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

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

• FDA Science Board Advisory Committee Meeting
• Nov. 4, 2005

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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.

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Internal ORA Pesticide Peer Review Report - 2004

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

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External ORA Pesticide Peer Review - 2005

• Focus on Science Issues
• Sampling
• Methods

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External Peer ReviewPanel 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

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External Peer ReviewSite Visit 1

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

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External Peer ReviewSite Visit 2

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

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External Peer ReviewSite Visit 3

• FDA Pacific Regional Lab SW, Irvine, CA
• Operation of a FDA pesticide lab
• Presentations from Investigators and CSOs

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Observation 1

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

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Observation 1RECOMMENDATIONS

• 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.

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Observation 2

• Pesticide sampling should be risk-based.

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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.

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Observation 3

• Current pesticide sampling is not statistically
  based.

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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.

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Observation 4

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

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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.

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Observation 5

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

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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.

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Observation 6

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

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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.

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Observation 7

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

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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.

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Observation 8

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

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Examples of Commodities with No EPA Tolerances
for pesticides
Schisandra fruit
Chinese Water chestnut
Chia seeds
Durian
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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.

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Observation 9

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

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Observation 9 RECOMMENDATIONS

• Implement a more effective Laboratory Information
  Management System (LIMS).
• Evaluate commercially available LIMS.
• LIMS should generate automatic reports.
• Dont develop individual stand-alone systems.

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Observation 10

• Quality assurance programs are inconsistent
  across ORA laboratories.

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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.

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Summary Overall Finding

• Clear articulation and definition of goals is
  needed to improve implementation of ORAs
  pesticide program.

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Acknowledgements

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