Administrative Order No. 2019- 0008 concerning New Rules and Regulations in the Registration of Household Pesticide Products and Their Active Ingredients

r> 0... 0 u w.J :::.") er. , Cl w.J cr.:: ~ a::; !..!...! .. ·~ . ..... ,, Republic of the Philippines Department of Health OFFICE OF THE SECRETARY ADMINISTRATIVE ORDER No. 2011~- ODO~ JUN l 4 Z019 SUBJECT: New Rules and Regulations in the Registration of Household Pesticide Products and Their Active Ingredients I. RATIONALE The evaluation of the safety and efficacy of household/urban hazardous substances (HUHS), such as household pesticide products, is essential to ensure that potential health risks to the general public and its applicators are kept at a minimwn or to prescribed acceptable levels. Pursuant to Republic Act (RA) 9711, otherwise known as the "Food and Drug Administration (FDA) Act of 2009", and its Implementing Rules and Regulations (IRR), the FDA is granted the authority to regulate health products, including household pesticide products, among others. Consistent with this Act, Administrative Order (AO) No. 2014-0038 entitled "RuJes and Regulations Governing Household/Urban Pesticides Licensing of Establishments and Operators, Registration of Their Products and for Other Purposes" was issued on 27 October 2014. As there is a need to provide updated guidelines and requirements consistent with international commitments such as but not limited to Montreal Protocol, Rotterdam Convention, and/or Stockbobn Convention, and related local pesticide regulations and standards, this AO shall replace AO 2014-0038 to (1) better protect public health and the environment from the risks associated with pesticide use; and (2) to ensure safety, efficacy and quality of pesticide products . II. OBJECTIVES This Order aims to: Provide guidelines on the registration of household pesticide products; and Establish guidelines for product stewardship. as applicable, in the market of household pesticide products. These guidelines shall cover household pesticide products and their active ingredient/s and the establishments that are engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applica~· Building I, SanU:laio Cornpound,RizalAveoue,Sta.Cruz, 1003Manila •TrunkLinc651-7800 local 1113, uo8? I~: I Di=t Linoo 711 ·9'02; 1J t -9503F"; 74~ 1829 • URL; http;//w~.doh.gov.ph; o-moit; offiooor.oh@doh 8"·•0 the use, testing, promotion, advertising, or sponsorship of such household pesticide products and/or active ingredient/s. This AO, however, shall not cover guidelines on genetically­ modified/engineered household pesticide products, and issuance of permits for experimental use to generate efficacy data for label expansion. IV. DEFINITION OF TERMS 1. Acute Toxicity - refers to those adverse effects occurring following oral or dennal administration of a single dose of a substance, or multiple doses given within twenty­ four (24) hours, or an inhalation exposure of four ( 4) hours. 2. Banned Pesticide - refers to a pesticide, all uses of which have been prohibited by final regulatory action to protect human health or the environment 3. Bio-efficacy Test - refers to a scientific study conducted to show, demonstrate or substantiate a claim of efficacy against pest/s as indicated in the label or as claimed by the applicant. The data or information generated from bio-efficacy studies shall be based on actual experiment with hypotheses consistent with the mechanism of action. 4. Certificate of Product Registration (CPR)- refers to the authoriz.ation issued by FDA for a household pesticide product after evaluation of its safety, efficacy and quality that permits its manufacture, importatio~ exportation sale, offer for sale, distributio~ transfer, and where applicable, its use, testing, promotion, advertisement, and/or sponsorship. 5. Chronic Toxicity - refers to adverse effects following chronic exposure. The term also refers to effects which persist over long period of time whether or not they occur immediately upon exposure or are delayed. 6. Emergency condition - means an urgent, non-routine situation that requires the use of a household pesticide product and shall be deemed to exist when: a . No effective household pesticide products are available that have labelled uses registered for control of the pest under the conditions of the emergency; and/or b. No economically or environmentally feasible alternative practices which provide adequate control are available; and/or c. The situation: l. 11. iii. Involves the introduction or dissemination of an invasive species or a pesticide new to or not theretofore known to be widely prevalent or distributed within or throughout the Philippines; or Will present significant risks to human health; or Will present significant risks to threatened or endangered s cies, ~ beneficial organisms, to the environmett~;~1{TirfED f RUE COPv' r .. JL O 12019 ~ ( ORiJ2..0ls..~ ··Ruz • :1:1:zr ~"'co~1~: ~-t · • m1 iv. Will cause significant economic loss due to an outbreak: of a pest. 7. FPA - refers to the Fertilizer and Pesticide Authority 8. Globally Harmonized System of Classification and Labelling of Chemicals (GHS) refers to a system for standardizing and harmonizing the classification and labelling of chemicals. It is a logical and comprehensive approach to: (a) defining health, physical and environmental hazards of chemicals; (b) creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and ( c) communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS). 