Pest Control Products (Registration) Regulations (Cap. 346)

CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 24 PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 1984 [L.N. 46/1984, L.N. 109/1984, L.N. 123/2006.] 1. Citation These Regulations may be cited as the Pest Control Products (Registration) Regulations, 1984. 2. Interpretation In these Regulations, unless the context otherwise requires— “accredited scientists/institution” 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; “active ingredient” means an ingredient of a pest control product to which the effects of the pest control product are attributed and includes a synergist; but does not include a component that by itself is not primarily responsible for the control effect of the pest control product; “biochemical pesticide” means a pest control product whose active ingredient constitutes a chemical derived from naturally occurring plant or animal intended to control invertebrate pests; “certificate of registration” means a certificate issued by the Board under regulation 7; “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 and efficacy trials prior to consideration for registration; “microbial and macrobial biopesticide” means a pest control product of naturally occurring micro-organisms (microbiological agents viruses and rickettsia; bacteria, protozoa, fungi,) and macro-organisms (macro biological agents such as predators, parasitoids and entomopathogenic nematodes ), respectively intended for the control of invertebrate pests weeds, pathogens of crops, and pests of livestock and public health and to which effects of the pest control products or active agent are attributed but does not include a component that by itself is not primarily responsible for the control effect of the pest control product or genetically modified living micro organism and macro-organism; “residue” means the ingredient of a pest control product that remains after the pest control product has been used and includes substances resulting from degradation or metabolism. [L.N. 123/2006, s. 2.] 3. Exemption from registration A pest control product shall be exempt from registration if— (a) it is for use by a person for research purposes if that use has been approved by the Board; (b) it is a type or kind set out in the First Schedule and meets the conditions relevant to that substance as set out in that Schedule. [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 25 [Issue 1] 3A (1) Every person desiring to introduce a pest control product for efficacy testing shall— (a) make application to the Board for an experimental permit in Form C set out in the Second Schedule; (b) provide all the details required in the form; (c) on request supply any further information which may be required by the Board; and (d) pay the prescribed application fees determined by the Board from time to time therefor. (2) (a) The Board shall evaluate the data provided and if satisfied that the application merits approval, shall issue an experimental permit in the prescribed Form D in the Second Schedule; (b) The Board shall, in addition, give the applicant information relating to the existing accredited scientists or institutions in the field of trial whom the applicant will work with; (3) When the efficacy trials are complete the accredited scientist or institution shall submit efficacy reports to the Board. [L.N. 123/2006, s. 3.] 4. Application for registration of pest control products (1) Every person desiring to register a pest control product shall make application to the Board in either Forms A, A1, A2 or A3 set out in the Second Schedule and shall, on request, supply any further information which may be required by the Board. 1 (A) (a) The application for registration of a synthetic or conventional pest control product under Regulation 4(1) shall be in the prescribed Form A completed by the applicant or duly authorized person and submitted in triplicate. (b) The Board shall supply the applicant with check lists and an index to ensure that the applicant has supplied the relevant data required in Form A in the Second Schedule. (B) (a) The application for registration of microbial biopesticide shall be in the prescribed Form A1. (b) Information in support of a request for registration, both published and unpublished (fully cited) shall be supplied in the form of a summary data sheet as required in Form A1. (c) Pre-registration consultations between the applicant and the registration authority shall be undertaken after the application has been made. (d) All applicants intending to import/export live organisms into or out of the country shall comply with any other existing laws governing such organisms. (e) The use of genetically modified organisms and living modified organisms as microbial biopesticides shall comply with any other existing laws governing such organisms before an application is made to the Board. (f) The Board shall supply check lists and an index to ensure that the applicant has provided all relevant data and cited material. (C) (a) The application form for registration of macrobial biopesticide shall be as set out in Form A2. (b) Information in support of a request for registration, both published and