[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

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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 
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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