[Federal Register: August 20, 2007 (Volume 72, Number 160)]
[Rules and Regulations]
[Page 46375-46378]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au07-2]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004N-0382]
RIN 0910-ZA23
Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to permit the egg industry to place the safe
handling statement for shell eggs on the inside lid of egg cartons if
the statement ``Keep Refrigerated'' appears on the principal display
panel (PDP) or information panel. This final rule will provide the
industry greater flexibility in the placement of safe handling
instructions on egg cartons, while continuing to provide consumers with
this important information. This action is in response to numerous
requests from the egg industry.
DATES: This final rule is effective August 20, 2007.
FOR FURTHER INFORMATION CONTACT: Catalina Ferre-Hockensmith, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.
SUPPLEMENTARY INFORMATION:
I. Background
On December 5, 2000 (65 FR 76092), FDA (we) published a final rule
(hereinafter referred to as the shell egg refrigeration and labeling
final rule) to require a safe handling statement on cartons of shell
eggs that have not been treated to destroy Salmonella microorganisms (
Sec. 101.17(h) (21 CFR 101.17(h))). The regulation also requires
retail establishments to store and display shell eggs under
refrigeration (21 CFR 115.50). FDA issued the shell egg refrigeration
and labeling final rule because of the number of outbreaks of foodborne
illnesses and deaths caused by Salmonella Enteriditis that are
associated with the consumption of shell eggs. After the publication of
the shell egg refrigeration and labeling final rule, the egg industry
asked FDA to allow safe handling statements to be placed on the inside
lid of egg cartons because of: (1) The lack of equipment to print on
the side panels of egg cartons (i.e., the information panel), (2) the
high cost to purchase equipment to print on the sides of egg cartons,
and (3) the high cost to change the graphic design of the PDP for each
brand that manufacturers produce for each customer.
In the Federal Register of May 5, 2005 (70 FR 23813), FDA published
a proposed rule (the 2005 proposed rule) to allow the egg industry to
place the required safe handling statement on the inside lid of egg
cartons, if the statement ``Keep Refrigerated'' appears on the PDP or
information panel. We tentatively concluded in the proposed rule that
the inside lid would serve as an acceptable panel for the safe handling
instructions without diminishing the effectiveness of the message. We
further tentatively concluded that providing flexibility to allow the
placement of the safe handling statement for shell eggs on the inside
lid of egg cartons if the statement ``Keep Refrigerated'' appears on
the PDP or information panel may result in cost savings for the egg
industry, and, thus, for consumers.
II. Comments and Agency's Responses
FDA received a total of eight responses, each containing one or
more comments, to the proposal. The comments were from consumer groups,
a State government agency, a consumer, a consulting firm, and a trade
association. Some of these comments were about issues that are outside
the scope of this rulemaking and will not be addressed in this
document. The majority of the remaining comments supported the
proposal. One comment directly opposed the proposal, whereas two
comments supported the proposal based on suggested modifications to the
proposal.
(Comment 1) The comment that opposed the proposal asserted that
there is no ``lack of equipment'' for printing the safe handling
statement on the side panel of egg cartons. The comment contended that
all the egg industry has to do is order new packages.
(Response) As we stated in the 2005 proposed rule, the egg industry
sent letters to FDA stating that placing the statement on the top or
sides of the carton would result in a financial hardship for their
companies because of, among other things, the lack of equipment to
print on the side panels of egg cartons (i.e., the information panel)
and the high cost to purchase equipment to print on the sides of egg
cartons. One of these letters provided specific information on the high
costs to purchase new equipment required for printing on the
information panel and on the high costs to redesign the egg carton. The
comment that opposed the proposal did not provide data or other
information that shows that the industry has the necessary equipment.
Consequently, we are not persuaded by this comment, and we maintain our
view that allowing the safe handling instructions on the inside of the
lid could result in cost savings for the industry and ultimately the
consumer, while continuing to provide mandatory safe handling
instructions to consumers.
(Comment 2) Several comments requested that FDA make format changes
for the safe handling statement. Two comments stated that FDA should
replace the current standard of ``conspicuous'' with specific
formatting requirements for the safe handling statement, e.g., use of
dark color, such as black, blue, dark blue, or brown on a light
background. In addition, several comments stated that the type size of
the safe handling statement should be increased and two of these
comments suggested specific sizes, e.g., 12-point or larger and ``10-
inch type'' \1\ or larger. In addition, one of these comments stated
that a survey of egg cartons found that the safe handling statement is
printed in type as small as 7-point and, sometimes, the statement is
printed directly on a gray cardboard carton, which makes the statement
difficult to read. Therefore, according to this comment, a significant
number of consumers may not notice or
[[Page 46376]]
may have difficulty reading this information.
