[Federal Register: December 5, 2000 (Volume 65, Number 234)]
[Rules and Regulations]
[Page 76091-76114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de00-9]
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Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 16, 101 and 115
Food Labeling, Safe Handling Statements, Labeling of Shell Eggs;
Refrigeration of Shell Eggs Held for Retail Distribution; Final Rule
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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;
Refrigeration of Shell Eggs Held for Retail Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revising its food
labeling regulations to require a safe handling statement on cartons of
shell eggs that have not been treated to destroy Salmonella
microorganisms. The agency also is requiring that, when held at 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 (SE) that are associated with
the consumption of shell eggs. These actions also respond, in part, to
petitions from Rose Acres Farm, Inc., and the Center for Science in the
Public Interest (CSPI). Safe handling statements will help consumers
take measures to protect themselves from illness or deaths associated
with consumption of shell eggs that have not been treated to destroy
Salmonella (all serotypes). Refrigeration of shell eggs that have not
been treated to destroy Salmonella will help prevent the growth of SE
in shell eggs.
DATES: This rule is effective September 4, 2001, except Sec. 115.50,
which is effective June 4, 2001.
FOR FURTHER INFORMATION CONTACT: For the labeling provisions: Geraldine
A. June, Center for Food Safety and Applied Nutrition (HFS-822), Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
4561. For refrigeration provisions: Nancy S. Bufano, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-401-2022.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Shell Egg Labeling
A. Rationale for the Safe Handling Statement
B. Safe Handling Statement
1. Comments on the Focus Group Research
2. Description of the Hazard
3. Description of At-Risk Consumers
4. Cooking Instructions
5. Other Comments on the Text of the Safe Handling Statement
6. Alternatives to the Proposed Label Statement
7. Placement and Prominence
a. Placement and Type Size of the Safe Handling Statement
b. Use of Graphics
c. Labeling for Shell Eggs Not for Direct Sale to Consumers
8. Other Labeling Issues
C. Comments on Effective Date
III. Refrigeration of Shell Eggs in Retail Establishments
A. Refrigeration Temperature Requirements
B. Enforcement of the Refrigeration Requirement
C. Changes to the Proposal
IV. Final Regulatory Impact Analysis
A. Benefit-Cost Analysis
1. Regulatory Options
2. Benefits
3. Costs
a. Labeling
b. Refrigeration
c. Changes in Consumer Practices
4. Summary of Costs and Benefits
B. Small Entity Analysis
1. Introduction
2. Economic Effects on Small Entities
a. Number of Small Entities Affected
b. Costs for Small Entities.
3. Regulatory Options
a. Exemption for Small Establishments.
b. Longer Compliance Periods.
4. Recordkeeping and Recording Requirements
5. Worst Case for a Small Establishment
6. Summary of Small Entity Analysis
V. Federalism
VI. Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. References
I. Background
FDA and the Food Safety and Inspection Service (FSIS) of the U.S.
Department of Agriculture (USDA) share Federal authority to regulate
eggs. The two agencies published in the Federal Register of May 19,
1998 (63 FR 27502), an advanced notice of proposed rulemaking seeking
information on how to identify farm-to-table actions that would
decrease food safety risks associated with shell eggs. On July 1, 1999,
FDA and FSIS, in testimony before the Subcommittee on Oversight of
Government Management, Restructuring, and the District of Columbia of
the Senate Committee on Governmental Affairs, committed to developing
by November 1, 1999, an action plan to address the presence of SE in
shell eggs using a farm-to-table approach. On August 26, 1999, FDA and
FSIS jointly held a public meeting to gather stakeholders' input and to
discuss the development of the action plan. On December 10, 1999, FDA
and FSIS presented the Egg Safety Action Plan (Ref. 1) to the
President. The plan identifies the systems and practices from
production to consumption that must be implemented to reduce and,
ultimately, eliminate eggs as a source of human SE illnesses. This plan
includes requirements for refrigeration at retail and requirements for
the safe handling statement being issued in this rulemaking. FDA, along
with FSIS, intends to use information gathered by both agencies to
develop and implement a comprehensive program to address the safety of
shell eggs from farm to table.
In the Federal Register of July 6, 1999 (64 FR 36492), FDA
published a proposed rule (hereinafter referred to as ``the proposal'')
to require safe handling label statements on shell eggs that have not
been treated to destroy Salmonella microorganisms and refrigeration of
these shell eggs while held by retail establishments. In a separate
document in the same issue of the Federal Register (64 FR 36516), FDA
published a Preliminary Regulatory Impact Analysis (PRIA) and Initial
Regulatory Flexibility Analysis of the proposal. FDA proposed these
regulations because of the number of outbreaks and deaths associated
with the consumption of shell eggs that have not been treated to
destroy Salmonella. Interested parties were given until September 20,
1999, to comment on the proposal.
FDA received approximately 790 responses, each containing one or
more comments, to the proposal. These responses were received from the
egg industry, egg packaging companies, trade associations, consumers,
consumer interest groups, animal interest groups, academia, State
Government agencies, members of Congress, and a foreign Government
agency. More than 700 of these comments addressed forced molting, which
is directed at the production of shell eggs, and, therefore, outside of
the scope of this rulemaking, and will not be addressed in this
document. Other comments also addressed issues that are outside the
scope of this rule and will not be addressed in this document (e.g.,
implementation of national standards for quality assurance (QA)
programs, implementation of Hazard Analysis and Critical Control Points
(HACCP) programs, use of sanitary standard operating procedures, Good
Agricultural Practices/Good Manufacturing Practices, and other
intervention procedures such as manipulation of feeds and competitive
exclusion to control SE, sell-by dates, uniform coding, repacking of
shell eggs, refrigeration of nest run
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shell eggs, and creation of a single food safety agency responsible for
eggs). These comments were considered by the agency in its action plan
to address the presence of SE in shell eggs and will be considered in
the development of subsequent proposed measures aimed at improving egg
safety.
Some of the remaining comments supported the proposal. Others
opposed the proposal or suggested modifications to the proposal. The
relevant comments and the agency's responses to the comments are
discussed below.
II. Shell Egg Labeling
A. Rationale for the Safe Handling Statement
In the proposal, FDA discussed the risk of foodborne illness
associated with the consumption of shell eggs. In 1997, there were
7,924 SE isolates reported to the Centers for Disease Control and
Prevention (CDC). In 1998, 58 percent of the SE outbreaks reported to
CDC where a food vehicle was identified implicated foods containing
eggs. Although recent CDC data show a 44 percent decrease in the
isolation rate of SE, FDA believes that the incidence of SE is still
too high. As discussed in the proposal (64 FR 36492 at 36501), FDA
believes that it could take considerable time to design and implement a
complete program that would eliminate eggs as a source of human SE
illnesses, and indeed the Egg Safety Action Plan has a 10-year
timeframe to achieve that goal (Ref. 1). However, as part of this
program, FDA determined that there are measures that can be put in
place quickly that can reduce the 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. The agency maintained in the proposal
that, unless informed about the risks presented by eggs contaminated
with SE and ways that they may reduce these risks, consumers could
suffer serious illness or death from consumption of raw or undercooked
eggs. Accordingly, FDA proposed to require safe handling statements on
shell eggs to inform consumers that there may be a risk associated with
consumption of eggs and ways that they can properly handle and prepare
eggs in order to reduce such risks.
(Comment 1) Several comments maintained that FDA overstated the
magnitude of the risk associated with SE. One comment contended that
the incidence of illness cited in the proposal was misleading. For
example, the comment stated that information on all cases of
salmonellosis was cited with the implication that it has a direct
application to salmonellosis from SE. The comment stated that
information on foodborne disease data from the years where
salmonellosis associated with SE was increasing were included in the
proposal, whereas, data from 1995 to 1998 showing a decrease in
salmonellosis associated with SE were omitted. Some comments pointed
out that recent data from CDC showing a 44 percent decrease in the
isolation rate of SE from 1996 to 1998 do not support FDA's conclusion
of a continued predominance of SE. Furthermore, one comment pointed out
that there was only a 14 percent decrease in the isolation rate of all
Salmonella serotypes in the same time period as the 44 percent decrease
in the isolation rate of SE.
FDA disagrees that it overstated the magnitude of the risk
associated with SE. The comment misunderstood how the data were
presented in the proposal. FDA did not present the data regarding the
incidence of all cases of salmonellosis to imply that these cases were
reflective of SE-associated cases of salmonellosis. Rather, FDA used
this information to place SE-associated salmonellosis in context of the
epidemiology of Salmonella overall. First, in the proposal, FDA
discussed the severity of salmonellosis and the magnitude of the
disease, i.e., numbers of reported illnesses. Next, the agency
discussed the numbers of SE-associated cases of salmonellosis and the
fact that shell eggs are the major source of SE-related cases of
salmonellosis where a food vehicle is identified.
The agency also disagrees with the comment stating that FDA did not
include information on the decrease in the rate of infections caused by
SE from 1996 to 1998. On the contrary, in the proposal (64 FR 36492 at
36493), FDA stated that recent CDC data showed a 44 percent decrease in
the isolation rate of SE. However, the agency concluded that, even with
the decrease in the isolation rate of SE reported by CDC, the incidence
of SE associated with eggs was still too high and additional measures
could and should be put in place to reduce the incidence even further.
B. Safe Handling Statement
In the proposal, FDA tentatively concluded that certain elements
were essential to an effective safe handling statement, i.e., an
informational statement that describes the hazard and the at-risk
consumers, an instructional statement that describes measures that
consumers can take to reduce or eliminate the risk, and a linking
statement that relates the informational statement to the instructional
statement. Applying the essential elements, FDA crafted several
examples of label statements. FDA conducted focus group research to
evaluate consumer understanding of the safe handling statements to test
their effectiveness in informing consumers of the risks associated with
shell eggs and of the safe handling practices that may be used to
mitigate the risks.\1\ Based on information from the focus groups, FDA
proposed to require the following safe handling statement on shell eggs
that have not been treated to destroy Salmonella:
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\1\ The moderator of the focus groups asked participants about
their knowledge of the possible health effects associated with eggs
as well as their personal experiences with handling eggs. After
assessing the participants' knowledge and attitudes, the moderator
gave the participants a series of safe handling statements for shell
eggs on individual sheets of 8.5 x 11-inch white paper. The
moderator engaged the participants in discussions on the impact of
the statements and asked them to compare each statement with the
other statements. The moderator also asked participants to comment
on the format of the statements. The focus of the discussions was
whether they understood the message.
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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.
1. Comments on the Focus Group Research
(Comment 2) Several comments questioned FDA's focus group research.
One comment maintained that, although focus groups are helpful tools to
obtain feedback on food safety messages, FDA tested four very similar
versions of the same label statement and, therefore, could not judge
whether its proposed statement provided consumers with information they
thought was necessary. The comment concluded that the label statements
tested by FDA did not adequately reflect how consumers perceived FDA's
proposed safe handling statement versus any other statement.
FDA disagrees with this comment. The comment misunderstood the
intent of the focus group research. The intent of the research was for
FDA to gauge how best to word the safe handling statement so that it is
understood by consumers, not to determine what information is necessary
in the statement. FDA developed several statements containing
information
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judged by FDA subject matter experts to be most necessary to consumers.
