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Public Meeting: Sprout Safety

Public Meeting: Sprout Safety. Michelle A. Smith, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration College Park, MD May 17, 2005. Outline. Background Outbreaks, Collaborative efforts Consumer advisories Sprout guidance documents

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Public Meeting: Sprout Safety

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  1. Public Meeting: Sprout Safety Michelle A. Smith, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration College Park, MD May 17, 2005

  2. Outline • Background • Outbreaks, Collaborative efforts • Consumer advisories • Sprout guidance documents • Observations: field assignments & investigations • Produce Safety Action Plan • Questions • Next steps

  3. Sprouts - a Special ProblemNACMCF Produce White Paper 1998

  4. NACMCF 1998 Produce White Paper • Fresh produce, including sprouts – Opportunities for contamination, e.g., production (agricultural) environment, subsequent handling, storage, distribution & marketing • In addition - Germination conditions foster bacterial growth • Treatments that inactivate pathogens may also decrease germination, yield, or affect appearance of sprouts.

  5. Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean Cases 1996 (2) 1 1 650 1997 (3) 3 1 277 1998 (3) 3 1 48 1999 (6) 5 2 389 2000 (1) - - 1 75 2001 (3) 1 2 88 2002 (2) 1 1 21 • (5) 5 52 • (2) 2 33 Total: 27 Outbreaks1633 cases

  6. Background – A Few Milestones • Sprouts identified as a problem by CDC in 1995 • Sprout work groups to identify and implement safe production practices for seeds and sprouts, public mtg, sprout summit…. • 1997 FDA asked NACMCF to study sprouts • 1999 NACMCF Sprout White Paper • 1999 FDA Sprout Guidance docs

  7. NACMCF 1999 Sprout White Paper Microbial Safety Evaluations and Recommendations on Sprouted Seeds - Adopted May 28, 1999 • Basis for FDA’s sprout guide • http:/vm.cfsan.fda.gov/~mow/sprouts2.html • International Journal of Food Microbiology, November, 1999

  8. NACMCF Sprout White Paper • Seeds are the most likely source of microbial contamination. • Damaged or scarified seed may increase the risk of internalization of pathogens and make disinfection more difficult. • 5-log seed disinfection treatment should be applied to seed before sprouting

  9. FDA’s Sprout GuidanceOctober 25, 1999 • Reducing Microbial Food Safety Hazards for Sprouted Seeds • Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production http://vm.cfsan.fda.gov/~dms/sprougd1.html http://vm.cfsan.fda.gov/~dms/sprougd2.html

  10. Objectives • Provide recommendations to seed suppliers and sprout producers about reducing microbial food safety hazards and sprout associated illness, and • Ensure all parties comply with the food safety provisions of the Food, Drug, and Cosmetic Act

  11. Federal Register Notice: Guidance Failure to adopteffective preventive controls can be considered insanitary conditions - FDA will consider enforcement actions against any party who does not have effective preventive controls in place, in particular, microbial testing

  12. Broad Sprout Guide Everyone has a responsibility: 1.Seed production - Good Agricultural Practices (GAPs) 2.Seed conditioning, storage, and transportation - minimize contamination 3.Sprout production - Good Manufacturing Practices (GMPs) should be standard operating procedure

  13. Broad Sprout Guide • Seed treatment - applying one or more approved treatments shown to reduce pathogens prior to sprouting (SUCH AS 20,000 ppm calcium hypochlorite) 5.Microbial testing – testing spent irrigation water from each batch of sprouts for pathogens before sprouts enter the food supply -Salmonella - E. coli O157:H7

  14. Broad Sprout Guide • Identifies the most important steps which should be implemented immediately to reduce the risk of sprouts as a vehicle for illness • Does notprovide detailed information on all individual steps that should be followed to produce seeds and sprouts • Resources and references • CDHS/FDA sprout video

  15. “Safer Processing of Sprouts” • Educational video produced and distributed by the CDHS – FDB and the FDA in cooperation with industry and academia. http://www.cfsan.fda.gov/~dms/sprouvid.html or http://www.dhs.ca.gov/fdb/PDF/SproutOrderForm4.PDF

  16. 1999 Consumer Advisory** Updated Alfalfa sprout advisory August 31, 1998 • Advised all persons to be aware of the risks associated with eating [all] raw sprouts. • People in high risk categories should not eat raw sprouts. • Persons wishing to reduce the risk of foodborne illness from sprouts should not eat raw sprouts.

  17. Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean Cases 1996 (2) 1 1 650 1997 (3) 3 1 277 1998 (3) 3 1 48 1999(6) 5 2 389 2000 (1) - - 1 75 2001 (3) 1 2 88 2002 (2) 1 1 21 • (5) 5 52 • (2) 2 33 Total: 27 Outbreaks1633 cases

  18. Turning the corner w/ sprouts? 1999, a tough year • Updated consumer advisory • Issuance of direct final sprout guidance • Initiated directed inspections sprout facilities 2000, NO outbreaks associated with alfalfa or clover sprouts, However…..

