November 4, 2004

1. FDA Science Board Advisory Committee MeetingOffice of Regulatory AffairsScience Peer ReviewPesticide and Industrial Chemical Programs November 4, 2004

2. Overview of ORA Science Peer Review • John R. Marzilli Deputy Associate Commissioner for Regulatory Affairs • John J. Specchio, Ph.D. Professor of Food Science Montclair State University

3. Overview of ORA Science Peer Review • Objectives: • Quality of Science across our organization • Adequacy of resources • Mission Relevance

4. Peer Review Process • Components: • Design and Implementation of Data Review Process • Comprehensive Work Product Review on Pesticide & Industrial Chemical data collected for one entire fiscal year • Structured discussions with Managers and Technical experts

5. Analysis of Data • 5 Key Areas Emerged • Program Management • Laboratory Science Issues • Productivity and Timeliness • Resources • Compliance and Regulatory Policy

6. Recommendations: Program Management • Compliance Programs 1. Update and issue current guidance in both the CPs and applicable CPGs 2. Develop a training module for the on-line ORA-U to explain the structure and function of compliance programs 3. Revise the Domestic CP to alter directions on sampling sites

7. Recommendations: Program Management • Imports 4. Continue shift of resources from domestic toward imported products 5. Obtain, organize, and disseminate pesticide use data to the field 6. Review the need for a “Perishable Policy” and establish it, as warranted

8. Recommendations: Program Management • Imports, cont. 7. Develop a regulatory structure for imports that takes advantage of resource savings achievable using the “appearance of a violation” standard in Sec. 801 of the FD&C act

9. Recommendations: Program Management • Imports, cont. 8. Review current policy and procedures for placing imported produce found violative for unapproved pesticide residues onto Import Alerts 9. Review the utility of the “pesticide specific” charge currently used on Import Alerts

10. Recommendations: Program Management • Pesticide Coordinating Teams (PCTs) • Resume sharing of pesticide violation information with EPA (FMD 129) • Develop an outline of PCT duties in the current environment • PCTs performing newly-established functions should be operating in each district by FY06.

11. Recommendations: Program Management • Data Reporting and Tracking • Carefully evaluate all requests for data reporting in systems other than FACTS or OASIS • Offer additional training to Centers on accessing data from FACTS and OASIS.

12. Recommendations: Program Management • Annual Reporting 15. Assure timely issuance of an annual pesticide report to be used by field to direct sampling 16. Disseminate all ORA-generated information on pesticide violations to field to aid in local planning

13. Recommendations: Program Management • Other Issues • Designate a specific individual to become ORA’s clearinghouse for all policy and regulatory issues concering the Pesticide and Chemical Contaminants Program 18. Establish a task force to establish documentation maintenance requirements

14. John J. Specchio, Ph.D. Professor of Food Science Montclair State University

15. Recommendations: Science • Expertise • Establish a Pesticide Steering Committee (PSC) to address national program issues • Create a National Pesticide Expert position within ORA.

16. Recommendations: Science • Methods 3. Incorporate state-of-the-art pesticide methodology into official regulatory procedures.

17. Recommendations: Science • Policy • Establish procedures for retention of analytical records in the analyzing lab • Review requirements for quantitation and check analyses for samples containing “no tolerance” pesticides as well as pesticides with tolerances.

18. Recommendations: Science • Domestic & Import Laboratory Service • Consolidate all domestic pesticide analyses within two labs: Arkansas (food) and Kansas City (feed) • Consolidate all import pesticide analysis in four laboratories: New York, Atlanta, Irvine, and Seattle • Focus programs in consultation with EPA to provide risk analysis data needed for tolerance reassessment.

19. Recommendations: Science • Instrumentation • PSC should determine configuration of instruments to be used in all pesticide labs; group purchases whenever possible • Maximize automation capabilities of instrumentation • Negotiate and fund service contracts for complex instrumentation

20. Recommendations: Science • Pesticide Analytical Manual (PAM) • Initiate a fast-track process for updating PAM I with methods and techniques currently used in ORA laboratories • Refocus PAM I as a methods manual, eliminating textbook chapters on general technologies • Establish critical limits for adjusting operating parameters when focusing on individual pesticides • Establish a schedule for routine updates of both PAM volumes

21. Recommendations: Science • Dioxin Analysis • Establish a research effort for dioxin method development at ARL • Reaffirm the need for a second dioxin laboratory at Kansas City; equip the lab appropriately with state-of-the-art instrumentation

22. Recommendations: Science • Total Diet Study 18. Implement the GC-MSD method in the Total Diet Study

23. Recommendations: Science • Science Dispute Resolution 19. Create and utilize a Science Dispute Resolution process based on the ad-hoc procedures described in RPM chapter 10.

24. John R. Marzilli Deputy Associate Commissioner for Regulatory Affairs

25. External Review: Feedback Needed The 19 Recommendations: Do you concur??

26. External Review: Feedback Needed • Additional Focus Sampling: • Stastically sound? • Risk-based? • Properly planned? • Well-coordinated across districts?

27. External Review: Feedback Needed • Additional Focus: Methods • Cost-effective / efficient? • Current science? • Properly validated? • Appropriate QA procedures?

28. External Review: Feedback Needed • Additional Focus: Guidance • Pesticide Analytical Manual (PAM) • Current? • Responsive? • Flexible? • Other “Standard Methods” • AOAC • Laboratory Information Bulletins (LIBs)

29. OFFICE OF REGULATORY AFFAIRS AK NH ME VT ND MN WA MA NY WI SD MT RI MI CT OR NJ PA ID OH MD IN DE IL WV VA KY NV CA WY IA NE TN NC AZ SC UT GA AL CO KS MS MO HI PR LA OK AR NM VI FL TX 03-04 Division of Planning, Evaluation, & Mgmt ORA Offices.ppt

30. OFFICE OF REGULATORY AFFAIRS Laboratories Nationwide WINCHESTER SEATTLE DETROIT NEW YORK PHILADELPHIA SAN FRANCISCO FORENSIC CHEMISTRY CENTER KANSAS CITY LOS ANGELES DENVER ATLANTA JEFFERSON SAN JUAN 5 MULTI-PURPOSE LABS ` 8 SPECIALTY LABS 10/02 Division of Planning, Evaluation & Mgmt ORALABSCurr.PPT

31. Team Members • John Marzilli, Deputy ACRA • Susan Setterberg, Regional Director, Central Region • Co-Chair, Pat Schafer, Compliance Director, New Orleans District • Tom Gardine, Philadelphia District Director • Sandra Whetstone, Director, Division of Compliance Management and Operations, Office of Enforcement • Michael Ellison, National Food Expert, Division of Field Investigations • Frank Mazzoni, Supervisor, Import Program, New England District • Barbara George, Program Support Specialist, New Orleans District

32. Team Members • Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Science (DFS) • Thomas Savage, Deputy Director, DFS • Larry D’Hoostelaere, Ph.D., Senior Scientific Coordinator, DFS • Charles Parfitt, Senior Scientific Coordinator, DFS • Tom Sidebottom, Assistant to Regional Director, Pacific Region • Meredith Grahn, Assistant to the Regional Director, Southwest Region • Richard Baldwin, Senior Science Advisor, ORA