These subject matter experts arrived at their determination of
necessary information content after considering suggestions for
messages that were submitted by outside organizations (Ref. 2). FDA
provided five different safe handling statements for discussion in the
focus groups. During the focus groups, participants discussed specific
phrasing or message elements within each statement to gauge the effect
of both the specific elements of the message and the overall message.
Participants also provided input on how formatting could make the
statement more readable. Thus, while adhering to the content judged
necessary by FDA subject matter experts, the agency assessed numerous
variations in how to best word and format the statement to communicate
effectively with consumers.
(Comment 3) One comment stated that, although FDA did conduct some
focus group testing, it should conduct direct testing such as mall-
intercept studies to further refine the statement. This comment
maintained that considering the susceptibility of older persons to
foodborne illness, FDA should direct its message testing to this group.
FDA disagrees that it needs to conduct mall-intercept studies to
fine tune the statement. If focus group results are not clear cut, then
an experimental quantitative method such as mall-intercept studies
could be used to fine tune the message. In this case, however, the
focus group results were so consistent that FDA did not deem it
necessary to conduct experimental testing. In addition, the focus group
testing of the safe handling statements included consumers 60 years of
age and older. These older consumers did not differ greatly from
younger consumers in their responses to the safe handling statements
that were tested. Consequently, FDA sees no need to conduct additional
testing on older persons.
2. Description of the Hazard
Most of the comments that responded to the proposed labeling
supported the concept of safe handling instructions for shell eggs.
However, some of these comments opposed the specific language in the
proposed statement for the reasons discussed below.
(Comment 4) Many of these comments asserted that including a
description of the hazard, i.e., ``eggs may contain harmful bacteria
known to cause serious illness, especially in children, the elderly,
and persons with weakened immune systems,'' is unwarranted.
Several comments contended that the hazard description will
distract consumers from the safe handling instructions. To support this
assertion, one comment presented consumer research from the American
Egg Board (AEB) and concluded from it that most respondents saw FDA's
proposed label statement as a warning that eggs are harmful rather than
a message to promote safe handling. Some comments asserted that
consumers have become weary of labels and warnings and no longer pay
attention to them. Other comments expressed their concern that, because
of the length of the hazard description, consumers may not read the
entire statement and, thus, would not read the safe handling
instructions.
Several comments that opposed the inclusion of the hazard statement
maintained that consumers are aware of risks associated with SE in eggs
and, therefore, the description is unnecessary. One of these comments
presented data from a survey conducted by the California Department of
Public Health Services that showed that 84 percent of the respondents
were aware that eggs contained bacteria that could cause illness. The
comment also pointed out that a consumer survey in Iowa reported that
93 percent of those surveyed were aware of Salmonella in eggs. Another
survey in California showed that 86 percent of the English-language
respondents were aware of Salmonella in eggs. The comment noted that a
FDA survey in 1998 showed that \2/3\ of respondents had heard of
Salmonella and knew that cooking would kill it. This represented a 60
percent increase from a survey done in 1993. According to another
comment, before FDA implements such a strongly worded safe handling
instruction, it should determine whether consumers are really
uninformed about the possibility of the presence of illness-causing
bacteria in eggs.
Several comments maintained that the proposed safe handling
statement for eggs is more harsh than the safe handling statement on
meat and poultry and, therefore, unfairly targets the egg industry. One
comment pointed out that USDA's risk assessment estimated that the
contamination rate for eggs is 1 egg in 20,000, which, according to the
comment, is several orders of magnitude lower than most animal
products. Thus, the comment maintained that because the risk of
becoming ill can be eliminated completely with proper handling and
cooking, such a harsh hazard description for a product with a small
risk is not justified.
In the proposal, FDA discussed its concern that unless consumers
are advised of the risks presented by eggs contaminated with SE and
ways that they could reduce these risks, consumers, especially those
that are at greatest risk, could suffer serious illness or death from
the consumption of raw or undercooked eggs. The agency's primary intent
in proposing the label statement for eggs was to give consumers ways to
reduce their risk, without having to avoid the product. In addition,
consumer research available to the agency indicated that label messages
generally are more credible when consumers know the reason for the
message (Ref. 3). Therefore, the agency tentatively concluded that to
adequately inform consumers there was a need to include information on
why there was a risk associated with consumption of raw or improperly
cooked shell eggs. However, in light of the comments that asserted that
the hazard description: (1) Is not new information, (2) is not
consistent with safe handling statements on other raw animal products,
and (3) may distract consumers from the safe handling instructions, the
agency is persuaded that it should reconsider the necessity of the
hazard description as proposed.
The agency is persuaded by information provided by FDA's consumer
research and comments to the proposal that the risks associated with
consumption of SE-contaminated eggs is not new information to
consumers. FDA survey data indicate that the percentage of consumers
eating raw eggs has declined in recent years, as appropriate food
safety practices have received more publicity (Ref. 4). FDA's own focus
group research indicated that many consumers were aware that Salmonella
is the major cause of foodborne illness associated with egg
consumption. Because many of the consumers stated that they knew of the
risk associated with eggs, they considered the safe handling statement
to be more of a reminder than to provide new information.
FDA recognizes that the proposed label statement is different than
that for meat and poultry. In crafting the label statement, the agency
relied on previous focus group research that indicates consumers prefer
messages that are more specific to the nature of the hazard and the
appropriate action to take because of the hazard (Ref. 3). The agency
points out, however, that there are differences in the labeling issues
involved, which result in some differences in wording. For example, in
the meat/poultry safe handling statement there is no specific mention
of the food, rather the statement uses ``some products'' whereas, the
proposed
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statement for eggs refers to ``eggs.'' The agency points out that the
meat/poultry statement was designed to appear on a very wide range of
products, therefore, it needed to be more general in the way that it
identifies foods. The egg label statement will appear only on eggs and,
therefore, can be more specific. However, FDA acknowledges that the
proposed hazard description on the labels of eggs may appear more harsh
than the hazard description on the packages of meat/poultry. The agency
does not want consumers to be confused about the level of risk
associated with the consumption of raw or undercooked eggs versus
consumption of any other raw or undercooked animal product.
FDA has decided to revise the safe handling statement by removing
the proposed hazard description, i.e., ``eggs may contain harmful
bacteria known to cause serious illness especially in children, the
elderly, and persons with weakened immune systems'' and replace it with
a shorter hazard description. FDA continues to believe that the safe
handling statement would be more effective if consumers knew that the
reason for following the safe handling instructions was to prevent
illness from bacteria. Consequently, FDA has decided to minimize the
potential for misunderstanding by shortening the introductory hazard
description to ``to prevent illness from bacteria.'' As was the case
with the proposed hazard statement, this statement alerts consumers to
the reason why it is important to adhere to the safe handling
instructions and does not have the same potential as the proposed
statement to distract consumers from the safe handling message.
Accordingly, based on the findings of the agency's consumer focus
group research and comments to the proposal, FDA is revising the safe
handling statement in proposed Sec. 101.17(h)(1) to read as follows:
SAFE HANDLING INSTRUCTIONS:
To prevent illness from bacteria: keep eggs refrigerated, cook
eggs until yolks are firm, and cook foods containing eggs
thoroughly.
3. Description of At-Risk Consumers
(Comment 5) A few comments opposed the description of at-risk
groups in the hazard statement. According to one comment, consumers
would perceive that the safe handling instructions are targeted only at
the groups listed in the statement. Another comment pointed out that
the safe handling labels on meat and poultry do not list at-risk
groups. This comment contended that because of the low probability of
contamination of eggs, vulnerable populations are no more at risk from
eggs, and probably at less risk, than they are from any other raw
animal product. One comment requested removal of the at-risk groups
from the proposed safe handling statement because the reference to at-
risk groups may heighten the misperception that eggs are a dangerous
food.
FDA points out that the new hazard description does not include the
listing of at-risk consumers. While FDA survey data indicated that most
consumers do not know that some people are at a higher risk of
foodborne illness than others and that focus group participants thought
that the information on at-risk groups was an important aspect of
communicating the nature of the hazard, the agency has reconsidered
whether, in this case, it is necessary to provide that information on
the labels of eggs. The agency acknowledges that the labels of meat/
poultry do not include the listing of at-risk consumers. Because
vulnerable populations are at greater risk of most foodborne illnesses,
FDA believes that it would be better to provide this information to
these consumers through educational channels rather than to tie the
information to specific products. FDA does not want at-risk populations
to be misled to believe that eggs present a greater risk to them than
other raw animal products. Thus, the agency decided to remove the at-
risk consumers from the proposed safe handling statement on eggs to be
consistent with label statements on other raw animal products.
FDA believes that the information that eggs may be harmful to
certain vulnerable populations is important information that must be
conveyed to these consumers. Therefore, FDA will continue to provide
information about food safety to consumers, including those at greater
risk. In addition, FDA plans to develop an educational and outreach
campaign after the publication of this final rule to bring attention to
the new requirements for shell eggs and to disseminate information to
consumers, particularly at-risk populations and those that prepare
their meals.
4. Cooking Instructions
(Comment 6) Most comments agreed that there should be an
instruction on proper cooking. Although some of the comments supported
the language in the cooking instruction, i.e., ``cook eggs until yolks
are firm, and cook foods containing eggs thoroughly,'' a few comments
objected to the cooking instruction. One comment stated that the phrase
``cook thoroughly'' may be too vague, but offered no alternative
language. Another comment contended that FDA should eliminate the
phrase ``cook foods containing eggs thoroughly'' because it is
impossible to cook some egg-containing foods thoroughly, e.g., meringue
and Caesar salad. The comment asserted that these foods can be made
safe by using pasteurized eggs or avoiding the food. Therefore, the
comment concluded that because the proposed phrase cannot be followed
in all cases, it should be removed.
FDA disagrees with the elimination of the phrase ``cook foods
containing eggs thoroughly.'' FDA believes that it is necessary to
inform consumers that, when cooking or preparing a food that contains
raw eggs, the food must be cooked thoroughly to reduce the risk of
illness. The agency rejects the notion that the cooking instruction
should be removed because it is not possible to cook all egg-containing
foods thoroughly. The intent of the cooking instruction is to give
consumers information generally on how to properly cook eggs and egg-
containing foods to reduce risks. The intent of the message is not to
cover every possible scenario as it relates to eggs. The agency
concludes that if consumers recognize that they are at risk of illness
if they consume a food that is made with a raw or undercooked egg, they
would avoid the food or use a substitute, e.g., pasteurized egg
product, to reduce the risk. Thus, FDA is retaining the cooking
instructions, as proposed, in the safe handling statement.
In the proposal, FDA requested 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 requested comment on whether it should
include on the label an explicit instruction to avoid the product for
at-risk consumers or for individuals preparing food for at-risk
consumers.
(Comment 7) One comment stated that FDA should not use the phrase
``use pasteurized eggs for recipes requiring raw or partially cooked
eggs'' because consumers cannot readily purchase certain pasteurized
egg products in retail stores, e.g., egg whites. However, the comment
did not provide data on the availability of the product. There were no
comments that supported use of the statement ``use pasteurized eggs for
recipes requiring raw or partially cooked eggs.''
Because there was no support for the subject statement, the agency
is not requiring it in the safe handling statement. In addition, FDA
did not receive any comments on whether it
[[Page 76096]]
should include an explicit instruction for at-risk consumers to avoid
the product, and therefore, is not requiring such a statement. However,
as announced in the Egg Safety Action Plan, FDA plans to take
additional steps to protect at-risk consumers by establishing safe egg
handling and preparation practices consistent with provisions in the
Food Code. (Refs. 1 and 5).
