[Federal Register Volume 63, Number 96 (Tuesday, May 19, 1998)]
[Proposed Rules]
[Pages 27502-27511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13056]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 63, No. 96 / Tuesday, May 19, 1998 / Proposed
Rules
[[Page 27502]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
7 CFR Part 59
[Docket No. 96-035A]
RIN 0583-AB
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 100
[Docket No. 97N-0322]
RIN 0583-AC52
Salmonella Enteritidis in Eggs
AGENCIES: Food Safety and Inspection Service, USDA; Food and Drug
Administration, HHS.
ACTION: Advance notice of proposed rulemaking; request for comments.
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SUMMARY: Eggs contaminated with Salmonella Enteritidis (SE) are
associated with significant numbers of human illnesses and continue to
be a public health concern. SE infected flocks have become prevalent
throughout the country, and large numbers of illnesses have been
attributed to consumption of mishandled SE-contaminated eggs. As a
result, there have been requests for Federal action to improve egg
safety. The Food Safety and Inspection Service (FSIS) and the Food and
Drug Administration (FDA) share Federal regulatory responsibility for
egg safety. However, regulation of shell eggs is primarily the
responsibility of FDA. Through joint issuance of this notice, FSIS and
FDA are seeking to identify farm-to-table actions that will decrease
the food safety risks associated with shell eggs. The agencies want to
explore all reasonable alternatives and gather data on the public
benefits and the public costs of various regulatory approaches before
proposing a farm-to-table food safety system for shell eggs. Interested
persons are requested to comment on the alternatives discussed in this
advance notice of proposed rulemaking (ANPR), suggest other possible
approaches, and provide information that will help the agencies weigh
the merits of all alternatives. In addition to the actions contemplated
in this ANPR, both agencies are planning to take actions that address
adoption of refrigeration and labeling requirements that are designed
to reduce the risk of foodborne illness.
DATES: Comments must be received on or before August 17, 1998.
ADDRESSES: Send an original and two copies of comments to: FSIS Docket
Clerk, Docket No. 96-035A, Room 102 Cotton Annex Building, 300 12th St,
SW., Washington, DC 20250-3700. Reference material cited in this
document and any comments received will be available for public
inspection in the FSIS Docket Room from 8:30 a.m. to 1:00 p.m. and 2:00
p.m. to 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Mr. Ralph Stafko, Food Safety and
Inspection Service, USDA, Washington, DC, 20250, (202) 720-7774, or Dr.
Marilyn Balmer, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, HHS, Washington, DC 20204, (202) 205-4400.
SUPPLEMENTARY INFORMATION:
Table of Contents
Background
1. Egg production and marketing.
2. Salmonella and the salmonellosis epidemic.
3. Salmonella in eggs; the risk.
--Contamination through the shell; current cleaning practices
--Transovarian contamination of eggs with SE
4. Mitigating the risk; current efforts.
--Production: preventing introduction of SE into laying flocks
and from hens to eggs.
--Processing and distribution: preventing growth of SE in eggs.
--Rewashing/repackaging: preventing growth of SE in eggs.
--Preparation and consumption: preventing ingestion of SE from
eggs.
5. Current regulation of shell eggs.
6. Need for additional information and analysis.
Information Requested
Background
This section provides information on the egg industry, data that
associate eggs with an epidemic of cases of human salmonellosis caused
by Salmonella Enteritidis, and past efforts and current plans to
alleviate this public health problem.
1. Egg Production and Marketing
Eggs are a nutrient-dense food that play an important part in most
Americans' diets, either alone or as a constituent of another food. On
a per capita basis, Americans consume about 234 eggs a year. The
National Agriculture Statistics Service (NASS) of the Department of
Agriculture (USDA) estimates the total value of the table eggs (eggs
produced for human consumption, not hatching) produced in the U.S. in
1995 at $3.96 billion.
The egg industry is fairly stable in terms of overall production.
U.S. production has increased only slightly in absolute terms in recent
years, from about 60 billion eggs in 1984 to about 63 billion in 1995.
About 70 percent are sold as whole ``shell'' eggs. The remaining 30
percent are processed into liquid, frozen or dried pasteurized egg
products, the majority of which are destined for institutional use or
further processing into other foods such as cake mixes, pasta, ice
cream, mayonnaise, and bakery goods.
International trade is a small but growing part of the U.S. egg
market. The U.S. does not import a significant quantity of shell eggs
and imports only 0.2 percent of processed egg products. Exports now
amount to more than 2 percent of the total U.S. production. In 1996,
exports of eggs and egg products reached a market value of nearly $20
million.
There are essentially three kinds of flocks associated with egg
production: breeder flocks, multiplier flocks, and laying flocks
(including both immature pullets and mature laying hens). There are
roughly 300,000 breeding hens (grandparents), 3 million multipliers
(parents), and 300 million laying hens. NASS estimates the value of the
laying flocks alone to be close to $1 billion.
Geographically, commercial egg production in the western United
States is concentrated in California, and in the east it is centered in
Ohio, Indiana, and Pennsylvania. According to NASS, which surveys the
number of egg laying flocks of 30,000 or more hens, California and Ohio
each have about 25 million layers, and Indiana and Pennsylvania each
have about 20 million. Other states in which major producers are
located
[[Page 27503]]
include Iowa, Texas, Minnesota, and Georgia. Twenty-one other states
are reported as having fewer than 10 million, but more than 2 million,
layers in production.
Egg production is being concentrated in fewer, larger firms.
Federal Regulations require commercial flocks of more than 3,000 hens
to be registered with USDA. USDA's Agricultural Marketing Service (AMS)
currently has 757 such egg producers registered. The United Egg
Producers (UEP), a cooperative that provides a variety of services to
member egg producers, reports that the number of major producers (those
with flocks of 75,000 or more, which produce about 94 percent of
America's table eggs) declined in just 3 years from 380 producers in
1994 to 329 producers in 1996.
Modern egg production facilities are increasingly large, ``in-
line'' facilities. They integrate laying, packing, and even processing
of egg products at one location. Freshly laid eggs go directly into a
processing system where they are cleaned, sorted, and packed for
distribution.
A significant portion of production, however, is still ``off-
line.'' Off-line operations are those that are not integrated with
laying facilities, but rather have eggs shipped from laying facilities
at other locations. The fresh eggs are collected and shipped from the
laying facilities periodically, usually once a day but sometimes less
often. These eggs are frequently placed in coolers at the laying
facility before shipment to a facility where they are processed and
packed.
Most packers either own or have contractual relationships with
their suppliers. Their laying hens are bred and cared for to ensure the
largest possible numbers of consistent quality eggs, and are housed
together in large hen houses.
Although shell egg cleaning and packing is configured differently
in different plants, after collection the eggs generally are (1)
washed, (2) rinsed and sanitized, (3) dried, (4) candled, sorted, and
graded, (5) packed in cartons and crates onto shipping pallets, and (6)
placed in a cooler pending shipment. Eggs that are found to be cracked
or otherwise unsuitable for sale as whole shell eggs are by law
``restricted.'' USDA allows a certain percentage of some classes of
restricted eggs to be moved in commerce. If restricted eggs sent to a
federally inspected facility (often referred to as a ``breaker plant'')
are determined acceptable, they are broken, inspected for
wholesomeness, pooled, and then processed into a pasteurized liquid,
frozen, or dried egg product.
