Food Labeling: Safe Handling Statements: Labeling of Shell Eggs; Shell Eggs: Refrigeration of Shell Eggs Held for Retail Distribution

SUMMARY: The Food and Drug Administration (FDA) is proposing to require

safe handling statements on labels of shell eggs that have not been

treated to destroy Salmonella microorganisms. The agency is also

proposing to require that, when held by retail establishments, shell

eggs be stored and displayed under refrigeration at a temperature of

7.2 deg.C (45 deg.F) or less. FDA is taking these actions because of

the number of outbreaks of foodborne illnesses and deaths caused by

Salmonella Enteritidis that are associated with the consumption of

shell eggs that have not been treated to destroy this pathogen. These

actions complement regulations of the Food Safety and Inspection

Service (FSIS) that require that shell eggs be stored and transported

at a temperature of 7.2 deg.C (45 deg.F) or less and that the

consumer containers of shell eggs be labeled to indicate that

refrigeration is required. FDA's proposal also responds, in part, to

petitions from Rose Acres Farm, Inc., and the Center for Science in the

Public Interest (CSPI). FDA expects that by requiring this information,

consumers will be able to take measures to protect themselves from

illness or deaths associated with consumption of shell eggs that have

not been treated to destroy Salmonella Enteritidis.

DATES: Written comments by September 20, 1999. See section VII for the

proposed effective date of a final rule based on this proposal.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. Copies of this proposed rule are available on the

Internet at ``http://www.fda.gov/cfsan''.

FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food

Safety and Applied Nutrition (HFS-158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. Epidemiology of Salmonellosis

B. Salmonella Contamination of Eggs

C. Infectious Dose

D. Inappropriate Handling of Eggs by Consumers and Other Food

Preparers

E. Current Commercial Practices for Handling Eggs

F. Limiting the Numbers of Salmonella Microorganisms in Eggs

G. Current Efforts

H. Petitions to the Agency

II. The Proposal to Require Refrigeration of Shell Eggs in Retail

Establishments

A. Rationale for Proposal

B. Legal Authority for FDA to Require Refrigeration of Shell

Eggs

C. Proposed Refrigeration Requirements at Retail

III. The Proposal for Shell Egg Labeling

A. Rationale for Shell Egg Labeling Proposal

B. Legal Authority for FDA to Require Label Statements

C. Covered Products

D. Essential Elements of Specific Label Statements

E. Placement and Prominence of Label Statements

IV. Analysis of Impact

A. Benefit/Cost Analysis

B. Small Entity Analysis

V. Executive Order 12612: Federalism

VI. Environmental Impact

VII. Effective Date

VIII. Paperwork Reduction Act of 1995

IX. Comments

X. References

I. Background

A. Epidemiology of Salmonellosis

Salmonella microorganisms are ubiquitous, and are commonly found in

the digestive tracts of animals, especially birds and reptiles. Human

illnesses are usually associated with ingesting food or drink

contaminated with Salmonella, although infection may also occur person

to person by the fecal-oral route where personal hygiene is poor and by

the animal to man route.

The disease salmonellosis results from an intestinal infection

with Salmonella microorganisms and is characterized by diarrhea, fever,

abdominal cramps, headache, nausea, and vomiting. Symptoms of

salmonellosis usually begin within 6 to 72 hours after consuming a

contaminated food or liquid and last for 4 to 7 days. Most healthy

people recover without antibiotic treatment. However, 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

severe and fatal illness (Ref. 1). This spreading phenomenon of

salmonellosis is more likely in children, the elderly, and persons with

weakened immune systems. In addition, about 2 percent of those who

recover from salmonellosis may later develop recurring joint pains and

arthritis (Ref. 2).

Salmonellosis is a serious health concern. It is a notifiable

disease, i.e., physicians are required to report cases (i.e., single

occurrences of illness) to the local health departments. These cases

are then, in turn, reported to state health departments, which report

the annual totals to the Centers for Disease Control and Prevention

(CDC). However, these reports are made only if there are test results

identifying the Salmonella microorganism that caused the illness.

In a 1979 to 1980 epidemiological study, CDC estimated that about

45 percent of those persons from whom Salmonella isolates\1\ were

reported were hospitalized for their illness and that 1.3 percent of

them died from complications associated with the illness (Ref. 3). Very

similar proportions were found in a 1984 to 1985 study. Using these

proportions, CDC estimated that, in 1988, the approximately 43,000

reported cases represented a minimum of 19,000 hospitalizations and 500

deaths. Reported cases likely represent only a small portion of the

actual number of illnesses that occur because: (1) Ill individuals do

not always seek care by medical professionals, especially if the

symptoms are not severe; (2) medical professionals may not establish

the cause of the illness but simply treat the symptoms; and (3) medical

professionals do not always report Salmonella cases to CDC. It is

estimated that the actual number of cases per year may be 20-fold to

100-fold greater than the number of reported cases. Therefore, the

number of actual cases of salmonellosis in 1988 was estimated to be

from 800,000 to 4 million (Ref. 4). In 1996, there were 39,027

confirmed cases\2\ of human salmonellosis reported to the CDC.

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\1\ When a physician sees a patient and suspects that the

patient has a case of salmonellosis, the physician may obtain a

patient's specimen (e.g., stool) for analysis. The specimen is sent

to the laboratory to be tested to identify and confirm any

Salmonella that may be present. Thus, the laboratory obtains the

actual isolate of Salmonella.

\2\ A case of illness is confirmed as salmonellosis only if an

isolate is confirmed by a laboratory as being Salmonella. Thus,

although all cases may not be confirmed, all confirmed cases are

associated with isolates of Salmonella.

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CDC surveillance data list close to 600 different Salmonella

serotypes (a group of related microorganisms distinguished by their

antigens) that have caused illness in the United States. The three

serotypes most frequently reported as

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causing illness are Salmonella Enteritidis (SE), S. Typhimurium, and S.

Heidelberg (Ref. 5). These microorganisms are found in poultry and

eggs.

Since 1976, SE-associated cases of salmonellosis have increased

and have been found throughout the country. SE accounted for only about

5 percent of the number of all reported Salmonella isolates in 1976. In

1985, 1990, 1994, 1995, 1996, and 1997, SE constituted 9.8 percent,

20.6 percent, 26 percent, 24.7 percent, 24.5 percent, and 22.9 percent,

respectively, of all Salmonella isolates. Currently, SE is one of the

most predominant reported serotypes. There were 7,924 SE isolates

reported in 1997 (Ref 7).

CDC surveillance data show that the overall rates of isolation\3\

of SE increased 680 percent during the period between 1976 to 1994

(Ref. 6). Initially, the increases in the United States largely

occurred in the Northeast. Later, the increase spread throughout the

country. While the trends for the years 1990 to 1994 show a 21 percent

decrease in the SE isolation rate in the Northeast, the rate increased

approximately 300 percent for the Pacific region.

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\3\ Rates of isolation are the number of reported isolates

divided by 100,000 total population.

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In 1985, the States reported 26 SE-related outbreaks (i.e.,

occurrences of 2 or more cases of a disease related in time and place)

to CDC but 77 outbreaks were reported by 1989. In 1996, there were 51

reported SE outbreaks (Ref. 9). From 1985 through 1996, there have been

a total of 660 SE-related outbreaks reported to CDC. Associated with

these outbreaks, there have been 25,935 reported cases of illness,

2,508 reported hospitalizations, and 77 reported deaths. Deaths have

occurred in all years of this time period. In 1997, there were 44

reported outbreaks (Ref. 10). Many SE outbreaks were attributed to food

served in commercial establishments, such as restaurants and other

commercial food service establishments, hospitals, nursing homes,

schools, prisons, private gatherings, and ships, with the implicated

food containing undercooked eggs (Ref. 11). Although most deaths linked

to reported SE-related outbreaks in recent years have occurred among

the elderly in hospitals and nursing homes (Ref. 3), salmonellosis can

be fatal to an otherwise healthy person if a sufficient dose is

ingested, and proper treatment is not administered (Ref. 12).

Until the mid-1980's, eggs were not associated with many Salmonella

outbreaks. Since the mid-1980's, however, the number of egg-associated

salmonellosis outbreaks have increased. Shell eggs are now the

predominant source of SE-related cases of salmonellosis in the United

States where a food vehicle is identified (Ref. 13). From 1985 to 1993,

consumption of eggs was associated with 83 percent of SE-related

outbreaks where a food vehicle was identified (Ref. 14). Recent data

indicate that egg-associated SE outbreaks still represent a significant

portion of the total number of all SE outbreaks reported to CDC. In

1996, 1997, and 1998, 60 percent, 70 percent, and 58 percent of the SE

outbreaks reported to CDC implicated foods containing eggs (Ref.

14A).\4\

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\4\ The total number of SE outbreaks implicating eggs is equal

to the total number of SE outbreaks minus the number of outbreaks

where the vehicle is unknown or where the implicated food is one

other than eggs, i.e., chicken or turkey.

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The Foodborne Diseases Active Surveillance Network (FoodNet\5\),

an active surveillance system for foodborne pathogens, recently

reported a 44 percent decrease in the isolation rate for SE (2.5 to 1.4

per 100,000 U.S. population) from 1996 to 1998 (Ref. 14B). This

decrease is substantial; however, the results are preliminary and the

reasons for this decrease are under investigation. Implementation of

egg quality assurance programs that included microbiological testing

and egg diversion may have contributed to this reported decrease.

However, the reported decrease may also be explained by a decline in

the presence of Salmonella isolated from poultry and meat products

because of recently implemented HACCP programs, or by some combination

of egg quality assurance and meat/poultry HACCP program. In any event,

FDA believes that the incidence of SE is still too high and that

additional measures can and should be put in place with respect to

shell eggs to reduce the incidence even further.

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\5\ FoodNet is a collaborative project among CDC, FSIS, FDA, and

8 sites in the U.S. where foodborne disease data are being

collected. To identify cases of foodborne illness, surveillance

personnel contact clinical laboratories weekly or monthly to obtain

data on numbers of cases.

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B. Salmonella Contamination of Eggs

Having evolved to protect the developing chick embryo, an egg

provides a uniquely inhospitable environment for Salmonella and other

bacterial contaminants. An egg's natural defenses are both mechanical

and chemical. Mechanically, there are four barriers that must be

overcome for bacteria to reach the nutrient-rich yolk where they can

rapidly multiply: (1) The shell, (2) the two membranes (inner and

outer) between the shell and the albumin (egg white), (3) the albumin,

and (4) the vitellin (yolk) membrane that holds the yolk. Additionally,

when laid, the egg shell is covered on the outside by the cuticle, a

substance similar to the shell membrane. When the cuticle dries, it

seals the egg's pores, thereby inhibiting initial bacterial

penetration. Consequently, a fresh egg is fairly resistant to invasive

bacteria. However, the cuticle is generally removed along with debris

on the surface of the shell during the cleaning process employed to

prepare eggs for commercial sale. Thus, this outermost defense is

generally not available to protect against trans-shell penetration of

bacteria.

The albumin is probably the most formidable defense against

microorganisms that have entered an egg. In a fresh egg, the albumin

has a high viscosity that both anchors the yolk in the center of the

egg and inhibits movement of microorganisms toward the yolk. Chemical

defenses of the albumin include: (1) A very alkaline pH (>9), (2) low

available nitrogen, and (3) proteins that have an anti-bacterial

effect, specifically, ova-transferrin and lysozyme. If, however,

conditions occur that allow SE to transverse the mechanical and

chemical barriers in an egg and reach the nutrient rich yolk, the

microorganisms may then increase in number.

Until recently, Salmonella contamination of shell eggs was thought

most likely to be by trans-shell penetration of bacteria present in the

egg's environment. The surface of an egg can become contaminated with

any microorganism that is excreted by the laying flocks. In addition,

contact with nesting materials, dust, feedstuff, shipping and storage

containers, human beings and other creatures may be a source of shell

contamination. The likelihood of trans-shell penetration increases with

the length of time that the eggs are in contact with contaminating

materials.

While environmental contamination is still a route for Salmonella

contamination, it has recently been found that an egg's contents can

become contaminated with SE before the egg is laid. Though the

mechanism is still not well understood, SE will infect the ovaries and

oviducts of some egg laying hens, permitting ``transovarian''

contamination of the interior of the egg while the egg is still inside

the hen (Refs. 15 and 16). The site of contamination is usually the

albumin.

It is believed that only a small number of hens in an infected

flock shed SE at any given time and that an infected hen

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may lay many uncontaminated eggs (Refs. 15 and 17). Nonetheless, it has

been estimated that of the 47 billion shell eggs consumed annually as

shell eggs, 2.3 million are SE-positive, exposing a large number of

people to the risk of illness (Ref. 8). FDA believes that it is this

transovarian contamination that is responsible for the increased number

of SE-related salmonellosis cases described in section I.A of this

document.

C. Infectious Dose

In general, the greater the numbers of microorganisms ingested,

the greater the likelihood of disease. The likelihood of disease is

also affected by the virulence of the microorganism and the

susceptibility of the host (Ref. 18). However, there is evidence that

the infectious dose (i.e., amount of microorganisms capable of causing

disease) for SE can be very low. For example, in a 1994 outbreak

attributed to consumption of SE-contaminated ice cream, the highest

level of contamination found in the implicated ice cream was only six

microorganisms per half-cup (65 gram) serving (Ref. 19). Another report

showed that by using a different method of determining levels of SE in

the implicated ice cream, the infective dose per serving was 25

microorganisms (Ref. 20). These reports indicate that low level

contamination of foods with SE, and thus, low doses, can lead to

illness. It is generally believed that SE-contaminated eggs initially

contain only a few microorganisms (less than 20 microorganisms (Ref.

21)). Thus, the small number of microorganisms that initially may

contaminate the egg may be sufficient to cause illness.

D. Inappropriate Handling of Eggs by Consumers and Other Food Preparers

SE outbreak investigations show that outbreaks commonly occur when

foods prepared with SE-contaminated eggs are not appropriately handled

by consumers or other food preparers. Common practices inappropriate

for foods containing SE-contaminated eggs include temperature abuse

(i.e., failing to keep the eggs and foods prepared with eggs

refrigerated) and inadequate cooking. Pooling eggs to prepare a large

volume of an egg-containing food that is subsequently temperature

abused or inadequately cooked can cause illness in large numbers of

people if any of the eggs were initially contaminated with SE.

Temperature abuse gives SE the opportunity to multiply, thereby

increasing the number of viable microorganisms ingested, especially

when eggs are consumed raw. Temperature abuse and consumption of raw

eggs were associated with an SE outbreak at a catered wedding reception

in New York, where Caesar salad dressing was implicated as the cause of

SE illnesses. The Caesar salad dressing was made with 18 raw shell

eggs, left unrefrigerated for 2 hours at the catering establishment,

held in an unrefrigerated truck until delivered, and served at the

reception 4\1/2\ hours later (Ref. 6).

Incomplete cooking of eggs (as in soft-boiled eggs or sunny-side

up eggs) also allows ingestion of viable microorganisms if any of the

eggs were initially contaminated. Incomplete cooking of eggs was

associated with an SE outbreak in Tennessee, where the consumption of

Hollandaise sauce served in a restaurant was linked to SE illnesses.

Review of the food handling practices showed that the sauce had been

prepared from eggs that were pooled, incompletely cooked, and served

more than one hour after preparation (Ref. 12). Another outbreak of SE

illness in an Indiana nursing home was linked to the consumption of

baked eggs. The baked eggs were prepared by pooling 180 Grade A raw

shell eggs, mixing with a whisk, and baking in a single pan at 204

deg.C (400 deg.F) for 45 minutes to 1 hour. Investigators believed

that inadequate cooking occurred because the mixture was not stirred

while baked (Ref. 6).

FDA is also aware that many consumers eat foods containing raw or

undercooked eggs. An FDA survey indicated that 53 percent of

respondents (total 1,620) ate foods containing raw eggs at some time

(Ref. 22). Raw egg-containing foods mentioned in this survey included

cookie batter, homemade ice cream, homemade eggnog, Caesar salad,

frosting, homemade shakes, homemade Hollandaise sauce, and homemade

mayonnaise. The Menu Census Survey (1992 to 1995) (Refs. 23 and 24)

showed that frosting accounted for 53 percent and salad dressing 19

percent of occasions when raw egg-containing products were consumed.