unpublished (fully cited) shall be supplied in the form of a summary data sheet laid out according to the format given in Form A2. (c) Pre-registration consultations between the applicant and the registration authority shall be undertaken after the application has been made. CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 26 (d) The applicant shall be required to— (i) submit a sample of the pest control product with National Museums of Kenya or National Collection Number obtained if already in collection; (ii) provide a sample of the technical grade of its active agent; (iii) send an additional sample to the National Agricultural Research Laboratories [NARL], Biological Control Unit, Muguga (Kenya Agricultural Research Institute), and Kenya Plant Health Inspectorate Service; (iv) supply any other sample as may be requested by the Board. (e) All applicants intending to import/export live organisms into or out of the country shall comply with any other existing laws governing such organisms. (f) The use of genetically modified organisms and living modified organisms as macrobial biopesticides shall comply with any other existing laws governing such organisms before an application is made to the Board. (g) the Board shall supply check lists and an index to ensure that the applicant has provided all relevant data and all cited material. (D) (i) The application form for the registration of a biochemical pesticide shall be in Form A3 in the Second Schedule. (ii) Information in support of a request for registration, both published and unpublished shall be supplied in form of a summary data sheet laid out according to the format given in Form A3. (iii) Pre-registration consultation between the applicant and the registration authority shall be undertaken. (2) An applicant who is not resident in Kenya shall appoint an agent permanently resident in Kenya to whom any notice or correspondence may be sent. (3) An application for the registration of a pest control product shall be accompanied by five copies of the proposed label for the pest control product or reasonable facsimiles thereof. (4) An applicant who is not resident in Kenya shall be required to deposit with the Board a binding agreement entered with the agent permanently resident in Kenya. [L.N. 123/2006, s. 4, s. 4] 5. Applicant to provide samples 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 its active ingredient; (c) a sample of the laboratory standard of its active ingredient; and (d) any other sample as may be required by the Board. 6. Registration fees The fees payable by an applicant for the registration of a pest control product shall be the prescribed fees determined by the Board from time to time where a pest control product is a device or it contains an active ingredient that has been previously assessed or evaluated for the purpose of the Act and these Regulations. 7. Issue of certificate of registration (1) The Board shall consider the application under regulation 4, and, if it is satisfied of the safety, efficacy, quality and economic value of the pest control product, shall register the pest control product, and issue a certificate of registration which shall be in Form B set out in the Second Schedule. [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 27 [Issue 1] (2) If the Board is not satisfied as to the safety, efficacy, quality and economic value of the pest control product it may, after providing an opportunity for the applicant to be heard, reject the application for the registration of the pest control product and inform the applicant the reasons for the rejection in writing. (3) No person to whom a certificate of registration has been issued under this Regulation shall lend, hire, sell, transfer or otherwise dispose of the certificate to any other person without the approval of the Board, which approval shall be endorsed on the certificate of registration. 8. Duration and renewal of certificate of registration (1) A certificate of registration issued under these Regulations shall, unless earlier suspended or revoked, be valid for a period of three years from the date of issue and may thereafter be renewed for periods not exceeding two years at any one time. (2) The fee for the renewal of a certificate of registration shall be the prescribed fees determined by the Board from time to time, and an application for renewal shall be accompanied by five copies of the current label for the pest control product. (3) A holder of a certificate of registration issued under these Regulations shall give a notice to the Board in writing at least 3 months before the expiry of the registration of any intentions to keep the product registration in abeyance for a period not exceeding 5 years and the notice shall— (a) give reasons for temporary withdrawal; and (b) show the records of all quantities of the pest control product in stock, manufactured or sold by him. (4) The Board shall consider the notification under subregulation (3) and if it is satisfied with the reasons for temporary withdrawal shall suspend the registration of the pest control product for a period not exceeding 5 years. (5) The information on suspended registration under subregulation (4) shall be made known to