After packing, shell eggs usually are loaded into refrigerated
transports for shipment to market. Some producers use their own trucks,
while others contract with trucking firms to deliver eggs to their
customers. Some are delivered directly to retail outlets, and others
are delivered to warehouses and other intermediate distribution points
before going to the retail store or food service facility where they
reach the consumer.
2. Salmonella and the Salmonellosis Epidemic
Salmonella is a gram-negative, motile, rod-shaped bacteria that can
grow under both aerobic and anaerobic conditions. Salmonella has
evolved into a successful human pathogen because of its survival
characteristics and virulence. The organisms are ubiquitous, and are
commonly found in the digestive tracts of animals, especially birds and
reptiles. Human illnesses are usually associated with ingestion of food
or drink contaminated with Salmonella, but infection may also be
acquired from an infected person by the fecal-oral route through poor
personal hygiene, or from pets.
More than 2,300 different serotypes have been identified and are
associated with a variety of animal reservoirs, geographic locations,
and frequencies. However, microbiologists are finding that atypical
biotypes have emerged that are difficult to identify and detect by
conventional means, placing more value on new molecular methods and
other technologies for identifying them.\1\
Epidemiologically, salmonellae can be grouped as follows:
1. Those that infect mainly humans. These include human pathogens
such as S. Typhi and S. Paratyphi (A and C) which cause typhoid
(enteric) and paratyphoid fevers, respectively, the most severe of the
Salmonella diseaseS. S. Typhi may be found in blood, as well as in
stool and urine before enteric fever develops. Typhoid fever has a high
mortality rate; the paratyphoid syndrome is generally milder. These
diseases are spread through food and water contaminated by feces and
urine of patients and carriers.\2\
2. Those that infect mainly animals. These include animal pathogens
such as S. Gallinarum (poultry), S. Dublin (cattle), S. Abortus-ovis
(sheep), and S. Choleraesuis (swine). Some of the organisms in this
group are also human pathogens and can be contracted through foods.
In general, salmonellae are quite resilient and able to adapt to
extremes in environmental conditions. They are resistant to freezing
and drying. They are able to grow within a wide temperature range; from
extremes as low as 2-4 deg.C (36-39 deg.F), and as high as 54 deg.C
(129 deg.F). They have been reported to grow within a pH range of 4.5
to 9.5. Salmonellae do not grow in foods with a water activity of 0.93
or less, and are inhibited by the presence of salt at levels between 3
and 4 percent. Preconditioning to thermal and acid stress has been
shown to allow strains to adapt to greater extremes.\3\ These
properties make many food products more likely to support the growth of
these organisms, such as many refrigerated products, fermented foods,
and cheeses.
The human infectious dose is highly variable, depending largely on
the strain, the food, and the susceptibility of the human host. Recent
evidence suggests that as few as one to ten Salmonella cells can cause
infection in humans. Human diarrheagenic response and enterocolitis
result from the migration of the pathogen from the mouth at ingestion
to the intestinal tract and mesenteric lymph nodes, and the coinciding
production of bacterial enterotoxin. Salmonella also produce a
cytotoxin that inhibits protein synthesis and causes lysis of host
cells, helping the organisms to spread to other tissues.\4\
The Centers for Disease Control and Prevention (CDC), which has
classified salmonellosis as a reportable disease since 1943, has found
it to be one of the most commonly reported bacterial infections of any
kind in the United States. Human salmonellosis is the second most
prevalent foodborne disease in the U.S. after illnesses from
Campylobacter (a generally milder illness associated with raw and
undercooked poultry, raw milk, and untreated water as well as improper
handling and preparation of food). In 1996, 39,027 confirmed cases of
human salmonellosis were reported to CDC by State and local departments
of health. Although this number of cases is below the peak year of
1985, when 57,896 cases were reported, the number of cases is
significant. From 1985 through 1996, there have been 508,673 reported
cases of salmonellosis.\5\
Salmonella usually cause an intestinal infection accompanied by
diarrhea, fever, and abdominal cramps starting 6 to 72 hours after
consuming a contaminated food or drink. The illness is usually 4 to 7
days in duration, and most people recover without antibiotic treatment.
About 2 percent of affected persons may later develop recurring joint
pains and arthritis.\6\ In
[[Page 27504]]
the very young, the elderly, and persons with compromised immune
systems, the infection can spread to the bloodstream, and then to other
areas of the body such as the bone marrow or the meningeal linings of
the brain, leading to a severe and occasionally fatal illness unless
treated promptly with antibiotics.\7\
Because many cases are not reported, these cases may represent only
a small fraction of the actual number of illnesses that occur. Not all
infected persons develop symptoms severe enough that they seek medical
attention, and physicians may not have patients' stool analyzed. It is
estimated that there are an additional 20 to 100 cases of salmonellosis
for every reported case, or some 800,000 to 4 million actual cases each
year in the U.S.\8\
The cost to Americans is considerable. The patient-related costs of
salmonellosis from medical expenses and loss of income were estimated
in 1988 to be about $1,560 per reported case and about $250 for each
unreported case.\9\ By applying the cost per reported case to the
41,222 cases and probable illnesses reported in 1995, the cost of
salmonellosis in 1995 can be estimated to be between $350 million and
$1.5 billion.
CDC's surveillance data on isolates reported by State and
territorial epidemiologists list close to 600 different serotypes that
have caused human illness in the U.S. Based primarily on outbreak data,
where Federal, State, and local epidemiologists have sought to identify
the source of infection, some serotypes are linked to particular food
vehicles. The three illness-causing serotypes most frequently
reported--S.Typhimurium, S. Heidelberg, and S. Enteritidis--are most
often traced to poultry or eggs when a food vehicle is found.
Salmonella Enteritidis emerged in epidemic proportions in the
United States about a decade ago in the northeast. Over the last 20
years, SE-associated illnesses have increased greatly in number. The
proportion of reported Salmonella isolates that were SE increased from
5 percent in 1976 to 26 percent in 1994.\10\ SE was the most frequently
reported Salmonella serotype in 1994, 1995, and 1996.
CDC surveillance data show that the rates of isolation of SE
increased in the U.S. during 1976-1994 from 0.5 to 3.9 per 100,000
population, and that illnesses are occurring throughout the U.S. While
the trends for the years 1990-1994 show a decrease in the SE isolation
rate in the northeast from 8.9 to 7.0 per 100,000 population, the rate
increased approximately threefold for the Pacific region, particularly
for southern California, which had rates as high as 14 per 100,000.\11\
From 1985 through 1996, there have been 660 SE outbreaks reported
to CDC. Associated with these outbreaks, there have been 77 reported
deaths, 2,508 reported hospitalizations, and 25,935 reported cases of
illness. The peak year for outbreaks was 1989 with 77 reported. Deaths
have occurred in all years. In 1995 and 1996, there were 57 and 51
reported outbreaks respectively with 8 deaths in 1995 and 2 deaths in
1996. The majority of the outbreaks occur in the commercial venue with
the implicated food containing undercooked eggs.
There is evidence that this increase in SE infections is global.