9. Household Pesticide - also known as "household/urban pesticide", refers to non­ agricultural pesticides used for the control of pests in homes, yards and gardens, domestic and/or commercial establishments such as schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. but shall exclude chemicals used in commercial agricultural production. The term also refers to a product used for the control of insect pests, rodents, and weeds that are found in places of human habitation., work and recreation. Examples of insect pests are flies, mosquitoes, coclcroaches, ants, termites, bedbugs, and others. Household pesticides shall include products such as, but not limited to, insecticides, rodenticides, herbicides, larvicides, termiticides, wood preservative, baits, and repellents. For the purpose of this AO, the term household pesticide shall not include disinfectants. Household pesticides can be classified as follows: a. For Professional Use - refer to household pesticide products used in the control of pests of public health significance and intended to be used or applied by a trained FDA-certified pesticide handler wider the supervision of a FDA-licensed Pest Control Operator to institutions such as but not limited to schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. because of its higher risk/probability to cause umeasonable adverse effects to man. b. For General Use - refer to household pesticide products intended to control pests in the household and its surroundings which when applied in accordance with its direction for use, will generally not cause unreasonable adverse effects to man. 10. Household Pesticide Establishment - refers to sole proprietorship, partnership, ~~ corporation, institution, association or organization engaged in the manufacture, ~ importation, exporation, distribution, transfer, promotion, advertising or ~ sponsorship of household pesticide products. Household Pesticide Establishments ~hall be classified as follow: a. Manufacturer b. Trader c. Distributor d. Distributor (Active Ingredient) I I I CtRTlf!ED TRUE COPY .!UL 0 1 2019 .-oRAZC~' S ~CRUZ •·•.11-" -r.r:RiJ, si=·-..-!1"' • · '-· i ... · . . , ~ ..... ... ...... ... 11, Dor: "tm :.f Ha.~· :.h 11. Household Pesticide Expert Panel - refers to the recommendatory body created by FDA to provide technical expertise in the review and development of strategic policy direction and guidance on household pesticide products. 12. Household/Urban Hazardous Substances means: a. Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, generates pressure through decomposition. heat or other means, jf such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shaJJ not include agricultural fertilizers, agricultural pesticides, and agricultural insecticides and other economic poisons, radioactive substances, or substances intended for use as fuels, coolants, refrigerants and the like~ b. Any substance which the FDA finds to be under the categories enumerated in clause (a) of this paragraph; c. Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard; and d. This term shall not apply to food, drugs, cosmetics, devices or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (a), by reason of bearing or containing such harmful substances described therein. 13. Label - means a display of written, printed, or graphic matter upon the immediate container, or other materials affixed thereto, of any article. The label of the product shall include other informative materials such as, but not limited to, pamphlets, leaflets, insets, hangtags, etc. 14. License to Operate (LTO) - refers to an authoriz.ation issued by FDA to establishment(s) authorizing the manufacture, importation. exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of pesticide products. 15. Marketing Authorization (MA) - is the approval granted by the National Regulatory Authority (NRA) to market a specific product in a particular cowitry. The NRA in the Philippines is the FDA. A CPR is a MA issued by the FDA. 16. Marketing Authorization Holder (MAH) - means the establishment or company ~~ named on the Marketing Authorization for a specific product in a particular country. ~he owner of the CPR issued by the FDA i s th e MAH · 1 CERTIFIED TRUE COPY I I 17. Pesticide Registration - means the process whereby the FDA approves the sale and use of a household pesticide product following the evaluation of comprehensive scientific data demonstrating that the product is effective for its intended purposes and does not pose an unacceptable risk to human or animal health or the environment. 18. Safety Data Sheet (SDS) - is a document that provides important physical characteristics, ecological, safety and toxicological information on chemical substances or mixtures of ingredients used at the workplace, transported or maybe utilized by the consumer. 19. Stability Study - refers to a scientific study performed to show data, demonstrate or substantiate a claimed shelf-life of a product. Stability tests are carried out to determine the acceptable period of storage at a specified condition within which the household pesticide product still meets its established specifications or claim of efficacy. 20. Toxicity - refers to the ability of a substance to cause injury to biologic material. 21. Toxicity Study - refers to a study performed in vivo or on animals that is initiated by exposure to a chemical, physical or biological agent, and to determine the toxicity level, adverse effects and to show a series of events. The toxicity reports contain sets of data or infonnation from an experiment for the purpose of risk assessment and risk analysis of the product. V. GENERAL GUIDELINES L The applicant for registration of household pesticide product and the active ingredient/s for use in the formulation of a household pesticide product shall be a holder of a valid LTO as Household Pesticide Establishment issued by the FDA. 2. All household pesticide products intended to be manufactured, imported, exported, sold, offered for sale, distributed, transferred, and where applicable, used, promoted, advertised, and/or sponsored shall be registered with the FDA in a per formulation and per packaging material type basis. 3. Household pesticide product shall contain a maximum of three (3) active ingredients. 