  19. Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean Cases 1996 (2) 1 1 650 1997 (3) 3 1 277 1998 (3) 3 1 48 1999 (6) 5 2 389 2000 (1) - - 1 75 2001 (3) 1 2 88 2002 (2) 1 1 21 • (5) 5 52 • (2) 2 33 Total: 27 Outbreaks1633 cases

  20. 2002 Updated Consumer Advisory • Advised all persons to be aware of the risks associated with eating raw and lightly cooked sprouts • Specifically included mung bean sprouts www.cfsan.fda.gov/~lrd/tpsprout.html

  21. FDA 1998 Field Assignment Target: 100 firms • GMP Inspection (21 CFR part 110) • 83 firms • Survey Questionnaire GMP + demographics • 80 firms • Samples for microbial analyses raw seed → finished product • 78 firms

  22. FDA 1998 Inspection Results • FDA-483 Report of Observations, issued when insanitary practices or conditions are observed • 83 Facilities Inspected FDA-483 Issued at 47 firms (57%)

  23. FDA 1998 Microbial Analyses Firm Stage of growth A RAW PRE GERM ----- FIN* B RAW PRE GERM ----- FIN* C RAW PRE* GERM* WW*FIN* * (+) Salmonella sp., alfalfa

  24. 2000 Field Assignment Target: 150 firms • Limited Inspections (focus on practices in guidance) • Questionnaire re: recommendations in guidance • Collect and test spent irrigation waterfrom firms that are testing

  25. 2000 Inspection Results 137 firms inspected: • Good news No positive water samples • Bad news - FDA-483 to 99 firms (72%) - Warning letters 65 firms (47%) • Unsanitary conditions • Failure to implement effective controls, emphasis on microbial testing (Seed treatment still important)

  26. 2000 Directed Inspections • No significant deficiencies 54 firms (39%) Firms inspected in 1998 did better than firms not previously visited Deficiencies: • Personnel cleanliness 20% • Unsanitary food contact surfaces 24% • Pests 28% • Water quality 28%

  27. Sprout Outbreaks 1996 - 2004 Alfalfa Clover Mung Bean Cases 1996 (2) 1 1 650 1997 (3) 3 1 277 1998 (3) 3 1 48 1999 (6) 5 2 389 2000 (1) - - 1 75 2001 (3) 1 2 (32) 88 2002 (2) 1 1 (5) 21 • (5) 552 • (2) 233 Total: 27 Outbreaks1633 cases

  28. Adequacy of Current Guidance Some inspectors recent outbreak investigations reported “sprouter appears to be following FDA sprout guidance.” Questions: • Consistent and Appropriate application of recommended practices? • Adequacy of current guidance?

  29. California Sprout Industry Inspection – February 2004 • CDHS – FDB and FDA inspectors visited every registered sprout grower in California • A standardized questionnaire was used to evaluate if practices consistent with current GAPs and GMPs guidance.

  30. California 2004 - Inspection Checklist • Seed Storage • Pest control • Sprout Production • Seed Treatment • Testing for Pathogens • Storage and Distribution of Sprouts • Traceback Capability • Cleaning and Disinfection

  31. California 2004 - Sanitation • 50% of firms were described as having deficiencies including: • unsanitary food contact surfaces (38%) • evidence of pests (33%) • lack of personnel cleanliness (25%) • water quality problems (8%)

  32. California 2004 - Seed Treatment • 70% of sprouts were treated with Ca(OCl)2 * • Sodium hypochlorite (25%), ozone, and peroxyacetic acid were also used. * only 2 used the correct concentration, duration, and method (e.g., agitation, seed:solution ratio)

  33. California 2004 - Sampling and Microbial Testing of Spent Irrigation Water • 71% of firms collected spent irrigation water for microbial testing • Almost all firms tested for Salmonella spp. and E. coli O157:H7 but the testing method varied greatly. • “unapproved” tests • Who does tests, where • Pooling, holding samples

  34. CA 2004 - Confirmatory Tests • 11/17 (65%) conduct confirmatory testing following an initial positive test result • 4/17 (24%) have never had an initial positive but would conduct confirmatory testing if necessary • 5/8 (63%) use spent irrigation water while 3/8 (38%) use enrichment media for conf. testing • Almost half wait to ship until the results have been received.

  35. California 2004Testing Spent Irrigation Water Record Keeping* • 15/17 (88%) that conduct testing maintain records of test results from 48 hour spent irrigation water samples. • 1/17 (6%) maintains a record of 48 hour spent irrigation water samples collected but not the results. *Data missing from 1 firm

  36. California 2004 – Record Keeping • Less than 20% that conduct confirmatory testing maintain records of the positive results. • A majority of firms (92%) do not maintain records of the disposition of the product where irrigation water is confirmed positive.

  37. CA 2004 - Traceback Capability • 17/24 (71%) of firms reported having the ability to trace sprouts back to their source seed supplier. • Maximum number of seed lots used to produce one finished product lot ranged from 1-10. • 12/24 (50%) of firms identify finished product with a lot number or date designation.

  38. Produce Safety From Production to Consumption: 2004 Action Planto Minimize Foodborne Illness Associated with Fresh Produce ConsumptionOctober, 2004http://www.cfsan.fda.gov/~dms/prodpla2.html

  39. 2005 CFSAN Program Priorities On the A - List: • Hold public meeting on sprout safety and initiate rulemaking • Evaluate testing protocol for the recovery of Salmonella in sprout seeds

  40. Sprouts are a high risk foodA rigorous risk reduction strategy is neededWhat should the strategy include?Who, how, when, where best applied?

  41. Complexities of issues & uncertainty about what current science can support Information on the current science • Sources of contamination • Interventions • Adequacy of current guidance • Expand? Revise? • How to better reach seed producers/distributors • Comments by July 18, 2005

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