5. Other Comments on the Text of the Safe Handling Statement
(Comment 8) Some comments maintained that the description of the
hazard will frighten consumers and will discourage consumers from
eating eggs. According to one comment, eggs have a history of consumer
avoidance because of the fear of heart disease from dietary cholesterol
provided by eggs. This comment asserted that, given the history and
perception that eggs are a dangerous food, the proposed statement may
likely lead to further avoidance of eggs. The comment suggested that
additional language be placed on the carton to combat the negative
connotation of the safe handling statement.
It is not the agency's intent to frighten consumers or discourage
consumption of eggs. Rather, the main purpose of the proposed label
statement is to provide consumers with information on how to prepare
eggs safely. FDA focus group research did not indicate that the
proposed hazard description frightened consumers. Rather, the research
indicated that consumers perceived the hazard statement as a helpful
reminder about why they should handle eggs safely. Thus, FDA is not
persuaded that additional language to combat a negative connotation of
the safe handling statement is warranted. Nevertheless, the agency
believes that it is less likely that the revised safe handling
statement would frighten consumers.
(Comment 9) A few comments asserted that the hazard description is
unwarranted for eggs produced under a proven risk-reduction program.
According to one of these comments, consumer perception of the
frightening or negative nature of the message would negate the effort
put forth by producers who use these food-safety programs. Another
comment contended that the proposed label statement with the hazard
description has the potential to increase foodborne illness because
producers would be less likely to participate in risk reduction
programs if their products would still be required to bear the hazard
component of the safe handling statement. The comments suggested a two-
tiered label system, i.e., one label statement for eggs produced under
QA systems and another for eggs that are not produced under QA systems.
Another comment that supported the two-tiered concept contended that
although the safe handling statement on eggs produced under on-farm QA
programs could have a less stringent hazard description, it should not
omit the reference to the potential hazard. The comment offered the
following two tiered labeling scheme:
For eggs not in QA programs:
Caution: Eggs may contain illness-causing bacteria. Keep
refrigerated. Do not eat raw.
Cook until yolk is firm.
For those in QA programs:
SAFE HANDLING INSTRUCTIONS:
To prevent illness, keep refrigerated. Do not eat raw. Cook until
yolk is firm.
As an alternative to the proposed label statement, one comment
suggested that FDA develop and adopt a ``positive'' label system that
would recognize eggs produced under proven risk reduction programs.
FDA recognizes and applauds the work being done by States and
industry to address egg safety. However, FDA believes that two
different label statements in the marketplace may be confusing to
consumers. A different safe handling statement for eggs produced under
QA programs could mislead consumers to believe that those eggs do not
require safe handling when, in fact, both categories of eggs should be
handled safely. However, in light of the agency's decision to revise
the hazard description to ``to prevent illness from bacteria,'' the
question of a two tiered labeling scheme with a less stringent hazard
description for eggs produced under QA plans becomes moot. Finally, the
agency is not persuaded to develop a ``positive'' labeling scheme for
eggs produced under QA plans, since like the two-tiered approach, it
could create confusion. However, FDA would not object to ``positive''
statements, or any other voluntary information on the labels of eggs,
as long as the information is truthful and not misleading. This
information may not appear inside of the box with the required safe
handling statement. FDA points out that information may be considered
misleading, for example, if it implies that a food is safer than other
similar products that may not be labeled.
(Comment 10) One comment from a foreign government stated that it
uses QA programs and HACCP principles to ensure egg safety and that its
eggs for export into the United States must be SE-free. Thus, the
comment asserted that the proposed label statement is unnecessary for
its products.
The agency does not agree with the comment that a foreign
government requirement that eggs for export into the United States be
SE-free negates the necessity for safe handling instructions. Unless
eggs have been specifically treated to destroy Salmonella, FDA believes
that there still is a chance that the eggs contain transovarian-
transmitted SE. Further, FDA notes that it regulates both domestic and
imported foods on an equal basis. As discussed above in this section,
FDA is not permitting a different safe handling statement for eggs
produced under QA plans. Thus, FDA is not establishing different
labeling criteria for imported eggs based on the requirements of the
country of origin.
(Comment 11) A few comments stated that the safe handling statement
should begin with the terms ``caution'' or ``notice.'' One of these
comments stated that the word ``caution'' or ``notice'' would attract
the consumer's attention. Another comment asserted that the serious
public health threat posed by SE warrants a cautionary statement on
labels that informs consumers that the way they are accustomed to
eating eggs may no longer be safe. This comment contended that the term
``safe handling instructions'' does not achieve the objective of
communicating to consumers quickly and unambiguously that eggs may be
unsafe. Further, according to the comment, the word ``caution'' unlike
``warning'' or ``danger'' would not cause the consumer to avoid the
product altogether.
Consumer research indicates that the word ``caution'' has the same
connotation to consumers as ``warning'' and is, therefore,
inappropriate for a safe handling statement (Ref. 6). Because FDA's
focus group research indicates that consumers believe that there are
practical, simple things they can do to control the risk from eggs, a
safe handling statement is more appropriate and, consequently, the most
appropriate signal words are ``safe handling instructions.'' In
addition, as discussed in the proposal (64 FR 36492 at 36505), FDA
considered the term ``notice'' to introduce the safe handling statement
and concluded that the term would not draw attention to the important
fact that there are ways to reduce the risks of foodborne illness other
than avoidance of the product. Therefore, FDA is not changing the
phrase ``safe handling instructions'' to ``caution'' or ``notice.''
(Comment 12) One comment expressed the concern that the safe
handling statement would be difficult to
[[Page 76097]]
understand because it is above a fifth grade reading level.
FDA points out that considerable effort was made to ensure that the
language in the statement would be understandable to consumers.
Specific phrases or message elements were tested for comprehensibility
either in the egg focus groups or in previous consumer research on food
safety issues. For example, results of the focus group research
indicated that some participants were confused by the term ``shell
eggs'' and found ``eggs'' more understandable. They also found the
phrase ``cook eggs until yolks are firm'' more understandable than
``cook thoroughly.'' These findings were used to craft the proposed
statement. Although focus group participants had varying educational
levels, those with high level of education, e.g., graduate degrees,
were excluded from participation. None of the participants appeared to
find the message difficult to understand. Thus, the agency is not
persuaded by the comment that the safe handling statement would be
difficult to understand.
Other comments addressing the length of the safe handling statement
and the specific wording of the hazard description in the safe handling
statement have become moot because FDA has revised the statement.
Therefore, those comments will not be addressed.
6. Alternatives to the Proposed Label Statement
(Comment 13) A few comments stated that the label statement on eggs
for household consumers should be different from that on eggs for food
service. One of the comments offered the following suggested labeling
in a two tiered labeling scheme:
For household eggs:
Keep refrigerated and cook thoroughly
For eggs in food service:
Handle Safely: refrigerate promptly; don't cross contaminate;
clean hands and surfaces often; cook to proper temperature.
FDA believes that the statement suggested by the comment for
household consumers does not provide adequate information. For example,
the statement required by Sec. 101.17(h)(1) uses the phrase ``cook eggs
until yolks are firm'' which is more descriptive than ``cook
thoroughly.'' Furthermore, FDA was not persuaded by these comments that
food service establishments need additional information on cartons of
eggs. Although the agency recognizes that many of the SE-associated
outbreaks occur in food service establishments, it does not agree that
additional labeling is the best way to address this issue. Thus, the
agency is not persuaded to change the safe handling statement to those
suggested by the comment.
(Comment 14) One comment stated that a lengthy safe handling
statement is unnecessary and, alternatively, supported the use of the
following on shell eggs:
IMPORTANT: Must Be Kept Refrigerated to Maintain Safety
or
IMPORTANT: Must Be Kept Refrigerated
According to this comment, if FDA determines that the labels of shell
eggs need safe handling instructions, then those instructions should be
in addition to the statement above.
The agency is not persuaded that this suggested label statement is
all that is needed on eggs to inform consumers of ways that they may
protect themselves. As discussed in the proposal, two measures that
would mitigate the risk of SE in shell eggs are refrigeration and
proper cooking. The suggested message does not instruct consumers that
proper cooking is a measure that they can take to protect themselves.
The agency also rejects the comment's suggestion that the suggested
statement appear on the label in addition to FDA's proposed safe
handling instructions. Two statements on the label informing consumers
to keep eggs refrigerated would be redundant. FDA believes that the
phrase ``to prevent illness from bacteria'' informs consumers that
refrigeration is one measure they can take to reduce or eliminate the
risk of foodborne illness. Thus, FDA concludes that it is implicit in
the safe handling statement that refrigeration helps maintain safety.
(Comment 15) A few comments preferred statements that were very
short, clear, and aimed at all consumers such as ``do not eat raw or
undercooked eggs'' and ``keep refrigerated, cook thoroughly, and do not
eat raw'' with each of the instructions preceded by bullets. Other
comments supported the following label statement that incorporates the
basics of the Fight Bac campaign:
Safe Handling Instructions
CLEAN: Wash hands and surfaces often. SEPARATE: Don't cross
contaminate
COOK: Cook to proper temperatures. CHILL: Refrigerate Promptly
This statement, according to one comment is a simple and positive
message and was designed based on consumer focus research. Furthermore,
the comment maintained that it does not single out a specific food
item.
FDA is not persuaded to adopt the safe handling statements
suggested by these comments. The agency believes that the suggested
statements do not inform consumers why the safe handling instructions
should be followed. Also, the agency notes that the statement
incorporating the basics of the Fight Bac campaign educates consumers
about food safety in general. However, FDA's proposal to require a safe
handling instruction is being issued under 201(n) and 403(a) of the
Federal Food, Drug, and Cosmetic (FD&C Act) (21 U.S.C. 321(n) and
343(a)). Under section 201(n) of the FD&C Act, in determining whether
labeling is misleading, it must be taken into account, among other
things, the extent to which labeling fails to reveal material
information with respect to consequences that may result from the usual
use of the product. FDA believes that, although instructions to wash
hands and not to cross contaminate products are useful pieces of
information, such information is not specific to eggs. Therefore, FDA
is not persuaded to adopt this suggested alternative phrasing.
7. Placement and Prominence
a. Placement and type size of the safe handling statement. As
discussed in the proposal, section 403(f) of the FD&C Act requires that
mandatory label information be placed on the label with such
conspicuousness as to render it likely to be read and understood by
ordinary individuals under customary conditions of use. In the past,
FDA has generally required label statements required by Sec. 101.17 (21
CFR 101.17) to be placed on the information panel. The agency noted
that the principal display panel (PDP) would provide even more
prominence. Accordingly, the agency tentatively concluded to require
the proposed safe handling statement either on the information panel or
the PDP. The agency also noted in the proposal that Sec. 101.2(c) (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 type size no less than \1/16\
inch. Consequently, the agency concluded that it was not necessary to
repeat the requirements in this rulemaking.
