Jim Gorny, Ph.D. Senior Advisor for Produce Safety

1. Jim Gorny, Ph.D. Senior Advisor for Produce Safety “Produce Food Safety” 1

2. The US FDA is “THE” Produce Food Safety Regulatory Agency • FD&C Act, (additives & preservatives, antimicrobials for processed foods, packaging components, labeling, etc.) Good Manufacturing Practices (cGMPs) • Bioterrorism Act • Food & Drug Administration Amendments Act Reportable Food Registry Guidance Good Agricultural Practices (GAPs)(1998) Fresh-cut Guidance (2008) CSG Leafy Greens, Melons & Tomatoes (2009) 2

3. White House Food Safety Working Group Mission: • To determine how to upgrade U.S. food safety laws for the 21st century • Foster coordination of food safety efforts throughout the government, • Ensure laws are being adequately enforced to keep the American people safe from foodborne illness • Co-chaired By Sec. of DHHS & USDA March 2009 3

4. White House Food Safety Working Group Recommended a new public health-focused approach to food safety based on three core principles: (1) Prioritizing prevention; (2)strengthening surveillance and enforcement; and (3)improving response and recovery July 1, 2009 4

5. Produce Safety Background • Produce safety depends on every participant in the farm-to-table supply chain implementing modern preventive controls to minimize and, where possible, eliminate contamination that can cause illness. • FDA has worked with the produce industry to develop and promote implementation of GAPs aimed at reducing contamination and improving produce safety. • FDA issued “Good Agricultural Practice” guidelines in 1998, and the industry has since developed commodity-specific guidances outlining specific control measures for such commodities as cantaloupe tomatoes & leafy greens. 5

6. Produce Safety Background • Despite these measures, foodborne outbreaks associated with fresh produce continue to occur. • To reduce the prevalence of produce associated disease, FDA has determined that science-based, enforceable standards, in conjunction with commodity-specific guidance on good agricultural practices are needed. • “Our long-term plan is to set enforceable produce safety standards through a regulation.” Michael R. Taylor, J.D., Deputy Commissioner for Foods U.S. FDA, before the subcommittee on domestic policy, committee on oversight and government reform, U.S. House of Representatives. JULY 29, 2009 6

7. Regulatory ToolsGuidance: “should” e.g. GAPs Regulations: “shall” e.g. GMPs Cooperative Agreements: e.g. Model Food Code 7

8. Good Manufacturing Practices - GMPs “GMPs are guidelines to assure that food for human consumption is safe and has been prepared, packed and held under sanitary conditions” 21CFR 110.1 • Personnel • Physical Plant & Grounds • Plant Construction & Design 8

9. “Guidance for Industry - Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” Issued February, 2008 www.cfsan.fda.gov/guidance.html Recommendations Compliment cGMP’s FDA Fresh-cut Produce Guidance 9

10. Melon – Published Oct ‘05 Lettuce – Published April ‘06 Tomato – Published June ‘06 Green Onions – Feb ‘10 Industry Commodity Specific Guidance 10

11. Evolving Food Safety Best Practices 1998 2006 2007 11

12. Produce Guidance FDA Commodity Specific Guidance • Melons, Tomatoes, Leafy Greens • Issued July 2009 FDA’s guidances recognize and embrace the progress industry has made in establishing quantitative metrics for the control of some of the factors affecting produce safety. FDA is studying the scientific basis for these metrics and will incorporate appropriate metrics in its produce safety regulation. 12

13. Produce Guidance • Tailoring the guidance to three specific commodities that have been associated with foodborne illness outbreaks; • Incorporating lessons learned by FDA since 1998 and those reflected in commodity-specific guidances developed by the produce industry; • Calling for preventive controls throughout the farm-to-market supply for fresh produce; • Emphasizing the importance of a careful environmental assessment to identify hazards and possible pathways of contamination; and • Recommending an array of risk reduction practices. 13

14. Produce Regulation • Produce Safety Regulation: “ The Food and Drug Administration is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house.” 7 December 2009 Unified Agenda & Regulatory Plan • FDA has begun work on a regulation to set science-based, enforceable standards for produce safety. • As a public health regulatory agency, FDA has a further and critical role in ensuring produce safety, which is to set and ensure compliance with enforceable standards so that best practices for produce safety become common practice. 14

15. Produce Regulation • The regulation will be based on the prevention-oriented public health principles embraced by the White House Food Safety Working Group and announced by Vice President Biden, and it will capitalize on what we have learned over the past decade. • Clear standards for implementation of modern preventive controls by all participants in the fresh produce supply chain, from farm to market; • These performance-oriented standards will recognize that operators must tailor their preventive controls to the particular hazards and conditions affecting their operations, but the regulation will ensure they do so in accordance with modern food safety principles. 15

16. Produce Regulation • Product-specific standards and guidance where appropriate. • Quantitative measures of the effectiveness of control systems to the extent scientifically feasible and valid. • Microbial testing protocols to verify the effectiveness of preventive controls. • FDA will work with the states to plan and implement an inspection and enforcement program to ensure high rates of compliance with the produce safety regulation. 16

