Agricultural pesticides
- Document symbol
- G/LIC/N/3/PHL/15/Rev.1
- Original language
- English
- Published on
- 21/02/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
No pesticide shall be imported into the country without the appropriate Certificate Authorizing Importation of Pesticides (CAIPs) issued by FPA.
Processing of import permits by the FPA is based on registration and licensing policies. No importation of locally produced technical grade material and its corresponding finished products is allowed by the FPA. However, the manufacturer is required to submit proof that the price of the technical material locally produced is competitive with the world market price.
Banned pesticides, if procured through importation, shall be transported back to the country of origin. This shall be certified by the Philippine consulate in the receiving country as a proof that such products really arrived. (Greenbook, pp. 88-189, 6.6 Importation).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Prior to the issuance of CAIP to the importing companies, the importer must have first a License to Operate (LTO) as importer and Certificate of Product Registration (CPR).
This particular import licensing procedure covers HS 38.08 – Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products, and plant growth regulators, disinfectants, and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly papers).
For purposes of registration, pesticides are grouped based on their nature and use pattern.
a) Chemical Pesticides
1. Agriculture/Home Garden/Turf Use
• Insecticide
• Fungicide
• Herbicide
• Rodenticide
• Avicide
• Nematicide
• Bactericide
• Molluscicide
• Acaricide (Miticide)
• Piscicide
2. Other Pesticides-related Chemicals
(used as is or in combination with others in the formulation)
• Growth regulator
• Defoliant
• Desiccant
• Systemic activator of Resistance
• Wood preservative
• Surfactant/Adjuvant
• Emulsifier, wetting agent, penetrant, synergist
• Manufacturing/Intermediate products
• Agricultural disinfectant
b) Biorational Pesticides
1. Biochemical pest control agents
• Semiochemical (pheromone, kairomone, allomone)
• Hormone
• Natural plant regulator
• Enzyme
2. Microbial pest control agents
• Bacterium
• Fungus
• Protozoa
• Virus
3. Plant-incorporated protectants (PIP)
• Single
• Combined/Stacked
Q3. The system applies to goods originating in and coming from which countries?
The requirement applies to pesticide products/technical materials originating from all countries and the prospective importers decide from what country they wish to import provided the product is registered with the FPA.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
There is no restriction based on the quantity of importation, however, if the product/active ingredient is for experimental use only, the quantity must not exceed on the amount needed for experimental trial/s.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The requirement for importation is covered by Pesticide Circular No. I, Series of 1981.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The application for CAIP must be apply 60 days or earlier before the estimated time of arrival (ETA) of the imported product/technical material.
Q7.b. Can a licence be granted immediately on request?
Depending on the urgency of the request and the completeness of the submitted requirements, CAIP/Certification could be granted immediately for emergency purposes only.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Applications may be filed on any working day of the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Licensing applications are considered by a single administrative office, the Pesticide Regulations Division (PRD) of Fertilizer and Pesticide Authority, FPA Building, BAI Compound, Visayas Avenue, Diliman, Quezon City, Manila 1101.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
In the event of denial or disapproval by the pertinent administrative body of an application for import license, the applicant is given the right to make a written appeal for reconsideration of the decision.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Only local companies registered with the Securities and Exchange Commission (SEC) to do business in the Philippines and with registered pesticide product/active ingredients may apply for a license to the FPA. (Please refer to Greenbook pp. 12; 2.2)
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
What information is required in applications?
For licensing of pesticide importer-distributor the information required in Application Form No. FPA PRD FORM NO. P-150 (https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agricultural-Pesticide-Importer-indentor-exporter-license.pdf) are the following: type of Application for Agricultural Pesticide Importer / Indentor / Exporter License (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Mechanism of the payment, type of activity, Pesticide imported (formulated, technical, name and address of the supplier); In country major warehouse point(s) (Name of warehouse/address, capacity); Form and package of imported material to be passed on to immediate recipient (as is, repacked, technical material, formulated products); Name of Accredited Responsible Care Officer (ARCO) attach photocopy of Accreditation ID (Name of ARCO, expiry date); Applicant's email address.