The 1996 to 1997 Food Consumption and Preparation Diary Survey

(Ref. 24) showed that 27 percent of all egg dishes consumed were

undercooked (described as being runny or having a runny yolk or runny

white). On average, each person consumed undercooked eggs 20 times a

year. Within those groups at risk, women over 65 and children under 6

consumed undercooked eggs 21 times a year and 8 times a year,

respectively. Moreover, consumer focus group research showed that many

participants did not realize that certain foods such as chocolate

mousse or key lime pie may contain raw or undercooked eggs, and,

therefore, are potentially hazardous (Ref. 25).

E. Current Commercial Practices for Handling Eggs

Egg production facilities are either ``in-line'' facilities or

``off-line'' facilities. An in-line facility integrates laying,

packing, and processing at one location. Freshly laid eggs go directly

into a processing system where they are cleaned, sorted, and packed for

distribution. An ``off-line'' facility receives eggs from laying

facilities at other locations. Generally eggs are cleaned before they

are packed. Typically, U.S. processors use hot water (43 to 49 deg.C

(110 to 120 deg.F)) to wash eggs. After the eggs are washed, they are

dried with forced ambient air and then packed. At the time that eggs

are packed, the internal temperatures are often in the 21 to 27 deg.C

(70 to 80 deg.F) range. Most processors hold packed eggs in coolers at

an ambient temperature of 7 to 16 deg.C (45 to 60 deg.F).

Currently, eggs are held at various temperatures for various times

prior to purchase by the consumer. The U.S. Department of Agriculture

(USDA) estimates the following times and temperatures in the

distribution of shell eggs: (1) 2 to 72 hours at temperatures of 7.2 to

32 deg.C (45 to 90 deg.F) at the processor, (2) 1 to 24 hours at

temperatures of 7.2 to 32 deg.C (45 to 90 deg.F) during

transportation, (3) 0 to 60 days at temperatures of 4 to 32 deg.C (40

to 90 deg.F) at retail (Ref. 8). These data indicate that, especially

at retail, eggs are being held, for long periods of time, at

temperatures that will not inhibit growth of SE. Currently, 37 States

and the District of Columbia require ambient temperatures of 7.2 deg.C

(45 deg.F) or less for egg storage and handling at retail. The other

States either require ambient temperatures of 16 deg.C (60 deg.F) or

less (i.e., the temperature required under USDA grading standards) or

have no temperature requirements for egg storage and handling at

retail.

These ambient temperatures, however, do not correlate to the

internal temperature of the egg. The internal temperature of the egg

when the eggs are transported ranges between 10 and 27 deg.C (50 and

80 deg.F), depending on the egg's temperature at the time of packing,

the way the eggs are packaged, how the crates are packed and stacked,

and the length of time they are in the cooler before they are shipped

(Ref. 26).

F. Limiting the Numbers of Salmonella Microorganisms in Eggs

Because studies suggest that infectious dose for SE can be low,

FDA

[[Page 36495]]

believes that the ideal solution to this public health problem would be

to adopt measures to eliminate viable SE in shell eggs, either through

preventing transovarian and trans-shell contamination or through

processing to destroy viable SE in shell eggs, with distribution

safeguards to prevent subsequent recontamination. However, FDA has

tentatively concluded that eliminating viable SE in shell eggs in

either of these two ways is not yet practicable. Other measures that

can limit SE and inform consumers how to avoid the risks posed by SE

are, however, practicable and thus FDA is proposing in this regulation

to put such measures in place. The agency has also, jointly with USDA,

published an advance notice of proposed rulemaking (ANPRM) (63 FR

27502, May 19, 1998; ``the 1998 ANPRM'') that requests comments on

farm-to-table actions that will decrease the food safety risks

associated with shell eggs.

As mentioned previously, although fresh shell eggs provide a

particularly inhospitable environment for Salmonella and other

microorganisms to multiply, the chemical and physical barriers against

bacterial movement and growth degrade over a period of time.

Consequently, as a result of degradation, SE and other bacteria, if

present, are better able to move into the nutrient rich yolk, which

provides a favorable environment for growth of SE.

Studies demonstrate that the rate of this degradation is time and

temperature related. C. J. Kim et al. (Ref. 27) found that SE

inoculated into the albumin of whole shell eggs multiplied to high

numbers if the inoculated eggs were not properly refrigerated. This

study examined the growth of SE inoculated into the albumin of shell

eggs in numbers ranging from approximately 2 to 200,000 organisms per

egg and held for 10, 20, or 30 days at 1 of 5 different temperatures

from 4 deg.C (39 deg.F) to 27 deg.C (81 deg.F).

The investigators in this study found that, of the variables

studied, temperature was the most important in determining the growth

of SE (Ref. 27). Furthermore, they found that the growth response was

directly proportional to the temperature at which the inoculated eggs

were held. The study demonstrated that SE inoculated in shell eggs can

multiply to substantial levels if held at 10 deg.C (50 deg.F) or

higher for up to 30 days. The authors concluded that ``because the

number of SE present at the time an infected egg is laid is probably

very low, egg storage at 4 deg.C (39 deg.F) could be expected to

result in a smaller risk to the public health than higher storage

temperatures'' (Ref. 27). Thus, although albumin is inhibitory to

Salmonella, these experiments show that SE inoculated into shell egg

albumin, even at low levels, can multiply to substantial levels if held

at 10 deg.C (50 deg.F) or higher for a significant period of time.

A subsequent study by Humphrey et al., (Ref. 21), of 5,700 eggs

from flocks naturally infected with SE, appears to show that albumin is

seeded with SE during passage of the egg through the oviduct. These SE

microorganisms remain dormant even in eggs stored at room temperature

(21 deg.C (70 deg.F)) for 2 to 3 weeks. However, after that period of

time, nutrients or factors that negate the inhibitory properties of

albumin appear to leak out of the yolk, possibly because of changes in

the yolk membrane. These substances obtain levels close to the yolk in

a sufficiently high concentration to support large populations of SE.

In a study of laying hens that were experimentally infected with

SE, R. K. Gast and C. W. Beard (Ref. 28) also found that infected hens

can produce eggs with SE contaminated contents. Their study indicates

that transovarian infection followed by limited room temperature

storage (25 deg.C (77 deg.F)) resulted in contamination of the yolk

membrane or albumin, or both, but not the contents of the yolk. In the

Gast and Beard experiments, all eggs were held at room temperature for

4 days before sampling. Although the number of microorganisms per egg

was not measured, indirect evidence, such as the higher recovery

frequency of SE from egg contents when incubated in broth for 48 hours

versus 24 hours, suggests that the number of microorganisms per egg was

low after holding the eggs for 4 days at room temperature.

Clay and Board (Ref. 29), by inoculating SE into the air cell of

eggs, were able to show that the movement of the microorganism from the

shell membrane to albumin and to the yolk was associated with aging

related changes in the egg structure. These changes, such as changes in

the relative densities of the albumin and yolk and enlargement of the

air cell, result in movement of the yolk towards the inoculated SE

during storage. These changes have the effect of bringing the yolk

closer to the contaminated shell membranes when the egg is incubated in

a position with the air cell uppermost. These investigators found that

gross contamination of the albumin with SE was inhibited when the eggs

were stored at 4 deg.C (39 deg.F) although the microorganism was

viable throughout 30 days of storage. However, storage of eggs at 4

deg.C (39 deg.F) or 10 deg.C (50 deg.F) for 20 days followed by an

increase in temperature to 25 deg.C (77 deg.F) led to generalized

infection of the egg contents. Clay and Board state that their

observations suggest that refrigerated storage of eggs should be a part

of a protective barrier between the laying flock and the consumer, and

to be effectively realized, refrigerated storage would have to be

imposed shortly after the egg is laid and continue until immediately

before cooking and consumption.

T. J. Humphrey (Ref. 30) studied the effect of storage

temperatures of 8, 10, 12, and 15 deg.C (46, 50, 54, and 59 deg.F) on

Salmonella growth in artificially inoculated eggs. No growth was

observed after 3 weeks at 8 deg.C (46 deg.F). Growth of SE phage type

4 and 13a was observed at 10, 12, and 15 deg.C (50, 54, and 59

deg.F). SE phage 8 showed no growth at temperatures below 12 deg.C (54

deg.F).

Bradshaw et al. (Ref. 30A) studied the effect of storage

temperatures on the growth of SE inoculated into the yolks of shell

eggs. The inoculated yolks were incubated at 37, 15.5 and 7 deg.C (99,

59, and 45 deg.F). They observed no significant growth when the eggs

were held at 7 deg.C (45 deg.F) for up to 94 days.

FDA finds that the scientific evidence on the growth of SE in eggs

shows that control of storage temperature of shell eggs can effectively

prevent the multiplication of any SE that may be present. While there

is some debate about the precise optimum storage temperature for eggs,

the research cited previously clearly indicates that refrigerating

shell eggs at 8 deg.C (46 deg.F) and 7.2 deg.C (45 deg.F) or less

greatly extends the time that an egg can maintain its defenses against

movement of contaminating bacteria such as Salmonella to the nutrient

rich yolk, and, therefore, substantially reduces the likelihood that

any SE that is present will be able to increase in numbers. Moreover,

there is evidence that cooling eggs reduces the heat resistance of SE

microorganisms, making any microorganisms that may be present in an egg

more likely to be killed when the egg is less than completely cooked

(Refs. 30 and 31). Thus, FDA believes that sustained refrigeration of

eggs plays an important role in reducing the likelihood that any SE

present will reproduce.

Although continued refrigeration of eggs reduces likelihood of

outgrowth of any SE that may be present, another measure a consumer may

take to reduce the likelihood of consuming contaminated eggs is to

thoroughly cook eggs. CDC reports that thorough cooking normally kills

Salmonella that may be present in eggs (Ref. 32). However, some

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cooking techniques commonly used for eggs or egg-containing foods do

not thoroughly cook the eggs. For example, eggs that are liquid or

runny after light cooking (e.g., soft boiled eggs, and sunny-side up

eggs) can still contain viable Salmonella microorganisms. FDA's Food

Code (a model code that is published by FDA and intended for adoption

by States and local authorities for governing food retail and food

service establishments) requires that raw eggs that are broken and

prepared in response to a consumer's order be cooked at 63 deg.C (145

deg.F) for 15 seconds. Other raw eggs are required to be cooked 15

seconds at 68 deg.C (155 deg.F) (Ref. 33).

G. Current Efforts

FDA and the Food Safety and Inspection Service (FSIS) of the USDA

share Federal authority to regulate eggs for safety. FDA has

jurisdiction over the safety of foods (except meat and poultry)

generally, including shell eggs, under section 201 of the Federal Food,

Drug, and Cosmetic Act (the act) (21 U.S.C. 321, et seq.) and under the

Public Health Service Act (PHS Act) (42 U.S.C. 201 et seq.).

USDA has primary responsibility for implementing the Egg Products

Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). Under the EPIA, FSIS,

and USDA's Agricultural Marketing Service (AMS) share responsibility to

inspect processed egg products and to ensure proper distribution of

eggs that are cracked or otherwise unsuitable for sale as whole shell

eggs.

Federal agencies are working cooperatively with egg producers and

others to enhance the safety of eggs that are sold to consumers. USDA's

Extension Service, FSIS, AMS, and FDA all provide educational material

on egg production methods that enhance food safety. FDA and FSIS work

with States to encourage uniformity among state laws in retail and food

service establishments through adoption of the Food Code. In addition,

FDA, which has responsibility for investigating reports of SE outbreaks

from foods in interstate commerce, performs trace backs to identify the

source of the implicated eggs, environmentally tests flocks, diverts

eggs from SE positive flocks, collects flock data to help track the

spread of SE among layer flocks, and encourages better quality control.

In recent years, several programs have been created for the

purpose of controlling the spread of SE on farms. One such program, the

National Poultry Improvement Plan (NPIP), a cooperative Federal-State

program sponsored by USDA's Animal Plant Health Inspection Service

(APHIS), was developed to provide assistance to breeders and hatcheries

in keeping flocks free of egg-transmitted diseases. In 1989, the NPIP

developed an SE control program to reduce the prevalence of SE in

hatching eggs and chicks through sanitation and other control measures.

Another APHIS-sponsored joint Federal, State, and academic program, the

Salmonella Enteritidis Pilot Program, was started in Pennsylvania in

1992. The objectives of the program were to develop effective and

efficient procedures for monitoring SE and effective and efficient ways

to prevent SE from contaminating eggs. The findings from the pilot

program were incorporated into the Pennsylvania Egg Quality Assurance

Program (PEQAP). The success of the PEQAP was indicated by a study,

conducted in 1995, that demonstrated a decline in the number of SE-

positive samples in houses that had been in the program from 1992 to

1995 (Ref. 34). Other programs have been developed to address the

spread of SE to eggs, such as California's Egg Quality Assurance Plan,

the New England Risk Reduction Program for SE, the United Egg

Producers' Five Star Program, and the United States Animal Health

Association's Best Management Practices for a Salmonella Enteritidis

Reduction Program For Egg Producers.

A spent hen and liquid egg survey conducted by USDA in 1991 and

repeated in 1995 showed that, despite the efforts described previously,

the nation-wide prevalence of SE-positive flocks and the incidence of

SE in shell eggs increased (Ref. 35). Because of the number of human

illnesses and deaths attributable to SE in shell eggs, FDA and USDA are

concerned that the current regulatory program for shell eggs is not

adequate. Consequently, FDA and USDA are looking at ways of addressing

the ``farm to table'' safety of shell eggs. FDA and FSIS recently have

taken several steps to address the issue of reducing the risk of SE

associated with shell eggs.

For example, in 1990, FDA reclassified eggs as a ``potentially

hazardous food'' in the Food Code. The 1999 Food Code stipulates that

potentially hazardous foods, including eggs, be maintained at 5 deg.C

(41 deg.F) or less (Ref. 33). However, because of the number of

illnesses associated with eggs and the fact that not all States have

adopted this aspect of the Food Code, FDA tentatively concludes that

stronger measures are necessary regarding handling of shell eggs.

On November 18 to 20, 1996, FDA and FSIS sponsored a 3-day

technical conference that provided a forum for discussion on

temperature control interventions and verification techniques in the

transportation and storage of meat, poultry, seafood, and eggs and egg

products. FSIS and FDA also published a joint ANPRM (61 FR 59372,

November 22, 1996) soliciting information on issues related to ensuring

the safety of potentially hazardous foods during transportation and

storage. Comments to that document are being analyzed.

In addition, in December 1996, FSIS began a science based risk

assessment for shell eggs and egg products. This project was conducted

by a multidisciplinary team of scientists from academia and USDA. The

project goals were to provide an understanding of egg-associated

foodborne disease, assist in evaluating farm to table risks and ways to

reduce risks, and verify additional data needs. The final report was

issued June 12, 1998.

On September 3, 1997, FDA and FSIS jointly held a public meeting

to review the current science, including technological and safety

factors, relating to shell eggs and egg products and to identify

intervention options that are most effective in reducing the public

health risk in a cost-effective manner. Experts from industry,

academic, regulatory, and consumer sectors presented information on

illnesses and the epidemiology of outbreaks arising from shell eggs and

foods containing raw and undercooked eggs; current concerns with

emerging pathogens; procedures for processing eggs; and new and

existing technology to control pathogens in shell eggs and egg

products. Comments from this meeting were considered in the risk

assessment project.

In addition, FDA and USDA recently published in the Federal

Register an ANPRM seeking to identify farm-to-table actions that will

decrease the food safety risks associated with shell eggs. Information

gathered from the foregoing measures will be considered as part of the

two agencies' approaches for a comprehensive program to address the

safety of shell eggs from farm to table. Because rulemaking to address

a comprehensive program will likely take considerable time, FDA

believes that it can meet an immediate goal of reducing the risk of

foodborne illness from SE by ensuring that shell eggs at retail are

held at appropriate temperatures and by providing safe handling

statements for shell eggs. In addition, as stated in section II.A of

this document, USDA published a final rule in the Federal Register of

August 27, 1998 (63 FR 45663), amending its regulations to require that

shell eggs packed for

[[Page 36497]]

consumer use be stored and transported at an ambient temperature that

does not exceed 7.2 deg.C (45 deg.F) and that containers of shell

eggs be labeled to indicate that refrigeration is required. Both FDA

and FSIS will consider actions based on comments to the ANPRM to

address issues other than labeling and refrigeration of eggs while held

for retail distribution.

