New Rules and Regulations in the Registration of Household Pesticides
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 minimum 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 “Rules 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 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.
This Order aims to:
- To provide guidelines on the registration of household pesticides; and
- To establish guidelines for product stewardship as applicable in the market of household pesticide products.
These guidelines shall cover household pesticide products in any form that are destined to be applied by end-users and the establishments that are 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.
This A.O., however, shall not cover genetically-modified/engineered household pesticide products.
- DEFINITION OF TERMS
- Acute Toxicity – refers to those adverse effects occurring following oral or dermal 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. (GHS 6th revised ed., 2015)
- Adulteration – refers to the manufacture of inferior products by use of less desirable ingredients. (RA 7394)
- Banned Pesticide – refers to a pesticide all uses of which have been prohibited by final regulatory action to protect human health or the environment.(International Code of Conduct on Pesticide Management, WHO and FAO, 2014)
- 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 based on a hypothesis consistent with the mechanism of action.
Certificate of Product Registration (CPR) – means the authorization issued by FDA to establishment(s) for the purpose of marketing and distribution of a household pesticide product after evaluation of its safety, efficacy and quality.
- 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. (IUPAC Glossary of Terms Used in Toxicology, 2007)
- Counterfeit household pesticide product – refers to a household pesticide product which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeliness thereof, of a household pesticide product manufacturer, processor, packer, distributor, other than the person or persons who in fact manufactured, processed, packed or distributed such product and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such household pesticide product manufacturer, processor, packer, repacker or distributor.
- Distribute – means the delivery or sale of any household pesticide product for purposes of distribution in commerce, except that such term does not include the manufacture or retail of such product.
- Distributor/Importer/Exporter – means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public, it shall also be considered as a retailer.
- Distributor/Wholesaler – means any establishment that procures raw materials, active ingredients and/or finished products from a local establishment for local distribution on wholesale basis.
- Emergency condition – means an urgent, non-routine situation that requires the use of a household pesticide product and shall be deemed to exist when:
- No effective household pesticides are available that have labelled uses registered for control of the pest under the conditions of the emergency; and/or
- No economically or environmentally feasible alternative practices which provide adequate control are available; and/or
- The situation:
- 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 species, beneficial organisms, to the environment; or
- Will cause significant economic loss due to an outbreak of a pest.
- End-user – refers to a person, individual, organization, establishment, or other legal entity that actually uses or applies the household pesticide product. The term end-user shall be understood to include but not limited to consumers, certified pesticide applicators, pest control operators, etc.
- FDA – refers to Food and Drug Administration
- FPA – refers to the Fertilizer and Pesticide Authority
- GHS is an acronym for Globally Harmonized System of Classification and Labeling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labelling of chemicals. It is a logical and comprehensive approach to: [GHS 5th rev]
- Defining health, physical and environmental hazards of chemicals
- Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and
- Communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS).
- 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 pesticides.
- Household/Urban Hazardous Substances means:
- 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, if 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 shall 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;
- Any substance which the FDA finds to be under the categories enumerated in clause (4.17.1) of this paragraph;
- 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
- 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 (4.17.1), by reason of bearing or containing such harmful substances described therein.
- Label – means a display of written, printed, or graphic matter upon the immediate container, or other materials affixed thereto, of any article. Any word, statement, or other information appearing on the label required under authority of the FDA Act of 2009 or other relevant laws shall be deemed complied with if such word, statement or other information also appears on the outside container or wrapper, if any there be, or the retail package of such article, or easily legible through the outside container or wrapper. The label of the product shall include other informative materials such as, but not limited to, pamphlets, leaflets, insets, hangtags, etc.
- License to Operate – refers to authorization 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.
- Marketing Authorization (MA) – is the approval granted by the National Regulatory Authority (NRA) to market a specific product in a particular country. The NRA in the Philippines is the FDA. A CPR is a MA issued by the FDA.
- Marketing Authorization Holder (MAH) – means the establishment or company named on the Marketing Authorization for a specific product in a particular country. The owner of the CPR issued by the FDA is the MAH.
- Manufacturer – means an establishment engaged in any and all operations involved in the production of household pesticide products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution.
- Misbranding – means, in addition to definitions provided in the Foods, Drugs and Devices, and Cosmetics Act and in other relevant laws, giving unsubstantiated claims, misinformation or misleading information on the label or other information materials, including those contained in brand names or trademarks. It shall not refer to copyright, trademark, or other intellectual property-like instruments.
