Note:  This draft is only intended as a copy for comments during the stakeholder consultation 
period of the proposed guidelines. The content of this draft may change and does not 
prejudge any policy nor decision of the FDA. Citation of any text in this draft, for purposes 
other than the submission of comments as indicated in the issued announcement, is not 
recommended.  
 
  1 
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FDA CIRCULAR  4 
No. ____________  5 
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SUBJECT  :  Guidelines on the Filing and Submission of Acceptable Variations  8 
on Protocols and Non-standard  Protocols for the Review and Pre - 9 
Approval by the Food and Drug Administration Prior to the 10 
Conduct of Bio -efficacy Test Studies of Household Pesticides for the 11 
Purposes of Securing a Certificate of Product Registration   12 
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I. RATIONALE  15 
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Pesticide registration involves an evaluation of comprehensive scientific data 17 
demonstrating that a pesticide is effective for its intended purposes and does not pose 18 
an unacceptable risk to human or animal health or the environment. In particular, the 19 
aspect of pesticide registration which reviews the effectiveness of a pesticide is the 20 
technical evaluation of the submitted bio-efficacy study. Following Department of 21 
Health (DOH) Administrative Order (AO) No. 2019 -0008, entitled, "New Rules and 22 
Regulations  in the Registration of Household Pesticide Products and their Active 23 
Ingredients", accepted protocols have been identified and that any deviation from 24 
standard protocols require  sufficient and compelling  justification to ensure soundness 25 
of the method and  the reliability to produce data to support product claims.  26 
 27 
In the  course of the implementation of the said AO,  updates to the internationally - 28 
accepted standards suggest that changes  to the list of accepted protocols must be made. 29 
Additionally, an assessm ent of the implementation of the AO showed that pesticide 30 
registration applications were found to display deficiencies in the submitted bio- 31 
efficacy test study which resulted in disapproved applications. Such applications 32 
displayed failure to substantiate claims and failure to justify modifications to accepted 33 
standards. In order to assist market authorization applicants, promote regulatory 34 
compliance, and ensure the efficient use of resources, this Circular hereby establishes 35 
the pre -approval process for m odified and non-standard  bio-efficacy test protocol s. 36 
 37 
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II. OBJECTIVES  39 
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This Circular aims to improve the regulatory compliance of pesticide registration 41 
applications and facilitate the same through the establishment of a pathway for the 42 
review and pre -approval of non-standard  and modified bio-efficacy test protocols, 43 
which will be submitted in support of pesticide registration under DOH AO No. 2019 - 44 
0008.  45 
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III. SCOPE  48  
 
 
  1 
This Circular shall cover household pesticide products pursuant to the definition and 2 
scope provided by DOH AO No. 2019 -0008 and the establishments that are engaged in 3 
the manufacture, importation, exportation, sale, offer for sale, distribution, donation, 4 
transfer, and where applicable, the use, testing, promotion, advertising, or sponsors hip 5 
of such household pesticide products.  6 
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      8 
IV. GENERAL GUIDELINES  9 
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A.  The applicant for pesticide registration shall be a holder of a valid License to 11 
Operate (LTO) as a Household Pesticide Establishment issued by the FDA. 12 
Consequently, applicants  seeking the review and approval of its non-standard  13 
or modified test protocol shall also be a licensed Household Pesticide 14 
Establishment.  15 
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B. All household pesticides shall preferably be tested in accordance with existing 17 
accepted protocols as listed in Annex A. Bio -efficacy tests conducted in strict 18 
adherence to existing accepted protocol shall directly proceed to pesticide 19 
registration under DOH AO No. 2019 -0008.  20 
 21 
C. Where a bio -efficacy test to be conducted for the purposes of applying for a 22 
household pesticide registration utilizes a non-standard  protocol or where 23 
justifiable circumstances require deviations from accepted test protocols, 24 
licensed household pesticide establishments shall submit the said modified or 25 
non-standard  test protocol to the FDA for review and approval prior the conduct 26 
of the bio -efficacy test study and any subsequent pesticide registration.  27 
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D. Applications for the pre -approval of non-standard  and modified bio -efficacy test 29 
protocols shall be filed following the procedure outlin ed in Section V.A. and 30 
the requirements provided in Section V.B.  31 
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E. Market authorization holders (MAHs) intending to use and strictly apply a bio - 33 
efficacy protocol previously approved following these Guidelines for a different 34 
pesticide registration application may conduct and present data on bio -efficacy 35 
studies generated using the accepted protocol; Provided, the product type, 36 
intended use and manner of use shall be similar to as the previously approved 37 
bio-efficacy protocol; Provided, further, that  that the market authorization 38 
applicant of the pesticide registration application shall be the same as the 39 
applicant of the previously approved bio -efficacy protocol.  40 
      41 
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V.  SPECIFIC GUIDELINES  43 
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Applications for pre -approval of bio -efficacy test protocols shall be filed in accordance 45 
with the following procedure and requirements:  46 
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A.  Filing of an application   48 
 49  
 