H. Petitions to the Agency

FDA received a petition from Rose Acres Farms, Inc., (filed

November 4, 1996, Docket No. 96P-0418) requesting, among other things,

that the agency amend Sec. 101.17 (21 CFR 101.17) by adding a

requirement that shell eggs bear a label statement that informs

consumers of safe handling practices for the product. In support of its

request, the petition contended that practically all SE outbreaks and

deaths have involved mishandling of eggs. The petition stated that,

therefore, reducing practices such as temperature abuse or inadequately

cooking eggs would virtually eliminate the problem. The petition also

asserted that some egg producers may not wish voluntarily to include

safe handling information on their labels because they fear their

competitors may not include the same information, and, therefore, their

product would seem less safe by comparison. However, if FDA required

safe handling instructions on all cartons of shell eggs, then no

producer would be at a competitive disadvantage. The petition suggested

the following label statement: ``Keep refrigerated and cook thoroughly

before eating. Use pasteurized egg products for any recipe which does

not require that the eggs be thoroughly cooked.''

FDA also received a petition from CSPI (filed May 14, 1997, Docket

No. 97P-0197) requesting, among other things, that the agency require

that the carton of shell eggs bear a label statement cautioning

consumers that eggs may contain harmful bacteria, and that consumers

should not eat raw or undercooked eggs. In support of its request, CSPI

stated that SE in eggs is a serious health problem and that illnesses

caused by SE in the United States have increased. CSPI further stated

that consumers have no way of knowing that an egg is contaminated

because eggs that are contaminated with SE have a normal appearance.

The petition suggested the following label statement: ``Caution: Eggs

may contain illness-causing bacteria. Do not eat raw. Cook until yolk

is firm.''

The petition also requested, among other measures, that the agency

require that eggs be refrigerated to an internal temperature of 5

deg.C (41 deg.F) as soon as possible and kept at that temperature at

all points up to and including the point of retail sale. This

temperature, according to CSPI, will ensure that SE cannot multiply.

USDA/FDA received approximately 73 responses to the 1998 ANPRM,

each containing one or more comments. Responses were received from egg

farmers, egg packers, associations for the egg industry, other trade

associations, consumers, consumer interest groups, animal interest

groups, academia, State government agencies, and foreign government

agencies. Many of these comments addressed issues not relevant to this

proposed rule, e.g., implementation of national standards for QA

programs, implementation of HACCP, transportation of shell eggs, sell-

by and expiration dates for shell eggs, housing and forced molting of

chickens, repacking of eggs, and exportation of SE-contaminated into

other countries. FDA will not address those comments in this proposed

rule. There were, however, several comments that did raise issues

relevant to this proposed rule such as the extent of the SE problem,

refrigeration of shell eggs, and safe handling instructions on consumer

packages of shell eggs. Although most of these comments supported the

approach proposed in this document, some comments suggested different

approaches than those in this proposal. These latter comments are

addressed below in the appropriate sections of this document.

II. The Proposal to Require Refrigeration of Shell Eggs in Retail

Establishments

A. Rationale for Proposal

As noted previously, the incidence and geographical distribution

of egg-associated SE illnesses have made SE a significant public health

concern. As discussed in section I.F of this document, one currently

practicable measure that can limit the number of viable SE present in

shell eggs is refrigeration, because it helps to maintain the

effectiveness of the egg's natural defenses against SE and slows the

growth rate of SE. Many of the comments to the 1998 ANPRM maintained

that refrigeration of eggs is an essential measure to inhibit the

growth of SE. Although there is the potential for SE to be present in

shell eggs in infective doses regardless of adequate handling,

temperature abuse increases the likelihood for the growth of any

microorganisms present, thus increasing the risk of illness.

As noted previously, USDA has the responsibility of implementing

the EPIA. Amendments to the EPIA in 1991 (Pub. L. 102-237) require that

shell eggs packed for consumers be stored and transported under

refrigeration at an ambient temperature (i.e., the air temperature

maintained in an egg storage facility or transport vehicle) not to

exceed 45 deg.F and that the egg containers be labeled to indicate

that refrigeration is required. FSIS has amended its regulations to

require that no shell egg handler shall possess any shell eggs that are

packed in containers destined for the ultimate consumer unless they are

stored and transported under refrigeration at an ambient temperature of

no greater than 45 deg.F (7.2 deg.C). In its regulation, FSIS defines

an egg handler as any person, excluding the ultimate consumer, who

engages in any business in commerce that involves buying or selling any

eggs or processing any egg products, or otherwise using any eggs in the

preparation of human food. FSIS defines an ultimate consumer as any

household consumer, restaurant, institution, or other party who has

purchased or received shell eggs or egg products for consumption. This

regulation is effective August 27, 1999.

Once the amendments to the EPIA are implemented, requirements will

be in place for the refrigeration of packed shell eggs up to the point

of retail distribution except that egg producers with a flock of 3,000

hens or less are exempt from this requirement. However, without the

continued refrigeration of shell eggs up to the time the eggs are

cooked, there would be an opportunity for the egg's defenses to degrade

and growth of SE to occur. FSIS's regulation does not require the

ultimate consumer to maintain shell eggs under refrigeration.

Consequently, the failure to refrigerate shell eggs in facilities such

as restaurants and institutions could result in SE outgrowth.

Therefore, to ensure that shell eggs are maintained under refrigeration

throughout retail distribution up until they are cooked. FDA

tentatively concludes that it should propose requirements that shell

eggs throughout retail distribution be kept refrigerated until they are

cooked. Without these requirements, the effectiveness of refrigeration

in any part of the farm-to-table continuum would not be maximized.

B. Legal Authority for FDA to Require Refrigeration of Shell Eggs

FDA is proposing these regulations under both the PHS Act and the

act. FDA's legal authority to require refrigeration of eggs at retail

derives from the provisions of sections 311, 361,

[[Page 36498]]

and 368 of the PHS Act (42 U.S.C. 243, 264, and 271) that relate to

communicable disease. The PHS Act authorizes the Department of Health

and Human Services (DHHS) to make and enforce such regulations as ``are

necessary to prevent the introduction, transmission, or spread of

communicable diseases from foreign countries into the States * * * or

from one State * * * into any other State'' (section 361(a) of the PHS

Act (42 U.S.C. 264(a))).

Salmonellosis is a communicable disease that can be caused by SE-

contaminated eggs. Temperature abuse can lead to the multiplication of

SE in shell eggs, and thereby, increase the likelihood of illness if

the eggs are not thoroughly cooked. Therefore, the agency tentatively

concludes that a regulation to require refrigeration is necessary to

prevent the spread of communicable disease.

Although the egg market is largely regional, it involves

significant shipment of eggs from State to State. Moreover, shipment of

SE-contaminated eggs from one State to another has contributed to the

geographical spread of disease outbreaks in the U.S. human population.

For example, eggs from Pennsylvania were implicated in an outbreak of

SE infection reported in Asbury Park, NJ, involving at least 47

persons, and eggs from Maryland were implicated in an outbreak in

Livonia, NY, where 12 patrons of a restaurant reported gastroenteritis

illness linked to consumption of omelets made from pooled grade A eggs

(Ref. 36). As discussed in section I.D of this document, an SE outbreak

at a wedding reception in New York was associated with the consumption

of Caesar salad dressing. Eggs used to make the dressing were traced to

a Pennsylvania producer (Ref. 6).

FDA tentatively concludes that a regulation to require

refrigeration of shell eggs at retail (proposed Sec. 115.50(b)) also

should apply to eggs that are not shipped across State lines by

producers or retailers because there have been SE outbreaks that were

associated with such eggs (Ref. 37). Therefore, the agency believes a

regulation to require refrigeration of eggs produced and sold within a

State would reduce the risk of illness. In addition, the agency

tentatively concludes that the spread of salmonellosis among States

from SE-contaminated eggs cannot be fully controlled without extending

the refrigeration requirement to sales within one State. FDA believes

that consumers who shop across State borders may purchase SE-

contaminated shell eggs from one State and carry the eggs across State

lines. Thus, FDA is concerned that if it does not require refrigeration

of shell eggs that are laid, processed, and sold in one State, the

regulations will not prevent the introduction of SE contaminated eggs

into other States and, thus, will not prevent the introduction of

salmonellosis from one State to another.

The agency also notes that in the normal course of business, many

food service establishments, e.g., restaurants, serve out-of-State

customers, e.g., truck drivers, tourists, and others who regularly

travel for work. The agency is concerned that if these out-of-State

consumers become ill with salmonellosis from SE-contaminated eggs

purchased through intrastate commerce, the disease could spread from

one State to another. For these reasons, the agency tentatively

concludes that refrigeration should also be required on all shell eggs

to prevent the spread of a communicable disease among States.

FDA's legal basis to require refrigeration of shell eggs also

derives from sections 402(a)(4), and 701(a) of the act (21 U.S.C.

342(a)(4) and 371(a)). Under section 402(a)(4) of the act, a food is

adulterated if it is prepared, packed, or held in insanitary conditions

whereby it may have been contaminated with filth or may have been

rendered injurious to health. Under section 701(a) of the act, FDA is

authorized to issue regulations for efficient enforcement of the act.

Thus, a regulation that prohibits food from being held under insanitary

conditions would provide for efficient enforcement.

FDA has traditionally not conducted enforcement activities in

retail establishments. The agency has, instead relied on State and

local authorities to provide enforcement at the retail level.

Nonetheless, the agency has been active in the retail arena in a number

of ways. First and foremost, FDA participates in the Conference on Food

Protection which is the cooperative body responsible for making

recommendations to FDA concerning the Food Code. FDA also publishes the

Food Code. In addition, FDA interacts with State and local regulatory

agencies in a number of ways to coordinate retail enforcement efforts.

Within FDA, the Division of Federal-State Relations, located in the

Office for Regulatory Affairs, in the Office of the Commissioner, was

created to enhance interactions between Federal, State, and local

officials. The Division of Federal-State Relations serves as the focal

point for providing cohesive and uniform food policies to State

associations and cooperating State and local officials. Retail food

specialists work with State and local retail food regulatory agencies

to assist them, when the Code has been adopted, in implementing the

Food Code and to ensure through standardization of local and State

health officials that the Food Code criteria are uniformly applied.

Retail food specialists are located in FDA regional offices. Some

districts may have partnership agreements with States. Goals of these

partnerships include increasing staff proficiency, improving

consistency of enforcement activities, and empowering cooperating

organizations. This may also include assisting with implementation of

retail food programs. FDA has structured the proposed regulation to

take into account the traditional sharing of responsibilities of food

safety at retail, augmented by a clear quantitative Federal standard

for temperature control.

Under the PHS Act, the Federal, State, and local governments have

a long tradition of cooperation, and the PHS Act specifically

recognizes cooperation between the Federal government and State and

local governments as an important tool for public health officials.

Previously, in the area of food safety, FDA has used those portions of

the PHS Act (e.g., sections 310 and 311 (42 U.S.C. 242n and 243)) that

focus on Federal assistance to the States. Indeed, the Conference on

Food Protection and the Model Food Code are a result of Federal/State/

Local cooperation and Federal assistance to the States and localities

under the PHS Act. However, section 311 of the PHS Act not only

recognizes Federal assistance to the States, it also recognizes that

the States and localities may be able to assist the Federal Government.

This section provides in part: ``The Secretary is authorized to accept

from State and local authorities any assistance in the enforcement of

quarantine regulations made pursuant to this chapter which such

authorities may be able and willing to provide.''

FDA believes that, under sections 311 and 361 of the PHS Act,

there are several ways the agency could accept assistance from the

States in the enforcement of the egg refrigeration regulation. For

example, FDA could accept State and local assistance in the inspection

of retail establishments and then use those inspections as the basis

for detention and diversion or destruction under proposed

Sec. 115.50(f) (as discussed in section II.C of this document) or as

the basis for an enforcement action under the act. Another option would

be to authorize

[[Page 36499]]

the States and localities to conduct inspections and enforce the

refrigeration requirement through the administrative enforcement

remedies set out in proposed Sec. 115.50(f) (as discussed in section

II.C of this document), while FDA could hear appeals, with judicial

review available after FDA's decision. FDA also believes it could

follow the example set out in the Nutrition Labeling and Education Act,

which allows the States, if certain conditions are met, to bring an

action to enforce various food labeling provisions in the act. See 21

U.S.C. 337; 21 CFR 100.2. Finally, FDA believes that section 311 of the

PHS Act, in conjunction with section 361 of the PHS Act, authorizes the

agency to issue a regulation that would allow States and localities to

enforce the refrigeration regulation themselves.

After examining these options, FDA is concerned that all except

the last option (allowing States and localities to enforce the

regulation themselves) would prove too cumbersome, especially in light

of the straightforward requirement at issue. Although a few comments

maintained that the regulatory responsibility of egg handling and

preparation in retail establishments remains at the State and local

level, other comments supported a federal-State cooperative approach.

FDA agrees that a cooperative approach would be the most effective

means to enforce the refrigeration requirement. Therefore, FDA has

tentatively concluded to propose to allow agencies of those States and

localities that are able and willing under section 311 of the PHS Act,

and that are authorized to inspect or regulate retail establishments,

to enforce the refrigeration regulation along with FDA. FDA has

tentatively concluded that this option will allow for the most

effective and efficient use of Federal, State, and local food safety

resources because it recognizes that States and localities, more than

FDA, currently do this kind of enforcement. Accordingly, proposed

Sec. 115.50(e) provides that those States and localities that are able

and willing are authorized under sections 311 and 361 of the PHS Act to

enforce proposed Sec. 115.50(b) as set out in proposed Sec. 115.50(f).

With respect to the hearing procedures, the proposed regulation

recognizes that many States and localities already have administrative

procedures in place for hearings by allowing them to use a similar

hearing process as long as that process satisfies basic due process

requirements.

FDA recognizes that some of these approaches are new approaches to

the enforcement of food safety regulations, and accordingly is

soliciting, and will carefully review, comments on this aspect of this

proposed regulation. FDA is particularly interested in comments on how

State, local, and Federal food safety authorities can best interface to

ensure effective and efficient implementation and enforcement of food

safety standards.

C. Proposed Refrigeration Requirements at Retail

FDA is proposing in new Sec. 115.50 to require that shell eggs

held for retail distribution be promptly placed under refrigeration and

be stored and displayed under refrigeration at an ambient temperature

not greater than 7.2 deg.C (45 deg.F) while held at the retail

establishment.

The evidence discussed in section I.A of this document shows that

shell eggs have been vehicles for salmonellosis. USDA's proposed

requirement for refrigeration of shell eggs includes storage at the

producer and storage during transportation, but does not include

storage or holding at all retail establishments. FDA tentatively finds

that the weight of the available evidence on the growth of SE in eggs

shows that this microorganism can multiply to high levels in eggs if

the eggs are not properly refrigerated during their shelf-life. Failure

to refrigerate shell eggs during retail handling of shell eggs provides

favorable conditions for degradation of the egg's defenses, movement of

SE to the yolk, and subsequent multiplication of SE. Therefore, FDA

tentatively concludes that it is necessary to require that eggs at

retail be held at temperatures that will help maintain the natural

defenses of the egg and limit the growth and reproduction of SE.

As discussed in section I.F of this document, research indicates

that SE multiplies at temperatures of 10 deg.C (50 deg.F) and above

but that multiplication of SE is inhibited at lower temperatures, e.g.,

8 deg.C (46 deg.F), 7.2 deg.C (45 deg.F), and 4 deg.C (39 deg.F).

Therefore, the agency tentatively concludes that it should require a

refrigeration temperature lower than 10 deg.C (50 deg.F) to ensure

the safety of shell eggs. As noted as follows in this section, the Food

Code recommends that potentially hazardous foods be maintained at a

temperature of 5 deg.C (41 deg.F). A temperature of 5 deg.C (41

deg.F) not only inhibits the growth of Salmonella, but also, inhibits

the growth of Listeria monocytogenes, which has been shown to grow at

7.2 deg.C (45 deg.F). The agency also notes that, as required under

the Egg Products Inspection Act, USDA has amended its regulations to

require that shell eggs packed for consumer use be stored and

transported at an ambient temperature of 7.2 deg.C (45 deg.F). Based

upon the data discussed in section I.F of this document, FDA

tentatively concludes that 7.2 deg.C (45 deg.F), i.e., the same

temperature required by USDA under the EPIA for the storage and

transportation of shell eggs, is sufficient to protect the public

health. Because eggs cool down only slightly faster at 5 deg.C (41

deg.F) than at 7.2 deg.C (45 deg.F), the lower temperature would have

a negligible effect on the SE risk.

