy trials. However, in some crops like pineapples and sugarcane, yield data may be waived due to duration of the cropping season. Raw data and analyzed data should be maintained by the testing institutions and should be readily available to the regulatory authority whenever required. 3.2.16 Phyto-toxicity and other side effects The type and extent of phyto-toxicity should be described and, where appropriate, regorded according to a recognized scale. Any detrimental effects on wildlife and/or beneficial organisms shall also be recorded. For high value crops such as roses and other flowers, varietal phytotoxicity tests should be carried out on a number of representative varieties. For herbicide and plant growth regulators, data should always be provided from trials on crops/plants where double of the normal dose is applied. 5.2.17 Residual effects The effect of the pest control product on subsequent crop should be documented. This is particularly important for herbicides. Information on effects on succeeding crops may be obtained from trials conducted outside Kenya, including published data. For further information on the assessment of the risk of effects on succeeding crops consult PCPB testing protocol and/or EPPO Standard on Effects on succeeding crops. These data are not required for perennial crops such as sugarcane, pineapple, coffee, etc. 24 1 1. Kenya Subsidiary Legislation, 2024 5.2.18 Monitor ing of ef f icacy tr ials The testing institution should send to the Board the study plan and schedule of activities showing critical milestones, including the i ni t i at ion of the tr i al s, treatment application, data collection and expected date of completion f or each season . T he B oard shall ensure that a representative sample of trials being conducted in Kenya in accordance with these requirements, are monitored for compliance. Evidence of peer review should be provided. 5.2.19 Statistical analysis of data The generated data should be subjected to statistical analysis to establish statistical significance. The statistical method(s) used should be indicated. The raw and statistical ly analyzed data should be held by the trial manager for submission to the Board on request . A l l data and information should be f iled appropriately by the testing institution for easy retrieval . Further information on statistical analysis of eff icacy trials may be obtained from PCPB testing protocol and/or EPPO Standard: Design and analysis of ef f icacy eva l ua t i o n t r ia l s . 6 .0 R epo r t i n g A progress report should be submitted at the end of each season. The report should undergo internal peer review before being submitted by the head of the institute to the Board. The report should be submitted in both hard copy and electronically. The final report should summarize the results and should be compiled in the fol lowing format . M ore information on reporting eff icacy trial s may be obtained from the Boardreporting standard and/or EPPO Standard: Conduct and repor ting of eff icacy trials including good .•i Bi Jac ffi n o i i i : exper imental practice. i d 6 .1 T i t l e The title should ref lect the content of the report . 6.2 Summary It should summarize the content of the report and the main f indings 6 .3 I ntr oduction , I t should contain a brief l iterature review and obj ectives of carrying out the study . 6 .4 M a ter ia l s a nd m eth od s I t should give a description of methods used and citations o f r elev an t ref ere ft ee m etho d s . T h e i nf o r m at i o n sh o u l d i nc l ud e th e c o m m o n and trade nam es of the caliSM i t e product, source of product, formulation, concentration of the active ingredienP,'̂ ê§t crop/commodity, target pests, experimental design and methods of statistical analysis.î 6 .5 R esu l ts The results should be fully described in relation to the stated obj ective. Tables should contain summaries of statistically analyzed results showing: means, minimum and maximum values for each treatment , coeff icient of variation (CV ) , levels of signif icance, appropriate mean separation etc. The report should summar i ze resul ts obtained f rom al l the test seasons and describe variations or consi stence am o ng seaso n s . 6 .6 D i sc uss i on s • 1 r -V. (a) State main f indings ̂ . Kenya Subsidiary Legislation, 2024 2411 5.2.18 Monitoring of efficacy trials The testing institution should send to the Board the study plan and schedule of activities showing critical milestones, including the initiation of the trials, treatment application, data collection and expected date of completion for each season. The Board shall ensure that a representative sample of trials being conducted in Kenya in accordance with these requirements, are monitored for compliance. Evidence of peer review should be provided. 5.2.19 Statistical analysis of data The generated data should be subjected to statistical analysis to establish statistical significance. The statistical method(s) used should be indicated. The raw and statistically analyzed data should be held by the trial manager for submission to the Board on request. All data and information should be filed appropriately by the testing institution for easy retrieval. Further information on statistical analysis of efficacy trials may be obtained from PCPB testing protocol and/or EPPO Standard: Design and analysis of efficacy evaluation trials. 6.0 REPORTING A progress report should be submitted at the end of each season. The report should undergo internal peer review before being submitted by the head of the institute to the Board. The report should be submitted in both hard copy and electronically. The final report should summarize the results and should be compiled in the following format. More information on reporting efficacy trials may be obtained from the Boardreporting standard and/or EPPO Standard: Conduct and reporting of efficacy trials including good experimental practice. 2 ia apiece rea (snour 6.1 Title , ft Ltt The title should reflect the content of the report. 6.2 Summary It should summarize the content of the report and the main findings 6.3 Introduction r . It should contain a brief literature review and objectives of carrying out the study. 6.4 Materials and methods It should give a description of methods used and citations of relevant reference methods. The information should include the common and trade names of the carididate product, source of product, formulation, concentration of the active ingredieritye8t crop/commodity, target pests, experimental design and methods of statistical analysis" 6.5 Results The results should be fully described in relation to the stated objective. Tables should contain summaries of statistically analyzed results showing: means, minimum and maximum values for each treatment, coefficient of variation (CV), levels of significance, appropriate mean separation etc. The report should summarize results obtained from all the test seasons and describe variations or consistence among seasons. “e. 6.6 Discussions 22499. (a) State main findings. aig 0" Kenya Subsidiary Legislation, 202424 12 (b) How the findings relate to stated objectives (c) Any inferences made (d) Explain any variations or factors that may have inf luenced the performance of the product under investigation (e) Relate results to previous findings 6 .7 Recommendations and Conclusions (a) State clearly whether the product is suitable for registration for the stated use based on the fi ndings, (b) The trial manager should clearly recommend: (i) Application rates expressed as amount per ha, amount of active ingredient per ha, amount of product per 20 L of water, (ii) Time of application (also in relation to harvesting) (iii) Number of applications per season (iv) Frequency of application (v) Spray volume (vi) A ny other observations (c) State clearly whether the data met the 2/3 consecutive seaso n c r i ter i a . 6.8 Acknowledgement Pertinent acknowledgement should be included. 6.9 Ref erences A l ist of references should be included with author , date of publication, title of article, name of j oumal/source, volume and the f irst and last page of the document . 2412 Kenya Subsidiary Legislation, 2024 (b) How the findings relate to stated objectives (c) Any inferences made (d) Explain any variations or factors that may have influenced the performance of the product under investigation (e) Relate results to previous findings 6.7 Recommendations and Conclusions (a) State clearly whether the product is suitable for registration for the stated use based on the findings. (b) The trial manager should clearly recommend: (i) Application rates expressed as amount per ha, amount of active ingredient per ha, amount of product per 20 L of water. (ii) Time of application (also in relation to harvesting) (iii) Number of applications per season (iv) Frequency of application (v) Spray volume (vi) Any other observations (c) State clearly whether the data met the 2/3 consecutive season criteria. 6.8 Acknowledgement Pertinent acknowledgement should be included. 6.9 References A list of references should be included with author, date of publication, title of article, name of journal/source, volume and the first and last page of the document. Kenya Subsidiary Legislation, 2024 24 13 ‘ / / /•.6 (1) REQUIREM ENTS FOR THE CONDUCT OF SUPERVISED PESTICIDE R E SI D U E F I E L D T R IA L S O N C R O PS A b b r ev i a t i o n s : A D I Acceptable Dai ly Intake B B C H “ Biologische Bundesanstalt , Bundessortenamt und C H em i sch el nd ust r i e” : Sc ale used to phenological development stages of a plant identify the C A C C o dex A l i m en tar i u s C o m m issio n C C PR C o m m i t tee o n Pest i c ide R esid u es D P Dustable powder E C E m u l si f i ab le C o ncen tr ate G R G ran u les JM PR FAOAVHO Joint M eeting on Pesticide Residues SC Suspension concentrates 1.. L . f SL So l u b le co ncen t rates W G W ater dispersible granules W P Wettable powder Kenya Subsidiary Legislation, 2024 2413 r.6(1) REQUIREMENTS FOR THE CONDUCT OF SUPERVISED PESTICIDE RESIDUE FIELD TRIALS ON CROPS ABBREVIATIONS: ADI Acceptable Daily Intake BBCH “Biologische Bundesanstalt, Bundessortenamt und CHemischelIndustrie”: Scale used to identify the phenological development stages of a plant CAC Codex Alimentarius Commission CCPR Committee on Pesticide Residues DP Dustable powder EC Emulsifiable Concentrate GR Granules JMPR FAO/WHO Joint Meeting on Pesticide Residues sc Suspension concentrates he SL Soluble concentrates ces WG Water dispersible granules ~ WP Wettable powder Kenya Subsidiary Legisiation, 202424 14 I . D E F I N I T I O N S Act iv e Ing r edient : means the part of the product that provides the pesticidal act ion [ ] ] . Adj uv ant refers to any product added to the spray tank for the purpose of improving the performance of the test substance/active ingredient . Adj uvants can be character ized for example as wetting agents, spreader-st ickers, compatibi l ity agents, buffering agents, de-foamers, non-ionic surf actants, crop oil concentrates, etc. [2] . Appl icant refers to a company and/or person who appl ies for a registration, amended registrat ion, reregistration or MRL . A lso .see Manuf acturer Appl icat ion Equipment means any technical aid, equipment , implement or machinery which is used for the appl ication of pesticides [ I ] . Commodity group: Commodities within a group based on si m i l ar r esi d ue c h ar ac te r ist ic s and w h ic h are d eem ed to b e su i t ab le for setting group M RL s are said to belong to a Commodity group, also known as a Crop group. Commodity groups (e.g., pome f ruits, cereal grains) wi thin the Codex Classif ication f o r F o od s and F eed s ar e suitable for establ ishing group M RLs. Cont r o l pl ot : The plot that is not appl ied/treaied w ith the test substance, or a substance that ha.s similar chemistry or belongs to the same pesticide class and is part of crop f ield trials, which could interfere with the trial . The use of other products may be necessary to maintain the health of the treated and untreated (control) plants. In that case, only those pesticides that do not i nterfere with the residue analysis may be used. The additiohaFbroducts used should be noted and, where possible, advice f rom the analyst should lleV̂ ught beforêuse. o li i C r o p F iel d T r ia l see “ Su per v ised Fiel d T r i a l ” ; these ter m s are co n sid ered synonymous for purposes of this guidel ine. Cr op Fiel d Tr ial Sit e is a geographically def ined address/ locatio n w i th i n a country/region/state of a f ield, space, greenhouse or other area in/on which a pesticide ‘f ield trial is conducted. A site may consist of several plots (areas with def ined boundaries on which a crop is grown), including control and one or more treated plots, each of which •receives a specif ic pesticide appl icat ion regimen. The tr ial locat ion for a post-harvest appl ication is def ined as the location where the post-harvest treatment takes place (for example treatment room or storage locat ion) . Additionally , t h e t r i al lo c at i o n f o r a seed treatment crop f ield trial is def ined as the locat ion where the seed is planted or sown.[2] boiiiorQpiQP Group refers to a group of crops in which the expected residues on the fcofnlmbdities are likely to be similar (from treatment under similar GAP) and where the group or subgroup M RLs can be considered. Crop grouping i s based o n si m i l ar i t ies i n appearance, harvestable commodity , edible port ions and/or growth habits etc. [2] End-Use Pr oduct is a product containing active mgredient(s) and usual ly formulants that has been manufactured, packaged, and l ab e l led w i t h i n st r uc t io n s f o r direct pest control use or application in a form that is usable by the consumer . Ext r apol at ion refers to a system proj ect ion of data f rom one system to another system. I n this sense, data received from one formulation can be extrapolated to another f orm ulat ion under certain c i rcumstances. I n some instances, extrapolation of f ield trial data obtained f rom one commodity are used to predict t he resid ue beh av io u r o f ano ther similar commodity under described circumstances and'tliu's proposing the same M RLs for both commod it ies. [2] . 9414 Kenya Subsidiary Legislation, 2024 1. DEFINITIONS ACTIVE INGREDIENT: means the part of the product that provides the pesticidal action [1]. ADJUVANT refers to any product added to the spray tank for the purpose of improving the performance of the test substance/active ingredient. Adjuvants can be characterized for example as wetting agents, spreader-stickers, compatibility agents, buffering agents, de-foamers, non-ionic surfactants, crop oil concentrates, etc. [2]. APPLICANT refers to a company and/or person who applies for a registration, amended registration, reregistration or MRL. Also see Manufacturer APPLICATION EQUIPMENT means any technical aid, equipment, implement or machinery which is used for the application of pesticides [1]. Commodity yroup: Commodities within a group based on similar residue characteristics and which are deemed to be suitable for setting group MRLs are said to belong to a Commodity group, also known as a Crop group. Commodity groups (e.g., pome fruits, cereai grains) within the Codex Classification for Foods and Feeds are suitable for establishing group MRLs. CONTROL PLOT: The plot that is not applied/treated with the test substance, or a substance that has similar chemistry or belongs to the same pesticide class and is part of crop field trials, which could interfere with the trial. The use of other products may be necessary to maintain the health of the treated and untreated (control) plants. In that case, only those pesticides that do not interfere with the residue analysis may be used. The additioriat products used should be noted and, where possible, advice from the analyst should be e solight beforélitse. © Crop FIELD TRIAL’+"see “SUPERVISED FIELD TRIAL”; these terms are considered synonymous for-purposes of this guideline. Crop FIELD TRIAL SITE is a geographically defined address/location within a country/region/state of a field, ‘space, greenhouse or other area in/on which a pesticide field trial is conducted. A site may consist of several plots (areas with defined boundaries on which a crop is grown), including control and one or more treated plots. each of which yeceives a specific pesticide application regimen. The trial location for a post-harvest application is defined as the location where the post-harvest treatment takes place (for example treatment room or storage location). Additionally, the trial location for a seed treatment crop field trial is defined as the location where the seed is planted or sown [2] pottioGRor Group refers to a group of crops in which the expected residues on the edifitUdities are likely to be similar (from treatment under similar GAP) and where the group or subgroup MRLs can be considered. Crop grouping is based on similarities in appearance, harvestable commodity, edible portions and/or growth habits etc. [2] END-USE PRODUCT is a product containing active ingredient(s) and usually formulants that has been manufactured, packaged, and labelled with instructions for direct pest control use or application in a form that is usable by the consumer. EXTRAPOLATION refers to a system projection of data from one system to another system. In this sense, data received from one formulation can be extrapolated to another formulation under certain circumstances. In some instances, extrapolation of field trial data obtained from one commodity are used to predict the residue behaviour of another similar commodity under described circumstances and ‘thus proposing the same MRLs for both commodities. [2]. Kenya Subsidiary Legislation, 2024 24 15 Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed and for the envisaged mode of application. [ 1] Good Agr icul t ur al Pr act ice in the use of pesticides includes the officially recommended or nationally authorized uses of pesticides un d er ac tu al co n d i t i o n s necessary for effective and reliable pest control . I t encompasses a range of levels of pesticide applications up to the highest authorized use, applied in a manner which leaves a residue which is the smallest amount practicable [ 1] . Cr it ical Good Agr icul t ur al Pr act ice (cGAP) is the GAP sel ec ted to represent the worst-case use scenario within the context of national , regional , or global uses that will be producing the highest possible field residues on crop commodities. I t usually includes the maximum use-rate and number of appl ications and the minimum re treatment and pre-harvest intervals. Good Exper iment al Fiel d Pr act ice is the formalized process for designing and recording the practices used in the performance of fi eld investigations with pesticides, and which assure the reliability and integrity of the data [3] . Good Labor at or y Pr act ice (GLP) is the formalized process and c o n d i t io n s under which laboratory studies on pesticides are planned, performed, monitored, recorded, reported and audited. Studies performed under G L P are b ased o n the n at i o n al regulations of a country and are designed to assure the rel iabil ity and integrity of the studies and associated data. T he U .S. Envi ronmental Protection Agency GLP defi nition also covers f ield experiments [3] . Highest Residue - The Highest residue (HR) level (expressed as mg/kg) in a, composite sample of the edible portion of a food commodity when a pesticide has been used according to the maximum GAP conditions. The HR is estimated as the highest of the residue values (typical ly , one fr om each trial ) from supervised trials conducted according to maximum GAP conditions, and includes residue components defi ned by the Joint M eeting on Pesticide Residues (JM PR) for estimation of dietary intake. [4] I m po r t T o l e r a n c e i s a M R L set f o r to f ac i l i t ate th e importation of products to meet the needs of international trade where (a) the use of the active substance in a plant protection product on a given product is not authorised in Kenya for reasons other than public health reasons for the specifi c product and specif ic use; or (b) a dif ferent level is appropriate because the existing MRL was set for reasons other than publ ic health reasons for the specif ic product and specif ic use. L imit Of Det ect ion (LOD) The LOD is the lowest concentration of a pesticide residue or contaminant that can be identified and quantitatively measured in a specifi ed food, agricultural commodity or animal feed with an acceptable degree of certainty by a regulatory method of analysis. (Codex A limentarius, Vol . 