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.
From onset, we used a risk assessment/risk management approach
USDA Risk Assessment

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.
USDA/FDA’s joint risk assessment on SE in eggs analyzed each step in the shell egg farm-to-table continuum to determine the relative risk that each step contributed to SE contamination of eggs.
The risk assessment revealed that preventive measures should be taken at each step of the continuum in order to maximize human health benefits.
The most effective preventive measures that can be taken to prevent illness from SE in eggs is to prevent eggs from becoming contaminated initially on the farm.

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:
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
There are measures than can be taken during egg production at the farm that will prevent SE from contaminating eggs.

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 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 Divert 1 test/month for life of flock No further testing
Neg.
Never pos.
Pos. before
Neg.
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 Training to Implement
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
Richard
Small businesses only responsible for refrigeration and registration. Some may still not be able to make it (they are not covered by the BT rules, exempt from those).

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)
This is to show that illnesses in the NE decreased after 1992, when Pennsylvania implemented their Egg Quality Assurance Program. Bottom Line: State efforts have shown this works.
Note: this graph could be put into its own slide

26. The red (or pink) line represents the decrease in illnesses in the Northeast after 1992, when PA implemented their Egg Quality Assurance Program.

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
We estimate that the cost to society of 125,000 egg-associated SE illnesses per year is $1.8 to $3.1 billion.

28. Economic Analysis Major Benefits Major Costs Small Business Effects
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
We estimate that the cost to society of 125,000 egg-associated SE illnesses per year is $1.8 to $3.1 billion.

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
800 Large Producers (>50,000 Hens)
3,300 Medium Producers ( ,000 Hens)
33,800 Small Producers (<3000 Hens)

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: Resources:
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: Comment Period: 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.