For the licensing of pesticide manufacturer/formulator/extruder, the information required in Application Form No. FPA PRD FORM NO. P-110
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agricultural-Pesticide-Formulator-Manu-Ext-license.pdf) are the following: type of Application for manufacturer/formulator/extruder (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Address of Formulation / Manufacturing / Extrusion Plant, Environmental Compliance Certificate No. / Permit to Operate No. / Expiry Date, List of Pesticides Formulated / Manufactured / Extruded (product, formulation type, product owner, volume/year); Formulation Capability Rated Capacity, No. of Employees, Area of Compound, Location of Plant, Occupational / Safety Arrangements, Technical Staff: Name, PRC License No., Plant Manager PRC license number, Formulation Chemist PRC license number, Quality Control Chemist PRC license number, Name and Address of Laboratory, Name of Accredited Responsible Care Officer (ARCO); Applicant's email address.
For the licensing of pesticide repacker, the information required in Application Form No. FPA FORM NO. P-120 (https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Agricultural-Pesticide-Repacker-License.pdf) are the following: type of Application for repacker (Conventional, Plant Incorporated Protectant (PIP), New, Renewal); Company information (Business Name of the Applicant, address, TIN number, Telephone number); Capitalization, Address of Repacking Plant, Environmental Compliance Certificate No./Permit to Operate No./Expiry Date, Repacking Set-Up and Equipment, Rated Capacity, No. of Employees, List of Pesticides Products Repacked (product, repacking type, formulation type, importer/distributor); Information regarding the usage of brand name, In-charge of affixing or attaching the labels of repacked products (brand/label owner or repacker), Source of labels brand/label owner or repacker), Occupational/Safety Arrangements, Location of Plant, Area of Compound, Technical Staff: Name, PRC License No. (Plant Manager, , Quality Control Chemist) , Name of Accredited Responsible Care Officer (ARCO); Applicant's Email Address.
For pesticide product registration the data and information required in FPA FORM NO. P-022 for the product and FPA FORM NO. P-012 for active ingredient.
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Registration-Pesticide-Product.pdf)
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/Registration-Pesticide-Active-Ingredient.pdf)
a) For the product, this shall include the following: Name and address of applicant, brand name, name of active ingredient and percent purity, formulation (% active ingredient and type); registration applied for: (new, new/tpa, renewal, resubmission); Use category (insecticide, herbicide, fungicide, others); name and address of manufacturer, name and address of formulator, packaging sizes, proposed use (crop/s, pest/s, A.I/HA [kg or Li], recommended dosage TBB/16Li[10CCT/BTS], product/ha[kg or li]); applicants representative (name, title, signature) and email address.
b) For the active ingredient, this shall include the following: Name and address of the applicant, active ingredient (common name and purity), chemical type, name and address of manufacturer, registration applied for (new, new/tpa, renewal, resubmission); proposed formulation(s) and composition (brand names of each); use category (insecticide, fungicide, herbicide and other); applicant’s representative (name, title, signature) and email address.
Application of Registration
Any person may file for registration of pesticide, which must be in the prescribed form addressed to the Authority and under oath, containing complete and detailed information.
Only local companies registered by the Securities and Exchange Commission to do business in the Philippines and duly licensed by the FPA may apply for registration of pesticide products. For purposes of these guidelines, a local company is a juridical person created under the Philippine law and licensed to do business in the country. Companies operating in the Philippines under PD 218 are excluded in this definition. Foreign suppliers or companies registered under the Securities and Exchange Commission as regional liaison offices (PD218) are not allowed to register products. For pesticides, the applicant or registrant should be the distributor or the local subsidiary of a foreign-based pesticide company.
A separate application shall be filed for each formulated product and active ingredient as well as for each source of the active ingredient.
For Experimental Use Permit (EUP)
Application form FPA Form No. P-002
(https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/PesticideAppsForm/2020/EUP.pdf)
shall include the following: Name and address of the applicant, product name, name of active ingredient & % purity, name and address of manufacturer of A.I, formulation % A.I. & type, use category (insecticide, herbicide, fungicide, others); crop(s) and target pest(s), total area covered by trial, total amount of A.I. equivalent/formulation needed, duration of trial, location of experiment, name of researcher, address of institution, applicants representative (name, title, signature, email address).
