FDA Science Board Advisory FDA Science Board Advisory Committee MeetingCommittee Meeting

ORA Science Peer Review-ORA Science Peer Review-Pesticide and Industrial Chemical Pesticide and Industrial Chemical

ProgramsPrograms

April 22, 2004April 22, 2004

Overview of ORA Science Peer Overview of ORA Science Peer ReviewReview

John R. MarzilliJohn R. Marzilli

Deputy Associate Commissioner for Deputy Associate Commissioner for Regulatory AffairsRegulatory Affairs

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

Professor of Food ScienceProfessor of Food Science

Montclair State UniversityMontclair State University

ORA Science Peer ReviewORA Science Peer Review

Objectives:Objectives:

– Quality of Science across our organizationQuality of Science across our organization: : Program Planning, Inspections, Investigations, Lab Program Planning, Inspections, Investigations, Lab Analysis, Regulatory Actions, Quality Management Analysis, Regulatory Actions, Quality Management SystemsSystems

– Adequacy of resourcesAdequacy of resources: Skills and Expertise, : Skills and Expertise, Technologies, Organizational InfrastructureTechnologies, Organizational Infrastructure

– Mission RelevanceMission Relevance

FDA’s MissionFDA’s Mission

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

ORA Science Peer ReviewORA Science Peer Review

Goal of Peer ReviewGoal of Peer Review

– Establish a roadmap for future improvement and Establish a roadmap for future improvement and coordination of ORA Pesticide and Industrial coordination of ORA Pesticide and Industrial Chemical ProgramsChemical Programs

– Establish a model for future review of additional Establish a model for future review of additional programsprograms

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)Tom Savage, Deputy Director, DFSTom 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

OFFICE OF REGULATORY AFFAIRS190 OFFICES IN FY 2004

NORTHEASTPACIFIC CENTRAL

SOUTHEAST

SOUTHWEST03-04

Division of Planning, Evaluation, & MgmtORA Offices.ppt

REGIONAL OFFICES - 5DISTRICT OFFICES - 20RESIDENT INSPECTION POSTS - 140OCI FIELD OFFICES - 6OCI RESIDENT OFFICES - 6OCI DOMICILES - 13

CA

NV

WA

MT

ORID

AK

HI

AZ

UT

WY

CO

NM

TX

OK AR

MO

IANE

KS

TN NC

GAALMS

LA

FL

SC

PR

MEVT

NY

NH

MA

CTRI

MN

WI

IL

MI

INOH

PA

WV

KYVA

NJ

ND

SD

MDDE

VI

OFFICE OF REGULATORY AFFAIRS13 FIELD LABORATORIES

CURRENT FY 2004NORTHEAST

PACIFIC CENTRAL

SOUTHEASTSOUTHWEST

10/02

Division of Planning, Evaluation & MgmtORALABSCurr.PPT

5 MULTI-PURPOSE LABS 8 SPECIALTY LABS

SEATTLE

SAN FRANCISCO

LOS ANGELES

`

DENVERKANSAS CITY

JEFFERSON

DETROIT

FORENSICCHEMISTRY

CENTER

PHILADELPHIA

NEW YORK

WINCHESTER

ATLANTA

SAN JUAN

Overview of ORA Overview of ORA Science Peer ReviewScience Peer Review

John J. Specchio, Ph.DJohn J. Specchio, Ph.DORA Science AdvisorORA Science AdvisorProfessor of Food ServicesProfessor of Food ServicesMontclair State UniversityMontclair State UniversityMontclair, New JerseyMontclair, New Jersey

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

Complexity of Review ModelComplexity of Review Model

8 District Offices visited8 District Offices visited

6 ORA Laboratories visited6 ORA Laboratories visited

12 additional District offices were 12 additional District offices were included in studyincluded in study

On-site visits included review On-site visits included review of: of:

Local SOPs for Domestic and Import WorkLocal SOPs for Domestic and Import Work

Sample Collection ReportsSample Collection Reports

Lab WorksheetsLab Worksheets

Establishment Inspection ReportsEstablishment Inspection Reports

Compliance ActionsCompliance Actions

Data Systems: FACTS, OASISData Systems: FACTS, OASISAll current guidanceAll current guidanceHistorical documents and earlier studiesHistorical documents and earlier studiesManagers and Technical Experts responsesManagers and Technical Experts responses

Database Research ModelDatabase Research Model

Used to validate the on-site interviewsUsed to validate the on-site interviewsReviewed 357 work productsReviewed 357 work productsFocused on all violative work products, Focused on all violative work products, and reviewed a portion of non-violativeand reviewed a portion of non-violativeOver 150 individuals interviewedOver 150 individuals interviewedAdditional comments received from all Additional comments received from all interested individualsinterested individualsAfter consolidation, nearly 100 pages of After consolidation, nearly 100 pages of comments were reviewed by the comments were reviewed by the committeecommittee

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

Next StepsNext Steps

Finalize Review Finalize Review

Design a timeline for execution of proposed Design a timeline for execution of proposed improvementsimprovements

Final Report in Summer 2004Final Report in Summer 2004

Presentation to Science Board, Fall 2004Presentation to Science Board, Fall 2004

Thank YouThank You

John R. MarzilliJohn R. Marzilli

Deputy Associate Commissioner for Deputy Associate Commissioner for Regulatory AffairsRegulatory Affairs

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

Professor of Food ScienceProfessor of Food Science

Montclair State UniversityMontclair State University