the holder in writing and the general public by Gazette notice. (6) A person whose certificate of registration has been suspended under subregulation (4) shall withdraw the product from the market within a period of 3 months from the date of expiry of registration. (7) A person whose certificate of registration has been suspended under these Regulations shall give a notice to the Board in writing of any intentions to reintroduce the product registration and the notice shall— (a) give reasons for reintroduction, (b) be accompanied by a fee for the renewal of a certificate of registration for the preceding two years and the current year, (c) be accompanied by five copies of the current label for the pest control product. (8) A holder of a certificate of registration issued under these Regulations whose product registration has been suspended for a period exceeding five years shall apply for registration afresh and shall, on request supply any further information, which may be required by the Board. 9. Temporary registration (1) The Board may upon such terms and conditions as it may specify, on payment of a prescribed fee determined by the Board from time to time, register a pest control product for a period not exceeding one year where— (2) Any terms and conditions specified by the Board under paragraph (1) shall be contained in the temporary certificate of registration. CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 28 10. Refusal to register pest control The Board may refuse to register a pest control product if in its opinion— (a) the applicant for registration or the label for the pest control product does not comply with, the provisions of the Act and these Regulation; (b) the information provided to the Board by the applicant is insufficient to enable the pest control product to be assessed or evaluated; (c) the applicant fails to establish that the pest control product has merit or value for the purpose claimed when the pest control product is used in accordance with its label directions; or (d) the 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. 11. Suspension and revocation of certificates of registration (1) The Board may suspend or revoke a certificate of registration issued under these Regulations for such time as the Board may determine. (2) The powers conferred by paragraph (1) shall not be exercised by the Board except on one or more of the following grounds— (a) that the matters stated in the application on which the certificate of registration was granted were false or incomplete in a material particular; (b) that new information has become available to the Board which renders the pest control product unsafe or dangerous; (c) that the premises on which, or on part of which, the pest control product is manufactured, assembled or stored by or on behalf of the holder of the certificate of registration are unsuitable for the manufacturing, assembly or storage of pest control products; (d) that the holder of a certificate of registration has given a notice to the Board in writing of any intentions to suspend product registration for a period not exceeding 5 years; 12. Notice to holder of certificate of registration, etc. Where the Board— (a) refuses to register a pest control products; or (b) suspends or revokes the certificate of registration, it shall send to the applicant or the holder of a certificate of registration, as the case may be, a notice by registered post notifying him of the refusal, suspension or revocation. 13. Appeals (1) An applicant or holder of a certificate of registration who has received a notice under regulation 12 may within thirty days from the date which the notice is received by him appeal to the Minister, who may amend or vary the decision as he thinks fit and whose decision shall be final. 14. Records A holder of a certificate of registration issued under these Regulations shall keep a record of all the quantities of pest control products stored, manufactured or sold by him and the record shall— (a) be maintained for five years from the time it is made; and [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 29 [Issue 1] (b) be made available to the Board at such times and in much manner as the Board may require. FIRST SCHEDULE [Regulation 3.] 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, 2. Electronic apparatus that is manufactured, represented or sold as a means to attract or destroy flying insects. 3. 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. 4. 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. 6. Devices that are sold for use with chemical products containing cyanide as a means to control animal pests. SECOND SCHEDULE FORM A APPLICATION FOR REGISTRATION OF A PEST CONTROL PRODUCT (CONVENTIONAL) TRADE NAME OF THE PRODUCT ..................................................................................................... 