[Federal Register Volume 64, Number 128 (Tuesday, July 6, 1999)]
[Proposed Rules]
[Pages 36492-36516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17122]
[[Page 36491]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 16, 101, and 115
Food Labeling: Safe Handling Statements: Labeling of Shell Eggs; Shell
Eggs: Refrigeration of Shell Eggs Held for Retail Distribution;
Proposed Rule
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; Proposed Rule
Federal Register / Vol. 64, No. 128 / Tuesday, July 6, 1999 /
Proposed Rules
[[Page 36492]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16, 101, and 115
[Docket Nos. 98N-1230, 96P-0418, and 97P-0197]
RIN 0910-AB30
Food Labeling: Safe Handling Statements: Labeling of Shell Eggs;
Shell Eggs: Refrigeration of Shell Eggs Held for Retail Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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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
[[Page 36493]]
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
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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)
of this section shall label or mark the shell eggs with official tags
that include the following information:
(1) A statement that the shell eggs are detained in accordance
with regulations issued under section 361(a) of the PHS Act (42 U.S.C.
264(a)).
(2) A statement that the shell eggs shall not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
(i) Relabel, divert them for processing in accordance with the Egg
Products Inspection Act, or destroy them; or
(ii) Move them to another location for holding pending appeal.
(3) A statement that the violation of the order or the removal or
alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act, 42 U.S.C. 271).
(4) The order number and the date of the order, and the name of
the government representative who issued the order.
(E) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order shall not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until the
notice is withdrawn after an appeal except, after notifying FDA's
district office or, if applicable, the State or local agency in
writing, to:
(1) Relabel, divert, or destroy them as specified in paragraph
(h)(8)(iv) of this section; or
(2) Move them to another location for holding pending appeal.
(ii) The person on whom the order for relabeling, diversion, or
destruction is served may either comply with the order or appeal the
order to the regional food and drug director.
(A) Appeal of a detention order. Any appeal shall be submitted in
writing to the FDA District Director in whose district the shell eggs
are located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5-working days after the appeal is filed or, if requested
by the appellant, at a later date, which shall not be later than 20-
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
(B) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the regional food and drug director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or
from matters officially noticed. If the regional food and drug director
determines that a hearing is not justified, written notice of the
determination will be given to the parties explaining the reason for
denial.
(C) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by the regional food and drug director or
his designee, and a written summary of the proceedings shall be
prepared by the regional food and drug director.
(1) The regional food and drug director may direct that the
hearing be conducted in any suitable manner permitted by law and this
section. The regional food and drug director has the power to take such
actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
(2) Employees of FDA will first give a full and complete statement
of the action which is the subject of the hearing, together with the
information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except
for the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
(3) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but
any party may comment upon or rebut any information and views presented
by another party.
(4) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the regional food and drug director's report of
the hearing.
(5) The regional food and drug director shall prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. Whenever time permits, the regional
food and drug director may give the parties the opportunity to review
and comment on the report of the hearing.
(6) The regional food and drug director shall include as part of
the report of the hearing a finding on the credibility of witnesses
(other than expert witnesses) whenever credibility is a material issue,
and shall include a recommended decision, with a statement of reasons.
(D) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the regional food and drug director
shall render a decision on the appeal affirming or revoking the
detention within 5-working days after the receipt of the appeal.
(E) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the regional food and drug director finds that the shell eggs
were held in violation of this section, he shall affirm the order that
they be relabeled, diverted under the supervision of an officer or
employee of the FDA for processing under the Egg Products Inspection
Act, or destroyed by or under the supervision of an officer or employee
of the FDA; otherwise, the regional food and drug director shall issue
a written notice that the prior order is withdrawn. If the regional
food and drug director affirms the order he shall order that the
[[Page 36514]]
relabeling, diversion, or destruction be accomplished within 10-working
days from the date of the issuance of his decision. The regional food
and drug director's decision shall be accompanied by a statement of the
reasons for the decision. The decision of the regional food and drug
director shall constitute final agency action, reviewable in the
courts.
