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Federal Register / Vol. 72, No.

160 / Monday, August 20, 2007 / Rules and Regulations 46375

it becomes Park Drive North; then south Pkwy., College Park, MD 20740, 301– supported the proposal. One comment
on Park Drive North to Rivington 436–2371. directly opposed the proposal, whereas
Avenue; then east on Rivington Avenue SUPPLEMENTARY INFORMATION: two comments supported the proposal
to Mulberry Avenue; then south on based on suggested modifications to the
Mulberry Avenue to Travis Avenue; I. Background proposal.
then northwest on Travis Avenue to the On December 5, 2000 (65 FR 76092), (Comment 1) The comment that
point where it crosses Main Creek; then FDA (we) published a final rule opposed the proposal asserted that there
south along the west shoreline of Main (hereinafter referred to as the shell egg is no ‘‘lack of equipment’’ for printing
Creek to Fresh Kills Creek; then west refrigeration and labeling final rule) to the safe handling statement on the side
along the north shoreline of Fresh Kills require a safe handling statement on panel of egg cartons. The comment
Creek to Little Fresh Kills Creek; then cartons of shell eggs that have not been contended that all the egg industry has
west along the north shoreline of Little treated to destroy Salmonella to do is order new packages.
Fresh Kills Creek to the Arthur Kill; microorganisms ( § 101.17(h) (21 CFR
(Response) As we stated in the 2005
then west to the New York/New Jersey 101.17(h))). The regulation also requires
proposed rule, the egg industry sent
State line in the Arthur Kill; then north retail establishments to store and
letters to FDA stating that placing the
along the New York/New Jersey State display shell eggs under refrigeration
statement on the top or sides of the
line to the point of beginning. (21 CFR 115.50). FDA issued the shell
carton would result in a financial
* * * * * egg refrigeration and labeling final rule
because of the number of outbreaks of hardship for their companies because of,
Done in Washington, DC, this 14th day of foodborne illnesses and deaths caused among other things, the lack of
August 2007. by Salmonella Enteriditis that are equipment to print on the side panels of
Kevin Shea, associated with the consumption of egg cartons (i.e., the information panel)
Acting Administrator, Animal and Plant shell eggs. After the publication of the and the high cost to purchase
Health Inspection Service. shell egg refrigeration and labeling final equipment to print on the sides of egg
[FR Doc. E7–16297 Filed 8–17–07; 8:45 am] rule, the egg industry asked FDA to cartons. One of these letters provided
BILLING CODE 3410–34–P allow safe handling statements to be specific information on the high costs to
placed on the inside lid of egg cartons purchase new equipment required for
because of: (1) The lack of equipment to printing on the information panel and
print on the side panels of egg cartons on the high costs to redesign the egg
DEPARTMENT OF HEALTH AND carton. The comment that opposed the
HUMAN SERVICES (i.e., the information panel), (2) the high
cost to purchase equipment to print on proposal did not provide data or other
the sides of egg cartons, and (3) the high information that shows that the industry
Food and Drug Administration
cost to change the graphic design of the has the necessary equipment.
PDP for each brand that manufacturers Consequently, we are not persuaded by
21 CFR Part 101
produce for each customer. this comment, and we maintain our
[Docket No. 2004N–0382] In the Federal Register of May 5, 2005 view that allowing the safe handling
(70 FR 23813), FDA published a instructions on the inside of the lid
RIN 0910–ZA23 proposed rule (the 2005 proposed rule) could result in cost savings for the
to allow the egg industry to place the industry and ultimately the consumer,
Food Labeling: Safe Handling required safe handling statement on the while continuing to provide mandatory
Statements: Labeling of Shell Eggs inside lid of egg cartons, if the statement safe handling instructions to consumers.
AGENCY: Food and Drug Administration, ‘‘Keep Refrigerated’’ appears on the PDP (Comment 2) Several comments
HHS. or information panel. We tentatively requested that FDA make format
ACTION: Final rule. concluded in the proposed rule that the changes for the safe handling statement.
inside lid would serve as an acceptable Two comments stated that FDA should
SUMMARY: The Food and Drug panel for the safe handling instructions replace the current standard of
Administration (FDA) is amending its without diminishing the effectiveness of ‘‘conspicuous’’ with specific formatting
food labeling regulations to permit the the message. We further tentatively requirements for the safe handling
egg industry to place the safe handling concluded that providing flexibility to statement, e.g., use of dark color, such
statement for shell eggs on the inside lid allow the placement of the safe handling as black, blue, dark blue, or brown on
of egg cartons if the statement ‘‘Keep statement for shell eggs on the inside lid a light background. In addition, several
Refrigerated’’ appears on the principal of egg cartons if the statement ‘‘Keep comments stated that the type size of
display panel (PDP) or information Refrigerated’’ appears on the PDP or the safe handling statement should be
panel. This final rule will provide the information panel may result in cost increased and two of these comments
industry greater flexibility in the savings for the egg industry, and, thus, suggested specific sizes, e.g., 12-point or
placement of safe handling instructions for consumers. larger and ‘‘10-inch type’’ 1 or larger. In
on egg cartons, while continuing to II. Comments and Agency’s Responses addition, one of these comments stated
provide consumers with this important that a survey of egg cartons found that
information. This action is in response FDA received a total of eight the safe handling statement is printed in
to numerous requests from the egg responses, each containing one or more type as small as 7-point and, sometimes,
industry. comments, to the proposal. The the statement is printed directly on a
comments were from consumer groups, gray cardboard carton, which makes the
DATES: This final rule is effective August a State government agency, a consumer, statement difficult to read. Therefore,
20, 2007. a consulting firm, and a trade according to this comment, a significant
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FOR FURTHER INFORMATION CONTACT: association. Some of these comments number of consumers may not notice or
Catalina Ferre-Hockensmith, Center for were about issues that are outside the
Food Safety and Applied Nutrition scope of this rulemaking and will not be 1 We believe that the comment did not actually
(HFS–820), Food and Drug addressed in this document. The mean ‘‘10-inch’’ type but meant another type size,
Administration, 5100 Paint Branch majority of the remaining comments such as a 10-point font.

