Asia Pesticide Residue Mitigation through the Promotion of Biopesticides and Enhancement of Trade Opportunities (APRMP), Virtual lab meeting 10 August 2020
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Asia Pesticide Residue Mitigation through the Promotion of Biopesticides and Enhancement of Trade Opportunities (APRMP), Virtual lab meeting 10 August 2020
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Asia Pesticide Residue Mitigation through the Promotion of Biopesticides and Enhancement of Trade Opportunities (APRMP), Virtual lab meeting 10 August 2020
- 1. Inception Workshop Wayne Jiang, PhD IR-4 Project Michigan State University jiangwa@msu.edu Lab Training Overview and Equipment
- 2. • Lab Training Overview • Laboratory Equipment Contents
- 3. • Training Dates Mon-Fri, Aug 10-14, 2020 (5 days) 3 Hours / day A coffee break 10-15 min/session Lab Training
- 4. • Good Laboratory Practices (GLP) • Protocol (Lab portion) • Standard Operating Procedures (SOP) • Amendments and deviations Training Contents
- 5. • Sample shipping, sample receipt, grinding, storage and disposal • Analytical Reference Substance • Instrument analysis • Data review and QC Training Contents
- 6. • Freezers and temperature monitoring • Grinders • Pipets, Shakers, SPE • Analytical instrumentation • LC-MS/MS Laboratory Equipment
- 7. Laboratory Equipment Country Crop Chemical Chemical Chemical LC- MS/MS GC-MS or GC-MS/MS GC- ECD GC- FID Indonesia Malaysia Sri Lanka Thailand Chili pepper Abamectin Chlorpyrifos Methomyl Yes No No No Acephate Diazinon Prochloraz Yes Yes Yes? No Acetamiprid Fipronil Profenophos Yes Yes Yes? No Amitraz Imidacloprid Yes Yes Yes? No Bangladesh Nepal Pakistan Sri Lanka Greens Acetamiprid Yes Yes Yes? No Imidacloprid Yes No No No Malathion Yes Yes Yes? No Laos Cambodia Basil Chlorpyrifos Yes Yes Yes? No Cypermethrin Yes Yes Yes? No Vietnam Dragon fruit Metalaxyl Yes Yes Yes? No Hexaconazole Yes Yes Yes? No Propiconazole Yes Yes Yes? No Cambodia Rice Tricyclazole Yes Yes Yes? No
- 8. Laboratory Equipment Country LC- MS/MS HPLC GC- MS/MS GC-MS GC- ECD GC- FID Bangladesh ? Cambodia ? ? ? Indonesia Yes Laos ? ? ? Malaysia Yes Nepal ? ? TBD Pakistan Yes Sri Lanka ? ? TBD Thailand Yes Vietnam Yes
- 9. Lab GLP Training New York Time, Monday - Friday, August 10-14, 2020 (Total 5 days) • Session 1: 6:00 AM - 7:00 AM • Coffee Break: 7:00 AM – 7:20 AM • Session 2: 7:20 AM – 8:20 AM • Questions: 8:20 AM – 8:50 AM
- 10. Questions ? • Any questions?
- 12. GLP TRAINING Wayne Jiang, PhD IR-4, Michigan State University, jiangwa@msu.edu Michael Braverman, PhD IR-4 Headquarters, Rutgers University
- 13. General Terms • GLP Good Laboratory Practices • GMP Good Manufacturing Practices • GCP Good Clinical Practices
- 14. • Protocol (or Work Plan) A document which clearly indicates the objectives and methods for the conduct of the study • SOPs Set of Standard Operating Procedures • Working Methods Individual working methods General Terms
- 15. General Terms • EPA Environmental Protection Agency • FDA Food and Drug Administration • OECD Organization for Economic Co-operation and Development
- 16. General Terms • SD Study Director • FRD and LRD Field Research Director Laboratory Research Director • QA Quality Assurance
- 17. Definitions • Good Laboratory Practice – Good Laboratory Practice (GLP) is a quality system with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
- 18. Definitions • Nonclinical laboratory study – In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article. – 21 CFR Part 58.3(d)
- 19. Definitions • Sponsor – A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; – A person who submits a nonclinical study to the FDA in support of an application for a research or marketing permit; or – A testing facility, if it both initiates and actually conducts the study. 21 CFR Part 58.3(f)(1)(2)(3)
- 20. Definitions • Sponsor – A person who initiates and supports, by provision of financial or other resources, a study; – A person who submits a study to the EPA in support of an application for a research or marketing permit; or – A testing facility, if it both initiates and actually conducts the study. 40 CFR 160.3 (7)
- 21. Definitions • Sponsor • Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study. – OECD GLP
- 22. Definitions • Testing Facility (FDA) – A person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. 21 CFR Part 58.3(g) • Testing Facility (EPA) – Testing facility means a person who actually conducts a study, i.e., actually uses the test substance in a test system. ``Testing facility'' encompasses only those operational units that are being or have been used to conduct studies. 40 CFR Part 160 (2.2)
- 23. Definitions • Testing Facility (OECD) - Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. OECD GLP 2.2