World Health Organization data show increases in SE on several
continents, including North America, South America, Europe, and perhaps
Africa.\12\ The trend towards centralized large-scale food processing
with wide distribution means that when contamination occurs, it can
affect large numbers of people over a large area. Although most eggs
are consumed individually, large numbers are sometimes pooled during
the production or preparation of some foods. This increases the
likelihood of SE being in the raw product. This potential was
illustrated by a major 1994 SE outbreak attributed to ice cream. FDA
reported the most likely cause was contamination of the pasteurized ice
cream mix by hauling it in a tanker improperly cleaned after carrying a
load of unpasteurized liquid eggs. The ice cream mix was not heat
treated after receipt from the contaminated tanker, and the ice cream
was distributed widely.\13\
In 1995 surveys, SE phage-type 13A was found to be the predominant
phage-type in egg laying flocks in the United States, followed by
phage-type 8 and, increasingly, phage-type 4. This represents a
significant change since 1991, when phage-type 8 was predominant and
phage-type 4 was undetected in laying flocks.\14\
3. Salmonella in Eggs; the Risk
a. Contamination Through the Shell; Current Egg Cleaning Practices
Eggs have long been valued for their natural protective packaging.
Having evolved to protect the developing embryonic bird inside, the egg
provides an inhospitable environment for Salmonella as well as other
bacterial contaminants. A fresh egg is fairly resistant to invasive
bacteria, a fact relied upon in many countries where shell eggs are not
refrigerated. The egg's defenses are both mechanical and chemical.
Mechanically, there are essentially four layers of protection
preventing bacteria from reaching the nutrient rich yolk: (1) the
shell, (2) the two membranes (inner and outer) between the shell and
the albumen, (3) the albumen (eggwhite), and (4) the vitelline (yolk)
membrane which holds the yolk.
When laid, the egg shell is covered on the outside by the cuticle,
a substance similar in composition to the shell membranes. When the
cuticle dries, it seals the pores and hinders initial bacterial
penetration. However, the cuticle usually is removed along with debris
on the surface of the shell during the cleaning process. Some
processors add a thin coating of edible oil or wax to eggs after they
are washed and dried to close the shell pores in a manner similar to
the cuticle.
The shell, although porous and easily penetrated by bacteria,
protects the outer membrane from physical abuse. The dry and much less
porous outer shell membrane is much more difficult for bacteria to
penetrate. The inner shell membrane and the yolk membrane also present
barriers. Perhaps the most substantial line of defense against bacteria
is provided by the egg albumen.
In fresh eggs, the albumen has a high viscosity, which both anchors
the yolk protectively in the center of the shell and prevents movement
of bacteria toward the yolk. (Eggs are stored with the blunt end up to
help keep the yolk, which has a lower specific gravity, from drifting
toward the inner membrane.) In addition, the albumen has chemical
properties that inhibit bacterial growth.
Originally, the potential for Salmonella to contaminate shell eggs
was primarily a matter of the organisms passing through the shell into
the egg's contents because of, mostly, environmental conditions. With
salmonellae other than SE, this still is the most likely means of
potential contamination of intact shell eggs.\15\
It has long been known that the laying environment can contribute
to egg shell contamination. The surface of the egg can become
contaminated with virtually any microorganism that is excreted by the
birds. Many serotypes of Salmonella as well as other bacteria have been
isolated from laying flocks. Contact with feces, nesting material,
dust, feedstuffs, shipping and storage containers, human beings, and
other creatures all contribute to the likelihood of shell
contamination. Penetration into the egg contents by both salmonella and
spoilage bacteria increases with duration of contact with contaminated
material, especially during storage at
[[Page 27505]]
high temperatures and high relative humidities. Therefore, eggs should
be collected as frequently as possible, and kept as clean and cool as
possible (short of freezing, which can damage the shell).
Other sources of shell contamination are always present in the
production environment. Producers should clean and sanitize equipment
and facilities as necessary to prevent egg contamination, and not rely
simply on egg washing to remove contaminants after the fact. One recent
study found high levels of Salmonella isolates from egg belts, egg
collectors, and ventilation fans (64-100 percent of samples on
different farms) as compared to isolates from egg shells before
collection (8 percent overall).
Cleaning the exteriors of shell eggs to remove fecal material and
other debris reduces the risk that pathogenic bacteria will have an
opportunity to penetrate the egg shell. The cleaning process provides
consumers with clean egg surfaces not likely to promote contamination
of the egg by penetration of bacteria through the intact shell or by
cross contamination upon cracking open the egg for use.
Most modern egg washing machines are spray-washers. The typical
continuous egg washer consists of three stages: a wash chamber where
the eggs are washed with warm water and detergent using moving brushes
or high pressure jets, a rinse chamber which usually includes a
sanitizing agent, and a drying chamber.
If not done properly, washing can contribute to microbial
contamination of the egg's contents and may contribute to increased
spoilage rates. Organisms have the potential to concentrate in the
recirculating wash water, and the liquid can be aspirated into the egg
through the shell under certain conditions. In particular, when wash
water outside the egg shell is colder than the eggs' contents, as the
eggs' contents cool it creates low pressure on the inside of the egg
shell that draws liquid outside the shell into the egg through the
shell's pores. This observation led to the USDA egg grading requirement
that wash water be at least 20 deg. F warmer than the eggs being
washed. Typically, U.S. processors use a hot wash water (110-120 deg.
F) to ensure temperatures hostile to most organisms that may collect in
the wash water as well as to ensure that the 20 deg. F egg-wash water
temperature difference is maintained even when cleaning quite warm
eggs, which are common in in-line facilities. However, the use of hot
water damages or removes the cuticle, which if left intact, helps
prevent bacterial contamination.
After washing, the eggs should be quickly and completely dried to
reduce the risk that any bacteria remaining on the surface of the eggs
are aspirated into the eggs as they cool to ambient temperature. They
must be handled carefully thereafter to avoid recontamination.
b. Transovarian Contamination of Egg Contents With SE
The increase in SE outbreaks associated with shell eggs in the
1970's and 1980's raised suspicions of transovarian contamination.\16\
This mode of contamination was confirmed by an experiment in which
laying hens were infected with SE and found to produce eggs
contaminated with the same strain of SE.\17\ The site of infection is
usually the albumen near the yolk membrane.
Based on USDA data, it can be estimated that such transovarian SE
contamination occurs in about 1 out of every 10,000 eggs produced in
the U.S. This prevalence is based on a model applying data on the
frequency of SE positive eggs from infected flocks to an estimation of
the number of infected flocks in the U.S. The frequency of infected
eggs in an infected flock can be determined from USDA tests of eggs
produced by SE-positive flocks. The number of positive flocks is based
on USDA's nationwide survey in 1995 of SE in spent hens at slaughter
and unpasteurized liquid eggs at breaker plants. Application of the
model resulted in a distribution of prevalences ranging from 0.2 to 2.1
positive eggs per 10,000 with a mean of 0.9 positive eggs per
10,000.\18\ The problem is nationwide, although there are some regional
differences.\19\
Although a prevalence of 1 in 10,000 seems low, it is significant
in terms of exposure. That frequency amounts to about 4.5 million SE-
contaminated eggs annually in the U.S., exposing a large number of
people to SE.