2A ) , [4] . L IMIT OF quant it at ion (LOQ) The LOQ is the smallest concentration of the analyte that can be quantifi ed. I t is commonly def ined as the minimum concentration of analyte in the test sample that can be determined with acceptable precision (repeatabil ity) and aceuracy under the stated conditions of the test . [5] See Explanatory n o t e M anuf act ur er means a corporation or other entity in the publ ic or private sector (including an individual) engaged in the business or function (whether direetly or through an agent or entity controlled by or under contract with it) of manufacturing a pesticide active ingredient or preparing i ts formulation or product [ 1] . @ Limit of quantification’ and ‘limit of quantitation’ are used synonymously and are abbreviated to LOQ . The FAO Panel estimates the LOQ of an analytical method for residues in specif ied substrates as being the lowest level where satisf actory recoveries Kenya Subsidiary Legislation, 2024 2415 Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed and for the envisaged mode of application. [1] GooD AGRICULTURAL PRACTICE in the use of pesticides includes the officially recommended or nationally authorized uses of pesticides under ‘actual conditions necessary for effective and reliable pest control. It encompasses a range of levels of pesticide applications up to the highest authorized use, applied ina manner which leaves a residue which is the smallest amount practicable [1]. CRITICAL GOOD AGRICULTURAL PRACTICE (CGAP) is the GAP selected to represent the worst-case use scenario within the context of national, regional, or global uses that will be producing the highest possible field residues on crop commodities. It usually includes the maximum use-rate and number of applications and the minimum re treatment and pre-harvest intervals. GooD EXPERIMENTAL FIELD PRACTICE is the formalized process for designing and recording the practices used in the performance of field investigations with pesticides, and which assure the reliability and integrity of the data [3]. GooD LABORATORY PRACTICE (GLP) is the formalized process and conditions under which laboratory studies on pesticides are planned, performed, monitored, recorded, reported and audited. Studies performed under GLP are based on the national regulations of a country and are designed to assure the reliability and integrity of the studies and associated data. The U.S. Environmental Protection Agency GLP definition also covers field experiments [3]. : HIGHEST RESIDUE — The Highest residue (HR) level (expressed as mg/kg) in a, composite sample of the edible portion of a food commodity when a pesticide has been used according to the maximum GAP conditions. The HR is estimated as the highest of the residue values: (typically, one from each trial) from supervised trials conducted according to maximum GAP conditions, and includes residue components defined by the Joint Meeting on Pesticide Residues (JMPR) for estimation of dietary intake. [4] IMPORT TOLERANCE is a MRL set for to facilitate the importation of products to meet the needs of international trade where (a) the use of the active substance in a plant protection product on a given product is not authorised in Kenya for reasons other than public health reasons for the specific product and specific use; or (b) a different level is appropriate because the existing MRL was set for reasons other than public health reasons for the specific product and specific use. LIMIT OF DETECTION (LOD) The LOD is the lowest concentration of a pesticide residue or contaminant that can be identified and quantitatively measured in a specified food, agricultural commodity or animal feed with an acceptable degree of certainty by a regulatory method of analysis. (Codex Alimentarius, Vol. 2A), [4]. LIMIT OF QUANTITATION (LOQ) The LOQ is the smallest concentration of the analyte that can be quantified. It is commonly defined as the minimum concentration of analyte in the test sample that can be determined with acceptable precision (repeatability) and accuracy under the stated conditions of the test. [5] See Explanatory note MANUFACTURER means a corporation or other entity in the public or private sector (including an individual) engaged in the business or function (whether directly or through an agent or entity controlled by or under contract with it) of manufacturing a pesticide active ingredient or preparing its formulation or product [1]. il Limit of quantification’ and ‘limit of quantitation’ are used synonymously and are abbreviated to LOQ. The FAO Panel estimates the LOQ of an analytical method for residues in specified substrates as being the lowest level where satisfactory recoveries Kenya Subsidiary Legislation, 202424 16 M a j o r c r o ps see M i n o r c r o ps Codex M ax imum L imit f or Pest ic ide Residues (M RL) is the m ax i m u m concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legal ly permitted in or on food com modi ties and anim al feeds. M RL s are based on GA P data and foods der ived from commodities that comply with the respective MRLs are intended to be toxicologically acceptable. Codex M RLs, which are primarily intended to apply in international trade, are derived from estimations made by the JM PR fol lowing: (a) toxicological assessment of the pesticide and its residue; and (b) review of residue data f rom supervised trials and supervised uses including those ref lecting national good agricultural practices. Data f rom supervised trials conducted at the highest nationally recommended, authorized or registered uses are included in the review . I n o r d er to acc o m m o d ate variations in national pest control requirements, Codex M R L s tak e i n to acc o u n t th e higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices. Consideration of the various dietary residue intake est i m ates and d eter m i n at io n s b o th at t he n at i o nal and international level in comparison with the ADI , should indicate that foods complying w i t h C o d ex M R L s are saf e f o r human consumption. [6] The M ax imum Residue Lev el is estimated by the JM PR as t he m ax i m u m concentration of residues (expressed as mg/kg) which may occur in a food or feed commodity following Good Agricultural Practices. The est i m ated m ax i m u m r esi d ue l ev e l is considefe'd by the JMPR to be'suitable for establishing Codex M RL s.[4] M inor Cr ops are crops for which a use of a pesticide o r c o n st i t uen t w o u l d no t produce sufficient economic return to an applicant for registration of the pesticide to meet the cost of registration of the product . [7] . M aj or crops would general ly be the converse of minor crops. PESTICIDE Residue means any specif ied substance in food, agricultural commodities, or animal feed resulting f rom the use of a pesticide. The term includes any deri vatives of a pesticide, such a conversion products, metabol i tes, reacti on products, and impurities considered to be of toxicological signif icance. [6] Pr e Har v est Int er va l (PHI) is the time interval in days between the last appl ication of a pesticide to a crop and harvest to m eet t he re lev an t m ax i m um r esid u e l imits for a particular crop. [3] Pr oduct (or pesticide product) means the formulated product (pesticide active ingredient(s) and co- formulants), in the form in which it is packaged and sold. [ 1] r Post Har v est Treatment refers to a pesticide application to the harvested crop, which may occur before or during storage. Raw Agr icul t ur al Commodit y (RAC) means the product in or nearly in its natural state intended for sale or consumption without further processing, or for processing into food for sale to the consumer . I t includes i rradiated primary food commodities and products after removal of certain parts of the plant or parts of animal tissue. The term “ raw agricultural commodity (RAC)” means the same as "primary food commodity” . [4] Responsibl e Aut hor it y : M eans the government agency or agencies responsible for regulating pesticides and more general ly for implementing pesticide legislation [ 1] . 2416 Kenya Subsidiary Legislation, 2024 MAJOR CROPS SEE MINOR CROPS CODEX MAXIMUM LIMIT FOR PESTICIDE RESIDUES (MRL) is the’ maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. MRLs are based on GAP data and foods derived from commodities that comply with the respective MRLs afe intended to be toxicologically acceptable. Codex MRLs, which are primarily intended to apply in international trade, are derived from estimations made by the JMPR following: " (a) toxicological assessment of the pesticide and its residue; and (b) review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices. Data from supervised trials conducted at the highest nationally recommended, authorized or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices. Consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI, should indicate that foods complying with Codex MRLs are safe for human consumption. [6] The MAXIMUM RESIDUE LEVEL is estimated by the JMPR as the maximum concentration of residues (expressed as mg/kg) which may occur in a food or feed commodity following Good Agricultural Practices. The estimated maximum residue level is considéréd by the JMPR to bé’suitable for establishing Codex MRLs.[4] MINOR Crops are crops for which a use of a pesticide or constituent would not produce sufficient economic return to an applicant for registration of the pesticide to meet the cost of registration of the product. [7]. Major crops would generally be the converse of minor crops. PESTICIDE RESIDUE means any specified substance in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such a conversion products, metabolites, reaction products, and impurities considered to be of toxicological significance. [6] PRE HARVEST INTERVAL (PHI) is the time interval in days between the last application of a pesticide to a crop and harvest to meet the relevant maximum residue limits for a particular crop. [3] PRODUCT (or pesticide product) means the formulated product (pesticide active ingredient(s) and co- formulants), in the form in which it is packaged and sold. [1] cai + POST HARVEST Treatment refers to a pesticide application to the harvested crop, which may occur before or during storage. RAW AGRICULTURAL COMMODITY (RAC) means the product in or nearly in its natural state intended for sale or consumption without further processing, or for processing into food for sale to the consumer. It includes irradiated primary food commodities and products after removal of certain parts of the plant or parts of animal tissue. The term “raw agricultural commodity (RAC)” means the same as "primary food commodity”. [4] RESPONSIBLE AUTHORITY: Means the government agency or agencies responsible for regulating pesticides and more generally for implementing pesticide legislation [1]. t Kenya Subsidiary Legislation, 2024 24 17 Responsible authority also refers to the regulatory authority responsible for the registration of pesticides Repr esent at ive Commodit ies are those designated commodities f r o m w h i ch extrapolations of residue levels and resulting MRLs c an b e m ade to o ne o r m o re r e l ated commodities or to an entire group of commodities (‘crops’). Sampl e is a def ined representative amount of individual raw agricultural commodity unit(s) (e.g. specif ic number of f ruits or tubers, a set +weight of grain, etc.) randomly selected from a plot which may be composited for pesticide analysis. Seed t r eat ment application is made to the seeds of crops prior to planting or sowing, which may occur at a seed treatment facility or in the f ield immediately prior to planting or sowing. [2] Super v ised Fiel d Tr ial s are r esid ue fi el d t r i al s c o n d uc ted o n crops, typical ly according to the principles of Good Laboratory Practice (GLP) , in order to assess the magnitude of the residues under the conditions o f t he c r i t i c al G o o d Agricultural Practice(cGAP) . Super v ised Tr ial s M edian Residue (STM R) is the expected resi d u e l ev el (expressed as mg/kg) in the edible portion of a food commodity when a pesticide has been used according to Maximum Good Agricultural Practice co nd i t io n s . T h e ST M R i s estimated as the median of the residue values (one f rom each trial) f rom supervised trials conducted according to maximum Good A gricultural Practice conditions [8] . Test Subst ance is the product or formulation .used in a crop f ield, .tri al for the purpose of generating residue data for a specif ic crop or commodity [4] . 2 . G en e r a l P r o v i s i o n s ;. o ,' The Board w il l ensure that all new pest control products or new uses of existing pest control products are subj ected to supervised residue fi e l d t r i al s w h ere t he JM PR d ata or such data is unavailable from another region before they are authorized for use or where new information from exposure assessment is received that may require a change in the use pattern. 2.1 The manufacturer shal l prepare the study protocol f o r sub m i ssi o n to t h e responsible authority for approval . Upon approval , the study protocol shall be submitted to the authorized testing institution to conduct the supervised residue fi eld trials. .' •'j i b -a j QPr 2.2 The testing institution shal l conduct the supervised resi d ue fi e l d t r i al s " i n accordance with the provisions laid out in the study protocol and in general accordance with provisions of GLP. 2.3 Samples of the test substance must be provided by the manufacturer to the testing institution upon approval by the responsible authority for pesticides. 2.4 A ll trials must be authorized by PCPB . I t is recommended that the responsible authority l iaise closely with the trial scientist/testing institution and the appl icant throughout the trial period. 2.5 Field residue trials and l aboratory analysis must be carried out by institutions that are off icially recognized by the PCPB . In case there is absence of recognized laboratory , the PCPB shall recommend to accredited reference laboratory . Kenya Subsidiary Legislation, 2024 2417 Responsible authority also refers to the regulatory authority responsible for the registration of pesticides REPRESENTATIVE COMMODITIES are those designated commodities from which extrapolations of residue levels and resulting MRLs can be made to one or more related commodities or to an entire group of commodities (‘crops’). SAMPLE is a defined representative amount of individual raw agricultural commodity unit(s) (e.g. specific number of fruits or tubers, a set +weight of grain, etc.) randomly selected from a plot which may be composited for pesticide analysis. SEED TREATMENT application is made to the seeds of crops prior to planting or sowing, which may occur at a seed treatment facility or in the field immediately prior to planting or sowing. [2] SUPERVISED FIELD TRIALS are residue field trials conducted on crops, typically according to the principles of Good Laboratory Practice (GLP), in order to assess the magnitude of the residues under the conditions of the critical Good Agricultural Practice(cGAP). SUPERVISED TRIALS MEDIAN RESIDUE (STMR) is the expected residue level (expressed as mg/kg) in the edible portion of a food commodity when a pesticide has been used according to Maximum Good Agricultural Practice conditions. The STMR is estimated as the median of the residue values (one from each trial) from supervised trials conducted according to maximum Good Agricultural Practice conditions [8]. TEST SUBSTANCE is the product or formulation used in a crop field,; trial for the purpose of generating residue data for a specific crop or ‘commodity [4]. ao 2. GENERAL PROVISIONS The Board will ensure that all new pest control products or new uses of existing pest control products are subjected to supervised residue field trials where the JMPR data or such data is unavailable from another region before they are authorized for use or where new information from exposure assessment is received that may require a change in the use pattern. 2.1 The manufacturer shall prepare the study protocol for submission to the responsible authority for approval. Upon approval, the study protocol shall be submitted to the authorized testing institution to: conduct the supervised residue field trials. .4 mpiboiant 2.2 The testing institution shall conduct the supervised residue field trials in accordance with the provisions laid out in the study protocol and in general accordance with provisions of GLP. 2.3 Samples of the test substance must be provided by the manufacturer to the testing institution upon approval by the responsible authority for pesticides. 2.4 All trials must be authorized by PCPB. It is recommended that the responsible authority liaise closely with the trial scientist/testing institution and the. applicant throughout the trial period. , 2.5 Field residue trials and laboratory analysis must be carried out by institutions that are officially recognized by the PCPB. In case there is absence of recognized laboratory, the PCPB shall recommend to accredited reference laboratory. Kenya Subsidiary Legislation, 202424 18 2.6 The report shall be submitted in hard and soft copies to PCPB 3 Resid u e T r ia l Req u ir emen t s In designing a residue trial , early consideration must be given to the intended use of the residue data to be obtained and to the sampl ing programme and analytical work that this entails. The trials should ref lect the proposed use with respect to the rate and mode of application, number and timing of applications, and formulations proposed. 3.1 Design of residue tr ials Trials should be designed to cover a range of representative f ield conditions, typical periods of the year, cropping and farming practices which are commonly encountered. If data are sought to support establishment of a maximum residue l im it , resul ts f rom a number of tri als in several geographical areas or during typical periods of the year and farming practices are required. When a product is applied to a crop near maturity , studies on residue disappearance whh time are usual ly needed to determine acceptable pre harvest intervals. Such considerations markedly inf luence the location of the test plots. The size and number of samples that must be t^ en from each plot determines the size of the experimental plots. Since climatic conditions may have an important inf luence on the persistence and performance of a chemical , trials shall be carried out in those areas where the product is to be f inally used. 3.1.1 Zoning The FAOAVHO Joint M eeting on Pesticide Residues agreed w i th the co nc l u si o n that the impact of climatic zones on pesticide residues is small , and residue data derived f rom simi lar use patterns and growing conditions may be compared regardless of the of the geographical location of the trials [9] . 3 .12 Selection of si tes Trials should be carr ied out in maj or areas of cultivation or production and should be sited to cover the range of relevant representative conditions including dif ferent bioclimatic regions, seasons of production, soil characteristics, cropping system, farming practices, cultivars etc.) likely to be met for, the intended use of the pesticide. 3.1.3 Number of sites and rep l ication The number of sites needed depends upon the range of condi tions to be covered , the uniformity of crops, variation in agricultural .practices, and the data already available. Since the variations in residue levels between repl icates at i nd i v i d u al si tes are sm al l compared with those found in data from ;different sites, it is usual ly not necessary to repl icate treatments at individual sites [ 10] . A s a general rule, a minimum of f ive trials (for maj or crops) or a minimum of four trials (for minor crops) are required. The trials sites should be at least thirty f ive (35) kilometres apart to be deemed independent . 3 .1 .4 P l o ts Residue data should not be generated from plots which are to o sm al l t o b e representative. The size of the individual plots will vary from crop to crop but should be large enough generally at least 10 m̂ for row crops and typically four trees or eight vines for orchard and vineyard crops respectively ; in order: (i) to apply the pesticide in an accurate and realistic manner , preferably under the same conditions as in normal local commercial/production practice; and (i i) to provide representative crop samples. 2418 Kenya Subsidiary Legislation, 2024 2.6 The report shall be submitted in hard and soft copies to PCPB 3. RESIDUE TRIAL REQUIREMENTS In designing a residue trial, early consideration must be given to the intended use of the residue data to be obtained and to the sampling programme and analytical work that this entails. The trials should reflect the proposed use with respect to the rate and mode of application, number and timing of applications, and formulations proposed. 3.1 Design of residue trials Trials should be designed to cover a range of representative field conditions, typical periods of the year, cropping and farming practices which are commonly encountered. If data are sought to support establishment of a maximum residue limit, results from a number of trials in several geographical areas or during typical periods of the year and farming practices are required. When a product is applied to a crop near maturity, studies on residue disappearance with time are usually needed to determine acceptable pre harvest intervals. Such considerations markedly influence the location of the test plots. The size and number of samples that must be taken from each plot determines the size of the experimental plots. Since climatic conditions may have an important influence on the persistence and performance of a chemical, trials shall be carried out in those areas where the product is to be finally used. 3.1.1 Zoning The FAO/WHO Joint Meeting on Pesticide Residues agreed with the conclusion that the impact of climatic zones on pesticide residues is small, and residue data derived from similar use patterns and growing conditions may be compared regardless of the of the geographical location of the trials [9]. 3.1.2 Selection of sites Trials should be carried out in major areas of cultivation or production and should be sited to cover the range of relevant representative conditions including different bioclimatic regions, seasons of production, soil characteristics, cropping system, farming practices, cultivars etc.) likely to be met for, the intended use of the pesticide. 3.1.3. Number of sites and replication The number of sites needed depends upon the range of conditions to be covered, the uniformity of crops, variation in agricultural practices, and the data already available. Since the variations in residue levels between replicates at individual sites are small compared with those found in data from .different sites, it is usually not necessary to replicate treatments at individual sites [10]. As a general rule, a minimum of five trials (for major crops) or a minimum of four trials (for minor crops) are required. The trials sites should be at least thirty five (35) kilometres apart to be deemed independent. 