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.

Proposed Rules Federal Register

27502

Vol. 63, No. 96

Tuesday, May 19, 1998

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.

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-totable 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
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules 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°C (36–39°F), and as high as 54°C

(129°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
27504 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules

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, SEassociated 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 phagetype 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
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules 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° F warmer than the eggs

being washed. Typically, U.S.

processors use a hot wash water (110–

120° F) to ensure temperatures hostile to

most organisms that may collect in the

wash water as well as to ensure that the

20° 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-distributionconsumption 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 eggtransmitted 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-
27506 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules

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 SEinfected 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 °C (68 °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 °C (64 °F) and 30

°C(86 °F).25 A different study of eggs

with SE inoculated under the shell

membrane found that after only 48

hours at 26 °C (78.8 °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 °C (approx. 45 °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 °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

°C or 110–120 °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
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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 °F range.

After packing, most processors hold

eggs in coolers at an ambient air

temperature of 45–55 °F, and transport

eggs at an ambient air temperature of 60

°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 °F and 80 °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 °F.

Ideally, reliance on the use of ambient

air temperature of 45 °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 °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 comingled 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

°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
27508 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules

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

°F or less, or, if permitted by other law

to be received at more than 41 °F, be

reduced to that temperature within 4

hours. Because eggs are often received at

temperatures well above 41 °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 °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 °F or less for that

purpose, others retain the 60 °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 SEcontaminated 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
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules 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 °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 °F. (21

U.S.C. §§ 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-totable 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

°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 °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 processoriented 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
27510 Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules

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 inshell 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 °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 °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
Federal Register / Vol. 63, No. 96 /Tuesday, May 19, 1998 / Proposed Rules 27511

that would build on current programs to

develop a comprehensive, national food

safety education and training campaign

directed at people who work in

restaurants and other food service

facilities, people who work in retail

stores, and at consumers. This campaign

would include lesson plans and

materials for classroom training that

could be used in public school curricula

as well as in food service settings.

Household Consumers

A primary tool for reducing the risk

of foodborne disease among consumers

is education. To ensure that consumers

are fully and adequately informed of the

significant risks associated with SE in

eggs and how to best avoid these risks,

FDA shortly will be proposing certain

labeling requirements for eggs. The

agencies also plan to intensify their

consumer education efforts in the

coming months and to institute

permanent food safety education

programs that will help consumers

protect themselves from all food safety

hazards.

Thus, by this notice, FDA and FSIS

are requesting comments and

information on a variety of issues

concerning ways to reduce the risk to

the public health from SE in shell eggs.

These issues need to be addressed

comprehensively by the agencies. FSIS

and FDA welcome discussion and

comments on the issues in this notice

and other issues related to the subject.

The agencies are particularly interested

in comments about alternatives that

would minimize the impact on small

entities.

Done in Washington, DC, on May 11, 1998.

Thomas J. Billy,

Administrator, FSIS.

William B. Schultz,

Deputy Commissioner for Policy, FDA.

References

1. D’Aoust, J. 1997, Salmonella Species. pp.

129–158. In, Doyle, M., Beuchat, L. and

Montville, L. (eds.), Food Microbiology

Fundamentals and Frontiers, ASM Press,

Washington, D.C.; Jay, J. 1996. Chapter

23. Foodborne Gastroenteritis caused by

Salmonella and Shigella. pp. 507–526, In

Modern Food Microbiology, Fifth ed.,

Chapman & Hall, New York.

2. Berenson, A. (ed). 1995. Typhoid Fever,

pp. 502–507. In, Control of

Communicable Diseases Manual,

Sixteenth ed., American Public Health

Assn., Washington, D.C.

3. id. n. 1.

4. id.

5. CDC. Laboratory Confirmed Salmonella,

Surveillance Annual Summary, 1993–

1995 and 1996.

6. Swerdlow, D. et al. Reactive arthropathy

following a multistate outbreak of

Salmonella typhimurium infections.

Abstract 916. 30th Interscience

Conference on Antimicrobial Agents and

Chemotherapy.

7. CDC. Memo to the Record dtd 2/8/96 from

Chief, Foodborne Diseases Epidemiology

Section, NCID.

8. Chalker, R. And Blaser, M. 1988. A Review

of Human Salmonellosis: III. Magnitude

of Salmonella Infections in the United

States. Rev Inf Dis. 10:111–123

9. id. n. 8.

10. CDC. 1996. Outbreaks of Salmonella

Serotype Enteriditis Infection Associated

with Consumption of Raw Shell Eggs—

United States, 1994–1995. MMWR

45:737–742.