Salmonellosis outbreaks commonly occur when mishandling permits the
SE organisms to multiply and inadequate cooking or mishandling during
preparation or service results in live pathogens being ingested with
the food. However, the dose required to make a person ill may vary with
the individual. The biggest factor in determining whether illness
occurs, and how severe it may be, appears to be the age and health of
the person ingesting the organisms.
4. Mitigating the Risk; Current Efforts
Mitigation of risks associated with SE in eggs requires analysis of
everything in the food production-distribution-consumption continuum
from the farm to table that might affect the likelihood that consumers
will become ill from SE in eggs.
a. Production: Preventing Introduction of SE Into Laying Flocks and
From Hens to Eggs
The Federal government has devoted significant efforts to
investigating and controlling SE in laying hens. Between 1990 and 1995,
USDA's Animal Plant Health Inspection Service (APHIS) conducted an SE
control program (9 CFR Parts 71 and 82; 56 FR 3730; January 30, 1991).
Under that program, APHIS restricted the movement of eggs from flocks
that tested positive for SE. In cooperation with FDA, CDC, and State
authorities, eggs implicated in SE outbreaks were traced back to their
farms of origin. If initial tests of manure and egg transport machinery
indicated the presence of SE, the flock became a ``test flock.'' Blood
and internal organ testing was done on the test flocks, and if any were
found positive, the flock was designated ``infected.'' The eggs from
test and infected flocks could not be sold as table eggs but could be
sent to processors for pasteurization, hard boiling, or export. A
flock's status as a ``test'' or ``infected'' flock was not lifted until
extensive testing, including additional tests of internal organs of
birds, detected no SE. Establishments had to clean and disinfect the
hen houses before installing replacement flocks.
In 1995, shortly after transfer of the program from APHIS to FSIS,
funding for the entire program was removed from the USDA's 1996
appropriations. FDA, which had worked closely with APHIS on its
tracebacks, assumed responsibility for all aspects of investigating
outbreaks, tracing back egg-associated SE illnesses to particular
producers/flocks, diverting eggs, collecting flock data to help track
the spread of SE, encouraging better quality control measures by
producers, and adoption by States of egg quality assurance programs.
State and county health departments usually perform the epidemiological
investigations of outbreaks.
The APHIS-sponsored National Poultry Improvement Plan (NPIP), a
cooperative Federal-State program, provides assistance to breeders and
hatchers on keeping birds free of egg-transmitted diseases. In 1989, an
SE control program was developed to reduce the prevalence of SE
organisms in hatching eggs and chicks. Participants in the program
follow sanitation and other control procedures at breeder farms and
hatcheries. Forty-
[[Page 27506]]
six SE-positive isolates have been found since its inception, with a
decline evident in recent years. Only two were found in 1995, and one
in 1996.\20\
A third APHIS program resulted in a variety of voluntary flock
control programs that appear to have had some effect in reducing the
numbers of infected flocks. In 1992, in the wake of APHIS tracebacks
implicating flocks in Pennsylvania, APHIS cooperated with industry
representatives, State government officials, and academic experts to
develop a program to reduce the prevalence of SE in laying hens. In the
Salmonella Enteritidis Pilot Program (SEPP), flock owners purchased
chicks from hatcheries participating in the NPIP program, imposed
strict rodent control measures, cleaned and disinfected hen houses
between flocks, controlled feed, and implemented other biosecurity
measures. The program relied on APHIS testing of environmental samples
to determine positive flocks, and egg testing by commercial
laboratories when environmental samples were positive.
In recent years, several other voluntary programs for controlling
SE in shell eggs have been developed. California's Egg Quality
Assurance Plan calls for producers and processors to apply current good
manufacturing practices and to implement risk reduction measures for
all hazards throughout the production and processing environments. The
New England Risk Reduction Program for SE in eggs is being adopted by
producers in Maine and other northeast States. United Egg Producers has
developed a ``Five Star'' program for its members, which requires
participants to ensure (1) poultry house cleaning and disinfecting, (2)
rodent and pest elimination, (3) proper egg washing, (4) biosecurity
measures, and (5) egg refrigeration during transport and storage. UEP
has recently added testing provisions for verification. The U. S.
Animal Health Association, a professional association of veterinarians,
developed ``Recommended Best Management Practices for a SE Reduction
Program for Egg Producers,'' guidelines intended for use by producers
without a State or industry program. Other States are working on egg
quality programs, and an increasing proportion of producers seem to be
adopting SE-control programs.
Much remains unknown about how SE infects flocks, and how the
organism contaminates eggs. USDA scientists believe that among birds in
an SE-infected flock, only a small number are shedding SE organisms at
any given time, and that an infected bird might easily lay many normal,
uncontaminated eggs, only occasionally laying an egg contaminated with
SE. There is speculation that the likelihood of infection or the laying
of contaminated eggs also may be related to factors other than
environmental conditions, such as the genetics of the birds, the age of
the birds, the site of infection in the hen, and whether the birds have
been stressed (e.g., because of molting).\21\ At this time, it may not
be possible to design an SE control program that will remove all
possibility of egg-laying chickens producing SE contaminated eggs. The
agencies seek comments on this issue.
b. Processing and Distribution: Preventing Growth of SE in Eggs
In addition to the presence of SE in shell eggs, many other factors
may influence the number and severity of salmonellosis cases. Key
factors are pathogenicity and virulence of the organism, the dose
level, and the numbers and susceptibility of the people exposed. In
general, the greater the dose, the greater the chance that the person
ingesting it will become ill.
The likelihood of SE multiplying depends primarily on the variables
of time and temperature, although other factors such as the site of the
egg contamination and the presence in the albumen of free iron also
appear to play a role.\22\ The site of contamination normally is the
albumen. Over time, beginning after the egg is laid, the albumen
proteins break down, ultimately rendering the albumen watery and less
viscous and reducing the mechanical as well as the chemical defenses
against bacterial motility and growth. At the same time, the yolk
membrane degrades and becomes more porous. This degradation of the
albumen and yolk membrane permits bacteria to reach the nutrient-rich
yolk and multiply. The rate at which this degradation takes place
relates to the temperature of the egg, with degradation delayed at cold
temperatures and occurring more rapidly at warm temperatures.\23\
Studies of the growth of SE adjacent to the yolk indicate that
there are three distinct phases in the growth curve of SE in eggs. The
first phase takes place in the first 24 hours after lay, when the pH of
the albumen rises from about 7 to about 9 and, it is suggested, the
bacterium have enough iron reserves of their own to support about four
generations. Studies suggest the numbers of salmonellae can increase
about 10-fold during that initial phase, before entering a lag phase
during which numbers remain fairly constant. The length of that lag
phase is largely temperature-dependent, and its end, the beginning of
the third phase, is signaled by penetration of the yolk membrane by the
bacteria and resumption of rapid growth.\24\
Failure to cool eggs clearly contributes to SE multiplication. One
study found that SE in eggs artificially inoculated in the albumen and
stored at 20 deg.C (68 deg.F) grew rapidly after they had been stored
for approximately 3 weeks, but that rapid growth occurred within 7 to
10 days when storage temperatures fluctuated between 18 deg.C (64
deg.F) and 30 deg.C(86 deg.F).\25\ A different study of eggs with SE
inoculated under the shell membrane found that after only 48 hours at
26 deg.C (78.8 deg.F) yolks contained high levels of SE.\26\ Although
there is consensus on the advisability of keeping eggs cool to prevent
SE growth, there is debate on precisely what temperature is required.
