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.

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Future Plans
• FDA plans to publish guidance on
acceptable manure removal subsequent to
this final rule.

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. 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. 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. 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. Final Rule
Shell egg producers must conduct egg
testing for SE when an environmental test
is positive for SE.
21 CFR 118.6

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Final Rule
Shell egg producers must register with
FDA.
21 CFR 118.11

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. 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. 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. 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. Pat Curtis
Interim Director
National Egg Processing Center
Pat_Curtis@auburn.edu
http://www.ag.auburn.edu/nepc