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) Other (Explain) ............................................................................................................................... Will the product he marketed under own label? Yes No If no, specify ......................................................................................................................................... Proposed date of marketing ................................................................................................................. CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 30 SECOND SCHEDULE, FORM A—continued 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) 1.2 Status (Importer/formulator/distributor) Business Registration No. 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. PRODUCT Trade name Trade mark 2.1 Designation (Description of product) Trade mark holder 2.2 Function of product: (eg. Insecticide, herbicide etc.) 2.3 Intended use: (Veterinary, public health, industrial, agriculture, forestry, etc. 2.4 Target pest(s) and host(s) 2.5 Method, dosage rates and frequency of application 2.6 Type of formulation (eg. EC, WP, etc.) Crop Life International(CLI*) Code (if available) Yes No 2.7 (a) Is the product registered in country of manufacture? If no, give reasons Yes No (b) Is the product registered in the country of formulation? 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) [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 31 [Issue 1] SECOND SCHEDULE, FORM A—continued 3. COMPOSITION OF ACTIVE INGREDIENT(S) (Technical grade) (Information on a.i. may be attached in sealed envelope) Active ingredient(s) (Common name/s) Manufacturer (Name and address) Minimum a.i.% purity a.i. Range % 4. FORMULATION 4.1 Formulator: (Name) Postal Address Physical address 4.2 Internal code 4.3 Composition (Information on composition may he attached in sealed envelope) Ingredients and Function g/l g/kg Range * Formerly GCPF * SEARCH - Southern and Eastern African Regulation Committee on Harmonization of Pesticide Registration. 5. TOXICOLOGY (formulated product) 5.1 Rat Acute Oral (LD50 mg/kg) Acute Dermal (LD50 mg/kg) Inhalation LC50 (mg/I/hour) Experimental Experimental Experimental Calculated Calculated Calculated 5.2 Rabbit Skin irritation Eye irritation None Mild Moderate Severe 5.3 Skin Sensitization in guinea pig: (tick) No Mild Moderate Severe 5.4 WHO classification Ia Ib II III Others 5.5. Summary of other mammalian toxicological studies: eg. livestock, 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 5.6.5 Toxicity to other non-target organisms CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 32 SECOND SCHEDULE, FORM A—continued 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 Human exposure (a) Dermal absorption. (b) Likely human 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 ............................................................................................................................. 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. ............................................................................. .......................................................................... Name in full (printed) Signature ............................................................................. .......................................................................... Official Title Date Official Stamp of Applicant / Company FOR OFFICIAL USE Remarks .......................................................................... .......................................................................... .................................... .................................... Signed: Date NOTE: The format of this application is recognized by all SEARCH countries. FORM A1 APPLICATION FOR REGISTRATION OF A MICROBIAL BIOPESTICIDE (PEST CONTROL PRODUCTS — MICROBIAL AGENT) TRADE NAME OF THE PRODUCT ..................................................................................................... POSE OF APPLICATION (tick as appropriate) .................................................................................... (a) Biopesticides containing a new active agent (b) Biopesticides where source of active and/or formulation is not identical to that of a registered product [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 33 [Issue 1] SECOND SCHEDULE, FORM A1—continued (c) Registration transfer (d) Amendments to existing registration (e) Other (Explain) Will the product be marketed under own label? Yes No If No, specify ......................................................................................................................................... 1. APPLICANT Name of applicant Corporate name of company Reg No. Name of registration holder: Name of local agent in country: (if different from registration holder) Status: (Importer/formulator/distributor etc.) Physical Address Postal Address Telephone (and area code) Fax (and area code) E-Mail 2. PRODUCT 2.1 Dentity and stage(s) of active agent and culture collection code. 2.2 Concentration of active agent in technical material. Trade name Trade mark Trade mark holder 2.3 Designation (Description of product). Internal code 2.4 Function of product: (e.g. Insecticide, herbicide etc.). 2.5 Intended use: (Veterinary, horticultural, public health, industrial, agriculture, forestry, etc). 2.6 Target pest(s) and host(s). 2.7 Method, dosage rates and frequency of application. CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 34 SECOND SCHEDULE, FORM A1—continued 2.8 Type of formulation (e.g. Suspension, WP, etc.). 