- 24. Definitions • Quality Assurance Unit (QAU) – Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. – 21 CFR Part 58.3(l) • Quality Assurance Unit (QAU) – Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies. – 40 CFR Part 160.105(a)
- 25. Definitions • Quality Assurance Unit (QAU) Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice. OECD GLP 2.2(8)
- 26. Definitions • Standard Operating Procedures – Documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines 40 CFR 160.16(3)
- 27. Definitions • Standard Operating Procedures SOPs means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines. OECD GLP 2.2 (9)
- 28. Definitions • Study Director (SD) – The individual responsible for the overall conduct of a nonclinical laboratory study. – 21 CFR Part 58.3(m) – Study director means the individual responsible for the overall conduct of a study. 40 CFR Part 105(3)
- 29. Definitions • Study Initiation Date The date the protocol is signed by study director • Term defined in FDA, EPA FIFRA, EPA TSCA, OECD GLPs • Experimental Start Date – The first date the test substance is applied to the test system. • Term defined in EPA FIFRA, EPA TSCA GLPs • Experimental Starting Date – The date on which the first study specific data are collected. • Term defined in OECD GLPs
- 30. Definitions • Study Completion Date – The date the final report is signed by SD • Term defined in FDA, EPA FIFRA, EPA TSCA, OECD GLPs • Experimental Termination Date – The last date on which data are collected directly from the study • Term defined in EPA TSCA, EPA FIFRA GLPs • Experimental Completion Date – The last date on which data are collected from the study • Term defined in OECD GLPs
- 31. • GLPs are regulations that are intended to ensure the quality and integrity of the data in a nonclinical laboratory study.
- 32. GLPs are the LAW! What are GLPs? GLPs are regulations that are intended to ensure the quality and integrity of the data in a laboratory study.
- 34. Basic Information GLPs deal with: – Planning – Performance – Monitoring – Recording – Reporting GLPs do NOT: Attempt to regulate science Ensure “good science”
- 35. Basic Information • Responsibility for establishing the safety and efficacy of human and veterinary drugs and devices, and the safety of food and color additives is placed on the sponsor (manufacturer) of the regulated product. • Public agencies (FDA, EPA, OECD, etc) are responsible for reviewing the sponsor’s test results and determine if they demonstrate the product’s safety and efficacy. • Only when the agencies are satisfied that safety and efficacy have been established adequately is the marketing of the product permitted.
- 36. Nonclinical laboratory studies GLP is needed for: GLP is not needed for: • Nonclinical safety studies of development of drugs • Agricultural pesticide development • Development of toxic chemicals • Food control (food additives) • Test of substance with regard to explosive hazards • Basic scientific research • Studies to develop new analytical methods (but Method Validation is GLP required) • Chemical tests used to derive the specifications of a marketed food product
- 37. International GLPs • Generally studies at will are conducted under GLPs from US, Japan, Australia, etc. and/or OECD – Some protocols list various GLPs – Formal claims of compliance with other national regulations should be avoided, if possible
- 38. KEYWORDS • Testing facility • Study Director • FFDCA • FIFRA • NAFTA • Sponsor • Raw data • Principal Investigator • QA/QAU • SOP • Master Schedule • Study plan • Amendment • Deviation
- 39. Questions ? • Any questions?
- 40. IR-4 Project Since 1963 IR-4 has been a US government funded research program to facilitate registration of sustainable pest management technology for specialty crops and minor uses http://ir4project.org USDA Interregional Research Project Number 4
- 41. The IR-4 Program - Partnerships
- 44. IR-4 Protocol Every page contains PR No. Objectives All Proposed Dates and Sites Study Director’s Signature, Date Sponsor Study Director’s Initial Study Director’s Name
- 45. ASR Page Testing Facility Study Director Sponsor Study Initiation Date Experimental Termination Date Title of Study PR Number
- 47. International Activities • Data-50 reports submitted to Canada’s JMPR/Reg. Authorities • Leadership-NAFTA, OECD, and Codex CCPR • Capacity Building w/FAS in Africa, Asia, Central and S. America • Global Residue Study • Global Minor Use Summit 2 • Capacity Building
- 48. IR-4 Activities • Food Use Program • Bio and Organic pesticides • Ornamental Program • Public Health
- 49. IR-4 Project Infrastructure - Pesticide Residue work 90 studies/550 field trials IR-4 HQ IR-4 Regional Program Office State Satellite Labs State Field Research Centers/Food Use Hawaii =ARS Labs ARS Field Research Centers State Field Research Centers/ Ornamentals and Non-food Use ARS Field Research Centers ARS Field Research Centers
- 50. jiangwa@msu.edu