Implications of the
  Egg Safety Final Rule for
Prevention of SE in Shell Eggs

        Patricia A. Curtis, Ph.D.
        ...
Final Rule
• Requires:
  – preventive measures
    during the production of
    eggs in poultry houses
  – subsequent refr...
Who must comply?
        • Requires that measures
          designed to prevent
          Salmonella Enteritidis be
      ...
Expected benefits of final rule…
• Expected to prevent
  each year approximately
  79,000 cases of
  foodborne illness and...
Salmonellosis
• CDC estimates that there
  are 38 cases of
  salmonellosis for every
  reported culture-
  confirmed case
...
Salmonellosis
     • Since 1995, Salmonella
       enterica serotype Enteritidis
       (SE) has been the second
       mo...
Why SE? Why Eggs?
• Healthy People 2010 goal of a
  50% reduction from the 1997
  baseline in both the number of
  SE food...
FDA response to measures
         previously enacted
“We believe egg quality assurance programs
  (EQAPs), consumer and re...
SE Risk Assessment


“Estimated that of the 47 billion eggs
  consumed annually as table eggs, 2.3
  million* are SE-posit...
Final Rule
1. Persons who produce shell eggs from a
   farm operating with 3,000 or more laying
   hens, unless that farm ...
Final Rule
2. Shell egg producers need only comply
   with refrigeration and registration
   requirements if all of their ...
Definition in Final Rule
• Treatment
  – A technology or process that achieves at least
    a 5-log destruction of SE for ...
Final Rule
3. Persons who transport or hold shell eggs
   for shell egg processing or egg products
   facilities are requi...
Final Rule
4. Shell egg producers are required to use
   the following SE prevention measures:
     Have and implement a w...
Changes in Final Rule as
   Opposed to Proposed Rule


• Shell egg producers must document that
  pullets were SE-monitore...
Changes in the Final Rule as
    Opposed to Proposed Rule
• “SE monitored” has been defined to mean that pullets are
  rai...
FDA Comments
• Environmental testing is required of pullets at 14 to
  16 weeks of age and cleaning and disinfection of
  ...
Final Rule
 Use a biosecurity program, meaning a
program that includes
  limiting visitors on the farm and in poultry hous...
Changes in the Final Rule as
   Opposed to Proposed Rule
• The requirements for protective clothing
  and sanitizing stati...
Final Rule Definition

• Poultry House
  – For structures comprising more than one
    section containing poultry, each se...
Future Plans

• FDA plans to make further specific
  recommendations for biosecurity steps
  and options for achieving the...
Final Rule
 Use a program to control rodents, flies
and other pests that includes monitoring
for pest activity and removin...
FDA Comments
• FDA intends to publish guidance on the
  requirement to monitor flies and on the
  level of fly activity co...
Final Rule
 Clean and disinfect poultry houses before
new laying hens are added if an
environmental or egg test was positi...
Future Plans

• FDA plans to publish guidance on
  acceptable manure removal subsequent to
  this final rule.
Final Rule
 Shell eggs being held or transported are
required to be refrigerated at or below
45°F ambient temperature begi...
Changes in Final Rule as
   Opposed to Proposed Rule

• Egg processors are now permitted to
  equilibrate refrigerated egg...
Final Rule
 Shell egg producers must conduct
environmental testing for SE when laying
hens are 40 to 45 weeks of age and 4...
Changes in Final Rules as
    Opposed to Proposed Rule
• The required time period to perform environmental
  testing after...
Final Rule

Shell egg producers must conduct egg
testing for SE when an environmental test
is positive for SE.




       ...
Changes in Final Rules as
     Opposed to Proposed Rule
• The requirement to begin egg testing within 24 hours after
  not...
Egg Sampling
• The rule requires that egg producers
  collect and deliver for testing a minimum of
  1,000 intact eggs rep...
Diversion Requirement
• Under the rule, diversion is required under
  the following 3 scenarios:
  1. When the environment...
Changes in Final Rule as
   Opposed to Proposed Rule
• Diverted eggs must have labeling on the
  shipping container, and a...
Diverted Eggs
• Diverted eggs may be
  – Sent to a breaker
  – In-shell pasteurized
  – Hard cooked
  – Any alternative pr...
Records
• The final rule requires that each facility
  establish and maintain records of plan
  activities, including egg ...
Final Rule
 Administration of the SE prevention
measures requires having one or more
supervisory personnel, who do not hav...
Changes in Final Rule as
    Opposed to Proposed Rule
• The requirement that one onsite supervisor at each
  farm be respo...
Final Rule
 Shell egg producers must maintain a
written SE prevention plan and records
documenting compliance with the
req...
Record Keeping Requirements
• The following records documenting SE
  prevention measures must be kept:
   1.   Written SE ...
Final Rule
 Shell egg producers must retain records
for 1 year after the flock to which they
pertain has been taken perman...
Final Rule


 Shell egg producers must register with
FDA.



