Joy Johanson FDA/CFSAN CAFPA Spring Meeting, 15 May 2012

1. Joy Johanson FDA/CFSAN CAFPA Spring Meeting, 15 May 2012

2. Presentation Overview • Sprout Safety Alliance • Proposed Produce Safety Regulation • Observations during inspections and investigations of sprout firms

3. Launched on 28 February 2012 • Funded by the U.S. Food and Drug Administration (FDA) Office of Foods through a cooperative agreement with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) • A collaboration between government, industry, academia and researchers to provide training and educational materials to industry and regulatory officials

4. Objectives • Develop training materials that: • Assist sprouters in adopting best practices for the safe production of sprouts based on: • FDA guidance documents • Other information • Facilitate understanding of: • Risks associated with sprouts • Current mitigation practices • Implementation of related requirements in the produce safety regulation, when final

5. Objectives (continued) • Provide training and workshops for stakeholders across the U.S. • Classroom training • Distance training, e.g., webinars • Collaborate with USDA, states, trade associations and land-grant university extension services to conduct training

6. Objectives (continued) • Provide tools to assist growers in conducting risk assessments of their sprouting facilities and production practices • Serve as a technical assistance network hub and information resource for the sprout industry, buyers, retailers, and federal and state regulatory agencies

7. Build on Work already Performed • Direct education and outreach efforts toward sprout growers and sprout seed and bean producers • Improve the dissemination of the materials to small producers

8. FDA’s History of Alliances • 1995 Seafood HACCP regulation published • 2001 Juice HACCP Alliance • FDA collaboration with industry, academia and researchers to provide training and educational materials to industry and regulatory officials

9. Recently-formed Alliances • In anticipation of the issuance of rules mandated by the FDA Food Safety Modernization Act, launched: • 2010: Produce Safety Alliance • 2011: Preventive Controls Alliance • 2012: Sprout Safety Alliance

11. Why an Alliance Specifically for Sprouts? • Sprouts present a unique food-safety risk • Warm, moist, and nutrient-rich conditions required to produce sprouts also facilitate pathogen growth • One contaminated seed lot sent to sprout growers around the country can cause a national outbreak • Unique food safety practices used by sprout growers and sprout seed and bean suppliers • Testing spent sprout irrigation water • Disinfecting seeds prior to sprouting

12. Why an Alliance Specifically for Sprouts?(continued) • Between 1996 and 2010, observed 34 multi-state outbreaks associated with sprouts • More than associated with any other type of fresh produce • Caused by Salmonella spp., E. coli O157:H7, and E. coli O157 NM • 2,150 cases of illness, 123 hospitalizations, and one death

13. Organizing Committee TJ Fu, FDA-CFSAN Stephen Grove, IFSH Joy Johanson, FDA-CFSAN Jane Reick, California Dept. of Public Health Oversee Alliance activities Steering Committee Claudia Coles, Association of Food and Drug Officials (AFDO) Kevin Dreesman, Illinois Dept. of Public Health David Gombas, United Fresh Produce Association JohnnaHepner, Produce Marketing Association Robert Hoeft, University of Illinois Bob Sanderson, International Sprout Growers Association Don Schaffner, Rutgers University Michelle Smith, FDA-CFSAN Jim Topie, MN Dept. of Agriculture Determine Alliance strategies and objectives Technical Committee Outreach Committee Researchers; Sprout industry representatives? TBD; Extension specialists, State Depts. of Health and Ag? Develop training materials Design and provide trainings

14. Next Steps • Website development (in progress) • Formation of working groups • Technical committee • Outreach and education committee • We welcome your participation! • Face-to-face meeting of Steering Committee in late May

15. Stephen Grove Institute for Food Safety and Health Illinois Institute of Technology (708) 563-8176 sgrove@iit.edu Joy Johanson Center for Food Safety and Applied Nutrition Food and Drug Administration (240) 402-1909 joy.johanson@fda.hhs.gov To participate in a working group, please contact:

16. FDA Regulatory Authority (Current) • Food Drug and Cosmetics Act -- covers fresh produce, including sprouts • prepared, packed, or held under insanitary conditions …whereby it may have been rendered injurious to health; • If it bears or contains any poisonous or deleterious substance which may render it injurious to health • No Implementable Regulation

17. FDA’s Sprout Guidance Documents(1999) • Reducing Microbial Food Safety Hazards for Sprouted Seeds http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm • Sampling and Microbial Testing of Spent Irrigation Water During Sprout Productionhttp://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120246.htm

18. Food Safety Modernization Act FSMA directs us, in coordination with USDA and states, in consultation with other agencies, to: Establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables (RACs) where we determine that such standards minimize the risk FDA's Current Thinking - Deliberative

19. Produce Rule – FSMA Directive: • Content - soil amendments, hygiene, packaging, temperature controls, animals in the growing area & water • Sufficient flexibility to be applicable to various types of entities engaged in production & harvesting of fruits & vegetables that are RACs • Appropriate to the scale & diversity of the production & harvesting of such commodities

20. Produce Safety Regulation Development Process • Draft regulatory and explanatory language • Economic analysis and environmental assessment • Internal (FDA) legal review • External (White House Office of Mgt & Budget) review • Other Federal agency review • Address comments/concerns and eventual “clearance” • Publish in Federal Register as PROPOSAL • Public comment period • Written comments – more detailed comments encouraged • Public Meetings • Review all comments and Issue Final Regulation

21. The Produce Safety Rule: It Won’t Happen Overnight • FDA proposes rule and requests comments • Public comment period • FDA considers comments and issues final rule • FDA sets dates for companies to comply, with additional time for small businesses We are here

22. Investigational Findings: • Seed most likely source of contamination in most if not all sprout outbreaks, though conditions at the facility can exacerbate conditions • Recent “contributing factors” show exceptions to the rule • Listeria positives on equipment and in sprouting facility • Facility practices and conditions, matching Salmonella outbreak strain in compost run-off

23. 2010 Sprout Firm Inspections • More than 60 firms identified for inspection • Many operations were taking steps to implement at least some of the recommendations in the FDA Sprout Guidance documents, • This effort was not universal across sprout farms visited • This effort was not universal across all current recommendations within a single operation.

24. General Observations – 2010 Inspections • Observations at one or more sprout farms included: • issues with equipment and facility design • sanitation • hygienic practices • All firms stored seed in clean dry areas • Many in closed covered containers, most stored seed off the floor and some away from walls.

25. 2010 Inspection Findings (continued) • About half of firms reported looking for seed grown under good agricultural practices (GAPs) • About half reported testing spent irrigation water • Fewer had SOPs for testing (sample size or frequency) logs of results • About 1/3 reported environmental testing for Listeria

26. Questions?