2.9 Is the product registered in country of— Yes No (a) origin If no, specify ........................................................ (b) manufacture Yes No (c) formulation If no, specify ........................................................ 2.10 Registration in SEARCH country/ies (country names, product name and registration number). 2.11 Registration in other country/ies, particularly OECD countries: (country name, product name and registration number). 2.12 Customs Tariff Code (Brussels Tariff Nomenclature). 3. IDENTIFICATION 3.1 Identification of Micro-organism. Life stage (spore, hyphae etc) 3.2 Identification Scientific. name common name(s). Genus Species Sub species 3.3 Contents.(number per Unit) 4. COMPOSITION OF MICROBIAL PEST CONTROL AGENT(S) (Technical grade) (Information on active agent may be attached in sealed envelope) Active agent(s) (Common name/) Manufacturer (Name and address) Minimum a.i.% purity a.i. Range % 5. FORMULATION 5.1 Formulator: (Name) Postal Address Internal code Physical address (8) Composition (Information on composition may be attached in sealed envelope) Ingredients and Function Units (w/w, w/v etc.) Units (e.g. cfu or IUP) Range 6. BIOLOGICAL PROPERTIES OF ACTIVE AGENT 6.1 History and geographical distribution of active agent 6.2 Mode of action and host range 6.3 Life cycle 6.4 Infectivity, dispersal and colonizing ability 6.5 Relationships to known plant, animal or human pathogens [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 35 [Issue 1] SECOND SCHEDULE, FORM A1—continued 6.6 Genetic stability 6.7 Information on the production of metabolites, especially antibiotics and toxins 7. TOXICOLOGY (active agent) 7.1 Rat Acute Oral (LD50mg/kg) Inhalation LC50 (mg/4/hour) Intra-peritoneal injection for infectivity (LD50 g/kg) Experimental Experimental Experimental Calculated Calculated Calculated Hypersensitivity/ allergies in humans 8. TOXICOLOGY (formulated product) Acute Oral (LD50 mg/kg) Acute Dermal (LD50 g/kg) Inhalation LC50 (mg/4/hour) Experimental Experimental Experimental Calculated Calculated Calculated 8.2 Rabbit Skin irritation Eye irritation None Mild Moderate Severe 8.3 Skin Sensitization in guinea pig: (tick) None Mild Moderate Severe 8.4 WHO classification (tick) Ia Ib II III Others 8.5 Summary of other mammalian toxicological studies: e.g. livestock, wildlife, poultry, pets 9. ECOTOXICOLOGY 9.1 Toxicity to bees 9.2 Toxicity to fish and other aquatic organisms 9.3 Toxicity to birds 9.4 Toxicity to earthworms or other soil invertebrates. and soil micro organisms 9.5 Toxicity to other non-target organisms 9.6 Persistence in environment 9.7 Available toxicological data relating to other ingredients in formulation (non active additives in formulation) 9.8 Other effects: Specify CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 36 SECOND SCHEDULE, FORM A1—continued 10. PACKAGING 10.1 Packaging material / container 10.2 Pack size(s) 10.3 Disposal of empty container(s) 11. OTHER SPECIFIC REQUIREMENTS 11.1 Operator exposure 11.2 Sanitary and phytosanitary measures Yes 11.3 Has the product been cleared by the phytosanitary authorities? (tick) (provide evidence) (a) in the country of origin No (b) the recipient country (give reasons) 12. DECLARATION For and on behalf 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. .................................................................... ............................................................................. Name in full (printed) Signature .................................................................... ............................................................................. Official Title Date FORM A2 APPLICATION FOR REGISTRATION OF A MACROBIAL BIOPESTICIDE (PEST CONTROL PRODUCTS — MACROBIOLOGICAL AGENT) PRODUCT TRADE NAME ................................................................................................................... PURPOSE OF APPLICATION (tick as appropriate) (a) Biopesticides containing a new active agent (b) Biopesticides 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) Other (Explain) Will the product be marketed under own label? Yes No If No, specify ......................................................................................................................................... Proposed date of marketing ................................................................................................................. ............................................................................................................................................................... [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 37 [Issue 1] SECOND SCHEDULE, FORM A2—continued 1. APPLICANT 1.1 Name of applicant 1.2 Corporate name of company 1.3 Reg. No. of the company 1.4 Name of registration holder 1.5 Name of local agent in country (if different from registration holder) 1.6 Status: (Importer/formulator/distributor etc.) 1.7 Physical Address 1 2 1.8 Postal Address 1 2 1.9 Telephone (and area code) 1 2 Fax (and area code) 1 2 E-Mail 1 2 2. PRODUCT 2.1 Identity and stage(s) of active agent and culture collection code. 2.2 Concentration of active agent in technical material. Trade name Trade mark Trade mark holder 2.3 Description of product. Internal code 2.4 Function of the product: (e.g. predator, parasitoid, entomopathogenic nematode). 