FDA notes that it is proposing an ambient and not an internal

temperature requirement for shell eggs displayed and stored in retail

establishments. The majority of comments to the 1998 ANPRM supported

refrigeration of shell eggs throughout the distribution chain from

packer to consumer. Most of these comments supported a requirement for

an ambient temperature of 7.2 deg.C (45 deg.F). A few of these

comments encouraged the agency to consider an internal temperature

requirement of 7.2 deg.C (45 deg.F) or ambient or internal

temperature requirements of 5 deg.C (41 deg.F), which, it was

asserted, would result in an additional margin of safety.

As discussed in section I.F, research indicates that refrigeration

of shell eggs at 7.2 deg.C (45 deg.F) greatly extends the time that

an egg can maintain its natural defenses, and, thus, inhibit the growth

of SE. FDA acknowledges that an internal temperature of 5 deg.C (41

deg.F) or 7.2 deg.C (45 deg.F) would also achieve this goal. However,

FDA believes that a uniform requirement for an internal temperature

would be difficult to monitor. As discussed in section I.E of this

document, the internal temperature of eggs when they are transported

depends on the temperature of the eggs when they are packed, the way

the eggs are packaged, how the crates are packed and stacked, and the

length of time they are in the cooler before they are shipped. Further,

according to one comment to the 1998 ANPRM, transportation of eggs in

refrigerated trucks do not provide cooling, but rather maintain the

temperature of the eggs. Moreover, it may be impracticable for egg

retailers to determine the internal temperatures of shell eggs.

Therefore, the agency tentatively concludes that, to provide a level

playing field for all egg retailers, it is appropriate to propose an

ambient temperature requirement for the display and storage of shell

eggs at retail. FDA requests comment on its tentative conclusion.

The agency notes that some States or localities may have

temperature requirements lower than 7.2 deg.C (45 deg.F). The agency

does not intend that this proposed regulation would, when finalized,

preempt the requirements of

[[Page 36500]]

the Food Code or other State or local requirements that require a lower

temperature. The proposed regulation would, however, preempt any State

or local requirements that allow a temperature greater than 7.2 deg.C

(45 deg.F).

The agency notes that the proposed temperature for storage of

shell eggs addresses growth of SE in shell eggs, whereas the

temperature required by the Food Code addresses all pathogens that may

be present in different types of potentially hazardous foods. Thus, in

addressing holding temperatures for potentially hazardous foods

generally, the Food Code requires a temperature for retail storage that

will prevent or slow the growth of most pathogens, including cold-

tolerant pathogens such as L. monocytogenes. As previously discussed in

this section, the agency tentatively concludes that a maximum storage

temperature of 7.2 deg.C (45 deg.F) will be effective in inhibiting

the growth of SE that may be present in shell eggs. FDA notes that a

requirement that shell eggs be stored at 7.2 deg.C (45 deg.F) or less

does not preclude retailers from maintaining shell eggs at lower

refrigeration temperatures. In fact, the agency would encourage it.

Moreover, it may be most practicable for establishments to have one

requirement for a maximum refrigeration temperature for all potentially

hazardous foods. FDA requests comment on the safety implications in the

difference between the proposed temperature requirement of 7.2 deg.C

(45 deg.F) for storage of shell eggs at retail and the refrigeration

temperature of 5 deg.C (41 deg.F), recommended in the Food Code.

Because failure to refrigerate shell eggs would provide conditions

for SE to multiply, the agency tentatively concludes that failure to

refrigerate eggs would constitute insanitary conditions that may render

the product injurious to health. Accordingly, the agency is proposing

that failure of responsible individuals in a retail establishment to

comply with the requirements of Sec. 115.50(b) will render the shell

eggs adulterated under section 402(a)(4) of the act.

Some shell eggs now available for retail sale have been

pasteurized in the shell (in-shell pasteurized) prior to packing and

distribution to destroy any Salmonella that may have been present in

the egg (e.g., Salmonella in the egg due to transovarian

contamination). FDA is proposing in Sec. 115.50(c) that these eggs be

exempt from the refrigeration requirement. However, such pasteurization

would not prohibit the in-shell pasteurized egg from subsequently

becoming contaminated with harmful microorganisms, if the egg were to

come in contact with Salmonella or other potentially hazardous

microorganisms during distribution and retail sale. The scientific

evidence indicates that it is possible for Salmonella as well as other

potentially harmful microorganisms to pass through the pores of the egg

shell and reach the egg yolk, which can then support subsequent growth

of the microorganisms, especially when adequate refrigeration is not

provided (Ref. 38). Because this proposed regulation addresses the

control of SE in shell eggs that are contaminated by transovarian

transmission, the agency considers pasteurization an effective means to

kill SE that may be present inside the egg when it is laid. Thus, the

scope of this proposed regulation does not extend to contamination of

eggs other than by transovarian transmission. FDA expects that

manufacturers of this premium product would ensure its continued

safety. Therefore, although this proposal would not require the

refrigeration of in-shell pasteurized shell eggs or any shell eggs that

have been otherwise processed to destroy Salmonella, because such eggs

would not be expected to contain transovarian transmitted Salmonella,

FDA recommends that such eggs be refrigerated by retail establishments.

In addition, FDA notes that shell eggs that have been processed to

destroy Salmonella are still considered to be potentially hazardous

foods under provisions in the Food Code in part because they are raw

eggs that are capable of supporting the growth of SE. Because these

eggs are considered potentially hazardous foods, State and local

regulations established under the recommendations in the Food Code may

have specific refrigeration requirements for these eggs in retail

establishments that this regulation would not preempt.

As discussed in section II.B of this document, the agency

tentatively concludes that the spread of salmonellosis among States

from SE-contaminated eggs cannot be fully controlled without extending

the refrigeration requirement to all eggs. Accordingly, FDA is

proposing in Sec. 115.50(d) that the requirements of this section are

applicable to all shell eggs.

As previously noted, FDA is proposing these regulations under both

the act and the PHS Act. Failure to comply with the refrigeration

requirement in proposed Sec. 115.50 would render the eggs adulterated

under section 402(a)(4) of the act. Enforcement of adulteration

regulations under the act is conducted under sections 301 to 304.

However, section 361 of the PHS Act authorizes the Secretary, and by

delegation FDA, to issue regulations that provide for the destruction

of articles and for other measures that are judged by the Secretary to

be necessary to carry out and enforce communicable disease regulations.

FDA tentatively concludes that the shell egg refrigeration regulation

can be most efficiently and effectively enforced through administrative

procedures. Accordingly, FDA is proposing procedures in Sec. 115.50(f)

under which FDA may order the diversion or destruction of shell eggs

that have been held in violation of the regulations. Under proposed

Sec. 115.50(f), FDA may issue to the person holding the shell eggs a

written order that the product be diverted or destroyed. The proposed

regulations would provide for diversion for processing in accordance

with the EPIA because FDA tentatively concludes that it may be possible

to produce safe egg products from shell eggs that have been held in

violation of the regulation. Because the EPIA requires pasteurization

of egg products, any Salmonella present would be eliminated. The

written order would identify the shell eggs that are affected, and the

grounds for issuing the order and would provide that, unless the order

is appealed, either by filing a written appeal or by requesting a

hearing, the shell eggs must be diverted or destroyed within 10-working

days of receipt of the order.

In addition, authority for the enforcement of section 361 of the

PHS Act is provided for in part under section 368 of the PHS Act. Under

section 368(a) of the PHS Act any person who violates a regulation

prescribed under section 361 of the PHS Act may be punished by

imprisonment for up to 1 year. Individuals may also be punished for

violating such a regulation by a fine of up to $100,000 if death has

not resulted from the violation or up to $250,000 if death has resulted

(18 U.S.C. 3559 and 3571(b)). Organizations may be fined up to $200,000

per violation not resulting in death and $500,000 per violation

resulting in death (18 U.S.C. 3559 and 3571(c)). In addition, Federal

district courts have jurisdiction to enjoin individuals and

organizations from violating regulations implementing section 361 of

the PHS Act.

III. The Proposal for Shell Egg Labeling

A. Rationale for Shell Egg Labeling Proposal

As discussed in section I.D of this document, data from SE

outbreaks show that outbreaks commonly occur when contaminated eggs are

mishandled by consumers or other food preparers. Furthermore,

consumption data

[[Page 36501]]

establish that some consumers eat raw or undercooked eggs.

The CSPI petition contends that the increase in the incidence of

foodborne illness has likely occurred, at least in part, because

consumers do not realize that partial cooking of raw eggs (e.g., soft-

boiled, sunny-side-up) or egg-containing foods will not prevent

illnesses. In addition, the petition from Rose Acres Farm, Inc.,

contends that practically all SE outbreaks and deaths associated with

eggs occurred because of mishandling of the eggs.

As discussed previously, FDA believes that it will be difficult

for the industry to rapidly design and implement a program that will

produce Salmonella-free eggs. However, as discussed in section I.F of

this document, in the meantime, there are measures that can reduce

risks to consumers: Refrigeration, which lengthens the effectiveness of

the eggs' natural defenses against SE and slows the growth rate of SE,

and thorough cooking, which kills viable SE that may be present. Many

comments to the 1998 ANPRM maintained that proper handling of shell

eggs is an important measure that could reduce the incidence of

foodborne illness. According to a few of the comments, the majority of

outbreaks occur because of improper handling of eggs, e.g., pooling and

incomplete cooking by food preparers. Most comments to the 1998 ANPRM

that addressed labeling supported labeling cartons of eggs with

instructions for proper handling. Although some comments supported the

use of short messages, such as ``keep refrigerated,'' others supported

safe handling instructions that also included instructions on proper

cooking of eggs.

The agency is concerned that unless consumers and food preparers

are advised about both the risks presented by eggs contaminated with SE

and the ways they can reduce these risks, consumers, particularly those

at greatest risk, could suffer serious illness or death from the

consumption of raw or undercooked eggs and egg-containing foods.

Accordingly, FDA tentatively concludes that there is an immediate need

to require label statements that inform consumers of the public health

risks associated with consumption of raw or improperly cooked shell

eggs and provide safe handling instructions.

B. Legal Authority for FDA to Require Label Statements

FDA is proposing these regulations under both the act and the PHS

Act. FDA's legal authority under the act to require label statements on

food products derives from sections 201(n), 403(a)(1), and 701(a) of

the act (21 U.S.C. 321(n), 343(a)(1), and 371(a)). FDA's legal basis to

require safe handling instructions on shell eggs also derives from the

provisions of sections 311, 361, and 368 of the PHS Act that relate to

communicable disease. Under section 403(a)(1) of the act, a food is

misbranded if its labeling is false or misleading in any particular.

Section 201(n) of the act provides that in determining whether labeling

is misleading, the agency shall take into account not only

representations made about the product, but also the extent to which

the labeling fails to reveal facts that are material in light of such

representations made or suggested in the labeling or material with

respect to consequences that may result from use of the product under

conditions of use prescribed in the labeling or under customary or

usual conditions of use. Section 701(a) of the act authorizes FDA to

issue regulations for the efficient enforcement of the act. FDA

previously has relied on these authorities when it required label

warning statements to alert consumers to the potential hazards of

certain ingredients of foods and dietary supplements, e.g., protein

products (49 FR 13679, April 6, 1984) and iron-containing dietary

supplements (62 FR 2218, January 15, 1997). Likewise, the agency is

relying on these authorities in proposing to require label statements

on shell eggs not processed to destroy all viable Salmonella.

As discussed previously, it is well documented that shell eggs may

contain Salmonella, especially transovarian transmitted SE, which can

result in serious, life-threatening illness. The risk is greatest for

children, the elderly, and persons who are immune compromised (Ref.

18). Therefore, the agency tentatively concludes that information

disclosing the risk of foodborne illness associated with consumption of

raw or undercooked shell eggs is material information that must be

given to consumers at the point of purchase.

However, the consequences that may result from consumption of SE-

contaminated eggs may be reduced or eliminated by proper handling

techniques that first limit the number of SE microorganisms and then

kill those microorganisms. Thus, consumers have effective ways, other

than avoidance of shell eggs, to reduce the risk of illness from

consumption of SE-contaminated shell eggs. In light of this, the agency

tentatively concludes that information on safe handling practices that

consumers can use to protect themselves from illness is material

information about the product that must be included in its labeling to

ensure that the product is not misbranded.

As discussed in section II.B of this document, the PHS Act

authorizes the Secretary of DHHS to make and enforce regulations that

prevent the introduction, transmission, or spread of communicable

disease from State to State. As discussed in that section, temperature

abuse of shell eggs can lead to the multiplication of SE in shell eggs,

and thus, increase the likelihood of illness if the eggs are not

thoroughly cooked. The agency tentatively concludes that, in addition

to a refrigeration requirement, a regulation requiring safe handling

instructions that inform consumers to properly refrigerate and cook

shell eggs (as fully discussed in section III.D of this document) is

also necessary to prevent the spread of communicable disease.

FDA tentatively concludes that a regulation to require label

statements that provide safe handling instructions on shell eggs

(proposed Sec. 101.17(h)(1)) also should apply to eggs that are not

shipped across State lines by producers or retailers (proposed

Sec. 101.17(h)(6)). As noted in section II.B of this document, there

have been outbreaks of salmonellosis associated with such eggs.

Therefore, FDA is concerned that if it does not require safe handling

instructions on shell eggs that are laid, processed, and sold in one

State, consumers will not have material information that would inform

them of ways to handle and cook eggs to prevent illness. Thus, without

the inclusion of all eggs in the scope of this proposed regulation, FDA

could not ensure that consumers who purchase eggs laid, processed, and

sold in one State would have information that would help protect them

from the risk of salmonellosis. In addition, as discussed in section

II.B of this document, the agency believes that consumers who shop

across State borders may purchase SE-contaminated shell eggs from one

State and carry them across State lines. Therefore, without the

inclusion of all eggs in the scope of this proposed regulation, the

agency would be hampered in preventing the spread of salmonellosis from

one State to another. The agency tentatively concludes that safe

handling instructions should be required on all shell eggs to prevent

the interstate spread of a communicable disease from one State to

another. FDA requests comment on its tentative conclusion.

Failure to comply with the requirements of proposed Sec. 101.17(h)

would render the food misbranded under section 403(a)(1) of the act and

would violate regulations issued under

[[Page 36502]]

section 361 of the PHS Act. As discussed in section II.C of this

document, enforcement of regulations is conducted under sections 301 to

304 of the act. Section 361 of the PHS Act authorizes FDA to issue

those regulations that are necessary to enforce communicable disease

provisions of the statute. Thus, the agency is proposing procedures in

Sec. 101.17(h)(8) that it may use to order the relabeling, diversion,

or destruction of shell eggs that do not comply with the regulation.

Under proposed Sec. 101.17(h)(8)(i)(A), FDA may issue to the person

holding the shell eggs a written order that the product must be

relabeled, diverted, or destroyed. As also discussed in section II.C of

this document, violations of the PHS Act are subject to injunctions and

criminal prosecutions.

As discussed in section II.B of this document, FDA has examined

several options on how the agency could accept assistance from the

States and localities in enforcement of the refrigeration provision of

this proposed regulation. The agency has considered similar options on

how it could accept State and local enforcement assistance of the

labeling provision. Because this proposed labeling requirement would

affect shell eggs that laid, processed, and sold in one State, the

agency believes that it would be an efficient use of resources for

State and local agencies to assist in enforcing the labeling

regulations. Moreover, FDA believes that sections 311 and 361 of the

PHS Act authorize the agency to issue a regulation that would allow

States and localities to enforce the labeling regulation themselves.

Therefore, the agency has tentatively concluded that it should allow

State and local regulators that are able and willing under section 311

of the PHS Act, and are authorized to regulate the labeling of shell

eggs within their States or localities, to enforce the requirement for

safe handling instructions. Accordingly, proposed Sec. 101.17(h)(7)

provides that those States and localities that are able and willing are

authorized under sections 311 and 361 of the PHS Act to enforce

proposed Sec. 101.17(h)(1) as set out in proposed Sec. 101.17(h)(7).