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\1\ We believe that the comment did not actually mean ``10-
inch'' type but meant another type size, such as a 10-point font.
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(Response) We do not agree that specific formatting requirements
for the safe handling statement are needed. Provisions in section
403(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(f))
and FDA implementing regulations in Sec. Sec. 101.2 and 101.15 (21 CFR
101.2 and 101.15) address the prominence and conspicuousness of
mandatory information on food labels. Specifically, Sec. 101.2(c)
provides that mandatory labeling information must appear prominently
and conspicuously and should be at least one-sixteenth inch in height.
In addition, Sec. 101.15(a)(6) provides that labeling information may
lack the necessary prominence and conspicuousness if it is crowded with
other written or graphic matter or has insufficient background
contrast. The comments did not provide data that show that the existing
requirements in Sec. Sec. 101.2 and 101.15 are not adequate when
followed. In addition, the type size required in Sec. 101.2 is a
minimum type size and does not restrict manufacturers from using a
larger type size to print information on food labels if they choose.
Also, while the comments stated that the safe handling statement may be
difficult to read, the comments did not provide any data that
demonstrate that consumers are unable to read the statement. Therefore,
we are not persuaded that specific formatting requirements are needed
in this regulation in addition to the requirements already in place in
Sec. Sec. 101.2 and 101.15 to ensure that the safe handling statement
is noticeable and legible.
We remind manufacturers that they must comply with FDA's
regulations on the prominence and conspicuousness of mandatory
information on food labels in Sec. Sec. 101.2 and 101.15. In addition,
we encourage manufacturers to print the safe handling statement in
fonts larger than the minimum required if space is available on the
carton.
(Comment 3) One comment stated that a referral statement should
accompany the ``Keep Refrigerated'' statement. The comment argued that
a referral statement is necessary so that consumers would know to look
on the inside of the lid for safe handling instructions. However, the
comment did not provide any supporting data.
(Response) We are not persuaded by the comment that a referral
statement should accompany the ``Keep Refrigerated'' statement. In the
proposal we did not propose to require a referral statement because we
assumed that the number of consumers who would read the safe handling
statement on the inside lid under this rule to be about the same as the
number who read it on the outside of the carton. We base this
assumption on the following reasons: (1) All consumers open egg cartons
before consumption; and (2) the greater potential for larger font sizes
and lower text density on the inside lid, which may equate to a larger
number of consumers reading the safe handling statement.
However, in the proposed rule we asked for comment on whether it is
necessary to require a referral statement on the outside lid when the
safe handling instructions are placed on the inside lid. The comment
did not provide any supporting data or other information that
demonstrates that when consumers open egg cartons before consumption,
they will not see the safe handling instructions. Therefore, we are not
persuaded that there is a need for a referral statement to accompany
the ``Keep Refrigerated'' statement.
III. Analysis of Economic Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 and safety, and other
advantages; distributive impacts; and equity). FDA has determined that
this final rule is not a significant regulatory action as defined by
the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The final rule provides additional options for
placing the safe handling statement on egg cartons. No small business
would be forced to use this option, and so the final rule imposes no
costs on small businesses. For those small businesses choosing the
option, the final rule reduces labeling costs. Therefore, the agency
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any 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 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
A. Need for This Regulation
The need for this regulation is to provide the shell egg industry,
which includes egg producers, carton manufacturers, egg distributors,
and retailers, additional flexibility in complying with FDA
requirements for the placement of safe handling instructions on egg
cartons, without reducing the prominence or conspicuousness of the
information and without undermining the effectiveness of the shell egg
refrigeration and labeling final rule. Allowing the inside lid to be
used for the safe handling instructions may create cost savings for
firms that were concerned that complying with the labeling requirement
of the shell egg refrigeration and labeling final rule would be a
financial hardship. This final rule allows for the safe handling
instructions to be placed on the inside lid of egg cartons if the words
``Keep Refrigerated'' are placed on the PDP or information panel.
B. Comments
In response to the proposed rule, FDA received several comments.
None of the comments provided information that would alter the
conclusions of the economic impact analysis of the proposed rule.
