FDA Science Board Advisory Committee Meeting ORA Science Peer Review Pesticide and Industrial Chemic

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FDA Science Board Advisory Committee MeetingORA
Science Peer Review-Pesticide and Industrial
Chemical Programs

• April 22, 2004

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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

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ORA Science Peer Review

• Objectives
• Quality of Science across our organization
  Program Planning, Inspections, Investigations,
  Lab Analysis, Regulatory Actions, Quality
  Management Systems
• Adequacy of resources Skills and Expertise,
  Technologies, Organizational Infrastructure
• Mission Relevance

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FDAs Mission
The FDA is responsible for protecting the public
health by assuring the safety, efficacy, and
security of human veterinary drugs, biological
products, medical devices, our nations food
supply, cosmetics and products that emit
radiation. The FDA is also responsible for
advancing the public health by helping to speed
innovations that make medicines and foods more
effective, safer, and more affordable and by
helping the public get the accurate science-based
information they need to use medicines and foods
to improve their health.
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ORA Science Peer Review

• Goal of Peer Review
• Establish a roadmap for future improvement and
  coordination of ORA Pesticide and Industrial
  Chemical Programs
• Establish a model for future review of additional
  programs

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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

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Team Members

• Co-Chair, John Specchio, Ph.D., Science Advisor,
  Division Field Science (DFS)
• Tom 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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OFFICE OF REGULATORY AFFAIRS 190 OFFICES IN FY
2004
NORTHEAST
AK
PACIFIC
CENTRAL
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
REGIONAL OFFICES - 5 DISTRICT OFFICES -
20 RESIDENT INSPECTION POSTS - 140 OCI FIELD
OFFICES - 6 OCI RESIDENT OFFICES - 6 OCI
DOMICILES - 13
FL
TX
SOUTHEAST
SOUTHWEST
03-04
Division of Planning, Evaluation, Mgmt ORA
Offices.ppt
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OFFICE OF REGULATORY AFFAIRS 13 FIELD
LABORATORIES CURRENT FY 2004
NORTHEAST
PACIFIC
CENTRAL
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
SOUTHEAST
SOUTHWEST
10/02
Division of Planning, Evaluation
Mgmt ORALABSCurr.PPT
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Overview of ORA Science Peer Review

• John J. Specchio, Ph.D
• ORA Science Advisor
• Professor of Food Services
• Montclair State University
• Montclair, New Jersey

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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

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Complexity of Review Model

• 8 District Offices visited
• 6 ORA Laboratories visited
• 12 additional District offices were included in
  study

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On-site visits included review of

• Local SOPs for Domestic and Import Work
• Sample Collection Reports
• Lab Worksheets
• Establishment Inspection Reports
• Compliance Actions
• Data Systems FACTS, OASIS
• All current guidance
• Historical documents and earlier studies
• Managers and Technical Experts responses

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Database Research Model

• Used to validate the on-site interviews
• Reviewed 357 work products
• Focused on all violative work products, and
  reviewed a portion of non-violative
• Over 150 individuals interviewed
• Additional comments received from all interested
  individuals
• After consolidation, nearly 100 pages of comments
  were reviewed by the committee

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Analysis of Data

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

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Next Steps

• Finalize Review
• Design a timeline for execution of proposed
  improvements
• Final Report in Summer 2004
• Presentation to Science Board, Fall 2004

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Thank You

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