(F) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
relabel, divert, or destroy them within 10-working days, or if the
demand is affirmed by the regional food and drug director after an
appeal and the person in possession of such eggs fails to relabel,
divert, or destroy them within 10-working days, the FDA district
office, or, if applicable, the State or local agency may designate an
officer or employee to divert or destroy such eggs. It shall be
unlawful to prevent or to attempt to prevent such diversion or
destruction of the shell eggs by the designated officer or employee.
(9) Persons engaged in handling or storing packed shell eggs for
retail distribution shall permit authorized representatives of FDA to
make at any reasonable time such inspection of the establishment in
which shell eggs are being held, including inspection and sampling of
the labeling of such eggs as may be necessary in the judgment of such
representatives to determine compliance with the provisions of this
section. Inspections may be made with or without notice and will
ordinarily be made during regular business hours.
5. New part 115 is added to read as follows:
PART 115--SHELL EGGS
Subpart A--General Provisions
Sec.
115.50 Refrigeration of shell eggs held for retail distribution.
Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271.
Subpart A--General Provisions
Sec. 115.50 Refrigeration of shell eggs held for retail distribution.
(a) For purposes of this section a ``retail establishment'' is an
operation that stores, prepares, packages, serves, vends, or otherwise
provides food for human consumption directly to consumers.
(b) Except as provided in paragraph (c) of this section, shell
eggs held for retail distribution:
(1) Shall promptly be placed under refrigeration as specified in
paragraph (b)(2) of this section upon receipt at a retail
establishment; and
(2) Shall be stored and displayed under refrigeration at an
ambient temperature not greater than 7.2 deg.C (45 deg.F) while held
at a retail establishment.
(c) Shell eggs that have been specifically processed to destroy
all viable Salmonella shall be exempt from the requirements of
paragraph (b) of this section.
(d) The requirements of this section are applicable to all shell
eggs.
(e) 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 paragraph (b) of this section, and is
authorized to inspect or regulate retail establishments, may, in its
own jurisdiction, enforce paragraph (b) of this section through
inspections under paragraph (g) of this section and through
administrative enforcement remedies identified in paragraph (f) of this
section until FDA notifies the State or locality in writing that such
assistance is no longer needed. When providing assistance under
paragraph (f) of this section, a State or locality may follow the
hearing procedures set out in paragraphs (f)(2)(iii) through (f)(2)(v)
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.
(f) This section 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 adulteration 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 diversion or destruction of shell eggs and for informal hearings
under the PHS Act:
(1) Upon finding that any shell eggs have been held in violation
of this section, an authorized FDA representative or a State or local
representative in accordance with paragraph (e) of this section may
order such eggs to be 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:
(i) Order for diversion or destruction. Any district office of FDA
or any State or local agency acting under paragraph (e) 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 diverted, 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 said district office, within
10-working days from the date of receipt of the order.
(ii) Issuance of order. The order shall include the following
information:
(A) A statement that the shell eggs identified in the order are
subject to diversion for processing in accordance with the Egg Products
Inspection Act or destruction;
(B) A detailed description of the facts that justify the issuance
of the order;
(C) The location of the eggs;
(D) A statement that these eggs shall not be sold, distributed, or
otherwise disposed of or moved except as provided in paragraph (g)(4)
of this section;
(E) Identification or description of the eggs;
(F) The order number;
(G) The date of the order;
(H) The text of this entire section;
(I) A statement that the order may be appealed by written appeal
or by requesting an informal hearing;
(J) The name and phone number of the person issuing the order; and
(K) The location and telephone number of the office or agency and
the name of its director.
(iii) Approval of District Director. An order, before issuance,
shall be approved by the Food and Drug Administration (FDA) District
Director in whose district the shell eggs are located. If prior written
approval is not feasible, prior oral approval shall be obtained and
confirmed by written memorandum as soon as possible.
