I. RATIONALE
Pesticide registration involves an evaluation of comprehensive scientific data demonstrating that a pesticide is effective for its intended purposes and does not pose an unacceptable risk to human or animal health or the environment. In particular, the aspect of pesticide registration which reviews the effectiveness of a pesticide is the technical evaluation of the submitted bio-efficacy study. Following Department of Health (DOH) Administrative Order (AO) No. 2019-0008, entitled, “New Rules and Regulations in the Registration of Household Pesticide Products and their Active Ingredients”, accepted protocols have been identified and that any deviation from standard protocols require sufficient and compelling justification to ensure soundness of the method and the reliability to produce data to support product claims.
In the course of the implementation of the said AO, updates on the internationally-accepted standards suggest that changes in the list of accepted protocols must be made. Additionally, an assessment of the implementation of the AO showed that pesticide registration applications were found to display deficiencies in the submitted bio-efficacy test study which resulted in disapproved applications. Such applications displayed failure in substantiating claims and in justifying modifications to accepted standards. In order to assist market authorization applicants, promote regulatory compliance, and ensure the efficient use of resources, this Circular hereby establishes the pre-approval process for modified and non-standard bio-efficacy test protocols.
II. OBJECTIVE
This Circular aims to improve the regulatory compliance of pesticide registration applications and facilitate the same through the establishment of a pathway for the review and pre-approval of non-standard and modified bio-efficacy test protocols, which will be submitted in support of pesticide registration under DOH AO No. 2019-0008.
III. SCOPE
This Circular shall cover household pesticide products pursuant to the definition and scope provided by DOH AO No. 2019-0008 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 such household pesticide products.
IV. GENERAL GUIDELINES
A. The applicant for pesticide registration shall be a holder of a valid License to Operate (LTO) as a Household Pesticide Establishment issued by the FDA. Consequently, applicants seeking the review and approval of its non-standard or modified test protocol shall also be a licensed Household Pesticide Establishment.
B. All household pesticides shall preferably be tested in accordance with existing accepted protocols as listed in Annex A. Bio-efficacy tests conducted in strict adherence to existing accepted protocol shall directly proceed to pesticide registration under DOH AO No. 2019-0008.
C. Where a bio-efficacy test to be conducted for the purposes of applying for a household pesticide registration utilizes a non-standard protocol or where justifiable circumstances require deviations from accepted test protocols, licensed household pesticide establishments shall submit the said modified or non-standard test protocol to the FDA for review and approval prior to the conduct of the bio-efficacy test study and any subsequent pesticide registration.
D. Applications for the pre-approval of non-standard and modified bio-efficacy test protocols shall be filed following the procedure outlined in Section V.A. and the requirements provided in Section V.B.
E. Market Authorization Holders (MAHs) intending to use and strictly apply a bio-efficacy protocol previously approved following these Guidelines for a different pesticide registration application may conduct and present data on bio-efficacy studies generated using the accepted protocol; Provided, the product type, intended use and manner of use shall be similar to the previously approved bio-efficacy protocol; Provided, further, that the market authorization applicant of the pesticide registration application shall be the same as the applicant of the previously approved bio-efficacy protocol.
V. SPECIFIC GUIDELINES
Applications for pre-approval of bio-efficacy test protocols shall be filed in accordance with the following procedure and requirements:
A. Filing of an application
Each application shall contain a single protocol which is a modification of an existing protocol or a non-standard protocol. An application shall be filed following the procedure outlined in Annex B. An application shall be considered final upon submission of complete requirements, following pre-assessment, including payment of the required fees and charges. Incomplete applications shall be returned to the applicant.
A successful filing following pre-assessment shall not be construed as an approval of the application, wherein the comprehensive evaluation for correctness and compliance with administrative and technical standards is performed in the evaluation step.
B. Documentary Requirements:
1. Letter of Intent specifying the reason for utilizing a non-standard or modified bio-efficacy test protocol
2. Integrated application form
3. Valid LTO
4. Copy of official receipt
5. Test Protocol
The test protocols shall contain the information as listed in Annex C.
C. Evaluation
The evaluation of the submitted test protocols shall be based on the correctness, accuracy, and compliance with administrative and technical standards of the submitted documents.
D. Processing time
The duration of the review and pre-approval of the submitted test protocols shall be twenty (20) working days. The processing time, however, may be extended for the same number of days with prior notice to the applicant.
E. Fees and Charges
An application fee of Php 500, and the corresponding Legal Research Fee, shall be charged for applications for the review and pre-approval of test protocols, following DOH AO No. 50 s. 2001 and any other amendment or supplemental issuances thereto.
F. Result of application
The result of the application shall be issued by the FDA to the email address of the applicant declared in the application form.
VI. TRANSITORY PROVISIONS
A six (6)-month transitory period shall be observed upon the effectivity of this Circular, wherein prospective registration applications using data generated from bio-efficacy test studies commenced from the date of issuance of the proposed policy until the end of the transitory period, shall not be required to undergo pre-approval as a precondition for product registration.
VII. PENALTY CLAUSE
Any person found in violation of this Circular shall be deemed a violation of Republic Act No. 3720 as amended by Republic Act No. 9711 and shall be penalized accordingly following the Uniform Rules of Procedures laid down under Book III of the Implementing Rules and Regulations of Republic Act No. 9711.
VIII. SEPARABILITY CLAUSE
The provisions of this Memorandum are hereby declared separable and in the event of any such provision/s is/are declared invalid or unenforceable, the validity of enforceability of the remaining portions or provisions which are not affected, shall remain in full force and in effect.
IX. REPEALING CLAUSE
All other administrative issuances, bureau circulars and memoranda and other regulations inconsistent with this Order are hereby withdrawn, repealed and/or revoked accordingly.
X. EFFECTIVITY
This Circular shall take effect fifteen (15) days after its publication in a newspaper of general circulation and filing with the University of the Philippines Law Center Office of the National Administrative Register.