Table 2.2 of the FPA “Manual on Pesticide Regulatory Policies and Implementing Guidelines” provides the technical data requirements for issuance of the pesticide registration or EUP.
Tables
For CAIP requirements: Pesticide Circular No. 1, Series of 1981, the following are the lists of requirements for importation of pesticides:
1. The importer must be licensed by the FPA.
2. The pesticide product(s) and active ingredient(s) must bear a registration, or covered by the appropriate Experimental Use Permit (EUP).
3. The following must be specified in the request for importation:
i) Product, specifying % purity if technical material or active ingredient if formulated product
ii) Unit price
iii) Quantity
iv) Payment terms
v) Country of origin
vi) Destination
vii) Carrier/vessel
4. The pro-forma invoice must be attached. This shall enable the FPA to correlate the source of supply to the registration of the product.
5. The bill of lading, which verifies that the above transaction transpired at the term(s) and price(s) stated on the pro-forma invoice must be attached to the subsequent request for importation.
All unused Import Certificates must be returned to the FPA at the end of each quarter.
What documents is the importer required to supply with the application?
For licensing of pesticide importer-distributor Upon application for license, importers are required to submit/accomplish the following:
a) For New Applications:
1.Duly accomplished and notarized application form (original copy) with documentary stamps required.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FR).
4. Distributorship agreement/certification from the pesticide supplier/s.
5. Recommendation / Inspection Report from FPA Regional / Provincial Officer.
6. Registration of Pesticide Warehouse/s.
7. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
8. Product Registration of pesticides to be sold. (Photocopy of Certificate of Product Registration (CPR) / Signed list of approved pesticide products).
9. Contract / Certification with the Manufacturer / Supplier.
10. Photocopy of Certificate of Attendance of one (1) symposium – Renewal ID.
11. Schedule of fees.
b) For renewal of license
1. Duly accomplished and notarized application form (original copy) with documentary stamps required.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FR).
4. Distributorship agreement/certification from the pesticide supplier/s.
5. Recommendation / Inspection Report from FPA Regional / Provincial Officer.
6. Registration of Pesticide Warehouse/s.
7. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
8. Product Registration of pesticides to be sold. (Photocopy of Certificate of Product Registration (CPR) / Signed list of approved pesticide products).
9. Photocopy of Certificate of Attendance of one (1) symposium – Renewal ID.
10. Schedule of fees.
A license good for one year shall be issued upon approval of application.
For pesticide manufacturer/formulator/extruder and repacker
Requirements for the licensing of pesticide manufacturer / formulator / extruder and repacker
1. Duly accomplished and notarized application form (original copy) with documentary stamps.
2. For:
i) Corporation/Partnership - Copy of SEC Registration and Articles of incorporation
ii) Cooperative - Copy of CDA Registration.
iii) Single Proprietorship - Copy of Certificate of Registration of
Business Name with DTI
3. Copy of latest Income Tax Return (ITR) and Financial Statements (FS).
4. Copy of Environmental Compliance Certificate (ECC) and Permit to Operate (PTO) with DENR.
5. Production Process / Flow Chart.
6. Recommendation and Inspection Report from FPA Regional / Provincial Officer.
7. Written authority to repack / formulate / extrude / manufacture from the supplier.
8. Pre-licensing inspection report by the Pesticide Audit Team.
9. Registration of Pesticide Warehouse/s.
10. Photocopy of Accredited Responsible Care Officer (ARCO) ID.
11. Product registration of pesticide to be sold.
12. Compliance of FPA Manual on Occupational and Technical Safety of Pesticides manufacturing, formulation, repacking and extrusion plant.
i) Occupational Health and Safety Program (OHSP)
ii) Medical Health Examinations of Workers
13. Photocopy of Certificate of Attendance of one (1) symposium - Renewal ID.
14. Annual Capacity Output.
15. Schedule of fees
A license good for one year shall be issued upon approval of application.