(Comment 16) Some of the comments stated that there is not enough
room on the egg carton to print such a lengthy safe handling statement
with the other Federal and State mandated labeling requirements such as
nutrition labeling, USDA grade and quality logos, product code,
registration numbers to identify packers, date of pack, sell-by date,
and count and weight. Some comments
[[Page 76098]]
maintained that the lack of space is greater for small (six or eight
count) cartons and pulp/open view cartons. Further, one comment pointed
out that some of the manufacturers of smaller egg cartons are incapable
of printing on the side of the lid. For those who have space to print
on the side of the lid, the comment pointed out that the cost to
purchase equipment needed to print on the side of the lid would cost
several million dollars. Some comments asserted that the space on the
label is used by some firms for promotional material, which is a
critical selling feature for the firm. Therefore, according to these
comments, further regulation would limit a firm's ability to market its
own products. While one comment stated that the safe handling statement
should be on the outside of the lid, other comments requested some
flexibility for placement of the label statement. Two comments
maintained that FDA should conduct more research to see if the
statement should appear on the information panel and whether consumers
would notice the statement there. One comment requested that for small
cartons the safe handling information be communicated with an 800
telephone number printed on the carton, e.g., ``FOR SAFE HANDLING
INSTRUCTIONS, PLEASE CALL 1-(800)____-____.''
FDA recognizes that manufacturers may have to redesign their
labels, but believes that, in many instances and, particularly in light
of the fact that the safe handling statement that will be required is
about one-half the length of the one proposed, simply reducing the type
size of non-mandatory information will provide sufficient space to
accommodate the safe handling statement in Sec. 101.17(h)(1). Further,
FDA believes that there is enough space on the foam type cartons of
shell eggs (both the small, i.e., 6 to 8 egg carton, and larger
cartons) to bear all other Federal and State mandated information as
well as FDA's safe handling statement. In fact, some of those cartons
now contain safe handling information that is comparable in length or
more lengthy than FDA's revised safe handling statement. Therefore, for
these cartons, FDA concludes that, as revised, there is ample space for
its safe handling statement.
FDA also recognizes the limitation of label space on pulp style egg
cartons. However, FDA believes that the pulp/open view cartons also
have ample space for the shorter revised safe handling statement as
evidenced by existing nonmandatory labeling. Thus, FDA is not revising
the requirement in Sec. 101.17(h)(2) that the safe handling statement
must appear either on the PDP or the information panel of the label.
The agency concludes that because there is ample space for the safe
handling statement on both large and small cartons of shell eggs, FDA
is not providing a telephone referral for the safe handling
instructions for these cartons. In addition, FDA rejects the comments
suggesting that it should conduct more research to determine whether
consumers would notice safe handling instructions on the information
panel. The comments did not provide any information that consumers
would not notice the safe handling statement on the information panel
and, therefore, FDA is not changing the provision of allowing the safe
handling statement on the information panel.
(Comment 17) A few comments requested that FDA require a minimum
type size. For example, one comment stated that 12-point type is best
for older persons to read. The comment acknowledged that some egg
cartons may not be able to accommodate 12-point type and stated that
type size of less than 8-point would be difficult to read. One comment
maintained that other formatting requirements would enhance the
readability of the statement. For example, the comment suggested that
FDA consider requirements for the use of simple type and use of ink and
paper with sufficient contrast. Another comment suggested that FDA
require that the statement appear in a hairline box with adequate space
around the statement and appear in dark words on light background to
enhance the visibility.
FDA does not agree that it should require a minimum type size. The
agency reiterates that Sec. 101.2(c) requires that mandatory
information appearing on the PDP and the information panel, including
information in Sec. 101.17, appear prominently and conspicuously in a
type size of no less than \1/16\ inch. Although comments recommended 12
point font for the safe handling statement to make it easier for older
persons to read, one of these comments acknowledged that there may be
insufficient space to accommodate the statement in that type size on
the egg carton. Furthermore, the comments did not provide data to
support the contention that older consumers are unable to read
information on the information panel and PDP that appear in \1/16\ type
size. Accordingly, FDA is not requiring a minimum type size for the
safe handling statement that is different from the minimum type size
requirements in Sec. 101.2(c). The agency also notes that 21 CFR 101.15
describes conditions that would make a label statement lack the
prominence and conspicuousness required by Sec. 101.2(c). Some of these
include insufficient background contrast, and crowding with other
written, printed, or graphic matter. Because these provisions are
already in place for prominence and conspicuousness for information
required by Sec. 101.17, the agency finds that it is not necessary to
repeat these requirements in this rulemaking.
b. Use of graphics. In the proposal, FDA recognized that safe
handling instructions on meat and poultry utilized graphic
illustrations. The agency tentatively concluded that its focus group
research did not indicate that graphic illustrations were necessary to
convey the safe handling instructions to consumers. However, the focus
groups did respond favorably to bullets and the agency requested
comment on whether graphics would enhance the visibility of the
statement and whether it should require them.
(Comment 18) Some comments maintained that icons depicting actions
to be taken (e.g., a refrigerator to indicate that product should be
refrigerated) make the safe handling statement easier to understand.
Other comments supported the use of bullets to enhance the safe
handling statement. One comment supported use of a graphic symbol to
attract the consumer's attention to the label such as an exclamation
point in a triangle. This symbol, the comment maintained, could become
a universal symbol for foods that present a hazard.
The agency is not requiring these suggested labeling options. None
of the comments provided data that showed that consumers would be
better informed with graphics and, thus, did not call into question
FDA's testing that showed that consumers would be adequately informed
of safe handling information without the use of graphics. However, the
agency would not object to the use of bullets or graphic illustrations
in addition to what is required. Accordingly, graphic illustrations and
bullets may appear with the safe handling statement to draw greater
attention to the statement. However, other wording may not appear in
the box with the prescribed label statement. As stated in the proposal
(64 FR 36492 at 36504), FDA believes that prescribing the specific
language of the safe handling statement gives manufacturers a level
playing field by requiring the same language for all products covered
by the regulation, while giving consumers a message that is not
confusing, misleading, or ineffective.
[[Page 76099]]
c. Labeling for shell eggs not for direct sale to consumers. In the
proposal, FDA stated that 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 repacked at a site other than originally processed or
are to be shipped for use in food service establishments, would serve
as a means to inform repackers and food preparers of the safe handling
instructions. The agency tentatively concluded that the same goal of
conveying the message could also be accomplished by customary practices
of the trade. Thus, FDA proposed that the safe handling statement on
shell eggs that are not for direct sale to consumers may be provided on
cartons or in labeling, e.g., invoices or bills of lading in accordance
with the practice of the trade.
(Comment 19) Some comments opposed labeling in invoices and bills
of lading because, they asserted, the labeling may be separated from
the product and not read by food handlers. The comments maintained that
the safe handling instructions must be read and understood by the food
handler because they are the ones who must use the safe handling
instructions when storing and preparing egg dishes. Moreover, according
to one comment, the majority of eggs shipped to food service
establishments are in 15 or 30 dozen cases that have ample room for
labeling and, therefore, there is no need for the flexibility. One
comment asserted that the proposed safe handling instructions should be
on shipping containers and other food service packages because most
incidents of SE-contamination in eggs occur in food service
establishments.
The agency agrees that the safe handling instructions must be
conveyed and understood by the food handler. However, the agency is not
persuaded by comments that the safe handling statement would not reach
the food preparers if it is not on the label. FDA believes that it is
the responsibility of the owner/operator of the establishment to make
sure that food preparers receive the safe handling instructions as well
as training on how to implement the instructions. Moreover, the agency
points out that it intends to ensure that food preparers receive safe
handling information for shell eggs by establishing safe egg handling
and preparation practices at retail consistent with the Food Code
(Refs. 1 and 5). Thus, FDA is not persuaded to prohibit the use of
labeling such as invoices and bills of lading as a means for meeting
the requirements of this rule when the eggs are to be repacked,
relabeled, or further processed.
8. Other Labeling Issues
(Comment 20) Some comments contended that the label statement will
not significantly reduce the numbers of SE-associated illnesses.
The agency disagrees that the label statement will not
significantly reduce the numbers of SE-associated illnesses. In the
PRIA, FDA used a Food Marketing Institute study (Ref. 7) of the effects
of USDA's meat and poultry safe handling instructions to estimate the
effect of the safe handling label statement for shell eggs. The agency
estimated that the likelihood that shell eggs would be undercooked or
consumed raw would decline by approximately 5 percent. FDA also
estimated that the likelihood that consumers would fail to refrigerate
shell eggs would decline by 2 percent. These percentages continue to be
the agency's best estimate of the approximate effects of the safe
handling label for shell eggs. In a separate simulation, FDA used its
modification of USDA's SE risk assessment model \1\ and CDC's
surveillance model to estimate the effect of the safe handling label.
With the FDA-modified SE risk assessment baseline, FDA estimated the
number of illnesses that would be prevented by labeling to be 4,948 to
162,846 with a mean of 46,339. Using the CDC baseline, the estimate of
the number of illnesses prevented by labeling was 2,813 to 42,892, with
a mean of 14,775. As discussed below in section IV.A of this document,
FDA used more recent data to adjust the CDC surveillance model used in
the proposal. Thus, FDA's estimate of the number of illnesses prevented
by labeling using the revised CDC baseline is 1,570 to 25,196 with a
mean of 8,784. Comments did not provide FDA with other estimates of the
prevention of salmonellosis. FDA maintains that its estimates represent
a significant reduction in illness.
---------------------------------------------------------------------------
\1\ The baseline for the cases of samonellosis was estimated in
three different ways. The USDA risk assessment estimated the number
of illnesses with a full farm-to-table model. The model included an
estimate of the number of eggs infected, the number of infected eggs
likely to be consumed, and an estimate of the number and severity of
illnesses caused by SE. In the second model, FDA modified the USDA
risk assessment model by using a 5 percent probability that shell
eggs are refrigerated at 7.2 deg.C (45 deg.F) in retail
establishments and institutions. FDA modified the original model
based on more recent information on the numbers of establishments
not refrigerating eggs at 7.2 deg.C (45 deg.F). The CDC model
estimates the number of illnesses based on the number of confirmed
cases as indicated by the number of SE isolates reported to CDC plus
estimated unreported cases.
---------------------------------------------------------------------------
(Comment 21) Some comments contended that most outbreaks occur in
food service establishments and, therefore, FDA's focus should be on
educating and providing safe handling instructions for food service
workers, not household consumers. On the other hand, one comment
maintained that label statements are not going to change the behavior
of food service workers who take shortcuts.
FDA disagrees with these comments. The agency believes that
information about food safety should be given to both household
consumers and food service workers. Previously in section II.A of this
document, FDA discussed its rationale for providing safe handling
instructions for consumers. The agency recognizes that food service is
an additional component of the farm-to-table continuum and points out
that, as part of FDA's and FSIS' Egg Safety Action Plan, FDA intends to
initiate rulemaking to establish safe handling and preparation
practices for food service establishments based on sections of the Food
Code related to egg safety (Refs. 1 and 5). FDA also points out that
the requirement for refrigeration of eggs at retail, including food
service establishments (see discussion below in section III of this
document) will be mandatory upon the effective date of this regulation.
FDA agrees that education is an important factor in providing
instructions on food safety. Thus, the agency intends to develop an
educational and outreach campaign related to this final rule to inform
the public, including both consumers and food service employees.
(Comment 22) Several comments pointed out that many existing egg
cartons already bear safe handling instructions. To eliminate costly
relabeling, these comments requested that FDA permit existing safe
handling label statements if they meet or exceed the statement required
by the final rule. One comment requested that if a carton already has a
``keep refrigerated'' label on the carton that it be allowed to delete
the phrase from the safe handling statement.