- 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. (World Health Organization Pesticide Evaluation Scheme, 2010)
- Pesticide – refers to any substance, or mixture of substances, or microorganisms including viruses, intended for repelling, destroying or controlling any pest, including vectors of human or animal disease, nuisance pests, unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products or animal feeding stuffs, or which may be administered to animals for the control of insects, arachnids or other pests in or on their bodies. The term also includes pesticide synergists and safeners, where they are integral to the satisfactory performance of the pesticide.
A pesticide, for the purpose of this Order, shall be specific to:
- Household Pesticide – also known as “household/urban pesticide”, refers to a non-agricultural pesticide 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 any material or mixture of substance used for the control of insect pests, rodents, plant diseases, and weeds that are found in places of human habitation, work and recreation. Examples of insect pests are flies, mosquitoes, cockroaches, ants, termites, bedbugs, and others.
Household pesticides shall include products such as, but not limited to, mosquito coils, aerosol sprays, insect repellents for personal use, rodenticides concentrates and baits, cockroach sprays and baits, and others.
Household pesticides can be classified as follows:
- 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 applicator 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 unreasonable adverse effects to man.
- 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.
- 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.
- 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.
- Trader – means any establishment which is a registered owner of a household pesticide, institutional use pesticide and/or public health pesticide product and procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such product to an FDA licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
- Toxicity – refers to the ability of a substance to cause injury to biologic material.
- 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 containing sets of data or information from an experiment for the purpose of risk assessment and risk analysis of the product.
- GENERAL GUIDELINES
- The term household pesticide shall be understood to include the following but not limited to:
- Wood Preservative
For the purpose of this A.O., the term household pesticide shall not include disinfectants.
- Each household pesticide product shall be registered with the FDA per formulation and packaging material/presentation. The complete ingredient listing of the formulated household pesticide product, including all its active ingredient/s and other inert materials shall be declared in the application for registration.
- In case of mixtures, the formulated household pesticide product shall contain a maximum of three (3) active ingredients.
- All local manufacturers, traders and importers shall register with the FDA each active ingredient used in pesticide formulation and the source/s of such active ingredient/s. If such active ingredient/s has current and valid registration with the FPA, the FDA shall recognize the FPA registration of such active ingredient/s.
- The applicant for registration of household pesticide product and/or any of its active ingredient/s shall be a holder of a valid License to Operate (LTO) issued by the FDA.
- All labelling materials shall follow the existing guidelines on the labelling of household pesticides and shall be compliant to the labelling requirements based on the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals, once the specific AO on GHS is approved.
- 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.
- All formulated household pesticide products containing any banned ingredient as declared by the FDA, and/or FPA shall be prevented from entering the Philippine market. Product bans are all based on international protocol and agreement such as Montreal Protocol, Rotterdam Convention, Stockholm Convention, etc. in which the Philippines is one of the signatories.
- Only pesticide products of GHS hazard Categories 3, 4, and 5 shall be allowed for registration for household use.
- Registration for household use shall not be allowed for pesticide products of GHS hazard Category 1.
- Registration of pesticide products of GHS hazard Category 2 shall be strictly for professional use only and shall be subject to the review and recommendatory action of the Household Pesticide Expert Panel.
- All formulated household pesticide products for professional use are not allowed for over the counter selling.
- Registered products may be subject to post-registration monitoring and evaluation, such as, but not limited to, periodic review of scientific evidence and market reports, to ensure continuous compliance with the latest standards.
- Marketing authorization holders shall immediately notify FDA in cases of serious adverse effects associated with the use of 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.
- The storage, transport and final disposal of expired, banned, obsolete, rejected, recalled and/or out of specification formulated household pesticide products, 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).
- SPECIFIC GUIDELINES
- All applicants for registration of new formulated household pesticide products or any of its active ingredient/s shall submit the registration requirements as specified by the FDA.
- For formulated household pesticide product with dual use as agricultural pesticide, the applicant shall register such dual-use pesticide product with the FDA and FPA.
- The establishment applying for registration of any household pesticide product shall submit stewardship program in protecting consumer health and the environment. The FPA guidelines on product stewardship and responsible care are hereby adopted for compliance by applicants of household pesticides for registration.
- Product changes such as but not limited to indications of use, hazard classification of active and/or inert ingredient/s, composition, manufacturer, address of manufacturer, and/or supplier, shall warrant a new registration.