Because the studies referenced above rely on inoculated eggs, they may
not accurately represent naturally occurring strains or the numbers of
organisms that occur and grow in eggs under similar conditions. The
conclusions suggest that internal egg temperatures of 7 deg.C (approx.
45 deg.F) or lower are unlikely to promote SE growth should SE be
present in the egg.
Although the studies suggest that there is a delay of at least
several days before the egg's natural defenses start breaking down,
they also suggest that the rate at which degradation occurs is
temperature related, and that eggs should be chilled as soon as
possible.\27\ The sooner an egg is chilled, the longer its defenses
will be retained and the less likely that any SE present will have an
opportunity to replicate.
The time it takes for an egg's contents to reach a temperature of
45 deg.F is affected by many things, including the temperature of the
egg when received at the packing plant, heat added during processing,
temperature when packed, insulation effect of the packaging, how packed
eggs are stacked in coolers during storage and transportation, and the
ambient air temperature and air circulation provided at all points
after packing.
Egg processing procedures in the U.S. typically result in eggs
being warmed. Warming begins as the eggs are loaded onto the conveyance
system, and increases as they are washed; surface temperatures of eggs
immediately after washing will approach that of the wash water, which
is normally about 43-40 deg.C or 110-120 deg.F.\28\ As noted, hot
wash water temperatures are intended to provide adequate cleaning of
the shell surface and an adequate temperature differential between the
wash water and
[[Page 27507]]
the egg. USDA studies have shown that water temperatures colder than
the internal egg temperatures cause the eggs' contents to cool leading
to a pressure gradient that pulls in water and any bacteria in the
water through the shell.\29\
After the eggs emerge from the wash and are dried with forced
ambient air, internal temperature at the time they are packed is often
in the 70-80 deg.F range. After packing, most processors hold eggs in
coolers at an ambient air temperature of 45-55 deg.F, and transport
eggs at an ambient air temperature of 60 deg.F or less. However, the
ambient air temperature does not correlate to egg temperature. The
temperature of the eggs' contents at the time they are transported from
the packer will range between 50 deg.F and 80 deg.F, depending on the
starting temperature, the packaging, how the crates are packed and
stacked, and the length of time they are in the cooler before shipping.
The rate at which eggs chill after leaving the processor is
similarly dependent on the initial temperature, packaging, loading
configurations, and the capability of the refrigeration equipment.
Transporters contend that their refrigeration units are designed to
maintain--not reduce--temperatures, and that they cannot be relied upon
to reduce the temperatures of products being transported. Further, the
driver of a truck making multiple deliveries must open the truck door
frequently, and if the outside temperature is warm, it would be
virtually impossible to maintain the ambient air temperature uniformly
throughout the load. Similarly, most retail stores' display cases have
been designed to keep products cool, not to cool down products. Eggs
received by retail stores are frequently at temperatures well above 45
deg.F.
Ideally, reliance on the use of ambient air temperature of 45
deg.F during distribution and retail as a reasonable measure of whether
the eggs are being maintained under appropriate conditions would
necessitate the eggs being chilled to an internal temperature of 45
deg.F before they are shipped. Significantly, there are a number of
actions processors may take to reduce the temperature at which eggs are
packed, and to cool them before shipment, including lowering the wash
temperatures and pre-pack chilling of eggs. Recent research has shown
that new technologies are available to processors to rapidly cool shell
eggs. One study found that carbon dioxide, as a cryogenic gas, can be
used instead of air chilling to rapidly chill eggs and results in no
increase in cracked shells.
c. Rewashing/Repackaging: Preventing Growth of SE in Eggs
It appears that eggs are occasionally removed from retail
establishments when they are within a few days of the expiration or
sell-by date stamped on the carton and returned to the processing
plant. These eggs are co-mingled with eggs that are being cleaned for
the first time, go through the hot water/sanitizing process again, and
are graded. The rewashed eggs are then packed into cartons and are
redistributed for sale. These eggs receive a new expiration or sell-by
date.
On April 17, 1998, USDA announced that as of April 27, 1998,
repackaging of eggs packed under its voluntary grading program will be
prohibited while the Department reviews its policies on egg repackaging
and engages in any necessary rulemaking. The prohibition on repackaging
affects eggs packed in cartons that bear the USDA grade shield. About
one-third of all shell eggs sold to consumers are graded by USDA.
In the wake of the USDA action, FDA is considering appropriate
measures to take to address this issue. FDA requests comments on how
widespread this practice is and on whether any aspect of rewashing/
repackaging of eggs significantly increases the risk that consumers
will contract SE-related illness from these eggs. FDA notes, for
example, that repackaged eggs are subjected to warming during
rewashing. Inasmuch as an egg's natural barriers to the multiplication
of SE may be compromised at temperatures above 45 deg.F (see
discussion in section 4b), does the warming of shell eggs during rewash
significantly increase the risk that SE (if present) will multiply in
rewashed/repackaged eggs during distribution or while held for sale,
service, or preparation? Does it significantly increase the risk of
illness for the consumer if the egg is not thoroughly cooked before
consumption?
Are there important aspects, for example, safety risks or
otherwise, of rewashed/repackaged eggs that would raise the question
whether rewashed/repackaged eggs should be labeled in the same manner
as other shell eggs? Are rewashed/repackaged eggs different enough from
other shell eggs such that label statements in addition to
``expiration'' or ``sell-by'' dates would be necessary to adequately
describe the product? If, for some segments of the U.S. population, the
standard egg labeling practices are not appropriate for rewashed/
repackaged eggs, how should these eggs be labeled to enable consumers
to understand the nature of this product and to communicate other
important information to the purchaser?
The issue of rewashing and repackaging of eggs also calls attention
to current practices regarding the expiration dating of eggs in
establishments that function primarily under State regulatory
oversight. While a few States have regulations governing expiration
dating of eggs, most do not and egg packers determine what expiration
dating practices they will employ. Processors that do not use USDA's
grading service, and that are not covered by State requirements,
typically choose to place a 30- or 45-day expiration date on egg
cartons. Some processors do not provide any expiration date. Section
403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) states that
a food is misbranded if its labeling is false or misleading in any
particular. FDA requests comments on the latter two practices described
above could violate 403(a) or other provisions of the Act. It also
seeks comments on whether the variety of expiration dating practices
for eggs could be misleading to consumers given their expectations when
they purchase eggs. FDA will evaluate comments received regarding
expiration dating and will consider providing guidance to the States on
appropriate controls. FDA also requests comments on whether any such
guidance should address appropriate practices for use of eggs that are
not sold by the expiration date.
d. Preparation and Consumption: Preventing Ingestion of SE from Eggs
Another risk factor is exposure--the number of people who ingest SE
organisms from SE-contaminated eggs. Pathogens like SE usually become a
public health problem as a consequence of changes in the agent itself,
the host, or the environment. Examples of such changes include the
types of food people eat, the sources of those foods, and the possible
decline in public awareness of safe food preparation. Antibiotic-
resistant strains of pathogens are emerging, and people are exposed to
new pathogens originating in other regions and other parts of the
world. People today have increased life expectancies, and there are
increasing numbers of immuno-compromised persons, increasing the
population susceptible to severe illness after infection with foodborne
pathogens.\30\
Finally, preparation and consumption patterns can greatly influence
the likelihood of foodborne illness from eggs. However, SE outbreaks of
foodborne illness from eggs continue to be associated with the use of
recipes
[[Page 27508]]
calling for uncooked eggs or with undercooking of eggs. Low numbers of
SE organisms in prepared foods can increase if the foods are held at
room temperature or are cross contaminated with other foods. The risk
is further amplified in commercial or institutional food service
settings where larger quantities of food are served to larger groups of
persons over extended periods of time.