(iv) Labeling or marking of shell eggs under order. An FDA, State
or local agency representative issuing an order under paragraph (g)(1)
of this section shall label or mark the shell eggs with official tags
that include the following information:
(A) A statement that the shell eggs are detained in accordance
with regulations issued under section 361(a) of the PHS Act (42 U.S.C.
264(a)).
(B) A statement that the shell eggs shall not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
(1) Divert them for processing in accordance with the Egg Products
Inspection Act or destroy them; or
[[Page 36515]]
(2) Move them to an another location for holding pending appeal.
(C) A statement that the violation of the order or the removal or
alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act, 42 U.S.C. 271).
(D) The order number and the date of the order, and the name of
the government representative who issued the order.
(v) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order shall not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until the
notice is withdrawn after an appeal except, after notifying FDA's
district office or, if applicable, the State or local agency in
writing, to:
(A) Divert or destroy them as specified in paragraph (f)(1)(i) of
this section; or
(B) Move them to another location for holding pending appeal.
(2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to the
regional food and drug director in accordance with the following
procedures:
(i) Appeal of a detention order. Any appeal shall be submitted in
writing to FDA's District Director in whose district the shell eggs are
located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5-working days after the appeal is filed or, if requested
by the appellant, at a later date, which shall not be later than 20-
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
(ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the regional food and drug director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or
from matters officially noticed. If the regional food and drug director
determines that a hearing is not justified, written notice of the
determination will be given to the parties explaining the reason for
denial.
(iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by the regional food and drug director or
his designee, and a written summary of the proceedings shall be
prepared by the regional food and drug director.
(A) The regional food and drug director may direct that the
hearing be conducted in any suitable manner permitted by law and this
section. The regional food and drug director has the power to take such
actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
(B) Employees of FDA will first give a full and complete statement
of the action which is the subject of the hearing, together with the
information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except
for the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
(C) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but
any party may comment upon or rebut any information and views presented
by another party.
(D) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the regional food and drug director's report of
the hearing.
(E) The regional food and drug director shall prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. Whenever time permits, the regional
food and drug director may give the parties the opportunity to review
and comment on the report of the hearing.
(F) The regional food and drug director shall include as part of
the report of the hearing a finding on the credibility of witnesses
(other than expert witnesses) whenever credibility is a material issue,
and shall include a recommended decision, with a statement of reasons.
(iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the regional food and drug director
shall render a decision on the appeal affirming or revoking the
detention within 5-working days after the receipt of the appeal.
(v) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the regional food and drug director finds that the shell eggs
were held in violation of this section, he shall affirm the order that
they be diverted, under the supervision of an officer or employee of
the FDA for processing under the Egg Products Inspection Act or
destroyed by or under the supervision of an officer or employee of the
FDA; otherwise, the regional food and drug director shall issue a
written notice that the prior order is withdrawn. If the regional food
and drug director affirms the order he shall order that the diversion
or destruction be accomplished within 10-working days from the date of
the issuance of his decision. The regional food and drug director's
decision shall be accompanied by a statement of the reasons for the
decision. The decision of the regional food and drug director shall
constitute final agency action, reviewable in the courts.
(vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the regional food and drug director after an appeal and the
person in possession of such eggs fails to divert or destroy them
within 10-working days, FDA's district office or appropriate State or
local agency may designate an officer or employee to divert or destroy
such eggs. It shall be unlawful to prevent or to attempt to prevent
such diversion or destruction of the shell eggs by the designated
officer or employee.
(g) Inspection. Persons engaged in retail distribution of shell
eggs shall permit authorized representatives of FDA to make at any
reasonable time such inspection of the retail establishment in which
shell eggs are being held, including inspection and sampling of such
eggs and the equipment in which shell eggs are held and any records
relating to such equipment or eggs, as may be necessary in the
judgement of such representatives to determine compliance with the
provisions of this section. Inspections may be made with or without
notice and will ordinarily be made during regular business hours.
[[Page 36516]]
Dated: June 10, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 99-17122 Filed 7-1-99; 11:12 am]
BILLING CODE 4160-01-F