For pesticide product registration
A complete application (submitted in duplicate) which consists of:
a) Form for registrant of an active ingredient (P-012) or registration of a Pesticide Product (P-022)
b) Complete data required to support the registration requested as specified in SECTION III of the Guidelines, particularly Table 2.2 on Data Requirements, with a certification that they comply with good scientific practice, GLP’s and test protocols.
c) A summary of the data submitted and an applicant’s assessment of how these data support registration for the purpose, uses and directions for use in the draft label.
d) Proof of registration in other countries where relevant.
e) Dummy label text.
f) A sample of the material to be registered must be submitted prior to registration unless the applicant presents convincing reason to the FPA as to why these should not be submitted at that time. The following must accompany an application: 1g analytical grade of the active ingredient(s). 10g technical material and 500ml or 0.500kg of the formulation.
g) Reviews of data done by other countries of international organizations, if available.
h) The appropriate fee.
i) Any authorization necessary to cite previously submitted data.
Data must be submitted in the standard 8 ½ x 14 paper, indexed and bound separately, i.e. one folder for each of the following sets of data: Specifications, Bioefficacy, Toxicology and Residues/ Environment Fate. The dummy label must appear as the first entry in each folder. Any additional data required must also be submitted as prescribed. Submission that does not follow these requirements shall not be accepted.
For Experimental Use Permit (EUP)
For experimental samples to be imported pesticide, an FPA-approved Experimental Use Permit (EUP) is required.
a) Accomplished application form
b) Technical data requirements
c) Application for a company license as Importer-National Distributor/End-user
Table 2 of the FPA "Manual on Pesticide Regulatory Policies and Implementing Guidelines" provides the technical data requirements for issuance of the pesticide registration or EUP.
Table 2.2
Data Requirement for the Registration and Experimental Uses of All Pesticide Products
(See Page 52-61 of the FPA Greenbook)
Name of data requirement | Use pattern1 | Active ingredient Tech Grade 2 | Formulation2 | EUP2 | Remarks |
---|---|---|---|---|---|
Agricultural | |||||
1.0 GENERAL | |||||
1.1 Name/address of applicant | R | R | R | A | Required in all cases |
1.2 Product Trade/Brand Name | R | R | R | 2, 3 | -do- |
1.3 Manufacturer of Technical Pesticide | R | R | R | A | -do- |
1.4 Description of Production Process3 | R | R | R | X | -do- |
2.0 SPECIFICATIONS | |||||
2.1 Common Name of Active Ingredient (Proposed or Accepted ISO name) | R | R | 2, 3 | -do- | |
2.2 Chemical Name of Active Ingredient (IUPAC designation) | R | R | R | 2, 3 | -do- |
2.3 Chemical Abstract Service Number | R | R | X | 2, 3 | -do- |
2.4 Formulas (empirical and structural) | R | R | X | 2, 3 | -do- |
2.5 Composition of Technical including impurities (all materials present at or over 0.1%)4 | R | R | X | 2 | -do- |
2.6 List of ingredients and per cent variations of each5 | R | R | R | 2, 3 | -do- |
2.7 Appearance, color, state, odor | R | R | R | A | -do- |
2.8 Melting point | R | R | X | A | If solid at room temp |
2.9 Boiling point | R | R | X | A | If liquid at room temp |
2.10 Vapor pressure | R | At 20-25 °C | X | A | Only if >10-3 Pascal |
2.11 Density or Specific Gravity | R | R | R | A | Required in all cases |
2.12 Octanol Partition Coefficient - half-life in soil - Koc1 organic carbon partition coefficient | R | R | X | A | Required if Technical A.I. is organic and non-polar |
2.13 Formulation Type (GCFP code) 6 | R | X | R | 2, 3 | |
2.14 Storage Stability | R | X | R | 2, 3 | |
2.15 Solubility in water and solvents | R | R | X | 2 | |
2.16 Suspensibility/Emulsifying Characteristics | R | X | R | 2 | |
2.17 Known capability/ incompatibility with other pesticide products or Active Ingredients | R | X | R | X | |