2.5 Intended use: (veterinary, horticultural, public health, industrial, agriculture, forestry, etc). 2.6 Target pest(s) and host(s). 2.7 Method, dosage rates and frequency of application. 2.8 Type of formulation: (if any). Yes No 2.9 Is the product registered in country of If no, specify ............................................... Yes No (a) origin If no, specify ............................................... (b) manufacture Yes No (c) formulation If no, specify ............................................... CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 38 SECOND SCHEDULE, FORM A2—continued 2.10 Registration in SEARCH country(ies) (country names, product name and registration number). 2.11 Registration in other country(ies), particularly OECD countries (country names, product name and registration number). 2.12 Customs Tariff Code (Brussels Tariff Nomenclature). 3. IDENTIFICATION Identification of Macrobiological agent Life stage (egg/adult/larva etc) Genus Species Sub species 3.1 Identification Scientific name Common name(s) 3.2 Contents (number per Unit) 4. SOURCE Source (original isolation) 5. FORMULATION 5.1 Formulator (Name) Postal Address 5.2 Internal code Physical address 5.3 Composition (information on composition may be attached in sealed envelop) Ingredients and Function Units Range 6. SUMMARY OF ENVIRONMENTAL EFFECTS (BIOSAFETY) 6.1 Risk assessment for replacement of indigenous or endangered species in same niche (exotic macrobials only) 6.2 Risk to bees 6.3 Risk to fish and other aquatic organisms 6.4 Risk to birds 6.5 Risk to earthworms and soil micro organisms 6.6 Risk to other non-target organisms 6.7 Other effects: specify (human health problems) 7. PACKAGING 7.1 Packaging material/container 7.2 Pack size(s) [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 39 [Issue 1] SECOND SCHEDULE, FORM A2—continued 8. OTHER SPECIFIC REQUIREMENTS 8.1 operator exposure 8.2 Likely operator exposure under field conditions 8.3 Sanitary and phytosanitary measures 8.4 Has the product been cleared by the phytosanitary authorities? Yes No 9. DECLARATION For and on behalf 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 ................................................................................. .................................................................... Name in full (printed) Signature ................................................................................. .................................................................... Official Title Date NOTE: The format of this application form is recognized by all SEARCH countries. FORM A3 APPLICATION FOR REGISTRATION OF A BIOCHEMICAL PESTICIDE (PEST CONTROL PRODUCT — BIOCHEMICAL PRODUCTS) PRODUCT TRADE NAME ................................................................................................................... PURPOSE OF APPLICATION (tick as appropriate) a. Biochemical pesticides containing a new active ingredient b. Biochemical pesticides 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. Other (Explain) ..................................................................................................................................................... ..................................................................................................................................................... Will the product be marketed under own label Yes No If no, specify ...................................................................................................................................... 1. APPLICANT 1.1 Identification CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 40 SECOND SCHEDULE, FORM A3—continued 1.2 Name of applicant/Corporate name of company 1.3 Reg No. 1.4 Name of registration holder 1.5 Name of local agent in country (if different from registration holder) 1.6 Status Importer/formulator/distributor) etc. 1.7 Physical Address 1.8 Postal Address 1.9 Telephone (and area code) 1.10 Fax (and area code) 1.11 E-mail 2. PEST CONTROL PRODUCTS 2.1 Identity 2.2 Concentration of a.i. Trade name Trade mark Trade mark holder 2.3 Designation (Description of pi (duct) Internal code 2.4 Function of product (e.g. Insecticide, herbicide etc.) 2.5 Intended use (Veterinary, public health, industrial, agricultural, forestry, etc. 2.6 Target pest(s) and host(s) 2.7 Method, dosage rates and frequency of application 2.8 Type of formulation (e.g. EC, WP, etc.) 2.9 Is the product registered in country of (a) origin Yes No If no, specify ..................................................... (b) manufacture Yes No If no, specify ..................................................... (c) formulation Yes No [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 41 [Issue 1] SECOND SCHEDULE, FORM A3—continued If no, specify ..................................................... 