Industry: Defining the Problem, Setting the Stage Catherine E. Woteki, Ph.D.

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Industry: Defining the Problem, Setting the Stage Catherine E. Woteki, Ph.D. September 29, 2009

Defining the problem/setting the stage Who s responsible for food safety? What does that mean for research? What are the current challenges? From a research perspective From a funding perspective From a public perception perspective Do we need new models for food safety research? 2

Who s responsible for food safety? Industry is responsible for safety of its products Government s role is to: set standards verify that industry is meeting them enforce when necessary 3

US Government Food Safety Decisions Inherently science based Pre-market approvals Naturally occurring hazards, environmental contaminants, economic adulterants Risk assessment assists the agencies in determining appropriate risk management response Risk communication occurs throughout process 4

US Government Food Safety Decisions Inherently science based Pre-market approvals Naturally occurring hazards, environmental contaminants, economic adulterants Risk assessment assists the agencies in determining appropriate risk management response Risk communication occurs throughout process.and the same is true in most countries 5

Who s responsible for food safety? Both industry and government those who produce food and those who regulate food share responsibilities for food safety and hence for food safety research. 6

What does that mean for research? Government programs: Monitoring/surveillance/inspection of food supply Monitoring/surveillance/outbreak investigation of human illnesses Risk assessment Fundamental research Foodborne disease processes and treatments Mitigation strategies Industry programs: Engineering Pre-market safety studies Priorities specific to products, processing methods, HACCP validation Pre-competitive, commonly shared problems 7

US Food Safety Budgets 1998 ($ in Millions) CDC NIH EPA FDA NMFS USDA Sub- Total Surveillance $14.5 $9.1 $1.5 $25.1 Inspection $23.2 $161.4 $11.8 $671.4 $867.9 Risk Assessment $126.7 $9.1 $7.6 $143.4 Research $52.9 $32.0 $25.6 $60.3 $170.8 Education $17.2 $5.5 $22.7 Total $14.5 $52.9 $181.9 $222.6 $11.8 $746.4 $1,236.8 8 Source: IOM, Ensuring Safe Food from Production to Consumption, 1998.

Industry Food Safety Research Funding? 9

What are the current challenges? From a research perspective From a funding perspective From a public perception perspective 10

Challenge #1 The breadth of the hazards Prevention, detection, mitigation/control/ eliminate in supply chain, during processing, post-processing, in distribution, in preparation Nutritional Pathogens Chemical contaminants Radiological Allergens Food additives Physical Economic adulteration 11

Challenge #2 Scope of the food system Fresh fruits and vegetables Meat, poultry, fish, egg, dairy products Processed foods Imported foods different matrices pose analytical challenges different countries of origin pose differing hazards 12

Challenge #3 No common research agenda No nationally coordinated research agenda Lack of adequate integration of research efforts among agencies Current funding is inadequate to support a science-based system National labs have not been engaged 13

Challenge #4 Prevention technologies Front-gate testing technologies to identify chemical contaminants, adulterants and pathogens Research talent and capacity exist in national labs, universities FDA lacks research funds, FSIS lacks research authority ARS and CSREES fund most food safety research Not a priority for NIH, NSF Food industry has applied band-aids, not mounted long-term research program National labs may have technologies and insights from other applications 14

15 Challenge #5 Public mistrust of industry research

16 Center for Science in the Public Interest Integrity in Science Project "Despite Official Spin, Report Shows FDA Can Easily Find Experts Without Conflicts of Interest "Science Groups Urge Agency to Adopt Restrictions on Conflicted Experts" "Fishing Group Funds Omega 3 Frenzy "Consumer, Enviro Groups Protest Nominees to EPA Acrylamide Panel "Groups Decry Broken Peer Review Process at EPA "Von Eschenbach: FDA Wants Closer Ties with Industry "Conflict of Interest Charges Roil Cochrane Collaboration"

Is it time for new models for food safety research? Common research agenda focusing on a small number of high priority issues Shared by Regulatory agencies Research agencies, including national labs Companies NGO s Involving new funding approaches to engage University, intramural government and industry scientists 17