3.14 Plots Residue data should not be generated from plots which are too small to be representative. The size of the individual plots will vary from crop to crop but should be large enough generally at least 10 m? for row crops and typically four trees or eight vines for orchard and vineyard crops respectively; in order: (i) to apply the pesticide in an accurate and realistic manner, preferably under the same conditions as in normal local commercial/production practice; and (ii) to provide representative crop samples. Kenya Subsidiary Legislation, 2024 24 19 A control plot for the supply of untreated samples is necessary to provide the analyst with a sample known to be f ree f rom residues of the pesticide under investigation. Where treated and control plots are in close proximity, m easu res sho u ld be t ak en to av o id contamination (e.g., covering or shielding crop if necessary) . It is also important to ensure that plots are adequately buffered or separated. T here i s no m i n i m u m d i stance between plots which ensures adequate buffering, however prevail ing wind, slope and distance between plots should all be considered prior to designing the f ield trial . Control samples are needed: (i) to ascertain that no artefact in the crop derived f r o m l o c al c o nd i t io ns co u ld give rise to interference in the analysis; (ii) to establish the recovery level of the pesticide from the crop or soi l by the analytical method; (i ii) in the case of a new crop or pesticide, to investigate the storage stabi lity of any resi d ue . The control plot should be large enough to satisfy these requirements and should be located close enough to secure identical growing and c l i m at ic co nd i t i o n s . Specific trial protocols (procedures) shall be prepared for specif ic pesticide / crop combinations based on the type of trials to be conducted. 5.7.5 Crop Var iety/Culti vars The type or variety of crop and the way in whic:|i ĵ t is grown may infl ôence the residue pattern. Data should be generated on the most copanionly used type qnyâ .iety and on the factor or combination of factors most l ikely to result in,the highest r̂ jiidue levels. If more than one variety of crops is commonly grown, then more than one variety should b e used i n t he tr i al s . 5.7.6 Number and Timing of Applications and additional pesticides' T he number of treatments and the i ntervals between appl ications should ref lect the latest and maximum use of the product to be recommended. No pesticide in addition to those to be analyzed should be appl ied to the control or experimental plots before or during the trial period. However , since it is of primary importance that both the untreated and treated plants be healthy , the use of other pesticides may be necessary. In this case only those pesticides that will not interfereowith, the analysis of the residues of the test compound may be u sed . 5.7.7 Number of seasons Residue data from only one season are considered sufficient provided that crop f ield trials are located in the typical crop production areas such that a variety of cl imatic conditions is taken into account. However, if a particular crop is mainly produced commercially in one geographic local ity/ climatic area, t hen tr i al si tes sho u ld be si t uated at least thirty f ive (35) kilometres apart. If this is not possible, trials should be separated by time e.g. done over a minimum of two seasons. . 3.J .8 Application rates Supervised residue f ield trials should be carried out according to the typical commercial practice(s) in regar(5 spray volume ensuring that the range of volumes utilized is captured. For all applications, the application rate should be expressed in terms of amount of product and/or active ingredient per unit area (e.g., kg a.i . per hectare or per ' sailqs t Kenya Subsidiary Legislation, 2024 2419 A control plot for the supply of untreated samples is necessary to provide the analyst with a sample known to be free from residues of the pesticide under investigation. Where treated and control plots are in close proximity, measures should be taken to avoid contamination (e.g., covering or shielding crop if necessary). It is also important to ensure that plots are adequately buffered or separated. There is no minimum distance between plots which ensures adequate buffering, however prevailing wind, slope and distance between plots should all be considered prior to designing the field trial. Control samples are needed: (i) to ascertain that no artefact in the crop derived from local conditions could give rise to interference in the analysis; (il) to establish the recovery level of the pesticide from the crop or soil by the analytica] method; (iii) in the case of a new crop or pesticide, to investigate the storage stability of any residue. The control plot should be large enough to satisfy these requirements and should be located close enough to secure identical growing and climatic conditions. Specific trial protocols (procedures) shall be prepared for specific pesticide / crop combinations based on the type of trials to be conducted. 3.1.5 Crop Variety/Cultivars The type or variety of crop and the way in which, jt is grown may influence the residue pattern. Data should be generated on the most commonly: used type ¢ or, ‘Variety and on the factor or combination of factors most likely to result inthe highest residue levels. If more than one variety of crops is commonly grown, then more than one variety should be used in the trials. 3.1.6 Number and Timing of Applications and additional pesticides’ . The number of treatments and the intervals between applications should reflect the: latest and maximum use of the product to be recommended. No pesticide in addition to those to be analyzed should be applied to the control or experimental plots before or during the trial period. However, since it is of primary importance that both the untreated and treated plants be=healthy, the use of other pesticides may be necessary. In this case only those pesticides that will not interfere.with, the analysis of the residues of the test compound may be used. seq MOS 3.1.7 Number of seasons “soilqas Residue data from only one season are considered sufficient provided that crop field trials are located in the typical crop production areas such that a variety of climatic conditions is taken into account. However, if a particular crop is mainly produced commercially in one geographic locality/ climatic area, then trial sites should be situated at Jeast thirty five (35) kilometres apart. If this is not possible, trials should be separated by time e.g. done over a minimum of two seasons. os 3.1.8 Application rates af Supervised residue field trials should be carried out according to the typical commercial practice(s) in regard to, spray volume ensuring that the range of volumes utilized is captured. For all applications, the application rate should be expressed in terms of amount of product and/or active ingredient per unit area (e.g., kg a.i. per hectare or per Kenya Subsidiary Legislation, 202424 2 0 acre) and where appropriate, the concentration (e.g., kg a.i . / l OO l iters or) at which it is applied. Due consideration should be made for foliar appl ication of “ tal l” crops, (e.g., orchard and vine crops, greenhouse tomatoes), where f lat boom spraying is not common practice and (air assisted) mist blowing equipment is of ten used. Spray concentration and spray volume should be considered and reported when conducting SRFT . Appl ication rates for seed and seedling treatments are expressed as concentration per unit of seed weight or seedling rate. For dip or drench of fruit, concentration of the active ingredient in solution should be recorded ((e.g., kg a.i . / l OO l iters) as wel l as the amount of f ruit treated per volume and contact t ime in seconds. Where dips are replenished to maintain the active ingredient concentration during treatment (i .e., where residue stripping occurs), the additional ‘top up’ treatments should also be recorded. The application rate for gases and aerosols used in fumigation should be expressed as amount per unit volume of treated bulk good. The maximum label rate or maximum proposed label rate of the active ingredient (according to the cGAP) should be used when applying the test substance for crop f ield tr ials. The maximum number of applications and minimum r e -t r eat ra en t i n ter v al f o r u se of the test substance under evaluat ion should ref lect the cGAP. It is important to indicate the types of crop varieties included in a trial in order to evaluate an appropriate range of pre- (PHIs) (e.g., shorter and longer intervals from planting to maturity in the case of pre emergence application to an annual crop). Basically in all trials both the growth stage at application (preferably as BBCH code) and PHI should be r ec o r ded . 3 .1.9 Equipment and Mode of appl ication.■ Applications should preferably be made with equipment si m i l ar to t hat u sed i n normal commercial practice for appl icat ion to that crop. Other forms of applicators may be used, provided the deposition and coverage achieved are s i m i l ar to w h at w o u ld o cc u r in normal practice. Consideration should also be given to selection of appropriate nozzles in crop f ield trials. Ensure that the appl icat ion is appropriate to the anticipated use of the pesticide, as indicated in the product label . Care sho u ld be tak en to av o id co n tam i n at io n of neighbouring plots. 3 .1.10 Equipment calibration Before application of the test substance, the application equipment must be cal ibrated for the intended del ivery , such as discharge and appl icat ion speed calibration. To ensure correct usage rates and uniformity of applicat ion the operation should be carried out under the supervision of qual if ied personnel . 3 .2 Other general considerations: O ther co n sid er at io n s t o t ak e i nto acc o un t inc l ude : (a) Adequate separation between plots should be provided t o av o i d c o n tam i nat io n especial ly during sampl ing, (b) Adequate buffering should be provided between plots, how ever , si tes at f ield edges, or near ditches, trees, hedges or other obstacles should be avo ided , as they are subj ect to interfering “ edge’’ effects f rom t ho se o b st ac l es , (c) Selection of crop variety should be taken into ac co u n t t o en su re th at v ar iet ies of commercial importance, size variation and t ime of maturity of the varieties. The tests should be carried out in plots with the same edaphic homogeneity . i 72420 Kenva Subsidiary Legislation, 2024 acre) and where appropriate, the concentration (e.g., kg a.i. /100 liters or) at which it is applied. Due consideration should be made for foliar application of “tall” crops, (e.g., orchard and vine crops, greenhouse tomatoes), where flat boom spraying is not common practice and (air assisted) mist blowing equipment is often used. Spray concentration and spray volume should be considered and reported when conducting SRFT. Application rates for seed and seedling treatments are expressed as concentration per unit of seed weight or seedling rate. For dip or drench of fruit, concentration of the active ingredient in solution should be recorded ((e.g., kg a.t. /100 liters) as well as the amount of fruit treated per volume and contact time in seconds. Where dips are replenished to maintain the active ingredient concentration during treatment (i.e., where residue stripping occurs), the additional “top up’ treatments should also be recorded. The application rate for gases and aerosols used in fumigation should be expressed as amount per unit volume of treated bulk good. The maximum label rate or maximum proposed label rate of the active ingredient (according to the cGAP) should be used when applying the test substance for crop field trials. The maximum number of applications and minimum re-treatment interval for use of the test substance under evaluation should reflect the cGAP. It is important to indicate the types of crop varieties included in a trial in order to evaluate an appropriate range of pre- (PHIs) (e.g., shorter and longer intervals from planting to maturity in the case of pre emergence application to an annual crop). Basically in all trials both the growth stage at application (preferably as BBCH code) and PH] should be recorded. 3.1.9 Equipment and Mode of application: Applications should preferably be made with equipment similar to that used in normal commercial practice for application to that crop. Other forms of applicators may be used, provided the deposition and coverage achieved are similar to what would occur in normal practice. Consideration should also be given to selection of appropriate nozzles in crop field trials. Ensure that the application is appropriate to the anticipated use of the pesticide, as indicated in the product label. Care should be taken to avoid contamination of neighbouring plots. 3.1.40 Equipment calibration Before application of the test substance, the application equipment must be calibrated for the intended delivery, such as discharge and application speed calibration. To ensure correct usage rates and uniformity of application the operation should be carried out under the supervision of qualified personnel. 3.2 Other general considerations: Other considerations to take into account include: (a) Adequate separation between plots should be provided to avoid contamination especially during sampling. (b) Adequate buffering should be provided between plots, however, sites at field edges, or near ditches, trees, hedges or other obstacles should be avoided, as they are subject to interfering “edge” effects from those obstacles. (c) Selection of crop variety should be taken into account to ensure that varieties of commercial importance, size variation and time of maturity of the varieties. The tests should be carried out in plots with the same edaphic homogeneity. s o 24 2 1Kenya Subsidiary Legislation, 2024 Crop protection measures in the trial plot should be chosen in such a way that they do not affect or interfere with the residue analysis of the pesticide and m etab o l i tes u nder t r i a l Soil types should be reported in all f ield sites. Trials can be conducted under complete protected conditions; the type of protection should be stated in the planning of the t r i a l . Appropriate care should be made to minimize drift especially i n to w ate r b o d ies suc h as l ak es and r i v er s . (d) (e) (f ) (g) 3 .3 D ec l i n e stud i es : Residue decline data are necessary for uses where the pesticide is appl ied when the edible portion of the crop has formed or it is expected that residues may occur on the food or feed commodities at , or close to, the earl iest harvest t ime. Residue decl ine data are used in residue evaluation for purposes such as: (a) Determining if residues are higher at longer PHIs than requested; (b) Estimating the half -life of the residues; (c) Determining whether alteration of the PHI to levels represented in the decline tr ial s around the GA P PH I af f ects the residue level s; (d) Allowing for a degree of interpolation to support use patterns, including PHIs, not directly equivalent to those used in the trials on a case-by-case basis; (e) Determining the profile of the residue over time to add to the understanding of metabolism of the pesticide under conditions more applicable to GAP and to assist in appropri ate selection of residue definitions; and (f) Determining the time interval to reach maximum residues for a systemic compound applied to crops such as potatoes or peanuts. W hen residue decline data are necessary , up to 50% o f t he resi d ue t r ial s sh o u ld b e decl i ne stud ies to demonstrate the behav ior of the active ingredient and relevant m etabo l i tes c l o se to h ar v est . \ When decline data is generated, sampling of more than one commodity or matrix be needed . T his w i l l be the case w henever d if ferent co m m od i t i es are u sedp er c r op m ay food or feed at different growth stages of the crop (e.g., cereal forage, cereal fodder, cereal grain and straw) . This wil l resul t in two or more sets of sampling dates witMti iOne r esid ue d ec l i ne t r i al . a s The design of residue decline .studies should include 3 to 5 sampl ing interval s in addition to the target PHI (if practical , include 0-day sampl ing) . These sampling intervals should be spaced somewhat equally and, where possible, sarripling should occur at shorter and longer time points relative to the target PHI , when such is permitted by the indow of commercial maturity. When multiple applications are involved, a sampl ing point immediately prior to the final application is desi rable to determ ine the contr ibut ion of earlier applications and the effect on residual h a lf - l i f e 3 .4 N u mber o f Cr o p Fiel d T r ia l s In the Kenya, trials should be conducted to represent the typical growing areas of crops. The number of crop field trials conducted at the cr it ical G A P should be in l i ne w ith international provision taking into account the following: w Kenya Subsidiary Legislation, 2024 2421 (d) Crop protection measures in the trial plot should be chosen in such a way that they do not affect or interfere with the residue analysis of the pesticide and metabolites under trial (e) Soil types should be reported in all field sites. (f) Trials can be conducted under complete protected conditions; the type of protection should be stated in the planning of the trial. (g) Appropriate care should be made to minimize drift especially into water bodies such as lakes and rivers. 3.3 Decline studies: Residue decline data are necessary for uses where the pesticide is applied when the edible portion of the crop has formed or it is expected that residues may occur on the food or feed commodities at, or close to, the earliest harvest time. Residue decline data are used in residue evaluation for purposes such as: (a) Determining if residues are higher at longer PHIs than requested; (b) Estimating the half-life of the residues; (c) Determining whether alteration of the PHI to levels represented in the decline trials around the GAP PHI affects the residue levels; (d) Allowing for a degree of interpolation to support use patterns, including PHIs, not directly equivalent to those used in the trials on a case-by-case basis; (e) Determining the profile of the residue over time to add to the understanding of metabolism of the pesticide under conditions more applicable to GAP and to assist in appropriate selection of residue definitions; and (f) Determining the time interval to reach maximum residues for a systemic compound applied to crops such as potatoes or peanuts. When residue decline data are necessary, up to 50% of the residue trials should be decline studies to demonstrate the behavior of the active ingredient and relevant metabolites close to harvest. When decline data is generated, sampling of more than one commodity or matrix per crop may be needed. This will be the case whenever different commodities are used as food or feed at different growth stages of the crop (e.g., cereal forage, cereal fodder, cereal grain and straw). This will result in two or more sets of sampling dates within one residue decline trial. The design of residue decline studies should include 3 to 5 sampling intervals in addition to the target PHI (if practical, include 0-day sampling). These sampling intervals should be spaced somewhat equally and, where possible, sampling should occur at shorter and longer time points relative to the target PHI, when such is permitted by the window of commercial maturity. When multiple applications are involved, a sampling point immediately prior to the final application is desirable to determine the contribution of earlier applications and the effect on residual half-life 3.4 NUMBER OF CROP FIELD TRIALS In the Kenya, trials should be conducted to represent the typical growing areas of crops. The number of crop field trials conducted at the critical GAP should be in line with international provision taking into account the following: Kenya Subsidiary Legislation, 202424 2 2 (a) Crop production regions, often defined or identif ied by the crop production practices (e.g., irrigation - beneath crop canopy vs. overhead sprinkler; planting densities of fruit trees) and the soils and cl imatic properties of the region, (b) Significance of the crop in the country of production, most often determined by the production area (acres or hectares) or production quantity (tons) , (c) The importance of the crop in the national diet. A minor use crop may be defi ned as a crop that is grown o n a sm al l ar ea and therefore uses amounts of pesticides that are too small to j ustify standard pesticide registration. A crop may be considered a minor crop based on the description provided in the Guidance to f aci l i tate the establ ishment of M RL s for pesticides for minor crops [10] . For major crops in Kenya, the minimum total number of trials in a complete (comprehensive) submission is eight but ideally at least f if teen ( 15) . A complete (comprehensive) data set in the context of the Crop Field Trials Test Guideline is the number of supervised fi eld trials matching the critical GAP (cGAP) which are required for setting an appropriate MRL and/or obtaining a new registration or new use (i .e. plant protection product in/on a crop). A red u ced d ata set o n the o the r h and refers to a reduced number of supervised fi eld trials matching the cGAP which may be adequate to obtain a new or amended registration and/or M RL for a plant protection product in/on a specific crop. A reduced data set may be suff icient when conducting trials in cases where no residues are anticipated at or above the limit of quantitation. To qualify for this comprehensive submission approach, all crop f ield trials should meet the following criteria': (i) Field trials are conducted according to the (cGAP) (w i thin ± 25% of the application rate, number of applications or PHI). At l east 50 % o f t he tr i a l s should be conducted at or above, but within 25% of th e cG A P . T r i al s w ho se intended application rates match the cGAP but actual rates fal l up to 10% below the cGAP (e.g., due to the normal variability in preparing spray solutions) are considered acceptable. In addition, at least 50% of the tr i al s need to be decl i ne studies, (ii ) The trials span a range of representative crop production practices for each crop includingothose likely to lead to the highest residues (e.g., irrigated vs. non-irrigated, trel lis vs. non-trel lis production, fal l-planted vs. spring-planted, etc .) . For minor crops Kenya shall adopt the decision from the 47"'Session of the CCPR w hich decided that the m inim um num ber of f our and f i ve independent supervised f ield trials would be conducted, reflecting the respective good agricultural practice for Category 2 and 3 respectively [11]. For minor crops in Category 1, fewer trials (four) may be acceptable on a case by case basis. Crops would be assigned to the Categories defi ned using the methodology described in the guidance d o c u m en t . 