With respect to the hearing procedures, the proposed regulation

recognizes that many States and localities already have administrative

procedures in place for hearings allowing them to use a similar hearing

process as long as that process satisfies basic due process

requirements.

C. Covered Products

As discussed in section II.C of this document, technology to

process shell eggs in a manner to destroy SE in the egg would

significantly reduce or eliminate the risk of transovarian transmitted

SE, and would thereby render the label statements unnecessary.

Accordingly, FDA is proposing in Sec. 101.17(h)(4) that shell eggs that

have been, before distribution to consumers, specifically processed to

destroy all viable Salmonella be exempt from the labeling requirements.

The standards of identity for liquid, dried, and frozen egg white,

egg yolk, and whole egg products (21 CFR part 160) require that these

products be pasteurized or otherwise treated to destroy all viable

Salmonella microorganisms. Further, the agency expects that the

standardized egg product ingredients in any nonstandardized egg

product, such as scrambled egg mixes, would also be pasteurized or

otherwise treated to destroy all viable Salmonella microorganisms. FDA

has no information about the existence of egg products that have not

been pasteurized or otherwise treated to destroy all viable SE and

other Salmonella. However, the agency specifically requests data or

other information that suggests that such products are commercially

available. Should such products exist, FDA tentatively concludes that

any final label statement required for shell eggs also be applicable to

these products as well.

The safe handling statement is intended to inform consumers of

ways that they may safely handle eggs to reduce their risk of foodborne

illness. Likewise, the use of the safe handling statement on cartons of

shell eggs that are not for direct sale to consumers, e.g., shell eggs

that are to be labeled or repacked at a site other than originally

processed or are shipped for use in food service establishments such as

schools, hospitals, and restaurants also serves to inform repackers and

food preparers of the safe handling procedures. However, FDA

tentatively concludes that the same goal of conveying the safe handling

labeling to repackers and food preparers could also be accomplished by

customary trade practices. For example, the safe handling statement

could be included on an invoice or product specifications sheet.

Accordingly, FDA is proposing in Sec. 101.17(h)(5) that the safe

handling statement for shell eggs that are not for direct sale to

consumers, e.g., those that are to be repacked or labeled at a site

other than where originally processed or are sold for use in food

service establishments may be provided on cartons or in labeling, e.g.,

invoices or bills of lading in accordance with the practice of the

trade. FDA requests comment on whether allowing this practice will

accomplish its intended goal.

D. Essential Elements of Specific Label Statements

Consumer research available to the agency indicates that when

consumers generally believe that a product is safe, messages that note

that the product is unsafe without providing information on the nature

of the hazard are likely to confuse or frighten them (Ref. 25). This

research also indicates that certain elements may be essential in label

statements to effectively inform consumers of a potential hazard (Ref.

25). Recently, the agency has used such consumer research to develop

effective warning labels. For example, the agency used such information

to craft a warning statement for iron-containing supplements in

Sec. 101.17(e). As discussed in the final rule requiring that iron-

containing supplements bear a warning statement (62 FR 2218), the

agency found that elements essential for an effective warning statement

for these products included an informational statement that describes

the nature and magnitude of the hazard and a handling instruction on

how to avoid the hazard. In addition, because the hazard associated

with iron-containing products was associated with accidental overdose

rather than ordinary conditions of use, essential elements for this

warning statement also included a provisional statement that describes

situations that require mitigation and an instructional statement that

describes what action to take under those circumstances.

In determining what information is essential in the proposed

statement, FDA tentatively concluded, based on the continued

predominance of SE in foodborne outbreaks, that consumers may not know

that there is a food safety hazard associated with shell eggs.

Consumption data indicating that some consumers eat raw or undercooked

eggs reinforce this tentative conclusion (Refs. 22 to 24). Therefore,

FDA tentatively concludes that it is essential that the label statement

describe the potential hazard, i.e., that eggs may contain pathogens

known to cause serious, life-threatening illness.

In addition, the young, elderly, and persons with immune

deficiencies are more susceptible to foodborne illness than others

(Ref. 18) but may not realize that they are particularly at risk for

serious illness from a food long recognized to be a safe and

inexpensive source of good nutrition. These people, especially, along

with their caregivers, need the information necessary to make informed

decisions about avoiding,

[[Page 36503]]

reducing, or eliminating the risk of salmonellosis from eggs and egg-

containing foods. Therefore, FDA tentatively concludes that the

information needed by consumers about the potential hazard should also

include information about the at-risk groups, so that they or their

caregivers are aware of their greater risk.

In some circumstances in which the agency has required a label

statement to inform consumers of consequences that could result from

consumption of a product, FDA has presumed that consumers' reaction to

a label statement would be a decision whether to avoid the product. For

example, in its recent rulemaking to require a label statement on juice

products that have not been processed to control pathogenic

microorganisms, FDA stated its belief that it was implicit in its

description of the hazard that at-risk groups could avoid the hazard by

not consuming the product (63 FR 20486 at 20489, April 24, 1998).

Consistent with this belief, one comment to the 1998 ANPRM opposed

``warning labels'' stating that eggs are potentially harmful because

the statement would alarm consumers and would reduce egg consumption.

However, as previously discussed, the consequences that may result from

consumption of SE-contaminated eggs may be reduced or eliminated by

proper handling techniques. Failure to make clear that there is a way

other than avoidance to reduce this risk could imply to consumers that,

similar to their options when faced with other label statements, their

only available option is to avoid the product. Therefore, FDA

tentatively concludes that an instructional statement that describes

measures (i.e., safe handling practices) that consumers can take to

reduce or eliminate the risk associated with consumption of SE-

contaminated eggs should be an essential element of the label

statement. Because temperature has been reported to play a role in

suppressing the growth of Salmonella microorganisms (see discussion in

section I.F of this document), and because thorough cooking kills SE

(see discussion in section I.F of this document), FDA also tentatively

concludes that the safe handling instructional statement should advise

that eggs be refrigerated until they are ready to be cooked and that

eggs be thoroughly cooked before they are eaten.

Because the more likely option for consumers who are presented

with a label statement that describes a hazard is avoidance, FDA

believes that a linking statement that clarifies that the recommended

safe handling practices are measures that consumers can take to reduce

or eliminate the risk is important to alleviate a potential

misperception that avoidance is their only option. Therefore, FDA

tentatively concludes that a linking statement that relates the

informational statement to the instructional statement is an essential

element of the label statement. These essential elements are similar to

those contained in other required label statements in Sec. 101.17.

FDA's consumer research on label statements for iron-containing

products also shows that the first sentence of a label statement is

likely to influence a consumer's decision to continue reading the

remainder of the statement (Ref. 25). Moreover, as a result of the safe

handling instructions that appear on raw meat and poultry under

rulemaking conducted by FSIS (59 FR 14528, March 28, 1994), consumers

are already accustomed to reading information about the risk before

reading the safe handling practices that can reduce or eliminate the

risk. Accordingly, FDA tentatively concludes that the first sentence of

the label statement should be an informational statement about the

potential hazard to consumers.

Applying the essential elements described previously, FDA crafted

examples of label statements. The agency notes that some of the

examples of acceptable label statements incorporate language suggested

by Rose Acres Farms, Inc., and CSPI. These examples illustrate some of

the variations in label statements developed by applying the essential

elements. Four such examples are provided as follows:

SAFE HANDLING INSTRUCTIONS: Shell eggs may contain harmful

bacteria known to cause serious illness, especially in children, the

elderly, and persons with weakened immune systems. For your protection,

keep eggs refrigerated and cook eggs and foods containing eggs

thoroughly before eating.

SAFE HANDLING INSTRUCTIONS: Shell eggs may contain harmful

bacteria known to cause serious illness, especially in children, the

elderly, and persons with weakened immune systems. For your protection,

keep eggs refrigerated and cook eggs until yolks are firm.

SAFE HANDLING INSTRUCTIONS: Eggs may contain illness-causing

bacteria. The risk of life-threatening illness is greatest for

children, the elderly, and persons with weakened immune systems. For

your protection, keep eggs refrigerated until cooked, and cook eggs

thoroughly until yolks are firm.

SAFE HANDLING INSTRUCTIONS: Some shell eggs have been found to

contain harmful bacteria known to cause life-threatening illness,

especially in children, the elderly, and persons with weakened immune

systems. Consumers may protect themselves by keeping eggs refrigerated

until cooked, by cooking eggs until the yolk is firm, and by cooking

foods containing eggs thoroughly.

In order to evaluate the label statements developed through use of

the essential elements and to test the effectiveness of such examples

in informing consumers of the risks associated with shell eggs and of

the safe handling practices that may be used to mitigate the risks, FDA

conducted focus group research to evaluate consumer understanding of

several possible safe handling instructions.

Six focus groups were conducted to test possible safe handling

statements (Ref. 39). All participants examined and discussed five safe

handling statements, including the four examples presented previously.

The participants had some awareness of the potential dangers associated

with eating eggs, and most were concerned about the safety of the eggs

that they were purchasing. They were aware that the main food safety

hazard posed by eggs was Salmonella contamination. Most of the

participants kept their eggs refrigerated. However, many of them

reported that they ate foods containing raw eggs, e.g., cookie batter,

cake batter, homemade ice cream, and Caesar salad. The participants

stated that most of the time they were aware when the foods they ate

contained raw eggs, although some were surprised that Caesar salad

could contain raw eggs. Generally, the participants were aware that

they should thoroughly cook eggs, although they often cooked eggs

according to their personal tastes, e.g., sunny-side up.

The participants were generally positive toward the idea of

handling instructions on egg packages. Although many of them were

already aware of the information presented in the handling statements,

they saw the handling statements as useful reminders. To some of the

participants, however, some of the information in the handling

statements was new. Further, the participants appreciated the fact that

with relatively simple steps they could be confident that their eggs

were likely to be safe to eat. In addition, many participants thought

that egg producers would not object to placing information presented in

the example statements on the labels of egg cartons if all egg

producers had to do so.

There were some discussions about certain words in the messages

that the

[[Page 36504]]

groups thought were unnecessary, e.g., ``shell'' eggs, and

``refrigerated until cooked.'' However, participants generally

understood the messages and found them to be informative and not

misleading. Further, they liked messages that were clear and easy to

read.

While the label statements that were tested effectively informed

the consumers of the potential hazard associated with the consumption

of eggs, the agency did not test all conceivable variations of label

statements incorporating the required information. Previous focus group

research (i.e., for juice warning labels) indicated that minor wording

differences may lead to confusion among consumers. The results of that

research led the agency to prescribe the language of the label

statement on juice products to ensure that consumers would not be

misled (63 FR 37030, July 8, 1998). Similarly, the agency believes that

it is also appropriate to prescribe the language of the safe handling

statement on eggs. Therefore, the agency tentatively concludes that

prescribing the language of each of the essential elements will be the

most effective way to ensure that consumers are not misled and will

correctly understand the safe handling instructions. This will ensure

that consumers know of the risks of consuming raw or undercooked eggs

and that they know the measures they can take to protect themselves. In

addition, a prescriptive label statement is consistent with label

statements for other food products.

FDA believes that a regulation requiring a label statement on

cartons of shell eggs must be sufficiently clear to allow the regulated

industry to determine that its labeling complies with that regulation.

Furthermore, the regulation should establish a so-called ``level

playing field'' for all products covered by the regulation by requiring

that each product's labeling provide the same information. FDA

tentatively concludes that prescribing the specific language for a

label statement for shell eggs would accomplish these two goals, as

well as ensure a message to consumers that is not confusing,

misleading, or otherwise ineffective.

Accordingly, based on information from the focus groups, FDA is

proposing in Sec. 101.17(h)(1) to require that the label of shell eggs

bear the following statement:

SAFE HANDLING INSTRUCTIONS: Eggs may contain harmful bacteria

known to cause serious illness, especially in children, the elderly,

and persons with weakened immune systems. For your protection: keep

eggs refrigerated; cook eggs until yolks are firm; and cook foods

containing eggs thoroughly before eating.

The agency notes that the language in the first sentence of this

prescribed label statement for eggs is similar to the label statement

that FDA recently required for some juice products. As discussed in the

final rule requiring warning statements on juice products that have not

been processed to control pathogenic microorganisms (63 FR 37030 at

37045), FDA concluded that the term ``serious illness'' is an accurate

description of the hazard caused by foodborne microorganisms that may

be present in juice. The agency based its conclusion on results of

focus group research which indicated that the term ``serious illness''

was understood and conveyed a strong message without being too extreme.

Participants of the focus group research viewed such terms as ``life

threatening'' or ``death'' less credible.

Also in that final rule, FDA recognized that the terms children

and elderly are not precise. Rather, they are terms chosen by the

Council for Agricultural Science and Technology to reflect groups that,

in general, have incompletely developed or declining immune systems.

Because the exact ages at which a child's immune systems is fully

developed and at which an elderly person's immune system has declined

are not precisely defined, FDA concluded that it had no basis to

specify particular ages for these at-risk groups nor to use terms other

than ``children'' or ``elderly.''

Several comments to the 1998 ANPRM expressed concerns about the

suggested language that would appear in a proposed label statement. The

issues raised in these comments were among those issues considered when

FDA developed this proposed rule.

The agency requests comments on other aspects of the proposed safe

handling statement and whether it effectively conveys information

necessary to adequately inform consumers of measures that they can take

to ensure the safety of the food. The agency tentatively concluded that

the cooking instructions in the safe handling statement, i.e., ``cook

eggs until yolks are firm and cook foods containing eggs thoroughly''

is adequate to inform consumers of ways to prepare eggs in order to

reduce the risk of illness. The agency notes that part of the cooking

instruction, i.e., ``cook eggs until yolks are firm,'' is one way to

describe proper cooking of an egg when consumed as an egg dish. For

example, it is expected that when an egg, e.g. fried egg, is cooked

until the yolk is firm, then the white would be sufficiently cooked.

For other foods that contain eggs, the safe handling statement

must convey to consumers that the food should be cooked thoroughly.

Focus group research showed that although many consumers are aware that

foods that contain raw or undercooked egg whites only, e.g., meringue,

can be a potential health hazard, many did not. However, the reason

some consumers were unaware of the potential health risk was that they

were unaware that foods like meringue may contain raw egg whites. When

informed that such foods may contain raw egg whites, consumers

understood the health risk. Thus, the agency tentatively concludes that

there is no reason to believe that, when informed of the risk of

illness associated with raw or undercooked eggs, consumers would

differentiate the potential health risk based on what part of the egg

is consumed. Therefore, FDA tentatively concluded that the part of the

statement that instructs consumers to cook foods containing eggs

thoroughly, would address foods that include any component of the egg,

e.g., whole egg, egg white, or egg yolk. The agency requests comments

on its tentative conclusion that this statement adequately instructs

consumers on the safe handling instruction for foods containing eggs.

Comments should include data or a rationale to provide a basis for the

agency to adopt alternate phrasing.

As previously discussed, certain subpopulations are at greatest

risk of serious illness and death caused by SE. For example, many

deaths have occurred in nursing homes (Ref. 3). Because certain

consumers, especially those at greatest risk, may want to avoid the

risk altogether by avoiding the product, the agency requests comment on

whether it should require a statement that the product should not be

used for certain purposes, e.g., ``use pasteurized eggs for recipes

requiring raw or partially cooked eggs.'' The agency also requests

comment on whether it should require an explicit instruction to avoid

the product for at-risk consumers or for individuals (e.g., parents,

nursing home staff) who are responsible for preparing foods for at-risk

consumers.

As discussed in section II.A of this document, FSIS amended its

regulations to require that shell eggs packed for consumer use be

stored and transported at an ambient temperature that does not exceed

7.2 deg.C (45 deg.F) and that the containers of such eggs be labeled

to indicate that refrigeration is required. The labeling statement

proposed in this document, if finalized, will permit

[[Page 36505]]

uniform label statements with the FSIS rule. Consequently, this safe-

handling statement would replace the label currently required by FSIS.

