FDA Science Board Advisory FDA Science Board Advisory Committee MeetingCommittee Meeting

Office of Regulatory AffairsOffice of Regulatory AffairsScience Peer ReviewScience Peer Review

Pesticide and Industrial Chemical ProgramsPesticide and Industrial Chemical Programs

November 4, 2004November 4, 2004

Overview of ORA Science Peer Overview of ORA Science Peer ReviewReview

John R. MarzilliJohn R. Marzilli

Deputy Associate Commissioner for Regulatory AffairsDeputy Associate Commissioner for Regulatory Affairs

John J. Specchio, Ph.D.John J. Specchio, Ph.D.

Professor of Food ScienceProfessor of Food Science

Montclair State UniversityMontclair State University

Overview of ORA Science Overview of ORA Science Peer ReviewPeer Review

Objectives:Objectives:

– Quality of Science across our organizationQuality of Science across our organization– Adequacy of resourcesAdequacy of resources– Mission RelevanceMission Relevance

Peer Review ProcessPeer Review Process

Components: Components: – Design and Implementation of Data Review Design and Implementation of Data Review

ProcessProcess– Comprehensive Work Product Review on Comprehensive Work Product Review on

Pesticide & Industrial Chemical data Pesticide & Industrial Chemical data collected for one entire fiscal yearcollected for one entire fiscal year

– Structured discussions with Managers and Structured discussions with Managers and Technical expertsTechnical experts

Analysis of Data Analysis of Data

5 Key Areas Emerged5 Key Areas Emerged– Program ManagementProgram Management– Laboratory Science IssuesLaboratory Science Issues– Productivity and TimelinessProductivity and Timeliness– ResourcesResources– Compliance and Regulatory PolicyCompliance and Regulatory Policy

Recommendations: Recommendations: Program Management Program Management

Compliance ProgramsCompliance Programs

1. Update and issue current guidance in both 1. Update and issue current guidance in both the CPs and applicable CPGsthe CPs and applicable CPGs

2. Develop a training module for the on-line 2. Develop a training module for the on-line ORA-U to explain the structure and function of ORA-U to explain the structure and function of compliance programscompliance programs

3. Revise the Domestic CP to alter directions 3. Revise the Domestic CP to alter directions on sampling siteson sampling sites

Recommendations: Recommendations: Program Management Program Management

ImportsImports

4. Continue shift of resources from domestic 4. Continue shift of resources from domestic toward imported productstoward imported products

5. Obtain, organize, and disseminate pesticide 5. Obtain, organize, and disseminate pesticide use data to the fielduse data to the field

6. Review the need for a “Perishable Policy” 6. Review the need for a “Perishable Policy” and establish it, as warrantedand establish it, as warranted

Recommendations: Recommendations: Program Management Program Management

Imports, cont.Imports, cont.

7. Develop a regulatory structure for imports 7. Develop a regulatory structure for imports that takes advantage of resource savings that takes advantage of resource savings achievable using the “appearance of a achievable using the “appearance of a violation” standard in Sec. 801 of the FD&C actviolation” standard in Sec. 801 of the FD&C act

Recommendations: Recommendations: Program Management Program Management

Imports, cont.Imports, cont.

8. Review current policy and procedures for 8. Review current policy and procedures for placing imported produce found violative for placing imported produce found violative for unapproved pesticide residues onto Import unapproved pesticide residues onto Import AlertsAlerts

9. Review the utility of the “pesticide specific” 9. Review the utility of the “pesticide specific” charge currently used on Import Alertscharge currently used on Import Alerts

Recommendations: Recommendations: Program Management Program Management

Pesticide Coordinating Teams Pesticide Coordinating Teams (PCTs)(PCTs)

10.10. Resume sharing of pesticide violation Resume sharing of pesticide violation information with EPA (FMD 129)information with EPA (FMD 129)

11.11. Develop an outline of PCT duties in the Develop an outline of PCT duties in the current environmentcurrent environment

12.12. PCTs performing newly-established functions PCTs performing newly-established functions should be operating in each district by FY06.should be operating in each district by FY06.

Recommendations: Recommendations: Program Management Program Management

Data Reporting and TrackingData Reporting and Tracking

13.13. Carefully evaluate all requests for data Carefully evaluate all requests for data reporting in systems other than FACTS or reporting in systems other than FACTS or OASISOASIS

14.14. Offer additional training to Centers on Offer additional training to Centers on accessing data from FACTS and OASIS.accessing data from FACTS and OASIS.