4. For a household pesticide product with dual use as agricultural pesticide, the applicant shall register such dual-use pesticide product with both the FDA and FP A. 5. All active ingredients for use in the formulation of household pesticide products sbaJl be registered with the FDA. If such active ingredient/s has current and valid ~~ registration with the FP A, the FDA shall recognize the FP A registration of such active ~ ingredient/s. ~The applicant for registration of household pesticide product shall submit stewardship program in protecting consumer health and the environment. The FP A guidelines on product stewardship and responsible care are hereby adopted for compliance by applicants of household pesticides for registration~ 2 t~TlFiED TRU£ COPY JUL 01 2019 ":QRAZOt-~~ CPU! 1::,11TS. R-':"f1=l" .SE". ON D pl !m · : • rlo " 7. Household pesticide product labels shall have the mandatory label elements of the Globally Harmonized System of Classification and Labeling of Chemicals. 8. The FDA shall adhere and promote the agreements such as the Montreal Protocol, Rotterdam Convention, Stockholm Convention, and other international convention/s wherein the Philippine government is one of the signatories, in the ban or restriction of ingredients used in the manufacture of household pesticide products. 9. All household pesticide products containing any banned ingredient as declared by the FDA, and/or FPA shall be prevented from entering the Philippine market. 1.0. Hazard Classification of the household pesticide product shall be based on GHS. 11. Only household pesticide products with GHS Acute Toxicity Categories 3, 4, and 5 shall be allowed for registration for household use. Household Pesticide products classified as GHS Acute Toxicity Category 1 and 2 shall be prohibited in household use. 12. Only household pesticide products with GHS Acute Toxicity Categories 2, 3, 4, and 5 shall be allowed for registration for professional use. Household pesticide products classified as GHS Acute Toxicity Category 2 shall be subject to the review and recommendatory action of the Household Pesticide Expert Panel. 13. FDA-registered household pesticide products for professional use shall not be allowed for over-the-counter selling. 14. FDA-registered products shall be subject to post-marketing surveillance activities including but not limited to product verification, laboratory analysis and product recall. 15. MAH shall be respons1ble for the continuous monitoring and evaluation of their household pesticide products, such as but not limited to periodic review of scientific evidence and market reports pertaining to the product's safety and efficacy, to ensure continuous compliance with the latest standards. 16. Variations involving changes in the product's indications of use GHS health haz.ard category (acute toxicity, skin corrosion/irritation, serious eye damage/ eye irritation and skin sensitization), composition, manufacturer, address of manufacturer, and/or supplier, shall warrant a new product registration. Any other changes shall only require CPR amendment. 17. MAH shall immediately notify FDA in cases of serious adverse effects associated with the use of household pesticide products. It shall be the responsibility of the MAH to ensure availability and adequate supply of antidote for their household pesticide products. The FDA shall work closely with local partners and international organizations to develop and strengthen FDA regulatory standards or approaches to the sound management of household pesticide products. ~----·-·· '. '., . .. \ 1 2019 CORAZ1.. ~~ - UZ r~MIT 1::1:. i:I::. ..,1;;1,; ON O 1, .... ,3n. f .-ten U1 19. MAH shall conform to the existing guidelines of Republic Act (RA) 6969, otherwise known as the "Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990" and its Implementing Rules and Regulations (IRR). for the storage, transport and final disposal of expired, banned, obsolete, rejected, recalled and/or out of specification formulated household pesticide products. VL SPECIFIC GUIDELINES All applicants for registration of active ingredients and household pesticide products shall submit the registration requirements as specified by the FDA. 1. Application Process a. Filing An application for Certificate of Product Registration (CPR), whether new, renewal, or variation, is considered valid and final upon submission of complete requirements including payment of required fees and charges. b. Evaluation The evaluation of all applications for CPR shall be based on the completeness and accuracy of the submitted documents, compliance with appropriate standards and acceptability of the product safety and efficacy. i. Submission of Bio-efficacy Study a. Product claims shall be based on the pests/insects tested, spectrwn of activity, mode of application and dose rate that shall be used in the bio­ efficacy study/ies to be conducted. b. The study shall be conducted locally by an independent researcher. Foreign generated data (laboratory and field trials) shall be acceptable provided the trials were conducted under similar environmental conditions and test animals or insects used are proven to be the same with the local species. c. The submitted bio-efficacy study shall comply with the requirements specified by the FDA in accordance with accepted protocols, if available, jnclucling but not limited to: Product Protocol Insecticidal Net WHO Guidelines for Laboratory and Field Testing of Long-Lasting Insecticidal Nets Human Mosquito Repellent WHO Guidelines for Efficacy Testing of Mosquito Repellents for Human Skin Mosquito Coils, Vaporizer Mats, WHO Guidelines for Efficacy Testing Liquid Vaporizersm Ambient of Household Insecticide Products Emanators and Aerosols /~ Mosquito Larvicide WHO Guidelines for Laboratory and Field Testin ofMo uito Larvicides d Test insects which will be used shall be the local strain. Any other deviation from the standard protocol shall be justified. e. The study shall be accepted if it has been conducted for not more than ten (10) years or upon proof of continued efficacy against the claimed target pest/s, unless there are reports of development of resistance, adverse effects, etc., prior to registration. f The treatments shall be composed of the positive control, negative control and the product being registered. In case of novel products, the positive control is allowed to be omitted from the bio-efficacy study. g. The FDA-registered positive control and the product being registered shall have the same active ingredient/s or active ingredients from the same family of chemicals at the very least, formulated into similar product type (i.e. aerosol, repellent lotion). h. The negative control shall simulate the concentration of the solvent used in the formulation. 