In the Federal Register of February 24, 1997 (62 FR 8248), FDA

published a notice, entitled ``Guidance on Labeling of Foods That Need

Refrigeration by Consumers'' (``the Refrigeration Guidance''). In that

document, FDA noted that refrigeration is only one of many barriers

(e.g., acidification, preservatives, and reduced water activity) that

can be used to control microbial risks. However, for many foods

(classified as ``Group A foods''\6\), refrigeration is the only

practicable barrier to reduce or retard pathogenic growth. The agency

also noted that Group A foods, including shell eggs, are potentially

hazardous foods, that, if subject to temperature abuse, will support

the growth of infectious or toxigenic microorganisms that may be

present. Growth of these microorganisms would render the food unsafe

(62 FR 8248). As stated in that document, FDA concluded that the

appropriate label statement for Group A foods is ``IMPORTANT Must be

kept refrigerated to maintain safety.''

---------------------------------------------------------------------------

\6\ Group A foods as defined in the Refrigeration Guidance are

potentially hazardous foods, which if subjected to temperature

abuse, will support the growth of infectious or toxigenic

microorganisms that may be present. They have the following

characteristics: (1) A pH of >4.6, (2) a water activity of >0.85,

(3) do not receive a thermal or other process in the final package

that is adequate to destroy foodborne pathogens that can grow under

conditions of temperature abuse, and (4) have no barriers built into

the product formulation that would prevent the growth of foodborne

pathogens that can grow under abuse conditions.

---------------------------------------------------------------------------

In the Refrigeration Guidance document, FDA stated that most

consumers seem to understand that foods displayed only in the

refrigerated sections of grocery stores such as dairy products, eggs,

cold cuts, fresh meats, poultry and seafood, must be refrigerated to

maintain quality. Further, the agency stated that, although it is

unlikely that consumers are aware of the hazards that temperature abuse

can present, it is likely that consumers will refrigerate these

products in the absence of labeling. Therefore, the agency did not

specifically address these products in the document. However, the

agency concluded that the fact that the foods are refrigerated provides

no evidence of the effectiveness of the ``keep refrigerated'' label.

Although the guidance provided in that document was specifically

directed toward products that appeared to be shelf stable or ones for

which consumers seemed to not understand the importance of a ``keep

refrigerated'' statement, the agency did not specifically exclude any

foods from the guidance.

In light of information regarding outbreaks of SE associated with

the temperature abuse of eggs and egg-containing products, FDA

tentatively concludes that it is important that consumers be informed

of the need for refrigeration of shell eggs. Further, the agency

believes that the ``keep refrigerated'' statement in the suggested safe

handling instructions in the proposed label statement conveys the same

message as the label statement in the Refrigeration Guidance. Because

the proposed linking statement, i.e., ``for your protection,'' shows

that there are measures that consumers can take to reduce or eliminate

the risk of foodborne illness, the agency believes that it is implicit

in the proposed safe handling instructions that refrigeration helps to

maintain the safety of shell eggs. Thus, FDA tentatively concludes that

there is no need for both statements in labeling of shell eggs.

Focus group participants responded favorably to a graphic format

that used bullets for the safe handling instructions. FDA encourages

the use of such a presentation. However, the agency recognizes that all

egg cartons may not be able to accommodate this format and, therefore,

FDA is not proposing to require it. The agency requests comment on this

tentative decision. The agency also requests comments on whether

graphics would enhance the visibility of the statement.

The agency notes that, under FSIS regulations (7 CFR 317.2 and

381.125), the safe handling statements that are currently required on

raw meats and poultry include graphic illustrations. As discussed in

the FSIS final rule (59 FR 14528), participants in consumer research

indicated that safe handling instructions accompanied with graphics

were preferred to those without graphics. As previously discussed in

this section, FDA conducted its own consumer focus group research to

evaluate consumer understanding of several safe handling labeling

statements for shell eggs. Based on its focus group research, the

agency tentatively concluded that the safe handling statement that it

is proposing is adequate and effectively informs consumers of the risks

associated with the consumption of shell eggs and of measures they can

take to reduce their risk of foodborne illness. Therefore, the agency

tentatively concludes that additional information, including graphic

illustrations, is not necessary to convey the safe handling

instructions to consumers. However, although FDA is not proposing to

require graphic illustrations in the safe handling statement for shell

eggs, the agency encourages use of illustrations similar to those used

on raw meat and poultry on the cartons of shell eggs. While the agency

did not specifically test the graphic illustrations with the consumer

focus groups, the agency believes that, because graphic illustrations

have been on meat and poultry product labels for some time, consumers

have become familiar with these kinds of symbols. The agency requests

comment on whether graphics should be required as part of the safe

handling statement for shell eggs.

The agency has solicited specific comments on various aspects of

this proposal as well as additional requirements. Any comments

supporting additional requirements should include data, information, or

a rationale in support of the position advocated. FDA will consider

such comments and depending on the administrative record that is

developed through the rulemaking process, may adopt as part of a final

rule additional requirements. The agency notes, however, that it does

not intend that this proposed regulation would, if finalized, preempt

any State or local requirements for additional safe handling labeling,

e.g., graphics, as long as it does not conflict with Federal

requirements.

The agency notes that current regulations in Sec. 101.17 use the

terms ``warning'' or ``notice.'' As previously discussed, FDA has

presumed that consumers' reaction to a warning statement about the

possible presence of harmful bacteria in eggs would be a decision

whether to avoid the product. The term ``notice'' could be used, but

does not draw attention to the important fact that there are ways to

reduce or eliminate the risks of foodborne illness other than avoidance

of the product. The agency tentatively concludes, therefore, that the

required elements of the label statement are best described as ``safe

handling instructions.'' In light of this fact, the agency is proposing

in this rulemaking to amend the title of Sec. 101.17 to include the use

of the term ``safe handling statements.''

E. Placement and Prominence of Label Statements

Section 403(f) of the act requires mandatory label information to

be prominently placed on the label with such conspicuousness (compared

with other words, statements, designs, or devices, in the labeling) as

to render it likely to be read and understood by the ordinary

individual under customary conditions of use. Two comments to the

[[Page 36506]]

1998 ANPRM requested that FDA provide flexibility in any food labeling

statement, e.g., placement of the statement could occur on the inside

of the carton, or elsewhere on the package, as long as it is

conspicuous. The comments argued that existing federal regulations

already require certain label information, such as grading information

and nutrition labeling. In addition, the comments maintained that many

States also require additional information on egg cartons such as

product codes and sell-by dates. Moreover, one comment contended that

some States may require certain information in type sizes of 10-point

type or 3/8 inch. Thus, the comment argued, there is limited label

space for additional information. One comment requested that FDA

consider allowing the use of a modified format for small packages

(packages of less than a dozen eggs) similar to that permitted for

nutrition labeling. The comment questioned whether federal requirements

would duplicate or preempt State requirements. One comment stated that

some States require the phrase ``Keep refrigerated at or below 45

deg.F.'' Another comment estimated that approximately 40 percent of egg

cartons on the market carry some form of ``warning label.'' The comment

pointed out that prior to the beginning of 1998, only 10 percent of the

cartons on the market bore safe handling instructions. The comment

requested that if existing safe handling instructions meet or exceed

federal requirements, FDA should allow manufacturers to retain such

labels. The issues raised in these comments were among those considered

by FDA as it developed this proposed rule.

In the past, FDA has generally determined that the information

panel is the appropriate location for label statements that are

required by Sec. 101.17. As discussed in the agency's rulemaking

requiring label statements on iron-containing dietary supplements (62

FR 2218), consumer focus group studies indicated that the label

statement need not be placed on the principal display panel (PDP) to be

effective in informing consumers of the hazard. Participants in the

focus group reasoned that the front of the product was used for

marketing purposes, and consumers were used to looking at the ``back of

products'' for nutrition and factual information including label

statements such as warning messages. Thus, the agency required that the

warning statement for iron-containing supplements appear on the

information panel, the portion of the label where most mandatory

information is located. The agency tentatively concludes that for label

statements on shell eggs, the requirement for prominence and

conspicuousness would similarly be met if the statements appeared on

the information panel. However, the agency would not object to firms

placing the label statement on the PDP, since the PDP would provide

even more prominence. Accordingly, FDA is proposing to require in

Sec. 101.17(h)(2) that the label statement appear either on the

information panel or on the PDP.

The requirement in the act for prominent display means that the

label statement must appear in a manner that makes the statement

readily observable and likely to be read. The agency notes that 21 CFR

101.2(c) requires that mandatory information appearing on the PDP and

information panel, including information required by Sec. 101.17,

appear prominently and conspicuously in a type size no less than 1/16

inch. The agency also notes that 21 CFR 101.15(a) provides that

information required on the label appear uncrowded and with sufficient

contrast to background material. The agency has concluded that it is

not necessary to repeat these requirements for prominence and

conspicuousness in the proposed regulation and, therefore, is not

including them in this proposal.

Current agency regulations that require a label ``warning''

statement (e.g., the statement required by Sec. 101.17(e) on iron-

containing dietary supplements in solid oral dosage form) or a label

``notice'' statement (e.g., the statement required by Sec. 101.17(d)(3)

on protein products that are not covered by the requirements of

Sec. 101.17(d)(1) and (d)(2)) require that the identifying term

``WARNING'' or ``NOTICE'' be capitalized and immediately precede the

language of the applicable label statement. Likewise, consistent with

these examples, the agency is proposing in Sec. 101.17(h)(1) to require

that the capitalized words ``SAFE HANDLING INSTRUCTIONS'' immediately

precede the message of the label statement.

Previous agency regulations that require cautionary information on

labels, e.g., on products containing aspartame (39 FR 27317, July 26,

1974), utilized bold type to make the information more prominent. In

addition, FDA regulations on nutrition labeling (21 CFR

101.9(d)(1)(iv)) require that certain nutrient information in the

Nutrition Facts panel be in bold type to provide more prominence.

Therefore, consistent with these examples, the agency is proposing in

Sec. 101.17(h)(2) to require that the words ``SAFE HANDLING

INSTRUCTIONS'' be in bold type to help alert the consumer that there is

new and critically important information about the egg product.

The agency notes that experience has shown that the prominence of

some labeling information may be enhanced by the use of a box around

the information. The agency's experience with the new nutrition label

has been that the box surrounding the nutrition information greatly

increases the prominence of the information. In addition, consumer

focus group research has shown that boxes around important messages

help consumers to distinguish the message from other information (Ref.

25). Therefore, the agency tentatively concludes that the use of a box

around the label statement for shell eggs will similarly increase the

prominence of the message by setting it off, thereby enhancing the

likelihood that consumers will notice and read the message.

Accordingly, FDA is including in the proposal a requirement (proposed

Sec. 101.17(h)(3)) that the label statement be set off in a box by use

of hairlines.

The agency requests comments on the prominence and placement of the

proposed label statement and whether the proposal provides sufficient

flexibility to accomodate the many types of egg cartons in the

marketplace. FDA is particularly interested in comments on whether

other measures, e.g., color enhancement, are necessary to focus the

consumer's attention on the label statement.

IV. Analysis of Impacts

A. Benefit/Cost Analysis

FDA has examined the economic implications of this proposed rule as

required by Executive Order 12866. Executive Order 12866 directs

agencies to assess all costs and benefits of available regulatory

alternatives and, when regulation is necessary, to select regulatory

approaches that maximize net benefits (including potential economic,

environmental, public health, safety, distributive, and equity

effects). Executive Order 12866 classifies a rule as significant if it

meets any one of a number of specified conditions, including: Having an

annual effect on the economy of $100 million; adversely affecting some

sector of the economy in a material way; or adversely affecting jobs or

competition. A regulation is also considered a significant regulatory

action under Executive Order 12866 if it raises novel, legal, or policy

issues. Under the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4)

requiring cost-benefit and other analyses, a significant rule is

defined in section

[[Page 36507]]

1531 (a) as ``a Federal mandate that may result in the expenditure by

State, local, and tribal governments in the aggregate, or by the

private sector, of $100,000,000 (adjusted annually for inflation) in

any 1 year * * *.'' Finally, the Small Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104-121) defines a major rule for the

purpose of congressional review as having caused or being likely to

cause one or more of the following: An annual effect on the economy of

$100 million; a major increase in costs or prices; significant effects

on competition, employment, productivity, or innovation; or significant

effects on the ability of U.S. based enterprises to compete with

foreign-based enterprises in domestic or export markets.

FDA tentatively finds that this proposed rule is economically

significant under Executive Order 12866. FDA has determined that this

proposed rule, based on the median estimate of cost contained in the

economic analysis, does not constitute a significant rule under the

Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Furthermore, in

accordance with the Small Business Regulatory Enforcement Fairness Act

of 1995 (Pub. L. 104-121) it has been determined that this proposed

rule would be a major rule for the purpose of congressional review.

This section summarizes the preliminary regulatory impact analysis

of the proposed rule. The full analysis and a list of references is

available in a separate document entitled ``Preliminary Regulatory

Impact Analysis and Initial Regulatory Flexibility Analysis of the

Proposed Rule to Require Refrigeration of Shell Eggs at Retail and Safe

Handling Labels'' (PRIA/IRFA) published elsewhere in this issue of the

Federal Register.

One comment to the 1998 ANPRM suggested that FDA consider mandatory

sell-by dates, prohibition of re-packaging, and mandatory

pasteurization of shell eggs intended for at-risk consumers (such as

residents of nursing homes). Several comments stated that in-shell

pasteurization was costly; according to one comment, pasteurization

equipment would cost $1.5 million. Several comments stressed the cost

and difficulty of placing the safe handling statement on egg cartons,

which are already crowded with printing. In one comment, a carton

manufacturer estimated that designing and producing new plates for all

of its egg cartons would cost about $2 million.

1. Regulatory Options

FDA considered several regulatory options for dealing with SE in

shell eggs. The options considered include: (1) No new regulatory

action, (2) labeling only, (3) refrigeration at 7.2 deg.C (45 deg.F)

only, (4) refrigeration at 5 deg.C (41 deg.F), (5) Hazard Analysis

Critical Control Point (HACCP) for shell eggs, (6) in-shell

pasteurization, (7) longer compliance periods, and (8) limited retail

sell-by period.

FDA believes that relying on current safeguards (option 1) would

not greatly reduce the number of illnesses from SE in shell eggs. Even

though the benefits from either labeling alone or refrigeration alone

(options 2 and 3) exceed the costs, the combined benefits of

refrigeration and labeling (the proposed rule) are much greater than

either taken separately. FDA found that option 4 (refrigerate shell

eggs at 5 deg.C (41 deg.F) in retail establishments and institutions)

would not have a significant additional effect on SE in shell eggs, but

would increase costs substantially. FDA believes that a HACCP-like

program (option 5) is currently not feasible. However, FDA is

evaluating whether in the future, a HACCP-like program including

possibly in-shell pasteurization, may be necessary to further ensure

the safety of shell eggs. In-shell pasteurization (option 6) would

greatly reduce SE, but FDA believes other interventions between farm

and table could reduce SE at lower cost. The main disadvantage of

longer compliance periods for the labeling provision (option 7) is that

the option would delay the realization of the benefits of the rule.

Finally, FDA finds that limiting the retail sell-by period to 30 days

(option 8) would have small public health benefits but could impose

substantial costs.

2. Benefits

Benefits from the proposed rule to require a safe handling label

and the refrigeration of shell eggs at 7.2 deg.C (45 deg.F) come from

reducing SE-related illness. The basic model for estimating benefits

is: ``marginal health benefits = baseline risk (number of SE illnesses

related to shell eggs) x expected reduction in the number of illnesses

brought about by the proposed rule x health cost per illness''.

FDA used the results of the USDA SE risk assessment for one

estimate of the baseline risk and the CDC Salmonella surveillance data

for another estimate of the baseline. FDA also used the risk assessment

model to estimate the expected reduction in illnesses attributed to the

proposed rule. The design of the USDA SE risk assessment model allowed

FDA to estimate the number of illnesses prevented by comparing the

baseline number of illnesses with the number of illnesses under the

provisions of the proposed rule. The range (5th to 95th percentile) of

estimated annual illnesses prevented for the USDA SE risk assessment

baseline was 12,000 to 407,000, with a median of 66,000. The range (5th

to 95th percentile) of estimated illnesses prevented for the CDC

surveillance baseline was 7,000 to 107,000, with a median of 25,000.