3.4.?l nRequirements for independent supervised residue t r i a l s ‘ jThe following trial conditions are usually recorded and ar e tak en i n to c o n si d er at i o n in defihihg'an independent supervised residue trial : (a) Geographical location and site - trialSnatcdifferent geographic locations are j -j V'l l Oi L :. considered independent; 2422 Kenya Subsidiary Legislation, 2024 (a) Crop production regions, often defined or identified by the crop production practices (e.g., irrigation - beneath crop canopy vs. overhead sprinkler; planting densities of fruit trees) and the soils and climatic properties of the region. (b) Significance of the crop in the country of production, most often determined by the production area (acres or hectares) or production quantity(tons). (c) The importance of the crop in the national diet. A minor use crop may be defined as a crop that is grown on a small area and therefore uses amounts of pesticides that are too small to justify standard pesticide registration. A crop may be considered a minor crop based on the description provided in the Guidance to facilitate the establishment of MRLs for pesticides for minor crops [10]. For major crops in Kenya, the minimum total number of trials in a complete (comprehensive) submission is eight but ideally at least fifteen (15). A complete (comprehensive) data set in the context of the Crop Field Trials Test Guideline is the number of supervised field trials matching the critical GAP (CGAP) which are required for setting an appropriate MRL and/or obtaining a new registration or new use (i.e. plant protection product in/on a crop). A reduced data set on the other hand refers to a reduced number of supervised field trials matching the cGAP which may be adequate to obtain a new or amended registration and/or MRL for a plant protection product in/on a specific crop. A reduced data set may be sufficient when conducting trials in cases where no residues are anticipated at or above the limit of quantitation. To qualify for this comiptéhensive submission approach, all crop field trials should meet the following criteria': (i) Field trials are conducted according to the (cGAP) (within + 25% of the application rate, number of applications or PHI). At least 50% of the trials should be conducted at or above, but within 25% of the cGAP. Trials whose intended application rates match the cGAP but actual rates fall up to 10% below the cGAP (e.g., due to the normal variability in preparing spray solutions) are considered acceptable. In addition, at least 50% of the trials need to be decline studies. (ii) The trials span a range of representative crop production practices for each crop includingsthose likely to lead to the highest residues (e.g., irrigated Vs. Oi be non-irrigated, trellis vs. non-trellis production, fall- “Planted vs. spring-planted, etc.). For minor crops Kenya shall adopt the decision from the 47"Session of the CCPR which decided that the minimum number of four and five independent supervised field trials would be conducted, reflecting the respective good agricultural practice for Category 2 and 3 respectively [11]. For minor crops in Category 1, fewer trials (four) may be acceptable on a case by case basis. Crops would be assigned to the Categories defined using the methodology described in the guidance document. 3 As lnRequirements for independent supervised residue trials h ‘Following trial conditions are usually recorded and are taken into consideration in defining an independent supervised residue trial: (a) Geographical location and site — trialsxatcdifferent geographic locations are considered independent; yi 24 2 3Kenya Subsidiary Legislation, 2024 (b) Dates of planting (annual crops) and treatments - trials involving dif ferent planting dates or treatment dates (> 30 days apart) are considered independent; (c) Formulations - comparability or independence of t r i al s w i t h d i f f er en t f orm ulations should to be assessed; (d) Types of treatment, e.g., foliar, seed treatment, directed appl ication - dif ferent types of treatment on different plots at the same site are considered as separate tr i als; (e) Addition of surfactants - a trial with the addition of surfactant may constitute suff icient difference to be treated as independent , provided the relevant label does not prescribe the use of adjuvant; (f) Application rates and spray concentrations - trials co n d uc ted at th e sam e location with signif icantly different application rates and spray concentrations are not independent; the principle of proportionality may be appl ied to select the tri al which leads to the highest residues; (g) Crop varieties - different varieties at a single site may not be ‘independent’ ; some varieties may be sufficiently different (different morphology etc.) to inf luence the residue; (h) Treatment operations - trials at the same site treated in the same spray operation are not counted as separate trials; (i) Application equipment - trials at the same site treated by dif ferent equipment , other things being equal, are not counted as se|),̂ ate t r i al s . 4 Test Subst ance ‘ i !" ' The test substance(s) (pesticide) should be stored under appropriate conditions for the study duration and applied soon after preparation or mixing. If residue data is generated for a single active ingredient, there are no additional data requirements for tank mix, pre-mix or other types of combinations with other active ingredients as long as there is no evidence of synergism associated with the combination(s) and as long as the cGAP for the active ingredient is not exceeded with any of the combinations. Active ingredients may be applied in combination (i .e., tank mix , pre-mix or sequential) in crop field trials to a single treated plot as long as there is clear analytical separation (i.e., no analytical interference) of active ingredients and any relevant metabolites. A single sample may then be collected from the treated plot and prepared for residue analysis for two or more active ingredients. 4 .1 F o r m u l a t i o ns Iw ' The formulation tested in crop f ield trials should be as close as possible to the intended enduse product for the crop or commodity. The requirements in this guideline in regard to a complete data set (the number of crop field trials matching the cGAP which are required) are generally based upon only one formulation type being requested for use on a specif ic crop. The decision will be based upon how sim i lar the f orm ulations are in composition and physical form, the mode of application, and the - timing of the application. Controlled release formulations (e.g., certain microencapsulated products) normally require a complete data set tailored to that particular use. Granules (GR) and ■ dusts (DP) are the most common examples of the latter. Granular formulations appl ied intact will generally require a îcomplete data set regardless of what data are already available for other formulation types. . ,0 o T ■l o t Kenya Subsidiary Legislation, 2024 2423 (b) Dates of planting (annual crops) and treatments - trials involving different planting dates or treatment dates (> 30 days apart) are considered independent, (c) Formulations — comparability or independence of trials with different formulations should to be assessed; (d) Types of treatment, e.g., foliar, seed treatment, directed application — different types of treatment on different plots at the same site are considered as separate trials; (e) Addition of surfactants — a trial with the addition of surfactant may constitute sufficient difference to be treated as independent, provided the relevant label does not prescribe the use of adjuvant; (f) Application rates and spray concentrations — trials conducted at the same location with significantly different application rates and spray concentrations are not independent; the principle of proportionality may be applied to select the trial which leads to the highest residues; (g) Crop varieties — different varieties at a single site may not be ‘independent’; some varieties may be sufficiently different (different morphology etc.) to influence the residue; (h) Treatment operations — trials at the same site treated in the same spray operation are not counted as separate trials; (i) Application equipment — trials at the same site treated by different equipment, other things being equal, are not counted as separate trials. ap oT 4 TEST SUBSTANCE ‘peat Sabot The test substance(s) (pesticide) should be stored under appropriate conditions for the study duration and applied soon after preparation or mixing. If residue data is generated for a single active ingredient, there are no additional data requirements for tank mix, pre-mix or other types of combinations with other active ingredients as long as there is no evidence of synergism associated with the combination(s) and as long as the cGAP for the active ingredient is not exceeded with any of the combinations. Active ingredients may be applied in combination (i.e., tank mix, pre-mix or sequential) in crop field trials to a single treated plot as long as there is clear analytical separation (i., no analytical interference) of active ingtedients and any relevant metabolites. A single sample may then be collected from the treated plot and prepared for residue analysis for two or more active ingredients. 4.1 Formulations The formulation tested in crop field trials should be as close as possible to the intended enduse product for the crop or commodity. The requirements in this guideline in regard to a complete data set (the number of crop field trials matching the cGAP which are required) are generally based upon only one formulation type being requested for use on a specific crop. The decision will be based upon how similar the formulations are in composition and physical form, the mode of application, and the: timing of the application. Controlled release formulations (e.g., certain microencapsulated products) normally require a complete data set tailored to that particular use. Granules (GR) and . dusts (DP) are the most common examples of the latter. Granular formulations ‘applied intact will generally require .al:complete data set regardless of what data are already available for other formulation types. Kenya Subsidiary Legislation, 202424 24 The most common formulation types which are diluted in water prior to appl ication include Emulsif iable Concentrates (EC) , Wetable Powders (WP), W ater dispersible Granules (WG), Suspension Concentrates (SC)(also called f lowable concentrates), and Soluble Concentrates (SL). Experience from trials demonstrates th at t hese f o r m u l at i o n s lead to similar residues. Residue data may be translated among these formulation types for applications that are made to seeds, prior to crop emergence, i .e., pre-plant , at-plant , and pre-emergence applications, j ust after crop emergence or directed to the soi l , such as row middle or post-directed applications (as opposed to foliar treatments) . M ost of the remaining types of formulations can be divided into two groups—those that are di luted with water prior to application and those which are applied intact . In many situations dif ferent formulations would cause no m o r e v ar i at io n t h an o th er f actors, and data der i ved w i th d if ferent f ormulat ions would be considered comparable. 5 B r i d g in g St u d ie s : Bridging studies are an essential extrapolation tool to make the best use of existing data to support minor changes or variations to existing uses. A bridging study normal ly involves a comparison of dif ferent formulations or application methods for the purpose of data extrapolation, but may or may not involve side-by-side comparisons. For late season foliar appl ications of formulations di luted i n w ater , the decision on the need for additional data depends upon two factors: 5.7.7 the presence of organic solvents or oils in the product and 5.1.2 the pre-harvest interval . Wider extrapolation of data will generally be permitted f o r f o r m u l at i o n s t h at d o no t contain'dfganic solvents or oil s'. Sonic active ingredients, e.g., phenoxy herbicides, can be appl ied as one or more salts and/or esters. Different salts of an active ingredient may be considered equivalent for residue purposes in most cases regardless of the timing of the application. However , examples for which additional data may be needed for a new sal t include the presence of counter ions that impart surfactant properties, significantly change the degree of dissociation, or chelate with the active ingredient ion. If the PHI is less than or equal to 7 days, the dif ferent esters are considered as new formulations of that active ingredient for the purposes of determining data needs, and bridging studies would be required as for d i f f e ren t f o r m u l at io n s . If bridging trials are deemed necessary and a pesticide is used on a wide range of crops, data should be generated for at least three maj or crop groups (one crop per crop gro up) , e.g., a leafy crop, a root crop, a tree frui t , a cereal grain, an oilseed with a minimum of four trials per crop. The trials should be carried out on crops that would be expected to show high levels of residue (often those with appl ications at or near harvest) . If a bridging study is conducted and residues are significantly higher with a new formulation or different application method, or the co m b ined r esi d ue d ata set o b tai ned with different formulations would lead to a higher MRL , generation of a complete new data set may be necessary . 6 Gener a l Gu id an c e o n Cr o p Gr o ups and Ex t r a po l a t io n 6.1 Extrapolation and principles of representative co m m o d i t i es Residue extrapolation is the process by which the residue levels on representative com modi ties are uti l ized to estim ate residue level s o n r el ated c o m m o d i t i es i n the sam e commodity group or subgroup for which trials have nd( b een c o nd u c ted . 2424 Kenya Subsidiary Legislation, 2024 The most common formulation types which are diluted in water prior to application include Emulsifiable Concentrates (EC), Wetable Powders (WP), Water dispersible Granules (WG), Suspension Concentrates (SC)(also called flowable concentrates), and Soluble Concentrates (SL). Experience from trials demonstrates that these formulations lead to similar residues. Residue data may be translated among these formulation types for applications that are made to seeds, prior to crop emergence, i.e., pre-plant, at-plant, and pre-emergence applications, just after crop emergence or directed to the soil, such as row middle or post-directed applications (as opposed to foliar treatments). Most of the remaining types of formulations can be divided into two groups—those that are diluted with water prior to application and those which are applied intact. In many situations different formulations would cause no more variation than other factors, and data derived with different formulations would be considered comparable. 5 BRIDGING STUDIES: Bridging studies are an essential extrapolation tool to make the best use of existing data to support minor changes or variations to existing uses. A bridging study normally involves a comparison of different formulations or application methods for the purpose of data extrapolation, but may or may not involve side-by-side comparisons. For late season foliar applications of formulations diluted in water, the decision on the need for additional data depends upon two factors: 5.1.J the presence of organic solvents or oils in the product and 5.1.2 the pre-harvest interval. Wider extrapolation of data will generally be permitted for formulations that do not contain6rganic solvents or oils: Somé active ingredients, e.g., phenoxy herbicides, can be applied as one or more salts and/or esters. Different salts of an active ingredient may be considered equivalent for residue purposes in most cases regardless of the timing of the application. However, examples for which additional data may be needed for a new sait include the presence of counter ions that impart surfactant properties, significantly change the degree of dissociation, or chelate with the active ingredient ion. If the PHI is less than or equal to 7 days, the different esters are considered as new formulations of that active ingredient for the purposes of determining data needs, and bridging studies would be required as for different formulations. If bridging trials are deemed necessary and a pesticide is used on a wide range of ‘crops, data should be generated for at least three major crop groups (one crop per crop group), e.g., a leafy crop, a root crop, a tree fruit, a cereal grain, an oilseed with a minimum of four trials per crop. The trials should be carried out on crops that would be expected to show high levels of residue (often those with applications at or near harvest). If a bridging study is conducted and residues are significantly higher with a new formulation or different application method, or the combined residue data set obtained with different formulations would lead to a higher MRL, generation of a complete new data set may be necessary. 6 GENERAL GUIDANCE ON CROP GROUPS AND EXTRAPOLATION 61 Extrapolation and principles of representative commodities Residue extrapolation is the process by which the residue levels on representative commodities are utilized to estimate residue levels on related commodities in the same commodity group or subgroup for which trials have not -been conducted. Kenya Subsidiary Legislation, 2024 24 2 5 The establ ishment of commodity group M RL s as opposed t o M R L s f o r i n d i v i d u al commodities has long been considered an acceptable procedure since economics may not j ustify residue trial s on all of the individual crops in a group. In principle the approach recognizes that adequate data for the maj or crop commodities of a group may be su f f i c ien t to est i m ate m ax i m u m resi d ue l ev el s f o r t he whole group. Since some pesticides may behave dif ferently in different circumstances. Consequently , it is not possible to def ine precisely those commodities on which trials wil l always provide data that can lead to a group M RL . Extrapolation is possible if the GAP of the minor crop is similar to that of a relevant maj or crop (e.g. in the same crop grouping) . Preconditions for extrapolation of residues Extrapolation of residue data for different crops presumes that the fol lowing are comparable: conditions of use with regard to the amount of active substance applied, (i i) the time of appl ication, (i ii ) the number of appl ications, (iv) the interval between applications, (v) application methods, (vi) formulation used, and (vi i) cl imatic conditions. The following are the principles of selection of representative commoditynwithin groups as agreed by the Codex Committee on Pesticide Residues (CCPR) [12] . A representative commodity is: most likely to contain the highest residues, likely to be maj or in terms of production and/or consumption, is most likely similar in morphology , growth habit , pest problems and edible portion to the related commodities within a group or subgroup. The appl ication of the three principles is based on the assumption that al l commodities of the respective group or subgroup are treated according to a simi lar use pattern or GAP. To facilitate the global use of the commodity groups for MRL s, altern ative representative commodities may be selected giving f lexibili ty for use of resi d ue r esear c h c o n du cted i n d i f f erent co u n t r i es o r regions that may vary due to reg'ion’al dif ferences in dietary consumption and/or areas of production for certain commodities *'” 6 .2 W i d e r E x t r a po l a t i o n s The term ‘wider extrapolations’ (also referred to as ‘cross group extrapolations’) is used in this context for extrapolations that go beyond the bounds of a crop group or subgroup. Such extrapolations may be possible in special ci rcum stances, on the basi s of residue data. Consideration on a case-by-case basis may be given to commodities with very similar shapes, volumes, and weights. For example, in Austral ia, apple, peach, and nectarine may be extrapolated to persimmon. Wider extrapolations may also be considered, on a case-by-case basi s, f or : (a) Situations where residues are expected to be <LOQ (e. g . pre-emergence herbicide uses, pre-f lower treatments); (i ) Kenya Subsidiary Legislation, 2024 2425 The establishment of commodity group MRLs as opposed to MRLs for individual commodities has long been considered an acceptable procedure since economics may not justify residue trials on all of the individual crops in a group. In principle the approach recognizes that adequate data for the major crop commodities of a group may be sufficient to estimate maximum residue levels for the whole group. Since some pesticides may behave differently in different circumstances. Consequently, it is not possible to define precisely those commodities on which trials wil! always provide data that can lead to a group MRL. Extrapolation is possible if the GAP of the minor crop is similar to that of a relevant major crop (e.g. in the same crop grouping). Preconditions for extrapolation of residues Extrapolation of residue data for different crops presumes that the following are comparable: (i) conditions of use with regard to the amount of active substance applied, (ii) the time of application, (iii) the number of applications, (iv) the interval between applications, (v) application methods, (vi) formulation used, and (vii) climatic conditions. The following are the principles of selection of representative commodity: within groups as agreed by the Codex Committee on Pesticide Residues (CCPR) [12]. A representative commodity is: most likely to contain the highest residues. likely to be major in terms of production and/or consumption. is most likely similar in morphology, growth habit, pest problems and edible portion to the related commodities within a group or subgroup. The application of the three principles is based on the assumption that all commodities of the respective group or subgroup are treated according to a similar use pattern or GAP. To facilitate the global use of the commodity groups for MRLs, alternative representative commodities may be selected giving flexibility for use ‘of residue research conducted in different countries or regions that may vary due to regiOnal differences in dietary consumption and/or areas of production for certain commodities." 