The agency is not persuaded to exempt eggs that have existing safe
handling instructions from requirements in Sec. 101.17(h)(1). FDA has
concluded that prescribing the language for a safe handling statement
for shell eggs would give consumers a clear and consistent message and
provide a ``level playing field'' for industry by requiring that all
products covered by the regulation bear the same information. Further,
FDA concludes that a prescribed safe handling statement would ensure a
message that is not misleading or confusing.
In addition, the agency is not persuaded to delete the phrase
``keep
[[Page 76100]]
eggs refrigerated'' from the safe handling statement on cartons that
already have a keep refrigerated statement. The agency recognizes that
many cartons already have refrigeration instructions and notes that
USDA requires in 9 CFR 590.50 that eggs packed for the ultimate
consumer be labeled to indicate that refrigeration is required.
However, FDA believes that the refrigeration instruction is an
essential component of the safe handling statement and, as such, should
not be taken out of the context of the rest of the statement. Further,
FDA's safe handling statement permits manufacturers to uniformly comply
with both FDA's safe handling statement and FSIS' refrigeration
labeling requirement because FSIS' requirement is that cartons be
labeled to indicate that refrigeration is required. Consequently, this
safe handling statement can replace that required by FSIS. The agency
recognizes the redundancy in having two refrigeration statements and
points out that, while firms are revising labels to add the safe
handling statement, they can delete the additional ``keep
refrigerated'' statement that is not a part of the safe handling
statement required in Sec. 101.17.
Although FDA is not exempting eggs that have existing safe handling
instructions from requirements in Sec. 101.17(h)(1), the agency does
see merit in using enforcement discretion with firms that want to
exhaust existing labels provided that the labeling meets or exceeds the
requirement for the instructional element, which includes: (1) A
refrigeration instruction and (2) a cooking instruction. FDA believes
that this would reduce the costs for some firms while still providing
consumers information on how to properly handle eggs. Firms with
existing inventories as of the effective date of this final rule may
exhaust those inventories as long as they contain the essential
elements listed above. Upon their next printing, however, these firms
must comply with the requirements in Sec. 101.17(h)(1).
Lastly, the agency is revising proposed Sec. 101.17(h)(1) and
deleting proposed Sec. 101.17(h)(6) to be consistent with the changes
made in Sec. 115.50 (as discussed in section III.C of this document).
The remainder of Sec. 101.17(h) is renumbered to reflect this change.
C. Comments on Effective Date
(Comment 23) A few comments asserted that the implementation time
for the proposed labeling requirement is insufficient. These comments
maintained that given the logistics of redesigning cartons, replacing
inventory, making necessary adjustments to distribution channels, and
accommodating seasonal product demand fluctuations, the egg industry
needs a 360-day implementation period. According to one comment, once
the rule is finalized, new designs will need to be developed, then sent
to customers for label approval. The comment stated that production of
the label could not take place until the design is approved, which
according to the comment, could take 60 to 90 days. The comment
maintained that once production begins, it will involve label changes
for thousands of stockkeeping units (SKU's) of hundreds of different
customers, which would be a burden given only the approximately 90 days
left to comply. The comment estimated that personnel would take 11,386
to 19,880 hours to redesign the label; retool all carton labels,
including artwork; communicate with customers; order plates; and
complete other required activities.
Further, the comment contended that it is not likely that egg
producers will have begun to use the proposed statement before the
compliance date in order to take advantage of FDA's willingness, as
stated in the proposal (64 FR 36492 at 36510), to allow producers to
use the safe handling statement as proposed and if printed before the
publication of the final rule. The comment asserted that producers
would not want to take the chance of changing labels twice. The comment
explained that egg carton stock is prepared well in advance and
customers' needs may be less than expected. Therefore, if cartons are
not used prior to the effective date, they will need to be discarded.
The comment stated that, on the other hand, a large inventory may be
needed to accommodate peak periods, such as Christmas and Easter and if
large stocks are not maintained, the inventory may run out.
Additionally, the comment expressed concern that, depending on when the
rule is published, the labeling requirement could be implemented during
the time of peak production, and, therefore would make compliance with
the requirement extremely difficult. Another comment disagreed with
FDA's assessment that a longer compliance period would delay benefits
of the rule because many cartons currently contain safe handling
instructions and, therefore, benefits are being realized now.
The agency notes that the purpose of the safe handling labeling
requirement is to protect the public health by providing consumers with
material information, i.e., instructions on how to safely handle and
prepare eggs in order to reduce the risk of illness. Therefore, FDA
believes that the safe handling statement should be placed on egg
cartons as soon as possible. However, FDA is persuaded by the comments
that it may be extremely burdensome for some producers to comply with
the labeling requirements in 180 days. The agency acknowledges the
difficulty in designing new labels, receiving label approval from
customers, and building up inventories. The agency also recognizes the
costliness of destroying inventories that do not comply with FDA's
requirements. The agency is persuaded by the economic concerns raised
in the comments that it should provide some flexibility to
manufacturers. As discussed below in more detail in section IV.A of
this document, the longer compliance period will generate savings in
costs that would exceed the reduction in benefits thus still meeting
the agency's need to address the public health concern. Therefore, FDA
is providing an additional 90 days for firms to come into compliance
with the requirements in Sec. 101.17(h).
III. Refrigeration of Shell Eggs in Retail Establishments
As discussed in section II of this document, SE in eggs is a
significant public health concern. As discussed in the proposal, FDA
concluded that one practicable measure to limit the number of viable SE
in shell eggs is refrigeration because it extends the effectiveness of
the egg's natural defenses against SE and slows the growth rate of SE.
USDA published a final rule (63 FR 45663, August 27, 1998) to require
that shell eggs packed for consumer use be stored and transported at an
ambient temperature not to exceed 7.2 deg.C (45 deg.F). This
regulation, however, does not apply to eggs while held at all retail
establishments. FDA is concerned that without continued refrigeration
up until the time that the eggs are cooked, there would be an
opportunity for the egg's defenses to degrade and growth of SE to
occur. The agency reviewed research indicating that SE multiplies at
temperatures of 10 deg.C (50 deg.F) and above but can be 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). Based on this research and USDA's temperature
requirement during transport, FDA proposed a maximum ambient
temperature of 7.2 deg.C (45 deg.F) for eggs stored and displayed at
retail establishments.
A. Refrigeration Temperature Requirements
(Comment 24) Most comments regarding the proposal to require
[[Page 76101]]
refrigeration of shell eggs supported a requirement for refrigeration.
Some of these comments supported the proposed maximum temperature
requirement, i.e., 7.2 deg.C (45 deg.F), whereas other comments
disagreed with this temperature requirement. Several comments suggested
that the agency set the maximum ambient temperature for shell eggs held
at retail at 5 deg.C (41 deg.F), instead of 7.2 deg.C (45 deg.F).
Some of these comments suggested that this would provide a margin of
safety, especially for eggs packed tightly together in large trays or
in large retail coolers. Other comments noted that a requirement of 5
deg.C (41 deg.F) would ensure consistency with the requirement in
FDA's Food Code that potentially hazardous foods be refrigerated at 5
deg.C (41 deg.F) (Ref. 5).
The agency is not persuaded that the temperature requirement should
be 5 deg.C (41 deg.F), rather than 7.2 deg.C (45 deg.F). As
discussed in section I.F of the proposal, research indicates that SE
multiplies at temperatures of 10 deg.C (50 deg.F) and above but that
multiplication is inhibited at lower temperatures. Therefore, by
requiring a refrigeration temperature lower than 10 deg.C (50 deg.F),
the agency is already providing a margin of safety for shell eggs. FDA
concludes that refrigeration at 7.2 deg.C (45 deg.F), i.e., the same
temperature required by USDA under the Egg Products Inspection Act
(EPIA) for the storage and transportation of shell eggs, is sufficient
to protect the public health. Because eggs cool down only slightly
faster when held at 5 deg.C (41 deg.F) as opposed to 7.2 deg.C (45
deg.F), as discussed in the PRIA (64 FR 36516 at 36518), requiring eggs
to be stored at the lower temperature would have a negligible effect on
the SE risk. Requiring a temperature of 5 deg.C (41 deg.F) as the
maximum ambient temperature would increase costs to the producer
without producing significant additional food safety benefits.
Furthermore, the agency notes that the storage temperature of shell
eggs addresses growth of SE in shell eggs, whereas the refrigeration
temperature required by the Food Code, i.e., 5 deg.C (41 deg.F),
addresses growth of all pathogens that may be present in potentially
hazardous foods. Thus, in addressing holding temperatures for
potentially hazardous foods in general, 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 Listeria
monocytogenes that have been shown to grow at 5 deg.C (41 deg.F). The
agency does not have data suggesting that L. monocytogenes or other
pathogens are a potential concern in shell eggs. The agency concluded
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. Of course, this requirement does not preclude States or retailers
from maintaining shell eggs at lower refrigeration temperatures.
(Comment 25) One comment contended that FDA based the 7.2 deg.C
(45 deg.F) ambient temperature requirement on studies that do not
provide a sound scientific foundation for the requirement. The comment
stated that none of the articles FDA cites in support of the proposed
refrigeration requirement examined SE growth in eggs stored under
conditions that simulate actual commercial storage conditions. The
comment maintained that, because commercially stored egg cartons are
often placed on pallets in large numbers and stacked to high levels in
high-volume coolers, the eggs' internal temperature may be
substantially higher than the coolers' ambient temperature, especially
for centrally located eggs that are insulated by surrounding eggs and,
therefore, exposed to warmer temperatures.
FDA disagrees with the comment. The studies noted by the comment
were not cited as evidence that eggs in commercial storage conditions
would achieve a certain temperature when refrigerated. Rather, these
studies provide evidence that SE growth is inhibited when eggs are at
the temperature studied. While the agency agrees that eggs packed near
the center of a large pallet may not cool as quickly as those near the
perimeter, the temperature of eggs, when refrigerated, will progress
towards the ambient temperature of the refrigeration unit. As discussed
above in this section, FDA has provided its rationale for why an
ambient temperature of 7.2 deg.C (45 deg.F) for storage of eggs is
the best available option for protecting the public health.
(Comment 26) One comment recommended that States be allowed to
require ambient temperatures lower than 7.2 deg.C (45 deg.F) for
shell eggs if they believe their citizens will be better protected by a
lower temperature, such as 5 deg.C (41 deg.F), particularly if gaps
exist in the scientific data on this issue.
The agency recognizes that some States and localities may have
temperature requirements lower than 7.2 deg.C (45 deg.F). As stated
in the proposal (64 FR 36492 at 36499), the agency does not intend that
this regulation would preempt recommendations of the Food Code or other
State or local requirements that require a lower temperature. The
regulation would, however, preempt any State or local requirements that
allow a temperature greater than 7.2 deg.C (45 deg.F).
(Comment 27) One comment supported the 7.2 deg.C (45 deg.F)
ambient temperature requirement, but urged the agency and others to
communicate effectively with retail establishments to minimize any
confusion that may result from the temperature difference between this
proposed requirement and the requirement in the Food Code.
While the new temperature requirement may create some confusion
initially, the Food Code will be revised to reflect this new
temperature for storage of shell eggs in its next reprinting (currently
anticipated to be 2001). The revision will include not only the new
temperature requirement, but also the scientific references and public
health reasons for the change in annexes 2 and 3, respectively, of the
Code. In the meantime, FDA will rely, as it has in the past, on State
and local authorities to assist retail establishments in complying with
the agency's regulations. The agency holds annual training courses for
State personnel and food service directors that focus on changes in the
Food Code. FDA will work closely with the States to ensure that they
communicate effectively with retail establishments to minimize any
confusion that may result from the temperature difference between this
requirement and the requirement in the 1999 Food Code and to ensure
that compliance assistance is consistent nationwide.