 
 Each application shall contain a single protocol which is a modification of an 1 
existing protocol or a non -standard protocol.  An applicatio n shall be filed 2 
following the procedure outlined in Annex B. An application is considered final 3 
upon submission of complete requirements, following pre -assessment, 4 
including payment of  the required fees and charges. Incomplete applications 5 
shall be return ed to the applicant.  6 
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A successful filing following pre -assessment shall not be construed as an 8 
approval of the application, wherein the comprehensive evaluation for 9 
correctness and compliance to administrative and technical standards is 10 
performed in the evaluation step.   11 
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B.  Documentary Requirements  13 
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1. Letter of Intent specifying the reason for utilizing a non-standard  or 15 
modified bio -efficacy test protocol  16 
2. Integrated application form  17 
3. Valid LTO  18 
4. Copy of official receipt  19 
5. Test Protocol  20 
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The test protocols shall contain the information as listed in Annex C.  23 
  24 
C. Evaluation  25 
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The evaluation of  the submitted  test protocols shall be based on the 27 
correctness, accuracy, and compliance with administrative and technical 28 
standards of the submitted documents.  29 
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D. Processing time  31 
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The duration of the review and pre -approval of the submitted test protocols shall 33 
be twenty (20) working days. The processing time may be extended for the same 34 
number of days with prior notice to the applicant.  35 
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E.  Fees and Charges  37 
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An ap plication fee of Php 500, and the corresponding Legal Research Fee, shall 39 
be charged for applications for the review and pre -approval of test protocols, 40 
following DOH AO No. 50 s. 2001.      41 
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F. Result of application  43 
  44 
The result of the application shall be issued by the FDA to the email address of 45 
the applicant declared in the application form.  46 
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VI.  TRANSITORY PROVISIONS  49 
 50  
 
 
 Applications submitted prior the effectivity  of this issuance shall be processed in 1 
accordance with DOH AO No. 2019 -0008. Upon effect ivity of this Circular, new 2 
applications shall adhere to the guidelines set  forth in this Circular.      3 
 4 
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VII. PENALTY CLAUSE  6 
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Applicable sanctions or regulatory actions shall be imposed upon those found in 8 
violation of the provisions of this Circular.  9 
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VIII.  REPEALING CLAUSE  12 
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All other administrative issuances, bureau circulars and memoranda and other 14 
regulations inconsistent with this Order are hereby withdrawn, repealed and/or revoked 15 
accordingly.  16 
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IX. SEPARABILITY CLAUSE  19 
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The provisions of this Memo randum are hereby declared separable and in the event of 21 
any such provision/s is/are declared invalid or unenforceable, the validity of 22 
enforceability of the remaining portions or provisions which are not affected, shall 23 
remain in full force and in effect.  24 
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X. EFFECTIVITY  27 
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This Circular shall take effect fifteen (15) days after its publication in a newspaper of 29 
general circulation and filing with the University of the Philippines Law Center Office 30 
of the National Administrative Register.  31 
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FRANCISCO T. DUQUE III, MD, MSc  36 
Secretary of Health  37 
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  50  
 