                                 21 CFR 118.11
Compliance Dates
• The compliance dates:
  – Producers with 50,000 or more laying hens is
    July 9, 2010.
  – Producers ...
Enforcement
• FDA intends to conduct inspections of egg farms to ensure
  that shell eggs are being produced under control...
FDA Comments within Rule
• FDA supports voluntary vaccination of layers as
  an addition SE prevention measure.
• FDA did ...
Public Hearings on Egg Final Rule
• FDA will held two public meetings to explain the
  requirements of the final rule for ...
Pat Curtis
Interim Director
National Egg Processing Center
Pat_Curtis@auburn.edu

http://www.ag.auburn.edu/nepc
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Dr. Pat Curtis - FDA's Salmonella Enteritidis Rule for Laying Chickens

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FDA's Salmonella Enteritidis Rule for Laying Chickens - Dr. Pat Curtis, Auburn University, from NIAA's One Health: Implications for Animal Agriculture, March 15 - 17, 2010, Kansas City, MO, USA.

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Dr. Pat Curtis - FDA's Salmonella Enteritidis Rule for Laying Chickens

  1. 1. Implications of the Egg Safety Final Rule for Prevention of SE in Shell Eggs Patricia A. Curtis, Ph.D. Interim Director National Egg Processing Center Auburn University
  2. 2. Final Rule • Requires: – preventive measures during the production of eggs in poultry houses – subsequent refrigeration during storage and transportation – producers to maintain records related to compliance – registration with FDA
  3. 3. Who must comply? • Requires that measures designed to prevent Salmonella Enteritidis be adopted by virtually all egg producers • Exemptions: – Producers with less than 3,000 laying hens – Shell eggs that are processed with a treatment, such as pasteurization, to ensure their safety – Eggs to be broken and made into egg products
  4. 4. Expected benefits of final rule… • Expected to prevent each year approximately 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella Enteritidis
  5. 5. Salmonellosis • CDC estimates that there are 38 cases of salmonellosis for every reported culture- confirmed case – Not all ill individuals seek medical care – Doctors don’t always establish cause of illness – No all illnesses are reported
  6. 6. Salmonellosis • Since 1995, Salmonella enterica serotype Enteritidis (SE) has been the second most frequently reported cause of Salmonella infection. • In 2008, SE was the leading reported cause of Salmonella infections accounting for 20.1% fall the Salmonella isolates that were serotyped.
  7. 7. Why SE? Why Eggs? • Healthy People 2010 goal of a 50% reduction from the 1997 baseline in both the number of SE foodborne outbreaks and the rate of isolation in the population of foodborne Salmonella infections. • Shell eggs are the predominant source of SE- related cases of salmonellosis in the US where a food vehicle is identified.
  8. 8. FDA response to measures previously enacted “We believe egg quality assurance programs (EQAPs), consumer and retailer education, and Federal Regulations requiring egg refrigeration have contributed to the decrease in SE illnesses since the mid-1990s, but that further reductions in SE illnesses and foodborne salmonellosis cannot be accomplished without additional Federal measures to address SE contamination of shell eggs.”
  9. 9. SE Risk Assessment “Estimated that of the 47 billion eggs consumed annually as table eggs, 2.3 million* are SE-positive, exposing a large number of people to the risk of illness.” (*This figure was based on data compiled from 1991 to 1995.)
  10. 10. Final Rule 1. Persons who produce shell eggs from a farm operating with 3,000 or more laying hens, unless that farm sells all of its eggs directly to consumers or does not produce shell eggs for the table market, are subject to this final rule. 21 CFR 118.1(a)
  11. 11. Final Rule 2. Shell egg producers need only comply with refrigeration and registration requirements if all of their shell eggs from a particular farm receive a treatment as defined in the final rule. 21 CFR 118.1(a)(2)
  12. 12. Definition in Final Rule • Treatment – 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 FSIS intends to issue proposed rules in the near future for egg products plants and egg handlers, including egg handlers who operate in-shell pasteurization treatments.
  13. 13. Final Rule 3. Persons who transport or hold shell eggs for shell egg processing or egg products facilities are required to comply with the refrigeration requirements of this final rule. 21 CFR 118.1(b)
  14. 14. Final Rule 4. Shell egg producers are required to use the following SE prevention measures: Have and implement a written SE prevention plan that includes all mandatory SE prevention measures (21 CFR 118.4) Procure pullets that are SE-monitored, or raise pullets under SE-monitored conditions (21 CFR 118.4(a)
  15. 15. Changes in Final Rule as Opposed to Proposed Rule • Shell egg producers must document that pullets were SE-monitored or raised under SE-monitored conditions.