1. Product efficacy of the product being registered shall be deemed acceptable if proven to be equivalent with or bether than the positive control, unless the standard protocol set a minimum limit for efficacy (2:80% mortality after 24 hours or 2:95% knock-down 60 minutes after exposure for insecticidal net). u. Submission of Toxicity Study a. Toxicity study/ ies shall be conducted using the household pesticide product being registered. b. The submitted toxicity study/ies shall comply with the requirements specified by the FDA in accordance with accepted protocols such as the Organization for Economic Cooperation and Development (OECD) guidelines or any international counterpart. In case the applicant made misrepresentations, false entries, or withheld any relevant data to the provisions the law or appropriate standards, the application shall be disapproved. In such cases, the applicant shall be investigated, and appropriate charges may be filed and penalties be imposed, if the circumstances so warrant. Issuance of CPR A CPR shall be issued to household pesticide products that comply with the documentary requirements and standards of safety, efficacy and quality based on existing FDA rules and regulations. l CERTIFIED TRUE COPY A registration number shall be assigned to a household pesticide product whose product registration application bas passed the product registration process of the FDA The validity of the CPR shall be for a minimum of two (2) years or maximum of five (5) years unless recaUed or banned by the FDA 3. Cancellation of CPR a. Automatic Cancellation The registration of a household pesticide product that is not renewed within one hundred twenty (120) days from the date of expiration shall be automatica11y cancelled and deleted from the list of registered household pesticide products without prejudice to their re-application. The product shall be re-applied for registration and shall follow the new registration process and requirements and pay the corresponding fees. b. Voluntary Cancellation The MAH may apply for voluntary cancellation of its existing CPR by filing a formal notification with the FDA citing the reasons thereof c. Cancellation and/or Revocation as a Penalty The FDA shall impose the penalty of cancellation and/or revocation of CPR as per Book TI, Article I, Sec. 4. Grounds for Djsapproval of Application and Suspension or Cancellation of License, Registration or Authorization of the IRR of RA 9711. The MAH shall remain to be accountable/liable for any violations committed, and are subject to the penalties levied and administrative sanctions imposed by FDA. 4. Accessibility The relevant forms, requirements for application, and the submission process shall be made accessible at the FDA website. 5. Responsibility of the Marketing Authorization Holder (MAH) In case the household pesticide product has been withdrawn for health and safety reasons due to violations, the MAH shall immediately undertake the necessary measures, as well as shoulder incidental costs, in banning its sale, distribution or donation, or its immediate recall, withdrawal or seizure from the market, and its disposal in accordance with existing rules and regulations and product stewardship j '\. comitments. ~ 1 ('ERT!F!Hl fRUE COPY 6. Issuance of Off-Label Use I Emergency Exemption Permit In emergency conditions as declared by the DOH or the respective Local Government Unit (LGU) such as pest outbreaks or disease/epidemfo, an off-Jabel permit may be applied for use by an unregistered household pesticide product or by a registered household pesticide product with use different from what bas been approved by the FDA. Application for an off-label use permit shall be evaluated on its merit based on the information submitted and shall be granted permission only for the duration of the emergency period and upon the recommendation of the Household Pesticide Expert Panel. VII. FEESANDCHARGES The FDA shall charge a fee for all CPR applications whether new, renewal or variation/s based on existing guidelines being implemented by the FDA. VID. PENALTY CLAUSE Establishments engaged in the manufacture, importation, exportation, sale. offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of household pesticide products including the facilities and installations needed for its activities who are found to be operating outside the rules and regulations of FDA shall be subjected to sanctions and penalties as prescribed by RA 9711. IX. REPEALING CLAUSE This Order effectively repeals AO 2014-0038 entitled "Rules and Regulations Governing Household/Urban Pesticides Licensing of Establishments and Operators, Registration of Their Products and for Other Purposes". All other administrative issuances, bureau circulars and memoranda and other regulations inconsistent with this Order are hereby withdrawn, repealed and/or revoked accordingly. X. SEP ARABILITY CLAUSE If any part or term of provision of this Order shall be declared invalid or unenforceable, the validity or enforceabiHty of the remaining portions or provisions shall not be affected and this Order shall be construed as if it did not contain the particular invalid or unenforceable part, tenn or provision. CERTJFIED TRUE COPY :uL Q ~i~~ r'ORA .. r.fs ~ -.JZ 1.rm- · - w .. s .. oN D< , t of Hoslt,, XI. EFFECTIVITY This Order shall take effect fifteen (15) days following the completion of its publication in two (2) newspapers of general circulation and submission of a copy hereof to the University of the Philippines Office of the National Registry (UP-ONAR). . DUQ ID, MD, MSc. ecretary of Health I 1 !