11. Letter dtd April 16, 1997, from J. Stratton,

Calif. Dept. of Health Services to T. Billy,

FSIS.

12. Altekruse S., et al, 1993. A Comparison

of Salmonella Enteritidis Phage Types

from Egg-associated Outbreaks and

Implicated Flocks. Epidemiol. Infect.

110–17–22.

13. Hennessy T., et al. A National Outbreak

of Salmonella Enteriditis Infections from

Ice Cream. N E J Med. 1996. 334:1281–

1286.

14. Khan M. And Nguyen A. 1995. A

Salmonella-Specific DNA Probe and Its

Use in Southern Hybridration for

Differentiation of Salmonella Enteriditis.

Avian Diseases. 39:368–374.

15. Buchanan, R., et al. 1997. Egg and Egg

Products. In, Microorganisms in Foods;

No. 6, Microbiology of Commodities.

International Commission on

Microbiological Specifications for Foods

(eds.); Chapman Hall, London, UK. (In

press)

16. id n. 11; Tauxe, R. 1966. An Update on

Salmonella. Health and Environment

Digest. 10:1–4; Mishu B., et al. 1994.

Outbreaks of Salmonella Enteriditis

Infections in the United States, 1985–

1991. J Infect Dis 169: 547–552.

17. St. Louis, M. et al. 1988. The Emergence

of Grade A Eggs as a Major Source of

Salmonella Enteriditis Infections, New

Implications for Control of

Salmonellosis. JAMA 259:2103–2107.

18. Gast, R., and Beard, C. 1990. Production

of Salmonella Enteritidis-Contaminated

Eggs by Experimentally Infected Hens.

Avian Diseases. 1990; 34: 438–446.

19. Schlosser, W., Hogue, A., Morales, R.

1996. An Estimation of the Prevalence of

Salmonella Enteritidis Positive Eggs in

the United States, A Working Model.

(unpublished) FSIS, USDA.

20. Rhorer, A. 1996. NPIP National Plan’s

Status Report. APHIS, USDA

(unpublished)

21. White, P.R. et al. 1996. Environmental

Survey (by Manure Drag Sampling) for

Salmonella enteritidis in Chicken Layer

Houses (unpublished)

22. Morse, D. New York Department of Public

Health. Presentation to Second Annual

Federal-State Conference on Food Safety,

Washington, DC., Oct., 1996.

23. Clay, C. And Board, R. 1991. Growth of

Salmonella Enteritidis in artificially

contaminated hens’ eggs. Epidemiol.

Infect. 106:271–281.

24. Humphrey, T. and Whitehead, A. 1993.

Egg age and the growth of Salmonella

Enteritidis PT4 in egg contents.

Epidemiol. Inf. 111:209–219; Humphrey,

T. 1994. Contamination of Shell Egg and

Contents with Salmonella Enteritidis: a

review. Intl. Jrnl. of Food Micro. 21:31–

40.

25. id, (Humphrey, T.).

26. Hammack, T., et al. Research note:

Growth of Salmonella Enteritidis in

Grade A Eggs During Prolonged Storage.

Poultry Sec. 1993; 72:373–377.

27. Kim, C., et al. 1989. Effect of Time and

Temperature Growth of Salmonella

Enteritidis in Experimentally Inoculated

Eggs. Avian Diseases. 33:735–742.

28. Humphrey, T.J. 1990. Growth of

Salmonella in Intact Shell Eggs:

Influence of Storage Temperature. Vet.

Rec. 1236:292

29. Anderson, K.E., 1993. Refrigeration and

Removal of Heat from Eggs. MissetWorld Poultry 9:11

30. Saeed, A.M., and Koons, C.W. 1993.

Growth and Heat Resistance of

Salmonella Enteritidis in Refrigerated

and Abused Eggs. Jrnl. Food Prot.

57:592–595.

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

DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Parts 273 and 274

RIN 0584–AC61

Food Stamp Program: Electronic

Benefits Transfer Benefit Adjustments

AGENCY: Food and Nutrition Service,

USDA.

ACTION: Proposed Rule.

SUMMARY: This rule proposes to revise

Food Stamp Program regulations

pertaining to State agencies’ ability to

make adjustments to a recipient account

in an Electronic Benefits Transfer (EBT)

system, in order to correct a system

error or an out-of-balance condition.

EBT stakeholders have proposed the

changes so that States and their

processors can correct errors when they

are identified, rather than 10 days after

the advance notice has been sent to the

household. The changes would enable

State agencies to correct errors in a more

timely manner, and bring EBT closer in

line with current commercial Electronic

Funds Transfer (EFT) practices. This

rule also proposes to revise the formula