6.2 WIDER EXTRAPOLATIONS The term ‘wider extrapolations’ (also referred to as ‘cross group extrapolations’) is used in this context for extrapolations that go beyond the bounds of a crop group or subgroup. Such extrapolations may be possible in special circumstances, on the basis of residue data. Consideration on a case-by-case basis may be given to commodities with very similar shapes, volumes, and weights. For example, in Australia, apple, peach, and nectarine may be extrapolated to persimmon. Wider extrapolations may also be considered, on a case-by-case basis, for: (a) Situations where residues are expected to be <LOQ (e. g. pre-emergence herbicide uses, pre- -flower treatments); Kenya Subsidiary Legislation, 20242 4 2 6 (b) Situations where the active substance is used early in the growing season (last application before consumable parts of the crop have started to form) . (This kind of extrapolation should be used with caution since for some crops the edible part of the crop is always present either as a food or a feed item.); (c) Seed treatments, i f data from treatment of several di fferent ‘representative’ seed types all report no detectable residues in the commodities from crops grown from the treated seed; (d) Post-harvest treatments for non-systemic pesticides t o c o m m o d i t i es o f si m i l ar size and morphology on the basis of the same treatment regimens; and (e) Soil treatments with granules (depending on extent of residue uptake and distribution in the plant as evidenced by data from different crop types including a root crop). A representative commodity should meet at least two (2) of the principles stated in 10.1 above. More details on the selection of representative c o m m o d i t i es c an b e f o u nd i n Principles and Guidance on the Selection of Representative Com modi ties f or the Extrapolation of M aximum Residue L imits for Pesticides to Commodity Groups (CAC/GL 84-2012). It may not always fit well with the growth habits or pest problems of morphology within one group or subgroup. In such situations, extrapolations beyond the members of a commodity group may be appropriate. These can be considered on a case-by-case basis when commodities (with similar GAPs) have similar size, shape and surface area. Examples of these possible wider extrapolations include: (a) Translation of certain stone or pome fruit MRLs to a tropical f ruit ; (b) Where residues are all <LOQ for pre-emergent herbicide u ses and (c) Seed treatments for non-systemic pesticides. 7 Fie l d Sampl in g For raw agricultural commodities (RAC), samples should be tak en o f th e commodity as it is traded. . The detailed sampling procedures ar e o u t l i ned i n th e F A O Manual [13] . " s-4j fcBelow are general provisions for sampling: 7.1 Sample handling Care should be taken not to remove surface residues during handling, packing or preparat ion . (i) Avoid any damage to or deterioration of the sample which might affect residue l ev el s . (ii) To provide a representative sample of the raw commodity, adhering soil may ■()) have to be removed from some crops, such as root crops. This may be done by brushing and, if necessary, gentle rinsing with,cold running water . (iii) Sample untreated control plots before treated plots 2426 Kenya Subsidiary Legislation, 2024 (b) Situations where the active substance is used early in the growing season (last application before consumable parts of the crop have started to form). (This kind of extrapolation should be used wiih caution since for some crops the edible part of the crop is always present either as a food or a feed item.); (c) Seed treatments, if data from treatment of several different ‘representative’ seed types all report no detectable residues in the commodities from crops grown from the treated seed; (d) Post-harvest treatments for non-systemic pesticides to commodities of similar size and morphology on the basis of the same treatment regimens; and (e) Soil treatments with granules (depending on extent of residue uptake and distribution in the plant as evidenced by data from different crop types including a root crop). A representative commodity should meet at least two (2) of the principles stated in 10.1 above. More details on the selection of representative commodities can be found in Principles and Guidance on the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Pesticides to Commodity Groups (CAC/GL 84-2012). It may not always fit well with the growth habits or pest problems of morphology within one group or subgroup. In such situations, extrapolations beyond the members of a commodity group may be appropriate. These can be considered on a case-by-case basis when commodities (with similar GAPs) have similar size, shape and surface area. Examples of these possible wider extrapolations include: (a) Translation of certain stone or pome fruit MRLs to a tropical fruit; (b) Where residues are all <LOQ for pre-emergent herbicide uses and (c) Seed treatments fornon-systemic pesticides. 7 FIELD SAMPLING For raw agricultural commodities (RAC), samples should be taken of the commodity as it is traded. , The detailed sampling procedures are outlined in the FAO Manual [13]. Dive, ot tBelow are general provisions for sampling: 7.1 Sample handling Care should be taken not to remove surface residues during handling, packing or preparation. (i) Avoid any damage to or deterioration of the sample which might affect residue levels. (ii) To provide a representative sample of the raw commodity, adhering soil may ‘yj have to be removed from some crops, such as root crops. This may be done by brushing and, if necessary, gentle rinsing with,cold running water. (iii) Sample untreated control plots before treated plots Kenya Subsidiary Legislation, 2024 24 2 7 7 .2 C o n ta m i na t io n It is essential to avoid any contamination with the pesticide under study or with other chemicals during sampl ing, transportation or subsequent operations. Special attention should, therefore, be paid to the following: (i) Ensure that sampling tools and bags are clean. To avoid contamination, use new bags and containers of suitable size and adequate strength. The bags or contai ners should be m ade of mater ial s w hich w i l l not i n ter f er e w i t h t h e analysis, (ii) Avoid contamination of the sample by hands and clothes which may have been in contact with pesticides, (ii i) Do not al low the samples to come into contact with containers or equipment (including vehicles) that have been used for transporting or storing pesticides, (iv) Avoid sampl ing at the plot borders because the residue deposit may not be representative, (v) Take special care to avoid contamination when commercial m ech an i c al harvesting practices are used (vi) A void cross-contamination of crop and soi l samples, (vi i) Sampl ing should proeeed from the control to the l o w est t r eatm en t an d so o n to the highest treatment . 7.3 Control samples Control samples (samples taken from the untreated plot) are in every way as important as samples from test plots. The quality of control samples should be similar to that of the test samples, e.g., maturity of f ruit , type of fol iage, etc. A lways take control samples. In decl ine studies of up to 14 days’ duration, control samples from the start and from the end of the study may suff ice. 7.4 Sampl ing in decl ine studies The f irst sampling in a deeline study may take place on the day of appl ication. These samples should be taken immediately after application, or in the case of spray appl ication, immediately after the spray has dried (approximately 1-2 hours) . Care should be taken to avoid contamination and samples should be taken to be representativj gpf the average size or weight of crop on the plot . 7.5 Sampl ing at normal harvest time (i) Take samples so as to be representative of typical harvesting practice, (ii) Avoid taking diseased or undersized crop parts or commodities at a stage when they would not normal ly be harvested. 8 D e t a i l e d Sa m pl in g Pr o c e d u r e s >0 ;:3l clab A l i i .: o'«' d ) The requirements give a detai l on the number of samples to take per si te for both treated and untreated controls; and the number of composite samples to be taken and the minimum f ield sample size (by weight and number of samples) . ■I' .-f I T," . . ■ Kenya Subsidiary Legislation, 2024 2427 7.2 Contamination It is essential to avoid any contamination with the pesticide under study or with other chemicals during sampling, transportation or subsequent operations. Special attention should, therefore, be paid to the following: (i) Ensure that sampling tools and bags are clean. To avoid contamination, use new bags and containers of suitable size and adequate strength. The bags or containers should be made of materials which will not interfere with the analysis. (ii) Avoid contamination of the sample by hands and clothes which may have been in contact with pesticides. (iti) Do not allow the samples to come into contact with containers or equipment (including vehicles) that have been used for transporting or storing pesticides. (iv) Avoid sampling at the plot borders because the residue deposit may not be representative. (v) Take special care to avoid contamination when commercial mechanical harvesting practices are used (vi) Avoid cross-contamination of crop and soil samples. (vii)Sampling should proceed from the control to the lowest treatment and so on to the highest treatment. babs. nih 7.3 Control samples tab adhe in ole Control samples (samples taken from the untreated plot) are in every way as important as samples from test plots. The quality of control samples should be similar to that of the test samples, e.g., maturity of fruit, type of foliage, etc. Always take control samples. In decline studies of up to 14 days’ duration, control samples from the start and from the end of the study may suffice. 7.4 Sampling in decline studies The first sampling in a decline study may take place on the day of application. These samples should be taken immediately after application, or in the case of spray application, immediately after the spray has dried (approximately 1-2 hours). Care should be taken to avoid contamination and samples should be taken to be representative:of the average size or weight of crop on the plot. 7.5 Sampling at normal harvest time (i) Take samples so as to be representative of typical harvesting practice. (ii) Avoid taking diseased or undersized crop parts or commodities at a stage when they would not normally be harvested. 8 DETAILED SAMPLING PROCEDURES we ff The requirements give a detail on the number of samples to take per Site for both treated and untreated controls; and :the-number of composite samples to be taken and the minimum field sample size (by weight and number of samples). EP T: ; 7 Kenya Subsidiary Legislation, 202424 2 8 Details of the sampl ing procedures are described in detai l in the FAO M anual [ 13] Recommended sampling methods for supervised residue f ield tr ials; as fo l low s, (a) Table V .l Sampling of f ruits (b) Table V .2 Sampling of bulb, root and tuber vegetables (c) Table V .3 Sampling of other vegetables (d) Table V .4 Sampling of cereals (e) Table V .5 Sampling of forage crops and animal feed (f) Table V .6. Sampling of herbs, spices; tea leaves; hops and beer 8.1 Samp le transpor tation Proper labelling of samples is of utmost importance. Sample labels must indicate crop, variety, trial site, active ingredient, pesticide formulation, dosage rate, date of sampling, time of sampling and name of sampler. Samples sh o u l d be f r o zen as so o n as possible following collection to avoid sample deterioration and decomposition of the residue(s). It is not advisable to allow samples to thaw once frozen; therefore, shipment of frozen samples should be either by freezer truck or packed in dry ice. It is acceptable to ship samples overnight, with coolant such as “blue ice” , to the sample preparation facility as long as they are “peeled” or “pitted” , or otherwise prepared for analyses and frozen immediately upon arrival . 8.2 Sample reception and handling Samples should be transported immediately to the laboratory and upon arrival the pesticide residue laboratory personnel should verify the following: Sampling record is included with the samples, and the sample details should match the sampl ing record Check and report the conditions of the samples upon ar r i v al Accuracy of the sampl ing record especially rate and i nter v a l d ata Completeness of information If there are any deviations of any consequence, or the Sampl ing Report is not received or is incomplete, the samples should be stored in the simplest form that wi l l preserve the residue and the crop. The trial organizer sho u ld th en be c o n tac ted immediately to determine how to proceed. Once the samples are packed and labelled, they may be stored or preferably immediately sent to the residue laboratory according to the nature of the sample. The mode of shipping (e.g. deep-frozen or at ambient temperature shall be selected taking into account the stabil ity of the residue and the kind of study undert aken. I t is import ant that packing and shipment are carried out in such a way that the samples arri ve as soon as possible (normally within 24- 36 hours) after being taken and without change of any kind, e.g., deterioration, physical damage, contamination, loss of residue, or change in moisture content. Storage and shipping should always be under deep-frozen conditions. M ixing of samples and sample size reduction at the f ield site is not recommended and should be av o i ded . 2428 Kenya Subsidiary Legislation, 2024 Details of the sampling procedures are described in detail in the FAO Manual [13] Recommended sampling methods for supervised residue field trials; as follows. (a) Table V.1 Sampling of fruits (b) Table V.2 Sampling of bulb, root and tuber vegetables (c) Table V.3 Sampling of other vegetables (d) Table V.4 Sampling of cereals (e) Table V.5 Sampling of forage crops and animal feed (f) Table V.6. Sampling of herbs, spices; tea leaves; hops and beer 8.1 Sample transportation Proper labelling of samples is of utmost importance. Sample labels must indicate crop, variety, trial site, active ingredient, pesticide formulation, dosage rate, date of sampling, time of sampling and name of sampler. Samples should be frozen as soon as possible following collection to avoid sample deterioration and decomposition of the residue(s). It is not advisable to allow samples to thaw once frozen; therefore, shipment of frozen samples should be either by freezer truck or packed in dry ice. It is acceptable to ship samples overnight, with coolant such as “blue ice”, to the sample preparation ‘facility as long as they are “peeled” or “pitted”, or otherwise prepared for analyses and frozen immediately upon arrival. . 8.2 Sample reception and handling Samples should be transported immediately to the laboratory and upon arrival the pesticide residue laboratory personnel should verify the following: Sampling record is included with the samples, and the sample details should match the sampling record Check and report the conditions of the samples upon arrival Accuracy of the sampling record especially rate and interval data Completeness of information If there are any deviations of any consequence, or the Sampling Report is not received or is incomplete, the samples should be stored in the simplest form that will preserve the residue and the crop. The trial organizer should then be contacted immediately to determine how to proceed. Once the samples are packed and labelled, they may be stored or preferably immediately sent to the residue laboratory according to the nature of the sample. The mode of shipping (e.g. deep-frozen or at ambient temperature shall be selected taking into account the stability of the residue and the kind of study undertaken. It is important that packing and shipment are carried out in such a way that the samples arrive as soon as possible (normally within 24-36 hours) after being taken and without change of any kind, e.g., deterioration, physical damage, contamination, loss of residue, or change in moisture content. Storage and shipping should always be under deep-frozen conditions. Mixing of samples and sample size reduction at the field site is not recommended and should be avoided. , 24 29Kenya Subsidiary Legislat ion, 2024 8.3 Sub-sampl ing and processing The laboratory samples should be prepared for analysis following the instructions of the Codex Standard on Portion of commodity to which M RLs apply and which is analyzed [14] . It is acceptable to subsample large commodities (e.g., head cabbage, melons, etc.) with procedures such as quarter ing and col lecting opposing quarters. However , this should be done in a laboratory environment to avoid contamination or degradation of pesticide residues. If analyses are planned on matrices such as pulp and peel (e.g ., for dietary risk assessment ref inement), the whole commodity should be shipped to the analysis lab to avoid cross contamination of peel and pulp. Shell ing, removing seeds or beans from pods, etc. should be u nd er tak en in t he pesticide residue laboratory to ensure minimum contamination e.g. through using clean tools and changing gloves between plot samples. In c ases w h ere c o m m o d i t ies suc h as peel and pulp or stone and pulp are separated for analyses, weights should be determined for each commodity Apart f rom superf icial cleansing i .e.. removal of any extraneous matter such as soi l , no intrusive cleaning should be attempted. In the case of root crops recovered with soi l , where light brushing is not suff icient to remove soil , gentle minimal rinsing under cold running water may be used. 8.4 Sample size reduction The Codex guidel ine on the Portion of Commodities to W h i c h C od ex M ax i m u m Residue L imits Apply and Which is A nalyzed [ 14] provides a table to guide on the part of the raw agricul tural commodity to which the maximum residue limit appl ies and which is to be prepared as the analytical sample for the determination of pest icide residues. 8.5 Storage Samples should be analyzed as quickly as possible after collection before physical and chemical changes occur . If prolonged storage is unavoidable, store the samples at a low temperature, preferably at or below - 20 °C.. Do not store samples (whole or homogenised) for analysis unless an adequate check has been made on the stabil ity of the residue. Fumigant residue samples need special attention and ideally should be analyzed immediately on receipt at the laboratory . 9 R e s i d u e A n a l y s i s ■’ V r . c t Residue analysis consists of a chain of procedures, d o n e in ac co r d anc e w i th t he principles of pesticide residue analysis and the requirements of A nalytical Qual ity A ssurance (AQA ) systems such as ISO 17025 (2005) [ 15] . Pesticide residue laboratories should use the requirements on good laboratory practice in pesticide residue analysis (CAC/GL 40- 1993) [ 16] . Further , the G uidance Document on pest icide residue analytical methods” , 2007 published by the OECD; should be used in providing guidance on the residue analytical methods used to generate the data for establ ishing M aximum Residue L imits (MRLs) and to determine processing factors [ 17] . M ethod val idation should be undertaken in accordance with principles set out in the said requirements. Kenya Subsidiary Legislation, 2024 2429 8.3 Sub-sampling and processing The laboratory samples should be prepared for analysis following the instructions of the Codex Standard on Portion of commodity to which MRLs apply and which is analyzed [14]. It is acceptable to subsample large commodities (e.g., head cabbage, melons, etc.) with procedures such as quartering and collecting opposing quarters. However, this should be done in a laboratory environment to avoid contamination or degradation of pesticide residues. If analyses are planned on matrices such as pulp and peel (e.g., for dietary risk assessment refinement), the whole commodity should be shipped to the analysis lab to avoid cross contamination of peel and pulp. Shelling, removing seeds or beans from pods, etc. should be undertaken in the pesticide residue laboratory to ensure minimum contamination e.g. through using clean tools and changing gloves between plot samples. In cases where commodities such as peel and pulp or stone and pulp are separated for analyses, weights should be determined for each commodity Apart from superficial cleansing i.e., removal of any extraneous matter such as soil, no intrusive cleaning should be attempted. In the case of root crops recovered with soil, where light brushing is not sufficient to remove soil, gentle minimal rinsing under cold running water may be used. 8.4 Sample size reduction The Codex guideline on the Portion of Commodities to Which CodeX Maximum Residue Limits Apply and Which is Analyzed [14] provides a table to guide on the part of the raw agricultural commodity to which the maximum residue limit applies and which is to be prepared as the analytical sample for the determination of pesticide residues. 8.5 Storage Samples should be analyzed as quickly as possible after collection before physical and chemical changes occur. If prolonged storage is unavoidable, store the samples at a low temperature, preferably at or below -20 °C.. Do not store samples (whole or homogenised) for analysis unless an adequate check has been made on the stability of the residue. Fumigant residue samples need special attention and ideally should be analyzed immediately on receipt at the laboratory. 