2.10 Registration in SEARCH**country/ies (names) 2.11 Registration in other country/ies, especially OECD countries (names) 2.12 Customs Tariff Code (Brussels Tariff Nomenclature) *Formerly GCPF. **SEARCH — Southern and Eastern African Regulatory Committee on Harmonization of Pesticide Registration 3. COMPOSITION OF ACTIVE INGREDIENT(S) (Technical grade) (Information on a.i may be attached in sealed envelope) Activei ngredient(s): (Common name/s) Manufacturer: (Name and address) Minimum a.i.% purity a.i. Range % 4. TOXICOLOGY OF ACTIVEINGREDIENTS (Technical grade) Acute Oral (LD50 mg/kg) Acute dermal (LD50 mg/kg) Inhalation LC50 (mg/I/hour) Experimental Experimental Experimental Calculated Calculated Calculated 5. FORMULATION 5.1 Formulator (Name) Postal Address 5.2 Internal code Physical address 5.3 Composition (Information on composition may be attached in sealed envelope) Ingredients and Function Units Units Range 6. TOXICOLOGY (formulated product) 6.1 Rat Acute Oral (LD50 mg/kg) Acute Dermal (LD50 g/kg) Inhalation LC50 (mg/I/hour) Experimental Experimental Experimental Calculated Calculated Calculated 6.2 Rabbit Skin irritation Eye irritation None Mild Moderate Severe 6.3 Skin Sensitization in guinea pig (tick) None Mild Moderate Severe 6.4 WHO classification Ia Ib H III Others CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 42 SECOND SCHEDULE, FORM A3—continued 6.5 Summary of other mammalian toxicological information may be required 6.6 Summary of environmental effects 6.6.1 Toxicity to bees 6.6.2 Toxicity to fish and other aquatic organisms 6.6.3 Toxicity to birds 6.6.4 Toxicity to earthworms and soil micro-organisms 6.6.5 Toxicity to other non-target organisms may be required 6.6.6 Persistence in environment 6.6.7 Other effects: Specify 7 PACKAGING 7.1 Packaging material / container 7.2 Pack size(s) 7.3 Disposal of empty container(s) 8. OTHER SPECIFIC REQUIREMENTS 8.1 Operator exposure 8.2 Dermal absorption 8.3 Likely operator exposure under field conditions 8.4 Available toxicological data relating to other ingredients in formulation (non- active additives in formulation). 9. DECLARATION For and on behalf 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. ............................................................................. ............................................................................. Name in full (printed) Signature ............................................................................. ............................................................................ Official Title Date FOR OFFICIAL USE Remarks ............................................................. ............................................................................. ............................................................................. ............................................................................. ..................................... .................................... Official Stamp of Applicant / Company Signed Date NOTE: The format of this application form is recognized by all SEARCH countries. [Rev. 2012] CAP. 346 Pest Control Products [Subsidiary] 43 [Issue 1] FORM C PEST CONTROL PRODUCTS ACT (CAP. 346) PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 2006 APPLICATION FOR THE INTRODUCTION OF NEW PEST CONTROL PRODUCT (To be Completed and Submitted in Triplicate) To: The Managing Director Pest Control Products Board P.O. Box 13794-00800 Westlands, Nairobi APPLICANT'S NAME AND ADDRESS ................................................................................................ ............................................................................................................................................................... Tel No ................................................................Fax No ...................................................................... STATUS OF APPLICANT (Manufacturer, agent etc) ........................................................................... ............................................................................................................................................................... ............................................................................................................................................................... 1. Approved Common Name(s) ......................................................................................................... 2. Chemical Name .............................................................................................................................. 3. Chemical formula ........................................................................................................................... 4. Chemical Structure. ........................................................................................................................ 5. Trade Name(s) ............................................................................................................................... 6. Proposed Kenyan Name(s) ............................................................................................................ 7. Formulation Type (W.P., E.C., Dust etc. ........................................................................................ 8. Concentration of Each Active Ingredients ...................................................................................... 