FDA calculated the health cost per illness prevented by classifying

SE illnesses into the following outcomes based on severity: Mild,

moderate, and severe acute gastrointestinal illnesses; resolved and

chronic reactive arthritis; and death. FDA then multiplied the

estimated monetary health cost per type of illnesses by the number of

illnesses prevented of each type. Total health benefits from the

proposed rule were calculated as follows:

total health benefits = (number of mild cases prevented x $ per

case) + (number of moderate cases prevented x $ per case) + (number

of severe-acute cases prevented x $ per case) + (number of resolved

cases of arthritis prevented x $ per case) + (number of chronic

cases of arthritis prevented x $ per case) + (number of deaths x $

per death)

The baseline risk, the expected reduction in risk, and the health

costs per illness are all uncertain. FDA therefore estimated a

distribution of possible health benefits for the proposed rule, with

the distribution based on the probability distributions associated with

the main uncertainties. The range (5th to 95th percentile) of estimated

annual benefits for the USDA SE risk assessment baseline was $87

million to $6.6 billion, with a median of $700 million. The range (5th

to 95th percentile) of estimated annual benefits for the CDC

surveillance baseline was $50 million to $1.7 billion, with a median of

$300 million. The benefits are large, although FDA estimates that 95

percent of shell eggs are already held at ambient temperatures of 7.2

deg.C (45 deg.F) or less.

3. Costs

The costs of the proposed rule are the sum of the costs of changes

in manufacturing practices--labeling and refrigeration and changes in

consumer practices--egg preparation and consumption.

a. Labeling. The costs of labeling are the sum of administrative

compliance, inventory disposal, and label redesign costs. FDA

calculated labeling costs with the following model: ``labeling cost =

($ administrative costs per firm x

[[Page 36508]]

number of affected firms) + ($ value of cartons manufactured x disposal

percentage of carton inventory ) + (number of affected labels x $

redesign cost per label)''.

FDA estimated the total labeling cost for a 6-month compliance

period to be a one-time cost of approximately $18 million. The total

cost included administrative costs of $280,000, inventory disposal

costs of $3 million, and label redesign costs of $15 million.

b. Refrigeration. FDA estimated the refrigeration costs to be the

cost of the additional equipment required for all establishments to

maintain an ambient temperature of 7.2 deg.C (45 deg.F). FDA

calculated the cost by multiplying the estimated number of

establishments that would require new (or upgraded) equipment by the

cost of equipment. Both the number of establishments affected and the

cost of equipment are uncertain. FDA estimated the number of

establishments that would require new equipment by assuming that no

establishments in States that had adopted the Food Code and an

uncertain fraction--with one-third the most likely value--of

establishments in States that had not adopted the Food Code would

require new equipment. FDA used industry sources to obtain estimates of

the range of costs of new or additional equipment necessary to meet the

refrigeration provision of the proposed rule. The estimated costs per

establishment ranged from close to zero for small equipment upgrades to

$6,000 for a large new refrigerator.

FDA estimated a distribution of possible refrigeration costs for

the proposed rule. The range (5th to 95th percentile) of estimated one-

time refrigeration costs was $7 million to $228 million, with a median

of $31 million.

c. Changes in consumer practices. FDA estimated the annual costs to

consumers of changing the way eggs are prepared and consumed as

follows:

cost of changes in consumer practices = annual number of eggs

consumed x baseline fraction of eggs consumed undercooked x

fractional reduction in undercooked eggs in response to safe

handling label x $ value of undercooking one egg

The cost to consumers is uncertain. The range (5th to 95th

percentile) of annual costs was $2 million to $20 million, with a

median of $10 million. The cost of changes in consumer practices is an

annual recurring cost of the proposed rule.

4. Summary of Benefits/Cost Analysis

Table 1 of this document shows the median estimated benefits and

costs of the proposed rule.

Table 1.--Median Annual Estimated Benefits and Costs of the Proposed Rule (In Millions of Dollars)

----------------------------------------------------------------------------------------------------------------

Incidents of Benefit and Cost Analysis First Year All Other Years

----------------------------------------------------------------------------------------------------------------

Median estimated benefits (USDA SE risk assessment baseline) $700 $700

Median estimated benefits (CDC surveillance baseline) $300 $300

Median estimated costs $60 $10

----------------------------------------------------------------------------------------------------------------

B. Small Entity Analysis

1. Introduction

FDA has examined the economic implications of this proposed rule as

required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a

rule has a significant economic impact on a substantial number of small

entities, the Regulatory Flexibility Act requires agencies to analyze

regulatory options that would lessen the economic effect of the rule on

small entities.

2. Economic Effects on Small Entities

a. Number of small entities affected. The proposed rule would

affect many small entities, including egg processors, grocery stores

and other stores including roadside stands, restaurants and other food

service establishments. FDA has not been able to determine how many of

the 669 egg processors registered with the USDA are small businesses

(Ref. 40). Egg processors generally fall into two industrial

classifications: Poultry slaughtering and processing (standard

industrial classification (SIC code 2015)) and whole poultry and

poultry products (SIC code 5144). The two classifications roughly

correspond to in-line and off-line processors. In-line processors

package the eggs at the egg laying facility. Off-line processors ship

the eggs to packers.

The Small Business Administration (SBA) defines in-line egg

processors (SIC code 2015-03) to be small businesses if they employ 500

or fewer people. According to a search in Dun's Market Identifiers

(Ref. 41), 25 in-line egg processing firms would be defined as small.

SBA defines off-line processors (SIC code 5144) to be small if they

employ 100 or fewer people. Dun's Market Identifiers did not have a

subcategory for egg processors. For the entire category of poultry and

poultry products (SIC code 5144), 80 percent of establishments employ

fewer than 100 workers. If the same proportion holds for the

subcategory composed of egg processors, then 470 firms would be

classified as small.\7\ FDA estimated the total number of small egg

processors to be 495 (= 25 + 470).

---------------------------------------------------------------------------

\7\ The estimated total number of in-line establishments is 134,

but 52 are branches of firms. If the total number of in-line firms

is 82 (= 134 - 52), and the number of processors is 669, then 587

firms are off-line processors. If 80 percent are small, then 470

off-line (= 0.8 x 587) processors are small.

---------------------------------------------------------------------------

The refrigeration provision would affect small establishments that

are not currently refrigerating at 7.2 deg.C (45 deg.F). The SBA

defines grocery stores (SIC code 5411) to be small if annual gross

revenue is less than $20 million. Other food stores (SIC codes 5431,

5451, and 5499), which include fruit and vegetable markets, dairy

product stores, and miscellaneous food stores, are small if annual

sales are less than $5 million. Restaurants are small if annual sales

are less than $5 million; institutions are small if sales are less than

$15 million.

As set out in Table 2 of this document, FDA estimates that the

number of small establishments affected by the proposed refrigeration

provision would be 25,400. The number of establishments (small and

large) currently not keeping eggs at an ambient temperature of 7.2

deg.C (45 deg.F) is approximately 44,400, which includes 10,700

grocery and other food stores, 24,000 restaurants, and 9,700

institutions (see the PRIA/IRFA document elsewhere in this issue of the

Federal Register). FDA assumed that the proportion of small

establishments affected by the refrigeration provision would be the

same as the fraction of institutions for the entire industry in that

category. According to SBA size standards for small entities, 71

percent of grocery and other food stores and 54 percent of restaurants

are small. Institutions are more complicated, because they cut across

SIC codes. FDA assumed that 50 percent of institutions serving eggs are

small. The agency asks for comments on this assumption. FDA estimated

the number of small establishments affected by the

[[Page 36509]]

refrigeration provision by multiplying the fraction in each category

defined to be small by the total number of establishments affected.

Table 2 of this document shows the number of small entities likely to

be affected by the refrigeration provision of the proposed rule.

Table 2.--Number of Small Entities Likely to be Affected by the Refrigeration Provision of the Proposed Rule

----------------------------------------------------------------------------------------------------------------

Number of Small

Establishments Currently

Category Storing Eggs Above 45 F (7

C)

----------------------------------------------------------------------------------------------------------------

Grocery and other stores 7,600

Restaurants 13,000

Institutions 4,800

Total 25,400

----------------------------------------------------------------------------------------------------------------

b. Costs to small entities. Redesigning the label accounts for most

of the estimated additional labeling costs for small processors. For a

6-month compliance period, redesign costs would be $1,000 per

stockkeeping unit (SKU) for pulp cartons and $500 per SKU for foam

cartons. The cost of the labeling provision borne by small processors

will vary with the number of SKU's. The average number of SKU's per

processor for the industry is 30; FDA assumes that the output of small

processors falls in the range of 2 to 20 SKU's. Additional redesign

costs could therefore be as high as $20,000 per processor (= 20 x

$1,000).

Refrigeration costs vary across establishments, depending on the

age of current refrigerators, the planned replacement cycle, and

whether the small establishments is currently keeping eggs at or below

7.2 deg.C (45 deg.F). Additional refrigeration costs for small

retailers would average $633, with $700 the most likely value. FDA

assumed that the proportion of additional refrigeration costs borne by

small entities would be the same as the proportion of small entities in

each category of establishments. The cost of the refrigeration

provision to small entities is shown in Table 3 of this document. The

agency requests comments on the effect of the refrigeration provision

on roadside stands and the practices they follow in marketing eggs.

Table 3.--Costs to Small Entities of the Refrigeration Provision of the Proposed Rule

----------------------------------------------------------------------------------------------------------------

Mean Cost per Small

Category Total Costs to Small Entities Entity

----------------------------------------------------------------------------------------------------------------

Grocery and other stores $4.8 million $633

Restaurants $8.2 million $633

Institutions $3.1 million $633

----------------------------------------------------------------------------------------------------------------

3. Regulatory Options

a. Exemption for small entities. The burden on small entities would

be lifted if they were exempt from the provisions of the proposed rule.

Most of the entities affected by this proposed rule, however, are

small. Thus, exempting small entities from its provisions would

effectively negate the rule.

b. Longer compliance periods. Lengthening the labeling compliance

period from 6 months to 18 months and lengthening the refrigeration

compliance period from the proposed rule's effective date to 12 months

after the effective date would provide regulatory relief (cost

reduction) to small entities. In order to estimate the regulatory

relief from lengthening the refrigeration compliance period, the agency

assumed that the cost reduction would equal the interest (discounted at

7 percent per year) on the cost of refrigeration equipment over the

extension of the compliance period. If the compliance period were

extended by 12 months, the interest on the cost of equipment would be

over $1 million (= $16.1 x 0.07). For the most likely equipment cost of

$700 per small establishment, the interest saving would be about $50

(=0.07 x $700).

In order to estimate the regulatory relief to small retail entities

from a longer labeling compliance period, FDA estimated that total

industry costs would fall by $11 million if the compliance period were

extended from 6 months to 18 months (see the PRIA/IRFA document

elsewhere in this issue of the Federal Register). Most of the relief to

small businesses would come from the reduced costs of redesigning the

carton label. For pulp cartons, extending the compliance period to 18

months would reduce redesign costs from $1,000 (for a 6-month

compliance period) to $500 per SKU. For foam cartons, extending the

compliance period to 18 months would reduce redesign costs from $500

(for a 6-month compliance period) to $100 per SKU.

Although lengthening the compliance periods would provide some

regulatory relief to small entities, they make up such a large part of

the affected industries that longer compliance periods would

significantly delay the full public health benefits of the proposed

rule.

4. Description of Recordkeeping and Recording Requirements

The Regulatory Flexibility Act requires a description of the

recordkeeping and recording required for compliance with this rule.

This rule does not require the preparation of a report or a record.

5. Worst Case to Small Entities

The greatest impact to a small retail establishment as a

consequence of the refrigeration provision would be to cause the entity

to bear the entire cost for the purchase of a new refrigerator. The

agency estimates that the cost of a new refrigerator is between $2,500

and $6,000 (see the PRIA/IRFA document published elsewhere in this

issue of the Federal Register). In order to estimate the worst possible

outcome for a small entity, FDA assumed that some small retail

establishment would purchase a new refrigerator at the maximum

estimated cost of $6,000. If the latter

[[Page 36510]]

cost were amortized over a 10-year period (using a discount rate of 7

percent) then the approximate annual expense would be $850 per year for

10 years. According to Dun and Bradstreet, 85 percent of all grocery

stores have annual sales of less than $20 million, and 71 percent of

all restaurants have annual sales of less than $5 million (Ref. 41).

Among the smallest 10 percent of these establishments, the average

sales volume is $100,000 per year for a grocery store and $50,000 per

year for a restaurant. Therefore, the additional expense of $850 per

year amounts to approximately 1 to 2 percent of average sales volume

per year. Grocery stores and restaurants typically have profit margins

on sales of 1 to 5 percent, so a reduction of the profit margin by 40

to 100 percent would be the worst-case outcome for the smallest

entities in retail.

The worst case to a small entity attributable to the labeling

provision would occur if a small packer were unable to pass along any

of the cost to its customers. As shown previously, FDA estimated that

the redesign cost to a small processor could be as high as $20,000. If

the one-time cost could be amortized over a 10-year period at an annual

discount rate of 7 percent, the small packer would incur an additional

annual expense of approximately $3,000. FDA has not estimated the

annual sales revenues of the smallest egg packers and is therefore

unable to compare the estimated amortized cost to annual profits. FDA

requests comments on this relationship.

6. Summary of Small Entity Analysis

FDA estimated that the labeling provisions could impose costs of up

to $20,000 on 495 small processing establishments. The refrigeration

provision would impose estimated costs of $633 per small entity on

approximately 25,400 small establishments. FDA finds that, under the

Regulatory Flexibility Act, this proposed rule would have a significant

economic impact on a substantial number of small entities.

V. Executive Order 12612: Federalism

FDA has examined the effects of the two requirements in this

proposal, i.e., refrigeration of shell eggs at retail and safe handling

labeling of shell eggs, on the relationship between the Federal

Government and the States, as required by Executive Order 12612 on

``Federalism.'' The agency concludes that preemption of State or local

rules that establish requirements for refrigeration of shell eggs that

would be less stringent than Federal law is consistent with this

Executive Order. The agency also concludes that the preemption of State

or local rules that establish requirements for safe handling

instructions on shell eggs that would not include, at a minimum, the

language required by the Federal law is also consistent with this

Executive Order.

Section 3(b) of Executive Order 12612 recognizes that Federal

action limiting the discretion of State and local governments is

appropriate ``where constitutional authority for the action is clear

and certain and the national activity is necessitated by the presence

of a problem of national scope.'' The constitutional basis for FDA's

authority to regulate the safety and labeling of foods is well

established.

Section 4(a) of Executive Order 12612 expressly contemplates

preemption when there is a conflict between the exercise of State and

Federal authority under Federal statute. Moreover, section 4(b) of the

Executive Order authorizes preemption of State law in the Federal

rulemaking context when there is ``firm and palpable evidence

compelling the conclusion that the Congress intended to delegate to the

* * * agency the authority to issue regulations preempting State law.''

State and local laws and regulations that would impose less stringent

requirements for refrigeration of shell eggs held for retail

distribution would undermine the agency's goal of ensuring that shell

eggs are properly refrigerated to prevent the growth of SE, and, thus,

reduce the risk of foodborne illness. Similarly, State and local

requirements for safe handling labeling that do not include, at a

minimum, the language required by Federal law would undermine the

agency's effort to provide consumers with material information that

would inform them how to properly handle and cook eggs so as to reduce

their risk of foodborne illness. FDA believes that a single temperature

requirement will ensure that all shell eggs for retail distribution

would meet minimal standards to ensure safety. The agency also believes

that consistent safe handling instructions are necessary so consumers

can find essential information in a message that is not confusing or

misleading.

The proposed rule would establish national minimum standards with

respect to refrigeration and labeling of shell eggs. However, the

refrigeration requirements of this proposed rule do not preempt State

and local laws, regulations, and ordinances that establish more

stringent requirements with respect to the refrigeration requirements,

e.g., lower storage temperature requirements. In addition, the labeling

provisions of this proposed rule do not preempt State and local laws,

regulations, and ordinances that require additional safe handling

instructions, e.g., graphics, on shell eggs that do not conflict with

the proposed Federal requirements.

As required by the Executive Order, States and local governments

will be given, through this notice of proposed rulemaking, an

opportunity to participate in the proceedings to preempt State and

local laws (section 4(e) of Executive Order 12612). In addition, under

the Order, appropriate officials and organizations will be consulted

before this proposed action is implemented (section 3(a) of Executive

Order 12612).

The agency concludes that the policy proposed in this document has

been assessed in light of the principles, criteria, and requirements in

Executive Order 12612; that this policy is not inconsistent with that

Order; that this policy will not impose additional costs and burdens on

the States; and that this policy will not affect the ability of the

States to discharge traditional State governmental functions.