C. Cost-Benefit Analysis
In the proposed rule, FDA evaluated three regulatory options to
allow the safe handling statement to be printed on the inside lid of
egg cartons. The options considered were the following: (1) No new
regulatory action, (2) allow the safe handling statement to be placed
on the inside lid with a referral statement on the outside of the
carton if the words ``Keep Refrigerated'' are placed on the PDP or
information panel, and (3) allow the safe handling statement to be
placed on the inside lid with no referral statement required if the
words ``Keep Refrigerated'' are placed on the PDP or information panel.
[[Page 46377]]
1. Costs: Potential Reduction in the Numbers of Consumers Reached
FDA estimated that the costs of this rule are likely to be zero.
The only costs that could arise are from changes in the number of
consumers who read the safe handling statement. The number of consumers
who would read the safe handling statement on the inside lid under this
rule is assumed to be about the same as the number who read it under
the existing regulation. The reasons for this assumption are: (1) The
consumer practice of looking inside the egg carton either at the time
of purchase or at a time before consumption, and (2) the potential for
more space on the inside lid of egg cartons because of its relatively
larger surface area.
At least one study has shown that labels that are larger and have
less text density attract more attention (Ref. 1). Another study has
shown that larger font sizes enhance label legibility (Ref. 2). Because
the inside lid may allow less text density and more space for printing
the safe handling statement in larger font sizes, such placement may
result in a larger number of consumers reading the safe handling
statement than under the existing regulation. Because all consumers
look inside the egg carton at some time before consumption, FDA
concludes that there are no costs of this final rule.
2. Benefits: Cost Savings Realized by Egg Carton Manufacturers
The benefits from this rule are the costs savings to firms from
avoiding placing the safe handling statement on the PDP or information
panel. The estimates of the total cost savings for this rule are based
on previous estimates of costs savings of option two in the proposed
rule. Under option two, the costs savings for a firm from additional
flexibility equal the difference between the sum of the costs of
printing the safe handling statement on the inside lid and printing a
referral statement and the costs of printing the safe handling
statement on either the PDP or information panel. The agency estimated
the cost savings associated with option two by computing the costs of
full label redesign and of adding a safe handling statement using the
FDA Labeling Cost Model, Final Report (Ref. 3). The range of cost
savings from option two is estimated to be between $5 and $19 million,
with a mean of $11 million, assuming a 12-month compliance period.
3. Comparing the Benefits of Option Two With Those of Option Three, the
Chosen Option
A comparison of the estimates of the total costs savings reported
for option two with those reported for option three, the chosen option,
indicates the potential for substantial cost savings with option three.
The larger cost savings from option three compared with option two
reflects the lower cost from not requiring a referral statement on an
outside panel in option three as well as the cost savings from a larger
share of the industry choosing the inside lid statement under option
three. The cost savings from option two and this final rule are
reported in table 1 of this document.
Table 1.--Cost Savings of Option Two and of Option Three, the Chosen Option
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Cost Savings of Option Two (12-Month Cost Savings of Option Three, the
Estimates of Cost Savings Compliance) Chosen Option (12-Month Compliance)
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Mean estimate $11,032,000 $14,843,000
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Low estimate (5th percentile) $5,125,000 $8,039,000
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High estimate (95th $19,022,000 $24,645,000
percentile)
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4. Summary of Costs and Benefits of this Final Rule
FDA estimated the costs and benefits for three regulatory options
for flexibility in the placement of the safe handling statement on egg
cartons. The analysis concludes that the costs, measured as the public
health effects of a decrease in the number of consumers that would read
the safe handling statement, are zero for option three, the chosen
option. We conclude that because all consumers open egg cartons before
consumption, and given the potential for larger font sizes and lower
text density on the inside lid, it is likely that most consumers will
notice the safe handling statement on the inside lid if it is located
there. The benefits from the options considered are measured as the
cost savings from allowing firms additional flexibility of printing the
safe handling statement on the inside lid. The estimated cost savings
from option three, the chosen option in this final rule, range from $8
to $25 million, with a mean of $15 million, assuming a 12-month
compliance period.