(Comment 28) One comment supported the refrigeration of shell eggs
at 7.2 deg.C (45 deg.F) provided that minor variations in ambient
temperature do not result in condemnation of eggs. The comment
suggested that FDA make refrigeration mandatory, but make the
temperature of 7.2 deg.C (45 deg.F) a voluntary standard, or
establish a level of temperature variation (e.g., 5 deg.F) that would
be tolerated before the eggs would be subject to regulatory action.
Another comment objected to the fact that FDA made no provision in its
proposal for eggs that are out of compliance for a limited amount of
time, and suggested that the allowance of a reasonable amount of time
to place eggs in a cooler after delivery would not compromise their
safety.
FDA disagrees with the comment that the temperature for
refrigeration of eggs be a voluntary standard, rather than a mandatory
requirement. The agency has proposed 7.2 deg.C (45 deg.F) as the
maximum ambient temperature for storage and display of shell eggs at
retail establishments. Realizing that minor variations in ambient
temperature are unavoidable, retailers may choose to
[[Page 76102]]
maintain shell eggs at temperatures below the maximum established
temperature to provide for a margin for variation. As with any
regulation, the enforcement of this temperature requirement will depend
on the particular circumstances regarding the situation (including the
temperature of the eggs themselves) as well as the discretion of the
agency. In Sec. 115.50(b)(1), FDA provided that ``shell eggs held for
retail distribution shall promptly be placed under refrigeration * * *
upon receipt at a retail establishment.'' The agency believes that
retailers should make every effort to promptly place shell eggs under
refrigeration upon receipt. In most cases, this can be done. However,
FDA recognizes that there may be some circumstances in which short
delays are unavoidable. For example, when eggs are delivered to a
grocery store, the stock clerk responsible for moving the eggs into the
cooler could be briefly delayed in the task because he is cleaning up
after an accident in one of the aisles involving a glass breakage. To
allow for a practical application of the refrigeration requirement in
such situations, FDA is adding a provision to Sec. 115.50(b)(1) that
provides that where short delays are unavoidable, the eggs should be
placed under refrigeration as soon as reasonably possible.
B. Enforcement of the Refrigeration Requirement
(Comment 29) One comment expressed concern that consequences for
violation of FDA's refrigeration requirement are inconsistent with
violation of FSIS' refrigeration requirement for shell eggs during
transportation. The comment noted that FSIS issues a facility violation
but does not retain the product if eggs are found to be held above 7.2
deg.C (45 deg.F), whereas FDA would require diversion or destruction
of the eggs.
As set out in the final rule, FDA has the authority, under sections
301 and 402(a)(4) of the FD&C act, to seize eggs that are held at
retail at an ambient temperature above 7.2 deg.C (45 deg.F), on the
grounds that those eggs have been held under insanitary conditions
whereby they may be rendered injurious to health and are, therefore,
adulterated. FDA may also use administrative procedures set out in this
rule to order that the eggs that have been held in violation of the 7.2
deg.C (45 deg.F) requirement established in this rule, be destroyed
or diverted. FSIS has the authority, under the EPIA, to detain eggs
that are transported at an ambient temperature above 7.2 deg.C (45
deg.F), pending judicial seizure. FSIS also has the option of seeking
civil money penalties against violators of the transport temperature
requirement. The two agencies will coordinate enforcement efforts as
closely as the different statutes allow. Both agencies agree that
enforcement of the temperature requirement will depend on the
particular circumstances regarding the situation (including the
temperature of the eggs themselves) as well as the discretion of each
agency.
(Comment 30) Two comments stated that they oppose complete
preemption of State and local egg safety provisions. One of these
comments from an association of State food and drug officials agreed
that temperature requirements should be uniform, but also argued that
the States should be free to enforce equivalent State requirements
under State laws and regulations. This comment also stated that States
should be permitted to require refrigeration temperatures lower than
7.2 deg.C (45 deg.F).
In the proposal, FDA tentatively concluded that the regulation
should preempt less stringent State and local requirements because
allowing them would interfere with the important public health
objective of refrigerating eggs at 7.2 deg.C (45 deg.F). FDA does not
intend that this regulation preempt State requirements that are the
same as or more stringent, i.e., 7.2 deg.C (45 deg.F) or lower. The
regulation does, however, preempt any State or local temperature
requirements greater than 7.2 deg.C (45 deg.F). FDA would like to
clarify that States will be permitted to enforce their own temperature
requirements that are equivalent to or lower than FDA's proposed
requirement. For example, if a State has a temperature requirement of 5
deg.C (41 deg.F) and eggs were found at a storage temperature of 6.7
deg.C (44 deg.F), then the eggs would be in compliance with the
Federal regulations, but not the State regulations and the State could
take enforcement action to enforce its own regulations.
(Comment 31) One comment also opposed preemption of State
administrative procedures. The comment asserted that, the
administrative procedures provided in the proposal would impose a
lengthy process on States and localities. The comment maintained that
it is doubtful that State or local jurisdictions would follow FDA's
proposed procedures, e.g., they would not call FDA district or regional
directors to remove adulterated eggs from establishments traditionally
under their jurisdiction. Nevertheless, the comment asks for
clarification on whether the proposed regulations preempt State
administrative procedures.
The agency is clarifying that the administrative procedures in
proposed Sec. 115.50 do not preempt State or local administrative
procedures. On the contrary, FDA explicitly provides in Sec. 115.50(d)
that State and localities may follow the hearing procedures set out in
Sec. 115.50(e) substituting, where necessary, appropriate State or
local officials for FDA officials, or they may follow comparable State
and local procedures as long as such procedures satisfy basic due
process. Thus, FDA intends that States could use their own
administrative procedures to enforce the regulation. FDA is removing
the word ``comparable'' to make it clearer that State and local
administrative procedures do not need to track FDA's procedures.
(Comment 32) One comment raised concerns about the breadth of the
preemptive effect of the proposed regulation. It questioned whether the
proposed rule might preempt all State laws relating to egg safety and
substitute FDA's regulation. This comment contended that States already
have systems in place that expeditiously remove unsafe foods from
commercial channels and that those should not be preempted.
FDA agrees with the comment. States do have systems already in
place that expeditiously remove adulterated food from the marketplace.
In the proposal, FDA acknowledged that States and localities, more than
FDA, currently enforce regulations in retail establishments. When
examining options for the enforcement of refrigeration requirements,
FDA tentatively concluded that a Federal-State cooperative approach
would be the best approach to enforce the refrigeration requirements.
Thus, FDA proposed to allow States and localities to enforce the
Federal regulation, along with FDA, if the States and localities so
desired.
FDA wants to make it very clear that the intended preemptive effect
of this regulation is very narrow. FDA does not intend to preempt
general food safety laws that apply to eggs, such as State food and
drug acts, or State or local laws, regulations, or ordinances applying
to retail establishments, e.g., the Food Code. A State or local food
safety agency can continue to enforce its own refrigeration
requirements or other egg safety requirements under its own
administrative or judicial enforcement procedures as long as the retail
refrigeration requirements for eggs are (equal to or less than 7.2
deg.C (45 deg.F). FDA is including State and local agencies in
[[Page 76103]]
the enforcement of this regulation to broaden their enforcement tools,
not to narrow them. To ensure that the limited preemptive effect of
these regulations is clear, FDA has added a statement on the preemptive
effect of the regulations to the codified text.
(Comment 33) A comment contended that the provisions in the
proposal that allow States and localities to enforce the provisions
``until FDA notifies the State or locality in writing that such
assistance is no longer needed'' appear to place State regulatory
actions subordinate to those of FDA. The comment maintained that it
knew of no other situation where regulatory actions of State or
localities constituted ``assistance'' to a Federal agency, especially
when intrastate commerce is involved. The comment asked for
clarification of this issue.
The provision that allows State and local agencies to enforce FDA's
regulations draws its terms from section 311 of the Public Health
Service Act (PHS Act). FDA does not consider State and local food
safety activities to be subordinate to Federal activities. In fact, FDA
created this cooperative model to ensure that State and local officials
continue to be the primary enforcement officials in retail
establishments while being provided the ability to enforce this Federal
requirement for egg refrigeration.
(Comment 34) One comment also expressed concern regarding the
precedent of using the PHS Act for enforcement of communicable disease
regulations when there are other collaborative and integrated
mechanisms available, e.g., the Food Code. The comment maintained that
many States adopt the provisions of title 21 of the Code of Federal
Regulations (CFR) and, therefore, the comment noted that it previously
requested that FDA adopt relevant sections of the Food Code as
regulations. The comment asserted that adopting relevant sections of
the Food Code as a Federal regulation would lower the risk of illness,
while promoting uniformity without preempting State and local
authority.
The agency notes that this regulation is not the first regulation
issued by FDA that utilized the PHS Act to address prevention of
communicable diseases. FDA used the PHS Act as its legal authority to
issue: (1) Regulations to control the interstate shipment of molluscan
shellfish (21 CFR 1240.60); (2) regulations to control the interstate
and intrastate commerce of turtles (Sec. 1240.62 (21 CFR 1240.62)); (3)
requirements for mandatory pasteurization of milk and milk products (21
CFR 1240.61); and regulations to control blood and tissue products (21
CFR 640 and 1270). However, the agency acknowledges that this
regulation represents a new approach to food safety as it relates to
matters traditionally addressed by the States. The agency believes that
the Federal-State cooperative approach that it is adopting in this
final rule for the regulation of eggs is the most effective and
efficient use of Federal, State, and local food safety authorities.
Further, FDA recognizes that many States adopt parts of 21 CFR by
reference. However, the agency is not persuaded by the comment that it
should adopt relevant sections of the Food Code in lieu of issuing this
regulation. FDA notes that its policy on the refrigeration of eggs,
i.e., that refrigeration at 7.2 deg.C (45 deg.F) is adequate to
maintain the safety of shell eggs would be the same whether or not the
agency issued rulemaking to codify in 21 CFR sections of the Food Code
relevant to shell eggs. Nevertheless, as announced in the Egg Safety
Action Plan, the agency plans to take additional steps to protect at-
risk consumers by establishing safe egg handling and preparation
practices at retail, consistent with provisions in the Food Code.
(Comment 35) One comment contended that FDA should evaluate each
State and local program to ensure that they have the expertise and
resources to enforce the regulations. This comment contended that if
the States and local programs do not have the capability to enforce the
rule, FDA should provide training or resources, or enforce the rule
itself. Furthermore, the comment stated that FDA should perform
comprehensive annual reviews and permit only those agencies that
satisfy strict performance standards to continue to enforce the rule.
FDA disagrees with this comment. As discussed in the proposal, the
agency recognizes that the inspection of retail establishments
traditionally has been the province of State and local food safety
agencies. FDA expects that these agencies would continue to inspect
these establishments and will be able to enforce the refrigeration
requirement. FDA considered a requirement that the States report to FDA
on their enforcement activities. However, the agency concluded that,
because of the vast number of food safety agencies at the State and
local level, reporting to FDA would be too resource intensive. Further,
the agency concluded that requiring States and localities to report to
FDA would remove valuable resources from egg safety enforcement and
place them into administrative activities. Consequently, FDA decided to
not require enforcement reports from State and local agencies.