Recommendations: Recommendations: Program Management Program Management

Annual ReportingAnnual Reporting

15. Assure timely issuance of an annual 15. Assure timely issuance of an annual pesticide report to be used by field to direct pesticide report to be used by field to direct samplingsampling

16. Disseminate all ORA-generated 16. Disseminate all ORA-generated information on pesticide violations to field information on pesticide violations to field to aid in local planningto aid in local planning

Recommendations: Recommendations: Program Management Program Management

Other IssuesOther Issues

17.17. Designate a specific individual to become Designate a specific individual to become ORA’s clearinghouse for all policy and ORA’s clearinghouse for all policy and regulatory issues concering the Pesticide and regulatory issues concering the Pesticide and Chemical Contaminants ProgramChemical Contaminants Program

18. Establish a task force to establish 18. Establish a task force to establish documentation maintenance requirements documentation maintenance requirements

John J. Specchio, Ph.D.John J. Specchio, Ph.D.

Professor of Food ScienceProfessor of Food Science

Montclair State UniversityMontclair State University

Recommendations: Recommendations: ScienceScience

ExpertiseExpertise

1.1. Establish a Pesticide Steering Committee Establish a Pesticide Steering Committee (PSC) to address national program issues(PSC) to address national program issues

2.2. Create a National Pesticide Expert position Create a National Pesticide Expert position within ORA.within ORA.

Recommendations: Recommendations: ScienceScience

MethodsMethods

3. Incorporate state-of-the-art pesticide 3. Incorporate state-of-the-art pesticide methodology into official regulatory methodology into official regulatory procedures.procedures.

Recommendations: Recommendations: ScienceScience

PolicyPolicy

4.4. Establish procedures for retention of Establish procedures for retention of analytical records in the analyzing labanalytical records in the analyzing lab

5.5. Review requirements for quantitation Review requirements for quantitation and check analyses for samples and check analyses for samples containing “no tolerance” pesticides as containing “no tolerance” pesticides as well as pesticides with tolerances.well as pesticides with tolerances.

Recommendations: Recommendations: ScienceScience

Domestic & Import Laboratory ServiceDomestic & Import Laboratory Service6.6. Consolidate all domestic pesticide analyses Consolidate all domestic pesticide analyses

within two labs: Arkansas (food) and Kansas within two labs: Arkansas (food) and Kansas City (feed)City (feed)

7.7. Consolidate all import pesticide analysis in Consolidate all import pesticide analysis in four laboratories: New York, Atlanta, Irvine, four laboratories: New York, Atlanta, Irvine, and Seattleand Seattle

8.8. Focus programs in consultation with EPA to Focus programs in consultation with EPA to provide risk analysis data needed for provide risk analysis data needed for tolerance reassessment.tolerance reassessment.

Recommendations: Recommendations: ScienceScience

InstrumentationInstrumentation

9.9. PSC should determine configuration of PSC should determine configuration of instruments to be used in all pesticide labs; instruments to be used in all pesticide labs; group purchases whenever possiblegroup purchases whenever possible

10.10. Maximize automation capabilities of Maximize automation capabilities of instrumentation instrumentation

11.11. Negotiate and fund service contracts for Negotiate and fund service contracts for complex instrumentationcomplex instrumentation

Recommendations: Recommendations: ScienceScience

Pesticide Analytical Manual (PAM)Pesticide Analytical Manual (PAM)12.12. Initiate a fast-track process for updating PAM I Initiate a fast-track process for updating PAM I

with methods and techniques currently used with methods and techniques currently used in ORA laboratoriesin ORA laboratories

13.13. Refocus PAM I as a methods manual, Refocus PAM I as a methods manual, eliminating textbook chapters on general eliminating textbook chapters on general technologiestechnologies

14.14. Establish critical limits for adjusting operating Establish critical limits for adjusting operating parameters when focusing on individual parameters when focusing on individual pesticidespesticides

15.15. Establish a schedule for routine updates of Establish a schedule for routine updates of both PAM volumesboth PAM volumes

Recommendations: Recommendations: ScienceScience

Dioxin AnalysisDioxin Analysis

16.16.Establish a research effort for dioxin Establish a research effort for dioxin method development at ARLmethod development at ARL