·ii·. fJ !'HUE COPY 11 ANNEX A Data Requirements for Registration of Active Ingredients for Use in Household Pesticides I. New Registration A. Identity and Specifications Data Reouirements Remarks A.I. Applicant Identity and Administrative Requirements 1.1 Completely Accomplished and Notarized Integrated Anolication Form with Declaration 1.2 Copy of valid License to Operate as household oesticide manufacturer. trader or distributor 1.3 Payment of fee A.2. Chemical Identity 2.1 Chemical Abstract Services Number 2.2 Name of active ingredient (proposed or accepted by ISO and synonyms) 2.3 Structural formula 2.4 Chemical name (according to internationally agreed nomenclature, preferably ruP AC) 2.5 Empirical formula 2.6 Molecular weight A.3. Physical properties of the Active ln~redient 3.1 Appearance (physical state. color, odor) 3.2 Melting/decomposition/boiling point 3 .3 Vapor pressure Figures shouJd be given at a stated temperature (preferably in the range of 20-25°C), but only when above 10·3 Pascal 3.4 Flammability: liquids - flash point; solids - a statement must be made as to whether the product is :flammable 3.5pH 3.6 Solubility in water and organic solvents At a stated temperature preferably in the range of20-25°C 3.7 Suspendibility/emulsifying characteristics 3.8 Octanol partition coefficient Required if A.I. is organic and non polar 3.9 Density For liquids only 3. I 0 Hydrolysis 3 .11 Photolysis 3.12 Absorption spectra e.g. ultra-violet, visible, infra-red, etc. 3.13 Known compatibility/incompatibility with other pesticide active ingredient 3.14 The minimum (and maximum) active ingredient content in g/kg 3.15 Identity and amount of isomers, impurities and other by-products 3.16 Name and address of the manufacturer I source 3 .17 Process of manufacture A.4. Product specifications A.5. Certificate of Analysis Shall be aligned with the product • Analytical test report of impurity profile and AI specifications content • Analytical test report of other specifications A.6. Safety Data Sheet (SDS) 6.1 Identification 6.2 Hazard identification 6.3 Composition and information of ingredients 6.4 First-aid measures 6.5 Fire-fil?:hting measures 6.6 Accidental release measures 6.7 Handling and storage 6.8 Exposure controls and personal protection 6.9 Physical and chemical properties 6.10 Stability and reactivity 6.11 Toxicological information 6.12 Ecological information 6.13 Disposal considerations 6 .14 Transport inf onnation 6.15 Regulatory information 6 .16 Other information A.7. Proof of Manufacturer's Compliance to Good Maoufacturio~ Practices (GMP)1 A.8. Submission of actual sample and reference - Min. 1 g for the reference standard standard - Min. l g for the Al sample B. Toxicity Data 2.J Data Requirements Remarks B.1. Acute Toxicity Tests 1. 1 Acute oral toxicity LD50 expressed as mg/kg of body weight 1.2 Acute dermal toxicity LD'° expressed as mg/kg of body weiaht 1.3 Acute inhalation toxicity LCso in mg/L B.2. Corrosion/Irritation tests 2. l Primary skin corrosion/irritation 2.2 Serious eye damage/irritation B.3. Aller!!V/sensitization test 2 ~ B.4. Sub-chronic toxicity tests Minimum 90 clays, oral in rats 8.5. Reproduction effects studies Minimum two generations in rats 8.6. Teratogenicity studies In two species, one in rats and other in non-rodents 8.7. Neurotoxicity studies In hens, for organophosphates, carbamates, 2n<1 generation pyrethroids 8 .8. Mutagenicity studies Minimum of Ames test and in vivo micronucleus test 8.9. Carcinogenicity tests and chronic (long term) toxicity studies in rats C. Human Exposure and Safety Data Reouirements Remarks C.1. Medical data/Poisonine symptoms/ Antidote C.2. Personal protective eauipment C.3. Other precautions D. Environmental Data Data Requirements Remarks D.l. Evaluation of Environmental Fate and Effects 1.1 Volatility 1.2 Data on translocation of pesticides in soil and water 1.3 Primary data on potential hazards ( infectivity) to mammals (including .humans) 1.4 Primary data on potential toxicity to birds and non- e.g. honey bees, pollinators, etc. targeted beneficial organisms 1.5 Primary data on aquatic toxicity 1.6 Primary data on pbytotoxicity effects 1. 7. Primary data on treatment of effluents and methods of destruction or disposal E. Labeling/Packaging Data Requirements Remarks E.1. Labeling Submit per pack size and include other information materials such as leaflets, brochure, etc. 1.1 Product Infonnation 1.1.1 Chemical Name 1.1.2 Trade Name 1.1.3 Net content 1.1. 4 Batch/Lot number 1.1.5 Manufacturing date 1.1.6 Registration number 1.2 Hazard and Safety Information 1.2.1 GHS oicto2I'am, signal word, hazard statement 1.2.2 Precautionary statement or warnings lndica1e the mandatory statement, "Keep out of Reach of Children"; include other precautionary statements recommended by GHS based on hazard category 1.2.3 Color band based on GHS Acute Toxicity 1.2.4 Sifill.S/svmotoms of poisoning 1.2. 5 First aid treatment I Antidote information 1.2.6 Medical advice/Note to physician 1.2. 7 Accidental so ills advice 1.3 Directions for Use 1.3.1 Field of use If applicable 1.3 .2 Storage and disposal 1.4 Name, address and contact information of the In case the MAH is not the marketing authorization holder (MAH) manufacturer, indicate the name and address of the manufacturer including countrv of origin 1.5 Contact information of the national/regional poison center E.2. Packaein2 2.1 Specification of primary package 2.2 Specification of secondary packaging Other information materials such as leaflets, brochure, etc. 2.3 Specification of bulk package for transoort Notes: 1 If active ingredient is sourced from a foreign country, submit any of the following documents: Certificate of Free Sale (CFS) issued by the National Regulatory Authority of country of origin Certificate of Good Manufacturing Practice (GMP) based on international manufacturing standards Manufacturing license ISO Certificate related to manufacturing 2 If allowed in GHS and if available, validated test methods based on accepted international standards may be used in lieu of in vivo animal testing 3 In lieu of in vivo and in vitro animal testing, GHS bridging principles may be applied as long as the hazard categories of each ingredient in concentration greater than or equal to I% are known, unless there is evidence that the ingredients in concentration less than 1 % are hazardous. 