1. Caroline Smith DeWaal Center for Science in the Public Interest Washington, DC May 17, 2005 May 17, 2005 CFSAN Sprout Safety Public Meeting

2. Introduction  1999 Sprout Guidance Documents were a step in the right direction  The effect seen on food-borne illnesses was not sustained  Further action, along with a longer- term strategy, is needed

3. FDA Questions  Should the Sprout Guidance Documents be expanded or revised?  Is a regulation likely to be effective in reducing food-borne illness linked to sprouts?  How can progress be measured?

4. Expanded or Revised Guidance?  Guidance recommendations should be made mandatory  Several of the recommendations in the guidance should be more specific and detailed

5. Effectiveness of a Regulation? A regulation would be more effective in addressing sprout safety:  Legal requirement to institute preventive controls  Ensures universal adoption of FDA recommendations

6. Measuring Progress…  FDA should determine how successful the microbial testing guidance has been since issued AND  Identify the proportion of industry who followed the sampling and testing guidelines  Testing results should be published and be readily accessible to the public

7. Unique Data CSPI tracks food-borne illness outbreaks with the Outbreak Alert! database  Contains almost 4,500 outbreaks with both known food source and known etiology which occurred in the U.S. between 1990-2003  Only source for outbreaks linked to specific foods, as well as specific pathogens  Outbreaks are grouped according to U.S. regulatory agency and placed in one of 13 food categories

8. Number of Outbreaks By Year and Regulating Agency, 1990-2003 Source: Outbreak Alert! Center for Science in the Public Interest, 2004

9. Trends in Outbreak Reporting: Produce 1990-2003 Source: Outbreak Alert! Center for Science in the Public Interest, 2004

10. Top Causes of Produce Outbreaks, 1990-2003 Source: Outbreak Alert! Center for Science in the Public Interest, 2004

11. Causes of 29 Sprout Outbreaks 1990-2003 Cause # Outbreaks # of Cases Escherichia E. coli O157:H7 E. coli O157:H7 E. coli O157:NM E. coli O157:NM53214112021 Salmonella S. Anatum S. Anatum S. Chester S. Chester S. Enteritidis S. Enteritidis S. Havana, S. Cubana, S. Tennessee S. Havana, S. Cubana, S. Tennessee S. Infantis, S. Anatum S. Infantis, S. Anatum S. Kottbus S. Kottbus S. Mbandaka S. Mbandaka S. Montevideo, S. Meleagridis S. Montevideo, S. Meleagridis S. Muenchen S. Muenchen S. Newport S. Newport S. Saint Paul S. Saint Paul S. Senftenberg S. Senftenberg S. Stanley S. Stanley S. Typhimurium S. Typhimurium Salmonella spp. Salmonella spp.241141111122212131948152624440109328365099202526015811959 Source: Outbreak Alert! Center for Science in the Public Interest, 2004

12. Summary of an Outbreak  February – April 2001: Multi-state  Salmonella Kottbus linked to alfalfa sprout consumption  32 cases of food-borne illness  Single imported seed lot from a single sprout producer  Seeds had undergone a decontamination treatment

13. CSPI Recommendations  Keep the seeds intended for agricultural use and those intended for human consumption separated  Encourage development of better decontamination methods  Greater government oversight of sprout industry  Consumer warning labels

14. Separate Seeds  The practice of using seeds that have been grown for agricultural use should be banned  Seed imports from other regions should only be allowed if produced under similarly strict guidelines

15. Separate Seeds (cont’d)  The practice of mixed batches should be banned for seeds intended for human consumption  Batches of seeds and packages of sprouts should be clearly labeled or tagged throughout the food production chain from farm to table

16. Decontamination Methods  All decontamination methods should be challenge-tested with seeds positive for E. coli O157:H7  Clear and accurate information on the effectiveness of the various decontamination methods should be provided to the public

17. Greater Government Oversight  Sprout processors should be registered and classified as food handlers  Sprout processing facilities should be regularly inspected by both state and federal inspectors  FDA should take steps toward applying HACCP principles to the sprout industry

18. Consumer Warning Labels  Effective package labeling to alert consumers of the risks  Label should be concise, easy-to- read, prominently placed, and include a graphic symbol to aid consumers in identifying and remembering the risks

19. Conclusions  A sprout regulation is the next step toward instituting consistent, effective, preventive controls  A longer-term strategy is needed, and consideration of HACCP principles should be made  Don’t just warn, label!