As the proportion of food that is eaten outside homes in the U.S.
increases, outbreaks associated with these foods increase in
importance. They accounted for more than 90 percent of reported
foodborne disease outbreaks in the 1990s.
5. Current Regulation of Shell Eggs
Federal authority to regulate eggs for safety is shared by FDA and
USDA. FDA has jurisdiction over the safety of foods generally,
including shell eggs, under the FFDCA (21 U.S.C. 301, et seq.). FDA
also has authority to prevent the spread of communicable diseases under
the Public Health Service Act (PHSA)(42 U.S.C. 201, et seq.). This
authority would include the authority to regulate foods when the foods
may act as a vector of disease, as is the case with eggs and SE. USDA
has primary responsibility for implementing the Egg Products Inspection
Act (EPIA)(21 U.S.C. 1031, et seq.), although FDA shares authority
under the statute (see, for example, 21 U.S.C. 1034). USDA's Food
Safety and Inspection Service and Agricultural Marketing Service share
responsibilities under the EPIA. FSIS has primary responsibility for
the inspection of processed egg products to prevent the distribution
into commerce of adulterated or misbranded egg products (7 CFR 2.53),
while AMS conducts a surveillance program to ensure proper disposition
of restricted shell eggs.
Under Federal regulations, all major commercial egg producers--the
757 producers who have more than 3,000 laying hens and collectively are
responsible for close to 94 percent of the nation's eggs--are required
to register with AMS. They are subject to periodic on-site visits by
AMS to ensure that eggs packed for commercial sale have no more than
the percentage of restricted eggs allowed for the grade of eggs being
packed, that they are properly labeled, and that proper disposition is
made of inedible and restricted eggs. Exempted from this oversight are
approximately 80,000 small egg producers.
States may have their own laws governing eggs, as long as they are
consistent with Federal laws (e.g., 21 U.S.C. 1052(b)(2)). Generally,
State laws and regulations specifically govern egg grading and labeling
in each of the States. These laws influence how eggs are packed and
shipped for sale and then handled by retail stores, restaurants, and
other food service establishments in those jurisdictions.
FDA and FSIS work with the States to encourage uniformity among the
State laws affecting food safety in retail and food service
establishments. The principal mechanism for this is the Food Code, a
model code published by FDA intended for adoption by State and local
authorities for governing retail food and food service establishments.
The provisions of the Food Code are modified periodically with input
from a broad spectrum of organizations--industry, academia, consumers
and government agencies at the Federal, State, and local levels. In
addition, training programs on the Food Code recommendations have been
conducted yearly with State agencies.
The Food Code states that ``potentially hazardous foods,''
including shell eggs, should be received and maintained at a
temperature of 41 deg.F or less, or, if permitted by other law to be
received at more than 41 deg.F, be reduced to that temperature within
4 hours. Because eggs are often received at temperatures well above 41
deg.F, the 1997 edition of the Food Code contains an exception for
shell eggs, requiring only that they be placed upon receipt in
refrigerated equipment that is capable of maintaining food at 41
deg.F.
The Food Code specifies that shell eggs, when prepared for service,
are to be cooked to specified temperatures for a specified time. If the
egg is not served immediately, hot and cold hold temperatures are
specified. The Food Code further specifies that pasteurized eggs be
substituted in delicatessen and menu items that typically contain raw
eggs unless the consumer is informed of the increased risk. Pasteurized
egg substitution is specified for eggs that are held before service of
vulnerable individuals.
In recent years, many States have enacted laws requiring specified
ambient air temperatures for shell egg storage and handling. While many
States specify 45 deg.F or less for that purpose, others retain the 60
deg.F temperature requirement traditionally required under the USDA
grading standards, and some have no requirement. A number of States
have stated that they are waiting for USDA implementation of the EPIA
shell egg refrigeration requirements before instituting any State law
governing shell egg refrigeration.
The egg industry clearly has an interest in finding a way to
constructively address the public concern about SE in eggs, and many in
the industry have communicated their desire to work with the government
toward an effective regulatory solution.
In November 1996, Rose Acre Farms, Inc., submitted a detailed
petition (Docket No. 96P-0418) to the Federal agencies that have played
a role in the regulation of shell eggs--FDA, FSIS, APHIS, and AMS--
requesting that in regulating the presence of pathogens in shell eggs,
the agencies ``adopt a comprehensive, coordinated regulatory program to
replace the patchwork of approaches they currently take.'' The
petitioner acknowledged the need to reduce the prevalence of SE in
shell eggs, but advocated a broad-based regulatory program that goes
beyond the traceback-and-sanction approach that, the petitioner
contended, is both inadequate to protect consumers and unfairly burdens
producers. The petitioner called for a collaborative process in
developing incentives to encourage improved handling of eggs throughout
the farm-to-table cycle and other modifications to promote greater
levels of food safety.
In May of 1997, the Center for Science in the Public Interest
submitted a petition (Docket No. 97P-0197) requesting that FDA issue
regulations requiring that shell egg cartons bear a label cautioning
consumers that eggs may contain harmful bacteria and that they should
not eat raw or undercooked eggs. The petitioner further requested that
all egg producers be required to implement on-farm HACCP programs to
minimize the risk that their eggs will be contaminated with SE.
FDA and FSIS are responding to these petitions by initiating such a
comprehensive, coordinated process with this ANPR.
Finally, USDA and FDA intend to encourage and assist in additional
research on how hens become infected with SE, the factors that relate
to infected hens' production of SE-contaminated eggs, better ways to
identify specific strains of SE, the virulence and other
characteristics of emerging SE strains, the extent of the potential
public health risk from SE, and identification of effective controls
and intervention strategies.
Because of the number of outbreaks of foodborne illness caused by
Salmonella Enteritidis that are associated with the consumption of
shell eggs, FDA and FSIS have tentatively determined that there are
actions that can be taken even at this time to reduce the risk of
foodborne illness from shell eggs while
[[Page 27509]]
additional measures are being considered pursuant to this ANPR. FSIS
intends to act to amend its regulations to require that shell eggs
packed for consumer use be stored and transported under refrigeration
at an ambient temperature not to exceed 45 deg.F, and that these
packed shell eggs be labeled to indicate that refrigeration is
required. FDA intends to act to publish shortly a proposal to (1)
require that retail food stores and food service establishments hold
shell eggs under refrigeration and (2) require safe handling statements
on the labeling of shell eggs that have not been treated to destroy
Salmonella microorganisms that may be present.