4 II. Variations to a CPR A. Minor Variations 1. Change in business name of the manufacturer/ distributor 1.1. Completely accomplished Integrated Application Form 1.2. Letter ofrequest 1.3. Copy of valid L TO reflecting the variation 1.4. Copy of the valid original CPR 1.5. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 1.6. Payment of fee 2. Change of address of the distributor of the product 2.1. Completely accomplished Integrated Application Form 2.2. Letter ofrequest 2.3. Copy of valid L TO reflecting the new address 2.4. Copy of the valid original CPR 2.5. Any valid document/s showing proof of transfer 2.6. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 2.7. Payment of fee 3. Addition or deletion of packaging of the product 3.1. Completely accomplished Integrated Application Form 3 .2. Letter ofrequest 3.3. Copy of valid LTO reflecting the new address 3 .4. Copy of the valid original CPR 3.5. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 3.6. Paymentoffee B. Major Variation 1. Change in GHS category/hazard class 1.1 Completely accomplished Integrated Application Form 1.2 Letter of request 1.3 Copy of valid LTO 1.4 Copy of the valid original CPR 1.5 Copy of SDS 5 1.6 Copy of complete toxicity studies, if request is for change in hazard class 1.7 Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 1.8 Payment of fee 6 r ANNEXB Data Requirements for Registration of Formulated Household Pesticides I. New Registration A. Identity and Specifications Data Reauirements Remarks A.1. Applicant Identity and Administrative Reauiremeots 1.1 Completely Accomplished and Notarized Integrated Application Form with Declaration 1.2 Copy of valid License to Operate as household pesticide manufacturer, trader or distributor (imoorter, wholesaler, ex~orter} 1.3 Payment of fee A.2. Product Identity 2.1 Formulator, s name and address 2.2 Proprietary name 2.3 Use category e.g. insecticide, rodenticide, etc. 2.4 Type of formulation e.g. EC, SC, WP, etc. A.3. Quantitative and Qualitative Composition of product 3.1 Content of technical grade active ingredient(s) Where more than one active ingredient, information shoold be given on each inl!tlldient seoaratelv 3 .2 Content and nature of other components included in the formulation including water or any other solvents A.4. Technical specifications of the formulated Submit whichever is applicable product 4 .1 Aooearance (physical state, color, odor) 4.2 Density For liquids only 4.3 Flammability: liquids - flash point; solids - a statement must be made as to whether the product is flammable 4 .4pH 4.5 Wettability For dispersible powders 4.6 Persistent foam For fonnulations applied in water 4 .7 Suspendibility For dispersible powders and suspension concentrates 4.8 Wet sieve test For dispersjble powders and suspension concentrates 4.9 Dry sieve test For granules, dusts 4.10 EmuJsion stability For emulsifiable concentrates 4.11 Corrosiveness (when necessary) 4.12 Known incompatibilities with other products 4.13 Shelf life1 Supported by stability studies A.5. Product specifications -Tolerance for the Active Imrredient/s2 A.6. Certificate of analysis containing the Shall be aligned with the product manufacturing date, batch/lot number, name and specifications silmature of the laboratory analyst and manaeer A.7. Test procedures/methods conducted on the Based on the technical specifications formulated product of the formulated product A.8. Safety Data Sheet (SDS) of the formulated product 8.1 Identification 8.2 Hazard identification 8.3 Composition and information of inJtredients 8.4 First-aid measures 8.5 Fire-fighting measures 8.6 AccidentaJ release measures 8.7 Handling and storage 8.8 Exposure controls and personal protection 8.9 Physical and chemical properties 8.10 St.abilitv and reactivitv 8.11 Toxicoloeical information 8.12 Ecological information 8.13 Disoosal considerations 8.14 Transport information 8.15 Refilllatorv information 8.16 Other infonnation A.9. Proof of Manufacturer's Compliance to Good Manufactur ine Practices lGMP)3 A.10. Substantiation to sunnort special product claims A.11. Product Stewardshin Pro2ram A.12. Submission of actual sample and reference - Min. l g for the reference standard standard - Min. 500mlJ0.5kg product sample B. Toxicity Data4 • 5 Data Reouirements Remarks B.1. Acute Toxicitv Tests 1.1 Acute oral toxicity LDso expressed as mg/kg of body weight 1.2 Acute dermaJ toxicity LDso expressed as mg/kg of body weight 1.3 Acute inhalation toxicitv LCso in mg/Lor ppmV 8.2. Corrosion/irritation tests 2.1 Primarv skin corrosion/irritation 22 Serious eve damage/irritation 8.3. Allerev/seositization test 8.4. Sub-chronic toxicitv tests Minimum 90 days, oral in rats 2 B.5. Reoroduction effects studies Minimum two generations in ra1s B.6. Teratogenicity studies In two species, one in rats and other in non-rodents 8.7. Neurotoxicity studies In hens, for orgWlophosphates, carbamates, 2n<i izeneration ovrethroids 8.8. Mutagenicity studies Minimum of Ames test and in vivo micronucleus test B.9. Carcinogenicity tests and chronic (long term) toxicity studies in rats C. Bio-efficacy Data6 Data Reouirements Remarks C.l Report desii!;n 1.1 Abstract This section is a short summary of the whole bio-efficacy study reoort. 