Moreover, FDA, in keeping with the principles of Executive Order 13132
on federalism, thought it prudent to allow States the maximum
administrative discretion possible in enforcing this rule. However, the
agency intends to stay informed of the enforcement of State and local
agencies. Where State or local coverage needs to be augmented, FDA
intends to act.
(Comment 36) One comment opposed the allowance of 10-working days
after the order is given for the destruction of eggs that are not in
compliance with the temperature requirement as proposed in
Sec. 115.50(e)(1)(i). This comment maintained that FDA provided no
rationale for the time period. Moreover, the comment contended that 10
days was an unnecessarily long period of time and could allow for
inadvertent repacking. The comment suggested that only 3 to 5 days be
allowed.
The agency disagrees with the comment. The time period of 10-
working days is consistent with other regulations that address the
prevention of communicable disease, e.g., regulations in Sec. 1240.62
that control the interstate and intrastate commerce of turtles.
Moreover, the agency believes that 10-working days allows sufficient
time for interested parties to appeal the detention order as provided
in Sec. 115.50(e)(2)(i). In addition, the agency points out that the
administrative procedures provide for sufficient safeguards against
inadvertent repacking of shell eggs that were not held in compliance
with the temperature requirement. Section 115.50(e)(1)(iv) provides
that eggs that are detained be labeled with official tags stating that
they not be sold, distributed, or otherwise disposed of except that
they be diverted or destroyed, or moved pending appeal. The comment did
not persuade FDA that there is sufficient cause to be concerned that
eggs will be inadvertently repacked if they are held for 10-working
days before they are destroyed or diverted. Thus, the agency is
retaining the provision in Sec. 115.50(e)(1)(i) for 10-working days
before eggs are diverted or destroyed.
(Comment 37) One comment suggested that inspectors check the
temperature of the shell eggs' environments at least twice a year. The
comment also suggested that, to ensure that retail establishments are
maintaining accurate temperatures, continuous temperature recording
devices be required and records made available to inspectors.
[[Page 76104]]
The agency agrees that the inspection of retail establishments
twice a year is reasonable. In fact, the Food Code recommends that
retail establishments be inspected once every 6 months. These
inspections include checking the temperature at which potentially
hazardous foods, including eggs, are being held. However, the agency
does not find that it is necessary to make the inspection a requirement
as part of this rulemaking. The agency expects that when State and
local agencies routinely inspect retail establishments, they will check
the temperature at which shell eggs are held. In addition, for any
establishment that FDA inspects, it will also check the temperature at
which shell eggs are held. Thus, FDA is not persuaded by the comment to
require a specific interval for checking the temperature at which shell
eggs are held.
FDA disagrees that it should require that retail establishments
maintain continuous recording devices. The agency notes that neither
the Food Code nor FSIS, in its directive regarding the enforcement of
refrigeration requirements for shell eggs (Ref. 8), recommends that
such devices be used. Furthermore, FDA notes that requirement of such
devices may be very costly, especially for small businesses.
Consequently, the agency is not persuaded by the comment to require
establishments to maintain continuous recording devices.
C. Other Changes to the Proposal
FDA is revising proposed Sec. 115.50 by deleting paragraph (d) and
revising paragraph (b) for clarification. The agency concludes that
Sec. 115.50(d) stating that the requirements of this section apply to
all eggs may be confusing in light of the fact that paragraph (b)
states that all requirements of the section, except paragraph (c) apply
to shell eggs. FDA is revising paragraph Sec. 115.50(b) to state
``except as provided in paragraph (c) of this section; shell eggs held
for retail distribution, whether in intrastate or interstate commerce,
shall bear the following statement: '' With this revision,
Sec. 115.50(d) becomes redundant. The rest of the section is renumbered
to reflect this change.
IV. Final Regulatory Impact Analysis
A. Benefit-Cost Analysis
FDA has examined the economic implications of this final 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 (Public Law 104-
4) requiring cost-benefit and other analyses, a significant rule is
defined in section 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 (Public Law 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 finds that this final rule is economically significant under
Executive Order 12866. FDA determined that this final 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 (Public Law 104-4). Furthermore, in accordance with the
Small Business Regulatory Enforcement Fairness Act of 1995 (Public Law
104-121) FDA determined that this final rule will be a major rule for
the purpose of congressional review.
This section contains the regulatory impact analysis of the final
rule. A more complete 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'' (64 FR 36516, July 6, 1999).
FDA received no comments that directly addressed the cost-benefit
analysis of the proposed rule. Several comments, however, discussed
aspects of the rule that would affect the cost-benefit analysis. In
this final regulatory impact analysis, FDA responds to those comments.
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) labeling and
refrigeration as proposed, (6) HACCP for shell eggs, (7) in-shell
pasteurization, (8) longer compliance periods, and (9) limited retail
sell-by periods. FDA received comments on the proposal that directly or
indirectly dealt with the economic analyses of some of these options.
(Comment 38) Several comments discussed the costs of in-shell
pasteurization (option 7). In the analysis of the proposal, FDA assumed
that the annual cost of pasteurization was $0.30 per dozen eggs. If 47
billion shell eggs were consumed per year, the annual cost of
pasteurizing all of them would be about $1.2 billion. One comment
estimated the cost to be $0.26 to $0.38 per dozen eggs, which implies
that the annual cost of pasteurizing 47 billion shell eggs would be $1
to $1.5 billion. Another comment estimated that pasteurization would
increase the price of a dozen eggs by 35 to 40 percent. The comment
listed no prices, but at an average price of $0.80, the additional cost
of pasteurizing 47 billion eggs would be $0.28 to $0.32 per dozen, or
$1.1 to $1.3 billion per year. FDA did not estimate the transition, or
set-up costs, (e.g., costs of equipment, redesign of processing
facilities, training) for processors switching to pasteurization, so
these estimates understate the full cost of in-shell pasteurizing all
shell eggs.
Although in-shell pasteurization would greatly reduce SE, the
agency concludes that other interventions between farm and table will
reduce SE at lower cost. The egg safety action plan includes these
other interventions, such as on-farm controls, controls at packer/
processor, and retail controls, in addition to in-shell pasteurization.
(Comment 39) Several comments requested a longer compliance period
for the new egg label.
The main disadvantage of longer compliance periods for the labeling
provision (option 8) is that the option would delay the realization of
the benefits of the rule. In this final rule, the agency will allow 9
months (instead of the proposed 6 months) for producers to comply with
the labeling provision. The
[[Page 76105]]
longer compliance period will probably generate savings in costs that
exceed the reduction in benefits (as measured with the revised CDC
surveillance baseline). FDA discusses the effects of the longer
compliance period in more detail in the sections on benefits and costs.
2. Benefits
Benefits from the final rule to require a safe handling label and
the refrigeration of shell eggs at 7.2 deg.C (45 deg.F) come from
reducing egg-related illness. The formula FDA used 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 final rule x health cost per illness.
(Comment 40) Although there were no comments directly on the
estimated benefits, several comments argued that FDA used too high a
baseline number of SE illnesses. In addition, some comments cited new
data from CDC on SE. In the economic analysis in the proposal, 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 (64 FR 36516 at 36520). The CDC active
surveillance data showed a 44 percent fall in SE between 1996 and 1998
(Ref. 9). CDC also released a new estimate of the total number of
illness associated with Salmonella (Ref. 10). The new estimate of the
total number of illnesses from Salmonella is lower than previous
estimates, which implies that the baseline number of SE-related
illnesses is also lower. In response to the comments on FDA's baseline
number of illnesses, FDA adjusted the CDC surveillance baseline to
incorporate the recent CDC surveillance data and estimated number of
SE-related illnesses.\2\ The SE risk assessment model baseline did not
use CDC cases, so it does not change. Table 1 of this document shows
the USDA SE risk assessment baseline, the FDA-modified USDA SE risk
assessment baseline (for explanation of this modification, see footnote
1 in section II.A.8 of this document), the CDC surveillance baseline,
and the adjusted CDC surveillance baseline.
---------------------------------------------------------------------------
\2\ In the analysis of the proposed rule, FDA estimated the
number of SE illnesses from shell eggs with a Monte Carlo
simulation. In one simulation, FDA used CDC surveillance data from
1988 through 1997 to calculate that the annual average number of SE
isolates was 8,400. FDA then applied the probability that an isolate
would be reported that was used in the USDA SE risk assessment,
i.e., 0.014, to estimate the total number of SE cases. FDA assumed,
based on outbreak and other information, that 10 to 60 percent of
all SE cases were associated with shell eggs. In the revised CDC
surveillance model, FDA used CDC surveillance data from 1989 through
1998 to calculate an average annual number of SE isolates of 8,300.
The agency applied the probability of reporting used in the new CDC
foodborne illness estimates, 0.026, to estimate the total number of
SE cases (Ref. 10). As in the proposed rule, FDA assumed that 10 to
60 percent of all SE cases were associated with shell eggs. Part d
of table 1 shows the results of the simulation based on the revised
CDC data.
Table 1.--Four Annual Illnesses from Estimates of Salmonella Enteritidis (SE) in Shell Eggs
----------------------------------------------------------------------------------------------------------------
95th
5th Percentile Median Mean Percentile
----------------------------------------------------------------------------------------------------------------
a. USDA SE Risk Assessment
----------------------------------------------------------------------------------------------------------------
Illnesses 126,374 504,082 661,633 1,742,592
Arthritis 3,631 14,864 19,994 55,915
Deaths 68 301 391 1,050
----------------------------------------------------------------------------------------------------------------
b. USDA SE Risk Assessment as Modified by FDA
----------------------------------------------------------------------------------------------------------------
Illnesses 115,645 416,156 569,231 1,508,814
Arthritis 3,372 12,548 17,175 48,594
Deaths 66 250 354 985
----------------------------------------------------------------------------------------------------------------
c. CDC Surveillance Model
----------------------------------------------------------------------------------------------------------------
Illnesses 63,884 189,599 191,511 319,275
Arthritis 1,330 5,533 5,727 12,202
Deaths 37 122 115 197
----------------------------------------------------------------------------------------------------------------
d. Revised CDC Surveillance Model
----------------------------------------------------------------------------------------------------------------
Illnesses 36,523 112,138 114,271 194,796
Arthritis 762 3,011 3,410 7,251
Deaths 21 66 68 117
----------------------------------------------------------------------------------------------------------------
FDA used the USDA SE risk assessment model to estimate the expected
reduction in illnesses attributed to the rule. The design of the USDA
SE risk assessment model allowed the agency to estimate the number of
illnesses prevented by comparing the baseline number of illnesses with
the number of illnesses under the rule.
FDA calculated the health cost per illness prevented by classifying
SE illnesses by the severity of outcome: Mild, moderate, and severe
acute gastrointestinal illnesses; resolved and chronic reactive
arthritis; and death. The agency then multiplied the estimated monetary
health cost per type of illnesses by the number of illnesses prevented
of each type. FDA calculated total health benefits from the final rule
with the following formula:
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 final rule, with the
distribution based on the probability distributions associated with the
main uncertainties. FDA estimated that this final rule would reduce the
number of egg-related illnesses by 6 to
[[Page 76106]]
49 percent (5th to 95th percentile), with the median equal to 14.5
percent and the mean equal to 19 percent. The ranges (5th to 95th
percentile) of estimated annual benefits for the three baselines are
shown in table 2 of this document.