  16. 16. Changes in the Final Rule as Opposed to Proposed Rule • “SE monitored” has been defined to mean that pullets are raised under SE control conditions that prevent SE including the following: 1. Procurement of chicks from SE monitored breeder flocks that meet NPIP’s standards for “US S. Enteritidis Clean” status (9 CFR 145.23(d) or equivalent standard 2. Environmental testing 3. Cleaning and disinfection of the environment as needed based upon the results of the environmental testing.
  17. 17. FDA Comments • Environmental testing is required of pullets at 14 to 16 weeks of age and cleaning and disinfection of the pullet environment is required if the environment tests positive. • If the environmental test is positive for SE, producers must begin egg testing within 2 weeks of the start of egg laying. • FDA does not require testing of birds used to backfill.
  18. 18. Final Rule Use a biosecurity program, meaning a program that includes limiting visitors on the farm and in poultry houses Maintaining personnel and equipment practices that will protect against cross-contamination from one poultry house to another Preventing stray poultry, wild birds, cats, and other animals from entering poultry houses Prohibiting employees from keeping birds at home 21 CFR 118.4(b)
  19. 19. Changes in the Final Rule as Opposed to Proposed Rule • The requirements for protective clothing and sanitizing stations have been removed from biosecurity program requirements. • The requirement for “wet clean the positive poultry house” has been removed.
  20. 20. Final Rule Definition • Poultry House – For structures comprising more than one section containing poultry, each section that is separated from other sections is considered a separate house.
  21. 21. Future Plans • FDA plans to make further specific recommendations for biosecurity steps and options for achieving these steps, based on current science and best practices, in a guidance that they plan to issue subsequent to this final rule. Page 33038 Federal Register in Final Rule
  22. 22. Final Rule Use a program to control rodents, flies and other pests that includes monitoring for pest activity and removing debris and vegetation that may provide harborage for pests. 21 CFR 118.4(c)
  23. 23. FDA Comments • FDA intends to publish guidance on the requirement to monitor flies and on the level of fly activity considered acceptable. – This rule establishes minimum national standards based on measures that have been shown to prevent SE. – The literature suggests that 50 or fewer hits on a spot card or sticky trap per week or a count of less than 20 on a Scudder grill indicate satisfactory fly control.
  24. 24. Final Rule Clean and disinfect poultry houses before new laying hens are added if an environmental or egg test was positive for SE during the life of the flock Cleaning and disinfecting must include removing all visible manure, dry cleaning to remove dust, feathers and old feed and disinfecting 21 CFR 118.4(d)
  25. 25. Future Plans • FDA plans to publish guidance on acceptable manure removal subsequent to this final rule.
  26. 26. Final Rule Shell eggs being held or transported are required to be refrigerated at or below 45°F ambient temperature beginning 36 hours after time of lay. 21 CFR 118.4(e)
  27. 27. Changes in Final Rule as Opposed to Proposed Rule • Egg processors are now permitted to equilibrate refrigerated eggs to room temperature just prior to processing. – Specifically, shell eggs that have been refrigerated may be held at room temperature for no more than 36 hours just prior to processing to temper them.
  28. 28. Final Rule Shell egg producers must conduct environmental testing for SE when laying hens are 40 to 45 weeks of age and 4 to 6 weeks after molt. (21 CFR 118.5)
  29. 29. Changes in Final Rules as Opposed to Proposed Rule • The required time period to perform environmental testing after a molt has been changed from 20 weeks to 4 to 6 weeks after molt. • Specific sampling instructions have been incorporated into the environmental testing method, “Environmental Sampling and Detection of Salmonella in Poultry Houses.” – http://www.fda.gov/Food/ScienceResearch/Lab oratoryMethods/ucm114716.htm
  30. 30. Final Rule Shell egg producers must conduct egg testing for SE when an environmental test is positive for SE. 21 CFR 118.6
  31. 31. Changes in Final Rules as Opposed to Proposed Rule • The requirement to begin egg testing within 24 hours after notification of a positive environmental test has been changed to require that results of egg testing be obtained within 10 calendar days after receiving notification of the positive environmental sample. • Eggs from a flock in a house that has tested environmentally positive for SE may continue to be marketed as table eggs until the producer is notified that an egg test is determined positive for SE. At that point, the producer must divert those eggs to treatment.
  32. 32. Egg Sampling • The rule requires that egg producers collect and deliver for testing a minimum of 1,000 intact eggs representative of a day’s production four times at 2-week intervals, resulting in a total test of 4,000 eggs over an 8-week period.