1.2 Introduction This section discusses the following: • Background information of the product (product classification, product owner, formulation type) including the active ingredient/s used and its concentration in the product, efficacy of the active ingredient against specific pest/s • Known or confirm acute and/or long-term toxicity of the active ingredient • Potential for the development of resistance and cross resistance • Significance of the study • In case ofinnovative products, justify the need (e.g . advantaizes of using the oroduct) for the oroduct 1.3 Objectives This section discusses the specific purpose of the study 1.4 Methodology This section discusses the whole test procedures/design in view of the objectives. If the test design has been patterned after an international guideline, said guideline is cited here. In case deviations are made from the standard, these are also discussed and justified in this section. Other information discussed in this section are the following: • Duration of the study • Adequacy of infrastructures and location where the test is conducted (ie. laboratory or field) • In case of field study, suitability of the location and plot size • Size and design (i.e. number of trials per replicate, minimum of three replicates) • Test organisms/species and the conditions of their handling 0 genus and species of the test insect 0 age and sex 0 laboratory-reared, wild collected, 0 rearing techniques including environmental conditions, food source 0 number of test insects used per trial, environmental conditions • Sampling methods and techniques used • Eauioment desian and dimension 3 • Treatments/controls used 0 infonnation on the ingredient/formulation as reference product or positive control • Inclusion/exclusion criteria used • Preparations performed such as: 0 Acclimatization 0 Washing of area of application 0 Weighing oftest animal (rodents) • Application method including equipment used, dilution rate, application rate, amount of treatments per application and timing of the application, if applicable • Schedule of monitorinl?/observation 1.5 Presentation, Analysis This section discusses the statistical methods used and its suitability and Interpretation of Data in achieving the objectives specified in Section 3. Other information found here are the following: • Raw data • Statistical analysis results • Interoretations 1.6 Summary of Findings, This section discusses the results of the bio-efficacy study. Conclusions and Recommendations for further studies are also discussed here in case Recommendations the researcher deems it necessary. 1.7 Bibliograohv This section cites the list of references 1.8 Annexes, if any This section contains the Qualifications of the Principal Investigator/Researcher (CV, FP A Accreditation) Copy of Ethical Clearance issued by an Ethics Review Committee (ERC) duly registered with and/or accredited by the Philippine Health Ethics Research Board in case human subiects are used D. Human Exposure and Safety Data Reauirements Remarks D.1. .Operators exposure data Detmal/inhalation exposure, biological monitorin2 D.2. Bystanders exposure data Dennal/inha1ation exposure, biological monitoring D.3. Medical data/Poisonine svmptoms/Antidote D.4. Permissible exposure level For professional bandlers/annl icators D.S. Personal orotective eauiument D.6. Other orecautions E. Environmental Data Data Reauirements Remarks E.1. Evaluation of Environmental Fate and Effects 1.1 Data on trans location of oesticides in soil and water 1.2 Primary data on potential hazards (mfectivity) to mammals (including humans) 4 1.3 Prim F. Labeling/Packaging Data Reauirements Remarks F.1. Labeling Submit per pack size and include other infonnation materials such as leaflets, brochure, etc. 1.1 Product Information 1.1.1 Brand and Product name 1.1.2 Product or user category Household use or Professional Use 1.1.3 Type of formulation 1.1.4 Intended use including the target pests 1.1.5 Active ingredient/s including percentage Indicate the active concentration in %w/w or %w/v ingre.dient in the primary packaging label 1.1.6 Net content 1.1. 7 Batch/Lot number 1.1.8 Manufacttrring date 1.1. 9 E:xpiry date 1.1.10 Registration number Specified as HSR No.:XXXX 1.2 Hazard and Safety Information 1.2.1 GHS pictogram, signal word, hazard statement 1.2 .2 Precautionary statement or warnings Indicate the mandatory statement, "Keep out of Reach of Children" " in the front panel; include other precautionary statements recommended by GHS based on hazard category 1.2.3 Color band based on GHS Acute Toxicity 1.2.4 Signs/symptoms of poisoning 1.2.5 First aid treatment I Antidote information 1.2.6 Medical advice/Note lo physician 1.2.7 Accidental spills advice 1.3 Directions for Use 1.3.1 Field of use If applicable 1.3.2 Dilution and aonlication rate If applicable 1.3.3 Directions for use l.3.4 Re-entry period If applicable 1.3 .5 Frequency of re-application If applicable 5 1.4 Name, complete address and contact information of the marketing authorization holder (MAH) 1.5 Contact information of the national/re oison center F.2. Packa in 2.1 S ecification of r · Notes: In case the MAH is not the manufacturer, indicate the name and complete address of the manufacturer including country of ori in 1 Stability studies may be acce1erated or rea1-time. For accelerated stability study, it sha11 be conducted under the following conditions which shall only be equivalent to two (2) year shelf-life: a. 54 ± 2°C for 14 days b. 50 ± 2°C for 4 weeks c. 45 ± 2°C for 6 weeks 2 Values for the tolerance limits for the active ingredient/s sha1J be in accordance with the Manual on Development and use ofFAO and WHO Specifications for Pesticides 3 If active ingredient is sourced from a foreign country, submit any of the follow.ing documents: Certificate of Free Sa1e (CFS) issued by the Nationa1 Regulatory Authority of country of origin Certificate of Good Manufactur.ing Practice (GMP) based on intemationa1 manufacturing standards Manufacturing license ISO Certificate related to manufacturing 4 If allowed in GHS and if available, validated test methods based on accepted international standards may be used .in lieu of in vivo anima1 test.ing. 5 In lieu of ;n vivo and in vitro animal testing, GHS bridging principles may be applied as long as the hazard categories of each ingredient in concentration greater than or equal to 1 % are known, unless there is evidence that the ingredients .in concentration less than l % are hazardous. 6 Identify the international standard where the bio-efficacy test design was patterned and justification when the design differs from the standard. 