6. Need for Additional Information and Analysis.
In 1991, the EPIA was amended in the wake of publicity about
foodborne disease outbreaks attributed to Salmonella in shell eggs. The
amendment requires, essentially, that shell eggs packed for consumers
be stored and transported under refrigeration at an ambient air
temperature not to exceed 45 deg.F. (21 U.S.C. Secs. 1034, 1037).
Congress also provided that these provisions would be effective only
after promulgation of implementing regulations by USDA.
After reviewing the issue in 1996, FSIS concluded and informed
Congress that a regulation establishing an ambient air temperature at
which eggs must be held and transported would not address the
underlying food safety problems, and that the problem could be dealt
with effectively only in the context of a broader process examining a
variety of issues in addition to ambient air temperatures. As part of
the 1998 Appropriations for Agriculture, Rural Development, Food and
Drug Administration, and Related Agencies (P.L. 105-86), however,
Congress provided that $5 million of FSIS' annual appropriation will be
available for obligation only after the Agency promulgates a final rule
to implement the refrigeration and labeling requirements included in
the 1991 EPIA amendments.
FSIS and FDA are now looking at how best to address the food safety
concerns associated with shell eggs in the context of their mutual,
HACCP-based, farm-to-table food safety strategy. FSIS and FDA believe
that comprehensive shell egg regulations must address the public health
risks identified; that such regulations must be fully considered in an
open, public process; and that each regulation adopted must have been
considered in light of available alternatives and be consistent with
other laws and regulations.
FSIS and FDA, in furtherance of their commitment to develop a
comprehensive strategy for shell eggs, have undertaken the following
actions:
(1) Time-temperature Conference. A 3-day technical conference on
November 18-20, 1996, provided a forum for information on temperature
control interventions and verification techniques in the transportation
and storage of meat, poultry, seafood, and eggs and egg products. The
egg session included many informative technical presentations and
policy discussions on the issue of implementing the EPIA's 45 deg.F
ambient temperature requirement. The opportunity to submit written
comments to supplement the record was provided.
(2) Transportation ANPR. In a related activity, FSIS and FDA
published a joint ANPR (61 FR 58780) soliciting information on issues
related to ensuring the safety of potentially hazardous foods during
transportation. The agencies posed a range of regulatory and non-
regulatory options, and solicited information to help them assess the
risks and decide what approaches are best suited to addressing those
risks. The comment period on this ANPR closed on February 20, 1997.
Fifty-two comments have been received.
(3) Risk Assessment. The agencies are conducting a quantitative
risk assessment for shell eggs. The project is being conducted by a
multidisciplinary team of scientists from USDA, FDA, and academia.
Begun in December, 1996, it is intended to (a) provide a more
definitive understanding of the risks of egg-associated foodborne
disease; (b) assist in evaluating risks and ways in which the risks
might be reduced; and (c) verify data needs and prioritize data
collection efforts. A draft report on risks of SE in eggs and egg
products is on the FSIS Homepage and was presented at a technical
meeting in September 1997. The draft report of the risk assessment team
will be available for public comment and subject to modification based
on that input before being made final. Interested persons are
encouraged to provide any data or information relevant to the risk
assessment for use in the analysis.
(4) Research. The Agencies are undertaking efforts to initiate:
--a nationwide surveillance program for SE and SE phage-type 4 to
track the spread among layer flocks.
--research (in conjunction with USDA's Agricultural Research
Service) on the molecular and virulence comparison of U.S. SE phage-
type 4 with isolates from other parts of the world (human and poultry).
(5) Dialogue. FDA and FSIS intend to engage affected industry,
Federal and State regulatory agencies, and business organizations in an
open, on-going dialogue regarding steps they might take voluntarily to
address the SE problem and ways in which the Federal agencies might
help such efforts.
(6) Forthcoming FDA/FSIS Actions. As stated above, because there
are actions that can be taken at this time to reduce the risk of
foodborne illness from shell eggs, FDA intends to publish shortly a
proposal to (1) require that retail food stores and food service
establishments hold shell eggs under refrigeration and (2) require safe
handling statements on the labeling of shell eggs that have not been
treated to destroy Salmonella microorganisms that might be present. In
that proposal, FDA will solicit comments and information concerning
these two matters. FDA requests that comments or information submitted
in response to this ANPR also be submitted in response to FDA's
proposed rule if such comments or information are relevant to the
issues raised therein. In addition, as stated above, FSIS intends to
act to amend its regulations to require that shell eggs packed for
consumer use be stored and transported at an ambient temperature that
does not exceed 45 deg.F.
Information Requested
FDA and FSIS have available a wide range of mechanisms for
administering the laws for which they are responsible. The agencies are
interested in the public's views on what regulations may be required to
reduce the public health risk of SE in shell eggs, including any
performance standards that might be developed.
One approach might be a process-oriented rule similar to the
agencies' HACCP regulations for meat, poultry, and seafood. Regulations
may be proposed to mandate HACCP-like process controls to reduce the
microbiological and other food safety hazards in shell egg production,
processing and handling. Such an approach requires each business to
develop controls that are best suited to its particular processes and
products. The agencies are interested in comments on whether HACCP-like
controls could be effective against SE in eggs, in how many producers
are presently using HACCP-like controls, and in the overall costs of
these controls. The agencies are interested in how such a program would
affect small entities.
The agencies may achieve public health objectives by providing
guidance to interested parties as a companion to or in lieu of
regulations. The agencies
[[Page 27510]]
provide a variety of technical information and guidance materials to
industries that must comply with Federal laws, to State and local
officials, and to consumers. These materials range from general advice
to fairly detailed examples or ``models'' of ways in which a plant may
ensure compliance with a particular statutory or regulatory provision.
Such guidance may be particularly useful for smaller plants with
limited resources.
A third general approach would be a Federal-State cooperative
program under which overall regulatory oversight is left primarily to
State agencies using mutually agreed-upon standards and procedures and
Federal assistance. The agencies frequently work cooperatively with
State and local government authorities. FDA currently participates in a
formal Federal-State cooperative program for the interstate shipment of
two commodities, Grade A milk and shellfish.
The agencies believe that a comprehensive, effective program for
the control of SE in shell eggs is likely to require some combination
of these three general approaches. The following sets out questions the
answers to which, the agencies believe, will help them to shape a
program that will be useful in reducing risk at each stage in the shell
egg farm-to-table continuum.
Production
Should the patchwork of voluntary quality assurance (QA) programs
be made consistent with a single, national standard for flock-based
quality assurance programs, and be applicable to all producers? Does
there need to be more uniformity among the QA programs to assure
consumers that producers in all States are uniformly doing all they can
to reduce the frequency of SE-contaminated eggs, and to provide ``a
level playing field'' among competing producers in the various States?
Should the agencies establish minimum QA requirements for all
commercial shell egg producers? This might be accomplished through
rulemaking or some form of cooperative program with the States. Should
the microbiological testing under such a program be done by a third
party (someone other than the producer) to ensure test uniformity and
the integrity of the program? Should the agencies require the
submission of testing data so that they can identify ways to improve
the program, including possible justification for regional variations,
verify the overall effectiveness of the program, track the prevalence
of emerging strains of SE and, as necessary, identify the need for
additional testing programs or other interventions required to protect
human or animal health? Should a QA program be voluntary?