17.17.Reaffirm the need for a second dioxin Reaffirm the need for a second dioxin laboratory at Kansas City; equip the laboratory at Kansas City; equip the lab appropriately with state-of-the-art lab appropriately with state-of-the-art instrumentationinstrumentation

Recommendations: Recommendations: ScienceScience

Total Diet StudyTotal Diet Study

18. Implement the GC-MSD method in the 18. Implement the GC-MSD method in the Total Diet StudyTotal Diet Study

Recommendations: Recommendations: ScienceScience

Science Dispute ResolutionScience Dispute Resolution

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

John R. MarzilliJohn R. Marzilli

Deputy Associate Commissioner for Deputy Associate Commissioner for Regulatory AffairsRegulatory Affairs

External Review: Feedback NeededExternal Review: Feedback Needed

The 19 Recommendations: Do you concur??The 19 Recommendations: Do you concur??

External Review: Feedback NeededExternal Review: Feedback Needed

Additional Focus Sampling:Additional Focus Sampling:– Stastically sound?Stastically sound?– Risk-based?Risk-based?– Properly planned?Properly planned?– Well-coordinated across districts?Well-coordinated across districts?

External Review: Feedback NeededExternal Review: Feedback Needed

Additional Focus: MethodsAdditional Focus: Methods– Cost-effective / efficient?Cost-effective / efficient?– Current science?Current science?– Properly validated?Properly validated?– Appropriate QA procedures?Appropriate QA procedures?

External Review: Feedback NeededExternal Review: Feedback Needed

Additional Focus: GuidanceAdditional Focus: Guidance– Pesticide Analytical Manual (PAM)Pesticide Analytical Manual (PAM)

Current?Current?

Responsive?Responsive?

Flexible?Flexible?

– Other “Standard Methods”Other “Standard Methods”AOACAOAC

Laboratory Information Bulletins (LIBs)Laboratory Information Bulletins (LIBs)

OFFICE OF REGULATORY AFFAIRS

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Division of Planning, Evaluation, & MgmtORA Offices.ppt

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OK AR

MO

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LA

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CTRI

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OFFICE OF REGULATORY AFFAIRSLaboratories Nationwide

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5 MULTI-PURPOSE LABS 8 SPECIALTY LABS

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DENVERKANSAS CITY

JEFFERSON

DETROIT

FORENSICCHEMISTRY

CENTER

PHILADELPHIA

NEW YORK

WINCHESTER

ATLANTA

SAN JUAN

Team MembersTeam Members

John Marzilli, Deputy ACRAJohn Marzilli, Deputy ACRASusan Setterberg, Regional Director, Central Region Susan Setterberg, Regional Director, Central Region Co-Chair, Pat Schafer, Compliance Director, New Orleans Co-Chair, Pat Schafer, Compliance Director, New Orleans District District Tom Gardine, Philadelphia District DirectorTom Gardine, Philadelphia District DirectorSandra Whetstone, Director, Division of Compliance Sandra Whetstone, Director, Division of Compliance Management and Operations, Office of EnforcementManagement and Operations, Office of EnforcementMichael Ellison, National Food Expert, Division of Field Michael Ellison, National Food Expert, Division of Field InvestigationsInvestigationsFrank Mazzoni, Supervisor, Import Program, New England Frank Mazzoni, Supervisor, Import Program, New England District District Barbara George, Program Support Specialist, New Orleans Barbara George, Program Support Specialist, New Orleans DistrictDistrict

Team MembersTeam Members

Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Science (DFS)Science (DFS)Thomas Savage, Deputy Director, DFSThomas Savage, Deputy Director, DFSLarry D’Hoostelaere, Ph.D., Senior Scientific Coordinator, DFSLarry D’Hoostelaere, Ph.D., Senior Scientific Coordinator, DFSCharles Parfitt, Senior Scientific Coordinator, DFS Charles Parfitt, Senior Scientific Coordinator, DFS Tom Sidebottom, Assistant to Regional Director, Pacific RegionTom Sidebottom, Assistant to Regional Director, Pacific RegionMeredith Grahn, Assistant to the Regional Director, Southwest Meredith Grahn, Assistant to the Regional Director, Southwest RegionRegionRichard Baldwin, Senior Science Advisor, ORARichard Baldwin, Senior Science Advisor, ORA