2.18 Flash point and other indicators of flammability | @ | R | R | 2, 3 | If product contains combustible liquid |
2.19 pH | R | R | R | 2, 3 | |
2.20 Methods of destruction or disposal | R | R | R | A | For EUP, includes treated crop disposition |
2.21 Packaging type, sizes and materials | R | R | R | A | |
2.22 Assessment of Need of Child-Resistant Packaging | X | X | R | X | For Toxicity Category I and II |
2.23 Analytical Methods for Constituents | R | R | R | 2 | |
2.24 Submittal of product samples | R | 10g | 500ml./0.5kg | X | Analytical Grade A.I, 1g required unless reasons provided by applicant |
3.0 BIOEFFICACY (Typical Formulation) | |||||
3.1 Description of mode of action or effect on pest for which control is claimed | R | X | R | X | |
3.2 Pests controlled and names of crops, materials or premises to be protected | R | X | R | A | |
3.3 Application rate (Kg a.i/Ha or % a.i. spray dilution of each site/pest listed | R | X | R | A | |
3.4 Frequency and timing or application for each site/pest listed | R | X | R | A | |
3.5 Method of application (ULV, backpack, sprayer, fumigation, etc.) | R | X | R | A | |
3.6 Phytotoxicity | R | X | R | 2,3 | |
3.7 Results of laboratory studies, if any | R | X | R | A | |
3.8 Complete description and data from local field trials or relevant test performed abroad or request for waiver for each site/pest on label | R | X | R | X | |
3.9 Effects on beneficial organisms | @ | R | Appropriate pest/predator or parasite complex | X | Technical or formulated material may be used; reflect field use conditions |
4.0 TOXICOLOGY | |||||
4.1 Estimation of Acute Oral LD 50 7 | R | Study in rat | Study in rat | A | Calculation permissible in some cases from TGAI |
4.2 Estimation of Acute Dermal LD 50 7 | R | Study in rabbit | Study in rabbit | A | -do- |
4.3 Inhalation LC 50 | @ | Study in rat | Study in rat | A | Required only if pesticide has high vapor pressure or if used as gas, fog, smoke, fumigant or contains respirable dust |
4.4 Skin Irritation/Corrosivity | R | Unabraded rabbit skin | Unabraded rabbit skin | A | |
4.5 Eye Irritation | @ | X | Study in rabbit | 2, 3 | Not required if pH is less than 3 or greater than 11.5; or if corrosive to skin |
4.5.1 Dermal Sensitization | R | X | Study in guinea pig | 2, 3 | |
4.6 Allergic Sensitization | @ | X | R | 2 | If positive in 4.5.1 |
4.7 Subchronic toxicity (21 day, dermal) | X | ||||
4.7.1 Subchronic toxicity (90 days, oral) | R | Studies in rodent (oral) | X | 2 | Two species for food crop, one for non-food; required for household if significant exposure |
4.7.2 Subchronic toxicity (90 days, dermal) | @ | Study in rodent (dermal) | X | 2 | Rarely required; Special exposure cases |
4.8 Teratology | R | Studies in rabbit and rat | X | 2, 3 | |
4.9 Reproduction | R | Study in rabbit or rat (preferred) | X | 2, 3 | Two generations adequate |
4.10 Chronic toxicity | R | Lifetime in rat | X | X | Not required for EUP but submit if available |
4.11 Oncogenicity | R | Lifetime in rat and mouse | X | X | -do- |
4.12 Mutagenicity | R | Multi-test battery | X | 2, 3 | Battery should include point mutation, chromosomal aberration and in vivo mammalian tests |
4.13 Acute delayed neurotoxicity | @ | Study in hen | X | 2, 3 | When cholinesterase depression expected |
4.13.1 Subchronic neurotoxicity | @ | Hens or mammals | X | 2, 3 | If effects noted in 4.13 or mammalian acute studies |
4.14 Pharmacokinetics (absorption, storage, metabolism and elimination) | R | Appropriate spec. | X | 2, 3 | For EUP only if crop is to be used |
4.15 Observations on Man, if any | R | R | R | A | |
5.0 HUMAN EXPOSURE AND SAFETY | |||||
5.1 Assessment of applicator exposure | @ | X | Monitoring or calculation | 2, 3 | Required when potential exposure is close to an effect level |
5.2 Assessment of farm worker exposure | @ | X | Monitoring or calculation | 2, 3 | Required for Toxicity Category 1 when hand labor in dense foliage is concern; and toxic compounds |
5.3 Signs and symptoms of acute human poisoning | R | Observations or judgements | Observations or judgments | A | |
5.4 Recommend first aid procedures | R | R | R | A | |
