[Federal Register: May 19, 1998 (Volume 63, Number 96)]

[Proposed Rules]               

[Page 27502-27511]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19my98-23]



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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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[[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 

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31. M. Taylor to J. Skeen, MC, dtd Sept. 5, 1996.



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