Processing
In-shell pasteurization of shell eggs is a relatively new
technological development by which harmful bacteria are destroyed
without significantly altering the nature of the egg. Were this
technology viable for broad scale adoption by producers, it could
conceivably significantly reduce the risk of foodborne illness through
the destruction of any SE in the egg at the time of processing. The
agencies seek comments and information that would address the current
viability of in-shell pasteurization for eggs. What factors will
determine whether and when in-shell pasteurization of eggs could be
applied to the whole industry? Comments should address technological
and cost factors.
FSIS and FDA believe that there are many interventions that might
be applied during processing that would reduce the risk to consumers
from SE in shell eggs. The agencies could continue to defer to States,
or processors could be required to use only shell eggs from production
facilities adhering to a QA program meeting national standards. This
would enable each processor to identify and control all hazards,
including SE, that might be introduced into the product during
processing. The systems would address those factors known to influence
SE growth in shell eggs during processing (principally the age and
temperature of the eggs), precluding the necessity of developing
detailed prescriptive regulations attempting to specify how such
control should be achieved. The agencies would like comments on how
such processing requirements might best be structured.
Another alternative might be a sliding scale approach similar to
that under consideration by the European Union. Under this approach, a
specific egg temperature is not required, but a ``sell by'' date is
mandatory, which would vary depending on the temperatures at which eggs
are maintained. Assuming packed eggs are transported and stored at an
ambient air temperature of 45 deg.F, the primary determinant of the
temperature of eggs in commercial channels will be the temperature of
the eggs when they are shipped from the packer. To provide an incentive
for processors to chill eggs before shipping, yet retain flexibility to
accommodate reasonable alternatives to an absolute temperature
requirement, a regulation might prescribe a range of ``sell-by'' dates
based on the egg temperature achieved by the packer. However, such an
approach might be difficult to verify and enforce. The agencies would
like comments on the feasibility and advisability of this kind of
approach.
Retail
FDA intends shortly to propose regulations to require that food
retail and food service establishment hold eggs under refrigeration. As
explained elsewhere in this document, FDA believes that these actions
are measures that can be taken at this time to reduce the risk of
foodborne illness from shell eggs. Pursuant to this ANPR, both agencies
will consider other matters that affect eggs at retail as part of the
comprehensive farm-to-table solution that the agencies ultimately put
in place.
The agencies are interested in whether retail stores should require
their suppliers to use temperature recording devices, or affix
temperature indicating devices on the egg cases or cartons, to help
ensure that the eggs have not been subject to temperature abuse during
transportation. Could any requirement for delivery at 45 deg.F be
enforced effectively as a matter of contract between the processors
(vendors) and the retail stores (purchasers)? Should the agencies
consider regulations to effect these changes?
Restaurants and Food Service Operations
Restaurants, food service operators, and many retail stores that
prepare food for immediate consumption are regulated primarily by State
and local governments. Should the agencies take a more direct role, or
should they continue to rely on the Food Code to provide guidance on
the maintenance and preparation of eggs and encourage State and local
authorities to adopt and enforce those standards?
The agencies believe that much of what must be done to reduce the
risk of foodborne disease transmission in restaurants and other food
service facilities involves education and training. Food service
managers play an increasingly important role in food safety, and they
must place a high priority on employee hygiene and proper food handling
techniques. Thus, the Federal agencies are currently exploring with
industry representatives (the major associations representing retail
stores and restaurants as well as major food producer groups),
representatives of State and local regulatory agencies, and consumer
groups the possibility of a partnership
[[Page 27511]]
that would build on current programs to develop a comprehensive,
national food safety education and training campaign directed at people
who work in restaurants and other food service facilities, people who
work in retail stores, and at consumers. This campaign would include
lesson plans and materials for classroom training that could be used in
public school curricula as well as in food service settings.
Household Consumers
A primary tool for reducing the risk of foodborne disease among
consumers is education. To ensure that consumers are fully and
adequately informed of the significant risks associated with SE in eggs
and how to best avoid these risks, FDA shortly will be proposing
certain labeling requirements for eggs. The agencies also plan to
intensify their consumer education efforts in the coming months and to
institute permanent food safety education programs that will help
consumers protect themselves from all food safety hazards.
Thus, by this notice, FDA and FSIS are requesting comments and
information on a variety of issues concerning ways to reduce the risk
to the public health from SE in shell eggs. These issues need to be
addressed comprehensively by the agencies. FSIS and FDA welcome
discussion and comments on the issues in this notice and other issues
related to the subject. The agencies are particularly interested in
comments about alternatives that would minimize the impact on small
entities.
Done in Washington, DC, on May 11, 1998.
Thomas J. Billy,
Administrator, FSIS.
William B. Schultz,
Deputy Commissioner for Policy, FDA.
References
1. D'Aoust, J. 1997, Salmonella Species. pp. 129-158. In, Doyle, M.,
Beuchat, L. and Montville, L. (eds.), Food Microbiology Fundamentals
and Frontiers, ASM Press, Washington, D.C.; Jay, J. 1996. Chapter
23. Foodborne Gastroenteritis caused by Salmonella and Shigella. pp.
507-526, In Modern Food Microbiology, Fifth ed., Chapman & Hall, New
York.
2. Berenson, A. (ed). 1995. Typhoid Fever, pp. 502-507. In, Control
of Communicable Diseases Manual, Sixteenth ed., American Public
Health Assn., Washington, D.C.
3. id. n. 1.
4. id.
5. CDC. Laboratory Confirmed Salmonella, Surveillance Annual
Summary, 1993-1995 and 1996.
6. Swerdlow, D. et al. Reactive arthropathy following a multistate
outbreak of Salmonella typhimurium infections. Abstract 916. 30th
Interscience Conference on Antimicrobial Agents and Chemotherapy.
7. CDC. Memo to the Record dtd 2/8/96 from Chief, Foodborne Diseases
Epidemiology Section, NCID.
8. Chalker, R. And Blaser, M. 1988. A Review of Human Salmonellosis:
III. Magnitude of Salmonella Infections in the United States. Rev
Inf Dis. 10:111-123
9. id. n. 8.
10. CDC. 1996. Outbreaks of Salmonella Serotype Enteriditis
Infection Associated with Consumption of Raw Shell Eggs--United
States, 1994-1995. MMWR 45:737-742.
11. Letter dtd April 16, 1997, from J. Stratton, Calif. Dept. of
Health Services to T. Billy, FSIS.
12. Altekruse S., et al, 1993. A Comparison of Salmonella
Enteritidis Phage Types from Egg-associated Outbreaks and Implicated
Flocks. Epidemiol. Infect. 110-17-22.
13. Hennessy T., et al. A National Outbreak of Salmonella
Enteriditis Infections from Ice Cream. N E J Med. 1996. 334:1281-
1286.
14. Khan M. And Nguyen A. 1995. A Salmonella-Specific DNA Probe and
Its Use in Southern Hybridration for Differentiation of Salmonella
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31. M. Taylor to J. Skeen, MC, dtd Sept. 5, 1996.
[FR Doc. 98-13056 Filed 5-14-98; 10:28 am]
BILLING CODE 3410-DM-P