17. Working with the Produce Industry To facilitate compliance with any new regulations: • Issuance of a science-based “hazards guide” to assist producers and processors in designing their preventive controls. • Provision of other technical assistance and guidance on how to comply with the regulations. • Establishment of reasonable time periods for implementation of the regulations, taking into account firm size. • Cooperation with USDA and state University extension programs and industry-sponsored education efforts to foster understanding and implementation of the regulations 17

18. Working with the Produce Industry • FDA recognizes that the produce sector consists not only of large national operators but also many small producers, including many who market directly to consumers at roadside stands and farmers markets; • FDA will carefully consider the public health and economic impacts of applying requirements to very small producers, and will consider appropriate adjustments in the regulations. 18

19. We Need Your Input • To ensure standards are developed that stakeholders can and will support, FDA must rely on significant input from all stakeholders – particularly those with first-hand, on-the-ground experience. • It also means close collaboration between FDA and its federal partners at USDA and elsewhere, its counterparts in foreign governments, state and local agencies, the industry and its trade associations, academia, and consumers. 19

20. FDA, USDA, State Dept’s of Ag & Public Health, Academia and Industry Stakeholder Meetings

21. A New Approach • Open Docket February 23, 2010 (before a proposed rule is issued) until July 23, 2010. FDA-2010-N-0085 “Preventive Controls for Fresh Produce: Request for Comments” • All relevant comments considered, including those received under the Draft Commodity-Specific Guidances (2009-10) • Proposed rule, reflecting all comments, expected before the end of 2010. 21

22. Requested Comments We requested comments that will inform the development of: • Safety standards for fresh produce at the farm and packing house and; • Strategies and cooperative efforts to ensure compliance. Source: Federal Register Volume 75, Number 35, Pg 8086-8087 Tuesday, February 23, 2010, Docket No. FDA-2010-N-0085 www.gpo.gov 22

23. Requested Comments • Role of the good agricultural practice guidelines entitled Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables; • Standards for domestic and foreign growers and packers; • Identification and prioritization of risk factors; • Environmental assessment of hazards and possible pathways of contamination; • The impact of scale of growing operations on the nature and degree of possible food safety hazards; • Methods to tailor preventive controls to particular hazards and conditions affecting an operation; • Possible approaches to tailoring preventive controls to the scale of an operation so that the controls achieve an appropriate level of food safety protection and are feasible for a wide range of large and small operations; 23

24. Requested Comments • Coordination of produce food safety practices and sustainable and/or organic production methods; • Coordination of produce food safety practices and environmental and/or conservation goals or practices; • Coordination of produce food safety practices and Federal, State, local and tribal government statutes and regulations; • Microbial testing; • Post-harvest operations and the role of the current good manufacturing practices in 21 CFR part 110; • Records and other documentation that would be useful to industry and regulators in ensuring the safety of fresh produce; and • Strategies to enhance compliance. 24

25. What has the FDA heard from stakeholders? • No one size fits all. • Scale-appropriate. • Use the best available science. • Must be risk-based • Must be flexible • Imports must be held to same standard as domestic industry • Education outreach is very important • Must utilize a practical commonsense approach • Must not conflict with other federal & state rules (EPA, NOP, NRCS, other rules) • Must not be overly burdensome • Must not be overly prescriptive • Utilize existing mechanisms/activities for compliance

26. Produce Safety Research • FDA will continue to cooperate with the industry and other food safety partners to identify and implement best practices for preventing food safety problems. • This cooperation includes conducting and fostering applied, problem-solving research to both better understand produce safety hazards and to develop the controls needed to minimize them. 26

27. Working with Congress • FDA recognizes and strongly supports the efforts in Congress to enact a modern food safety law that will mandate preventive controls for all facilities and likely call specifically for produce safety standards. • Such legislation would provide the necessary mandate and authority to modernize the FDA’s food safety program and significantly enhance FDA’s current legal authority and tool kit for produce safety. • FDA and the Obama Administration will also continue to work with Congress to provide the resources for research, standard-setting and inspection that are essential to FDA’s success in setting and enforcing science-based food safety standards. 27

28. Working with Congress U.S. House of Representatives HR 2749: Food Safety Enhancement Act(FSEA) Passed: 280 Ayes, 150 Nays July 29, 2009 U.S. Senate S 510 FDA Food Safety Modernization Act (Durbin) 28

29. Hazard analysis and risk-based preventive controls, and food safety plans Finished product test results from category I facilities Performance standards Produce safety standards Records access Product tracing HR 2749: Food Safety Enhancement ActSelected Provisions 29

30. HR 2749: Food Safety Enhancement ActSelected Provisions (cont’d) Certification and accreditation of importers Testing by accredited labs Quarantine of geographic locations Country of origin labeling for food and food ingredients Food facility registration Risk-based Inspections 30

31. Jim Gorny, Ph.D. Senior Advisor for Produce Food Safety U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20759 Tel: 301.436.1925 Email: James.Gorny@fda.hhs.gov 31