VI. Environmental Impact

The agency has determined under 21 CFR 25.30(j) and (k) that this

action is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VII. Effective Date

FDA is proposing that any final rule that may be issued based upon

this proposal become effective 180 days after its publication in the

Federal Register. However, because FDA believes that it is in the best

interest of all consumers for manufacturers to label shell eggs as soon

as possible, the agency urges manufacturers and packers of shell eggs

to label their products with safe handling statements consistent with

this proposal immediately. FDA recognizes that it is possible that the

requirements for the label statements in the final rule may be

different from those in the proposal. However, to encourage

manufacturers to use the label statements as soon as possible, the

agency advises that it intends to allow the continued use of any label

that complies with the proposed regulation and is printed prior to date

of publication of any final rule resulting from this proposal until

that inventory is depleted.

[[Page 36511]]

VIII. Paperwork Reduction Act of 1995

FDA tentatively concludes that the labeling requirements proposed

in this document are not subject to review by the Office of Management

and Budget because they do not constitute a ``collection of

information'' under the Paperwork Reduction Act of 1995 (44 U.S.C.

3501-3520). Rather the proposed safe handling instructions would be a

``public disclosure of information originally supplied by the Federal

Government to the recipient for the purpose of disclosure to the

public'' (5 CFR 1320.3(c)(2)).

IX. Comments

Interested persons may, on or before September 20, 1999, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments are to

be identified with the docket number found in brackets in the heading

of this document. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

X. References

The following references have been placed on display at the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. Centers for Disease Control and Prevention Memorandum from

Chief, Foodborne Diseases Epidemiology Section, February 8, 1996.

2. Swerdlow, D. L., L. A. Lee, R. V. Tauxe, N. H. Bean, and J.

Q. Jarvis. ``Reactive Arthropathy Following a Multistate Outbreak of

Salmonella typhimurium Infections,'' Abstract 916. Thirthieth

Interscience Conference on Antimicrobial Agents and Chemotherapy.

3. Tauxe, R., ``Salmonella: A Postmodern Pathogen,'' Journal of

Food Protection, 54:563-568, 1991.

4. Chalker, R. and M. Blaser, ``A Review of Human Salmonellosis:

III. Magnitude of Salmonella Infections in the United States,''

Reviews of Infectious Disease, 10:111-123, 1988.

5. Centers for Disease Control and Prevention, Laboratory

Confirmed Salmonella Surveillance Annual Summary, 1993-1995.

6. Centers for Disease Control and Prevention, ``Outbreaks of

Salmonella Serotype Enteritidis Infection Associated with

Consumption of Raw Shell Eggs--United States, 1994-1995,'' Morbidity

and Mortality Weekly Report, 45:737-742, 1996.

7. Centers for Disease Control and Prevention, Annual Tabulation

Summary, Salmonella Surveillance, 1997.

8. Salmonella Enteritidis Risk Assessment, Shell Eggs and Egg

Products, Final Report, June 12, 1998.

9. Tauxe, R. V., ``The Continuing Challenge of Salmonella

Enteritidis Infections in the United States: A Public Health

Perspective,'' Presentation at the Technical Meeting on Shell Eggs

and Egg Products Risk Assessment, 1997.

10. FDA memorandum, Marilyn Balmer to the Record, August 31,

1998.

11. Mishu, B., J. Koehler, L. A. Lee, D. Rodrigue, F. H.

Brenner, P. Blake, and R. V. Tauxe, ``Outbreaks of Salmonella

enteritidis Infections in the United States, 1985-1991,'' Journal of

Infectious Diseases, 169:547-552, 1994.

12. Centers for Disease Control and Prevention, ``Update:

Salmonella enteritidis Infections and Grade A Shell Eggs--United

States, 1989,'' Morbidity and Mortality Weekly Report, 38:877-880,

1990.

13. St. Louis, M. E., D. L. Morse, M. E. Potter, T. M. DeMelfi,

J. J. Guzewich, R. V. Tauxe, P. A. Blake, ``The Emergence of Grade A

Eggs as a Major Source of Salmonella enteritidis Infections,''

Journal of the American Medical Association, 259:2103-2107, 1988.

14. Centers for Disease Control and Prevention, ``Outbreak of

Salmonella enteritidis Associated With Homemade Ice Cream--

Florida,'' Morbidity and Mortality Weekly Report, 43:669-671, 1994.

14A. FDA memorandum, Marilyn F. Balmer to Darryl Patterson,

February 18, 1999.

14B. Centers for Disease Control and Prevention, ``Incidence of

Foodborne Illnesses: Preliminary Data from the Foodborne Diseases

Active Surveillance Network (FoodNet)--United States, 1998,''

Morbidity and Mortality Weekly Report, 48:189-194, 1999.

15. Keller, L. H., C. E. Benson, K. Krotec, and R. J. Eckroade,

``Salmonella enteritidis Colonization of the Reproductive Tract and

Forming and Freshly Laid Eggs of Chickens,'' Infection and Immunity,

7:2443-2449, 1995.

16. Snoeyenbos, G. H., C. F. Smyser, and H. Van Roekel,

``Research Note: Salmonella Infections of the Ovary and Peritoneum

of Chickens,'' Avian Diseases, 13:668-670, 1969.

17. Salmonella Enteritidis Pilot Project Progress Report, May

22, 1995.

18. Council for Agricultural Science and Technology, Foodborne

Pathogens: Risks and Consequences, Ames, Iowa: Council for

Agricultural Science and Technology, Task Force Report No. 122, ch.

3, 1994.

19. Hennessey, T. W., C. W. Hedberg, L. Slutsker, K. E. White,

J. M. Besser-Wiek, M. E. Moen, J. Feldman, W. W. Colemen, L. M.

Edmonson, K. L. MacDonald, and M. T. Osterholm, ``A National

Outbreak of Salmonella enteritidis Infections from Ice Cream,'' The

New England Journal of Medicine, 334:1281-1286, 1996.

20. Vought, K. J. and S. R. Tatini, ``Salmonella enteritidis

Contamination of Ice Cream Associated with a 1994 Multistate

Outbreak,'' Journal of Food Protection, 61:5-10, 1998.

21. Humphrey, T. J., A. Whitehead, A. H. L. Gawler, A. Henley,

and B. Rowe, ``Numbers of Salmonella enteritidis in the Contents of

Naturally Contaminated Hens' Eggs,'' Epidemiology and Infection,

106:489-496, 1991.

22. Klontz, K. C., B. Timbo, S. Fein, and A. Levy, ``Prevalence

of Selected Food Consumption and Preparation Behaviors Associated

With Increased Risks of Food-borne Disease,'' Journal of Food

Protection, 58(8):927-930, 1995.

23. Market Research Corp. of America, Consumption of Raw Beef,

Raw Fish, Raw Eggs. Menu Census Report to the U.S. Department of

Agriculture--ERS, 1995.

24. Lin, C-T. J., R. A. Morales, and K. Ralston, ``Raw and

Undercooked Eggs: A Danger of Salmonellosis,'' Food Review, 20:27-

32, 1997.

25. FDA Memorandum, Alan S. Levy, Ph.D. to Kenneth Falci, Ph.D.,

June 26, 1997.

26. Anderson, K. M., F. T. Jones, and P. A. Curtis, ``Heat Loss

from Commercially Packed Eggs in Post-processing Coolers,''

Commercial Egg Special Report, vol. I, ER-1, April 1992.

27. Kim, C. J., D. A. Emery, H. Rinke, K. V. Nagaraja, and D. A.

Halvorson, ``Effect of Time and Temperature on Growth of Salmonella

enteritidis in Experimentally Inoculated Eggs,'' Avian Diseases,

33:735-742, 1989.

28. Gast, R. K. and C. W. Beard, ``Production of Salmonella

enteritidis--Contaminated Eggs by Experimentally Infected Hens,''

Avian Diseases, 34:438-446, 1990.

29. Clay, C. E. and R. G. Board, ``Growth of Salmonella

enteritidis in Artificially Contaminated Hens' Shell Eggs,''

Epidemiology and Infection, 106:271-281, 1991.

30. Humphrey, T. J., ``Growth of Salmonellas in Intact Shell

Eggs: Influence of Storage Temperature,'' The Veterinary Record,

126:292, 1990.

30A. Bradshaw, J. G., D. B. Shah, E. Forney, and J. M. Madden,

``Growth of Salmonella enteritidis in Yolk of Shell Eggs from Normal

and Seropositive Hens,'' Journal of Food Protection, 53:1033-1036,

1990.

31. Saeed, A. M. and C. W. Koons, ``Growth and Heat Resistance of

Salmonella enteritidis in Refrigerated and Abused Eggs,'' Journal of

Food Protection, 56:927-931, 1993.

32. Centers for Disease Control and Prevention, ``Update:

Salmonella enteritidis Infections in the Northeastern United

States,'' Morbidity and Mortality Weekly Report, 36:204-205, 1987.

33. U.S. Public Health Service, ``Food Code: 1999,

Recommendations of the United States Public Health Service, Food and

Drug Administration,'' Sections 3-401.11 and 3-501.16.

34. White, P. L., W. Schlosser, C. E. Benson, C. Maddox, and A.

Hogue, ``Environmental Survey by Manure Drag Sampling for Salmonella

enteritidis in Chicken Layer Houses,'' Journal of Food Protection,

60:1189-1193, 1997.

35. Salmonella Enteritidis Review Team Report, January 18, 1997.

36. Centers for Disease Control and Prevention, ``Update:

Salmonella enteritidis Infections in Grade A Shell Eggs--United

[[Page 36512]]

States,'' Morbidity and Mortality Weekly Report, 37:490, 495-496,

1988.

37. FDA memorandum, Marilyn Balmer to the Record, December 18,

1998.

38. Miyamoto, T., T. Horie, E. Baba, K. Susai, T. Fukata, and A.

Arakawa, ``Salmonella Penetration Through Eggshell Associated With

Freshness of Laid Eggs and Refrigeration,'' Journal of Food

Protection, 61:350-353, 1998.

39. Macro International, Inc., Focus Group Testing of Safe

Handling Statements on Shell Eggs, April 1998.

39A. Macro International, Inc., Focus Group To Assess Consumer

Reactions to Food Safety Issues (U.S. Food and Drug Administration),

Certified Tape Transcripts.

40. FDA memorandum, Peter Vardon to the Record, October 7, 1998.

41. The Dialog Corp., Dun's Market Identifiers, Mountain View,

CA, March 19, 1998.

List of Subjects

21 CFR Part 16

Administrative practice and procedure.

21 CFR Part 101

Administrative practice and procedure, Food labeling, Nutrition,

Reporting and recordkeeping requirements.

21 CFR Part 115

Administrative practice and procedure, Eggs, Refrigeration.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the

Public Health Services Act, and under the authority delegated to the

Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be

amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

1. The authority citation for 21 CFR part 16 continues to read as

follows:

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,

467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

2. Section 16.5 is amended by adding paragraph (a)(4) to read as

follows:

Sec. 16.5 Inapplicability and limited applicability.

(a) * * *

(4) A hearing on an order for relabeling, diversion, or destruction

of shell eggs under section 361 of the Public Health Service Act (42

U.S.C. 264), Secs. 101.17(h) and 115.50 of this chapter.

* * * * *

PART 101--FOOD LABELING

3. The authority citation for 21 CFR part 101 is revised to read as

follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,

343, 348, 371; 42 U.S.C. 243, 264, 271.

4. Section 101.17 is amended by revising the section heading and

by adding paragraph (h) to read as follows:

Sec. 101.17 Food labeling warning, notice, and safe handling

statements.

* * * * *

(h) Shell eggs. (1) The label of shell eggs shall bear the

following statement:

SAFE HANDLING INSTRUCTIONS: Eggs may contain harmful bacteria

known to cause serious illness, especially in children, the elderly,

and persons with weakened immune systems. For your protection: keep

eggs refrigerated; cook eggs until yolks are firm; and cook foods

containing eggs thoroughly.

(2) The label statement required by paragraph (h)(1) of this

section shall appear prominently and conspicuously, with the words

``SAFE HANDLING INSTRUCTIONS'' in bold type, on the information panel

or the principal display panel of the container.

(3) The label statement required by paragraph (h)(1) of this

section shall be set off in a box by use of hairlines.

(4) Shell eggs that have been, before distribution to consumers,

specifically processed to destroy all viable Salmonella shall be exempt

from the requirements of this paragraph (h).

(5) The safe handling statement for shell eggs that are not for

direct sale to consumers, e.g., those that are to be repacked or

labeled at a site other than where originally processed, or are sold

for use in food service establishments, may be provided on cartons or

in labeling, e.g., invoices or bills of lading in accordance with the

practice of the trade.

(6) The requirements of this section are applicable to all shell

eggs.

(7) Under sections 311 and 361 of the Public Health Service Act

(PHS Act), any State or locality that is willing and able to assist the

agency in the enforcement of paragraphs (h)(1) through (h)(5) of this

section, and is authorized to inspect or regulate establishments

handling packed shell eggs, may in its own jurisdiction, enforce

paragraphs (h)(1) through (h)(5) of this section through inspections

under paragraph (h)(9) of this section and through administrative

enforcement remedies identified in paragraph (h)(8) of this section

until FDA notifies the State or locality in writing that such

assistance is no longer needed. When providing such assistance, a State

or locality may follow the hearing procedures set out in paragraphs

(h)(8)(ii)(C) through (h)(8)(ii)(D) of this section, substituting,

where necessary, appropriate State or local officials for designated

FDA officials or may utilize comparable State or local hearing

procedures if such procedures satisfy due process.

(8) This paragraph (h) is established under authority of both the

Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under

the act, the agency can enforce the food misbranding provisions under

21 U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for

the issuance of implementing enforcement regulations; therefore, FDA

has established the following administrative enforcement procedures for

the relabeling, diversion, or destruction of shell eggs and informal

hearings under the PHS Act:

(i) Upon finding that any shell eggs are in violation of this

section, an authorized FDA representative or State or local

representative in accordance with paragraph (h)(7) of this section may

order such eggs to be relabeled under the supervision of said

representative, diverted, under the supervision of said representative

for processing in accordance with the Egg Products Inspection Act (21

U.S.C. 1031 et seq.), or destroyed by or under the supervision of an

officer or employee of the FDA, or, if applicable, of the State or

locality, in accordance with the following procedures:

(A) Order for relabeling, diversion, or destruction under the PHS

Act. Any district office of the FDA or any State or locality acting

under paragraph (h)(7) of this section, upon finding shell eggs held in

violation of this regulation, may serve upon the person in whose

possession such eggs are found a written order that such eggs be

relabeled with the required statement in paragraph (h)(1) of this

section before further distribution. If the person chooses not to

relabel, the district office of the FDA or, if applicable, the

appropriate State or local agency may serve upon the person a written

order that such eggs be diverted (from direct consumer sale, e.g., to

food service) under the supervision of an officer or employee of the

issuing entity, for processing in accordance with the Egg Products

Inspection Act (21 U.S.C. 1031 et seq.)) or destroyed by or under the

supervision of the issuing entity, within 10-working days from the date

of receipt of the order.

(B) Issuance of order. The order shall include the following

information:

(1) A statement that the shell eggs identified in the order are

subject to relabeling, diversion for processing in

[[Page 36513]]

accordance with the Egg Products Inspection Act, or destruction;

(2) A detailed description of the facts that justify the issuance

of the order;

(3) The location of the eggs;

(4) A statement that these eggs shall not be sold, distributed, or

otherwise disposed of or moved except as provided in paragraph

(h)(8)(i)(E) of this section;

(5) Identification or description of the eggs;

(6) The order number;

(7) The date of the order;

(8) The text of this entire section;

(9) A statement that the order may be appealed by written appeal

or by requesting an informal hearing;

(10) The name and phone number of the person issuing the order;

and

(11) The location and telephone number of the responsible office

or agency and the name of its director.

(C) Approval of director. An order, before issuance, shall be

approved by the director of the office or agency issuing the order. If

prior written approval is not feasible, prior oral approval shall be

obtained and confirmed by written memorandum as soon as possible.

(D) Labeling or marking of shell eggs under order. An FDA, State,

or local representative issuing an order under paragraph (h)(8)(i)(A)

o

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