Table 2.--Total Annual Health Benefits from the Reduction in Salmonellosis Attributable to the Proposed Shell
Egg Rules: USDA \1\ SE \2\ Risk Assessment Baseline, CDC \3\ Surveillance Baseline, and Adjusted CDC
Surveillance Baseline
----------------------------------------------------------------------------------------------------------------
Variable 5th Percentile Median Mean 95th Percentile
----------------------------------------------------------------------------------------------------------------
a. Modified USDA SE Risk Assessment Baseline
----------------------------------------------------------------------------------------------------------------
Illnesses prevented 12,369 65,801 115,848 407,064
Health benefits $86.7 million $703 million $1,700 million $6,610 million
----------------------------------------------------------------------------------------------------------------
b. CDC Surveillance Baseline
----------------------------------------------------------------------------------------------------------------
Illnesses prevented 7,032 25,132 36,937 107,230
Health benefits $49.2 million $303 million $501 million $1,679 million
----------------------------------------------------------------------------------------------------------------
c. Revised CDC Surveillance Baseline
----------------------------------------------------------------------------------------------------------------
Illnesses prevented 3,925 14,958 21,961 62,991
Health benefits $32.9 million $259.5 million $466.3 million $1,619 million
----------------------------------------------------------------------------------------------------------------
\1\ USDA means U.S. Department of Agriculture.
\2\ SE means Salmonella Enteritidis.
\3\ CDC means the Centers for Disease Control and Prevention.
FDA estimated the benefits derived from extending the compliance
period for the labeling regulation. With the longer compliance period
for the labeling provision, some of the labeling benefits will be
postponed for 3 months. In the analysis of the proposal, the agency
estimated the median benefits attributable to labeling alone to be $261
million using the USDA SE risk assessment baseline and $103 million
using the CDC surveillance baseline. With the revised CDC surveillance
baseline, median labeling benefits are $91 million. FDA used a 7
percent rate of discount to estimate the reduction in benefits from
increasing the compliance period for labeling by 3 months. The later
effective date will reduce median health benefits by, at most, $5
million under the USDA SE risk assessment baseline and $2 million under
either version of the CDC surveillance baseline because some labels
would be in place before the effective date. Because it is based on
more recent information, the agency believes that $2 million is the
best estimate of the reduction in benefits associated with the later
effective date for the safe handling label.
The benefit estimates above depend on a number of assumptions
including assumptions about individual response to the egg labels.
Modification of these assumptions would lead to changes (increases or
decreases) in the estimate of the benefits of this rule.
3. Costs
FDA received no comments on the estimated costs of this rule and,
therefore, will use the same estimate reported in the analysis of the
proposal. The costs of the final rule are the sum of the costs of
changes in manufacturing practices--labeling and refrigeration--and
changes in consumer practices--egg preparation and consumption.
a. Labeling. The costs of labeling are the sum of inventory
disposal, label redesign and administrative costs. FDA calculated
labeling costs with the following model:
Labeling cost = ($ administrative costs per firm x number of
affected firms) + ($ value of cartons manufactured x disposal
percentage of carton inventory) + (number of affected labels x $
redesign cost per label).
In the analysis of the proposed rule, FDA estimated the total cost
of labeling for a 6-month compliance period to be a one-time cost of
approximately $18 million. The cost included administrative costs,
inventory disposal costs, and label redesign costs. Several comments
stated that inventory and redesign costs would be high, but did not
state whether the cost estimates FDA presented were high. One comment
from a carton manufacturer stated that redesign costs for its foam
labels would be $2 million. Based on the market share cited in the
comment, the cost per SKU would be about $500, which is the cost used
in the proposal for a 6-month compliance period.
Another comment stated that in order to print on the sides of
cartons manufacturers of smaller egg cartons would have to purchase new
equipment costing several million dollars. The agency disagrees that
such purchases will be necessary. With redesign and reduced type size
for non-mandatory material, sufficient free space will be available for
the safe handling statement without the need to print on the sides of
the cartons. The shorter safe handling statement in this final rule
(compared to the statement in the proposal) increases the agency's
confidence that smaller egg cartons will have sufficient space.
In light of FDA's decision to extend the compliance period to 9
months, labeling costs will decrease. In the analysis of the proposal,
FDA compared a 6-month compliance period with a 12-month compliance
period. FDA now assumes that the labeling costs for a 9-month
compliance will be about halfway between the costs for 6- and 12-month
periods. As table 3 of this document shows, this assumption leads to
estimated costs of $15 million.
[[Page 76107]]
Table 3.--Estimated Total Costs to Incorporate Safe Handling Statements (Total Costs Rounded to Nearest Million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Period 6 Months 9 Months 12 Months
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total administrative costs $280,000 $240,000 $200,000
Total inventory disposal costs $3,000,000 $2,250,000 $1,500,000
Total label redesign costs $15,000,000 $12,500,000 $10,000,000
Total labeling costs $18,000,000 $15,000,000 $12,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA believes that the 9-month compliance period combined with the
shortening of the safe handling statement may reduce labeling costs by
more than the $3 million difference shown in table 3. The shorter
statement should eliminate many of the problems associated with fitting
the statement on cartons with limited flat space. With 3 more months
for compliance, many more establishments will be able to use up all of
their carton inventories before the effective date.
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). The agency
calculated the cost by multiplying the estimate of the number of
establishments that would require new (or upgraded) equipment by the
cost of equipment. FDA estimated the number of establishments that
would require new equipment by assuming that no establishments in
States that have adopted the Food Code and some fraction--with one-
third the most likely--of establishments in States that have 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 final
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 the total possible refrigeration
costs for the final 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:
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.
This 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 final rule.
4. Summary of Costs and Benefits
Table 4 of this document shows the median estimated benefits and
costs of the final rule.
Table 4.--Median Annual Estimated Benefits and Costs of the Final Rule (in Millions of Dollars)
----------------------------------------------------------------------------------------------------------------
Benefits/Costs First Year All Other Years
----------------------------------------------------------------------------------------------------------------
Median estimated benefits (USDA\1\ SE\2\ risk assessment $700 $700
baseline)
Median estimated benefits (original CDC\3\ surveillance $300 $300
baseline)
Median estimated benefits (revised CDC surveillance baseline, $260 $260
final rule)
Median estimated costs (proposed rule) $60 $10
Median estimated cost (final rule) $56 $10
----------------------------------------------------------------------------------------------------------------
\1\ U.S. Department of Agriculture
\2\ Salmonella Enteritidis
\3\ Centers for Disease Control and Prevention
B. Small Entity Analysis
1. Introduction
FDA has examined the economic implications of this final 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. FDA finds that, under the Regulatory Flexibility Act,
this final rule will have a significant economic impact on a
substantial number of small entities.
2. Economic Effects on Small Entities
a. Number of small entities affected. The final rule will 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. 11).
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. 12) 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.\3\ FDA, therefore,
[[Page 76108]]
estimated the total number of small egg processors to be 495 (= 25 +
470).
---------------------------------------------------------------------------
\3\ 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 will affect small establishments that
are not currently refrigerating at 7.2 deg.C (45 deg.F). 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 and institutions are small if sales are less than $15 million.
As shown in table 5 of this document, FDA estimated that the number
of small establishments affected by the final refrigeration provision
will be 25,400. One comment questioned how FDA derived this estimate.
The agency derived this estimate of small businesses affected from the
estimate for all establishments affected. FDA estimated the number of
establishments (small and large) currently not keeping eggs at an
ambient temperature of 7.2 deg.C (45 deg.F) by assuming that some
fraction of establishments in States without temperature requirements
were holding eggs at temperatures greater than 7.2 deg.C (45 deg.F).
FDA does not know the fraction of establishments holding shell eggs at
temperatures greater than 7.2 deg.C (45 deg.F), so the agency used a
Monte Carlo simulation to estimate a distribution for the number of
establishments affected. In the simulation, FDA assumed that in each
State without a 7.2 deg.C (45 deg.F) requirement, between 0 and 100
percent (with 33 percent the most likely proportion) of the
establishments held shell eggs at a higher temperature. The mean result
of the 1,000 iterations of the simulation was a total of approximately
44,400 large and small establishments, which included 10,700 grocery
and other food stores, 24,000 restaurants, and 9,700 institutions
(including schools, hospitals, nursing homes, prisons, military
establishments, and universities) (64 FR 36516 at 36536, July, 9 1999).
FDA reported only the mean of the distribution of simulation results.
The results for the simulated number of establishments ranged from a
5th percentile of 12,320 to a 95th percentile of 81,700.
To estimate the number of small establishments holding eggs at
temperatures above 7.2 deg.C (45 deg.F), 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 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. FDA then estimated the number of small establishments affected
by the refrigeration provision by multiplying the fraction assumed to
be small by the total number of establishments affected. Table 5 of
this document shows the mean number of small establishments likely to
be affected by the refrigeration provision of the final rule. The
agency also has included the 5th and 95th percentiles to show the
uncertainty associated with the mean estimates. FDA emphasizes that
these are estimates, not a count of the actual firms affected. The
agency uses them to demonstrate that this final rule will affect a
substantial number of small establishments.
Table 5.--Number of Small Entities Likely to be Affected by the Refrigeration Provision of the Final Rule
(Simulation Results; Rounded to Nearest 100)
----------------------------------------------------------------------------------------------------------------
Category 5th Percentile Mean 95th Percentile
----------------------------------------------------------------------------------------------------------------
Grocery and Other Stores 2,100 7,600 14,000
Restaurants 3,600 13,000 23,900
Institutions 1,300 4,800 8,900
Total 7,000 25,400 46,800
----------------------------------------------------------------------------------------------------------------
b. Costs for small entities. For the 9-month compliance period in
the final rule, redesign costs per SKU will be about $875 for pulp
cartons and $375 for foam cartons.\4\ The cost of the labeling
provision borne by small processors will vary with the number of SKU's
and the fraction of the costs passed to the processors from carton
manufacturers. The average number of SKU's per processor for the
industry is 30; FDA assumed small processors will market somewhere
between 2 and 20 SKU's. Additional redesign costs could, therefore, be
as high as $17,500 for a small processor (= 20 x $875), although it is
unlikely that the processor would bear all redesign costs.
---------------------------------------------------------------------------
\4\ In the analysis of the proposal, FDA estimated that the
average redesign cost for foam cartons would be $500 for a 6-month
compliance period and $250 for a 12-month compliance period. In the
analysis of the final rule, FDA assumed that the redesign cost for a
9-month compliance period will by $375, midway between the two.
Similarly, the agency assumed that the redesign costs for a pulp
carton will be $875 for a 9-month compliance period, midway between
the $1,000 and $750 estimated for 6-month and 12-month compliance
periods.
---------------------------------------------------------------------------
Refrigeration costs vary across establishments, depending on the
age of current refrigerators, the planned replacement cycle, and
whether the small establishments are currently keeping eggs at or below
7.2 deg.C (45 deg.F). FDA assumed that additional refrigeration costs
for small retailers will average $633, with $700 the most likely value.
The agency also assumed that the proportion of additional refrigeration
costs borne by small entities will be the same as the proportion of
small entities in each category of establishment. The cost of the
refrigeration provision to small entities is shown in table 6.
Table 6.--Costs to Small Entities of the Refrigeration Provision of the Final Rule
----------------------------------------------------------------------------------------------------------------