5.5 Recommend medical treatment for poisoning, include antidote, if any | R | R | R | A | |
5.6 Proposed Acceptable Daily Intake | R | Calculated | X | 2,3 | Food uses only; For EUP if not crop destruct basis |
5.7 Protective equipment | @ | R | R | A | If needed; Required for Toxicity Category I and II |
5.8 Other precautions | @ | R | R | A | If needed |
6.0 ENVIRONMENTAL EFFECTS | |||||
6.1 Avian acute oral toxicity | R | X | Test in one species for each typical formulation | 2, 3 | Suitable species, pigeon, quail, pheasant, duck, or a Bengalese finch; hen not suitable |
6.2 Avian dietary acute toxicity | @ | X | Test in one species needed to assess potential effects | X | If indicated by acute test results and type of formulation and use |
6.3 Fish acute toxicity | R | 96-hour test in two species one of which is a local species | X | 2, 3 | Suitable specifies include rainbow trout, zebra fish, fat head minnow, tilapia fingerlings |
6.4 Sub-acute fish toxicity | @ | Prolonged exposure test, one or more species | X | X | Where prolonged exposure likely; Test period up to 30 days |
6.5 Aquatic acute toxicity | R | 48-hour acute test suitable species | X | X | Suitable fish food species, e.g., Daphnia |
6.6 Accumulation in fish | @ | Test in one species | X | X | Where indicated by use pattern, formulation type and partition coefficient |
6.7 Avian reproduction | @ | Test in one species | X | X | If need is indicated by feeding study results |
6.8 Fish reproduction | @ | Test in Daphnia and one fish species | X | X | Test to be performed if persistent exposure indicated by use pattern and chemical persistence |
6.9 Acute toxicity to honeybees | @ | R | X | X | Test to be performed if use involves crop where bees are present during or just after treatment |
6.10 Contact toxicity to honeybees | @ | X | Typical formulation | X | Test needed for uses involving exposure and acute test shows high bee toxicity |
6.11 Soil non-target microorganisms | @ | X | Typical formulation | X | Required if high soil concentrations expected from use; Test maybe conducted with TGAI or formulation |
6.12 Soil non-target macroorganisms | @ | X | Earthworms | X | Same as above; also collect residue data if high avian toxicity |
Note: Special pen and field studies may be required depending upon uses, formulation and results of above studies.
7.0 RESIDUE IN FOODS |
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For food use only |
7.1 Identity of principal residues, metabolites and degradation products in edible crops, foods or feeds |
7.2 Residue decay curves for residues on crops to be treated |
7.3 Residues of active ingredient and principal metabolite in animals fed treated feeds or grazed on treated fields or pastures |
7.4 Effects of food processing or home preparation on residues |
7.5 Analytical method for detection of principal residues, metabolites on treated commodities |
7.6 Proposed maximum residue level for each crops, food, feed or animal expected to contain residues |
Note: Residue data may also be required for inerts which are not provided a general exception or generally regarded as safe. Above residue data not required for EUP on a crop-destruct basis.
8.0 ENVIRONMENTAL FATE AND TRANSPORT |
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8.1 Volatility |
8.2 Adsorption/desorption |
8.3 Leaching |
8.4 Degradation in soil |
8.5 Biodegradation |
8.6 Hydrolysis |
8.7 Aqueous photolysis |
8.8 Analytical method – residues in soil |
8.9 Analytical method – residues in water |
9.0 LABELLING |
9.1 Proposed toxicity category |
9.2 Draft label (3 copies) |
Note: EUP labels may be typewritten and need to contain product identification warnings and precautions for storage, use and disposal, symptoms and signs of poisoning, first aid procedures and medical treatment.
For CAIP requirements: Pesticide Circular No. 1, Series of 1981, the following are the lists of requirements for importation of pesticides:
- The importer must be licensed by the FPA.
- The pesticide product(s) and active ingredient(s) must bear a registration, or covered by the appropriate Experimental Use Permit (EUP).
