Proposed Rule for Prevention of Shell Eggs During Production

1. Proposed Rule for Prevention of Shell Eggs During Production

2. Proposed Rule One step in a broader farm-to-table egg safety effort that includes our requirements for safe handling statements on egg cartons, refrigerated storage of eggs at retail, and egg safety education for consumers and retail establishments

3. Main Points • Eggs are a major cause of foodborne illness. • From 1993 to 2000, an average of 80% of source-confirmed SE outbreaks were egg-associated. • Eggs cause approximately 118,000 illnesses/yr • Prevention is the key • The best way to prevent it is “on the farm”

4. Main Points • Our approach was developed with support from both industry and consumer groups. • Our proposed requirements have already been “tested” at the State level, and they work. • The benefits from selected option: $580 M (plausibly ranging from $250 M to $1,000 M) annually; 33,000 illnesses avoided ( between 21,000 and 50,000) annually. • Costs: $90 M (ranging from $55 M to $123 M) annually. • Health outcomes can be clearly measured.

5. Risk Assessment: How to Prevent These Illnesses • If the hen is infected, the egg may have the bacteria inside when it is laid. • Therefore, stop the hen from getting infected. • We call this “on-farm” preventive measures • Some infection is unavoidable, so refrigeration throughout the food chain stops bacteria from multiplying. • Pasteurization and/or thorough cooking kill the bacteria.

6. What Does the Regulation Say?

7. Which Farms Are Covered? • All requirements for a farm if : • More than 3,000 layers • Do not sell all eggs directly to consumers • Any of your eggs are not treated* • Only refrigeration requirements if: • More than 3,000 layers • Do not sell all eggs directly to consumers • All of your eggs are treated*

8. *Definition of Treated To treat shell eggs means to use a technology or process that achieves at least a 5-log destruction of SE for shell eggs, or the processing of egg products in accordance with the Egg Products Inspection Act

9. SE Prevention Measures • SE-free Chicks • Biosecurity • Rodent/Pest control • Poultry House Cleaning and Disinfection • Refrigeration

10. Chicks and Pullets Must come as chicks from SE-monitored breeder flocks that meet NPIP’s standards for U.S. S. Enteritidis monitored status or equivalent standards

11. Biosecurity Program Applies to grounds and all facilities and seeks to reduce SE from environmental, personal, animal contact: • Limit visitors on farm and in houses • Restrict movement of equipment between houses so is not a source of SE • Restrict persons moving between houses so they are not a source of cross-contamination • Prevent stray poultry and other animals from entering grounds • Require employees to not keep poultry at home

12. Rodent and Pest Control • Mice, rats and flies are primary carriers and must be controlled • The presence of SE in rodent populations has been highly correlated with the presence of SE in poultry houses and eggs • Assess populations of rodents and pests using appropriate monitoring methods and, if needed, use an appropriate method to decrease population • Remove debris within houses and vegetation and debris outside houses that may harbor pests

13. Cleaning and Disinfection of Houses • Required at depopulation when either the house or eggs from that house have tested positive for SE (but recommended in general) • Remove visible manure, dry clean, wet clean, and then disinfect using appropriate disinfectants

14. Refrigeration • Must refrigerate eggs at an ambient temperature of 45 F (7.2 C) or less if they are held at the farm more than 36 hours after laying • Refrigeration has been shown to minimize the growth of any SE that might be present in the eggs • Applies to all eggs regardless of whether or not they will receive a treatment

15. Environmental Testing for SE • Once per laying cycle when any group of hens in house are 40-45 weeks of age • If positive: • Review and make adjustments to SE prevention measures • Begin egg testing within 24 hours OR divert all eggs from positive house to treatment for life of flock in house

16. Environmental Testing After an Induced Molting Period • Environmental test at approx. 20 weeks after each molt • If positive: • Review and make adjustments to SE prevention measures • Begin egg testing within 24 hours OR divert all eggs from positive house to treatment for life of flock in house

17. Egg Testing • Each test is 1,000 randomly-collected eggs from a day’s production • 4 tests at 2-week intervals • If all are negative, no further testing • If any are positive, must divert all eggs until 4 tests at 2-week intervals are negative. Once 4 tests at 2-week intervals are negative, must still conduct 1 test per month for life of flock • If any of the monthly tests are positive, must divert all eggs until 4 tests at 2-week intervals are negative.

18. Egg Testing 1 test/month for life of flock No further testing Neg. Pos. before Neg. Never pos. Start Pos. 1,000-egg Test 1,000-egg Test 1,000-egg Test 1,000-egg Test Neg. 2 weeks Neg. 2 weeks Neg. 2 weeks Pos. Pos. Pos. Pos. Divert

19. Environmental Sampling Methodology • Must use a scientifically valid sampling procedure • Rule discusses two environmental drag-swab sampling methods • Rule requests comments and data on drag-swabbing methods and alternative methods for sampling that might be more uniform, e.g., air sampling. • FDA will consider comments and determine what method(s) should be required in the final rule.

