Protocol Template Annual Crops

1. PROJECT TITLE:

PYRIPROXYFEN: Magnitude of the Residue on PAPAYA

2. JUSTIFICATION AND OBJECTIVES:

IR-4 has received a request from USDA-FAS to assist for the minor use of pyriproxyfen on PAPAYA in Malaysia as part of the ASEAN tropical fruit residue project

To establish an MRL, it is required that the magnitude of the residue in or on the commodity.Be determines. The purpose of this study is to collect and analyze treated and untreated residue samples from appropriate field sites according to the application parameters requested to provide JMPR with residue chemistry data to support a pesticide tolerance.or CODEX MRL.

To determine the magnitude of residues of total Pyriproxyfen in or on PAPAYA, this protocol will be employed using appropriate Standard Operating Procedures (SOP's) and will be conducted under provisions outlined in IN ACCORDANCE WITH EPA GOOD LABORATORY PRACTICE STANDARDS and consistent with the provisions outlined in the Organization for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring.

3. SPONSOR/TESTING FACILITY NAME, ADDRESS AND PHONE:Fertilizer and Pesticide Authority of the Philippines, Department of Agriculture, FPA Building B. A. I Visayas Ave. Dillman, Quezon City 920-8173

4. STUDY DIRECTOR[footnoteRef:1]: [1: .]

Dr. Michael P. Braverman, IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540, (732) 932-9575 extension 4610, FAX# (609) 514-2612, E-mail: braverman@aesop.rutgers.edu

5. PROPOSED DATES: 6. PROPOSED TEST SITES:

Experimental Start : August 2013Field sites: Refer to Section 23

Experimental Termination: December 2014Laboratory: Refer to Section 24

Study Completion:June 2015

7. STUDY AUTHORIZATION:

Dr Amelia Tejada, Sponsor/Faciltiy Management / Dateawtejada@yahoo.com

Michael P. Braverman / Study Director / DateBraverman@aesop.rutgers.edu

7.1 STUDY DIRECTOR INITIALS: _______________

7.2 QUALITY ASSURANCE PROTOCOL /STUDY PLAN REVIEW:

This protocol/study plan has been reviewed by quality assurance.

Ms. Jerolet Sahagun, Quality Assurance / Date jerolet.sahagun@gmail.com

8. GOOD LABORATORY PRACTICE COMPLIANCE:

The appropriate cooperative testing facility (field and laboratory) will be responsible for certifying that its portion of the study will be conducted in accordance with Good Laboratory Practice (GLP) Standards.

A statement of compliance, together with any GLP deviations will be signed and submitted by the appropriate Research Directors in their report or data package.

9. QUALITY ASSURANCE:

Quality Assurance duties and responsibilities will be in conformance with Good Laboratory Practices A Quality Assurance Statement will be submitted in the final report and shall include the date inspections were made and date(s) the findings were reported to the Study Director and management.

10. TEST SYSTEM/CROP:

PAPAYA - Use a commercial variety. Report: variety if available.

Field trials will be conducted at the appropriate sites to support the establishment/maintenance of a national residue tolerance, see Section 23 for these assignments. Refer to Section 11.4 for requirements to differentiate multiple trials by the same field researcher.

11. TEST SYSTEM DESIGN and STATISTICAL METHOD:

11.1 Each test site will consist of one untreated and one treated plot . Each plot will consist of a minimum of 6 trees, 8 trees are preferable. Consider lager plots for the decline study since multiple harvests will be required..

The individual plots shall be of adequate size to ensure that no more than 50% of the harvestable crop in the sampled area will be needed to provide the necessary plant material. See Parts 17 & 18 for requirements for residue sampling.

11.2Employ adequate buffer zones (minimum 20 meters) between each of the plots to prevent contamination but a minimum of 30 meters is strongly preferred. When plants are used as a buffer between the untreated and treated plots, a lower distance is needed to prevent contamination, but the minimums indicated above must be observed. If another study using a test substance with the same active ingredient is being conducted at the same research site, the untreated plot from one study must be separated from the treated plot(s) of the other by the appropriate buffer zone indicated above.

11.3 If this pesticide use is not registered on this crop, the treated crop must be destroyed or handled in such a way that it is not consumed as a human food or animal feed in a manner consistent with local government laws.

11.4 If a Field Research Director is assigned more than one trial in this study, the following requirements must be met:An independently prepared tank-mix must be used in each trial. (Not applicable for granular applications) Also:Preharvest interval (PHI)