 
 ANNEX A  1 
List of Bio -efficacy Test Studies with accepted Test Protocol/s  2 
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1. Human Mosquito Repellent  5 
 1.1 WHO Guidelines for Efficacy Testing of Mosquito Repellents for Human Skin  6 
 1.2 OPPTS 810.3700:  Insect Repellents to be Applied to Human Skin  7 
 1.3 MS 1497:2007: Household Insecticide Products – Personal Mosquito  8 
Repellent – Evaluation Method for Biological Efficacy (First revision)  9 
 10 
2. Insecticides  11 
2.1 WHO Guidelines for Efficacy Testing o f Insecticides for Indoor and O utdoor 12 
Ground -Applied Space Spray Applications  (May  also be used  for houseflies)  13 
2.2 ECHA Appendix 18 “List of Currently A vailable Standard Test Methods f or 14 
Product Type 18 Insecticides /Acaricides and Product Type 19 15 
Repellents/Attractants (As Far a s They Concern Insects and Other 16 
Arthropods)”  17 
2.3 OCSPP 810.3500:  Premises Treatments   18 
2.4 WHO G uidelines for Testing Mosquito A dulticides for Indoor Residual 19 
Spraying and Treatment o f Mosquito Nets  (May  also be used  for houseflies)  20 
2.5 MS 1911: Part 1: 2006: Household Insecticide Products – Evaluation Method 21 
for Biological Efficacy – Part 1: Glass Chamber Method  22 
2.6 MS 1911: Part 2: 2006: Household Insecticide Products – Evaluation Method 23 
Biological Efficacy – Part 2: Peet G rady Method  24 
2.7 MS 1911: Part 3: 2006: Household Insecticide Products – Evaluation Method 25 
for Biological Efficacy – Part 3: Cylinder Method  26 
2.8 MS 1911: Part 4: 2006: Household Insecticide Products – Evaluation Method 27 
for Biological Efficacy – Part 4: Plaq ue Method  28 
2.9 MS 1984: 2007: Laboratory Colonisation of Insects of Public Health 29 
Importance – Guidelines  30 
2.10 MS 1985: 2007: Household Insecticide Products – Ant Bait – Evaluation 31 
Method for Biological Efficacy  32 
2.11 MS 1986: 2007: Household Insecticide Products – Containerised Ant Bait – 33 
Specification  34 
2.12 MS 1326: Part 3:2007: Household Insecticide Products – Cockroach Bait – 35 
Evaluation Method for Biological Efficacy (Second revision)  36 
2.13 MS 1326 -2:2010: Household Insecticide Products – Containerised Cockroach 37 
Bait – Specification (First revision)  38 
 39 
3. Insecticidal Net  40 
3. 1 WHO Guidelines for Laboratory and Field Testing of Long -Lasting 41 
Insecticide Nets  42 
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4. Mosquito Coils, Vaporizer Mats, Liquid Vaporizers Ambient Emanators and Aerosols  45 
 4.1 WHO Guidelines for Efficacy Testing of Household Insecticide Products  46 
 4.2 MS 23 PART 1 2006 : Household Insecticide Product – Physical, Chemical  47 
and Biological Efficacy Requirements – Mosquito Coil (Fourth revision)  48 
4.3 MS1044: 2012: Household insecticide products – Mosquito vapourising mat – 49 
Specification (Second revision)  50  
 
 
 4.4 MS 1255:2006: Household Insecticide Products – Physical, Chemical and 1 
Biological Efficacy Requirements – Surface and Direct Spray Aerosol (First 2 
revision)  3 
4.5 MS 1257:2010 Household Insecticide Products – Aerosol Against Flying 4 
Insects – Specification (First revision)    5 
 6 
5. Mosquito Larvicide  7 
 5.1 WHO Guidelines for Laboratory and Field Testing of Mosquito Larvicides  8 
 9 
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6. Termiticide, Wood preservative and  Termite baits  11 
6.1 ASTM D3345: Standard Test Method for Laboratory Evaluation of Solid 12 
Wood for Resistance to Termites, ASTM D3345 -17 (West Conshohocken, 13 
PA: ASTM International, approved January 1, 2017), 14 
https://doi.org/10.1520/D3345 -17 15 
6.2 OPPTS 810.3800: Method for Efficacy Testing of Termite Baits  16 
6.3 OPPTS 810.3600 : Structural Treatment  17 
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The afore -mentioned list  of bio-efficacy test studies  with accepted test protocols  may be 20 
amended or updated as determined by FDA . 21 
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 ANNEX B  1 
Step -by-step Application Procedure   2 
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1. Pathways for  pre-approval of Bio -efficacy test protocols  5 
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 50 File application  
Pre-assessment  
(CCHUHSRR)  
Correctness 
and 
Completenes
s No 
Payment  Yes 
Evaluation of application  
(Consultant)  
Approved Bio -efficacy 
test protocol  Acceptable  
Bio-efficacy 
test protocol?  No 
Disapproved  Bio-efficacy 
test protocol  
 