20. Testing Methodology • Environmental samples: “Detection of Salmonella in Environmental Samples from Poultry Houses” (1/19/2001) or equivalent method. Available on CFSAN’s website. • Egg samples: Pre-enrichment method described by Valentin et al. in the Journal of Food Protection or equivalent method.

21. Administration on Farm • One individual at each farm is responsible for administration of the SE prevention measures • Must have completed training or have job experience equivalent to training • Responsibilities: • Develop and implement SE prevention measures • Reassess and modify measures as necessary • Review records

22. Recordkeeping Requirements • Records of environmental and egg sampling and results of SE testing • Records indicating compliance with diversion requirements • Records indicating that all eggs will undergo treatment, if applicable

23. Guidance/Training • Guidance • FDA plans to publish guidance on standards for each provision. Per GGP’s, each guidance will be published for comment prior to implementation. • Training to Implement • Industry and Government • Alliance with industry on best practices and how to implement rule

24. Small Business Provision • Small farms, 3,000 layers or less, exempted from all provisions • Effect of this provision: • Costs of rule reduced by $40 million • But fewer than 200 additional illnesses

25. How Do We Know It Works? Preventive Measures WORK • Specific States’ experiences • Regional shifts in illnesses once controls were put in place (see graph on next slide)

27. Health Outcome Goals • Goal of Egg Safety Program is Outcome-based • Current goal is to achieve a 50% reduction in illnesses by 2010. • Incorporating into Healthy People 2010

28. Economic Analysis • Major Benefits • Preventing severe acute cases and deaths • Preventing reactive arthritis as chronic sequelae of acute illnesses • Major Costs • Pest control and biosecurity • Refrigeration • Testing and diversion • Records • Small Business Effects • Exempt farms with < 3,000 layers • Most layer farms are small businesses

29. Benefits - Economic • Benefits from averting 33,000 illnesses annually plausibly range from $250 to $1,000 M. • Full uncertainty range is $50 M to $2.5 B • Includes healthcare costs, pain and suffering, and lost productivity. • Cost saving to HHS/CMS for reduced medical costs • $4 M

30. Annual Costs to Industry • $82 million annually • 4100 farms affected: • 2,350 farms with 3,000 to 19,999 layers • 950 farms with 20,000 to 49,999 layers • 350 farms with 50,000 to 99,999 layers • 450 farms with more than 100,000 layers

31. Annual Costs to Government • 4,100 farms (inspection sites) • Inspection and enforcement- FDA with State and other federal agency partnerships • Phased in over 2-3 years • Expected annual cost is $8 million Annual Cost = State contracts, audits, lab testing and training/outreach for industry plus FDA

32. Key Results of the Economic Analysis • Benefits exceptionally high because of present value of future reactive arthritis costs prevented. • Uncertainty analysis showed that 5th percentile benefits still much higher than estimated costs.

33. Request for Comments • Three additional areas for comment: • Measures for at-risk populations • Registration • Recordkeeping

34. Request for Comments:Measures for at-risk Populations • Does the current FDA Food Code system with State adoption and implementation achieve the desired public health outcome among high-risk populations? • Or can the public health outcome for high-risk populations only be achieved through mandatory Federal standards? • If so, how would those standards be best implemented? • Specifically which, if any, of the egg-related provisions in the 2001 Food Code should be mandated for retail establishments that serve at-risk populations?

35. Request for Comments:Registration Should FDA require egg producers to register the name and location of their business with FDA? Note: Farms are exempted from registering with FDA under the Interim Rule on Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

36. Request for Comments:Recordkeeping • Should FDA expand the recordkeeping provisions to include: • Establishment and maintenance of a written SE prevention plan? • Maintenance of records indicating performance and compliance in implementing specific SE prevention measures, e.g., monitoring records and activity logs?

37. Participatory Process • Set public health goal • Consulted industry, States, Federal partners, and consumers • Lessons learned and steps from EQAP

38. Enforcement • Tools: • On-Farm measures in place and administered • Testing of eggs and results • Diversion of SE-positive eggs • Resources: • FDA • States • Federal partners

39. Stakeholder Comment • Public Meetings: • College Park, MD • Chicago, IL • Los Angeles, CA • Comment Period: • 90 days – ends Dec 21, 2004

40. Conclusion FDA expects that the proposed rule will, if finalized, significantly decrease the number of SE-contaminated eggs produced on farms, and ultimately, decrease the number of SE-associated illnesses and deaths caused by consumption of shell eggs.