9 RESIDUE ANALYSIS at Residue analysis consists of a chain of procedures, done in accordance with the principles of pesticide residue analysis and the requirements of Analytical Quality Assurance (AQA) systems such as ISO 17025 (2005) [15]. Pesticide residue laboratories should use the requirements on good laboratory practice in pesticide residue analysis (CAC/GL 40-1993) [16]. Further, the Guidance Document on pesticide residue analytical methods’, 2007 published by thé OECD; should be used in providing guidance on the residue analytical methods used to generate the data for establishing Maximum Residue Limits (MRLs) and to determine processing factors [17]. Method validation should be undertaken in accordance with principles set out in the said requirements. Kenya Subsidiary Legislation, 202424 3 0 10 D a t a R e po r t i n g The data obtained from the supervised residue f ield trials shall be reported using international ly harmonized formats. The reporting of supervised trials are assisted with t he at t ac hed e lec t r o n i c v e r si o n s of the Excel templates and spreadsheets to the M anual th at c an b e d o w n lo aded f ro m the FAO Homepage [18] . Detai led outline of how to organize the data is described i n t he F A O M anu al o n the Submission and evaluation of pesticide residue data f o r the est i m at i o n o f m ax i m u m residue levels in food and feed [19, Appendix VII : Standardized Format for Organizing the Data Directory (Index) of Information to be Submitted for Evaluation] . A summary of the data layout in table form is also described in the FAO M anual [20, Appendix XI : “ Table and Spreadsheet Examples] . The following information shall be provided: 1. Summary (a) Study ID, Title, Author(s), Publication date. Report No., Study dates (b) Testing Laboratory (c) Test Guideline, including deviations (d) Purpose of studies (e) Description and rationale for the total number o f f ie ld t r i al s and the l o c at i o n s chosen (countries/regibHs) (f ) Results (including explanations for apparently aberrant or atypical values, discussion of geographical representation (major growing areas) , seasonal variation (summer/winter , wet/dry , etc.) and representative nature of types and varieties of the raw agricul tural commodity) , (g) Field procedures (h) Analytical procedures/instrumentation (i ) Method recovery and validation data (j ) Storage stability / Storage period for samples should be compared to those uti lized in storage stabil ity study . Discussion (including Qual ity Control measures taken; GLP compl iance; ■'>nB ,z sfafistical treatments of data; and information on the levels of the components of the residue definition in or on the RAC (specif ic plant parts) arising from the use of the pesticide formulated product on the test crop under specif ic use conditions and storage stabi li ty) . (1) Conclusions 2. The following information shall be provided on the d ata t ab l es and o th er graphical representations: (a) ‘Summary map of crop field study sites (by crop) (b) Summary tables of residue results of individual f i e l d t r i al s (c) Graphic representations (e.g., residue decline, f igures, f lowcharts, etc.) 2430 Kenya Subsidiary Legislation, 2024 10 DATA REPORTING The data obtained from the supervised residue field trials shall be reported using internationally harmonized formats. The reporting of supervised trials are assisted with the attached electronic versions of the Excel templates and spreadsheets to the Manual that can be downloaded from the FAO Homepage [18]. Detailed outline of how to organize the data is described in the FAO Manual on the Submission and evaluation of pesticide residue data for the estimation of maximum residue levels in food and feed [19, Appendix VII: Standardized Format for Organizing the Data Directory (Index) of Information to be Submitted for Evaluation]. A summary of the data layout in table form is also described in the FAO Manual [20, Appendix XI: “Table and Spreadsheet Examples]. The following information shall be provided: 1. Summary (a) Study ID, Title, Author(s), Publication date, Report No., Study dates (b) Testing Laboratory (c) Test Guideline, including deviations (d) Purpose of studies (e) Description and rationale for the total number of field trials and the locations chosen (countries/regidiis) (f) ‘Résiilts (including explanations for apparently aberrant or atypical values, discussion of geographical representation (major growing areas), seasonal variation (summer/winter, wet/dry, etc.) and representative nature of types and varieties of the raw agricultural commodity). (g) Field procedures (h) Analytical procedures/instrumentation (i) Method recovery and validation data (j) Storage stability / Storage period for samples should be compared to those utilized in storage stability study. cu b a Discussion (including Quality Control measures taken; GLP compliance; 5.21" statistical treatments of data; and information on the levels of the components of the residue definition in or on the RAC (specific plant parts) arising from the use of the pesticide formulated product on the test crop under specific use conditions and storage stability). (1) Conclusions 2. The following information shall be provided on the data tables and other graphical representations: (a) ‘Summary map of crop field study sites (by crop) (b) Summary tables of residue results of individual field trials (c) Graphic representations (e.g., residue decline, figures, flowcharts, etc.) Kenya Subsidiary Legislation, 2024 24 3 1 (d) Summary tables of recovery data via the analytical methodology (e) Summary tables of storage stability validation d ata (f ) Chromatograms (as applicable) 3. Raw data on individual f ield trials (specif ically , eac h i nd i v i d u al f i e l d t r i al report should include the fol lowing information): (A ) Reporting of Test substance(pesticide) . (i ) Identif ication of the test pesticide active ingredient (a.i .) . including CAS and l UPA C chemical name, common name (e.g., BSI , ISO) , and company developmental or experimental name, (i i) Identif ication of the pesticide formulated products used in the f ield trial , including trade name, type (EC, WP, G, etc.) , and amount of active ingredient per gal lon, pound, l i ter , kg, etc., and manufacturer , (iii) Information on other relevant parameters, as pertinent , (e.g., tank mates, spray additives, carrier (encapsulating polymer, etc.)) , (iv) Other . Any and al l additional information the appl icant considers appropriate and relevant to provide a complete and thorough description o f t he test su b stanc e . (B) Test commodity (RAC) , (i) Identif ication of the RAC, including type/variety , (ii) Identification of specif ic crop parts harvested; used in residue analytical methodology validations; and subj ected to residue analysis f o r a d eterm i n at i o n of the components of the residue def inition, (ii i) The developmental stages, general condition (immature/mature, green/ripe, fresh/dry , etc.) and sizes of the RAC at time of pesticide appl ication(s) and at harvestings, (iv) A ny other information that may be considered appropriate and r el ev an t to provide a complete and thorough description of the R A C . 4. Reporting test procedures. (A ) A detailed description of the experimental design and procedures follî ed in the growing of the RAC, appl ications of the pesticide formulated products, and harvestings of samples. The information provided, which should be presented on standardized f ield sheets, should include (in addition to a description of the test substance and test commodity): (i) Trial identif ication number , (ii ) Cooperator (name, address) , test location (e.g., state, country) and year , (i i i) Field trial lay-out (e.g ., size and number of control and experimental plots; number of plants per plot/unit area, number of rows per plot , length of rows and row spacing) . 1. r .O f l O (iv) Cultural treatments — farming practice (cul tivation, irrigation, etc.) and cropping system. ’ Kenya Subsidiary Legislation, 2024 2431 (d): Summary tables of recovery data via the analytical methodology ~ (e) Summary tables of storage stability validation data (f) Chromatograms (as applicable) 3. Raw data on individual field trials (specifically, each individual field trial report should include the following information): (A) Reporting of Test substance(pesticide). (i) Identification of the test pesticide active ingredient (a.i.), including CAS and IUPAC chemical name, common name (e.g., BSI, ISO), and company developmental or experimental name. (ii) Identification of the pesticide formulated products used in the field trial, including trade name, type (EC, WP, G, etc.), and amount of active ingredient per gallon, pound, liter, kg, etc., and manufacturer. (iii) Information on other relevant parameters, as pertinent, (e.g., tank mates, spray additives, carrier (encapsulating polymer, etc.)). (iv) Other. Any and all additional information the applicant considers appropriate and relevant to provide a complete and thorough description of the test substance. (B) Test commodity(RAC). . ost (i) Identification of the RAC, including type/variety. .., corto (ii) Identification of specific crop parts harvested; used in residue analytical methodology validations; and subjected to residue analysis for a determination of the components of the residue definition. (iii) The developmental stages, general condition (immature/mature, green/ripe, fresh/dry, etc.) and sizes of the RAC at time of pesticide application(s) and at harvestings. (iv) Any other information that may be considered appropriate and relevant to provide a complete and thorough description of the RAC. 4. Reporting test procedures. (A) A detailed description of the experimental design and procedures followed in the growing of the RAC, applications of the pesticide formulated products, and harvestings of samples. The information provided, which should be presented on standardized field sheets, should include (in addition to a description of the test substance and test commodity): (i) — Trial identification number. (ii) | Cooperator (name, address), test location (e.g., state, country) and year. (iii) Field trial lay-out (e.g., size and number of control and experimental plots; number of plants per plot/unit area, number of rows per plot, length‘of rows and row spacing). (iv) Cultural treatments — farming practice (cultivation, irrigation, etc.) and cropping system. ’ Kenya Subsidiary Legislation, 202424 3 2 (v) Soi l characteristics (name/designation of the soil type) . I f appl ication rate of the pesticide is dependent on any soi l properties such as percent of organic matter , these should also be descri bed , (vi ) M ethods of application (air or ground) of the pesticide formulated products, description of the appl ication equipment , type of appl ication (band/broadcast , soil/fol iar/ directed, ULV /concentrate/dilute, other) , and cal i b r at io n o f pesticide application equipment , including methods and d ates , (vii) Application rates (amount of active ingredient and formulated product per acre, row , volume, etc.) and spray volumes per acre o r hec tare , (vii i) Number and timing of appl ications (total number , during dormancy , pre plant, pre-emergence, pre-bloom, etc., between-application-interval s, and treatment-to-sampling intervals (pre-harvest intervals =PH I )) . (ix) Other pesticides applied (identity (name and type of formulated products, active ingredients), rates, dates, purpose of use, indicate whether appl ied separately or mixed with active ingredient of interest i n tr ial s) , (x) Cl imatological data (record of temperature and rainfal l during the growing season from the nearest weather station, and wind speed during application) , (xi) Dates (planting/sowing/transplanting, as appl icable, other signif icant dates in the growing of the crop (e.g., husk spl it for tree crops), pesticide applications, harvests) . (xii) i:Harvest procedures (method of harvesting (mechanical/hand, f rom the srfplant/ground/f lotation, etc.) , type equipment used, number/weight of samples collected per replication and number of replications per treatment level , statistical nature of sampling (e.g., f ruit taken from upper , middle, and lower portions of tree exterior and interior) , sample coding (cross-ref erenced to sample history) , etc.) , (xi ii ) Qual ity control (control measures/precautions fol lowed to ensure the f idelity of the crop f ield test) , (xiv) Other . A ny and al l additional information the appl icant considers appropriate and relevant to provide a complete and thorough description of the growing of the RAC, appl ications of the pesticide formulated products, and harvesting of samples. ^ detai led description of the handl ing, pre-shipping storage, and shipping procedures for harvested RAC samples. The information provided, which shal l be presented on a standardized form, should include (in addition to a description of the test substance and the test commodity): (i) Sample identif ication (means of labeling/coding), (ii) Conditions (temperatures, container types/sizes, sample sizes, form (e.g., whole commodity; chopped), etc.) and duration of storage before shipping, (iii) Methods of packaging for shipment (container types/sizes, sample sizes, ambient/ iced, labeling/coding, etc.) , (iv) Means of transport from the fi eld to the laboratory. ./ ■i (v) Dates (harvest, pre-shipping storage, shipping, ari d receipt in the laboratory). 2432 Kenya Subsidiary Legislation, 2024 (v) Soil characteristics (name/designation of the soil type). If application rate of the pesticide is dependent on any soil properties such as percent of organic matter, these should also be described. (vi) Methods of application (air or ground) of the pesticide formulated products, description of the application equipment, type of application (band/broadcast, soil/foliar/ directed, ULV/concentrate/dilute, other), and calibration of pesticide application equipment, including methods and dates. (vii) Application rates (amount of active ingredient and formulated product per acre, row, volume, etc.) and spray volumes per acre or hectare. (viii) Number and timing of applications (total number, during dormancy, pre (ix) (x) (xi) plant, pre-emergence, pre-bloom, etc., between-application-intervals, and treatment-to-sampling intervals (pre-harvest intervals =PHI)). Other pesticides applied (identity (name and type of formulated products, active ingredients), rates, dates, purpose of use, indicate whether applied separately or mixed with active ingredient of interest in trials). Climatological data (record of temperature and rainfall during the growing season from the nearest weather station, and wind speed during application). Dates (planting/sowing/transplanting, as applicable, other significant dates in the growing of the crop (e.g., husk split for tree crops), pesticide applications, harvests). (xii) Harvest procedures .(method of harvesting (mechanical/hand, from the <Uplant/ground/flotation, etc.), type equipment used, number/weight of samples collected per replication and number of replications per treatment level, statistical nature of sampling (e.g., fruit taken from upper, middle, and lower portions of tree exterior and interior), sample coding (cross-referenced to sample history), etc.). (xiii) Quality control (control measures/precautions followed to ensure the fidelity of the crop field test). (xiv) Other. Any and all additional information the applicant considers appropriate ising Der twlor and relevant to provide a complete and thorough description of the growing of the RAC, applications of the pesticide formulated products, and harvesting of samples. A detailed description of the handling, pre-shipping storage, and shipping procedures for harvested RAC samples. The information provided, which shall be presented on a standardized form, should include (in addition to a description of the test substance and the test commodity): Sample identification (means of labeling/coding). Conditions (temperatures, container types/sizes, sample sizes, form (e.g., whole commodity; chopped), etc.) and duration of storage before shipping. Methods of packaging for shipment (container types/sizes, sample sizes, ambient/iced, labeling/coding, etc.). Means of transport from the field to the laboratory. ob Dates (harvest, pre-shipping storage, shipping, and receipt in the laboratory). Kenya Subsidiary Legislation, 2024 24 3 3 (vi) Quality control (control measures/precautions fol lowed to ensure the integrity of harvested samples during handling, pre-shipping storage, and shipping operations), (vii) Other: All additional information the applicant considers appropriate and relevant to provide a complete and thorough description of the handling, pre shipping storage, and shipping procedures for harvested samples. (C) A detailed description of the conditions and length of storage of harvested RAC samples following their receipt in the laboratory. (D) A detailed description of the residue analyses used in determining the components of the residue def inition in fi eld trial RAC and storage stabi lity samples. I f the specifi ed information is provided elsewhere w i th i n t he o v er al l data submission package, i t need not be reiterated here . I n that case, a reference to the relevant analytical methodology would be su f fi c i en t . (E) M ethod recovery val idation studies should be run concurrently with the residue analyses of crop field trial samples from each i nd i v id u al fi e l d t r i al i n order to provide information on the recovery levels of the test compounds f rom the test substrates at var ious f orti f icat ion levels using the residue analytical methods, and to establ ish a validated l imit of quantifi cation. The fol lowing information specif ic to the method val idations, which may be presented on a standardized form, should include: (i ) Experimental design: Identity of test substrates (specifi c plant parts) and test compounds (parent/specif ic metabol ites). Number and magnitude of fortifi cation levels, number of replicate samples per test compound per fortif ication level , sample coding, control samples, e t c . (ii ) Fortif ication procedure: Detail the preparation of the test compounds and test substrates and the manner in which the test compounds w ere i n tr o du c ed to th e test sub st r ates , (ii i ) Dates: Test sample preparation (maceration/extraction/etc.) , test compounds preparation (standard solutions of known concentration), residue analyses, (iv) Residue results: Raw data, ppm or mg/kg found uncorrected (corrected values may also be reported but the basis of correction should be explained) , procedures for calculating percent recoveries,' recovery levels (range), and limits of quanti tation and detection, (v) Other. Any and all additional information the applicant considers appropriate and relevant to provide a complete and thorough description of analytical methodology val idation procedures. 5. Organization of data tables and forms. (A ) Tables of residue assay data for specif ic plant parts analyzed. Residue levels should be reported uncorrected. Corrected values may also be presented but the procedure needs to be explained with sample calculations. (B) Tables on residue recovery values. (C) Graphs, as pertinent (e.g., residue decline). (D) Forms containing f ield trial history information. (E) Forms containing harvesting, shipping, storage i n f o r m at i o n . Kenya Subsidiary Legislation, 2024 2433 (vi) (vii) (C) (D) (E) (i) (ii) (iii) (iv) (v) Quality control (control measures/precautions followed to ensure the integrity of harvested samples during handling, pre-shipping storage, and shipping operations). Other: All additional information the applicant considers appropriate and relevant to provide a complete and thorough description of the handling, pre shipping storage, and shipping procedures for harvested samples. A detailed description of the ‘conditions and length of storage of harvested RAC samples following their receipt in the laboratory. A detailed description of the residue analyses used in determining the components of the residue definition in field trial RAC and storage stability samples. If the specified information is provided elsewhere within the overall data submission package, it need not be reiterated here. In that case, a reference to the relevant analytical methodology would be sufficient. Method recovery validation. studies should be run concurrently with the residue analyses of crop field trial samples from each individual field trial in order to provide information on the recovery levels of the test compounds from the test substrates at various fortification levels using the residue analytical methods, and to establish a validated limit of quantification. The following information specific to the method validations, which may be presented on a standardized form, should include: Experimental design: Identity of test substrates (specific plant parts) and test compounds (parent/specific metabolites). Number and magnitude of fortification levels, number of replicate samples per test compound per fortification level, sample coding, control samples, etc. ff Fortification procedure: Detail the preparation of the test compounds and test substrates and the manner in which the test compounds were introduced to the test substrates. Dates: Test sample preparation (maceration/extraction/etc.), test compounds preparation (standard solutions of known concentration), residue analyses. Residue results: Raw data, ppm or mg/kg found uncorrected (corrected values may also be reported but the basis of correction should be explained), procedures for calculating percent recoveries,’ recovery levels (range), and limits of quantitation and detection. Other. Any and all additional information the applicant considers applopriate and relevant to provide a complete and thorough description of analytical methodology validation procedures. 