Yes 
HUP Registration  Generation of data and 
preparation of product 
dossier   
 
 
 2. Application procedure for the review and pre -approval of test protocols:  1 
 2 
2.1 Applicant sends a request for schedule of submission of application 3 
requirements to FDAC (fdac.pacd@fda.gov.ph). Requests for schedule may be 4 
submitted from Monday to Friday. The schedule of the  applications for  pre- 5 
assessment  is on Thursdays, except for Holidays, from 8AM to 12NN.  6 
2.2 Applicant submits the application requirements for pre -assessment to FDAC 7 
(fdac.pacd@fda.gov.ph) on the day of the schedule, from 8AM to 12NN.  Only 8 
applications with complete requirements  pre-assess ed by the Center  shall 9 
proceed to payment.  10 
2.3 Applicant pays  for the corresponding  fee.  11 
2.4 Applicant submits the paid application (electronic copies of the complete 12 
requirements) to FDAC ( fdac.pacd@fda.gov.ph ). 13 
2.5 The FDA forwards the application to the Center.  14 
2.5 The Center receives and  forward s the application to Center’s HUP Consultant.  15 
2.6 The Center’s  HUP Consultant e valuates the correctness of  the documents and 16 
renders the final decision.  17 
2.8 Releasing  of the final issued document.   18 
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 50  
 
 
 ANNEX C  1 
Test Protocol Content  2 
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The test protocol/s shall contain the following information:  4 
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Background  (combining the 
introduction, objective and 
literature review)  Information on the Product  
 product owner  
 product classification  
 formulation type  
 identity and concentration of the active ingredient/s  
 available information on the efficacy of the active 
ingredient/s against the intended target pest  
 available information on the toxicity of t he active 
ingredients, both acute and chronic toxicity  
 available information on resistance and cross -resistance of 
target pests against the active ingredient/s  
 information whether the test/s have been previously 
accepted by other regulatory agency  
  
Purpo se of the proposed test  
 specific claim of the household pesticide (includes field of 
use, mode of application, target pest/s, dilution rate, 
application rate, frequency of re -application)  
  
Justification/Reason for the modified  or non-standard  protocol  
 Existing accepted protocol, if available  
 compelling reason for the modification or use of non-
standard  test protocol  
  
Methodology  Test Duration  
Test insect/s  
 species (in binomial nomenclature)  
 source (i.e. laboratory -reared, wild -collected)  
 rearing technique for laboratory -reared target insect/s 
including environmental conditions and food  
 age and sex  
Positive Control  
 registered HUP product with the same active ingredient/s or 
active ingredient belonging from the same chemical family  
 include the HSR number  
Negative Control  
Test Procedure including but not limited to:  
 environmental conditions  
 acclimatization of test insect/s  
 mode of application  
 dilution rate,  
 application rate  
 size of the test  
 number of test insect/s per replicate  
 number of replicates ( min. of 3)  
 test area / facility / equipment   
 
 
  laboratory trial: design of chamber including material 
and dimension, cleaning/washing protocol, etc  
 field trial: plot size, selection criteria for the test 
location, equipment design, cleaning/washing protocol, 
etc 
 schedule of observation  
 efficacy Parameter  
 in case of modified protocol, include a description of the 
modifications made in their respective sections  
Statistical Analysis  
  
In case human subjects are part of the proposed test protocol, 
include the sele ction criteria, copy of informed consent form, 
certification/approval from a Research Ethics Committee  
References  Include in -text citation, reference list at the end of the document 
and pdf copies of the references  
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