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46376 Federal Register / Vol. 72, No. 160 / Monday, August 20, 2007 / Rules and Regulations

may have difficulty reading this the safe handling statement on the includes any Federal mandate that may
information. inside lid under this rule to be about the result in the expenditure by State, local,
(Response) We do not agree that same as the number who read it on the and tribal governments, in the aggregate,
specific formatting requirements for the outside of the carton. We base this or by the private sector, of $100,000,000
safe handling statement are needed. assumption on the following reasons: (1) or more (adjusted annually for inflation)
Provisions in section 403(f) of the All consumers open egg cartons before in any one year.’’ The current threshold
Federal Food, Drug, and Cosmetic Act consumption; and (2) the greater after adjustment for inflation is $122
(21 U.S.C. 343(f)) and FDA potential for larger font sizes and lower million, using the most current (2005)
implementing regulations in §§ 101.2 text density on the inside lid, which Implicit Price Deflator for the Gross
and 101.15 (21 CFR 101.2 and 101.15) may equate to a larger number of Domestic Product. FDA does not expect
address the prominence and consumers reading the safe handling this final rule to result in any 1-year
conspicuousness of mandatory statement. expenditure that would meet or exceed
information on food labels. Specifically, However, in the proposed rule we
§ 101.2(c) provides that mandatory asked for comment on whether it is this amount.
labeling information must appear necessary to require a referral statement A. Need for This Regulation
prominently and conspicuously and on the outside lid when the safe
should be at least one-sixteenth inch in handling instructions are placed on the The need for this regulation is to
height. In addition, § 101.15(a)(6) inside lid. The comment did not provide the shell egg industry, which
provides that labeling information may provide any supporting data or other includes egg producers, carton
lack the necessary prominence and information that demonstrates that manufacturers, egg distributors, and
conspicuousness if it is crowded with when consumers open egg cartons retailers, additional flexibility in
other written or graphic matter or has before consumption, they will not see complying with FDA requirements for
insufficient background contrast. The the safe handling instructions. the placement of safe handling
comments did not provide data that Therefore, we are not persuaded that instructions on egg cartons, without
show that the existing requirements in there is a need for a referral statement reducing the prominence or
§§ 101.2 and 101.15 are not adequate to accompany the ‘‘Keep Refrigerated’’ conspicuousness of the information and
when followed. In addition, the type statement. without undermining the effectiveness
size required in § 101.2 is a minimum of the shell egg refrigeration and
III. Analysis of Economic Impacts
type size and does not restrict labeling final rule. Allowing the inside
manufacturers from using a larger type FDA has examined the impacts of the
lid to be used for the safe handling
size to print information on food labels final rule under Executive Order 12866
instructions may create cost savings for
if they choose. Also, while the and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded firms that were concerned that
comments stated that the safe handling complying with the labeling
statement may be difficult to read, the Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866 requirement of the shell egg
comments did not provide any data that
directs agencies to assess all costs and refrigeration and labeling final rule
demonstrate that consumers are unable
benefits of available regulatory would be a financial hardship. This
to read the statement. Therefore, we are
not persuaded that specific formatting alternatives and, when regulation is final rule allows for the safe handling
requirements are needed in this necessary, to select regulatory instructions to be placed on the inside
regulation in addition to the approaches that maximize net benefits lid of egg cartons if the words ‘‘Keep
requirements already in place in (including potential economic, Refrigerated’’ are placed on the PDP or
§§ 101.2 and 101.15 to ensure that the environmental, public health and safety, information panel.
safe handling statement is noticeable and other advantages; distributive B. Comments
and legible. impacts; and equity). FDA has
We remind manufacturers that they determined that this final rule is not a In response to the proposed rule, FDA
must comply with FDA’s regulations on significant regulatory action as defined received several comments. None of the
the prominence and conspicuousness of by the Executive order. comments provided information that
mandatory information on food labels in The Regulatory Flexibility Act would alter the conclusions of the
§§ 101.2 and 101.15. In addition, we requires agencies to analyze regulatory economic impact analysis of the
encourage manufacturers to print the options that would minimize any proposed rule.
safe handling statement in fonts larger significant impact of a rule on small
than the minimum required if space is entities. The final rule provides C. Cost-Benefit Analysis
available on the carton. additional options for placing the safe
(Comment 3) One comment stated handling statement on egg cartons. No In the proposed rule, FDA evaluated
that a referral statement should small business would be forced to use three regulatory options to allow the
accompany the ‘‘Keep Refrigerated’’ this option, and so the final rule safe handling statement to be printed on
statement. The comment argued that a imposes no costs on small businesses. the inside lid of egg cartons. The
referral statement is necessary so that For those small businesses choosing the options considered were the following:
consumers would know to look on the option, the final rule reduces labeling (1) No new regulatory action, (2) allow
inside of the lid for safe handling costs. Therefore, the agency certifies the safe handling statement to be placed
instructions. However, the comment did that this final rule will not have a on the inside lid with a referral
not provide any supporting data. significant economic impact on a statement on the outside of the carton if
(Response) We are not persuaded by substantial number of small entities. the words ‘‘Keep Refrigerated’’ are
the comment that a referral statement Section 202(a) of the Unfunded placed on the PDP or information panel,
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should accompany the ‘‘Keep Mandates Reform Act of 1995 requires and (3) allow the safe handling
Refrigerated’’ statement. In the proposal that agencies prepare a written statement to be placed on the inside lid
we did not propose to require a referral statement, which includes an with no referral statement required if
statement because we assumed that the assessment of anticipated costs and the words ‘‘Keep Refrigerated’’ are
number of consumers who would read benefits, before proposing ‘‘any rule that placed on the PDP or information panel.