IV. Analysis of Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
VI. Federalism
FDA has analyzed this rule in accordance with the principles set
forth in Executive Order 13132. FDA has determined that the rule would
have a preemptive effect on State law. Section 4(a) of the Executive
Order requires agencies to ``construe * * * a Federal statute to
preempt State law only where the statute contains an express preemption
provision, or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
The shell egg refrigeration and labeling final rule set minimum
national standards to ensure the safety of eggs for all consumers in
this country. Because State and local public health officials are the
primary enforcement officials in retail establishments, FDA has
recognized that it must rely on these officials to provide the bulk of
the enforcement of this regulation. If less stringent State or local
refrigeration and labeling requirements are not preempted, enforcement
of those less stringent requirements will interfere with the
cooperative enforcement of the Federal egg refrigeration and labeling
requirements. FDA believes that such cooperative enforcement is
critical to effective implementation of this important food safety
requirement.
Thus, although Congress did not expressly preempt State law in this
area,
[[Page 46378]]
FDA found in the shell egg refrigeration and labeling final rule that
preemption is needed because State and local laws that are less
stringent than the Federal requirements will significantly interfere
with the important public health goals of this regulation (65 FR 76092
at 76109-76110). This final rule amends the shell egg refrigeration and
labeling final rule to permit the egg industry to place the safe
handling statement for shell eggs on the inside lid of egg cartons if
the statement ``Keep Refrigerated'' appears on the PDP or information
panel. FDA believes that preemption of State and local labeling
requirements that are the same as or more stringent than the
requirements of this regulation would not be necessary, as enforcement
of such State and local requirements would not interfere with the food
safety goals of this regulation. Further, it is likely that any states
that enacted similar labeling requirements to those in this final rule
would change those requirements to be consistent with any changes made
by FDA as a result of this rulemaking. Accordingly, the preemptive
effect of this rule would be limited to State or local requirements
that are not as stringent as the requirements of this regulation.
Requirements that are the same as or more stringent than FDA's
requirement would remain in effect.
Further, section 4(e) of the Executive Order provides that ``when
an agency proposes to act through adjudication or rulemaking to preempt
State law, the agency shall provide all affected State and local
officials notice and an opportunity for appropriate participation in
the proceedings.'' FDA provided the States with an opportunity for
appropriate participation in this rulemaking when it sought input from
all stakeholders through publication of the 2005 proposed rule. FDA
received two comments from a State Department of Agriculture, which
agreed with the proposal.
In addition, on March 12, 2007, FDA's Division of Federal and State
Relations provided notice by fax and e-mail transmission to State
health commissioners, State agriculture commissioners, and food program
directors of FDA's intended amendment to its food labeling regulations
to permit the egg industry to place the safe handling statement for
shell eggs on the inside lid of egg cartons if the statement ``Keep
Refrigerated'' appears on the PDP or information panel (Sec.
101.17(h)). The notice provided the States with further opportunity for
input on this rulemaking. It advised the States of the intended
publication of the final rule and encouraged State and local
governments to review the notice and to provide any comments to the
docket (Docket Number 2004N-0382), opened May 5, 2005, when the 2005
proposed rule was published in the Federal Register, by a date 30 days
from the date of the notice (i.e., by April 11, 2007). FDA received no
comments in response to this notice. The notice has been filed in the
previously referenced docket.
For the reasons set forth previously in this document, the agency
believes that it has complied with all of the applicable requirements
under the Executive order. In conclusion, FDA has determined that the
preemptive effects of this rule are consistent with Executive Order
13132.
VII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Tuominen, R., ``Why Do Some Yellow Page Advertisements
Capture Attention Better Than Others?,'' Acta Odontologica
Scandinavia, 59: 79-82, 2001.
2. Dietrich, D.A., ``Enhancing Label Readability for Over-the-
Counter Pharmaceuticals by Elderly Consumers,'' Journal of Safety
Research, 27: 132, 1996.
3. RTI International, ``FDA Labeling Cost Model, Final Report,''
prepared by Mary Muth, Erica Gledhill, and Shawn Karns, RTI,
prepared for Amber Jessup, FDA, Center for Food Safety and Applied
Nutrition, April 2002.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Section 101.17 is amended by revising paragraph (h)(2) to read as
follows:
Sec. 101.17 Food labeling warning, notice, and safe handling
statements.
* * * * *
(h) * * *
(2) The label statement required by paragraph (h)(1) of this
section shall appear prominently and conspicuously, with the words
``SAFE HANDLING INSTRUCTIONS'' in bold type, on the principal display
panel, the information panel, or on the inside of the lid of egg
cartons. If this statement appears on the inside of the lid, the words
``Keep Refrigerated'' must appear on the principal display panel or
information panel.
* * * * *
Dated: May 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16272 Filed 8-17-07; 8:45 am]
BILLING CODE 4160-01-S