Implications of the Egg Safety Final Rule for

Prevention of SE in Shell Eggs

Patricia A. Curtis, Ph.D.Interim Director

National Egg Processing CenterAuburn University

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

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

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 SalmonellaEnteritidis

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

Salmonellosis

• Since 1995, Salmonella enterica serotype Enteritidis (SE) has been the second most frequently reported cause of Salmonellainfection.

• In 2008, SE was the leading reported cause of Salmonellainfections accounting for 20.1% fall the Salmonellaisolates that were serotyped.

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.

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.”

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.)

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)

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)

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.

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)

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)

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.

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 testing3. Cleaning and disinfection of the environment as needed

based upon the results of the environmental testing.

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.

Final Rule

Use a biosecurity program, meaning a program that includes

limiting visitors on the farm and in poultry housesMaintaining personnel and equipment practices that will protect against cross-contamination from one poultry house to anotherPreventing stray poultry, wild birds, cats, and other animals from entering poultry housesProhibiting employees from keeping birds at home

21 CFR 118.4(b)

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.

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.

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

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)

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.

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)

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 beginning 36 hours after time of lay.

21 CFR 118.4(e)

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.

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)

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

Final Rule

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

21 CFR 118.6

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.

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.

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; and3. 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.

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)

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

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.

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

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.

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.

21 CFR 118.10

Record Keeping Requirements• The following records documenting SE

prevention measures must be kept:1. Written SE prevention plan2. 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.

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))

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 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.

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.

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.

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.

Pat CurtisInterim DirectorNational Egg Processing CenterPat_Curtis@auburn.edu

http://www.ag.auburn.edu/nepc