# Presentation: 182015

## External Peer Review of the FDA Office of Regulatory Affairs Pesticide Program

- FDA Science Board Advisory Committee Meeting
**Nov. 4, 2005**

## Internal ORA Pesticide Peer Review Report - 2004

- Report completed in October, 2004.
- 18 Management Issues
- 21 Science Issues
- Presented to Science Board in November 2004.

## Internal ORA Pesticide Peer Review Report - 2004

- 5 Key Areas Emerged
- Program Management
- Laboratory Science Issues
- Productivity and Timeliness
- Resources
- Compliance and Regulatory Policy

## External ORA Pesticide Peer Review - 2005

- Focus on Science Issues
**  **Sampling
-   Methods

## External Peer ReviewPanel Members

- Katherine M.J. Swanson, Ph.D., Vice President for Food Safety, Ecolab Inc. , Eagan, MN (*Co-chair*)
- John A. Thomas, Ph.D., Professor (emeritus) Pharmacology & Toxicology, University of Texas Health Science Center – San Antonio, Texas (*Co-chair*)
- Joanne M. Cook, Chief, Bureau of Chemical Residue Laboratories, Florida Dept. of Agriculture and Consumer Services, Tallahassee, FL
- Mark Lee, Ph.D., Research Agricultural Chemist, Center for Analytical Chemistry, California Department of Food & Agriculture, Sacramento, CA
- Steven Musser, Ph.D., Chief, Instrumentation and Biophysics Branch, and Lead Scientist for Chemistry CFSAN, FDA, College Park, MD

## External Peer ReviewSite Visit #1

- Florida State Pesticide Residue Lab
-        Tallahassee, FL
- Presentations from
-     Florida state staff
- Presentations from
- FDA Florida District staff

## External Peer ReviewSite Visit #2

- FDA Headquarters, Rockville, MD
- CFSAN presentations
- ORA presentations

## External Peer ReviewSite Visit #3

- FDA Pacific Regional Lab SW, Irvine, CA
- Operation of a FDA pesticide lab
- Presentations from Investigators and CSO’s

## Observation 1	

- Observation 1

- FDA needs to clearly define goals, requirements, and desired outcomes for its pesticide program.

**?**

## Observation 1RECOMMENDATIONS

- Collaboration within FDA and across other agencies to clearly define goals of ORA's pesticide program.
- Implement a more effective information management system for sampling and methods.
- Re-focus available resources to better mirror public health and safety interests.

## Observation 2	

- Pesticide sampling should be risk-based.

## Observation 2 RECOMMENDATIONS

- ORA and CFSAN should jointly reevaluate commodities to be sampled using a risk-based approach focused on public health needs and patterns of non-compliance.

## Observation 3 

- Current pesticide sampling is not statistically based.

## Observation 3 RECOMMENDATIONS

- On-going consultation with statisticians is recommended to meet defined program goals.
- Develop a sampling plan that clearly articulates the data needs of the program.

## Observation 4

-  There is a general lack of coordination
-     between sample collection and analysis.

## Observation 4 RECOMMENDATIONS

- Enhance coordination to select the right samples, & timing of collection & analysis.
- CFSAN, ORA, states, others
- Revitalize the Pesticide Coordination Teams.
- Establish a notification process for scheduled sample submission.
- Interact with EPA & USDA to support risk assessment for commodities they do not sample.

## Observation 5

- The Pesticide Analytical Manual (PAM) is important, and should be updated in a timely manner.

## Observation 5 RECOMMENDATIONS

- Update the PAM I immediately.
- Create a process to get validated methods into the PAM in a timely manner.
- Create an incentive for scientists to enter validated methods into PAM.
- Utilize stakeholders and experts in the field for editorial support.

## Observation 6

- There should be a defined process for method validation and acceptance.

## Observation 6 RECOMMENDATIONS

- Define a formal process for method validation.
- Use validated methods for official regulatory samples.
- Define a process for use of methods in emergency situations.

## Observation 7

- Most methods used to analyze samples are generally cost-effective and efficient, but not comprehensive.

## Observation 7 RECOMMENDATIONS

- Harmonize methodology internationally.
- Investigate alternative cost effective, faster & efficient procedures.
- Complete adoption of efficient multi-residue procedure for all labs.
- Expand screening to LC/MS to assay broader class of pesticides.
- Define pesticide confirmation & quantitation criteria similar to other international & state agencies.

## Observation 8

- Additional confirmation testing for “no-tolerance pesticides” increases time and resource requirements.

## Examples of Commodities with No EPA Tolerances for pesticides

- Chinese
- Water chestnut

- Durian

- Schisandra
- fruit

- Chia seeds

## Observation 8 RECOMMENDATIONS

- Update the Criteria for Analytical Packages to Support Regulatory Action on pesticide residues, including “no tolerance pesticides" to keep pace with new technology.

## Observation 9

- Uniform procedures for capturing, sharing, reporting, and auditing raw data are lacking.

## Observation 9 RECOMMENDATIONS

- Implement a more effective Laboratory Information Management System (LIMS).
- Evaluate commercially available LIMS.
- LIMS should generate automatic reports.
- Don’t develop individual stand-alone systems.

## Observation 10

- Quality assurance programs are inconsistent across ORA laboratories.

## Observation 10 RECOMMENDATIONS

- Complete ISO accreditation.
- Collaborate across laboratories on Quality Assurance Policies and Procedures.
- Introduce or augment statistically based quality control measures to reduce unnecessary repetition in assaying.

## Summary & Overall Finding

- Clear articulation and definition of goals is needed to improve implementation of ORA’s pesticide program.

## Acknowledgements

- Bureau of Chemical Residue Laboratories, Florida Department of Agriculture and Consumer Services, Tallahassee, FL
- FDA Headquarters Staff
- Pacific Regional Laboratory Southwest, Irvine, CA