FDA Science Board Advisory Committee Meeting ORA Science Peer Review- Pesticide and Industrial Chemical Programs April 22, 2004

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

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

FDA’s 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.

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

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

Team Members Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Science (DFS) Tom Savage, Deputy Director, DFS Larry D’Hoostelaere, 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

OFFICE OF REGULATORY AFFAIRS 190 OFFICES IN FY 2004 NORTHEAST PACIFIC CENTRAL SOUTHEAST SOUTHWEST Division of Planning, Evaluation, & Mgmt ORA Offices.ppt REGIONAL OFFICES - 5 DISTRICT OFFICES - 20 RESIDENT INSPECTION POSTS OCI FIELD OFFICES - 6 OCI RESIDENT OFFICES - 6 OCI DOMICILES - 13 CA NV WA MT OR ID AK HI AZ UT WY CO NM TX OK AR MO IA NE KS TN NC GA AL MS LA FL SC PR ME VT NY NH MA CT RI MN WI IL MI IN OH PA WV KY VA NJ ND SD MD DE VI

OFFICE OF REGULATORY AFFAIRS 13 FIELD LABORATORIES CURRENT FY 2004 NORTHEAST PACIFIC CENTRAL SOUTHEAST SOUTHWEST 10/02 Division of Planning, Evaluation & Mgmt ORALABSCurr.PPT 5 MULTI-PURPOSE LABS 8 SPECIALTY LABS SEATTLE SAN FRANCISCO LOS ANGELES ` DENVER KANSAS CITY JEFFERSON DETROIT FORENSIC CHEMISTRY CENTER PHILADELPHIA NEW YORK WINCHESTER ATLANTA SAN JUAN

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

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

Complexity of Review Model 8 District Offices visited 6 ORA Laboratories visited 12 additional District offices were included in study

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

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

Analysis of Data 5 Key Areas Emerged –Program Management –Laboratory Science Issues –Productivity and Timeliness –Resources –Compliance and Regulatory Policy

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

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