5. Organization of data tables and forms. (A) (B) (C) (D) (E) Tables of residue assay data for specific plant parts analyzed. Residue levels should be reported uncorrected. Corrected values may also be presented but the procedure needs to be explained with sample calculations. Tables on residue recovery values. Graphs, as pertinent (e.g., residue decline). Forms containing field trial history information. Forms containing harvesting, shipping, storage information. Kenya Subsidiary Legislation, 202424 34 (F) Tables of weather data if unusual conditions claimed to resu l t i n aberr an t r esid u es . (6) Trial Information (A ) Geographic Location (Trial Specif ic information - should be provided for all trial locations) (i) Trial ID No (Trial Specif ic, unequivocal identif ication code (e.g., Company Internal Code) (a) Trial Deviation (L ist any deviations which may impact the tri al results or study conclusions) (i i) Year (the year in which the fi rst GLP data are collected in trial) (i i i ) Country (iv) Geographic Region (e.g., lowland, coastal , high al t i t ud e and m i d al t i t ud e o r stating agroecological zone) (v) Province/Country (e.g.JCwale/Kenya) (vi) County (vii ) GPS Coordinates (if possible) (viii) Describe the agricultural practice of producing this crop in this region (ix),,. Crop Grouping (x) Crop (a) Crop V ariety (e.g., Apple mango) . ' j ( ■ f r (xii ) Crop Code C o des c an b e o b tai ned f r o m F A O A V H O . 19 9 3 . C o dex C l assi f i c at i o n o f F o o d s and A nimal Feeds in Codex A limentarius, 2nd ed.. Volume 2 . Pest i c i d e Residues, Section 2 Joint FA OAVHO Food Standard Programme. FA O , Rome. Note: the CCPR currently is working on the revision o f c l assi f i c at i o n o f commodities. The implementer is advised to check which groups have been fi nal ised and enforced By the Committee/Codex A l imentarius C o m m i ssi o n (xii i ) Soil Characterization (e.g., sandy loam, sandy clay loam, etc.) (B) Plot (Information should be provided for all plots) (i) Plot ID (Unequivocal Plot Identification; e.g., consecutive number) . N u m er ic al fi e l d o r co m b i n at i o n (i i) Control Plot (yes or no) (i i i) Plot Description - Describe plot specific information: e.g., plot size or area, row spacing, plant spacing, plants/area, crop height, seeding rates, number of seeds/area, exaggerated appl ication rate, type of protection i n c ase o f a protected crop scenario , in case of a storage protection use give type, size and volume of store, also type and size of package of stored products (e.g., bulk , paper , plastic bag) etc. , ■- i 1 Kenya Subsidiary Legislation, 2024 (F) Tables of weather data if unusual conditions claimed to result in aberrant residues. (6) Trial Information (A) Geographic Location (Trial Specific information — should be provided for all trial locations) (i) ‘Trial ID No (Trial Specific, unequivocal identification code (e.g., Company Internal Code) (a) Trial Deviation (List any deviations which may impact the trial results or study conclusions) (ii) Year (the year in which the first GLP data are collected in trial) (iii), Country (iv) Geographic Region (e.g., lowland, coastal, high altitude and mid altitude or ‘ stating agroecological zone) (v) Province/Country (e.g.,K wale/Kenya) (vi) County (vii) GPS Coordinates (if possible) (vill) Describe the agricultural practice of producing this crop in this region Panay oe (ix), Crop Grouping. (x) Crop (a) Crop Variety (e.g., Apple mango) (xii) Crop Code Codes can be obtained from FAO/WHO. 1993. Codex Classification of Foods and Animal Feeds in Codex Alimentarius, 2nd ed., Volume 2. Pesticide Residues, Section 2 Joint FAO/WHO Food Standard Programme. FAO, Rome. Note: the CCPR currently is working on the revision of classification of commodities. The implementer is advised to check which groups have been finalised and enforced By the Committee/Codex Alimentarius Commission (xiii) Soil Characterization (e.g., sandy loam, sandy clay loam, etc.) (B) Plot (Information should be provided for all plots) (i) Plot ID (Unequivocal Plot Identification, e.g., consecutive number). Numerical field or combination (ii) Control Plot (yes or no) (iii) Plot Description - Describe plot specific information: e.g., plot size or area, row spacing, plant spacing, plants/area, crop height, seeding rates, number of ° seeds/area, exaggerated application rate, type of protection in case of a protected crop scenario, in case of a storage protection use give type, size and volume of store, also type and size of package of stored products (e.g., bulk, paper, plastic bag) etc. aan i @ Kenya Subsidiary Legislation, 2024 24 35 (iv) Environmental Conditions Describe abnormal weather conditions, if applicable, soil properties, any other environmental ef fect that might have had an impact on the results observed in this study; for storage protection or glasshouse appl ication give room/glasshouse temperatures/humidities (v) Describe crop maintenance on the plot, e.g., all procedures used in planting, maintenance, and harvest , including irrigation, appl ication o f f er t i l i ze r s an d o the r m ai n ten ance c h em ic al s (vi) Date of planting/sowing (for permanent crops year of planting is suff icient); in case of seed treatment give date of seed treatment and date of sowing, beginning and end of f lowering, beginning and end of co m m er c i al h ar v est (v ii) Application (a) Application No (e.g. 1, 2, ...) Consecutive numbers of the applications, i .e., D' application = 1,2"‘‘application = 2. In the case of seed treatment, the sowing of the seeds is the f irst application, (b) Growth stage at appl ication, height of plants at appl ication in case of “ tal l crops” (e.g., vines) and both height and crown height of plants in case of tree cr o p s (c) Date of Appl ication (indicate format e.g.:dd/mm/yyyy) In case of seed treatment , state the date of sowing, in case of post-harvest dip, state the date of dip. In case of storage treatment give beginning’ and end of treatment together with beginning and end of ventilation (d) M ethod of Appl ication (e) Seeding Rate (Used in conj unction with seed treatment . Using this, combined with no. seeds/ Unit , one can determine TGW (Thousand Grain Weight), etc.) — Number of seeds/unit (no. seeds/kg) (f ) Test Item (Pesticide(s) tested in thi s study) — Description of Test I tem; information regarding tested Pesticide Product , End Use Product, formulation, treated/dressed seedj’ etc. u sed i n th e test i tem appl ied to the trial plot , crop, and/or the harvested commodity — Test I tem Formulation Type — T est I tem T r ad e N am e — Test I tem Active Ingredient Code/unique identif ier (e.g.. Company Internal Code) — Test I tem Active ingredient name(s) — Test I tem Nominal active ingredient content (e.g., grams a.i ./l iter) i , ■ i ; . (g) Test I tem actual amount active ingredient applied (e.g., grams a.i,/ha); for storage protection uses: application rate (e.g., kg a.i ./m3) , duration of treatment (h), duration of ventUation, • 'c ' • . (h) Test I tem actual amount active ingredient/seed if seed treatment (e.g ., g a.i ./ 100 kg seed) r i ' ■ 1. i i l x ) Kenya Subsidiary Legislation, 2024 2435 (iv) Environmental Conditions Describe abnormal weather conditions, if applicable, soil properties, any other environmental effect that might have had an impact on the results observed in this study; for storage protection oor glasshouse application give room/glasshouse temperatures/humidities (v) Describe crop maintenance on the plot, e.g., all procedures used in planting, maintenance, and harvest, including irrigation, application of fertilizers and other maintenance chemicals (vi) Date of planting/sowing (for permanent crops year of planting is sufficient); in case of seed treatment give date of seed treatment and date of sowing, beginning and end of flowering, beginning and end of commercial harvest (vii) Application (a) Application No (e.g. 1, 2, ...) Consecutive numbers of the applications. i.e., 1‘ application = 1, 2" application = 2. (b) (c) In the case of seed treatment, the sowing of the seeds is the first application. Growth stage at application, height of plants at application in case of “tall crops” (e.g., vines) and both height and crown height of plants in case of tree crops Date of Application (indicate format e.g.:dd/mm/yyyy) In case of seed treatment, state the date of sowing, in case of post- ~haryest dip, state (h) the date of dip. In case of storage treatment giVé beginning’ ard end of treatment together with beginning and end of ventilation WD Method of Application Seeding Rate (Used in conjunction with seed treatment. Using this, combined with no. seeds/ Unit, one can determine TGW (Thousand Grain Weight), etc.) Number of seeds/unit (no. seeds/kg) ; Test Item (Pesticide(s) tested in this study) Description of Test Item; information regarding tested Pesticide Product, End Use Product, formulation, treated/dressed seed;"etc. used in the test item applied to the trial plot, crop, and/or the harvested commodity Test Item Formulation Type i) Test Item Trade Name Test Item Active Ingredient Code/unique identifier (e.g., Company Internal Code) Test Item Active ingredient name(s) Test Item Nominal active ingredient content (e.g., grams a.i./liter)} a Woe Test Item actual amount active ingredient applied (e.g., grams a.i,/ha); for storage protection uses: application rate (e.g., kg a.i./m3), duration of treatment (h), duration of ventilation, Test Item actual amount ‘active ingredient/seed if seed treatment (e.g., g a.i/100 kg seed) Kenya Subsidiary Legislation, 202424 36 (h) Test I tem cumulative amount applied (i) Adj uvant Added, Adj uvant Type, Adj uvant Name, Adj uvant amount in Spray V o lume (%) (j ) A mount of water used in spray appl ication(actual) (vii i) Sampling (a) Sampl ing No. Consecutive numbering of sampling events (b) Sample ID - Unique sample ident if ication code (c) Sampling Timing: Provide any information regarding the timing of the sampling, e.g., relation to appl ication events, days after last appl ication, etc. PHI - pre-harvest interval DALA — Days after last application Days Before Harvest (d) Growth Stage at sampl ing (e) Date of Sampling(dd/mm/yyyy) (f ) Sampl ing Information: Description of sampl ing method, special remarks (e.g., cabbage was harvested according to agricultural practice, 1st set of outer leaves w ere removed) , sample handl ing (e.g., samples were f rozen within 24 hours) (g) Sampled M aterial/Commodity (Field RAC Sample) (k) A nalysis Sample (Description of Analysis sample) Field Sample should be separated into several analysis samples, e.g., whole mango may be separated into a peel sample and a f lesh sample for analysis (in that case also give weights of peel and pulp) . (I) A nalysis Sample ID (m) A nalysis Sample Description (n) A naly te measured (o) A nalyte ID . (p) Extraction Date(dd/mm/yyyy) (q) Actual date of extraction (r) A nalysis Date(dd/mm/yyyy) (s) Actual date of analysis (t) M ethod I D (u) Recovery (v) Residue Level (e.g., mg/kg). The value should not be corrected for recovery and rely on the measured level of the analyte. Additional ly , give calculated residue if appropriate (e.g., residue xy calculated/expressed as yz or acid calculated/expressed as carboxylic ester, sum of a.i . and metabol ites x and y , expressed as a.i . .. .) (w) Number of analytical replicates I Kenya Subsidiary Legislation, 2024 (h) Test Item cumulative amount applied (i) Adjuvant Added, Adjuvant Type, Adjuvant Name, Adjuvant amount in Spray Volume (%) G) Amount of water used in spray application(actual) (viii) Sampling (a) Sampling No. Consecutive numbering of sampling events (b) Sample ID — Unique sample identification code (c) Sampling Timing: Provide any information regarding the timing of the sampling, e.g., relation to application events, days after last application, etc. PHI — pre-harvest interval DALA — Days after last application Days Before Harvest (d) Growth Stage at sampling (e) Date of Sampling(dd/mm/yyyy) (f) Sampling Information: Description of sampling method, special remarks (e.g., cabbage was harvested according to agricultural practice, Ist set of outer leaves were removed), sample handling (e.g., samples were frozen within 24 hours) (g) Sampled Material/Commodity (Field RAC Sample) (k) Analysis Sample (Description of Analysis sample) Field Sample should be separated into several analysis samples, e.g., whole mango may be separated into a peel sample and a flesh sample for analysis (in that case also give weights of peel and pulp). (1) Analysis Sample ID (m) Analysis Sample Description (n) Analyte measured (o) Analyte ID. (p) Extraction Date(dd/mm/yyyy) (q) Actual date of extraction (r) Analysis Date(dd/mm/yyyy) (s) Actual date of analysis (t) Method ID (u) Recovery (v) Residue Level (e.g., mg/kg). The value should not be corrected for recovery and rely on the measured level of the analyte. Additionally, give calculated residue if appropriate (e.g., residue xy calculated/expressed as yz or acid calculated/expressed as carboxylic ester, sum of a.i. and metabolites x and y, expressed as a.i....) (w) Number of analytical replicates 24 37Kenya Subsidiary Legislation, 2024 (7) Analytical Methodology: Describe basic principle of analytical method(s) and their LOQ(s) , M ethod ID or cross-reference to relevant method template (A) analytical Method Information (B) Fortif ication Level (C) Recovery (%) (8) References L ist of references used should also be included in the Report . a Kenya Subsidiary Legislation, 2024 2437 (7) Analytical Methodology: Describe basic principle of analytical method(s) and their LOQ(s), Method ID or cross-reference to relevant method template (A) analytical Method Information (B) Fortification Level (C) Recovery (%) (8) References List of references used should also be included in the Report. Kenya Subsidiary Legislation, 202424 3 8 R6(l ) T EC H N I C A L CRI T ERIA FOR D E SI GN A T I N G EFFI C A CY T RI A L C E N T E R S I n tr o d u c t i o n This document prescribes the technical requirements for private or public institutions for designation as Efficacy Trial Centers for conducting ef ficacy studies that support or are intended to support applications for registration of pesticides in Kenya. It is intended to ensure the quality and integrity of efficacy study resul ts that are submitted Kenya in support of pesticides registration or an extension o f u ses . D ef i n i t io n s B atch — means a specific quantity of the control and test sub stance , means any material (e.g. water , soi l , nutrient media, e.t .c) combined with test substance, means any chemical substance or mixture, or any other substance (e.g. microbials) other than the test substance and used for comparison with the test su b stance , means a private or publ ic institution that meets the technical criteria and so designated by the Government of Kenya, means the f date that the test substance is applied in the study , m ean s the l ast d ate o n w h ic h d ata i s co l lec ted f ro m the study , means compliance with qual ity assurance of the stu d ies , means the internal process for designated Center to ensure al l steps in the study protocols are fol lowed, means all original information col lected from the study and necessary for the evaluation of study r esu l t s , means any study subj ect (target pest) intended for examination and analysis, means the applicant (registration) that f inancially supports the study, means the efficacy trial conducted in a laboratory, greenhouse, or in the f ield at one or more sites in which the test substance is applied. C arr i er — C o n tr o l su b stanc e 3 i Koq >? V j .I1 Ef f icacy Trial Center — Experimental start date — Experimental end date — Qual i ty assurance — i n ^ Qual ity registration control — R aw d ata — Specimen — Sponsor — Study — 2438 Kenya Subsidiary Legislation, 2024 R6(1) TECHNICAL CRITERIA FOR DESIGNATING EFFICACY TRIAL CENTERS Introduction This document prescribes the technical requirements for private or public institutions for designation as Efficacy Trial Centers for conducting efficacy studies that support or are intended to support applications for registration of pesticides in Kenya. It is intended to ensure the quality and integrity of efficacy study results that are submitted Kenya in support of pesticides registration or an extension of uses. Definitions Batch — means a specific quantity of the control and test substance. Carrier — means any material (e.g. water, soil, nutrient media, e.t.c) combined with test substance. Control substance — means any chemical substance or mixture, or any HED ‘4 “YS other substance (e.g. microbials) other than the test +499 " yut Tt substance and used for comparison with the test substance. Efficacy Trial Center — means a private or public institution that meets the technical criteria and so designated by the Government of Kenya. Experimental start date — ‘ means the 1" date that the test substance is applied in the study. wae Experimental end date — means the last date on which data is collected from the study. Quality assurance — means compliance with quality assurance of the in studies. Quality registration control — — means the internal process for designated Center to & ensure all steps in the study protocols are followed. Raw data — means all original information collected from the study and necessary for the evaluation of study results. Specimen — means any study subject (target pest) intended for examination and analysis. Sponsor — means the applicant (registration) that financially supports the study. “AUN Ts Study — . means the efficacy trial conducted in a laboratory, greenhouse, or in the field at one or more sites in which the test substance is applied. i d of 24 39Kenya Subsidiary Legislation, 2024 means the individual responsible for the overall conduct of the study , means al l individuals involved in the eff icacy study , means all processes and steps required for testing the test substance and all documentation that is required by the study, means any chemical substance or mixture, or any other substance which is the subject of the efficacy study . Study Director — Study Personnel — Study Protocol — T est sub st anc e — Appl ication Process Private or public institutions shall formally apply for designation as Kenya Designated Efficacy Trial Centre s. Application form attached (A nnex A ) shal l be submitted to PCPB and provide the technical information required by the criteria as explained below. PCPB shall accredit a public or private insti tution to conduct the trials. The duration for which accreditation is valid should be specif ied. Inspection of Efficacy Trial Centre A prospective or Designated Efficacy Trial Centre shall permit an authorized off icial of PCPB at reasonable times and in a reasonable manner , to conduct physical verif ication of the information provided through an inspection. Assessment criteria of institutions involved/ to be involved in carrying out efficacy trials on Pest Control Products is attached (Form B) . A. Testing Institution The Testing Institution shall ensure that: (1) A Study Director is assigned to oversee the execution of an eff icacy trial . The Study Director shall be a scientist or a professional with the required education, training, and experience. The Study Director shall have overall responsibility of conducting the trial , ensuring that all steps in the protocol are followed; trained personnel implement the trial; and appropriate tools are avai l able f or data col lection and do cu m entat i o n . (2) There is a Quality Assurance/Quality Control (QA/QC) Unit , independent of the Study Director. The QA/QC Unit shall be responsible for inspecting aiidujQ ensuring the quality and integrity of the efficacy tri al . I t shal l periodical ly inspect the trial steps and report to the institution management. I t shal l al so rev iew al l documentation and the final report to ensure that the reported results accurately reflect the raw data of the study . (3) Quality Assurance/Quality Control Unit communicate any deviations or problems to the Study Director and ensure corrective actions are taken . (4) Evaluation of test substances against the control for identity , amount , stability, and effectiveness in accordance with the submitted pesticide label is carried , r s . - i ! o u t . Kenya Subsidiary Legislation, 2024 2439 Study Director — means the individual responsible for the overall conduct of the study. Study Personnel — means all individuals involved in the efficacy study. Study Protocol — means all processes and steps required for testing the test substance and all documentation that is required by the study. Test substance — means any chemical substance or mixture, or any other substance which is the subject of the efficacy study. Application Process Private or public institutions shall formally apply for designation as Kenya Designated Efficacy Trial Centre s. Application form attached (Annex A) shall be submitted to PCPB’ and provide the technical information required by the criteria as explained below. PCPB shall accredit a public or private institution to conduct the trials. The duration for which accreditation is valid should be specified. Inspection of Efficacy Trial Centre A prospective or Designated Efficacy Trial Centre shall permit an authorized official of PCPB at reasonable times and in a reasonable manner, to conduct physical verification of the information provided through an inspection. Assessment criteria of institutions involved/ to be involved in carrying out efficacy trials on Pest Control Products is attached (Form B). A. Testing Institution The Testing Institution shall ensure that: (1) A Study Director is assigned to oversee the execution of an efficacy trial. The Study Director shall be a scientist or a professional with the required education, training, and experience. The Study Director shall have overall responsibility of conducting the trial, ensuring that all steps in the protocol are followed; trained personnel implement the trial; and appropriate tools are available for data collection and documentation. (2) There is a Quality Assurance/Quality Control (QA/QC) Unit, independent of the Study Director. The QA/QC Unit shall be responsible for inspecting andsuO ensuring the quality and integrity of the efficacy trial. It shall periodically inspect the trial steps and report to the institution management. It shall also review all. documentation and the final report to ensure that the reported results accurately reflect the raw data of the study. (3) Quality Assurance/Quality Control Unit communicate any deviations or problems to the Study Director and ensure corrective actions are taken. (4) Evaluation of test substances against the control for identity, amount, stability, and effectiveness in accordance with the submitted pesticide label is carried out. Jabot Mabie! Kenya Subsidiary Legislation, 20242 44 0 (5) They provide personnel , resources, faci l ities, equipment , materials, and protocols (and methodologies) before commencement of the experiment . (5) personnel have been properly trained and can perform the functions they are to perform in the study . B . Testing Centre Faci li ty The Testing Centre shal l have: (a) Shall Standard Operating Procedures (SOP) for conducting ef fi cacy trials, (b) Adequate space and infrastructure for effective conduct of the ef fi cacy trial , (c) Indoor , greenhouse or outdoor faci lities. Studies conducted in outdoor f aci l i t ies must be located i n sui table locations, (d) Proper isolation of trial sites to prevent drif t or contami nati on on the efficacy trial , (e) Adequate space for storing and handling of samples and equipment and collection facilities for pesticide waste. C. Eff icacy Trial Personnel The personnel to engage in the effi cacy trials shall (1) Have the minimum professional competence required to conduct effi cacy trial . 