9. Quantity required for testing ........................................................................................................... 10. Proposed Uses (Agricultural, Health, Veterinary, Forestry etc. ...................................................... 11. Location and Area of Test Plots ..................................................................................................... 12. Target pest(s) Host(s) or Area of Application ................................................................................. 13. Mode of action ................................................................................................................................ 14. Toxicity of the product to test animals (Acute Oral and Dermal LD50 Inhalation LC50 etc. .......... 15. The effects of the product on the environment— (a) Toxicity to bees ....................................................................................................................... (b) Toxicity to fish ......................................................................................................................... (c) Toxicity to birds ....................................................................................................................... (d) Toxicity to soil micro-organisms ............................................................................................. 16. Proposed precautions to users ...................................................................................................... 17. Antidote, Treatment of poisoning ................................................................................................... 18. Shelf life of the product .................................................................................................................. 19. Country of Origin of the product ..................................................................................................... 20. Name and Address of manufacturer .............................................................................................. 21. Name and address of formulator .................................................................................................... 22. Countries where tested and registered .......................................................................................... 23. Ownership of data (name, address) ............................................................................................... CAP. 346 [Rev. 2012] Pest Control Products [Subsidiary] [Issue 1] 44 SECOND SCHEDULE, FORM C—continued 24. Patent sit (lilt ion/patent holder ....................................................................................................... Confirm that the information contained herein is true to the best of by knowledge and belief. ............................................................................. ............................................................................. Date of application Signature of applicant Name ............................................................ Designation/Position held ............................................ Note Every application must he accompanied by 1. Supporting data and information which should include— (a) Chemistry specifications, composition of the product, and the technical a.i. method of analysis for the a.i. determination (b) information on biological activity on the product, directions for use (c) Metabolism. Residues, methods of analysis for residues (d) Toxicological data on the technical and formulated product(s) (e) Environmental toxicity. 2. Experimental labels (typed). 3. Analytical standards (approximate 100% a.i.) — 1.0 gram. FORM D PEST CONTROL PRODUCTS ACT (CAP. 346) PEST CONTROL PRODUCTS (REGISTRATION) REGULATIONS, 2006 Date .................................................................... REF: PERMIT NO. .................................................................................. PERMIT FOR EXPERIMENTAL AND EFFICACY TRIALS OF NEW PEST CONTROL PRODUCTS This is to grant permission as requested for your Centre/Organization to carry out efficacy trials of the new pest control product(s) as indicated below— Pest Control Product(s) Crop(s)/Commodity(ies)/Use(s)/Target Pest(s) You are requested to inform the Pest Control Products Board of the commencement of the experimental/efficacy trials and also periodically submit to the Board progress reports. The trial should he carried out using a Pest Control Products Board approved trial protocol. At the conclusion of the experimental/efficacy trials, a detailed confidential report on the performance of the candidate pesticide and recommendations for its use shall he submitted to the Board quoting the above reference and date. It would he highly appreciated if trials are completed as quickly as possible to avoid delays in introducing suitable products in the market. The company will provide you with the required trial samples/materials but the Board shall not meet expenses for the trials. It is the responsibility of the applicant to ensure that the efficacy trials are carried out to the satisfaction of the Board. Managing Director, Pest Control Products Board.