An estimated 118,000 illnesses per year
are caused by consumption of SE-contaminated eggs. If an individual
eats an SE-contaminated egg that is not fully cooked, the individual
may suffer mild to severe gastrointestinal illness, short term or
chronic arthritis, or death.
"The implementation of the
provisions of this rule would reduce the number of SE-related
illnesses by 33,500 and is a major step in realizing our public
health goal of a 50 percent reduction in all salmonellosis and a 50
percent reduction in SE outbreaks by 2010," said Dr. Lester M.
Crawford, acting commissioner. The proposal "builds upon the safe
consumer handling labeling and egg refrigeration and retail rule of
2000," he said.
The proposed regulation would
require implementation of SE prevention measures for all egg
producers that have 3,000 or more laying hens, produce shell eggs
for retail sale, and do not process their eggs with a treatment,
such as pasteurization, to ensure their safety. The proposed rule's
SE prevention measures include:
- Provisions for procurement of
chicks and pullets.
- A biosecurity program.
- A pest and rodent control
- Cleaning and disinfection of
poultry houses that have had an environmental sample or egg test
positive for SE.
- Refrigerated storage of eggs at
- Producer testing of the
environment for SE in poultry houses. If the environmental test is
positive, FDA proposes that egg testing for SE be undertaken and,
if the test is positive, that the eggs be diverted from the table
- Identification of a person
responsible for SE prevention at each farm
Through these proposed measures, FDA
believes SE prevalence will be reduced in the poultry house
environment and consequently in the eggs themselves. Most SE
contamination of eggs is a result of SE infection in the laying
hen's reproductive tract, known as transovarian contamination. The
proposed prevention measures are designed to reduce the likelihood
of transovarian contamination.
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To fully implement this proposed
rule will cost an estimated $82 million annually for the more than
4,100 farms that have 3,000 or more hens. The actual cost will vary
with the number of poultry houses and layers under production and
will range from a low of 19 cents per layer to $1 per layer per
While the proposal focuses primarily
on the farm, FDA is aware of illnesses and outbreaks associated with
serving undercooked eggs at retail establishments. Therefore, FDA is
soliciting comment on whether to propose potential retail
establishment requirements to address that concern.
The proposed rule is part of a joint
and coordinated strategy by FDA and the Food Safety Inspection
Service of the U.S. Department of Agriculture to more effectively
deal with egg safety for both shell eggs and egg products. The
agencies will continue to work closely together to ensure that egg
safety measures are consistent, coordinated and complementary.
A comment period of 90 days will be
provided on the proposal. Written comments can be submitted to FDA
at: Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
It is important to include docket numbers 1996P-0418, 1997P-0197,
1998P-0203 and 2000N-0504 and RIN Number 0910-AC14.
and Drug Administration