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Federal Register / Vol. 72, No. 160 / Monday, August 20, 2007 / Rules and Regulations 46377

1. Costs: Potential Reduction in the a larger number of consumers reading of full label redesign and of adding a
Numbers of Consumers Reached the safe handling statement than under safe handling statement using the FDA
FDA estimated that the costs of this the existing regulation. Because all Labeling Cost Model, Final Report (Ref.
rule are likely to be zero. The only costs consumers look inside the egg carton at 3). The range of cost savings from option
that could arise are from changes in the some time before consumption, FDA two is estimated to be between $5 and
number of consumers who read the safe concludes that there are no costs of this $19 million, with a mean of $11 million,
handling statement. The number of final rule. assuming a 12-month compliance
consumers who would read the safe period.
2. Benefits: Cost Savings Realized by
handling statement on the inside lid Egg Carton Manufacturers 3. Comparing the Benefits of Option
under this rule is assumed to be about Two With Those of Option Three, the
the same as the number who read it The benefits from this rule are the
Chosen Option
under the existing regulation. The costs savings to firms from avoiding
reasons for this assumption are: (1) The placing the safe handling statement on A comparison of the estimates of the
consumer practice of looking inside the the PDP or information panel. The total costs savings reported for option
egg carton either at the time of purchase estimates of the total cost savings for two with those reported for option
or at a time before consumption, and (2) this rule are based on previous estimates three, the chosen option, indicates the
the potential for more space on the of costs savings of option two in the potential for substantial cost savings
inside lid of egg cartons because of its proposed rule. Under option two, the with option three. The larger cost
relatively larger surface area. costs savings for a firm from additional savings from option three compared
At least one study has shown that flexibility equal the difference between with option two reflects the lower cost
labels that are larger and have less text the sum of the costs of printing the safe from not requiring a referral statement
density attract more attention (Ref. 1). handling statement on the inside lid and on an outside panel in option three as
Another study has shown that larger printing a referral statement and the well as the cost savings from a larger
font sizes enhance label legibility (Ref. costs of printing the safe handling share of the industry choosing the
2). Because the inside lid may allow less statement on either the PDP or inside lid statement under option three.
text density and more space for printing information panel. The agency The cost savings from option two and
the safe handling statement in larger estimated the cost savings associated this final rule are reported in table 1 of
font sizes, such placement may result in with option two by computing the costs this document.