- SPECIAL GUIDELINES
- Authority of the FDA Director-General
Pursuant to RA 3720, as amended by RA 9711, and its IRR, and other related laws, the FDA Director-General has the authority to order the following:
- Issue cease and desist orders motu proprio or upon verified complaint against any individual, company or establishment responsible for placing the reported household pesticide product in the market which may be due to non-compliance to pertinent standards, whether or not said household pesticide product is registered with FDA;
- After due process, order the ban, recall, and/or withdrawal of any household pesticide product proven to have caused the death, serious illness or injury to a consumer that may or may not be connected to false claims, or is immediately injurious, unsafe, or dangerous;
- To issue orders of seizure, to seize and hold in custody pending proceedings, any article of household pesticide products that is adulterated, counterfeited, misbranded, or unregistered;
- Impose administrative sanctions on the erring persons or entities; and
- Implement or administer all legal measures to protect the health and safety of the public.
In addition, as per A.O. 2016-003 entitled “Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration (FDA)”, in case the household pesticide product has been withdrawn for health and safety reasons due to violations, the marketing authorization holder (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.
- Issuance of Off-Label Use / Emergency Exemption Permit
In emergency conditions as declared by the DOH or the respective Local Government Unit (LGU) such as pest outbreaks or disease/epidemic, an off-label permit may be applied for use by an unregistered household pesticide product or by a registered household pesticide product with use different from what is indicated on the label.
Application for an off-label use permit shall be evaluated on its merit based on the information submitted and may be granted permission only for the duration of the emergency period and upon the recommendation of the Household Pesticide Expert Panel.
Permits for experimental use to generate efficacy data for label expansion shall likewise be covered by another administrative issuance.
- Application Process
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.
The evaluation of all applications for CPR shall be based on the completeness and accuracy of the submitted documents and compliance with appropriate standards.
- Submission of Bio-efficacy Study
- Product claims will be based on the pests/insects tested, spectrum of activity, mode of application and dose rate that will be used in the bio-efficacy study/ies to be conducted.
- The submitted bio-efficacy study shall comply with the requirements specified by the FDA in accordance with accepted protocols such as the World Health Organization Pesticide Evaluation Scheme (WHOPES), or any international counterpart.
- The study must 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.
- The study will 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.
- The treatments must be composed of the positive control, negative control and the product being registered.
- The FDA registered positive control and the product being registered must have active ingredient/s with proven high efficacy for the same target pest.
- The negative control shall simulate the concentration of the solvent used in the formulation.
- Submission of Toxicity Study
- Toxicity study/ies must be conducted using the finished product being registered.
- The submitted toxicity study/ies shall comply with the requirements specified by the FDA in accordance with accepted protocols such as the 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 that 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.
A registration number shall be assigned to an application that satisfies the requirements for new registration and such registration number shall be printed on the label of such registered household pesticide products.
The validity of the CPR shall be for a minimum of two (2) years or maximum of five (5) years unless recalled or banned by the FDA.
- Cancellation of CPR
The registration of a household pesticide product that is not renewed within one hundred twenty (120) days from the date of expiration shall be automatically 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.
The MAH may apply for voluntary cancellation of its existing CPR by filing a formal notification with the FDA citing the reasons thereof.
- Cancellation and/or Revocation as a Penalty.
The FDA shall impose the penalty of cancellation and/or revocation of CPR as per Book II, Article I, Sec. 4. Grounds for Disapproval 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.
- It shall be the responsibility of the MAH to ensure that registered household products with cancelled registrations shall be recalled from, shall not be made available to the market, and shall be safely disposed of in accordance to acceptable standards and product stewardship commitments.
The relevant forms, requirements for application, and the submission process shall be made accessible at the FDA website (http://www.fda.gov.ph).
- Annex A: Table of Requirements for the Registration of Household Pesticide
- Annex B: Checklist of Requirements for Off-Label Use / Public Health
Emergency Exemption Permit
- Annex C: Schematic Diagram of the Household Pesticide Product Registration
- FEES AND CHARGES
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.
- 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.
- SEPARABILITY CLAUSE
If any part or term of provision of this Order shall be declared invalid or unenforceable, the validity or enforceability 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, term or provision.
- REPEALING CLAUSE
This Order effectively repeals A.O. 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.
This A.O. 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).