6 IL Renewal of Product Registration I. Completely accomplished Integrated Application Form with Declaration 2. Post-market surveillance monitoring report Determination of developed pesticide resistance 3. Unattached legible, comprehensive and indelible specimen of all labeling materials per pack size (including outer, immediate, package inserts, if any) in English and/or Filipino language with local dialects as applicable 4. Payment of fee Ill. Variations to a CPR A. Minor Variations l. Change in business name of the manufacturer/ distributor 1.1. Completely accomplished Integrated Applfoation Form 1.2. Letter ofrequest 1.3. Copy of valid LTO reflecting the variation 1.4. Copy of the valid original CPR 1.5. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 1.6. Payment of fee 2. Change in product ownership 2.1. Completely accomplished Integrated Applicatfon Fann 2.2. Letter ofrequest 2.3. Copy of valid LTO reflecting the variation 2 .4. Copy of the valid original CPR 2.5. Copy of Termination Contract/Deed of Assignment 2.6. Copy of the Agreement of the new MAH and manufacturer 2.7 . Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 2.8. Payment of fee 3. Change of address of the distributor of the product 3 .1. Completely accomplished Integrated Application Form 3.2. Letter of request 3 .3. Copy of va]jd LTO reflecting the new address 3.4. Copy of the valid original CPR 3 .5. Any valid document/s showing proof of transfer 7 ~· 3.6. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 3.7. Paymentoffee 4. Addition or deletion of packaging of the product 4.1. Completely accomplished Integrated Application Form 4.2. Letter ofrequest 4.3. Duly notarized affidavit/declaration of no change in the formulation 4 .4. Copy of valid L TO reflecting the new address 4.5. Copy of the valid orjginal CPR 4.6. Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dfalects as applicable 4.7. Payment of fee 8. Maior Variations I. Change in product name (brand name/ variant name) 1.1 Completely accomplished Integrated Application Form 1.2 Letter of request 1.3 Duly notarized affidavit/declaration of no change in the formulation 1.4 Copy of valid L TO 1.5 Copy of the valid original CPR 1.6 Extension of use or claim and new bio-efficacy study, if there is request to include additional target pests 1.7 Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 1.8 Payment of fee 2. Change in rate, timing or frequency of application or method of application 2.1 Completely accomplished Integrated Application Form 2 .2 Letter ofrequest 2.3 Copy of valid LTO 2.4 Copy of the valid original CPR 2.5 Extension of use or claim and new bio-e:fficacy study, if there is request to include additional target pests 2.6 Study or studies that shall justify request for change in rate, timing or frequency of application, or method of application 2.7 Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local walects as applicable 8 2.8 Payment of fee 3. Change in label claim/Request for additional target pest(s) 3.1 Completely accomplished Integrated Application Form 3 .2 Letter of request 3 .3 Copy of valid LTO 3 .4 Copy of the valid origin.al CPR 3.5 Extension of use or claim and new bio-efficacy study, if there is request to include additional target pests 3.6 Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 3. 7 Payment of fee 4. Change in GHS category/hazard class 4.1 Completely accomplished Integrated Application Form 4 .2 Letter ofrequest 4.3 Copy of valid LTO 4.4 Copy of the valid original CPR 4.5 Copy ofSDS 4 .6 Copy of complete toxicity studies, if request is for change in hazard class 4.7 Complete labeling requirements reflecting the change (primary, secondary and inserts, if any) in English and/or Filipino language with local dialects as applicable 4.8 Payment of fee 9 ANNEXC Requirements for Off-Label Use I Public Health Emergency Exemption Permit 1. Application Form / Letter of Request 2. Information required for public health exemption: 2.1 The scientific and common name of the pest to be controlled and, if the pest is a vector, a description of the disease it is expected to transmit; 2.2 A discussion of the magnitude of the health problems which are expected to occur without the possible use; and 2-3 Discussion of the availability of medical treatment for the health problem. 3. Description of the pesticide: 3.1 Complete ingredient Listing of the formulated finished product (expressed in %w/w; %w/v; %v/v) 3.2 Complete labeling to be used in connection with the proposed exemption use. 4. Description of the proposed use: 4.1 Sites to be treated, including their locations within the country; 4.2 The method of application; 4.3 The rate of application in terms of active ingredient and product; 4.4 The maximum number of applications; 4.5 The total area proposed to be treated; 4.6 The total amount of household pesticide proposed to be used in terms of both active ingredient and product; 4.7 All applicable restrictions and requirements concerning the proposed use which may not appear on labelling; and 4.8 The duration of the proposed use. 5. Alternative methods of control: 5.1 A detailed explanation of why the household pesticide(s) currently registered for the particular use proposed in the application is not available in adequate supplies and/or effective to the degree needed to control the emergency. If the applicant states that an available registered household pesticide is ineffective for the given situation, the statement must be supported by data which demonstrate ineffectiveness ofregistered household pesticides, or, if such data are unavailable, statements by qualified pesticide experts, academe or other person similarly qualified in the field of pest control; and 5.2 A detailed explanation of why alternative practices, if available, either would not provide adequate control or would not be economically or environmentally feasible. 6. Effectiveness of proposed use. (Bio-efficacy Study) 7. Discussion of risk information. (Toxicity Study) 8. Description of the proposed enforcement program. Prior to approval, the applicant shall provide an explanation of the authority of the applicant for ensuring that use of the household pesticide under the proposed exemption would comply with any special requirements imposed by FDA and a description of the program and procedures for assuring such compliance. 2