Proposed Rule for Prevention of Shell Eggs During Production

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Proposed Rule for Prevention of Shell Eggs During
Production
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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

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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

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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.

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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.

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What Does the Regulation Say?
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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

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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

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SE Prevention Measures

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

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Chicks and Pullets

• Must come as chicks from SE-monitored breeder
  flocks that meet NPIPs standards for U.S. S.
  Enteritidis monitored status or equivalent
  standards

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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

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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

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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

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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

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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

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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

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Egg Testing

• Each test is 1,000 randomly-collected eggs from a
  days 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.

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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
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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.

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Testing Methodology

• Environmental samples Detection of Salmonella
  in Environmental Samples from Poultry Houses
  (1/19/2001) or equivalent method. Available on
  CFSANs website.
• Egg samples Pre-enrichment method described by
  Valentin et al. in the Journal of Food Protection
  or equivalent method.

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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

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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

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Guidance/Training

• Guidance
• FDA plans to publish guidance on standards for
  each provision. Per GGPs, 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

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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

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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)

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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

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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 lt 3,000 layers
• Most layer farms are small businesses

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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

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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

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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

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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.

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Request for Comments

• Three additional areas for comment
• Measures for at-risk populations
• Registration
• Recordkeeping

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Request for CommentsMeasures 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?

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Request for CommentsRegistration

• 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.

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Request for CommentsRecordkeeping

• 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?

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Participatory Process

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

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Enforcement

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

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Stakeholder Comment

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

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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.