- The following must be specified in the request for importation:
- i) Product, specifying % purity if technical material or active ingredient if formulated product
- ii) Unit price
iii) Quantity
- iv) Payment terms
- v) Country of origin
- vi) Destination
vii) Carrier/vessel
- The pro-forma invoice must be attached. This shall enable the FPA to correlate the source of supply to the registration of the product.
- The bill of lading, which verifies that the above transaction transpired at the term(s) and price(s) stated on the pro-forma invoice must be attached to the subsequent request for importation.
All unused Import Certificates must be returned to the FPA at the end of each quarter.
Q11. What documents are required upon actual importation?
Documents necessary prior to the issuance of Certificate Authorizing Importation of Pesticides (CAIP) are the following:
(a) The following must be specified in the request letter for importation:
• Product, specifying % purity if technical material or active ingredient and concentration if formulated product
• Unit price
• Quantity
• Payment terms
• Country of origin
• Destination
• Carrier/vessel
• Brokers Name and TIN number
(b) The pro-forma invoice must be attached. This shall enable the FPA to correlate the source of supply to the registration product.
(c) Photocopy of Certificate of Product Registration (CPR) / appropriate Experimental Use Permit (EUP).
(d) Photocopy of License to Operate (LTO)
(e) The bill of lading, which verifies that the above transaction transpired at the term(s) and price(s) stated on the pro-forma invoice, must be attached to the subsequent request for importation.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Is there any licensing fee or administrative charge?
Yes
What is the amount of the fee or charge?
Schedule of fees for licensing:
A. Filing fee/activity for new applications
1. Pesticide Manufacturer, Formulator, Repacker,
Institutional Users - ₱7,500.00
Other Activities - ₱2,000.00
B. License Fees - For pesticide Handlers based on the company's capitalization
Annually (subscribed/paid-up capital plus retained earnings)
1. Over ₱5M capitalization
1st activity - ₱8,500.00
Succeeding activities - ₱5,000.00
2. Over ₱1M to ₱5M capitalization
1st activity - ₱5,500.00
Succeeding activities - ₱4,000.00
3. Over ₱500T to ₱1M capitalization
1st activity - ₱4,000.00
Succeeding activities - ₱2,000.00
4. ₱500T and below capitalization
1st activity - ₱2,000.00
Succeeding activities - ₱1,000.00
C. Pest Control Operator (Annually) - ₱1,200.00
D. Accreditation fee for CPA (Annually) - ₱600.00
E. Warehouse (Annually)
• Pesticide - ₱2,000.00
• Both Fertilizer and Pesticide - ₱2,400.00
Schedule of fees for Agricultural Pesticide Registration
A. New Application – Filing fee
Active Ingredient - ₱4,500.00
Product - ₱3,000.00
B. Conditional Registration/Renewal (Annually)
Product
Category 1 & 2 - ₱5,000.00
Category 3 & 4 - ₱3,000.00
Active Ingredient
Category 1 & 2 - ₱7,000.00
Category 3 & 4 - ₱5,000.00
C. Full Registration/Renewal (three years validity)
Product
Category 1 & 2 - ₱15,000.00
Category 3 & 4 - ₱7,000.00
Active Ingredient
Category 1 & 2 - ₱20,000.00
Category 3 & 4 - ₱15,000.00
D. Submission of Additional Data - ₱4,000.00
E. EUP Application/Protocol/Crop/Season
I-A & B - ₱1,500.00
II & III - ₱3,000.00
F. Label/Expansion/Crop - ₱3,000.00
For CAIP Processing and Issuance Fee:
• General Use - ₱750.00
• Red labelled & Restricted Use - ₱3,000.00
Amendment Certification - ₱750.00
Export Permit - ₱1,500.00
All other Certification - ₱350.00
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment requirement associated with the issuance of licenses.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The validity of CAIP is only 60 days starting on the date indicated, however, if the shipment is delayed, they can re-apply for CAIP amendment for their shipment date.
For pesticide importers, approved license shall be valid for one year. Application for renewal filed within one after its expiry date shall be subject to a 50% surcharge while those filed after the said period shall be subjected to a 100% surcharge.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
All unused CAIPs must be returned to the FPA at the end of each quarter.