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FDA Science Board Advisory Committee Meeting Office of Regulatory Affairs Science Peer Review Pestic

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Overview of ORA Science Peer Review. John R. ... Michael Ellison, National Food Expert, Division of Field Investigations ... Thomas Savage, Deputy Director, DFS ... – PowerPoint PPT presentation

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Title: FDA Science Board Advisory Committee Meeting Office of Regulatory Affairs Science Peer Review Pestic


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 FDC 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 ORAs
    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
IL
DE
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 DHoostelaere, 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
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