2) be knowledgeable of the Study Protocol . 3) be properly trained in the safe use and application of pesticides. D . Records and D ocumentation The Testing Center Facility shall demonstrate the ability to maintain al l raw data, protocols, and fi nal reports resulting from the effi cacy t r i al s . O th er C r i ter i a 1) Previous experience in conducting pesticide effi cacy t r i al s . 2) International accredi tations obtained by the Center . A N N E X E S Form A —Application Form Form B —Inspection Form 2440 Kenya Subsidiary Legislation, 2024 (5) They provide personnel, resources, facilities, equipment, materials, and protocols (and methodologies) before commencement of the experiment. .(5) personnel have been properly trained and can perform the functions they are to perform in the study. B. Testing Centre Facility The Testing Centre shall have: (a) Shall Standard Operating Procedures (SOP) for conducting efficacy trials. (b) Adequate space and infrastructure for effective conduct of the efficacy trial. (c) Indoor, greenhouse or outdoor facilities. Studies conducted in outdoo facilities must be located in suitable locations. ; (d) Proper isolation of trial sites to prevent drift or contamination on the efficacy trial. (e) Adequate space for storing and handling of samples and equipment and collection facilities for pesticide waste. C. Efficacy Trial Personnel ’ The personnel to engage in the efficacy trials shall (1) Have the minimum professional competence required to conduct efficacy trial. 2) be knowledgeable of the Study Protocol. 3) be properly trained in the safe use and application of pesticides. D. Records and Documentation The Testing Center Facility shall demonstrate the ability to maintain all raw data, protocols, and final reports resulting from the efficacy trials. Other Criteria 1) Previous experience in conducting pesticide efficacy trials. 2) International accreditations obtained by the Center. ANNEXES Form A— Application Form Form B— Inspection Form 244 1Kenya Subsidiary Legislation, 2024 APPL ICATION FORM FOR INSTITUTIONS INV OLVED/ TO BE INVOLVED I N CARRYING OUT EFH CACY TRIAL S ON PEST CONTROL PRODUCTS I . In f o r ma t io n f o r A ppl ic an t s a. The Application Form shall be completed by a duly authorized person, b. The application shall be submitted in triplicate to PC P B : c. Every Application shall be accompanied by application fee as prescribed d. The Application shall be accompanied by the evidence as per the specific data requirements 2 . D e t a i l s OF A ppl i c a n t a) Name and Address of institution/researcher: b) Contact person: c) Tel No: , d) Email Address: e) Signature: f) Date: 3 . A r e a s f o r A c c r e d i t a t i o n a) Pest Control Products Category (e.g. Herbicides, Insecticides, Fungicides, et): b) Crops: 4 . Spec i f ic Req u ir ement s f t C i ■ 4 Duri ng the visit the following items shall be evaluated: Please i ndicate level of compl iance Kenya Subsidiary Legislation, 2024 2441 APPLICATION FORM FOR INSTITUTIONS INVOLVED/ TO BE INVOLVED IN CARRYING OUT EFFICACY TRIALS ON PEST CONTROL PRODUCTS 1. INFORMATION FOR APPLICANTS a. The Application Form shall be completed by a duly authorized person. b. The application shall be submitted in triplicate to PCPB: c. Every Application shall be accompanied by application fee as prescribed d. The Application shall be accompanied by the evidence as per the specific data requirements 2. DETAILS OF APPLICANT a) Name and Address of institution/researche®: ..........cccsccccsceseseeeesnersnsersnenseneeerseeens C) Tel NO: .....ccccccccctccec ee cet eee e ence ene n een ee ent e een snes nee ee ere eee s ante e nen ese eee tee neg es ) Email Address: o........ccssesssssssssesssscssssesesesestensscsenseneenpeseseestcsssnssvenssanssesenseeseanenens ©) SiQMature: 00... .cccec cess eee ece eee ence eee e EEE EEE EEE EER EEE EMRE EER EEC EE EE a Ee 3. AREAS FOR ACCREDITATION a) Pest Control Products Category (e.g. Herbicides, Insecticides, Fungicides, et): 4, SPECIFIC REQUIREMENTS During the visit the following items shall be evaluated: Please indicate level of compliance Kenya Subsidiary Legislation, 202424 4 2 ■ i f A G E N E R A L Physical facil ities Of fice space Location/accessibility Availability of Transport Equipment maintenance Cost of doing trials Procedures of keeping records and for how long (archiving) A w areness/ut i l i zation of PCPB tr i al protocol B I M PO R T A N T Facilities: part icularly chemical store, equipment store, other relevant on and off site facil ities) Disposal consideration af ter testing • ■Workers’ safety Mode of assessment (type, time and frequency of assessment, phytotoxicity). Proposed System of report ing Individual report s for each season su b m i t ted ? Subj ected to internal Peer Review C o m m i t tee ? Submission by Head of Depart ment? C C R IT I C A L A vai labi li ty of land/green houses Availability of crops/animals for trials Staf f management - (structure and responsibil ities) 2442 Kenya Subsidiary Legislation, 2024 “AT GENERA Physical facilities Office space Location/accessibility Availability of Transport Equipment maintenance Cost of doing trials Procedures of keeping records and for how long (archiving) Awareness/utilization of PCPB trial protocol B IMPORTANT Facilities: particularly chemical store, equipment store, other relevant on and off site facilities) Disposal consideration after testing Workers’ safety Mode of assessment (type, time and frequency of assessment, phytotoxicity). Proposed System of reporting — Individual reports for each season submitted? Subjected to internal Peer Review Committee? Submission by Head of Department? Cc CRITICAL Availability of land/green houses Availability of crops/animals for trials Staff management — (structure and responsibilities) 244 3Kenya Subsidiary Legislation, 2024 Comniciiis-iiii nl 'C ompli.'IiTiyj*̂ | V E R Y C R I T I C A LD H u m an R eso u r ces: Qualif ications Experience in carrying out efficacy trials A D D E D A D V A N T A G EE Any specif ic internationally recognized testing requirements to be followed Copies of study plans (Trial Protocols for specif ic trials) Testing organization accreditation for any o th er w o r k Standard Operating Procedures Any other uniqueness of the i n st i t u t i o n /c o m m en t . i l t l i an ' rj tn " ' « I i .i u z f . - • 5 ' ■ f Kenya Subsidiary Legislation, 2024 2443 VERY CRITICAL Human Resources: Qualifications Experience in carrying out efficacy trials ADDED ADVANTAGE Any specific internationally recognized testing requirements to be followed Copies of study plans (Trial Protocols for specific trials) Testing organization accreditation for any other work Standard Operating Procedures Any other uniqueness of the institution/comment agi vitsle . se dion Kenya Subsidiary Legislation, 202424 4 4 N O T E : M ET H OD OL OG Y OF A SSESSM EN T Actual visit to the institutions and private researchers shall be undertaken to inspect the faeilities and interview staff involved in effi cacy t r i a l s . D ate F I N A L M A R K S A W A R D E D A ssessmen t Cr i t er ia Of In st i t ut io n s In v o l v ed / T o B e I n v o l v e d I n C a r r y i n g O u t Ef f ic a c y T r i a l s On Pest Con t r o l Pr o d uc t s SC OR E SH EET A N D CRI TERI A OB JECT I V ES OF T H E V I SI T To assess the capacity of private/public institutions to carry out ef f icacy trials on pest control products for registration purposes. To assess the safety of workers involved in efficacy tr i al s and the concerns to t h e en v i r o n m en t . Make recommendations to the Regulatory Authority based on the fi ndings. M E T H O D O F W O R K Actual visit to the institutions and private researchers, inspecting the faci l ities and interviewing staff involved in eff icacy trials, a) N ame and A ddress of insti tution/researcher : b) Contact person: T el . N o : E m ai l A d dr ess : 1. a) b) c) 2 . t 2444 Kenya Subsidiary Legislation, 2024 NOTE: METHODOLOGY OF ASSESSMENT Actual visit to the institutions and private researchers shall be undertaken to inspect the facilities and interview staff involved in efficacy trials. ASSESSMENT CRITERIA OF INSTITUTIONS INVOLVED/ TO BE INVOLVED IN CARRYING OUT EFFICACY TRIALS ON PEST CONTROL PRODUCTS SCORE SHEET AND CRITERIA 1. OBJECTIVES OF THE VISIT a) To assess the capacity of private/public institutions to carry out efficacy trials on pest control products for registration purposes. b) To assess the safety of workers involved in efficacy trials and the concerns to the environment. c) Make recommendations to the Regulatory Authority based on the findings. 2. METHOD OF WORK Actual visit to the institutions and private researchers, inspecting the facilities and interviewing staff involved in efficacy trials. a) Name and Address of institution/researcher: ....csscccccsssscsscsssesessssssesssssssseveceseseeecsssee eo Email Address: ............cccccccccscssscssesecesseseccecersceseeessssesesens streeneecossersencesenssansssneossucaeseeane® e Kenya Subsidiary Legislation, 2024 24 4 5 3. SPECIFIC INSPECTION REQUIREMENTS During the visit the following items shal l be evaluated: I n se r t the sc o re f o r eac h cr i ter i a as i nd i c ated b el o w Recom m ended Total M ari es / Hamionized m arks Evaluator Evaluator Ev aluator Ev aluator I tem Requirements Evaluator 1 2 3 54 Possible by I nd i v i du al G E N E R A LA a s s e s s o r Physical f ac i l i t i e s1 Sh o u l d h a v e com puter , telephone, i n t er n e t ser v i c es Off ice space 1 L o c at i o n / accessibi l ity Sh o u l d b e easy to locate 1 E v i d en c e o f transport for easy access to t r i a l si t e s / A vailabil ity of Transport« 1 M ai n te n an c e sc h ed u l e sh o u l d b e shown (is it reasonable) Equipment m ai n ten an c e 1 A pproximate c o st s f o r v ar i o u s categories sh o u l d b e given C o st o f doing trials 1 P r o c ed u r e s of keeping r ec o r d s an d f o r h o w long (archiving) R ec o r d s m u st b e sh o w n 1 A w are n ess/ u t i l i z a t i o n o f PC P B t r i a l protocol E v id e n ce sh o u l d b e provided for inspection 10 Kenya Subsidiary Legislation, 2024 2445 3. SPECIFIC INSPECTION REQUIREMENTS During the visit the following items shall be evaluated: Insert the score for each criteria as indicated below ‘Recor TOIT rded| Evaluator|Evaluator|Evaluator|Evaluator| Item Requirements |Evaluator 1 4 4 4 5 Total Marks |/ Harmonized marks . Individual assessor 1 Physical facilities Should have computer, Office space| telephone, internet services 1 Location/ Should be accessibility |@asy to locate ; Evidence of Availability |transport for of Transport|easy access to trial sites 1 Maintenance schedule should be shown (is it reasonable) 1 Equipment maintenance Approximate costs for Cost of various doing trials |categories should be given 1 Procedures of -keeping| records and|Records must for how|be shown long (archiving) 1 Awareness/ utilization of — PCPB provided for trial : . inspection protocol 10 Evidence should be Kenya Subsidiary Legislation, 202424 4 6 Recommended Total Maiks t Hannonized tnai k s Evaluator Evaluator Ev aluator Evaluator I tem Requirements Ev aluator 1 2 3 4 5 R em ar k s Total ( 16) B I M P O R T A N T F ac i l i t i e s : particularly c h em i c a l st o r e , equipment store , other r e l ev an t o n an d o f f - si t e facil i ties) Sh o u l d b e sh o w n 5 Disposal consideration after testing 5 W o r k er s ’ safety P er so n a l protective Equipment m u st b e sh o w n 5 M o d e o f a s se s s m e n t i (type, time an d f requency of assessm ent , phytotoxicity) . i t 5 Proposed System of reporting I n d i v i d u al reports for eac h se aso n su b m i t te d ? E v i d en c e o f st r u c tu r ed reporting Subjected to system must internal Peer be provided R ev i ew C o m m i t tee ? for inspection Su b m i ssi o n by Head of Department? 5 R em ar k s Total (25) C C R I T I C A L A vailabi l i ty I f l eased documentary proof requi red o f land/green h o u se s 10 2446 Kenya Subsidiary Legislation, 2024 Item Requirements Evaluator 1 2 3 4 Evaluator|Evaluator|Evaluator/Evaluator| 5 Total Marks Harmonized} Remarks Total (16) IMPORTANT Facilities: particularly chemical store, equipment store, other relevant on and off-site] facilities) Should be shown Disposal consideration after testing Workers’ safety Personal protective Equipment must be shown Mode of assessment (type, time and frequency of assessment, phytotoxicity). i i --|submitted? Proposed System of reporting — Individual reports for each season Subjected to internal Peer} Review Committee? Submission by Head of Department? Evidence of structured reporting system must be provided for inspection 5 Remarks Total (25) CRITICAL Availability of land/green If leased documentary proof required| houses 10 co Kenya Subsidiary Legislati on, 2024 244 7 Reootnmended Evaluator Ev aluatoi Ev aluator EvaluatorI tem Require ments Evaluator 1 T otal M ark s / H armonized m aik s 2 3 4 5 E v i d en c e sh o u l d b e sh o w n o r l ease agreem ent , as appl icable A vai labi lity of crops for t r i a l s 10 Labaratory f aci l i t ies 5 St af f m anagem ent (structure Responsible of f i cer m ust be clearly i d en t i f i ed an d responsibi l i ties) 10 R e m ar k s Total (35) V E R Y C R I T I C A L D H u m an R e so u r c es : Qual ifi cations Experience in carry ing out ef fi cacy t r i a l s L ead r e sear c h er m u st h av e m i nim um of a r e l ev an t M .Sc degree (Masters 10 & PhD 15) L ead r e se ar c h er m u st h av e practical experience on r e l ev an t crop/pest ; • ! .-rn / St i l t « 15 5 R em ar k s (Total 20) A D D E D A DV A NT A GE E ■i r i i j ''" A ny specifi c intera ationally recognized testing requirements to b e f o l l o w ed . 1 Copies of study plans (Trial Protocol s for specifi c trials) M u st b e provided for inspection 1 Kenya Subsidiary Legislation, 2024 Item Requirements Evaluator 1 Evaluator|EvaluatorEvaluator|Evaluator 2 3 4 5 Total Marks Availability of crops for trials Evidence should be shown or lease agreement, as applicable 10 Labaratory facilities Staff management — (structure) and responsibilities) Responsible officer must be clearly identified 10 Remarks Total (35) VERY CRITICAL Human Resources: Qualifications Experience in carrying} out efficacy trials Lead researcher must have minimum of a relevant M.Sc degree (Masters 10 &PhD 15) Lead researcher must have practical experience on relevant crop/pest wt crust ant 15 5 Remarks (Total 20) ADDED ADVANTAGE Tia oh GLee: 4 Any specific internationally recognized testing requirements to be followed. Copies of study plans (Trial Protocols for specific trials) Must be provided for inspection Kenya Subsidiary Legislation, 20242 4 4 8 Reccm mended Total M ari es ̂ Harmonized mari cs Evaluator Ev aluator Evaluato r Evaluato r I tem Requirements Evaluato r 1 2 3 4 5 Testing organization ac c r ed i ted for any other w ork ? 1 St an d ar d Operating P r o c ed u r e s SO P ’ S sh o u l d be provided for inspection 1 R em ar k s 4)Su b -t o t al T O T A L M A R K S 10 0 Reoemmendation Pass M ark = 70% but part D is mandatory N am e o f A ssesso r : — . .. O 'l - a F i n al R ec o m m en d at i o n : [R eco m m en d ed t f o r G en er al r em ark s: [N o t R eco m m end ed 2448 Kenya Subsidiary Legislation, 2024 Item ‘Requirements Evaluator Joye ‘orpvauinor eva " Total Marks !/ Harmonized! Testing organization accredited for any other work? 1 Standard SOP’s should Operating be provided Procedures |for inspection 1 Remarks Sub-total 4) TOTAL MARKS 100 Recommendation Pass Mark = 70% but part D is mandatory Name of ASSCSSOL: — .......esescsesscescessessecesecnecnesncenceacenseenecaseneesecenseenecueoressssossessassseosasseaones O1-8 ie. Final Recommendation: Recommended | General remarks: .0.......ccccccccccessssssscesssvnssscuecssuceesesvecceeeseseasceseccecsnsseceeeecesseneeeescesenneeseceseseneees Not Recommended [| “ Kenya Subsidiary Legislation, 2024 24 4 9 Marks shall be awarded according to the criteria, where the M aximum possible mark is indicated. The categories are as indicated b el o w G e n e r a l (where max awarded f or ea ch = 1 I m po r t a n t W h er e m ax awarded f or ea ch - 5 C r i t i c a l Wh er e ma x awarded f or each = 10 Ver y C r i t i c a l W her e m ax awarded f or ea ch = 10 A d d ed A D V A N T A G E max f or each = 1 OlTice space C h em i c al sto r e L an d /G r een ho u se/ Lease agreement H u m an reso u r ce Stan d ar d operating procedures Avai labil ity of transport Disposal c o n si der at i o n Crops Study plans L o c at i o n Workers safety Pr o to co l a w a r e n e s s O th er internationally recognized protocols Pr o ced ur es o f keeping records A ssessm en t m o de Staf f management st r u c t u r e O ther ac c red i tat i o n C o sts o f t r i al s System of reporting O th er t r i al si tes M ai n ten an ce o f equipment Sub -t o t a l = 16 Su b -t o t a l = Su b -t o t a l = 35 Sub -t o t a l = 20 Sub -t o t a l = 04 2 5 * Any other observations — ♦ t . Kenya Subsidiary Legislation, 2024 2449 Marks shall be awarded according to the criteria, where the Maximum possible mark is indicated. The categories are as indicated below GENERAL IMPORTANT CRITICAL VERY CRITICAL ADDED (where max Where max Where max Where max ADVANTAGE awarded for awarded for | awarded for each| awarded for max for each = I each = 1 each = 5 =10 each = 10 ~ Office space Chemical store |Land/Greenhouse/|Human resource |Standard Lease agreement operating procedures Availability of {Disposal Crops Study plans transport consideration Location Workers safety |Protocol Other awareness internationally recognized protocols Procedures of |Assessment Staff management Other keeping records jmode structure accreditation Costs of trials |System of Other trial sites reporting Maintenance of equipment SUB-TOTAL = 16 |SUB-TOTAL= |SUB-TOTAL=35 |SUB-TOTAL=20 |SUB-TOTAL = 04 25 vit Any other observations — Kenya Subsidiary Legislation, 202424 50 (r .30(2))SE C O N D SC H E D U L E I t e m s E x e m pt e d F r o m R eg i st r a t i o n Garment bags, cabinets or chests that are manufactured, represented or sold as a . means to protect clothing or fabrics from pests. Electronic apparatus that is manufactured, represented o r so ld as a m ean s to at t r ac t or destroy f lying insects. Devices of products that are manufactured, represented or sold to repel birds and other pests by causing physical discomfort by means o f so u nd o r t o uc h . Devices of attachment to garden watering hoses that are manufactured, represented or sold as pest control product . 5. . Devices that are manufactured, represented or sold as a means of providing the automatic or unattended application of a pest control product . Devices that are sold for use with chemical products containing cyanide as a means to control animal pests. Devices that are meant to control any pest through physical or mechanical means provided that there are no known environmental hazards expected from the use of th e d ev i ce . M ade on the 22nd M ay , 2024. 1 . 2 . 3 . 4 . 6 . 7 . M I T H I K A L IN T UR I , Cabinet Secretary f or Agr icul ture and L ivestock Development. * PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTER , NAIROBI 2450 Kenya Subsidiary Legislation, 2024 SECOND SCHEDULE | — (r.30(2)) ITEMS EXEMPTED FROM REGISTRATION 1. Garment bags, cabinets or chests that are manufactured, represented or sold as a . means to protect clothing or fabrics from pests. Electronic apparatus that is manufactured, represented or sold as a means to attract or destroy flying insects. Devices of products that are manufactured, represented or sold to repel birds and other pests by causing physical discomfort by means of sound or touch. Devices of attachment to garden watering hoses that are manufactured, represented or sold as pest control product. . Devices that are manufactured, represented or sold as a means of providing the automatic or unattended application of a pest control product. Devices that are sold for use with chemical products containing cyanide as a means to control animal pests. Devices that are meant to control any pest through physical or mechanical means provided that there are no known environmental hazards expected from the use of the device. Made on the 22nd May, 2024. MITHIKA LINTURI, Cabinet Secretary for Agriculture and Livestock Development. PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTER, NAIROBI o e * % I EV bh r i ■V J — —