  33. 33. Diversion Requirement • Under the rule, diversion is required under the following 3 scenarios: 1. When the environment tests positive for SE, and the producer chooses not to test eggs from that house to determine whether eggs are also positive, 2. When the eggs in a house test positive for SE; and 3. By order of an FDA, State or local representative after a finding that shell eggs have been produced or held in violation of this regulation.
  34. 34. Changes in Final Rule as Opposed to Proposed Rule • Diverted eggs must have labeling on the shipping container, and all documents accompanying the shipment must state “Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act.” 21 CFR 118.6(f)
  35. 35. Diverted Eggs • Diverted eggs may be – Sent to a breaker – In-shell pasteurized – Hard cooked – Any alternative process that achieves at least a 5-log reduction in SE
  36. 36. Records • The final rule requires that each facility establish and maintain records of plan activities, including egg sampling. • FDA will review these records to determine whether sampling was preformed appropriately.
  37. 37. Final Rule Administration of the SE prevention measures requires having one or more supervisory personnel, who do not have to be onsite employees, who are responsible for ensuring compliance with each farm’s SE prevention plan. 21 CFR 118.9
  38. 38. Changes in Final Rule as Opposed to Proposed Rule • The requirement that one onsite supervisor at each farm be responsible for administration of the SE prevention measures has been changed to allow for more than one supervisor and for offsite supervisors to be responsible. • The rule requires this individual be trained. – FDA plans to work with trade associations, State regulatory officials, and academia/extension officials to develop and offer training opportunities at venues that should satisfy the needs of small, medium and large size facilities. The rule provides that equivalent job experience can be substituted for training.
  39. 39. Final Rule Shell egg producers must maintain a written SE prevention plan and records documenting compliance with the requirements of the plan. The written plan must set forth a producer’s plan to implement the regulation’s prevention, testing, and diversion measures.
  40. 40. Record Keeping Requirements • The following records documenting SE prevention measures must be kept: 1. Written SE prevention plan 2. Documentation that pullets were “SE monitored’ or were raised under “SE monitored” conditions, including environmental testing records for pullets 3. Records documenting compliance with the SE prevention measures 4. Records of review and of modification of the SE prevention plan and corrective actions taken • FDA plans to issue guidance regarding the record keeping requirement.
  41. 41. Final Rule Shell egg producers must retain records for 1 year after the flock to which they pertain has been taken permanently out of production. (21 CFR 118.10(c)) Shell egg producers must make records available within 24 hours from the time of receipt of the official request. (21 CFR 118.10(d))
  42. 42. Final Rule Shell egg producers must register with FDA. 21 CFR 118.11
  43. 43. Compliance Dates • The compliance dates: – Producers with 50,000 or more laying hens is July 9, 2010. – Producers with fewer than 50,000 but at least 3,000 laying hens is July 9, 2012. – Persons who must comply only with refrigeration requirements is July 9, 2010.
  44. 44. Enforcement • FDA intends to conduct inspections of egg farms to ensure that shell eggs are being produced under controls that will prevent SE contamination and reduce the likelihood that SE – contaminated eggs will cause foodborne illness. • A State or locality may, in its own jurisdiction, enforce this rule by carrying out inspections under 21 CFR 118.12(b) and by using the administrative remedies in 21 CFR 118.12(a) unless FDA notifies them in writing that its assistance is no longer needed. • FDA plans to provide guidance to States and localities through an enforcement and implementation guidance subsequent to the final rule.
  45. 45. FDA Comments within Rule • FDA supports voluntary vaccination of layers as an addition SE prevention measure. • FDA did not have adequate evidence to support including a prohibition on induced molting. • FDA intends to provide guidance on record keeping and other provisions of the rule, including small entity compliance guidance.
  46. 46. Public Hearings on Egg Final Rule • FDA will held two public meetings to explain the requirements of the final rule for prevention of Salmonella Enteritidis in shell eggs during production, storage and transportation. – September 30, 2009 • 1-5 p.m. at the Hyatt Regency Chicago, 151 East Wacker Drive, Chicago, Ill., 60601. – November 5 , 2009 • 1-5 p.m. at the Westin Peachtree Plaza Hotel, 210 Peachtree Street, N.W., Atlanta, Ga., 30303.
  47. 47. Pat Curtis Interim Director National Egg Processing Center Pat_Curtis@auburn.edu http://www.ag.auburn.edu/nepc
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