Cost Savings of Option Two (12-Month Cost Savings of Option Three, the Chosen
Estimates of Cost Savings Compliance) Option (12-Month Compliance)

Mean estimate $11,032,000 $14,843,000

Low estimate (5th percentile) $5,125,000 $8,039,000

High estimate (95th percentile) $19,022,000 $24,645,000

4. Summary of Costs and Benefits of this IV. Analysis of Environmental Impact preemption provision, or there is some
Final Rule The agency has determined under 21 other clear evidence that the Congress
FDA estimated the costs and benefits CFR 25.30(k) that this action is of a type intended preemption of State law, or
for three regulatory options for that does not individually or where the exercise of State authority
flexibility in the placement of the safe cumulatively have a significant effect on conflicts with the exercise of Federal
handling statement on egg cartons. The the human environment. Therefore, authority under the Federal statute.’’
analysis concludes that the costs, neither an environmental assessment The shell egg refrigeration and
measured as the public health effects of nor an environmental impact statement labeling final rule set minimum national
a decrease in the number of consumers is required. standards to ensure the safety of eggs for
that would read the safe handling all consumers in this country. Because
statement, are zero for option three, the V. Paperwork Reduction Act of 1995 State and local public health officials
chosen option. We conclude that FDA concludes that this final rule are the primary enforcement officials in
because all consumers open egg cartons contains no collection of information. retail establishments, FDA has
before consumption, and given the Therefore, clearance by the Office of recognized that it must rely on these
potential for larger font sizes and lower Management and Budget under the officials to provide the bulk of the
text density on the inside lid, it is likely Paperwork Reduction Act of 1995 is not enforcement of this regulation. If less
that most consumers will notice the safe required. stringent State or local refrigeration and
handling statement on the inside lid if labeling requirements are not
it is located there. The benefits from the VI. Federalism preempted, enforcement of those less
options considered are measured as the FDA has analyzed this rule in stringent requirements will interfere
cost savings from allowing firms accordance with the principles set forth with the cooperative enforcement of the
additional flexibility of printing the safe in Executive Order 13132. FDA has Federal egg refrigeration and labeling
handling statement on the inside lid. determined that the rule would have a requirements. FDA believes that such
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The estimated cost savings from option preemptive effect on State law. Section cooperative enforcement is critical to
three, the chosen option in this final 4(a) of the Executive Order requires effective implementation of this
rule, range from $8 to $25 million, with agencies to ‘‘construe * * * a Federal important food safety requirement.
a mean of $15 million, assuming a 12- statute to preempt State law only where Thus, although Congress did not
month compliance period. the statute contains an express expressly preempt State law in this area,

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46378 Federal Register / Vol. 72, No. 160 / Monday, August 20, 2007 / Rules and Regulations

FDA found in the shell egg refrigeration governments to review the notice and to principal display panel, the information
and labeling final rule that preemption provide any comments to the docket panel, or on the inside of the lid of egg
is needed because State and local laws (Docket Number 2004N–0382), opened cartons. If this statement appears on the
that are less stringent than the Federal May 5, 2005, when the 2005 proposed inside of the lid, the words ‘‘Keep
requirements will significantly interfere rule was published in the Federal Refrigerated’’ must appear on the
with the important public health goals Register, by a date 30 days from the date principal display panel or information
of this regulation (65 FR 76092 at of the notice (i.e., by April 11, 2007). panel.
76109–76110). This final rule amends FDA received no comments in response * * * * *
the shell egg refrigeration and labeling to this notice. The notice has been filed
Dated: May 25, 2007.
final rule to permit the egg industry to in the previously referenced docket.
place the safe handling statement for For the reasons set forth previously in Jeffrey Shuren,
shell eggs on the inside lid of egg this document, the agency believes that Assistant Commissioner for Policy.
cartons if the statement ‘‘Keep it has complied with all of the [FR Doc. E7–16272 Filed 8–17–07; 8:45 am]
Refrigerated’’ appears on the PDP or applicable requirements under the BILLING CODE 4160–01–S
information panel. FDA believes that Executive order. In conclusion, FDA has
preemption of State and local labeling determined that the preemptive effects
requirements that are the same as or of this rule are consistent with DEPARTMENT OF THE TREASURY
more stringent than the requirements of Executive Order 13132.
this regulation would not be necessary, Fiscal Service
as enforcement of such State and local VII. References
requirements would not interfere with The following references have been 31 CFR Part 208
the food safety goals of this regulation. placed on display in the Division of RIN 1510–AB07
Further, it is likely that any states that Dockets Management (see ADDRESSES)
enacted similar labeling requirements to and may be seen by interested persons Management of Federal Agency
those in this final rule would change between 9 a.m. and 4 p.m., Monday Disbursements
those requirements to be consistent with through Friday.
any changes made by FDA as a result of 1. Tuominen, R., ‘‘Why Do Some Yellow AGENCY: Financial Management Service,
this rulemaking. Accordingly, the Page Advertisements Capture Attention Fiscal Service, Treasury.
preemptive effect of this rule would be Better Than Others?,’’ Acta Odontologica ACTION: Final rule.
limited to State or local requirements Scandinavia, 59: 79–82, 2001.
that are not as stringent as the 2. Dietrich, D.A., ‘‘Enhancing Label SUMMARY: On August 7, 2006, the
requirements of this regulation. Readability for Over-the-Counter Financial Management Service (FMS)
Pharmaceuticals by Elderly Consumers,’’ published an interim final rule
Requirements that are the same as or Journal of Safety Research, 27: 132, 1996.
more stringent than FDA’s requirement amending 31 CFR Part 208 (Part 208) to
3. RTI International, ‘‘FDA Labeling Cost facilitate the delivery of Federal
would remain in effect. Model, Final Report,’’ prepared by Mary
Further, section 4(e) of the Executive Muth, Erica Gledhill, and Shawn Karns, RTI,
payments to victims of disasters and
Order provides that ‘‘when an agency prepared for Amber Jessup, FDA, Center for emergencies. See 71 FR 44584. The
proposes to act through adjudication or Food Safety and Applied Nutrition, April interim final rule was published
rulemaking to preempt State law, the 2002. without prior notice and comment and
agency shall provide all affected State took effect immediately upon
List of Subjects in 21 CFR Part 101 publication due to the need to be
and local officials notice and an
opportunity for appropriate Food labeling, Nutrition, Reporting prepared to deliver Federal assistance
participation in the proceedings.’’ FDA and recordkeeping requirements. and benefit payments during the 2006
provided the States with an opportunity ■ Therefore, under the Federal Food, hurricane season. However, we invited
for appropriate participation in this Drug, and Cosmetic Act and under comments on the interim rule and
rulemaking when it sought input from authority delegated to the Commissioner indicated that we would consider all
all stakeholders through publication of of Food and Drugs, 21 CFR part 101 is comments received. We have reviewed
the 2005 proposed rule. FDA received amended as follows: and considered the comments received
two comments from a State Department on the interim rule and are adopting
of Agriculture, which agreed with the PART 101—FOOD LABELING that rule as final without change.
proposal. DATES: Effective August 20, 2007, the
In addition, on March 12, 2007, FDA’s ■ 1. The authority citation for 21 CFR interim rule published on August 7,
Division of Federal and State Relations part 101 continues to read as follows: 2006 (71 FR 44584) is confirmed as
provided notice by fax and e-mail Authority: 15 U.S.C. 1453, 1454, 1455; 21 final.
transmission to State health U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
ADDRESSES: You can download this rule
commissioners, State agriculture 243, 264, 271.
commissioners, and food program at the following Web site: http://
■ 2. Section 101.17 is amended by www.fms.treas.gov/ach. You may also
directors of FDA’s intended amendment revising paragraph (h)(2) to read as
to its food labeling regulations to permit inspect and copy this rule at: Treasury
follows: Department Library, Freedom of
the egg industry to place the safe
handling statement for shell eggs on the § 101.17 Food labeling warning, notice, Information Act (FOIA) Collection,
inside lid of egg cartons if the statement and safe handling statements. Room 1428, Main Treasury Building,
‘‘Keep Refrigerated’’ appears on the PDP * * * * * 1500 Pennsylvania Avenue, NW.,
or information panel (§ 101.17(h)). The (h) * * * Washington, DC 20220. Before visiting,
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notice provided the States with further (2) The label statement required by you must call (202) 622–0990 for an
opportunity for input on this paragraph (h)(1) of this section shall appointment.
rulemaking. It advised the States of the appear prominently and conspicuously, FOR FURTHER INFORMATION CONTACT:
intended publication of the final rule with the words ‘‘SAFE HANDLING Sally Phillips, Director, EFT Strategy
and encouraged State and local INSTRUCTIONS’’ in bold type, on the Division, at (202) 874–7106 or

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