[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Proposed Rules]
[Pages 44855-44865]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2011-18793]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 319 and 381
[Docket No. FSIS-2010-0012]
RIN 0583-AD41
Common or Usual Name for Raw Meat and Poultry Products Containing
Added Solutions
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend its regulations to establish a common or usual name for raw meat
and poultry products that do not meet standard of identity regulations
and to which solutions have been added. Products with added solutions
are sometimes referred to as ``enhanced products.'' The Agency is
proposing that the common or usual name for such products include an
accurate description of the raw meat or poultry component, the
percentage of added solution incorporated into the raw meat or poultry
product, and the individual ingredients or multi-ingredient components
in the solution listed in the descending order of predominance by
weight. FSIS is also proposing that the print for all words in the
common or usual name appear in a single font size, color, and style of
print and that the name appear on a single-color contrasting
background. In addition, the Agency is proposing to remove the standard
of identity regulation for ``ready-to-cook poultry products to which
solutions are added.''
[[Page 44856]]
DATES: Submit comments by September 26, 2011.
ADDRESSES: FSIS invites interested persons to submit relevant comments
on the implementation of this proposed rule. Comments may be submitted
by either of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Room 2-2127, George Washington Carver Center,
5601 Sunnyside Avenue, Beltsville, MD 20705-5273.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2010-0012. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8:30 a.m.
and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Ms. Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery Division, Office of Policy and Program
Development, FSIS, USDA, (301) 504-0879.
SUPPLEMENTARY INFORMATION:
Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695) and
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470) (``the
Acts'') provide that the labels of meat and poultry products must be
approved by the Secretary of Agriculture, who has delegated this
authority to FSIS, before these products can enter commerce. The Acts
also prohibit the distribution in commerce of meat or poultry products
that are adulterated or misbranded.
Under the Acts, a meat or poultry product is misbranded, among
other circumstances, if its labeling is false or misleading in any
particular or it is offered for sale under the name of another food (21
U.S.C. 601(n)(1), 453(h)(1), 601(n)(2), and 453(h)(2)). A meat or
poultry product that is not subject to a standard of identity (9 CFR
Part 319 and Part 381 Subpart P) is also misbranded ``* * * unless its
label bears the common or usual name of the food, if any there be * *
*'' (21 U.S.C. 601(n)(9)(A) and 453(n)(9)(A)). The FMIA and PPIA give
FSIS broad authority to promulgate such rules and regulations as are
necessary to carry out the provisions of the Acts (21 U.S.C. 621 and
463(b)).
To prevent meat and poultry products from being misbranded, the
meat and poultry products inspection regulations require that the
labels of meat and poultry products contain specific information and
that such information be displayed as prescribed in the regulations (9
CFR part 317 and 381 subpart N). Under the regulations, the principal
display panel on the label of a meat product and the label of a poultry
product must, among other information, show the name of the product.
For products that purport to be or are represented by a regulatory
standard of identity, the name of the product on the label must be the
name of the food specified in the standard. For any other product, the
name on the label must be ``the common or usual name of the food, if
any there be.'' If there is no common or usual name, the name on the
label must be a ``truthful, descriptive designation'' (9 CFR
317.2(c)(1) and 381.117).
FSIS poultry products regulations (9 CFR 381.169) provide that
solutions may be added to ready-to-cook, bone-in poultry carcasses and
parts, increasing the weight by approximately 3 percent over the weight
of the raw product after chilling and washing. Poultry products with
solutions that have been added in accordance with this regulation must
be labeled with a conspicuous, legible, and descriptive name, including
terms that concisely describe the method of addition and function of
the added material. The regulation requires that all major terms in the
product name be printed with the same prominence, except that the words
that describe the function of the added materials (such as ``injected
for Flavored Basting'') may be more prominent. A qualifying statement
that identifies the percentage of added solution must be printed at
least one-fourth the size of the most prominent letter in the product
name. The ingredients in the solution must be identified in the
qualifying statement and must be displayed with a minimum size
requirement of one-eighth the size of the most prominent letter in the
product name. In addition, 9 CFR 381.169 contains labeling compliance
quality control criteria that must be approved by the Administrator.
Since 9 CFR 381.169 was codified on May 16, 1972 (37 FR 9706), and
subsequently amended on October 7, 1974 (39 FR 36000), several changes
have taken place that have diminished the relevance of 9 CFR 381.169 in
preventing the labels of poultry that contain added solutions from
being false or misleading. Poultry processors have developed
technologies, such as using injectors to inject solutions deep into the
muscle tissue, that incorporate more than 3 percent solution into
products. While the practice of adding liquid solution was initially
used to flavor the raw poultry product without significantly increasing
the product's net weight, the addition of the increased levels of
solution has resulted in increasing the total weight of the finished
product. Also, with the May 30, 2000, publication of the Elimination of
Requirements for Partial Quality Control Programs Final Rule (65 FR
34381), the quality control criteria used to monitor the percent added
solution per 9 CFR 381.169(c) are no longer in effect.
To provide labeling guidance for ready-to-cook, bone-in poultry
products with solutions above 3 percent and for boneless poultry
products with any amount of added solution, neither of which are
covered under 9 CFR 381.169, the Agency issued Policy Memo 042, Raw
Bone-In Poultry Products Containing Solutions (February 1982) and
Policy Memo 044A, Raw Boneless Poultry Containing Solutions (September
1986). FSIS also issued Policy Memo 066C, Uncooked Red Meat Products
Containing Added Substances (November 2004) to provide similar guidance
for the labeling of ``enhanced'' uncured meat products. The Policy
Memos are available on the FSIS Web site at http://www.fsis.usda.gov/OPPDE/larc/Policies/Policy_Memos_082005.pdf.
The intent of labeling guidance provided in the policy memoranda
was to provide guidance to industry to develop truthful, easy-to-read
labeling information concerning the solutions added to products so that
consumers could make informed purchasing decisions. However, it has
come to the Agency's attention, through the petitions discussed below,
comments submitted by the public, and FSIS review of labels, that some
product labels may not clearly and conspicuously identify that the raw
meat or poultry products contain added solution.
Under FSIS's current regulatory approach, raw products that contain
added solution and products that do not contain added solution may have
the same product name. For example, the name for a single-ingredient
chicken breast and a chicken breast with added solution is ``chicken
breast,'' even though one is 100 percent chicken
[[Page 44857]]
breast and one may be 60 percent chicken breast and 40 percent
solution. Although the labeling of the product must include a
qualifying statement that reflects the fact that the product contains
added solution, this may not be readily apparent to consumers because
the statement is not part of the product name. For example, through
label review, FSIS has found that it is common for product labels to
contain product names in bold fonts with strong contrasting
backgrounds, with the qualifying statement on added solution printed in
tall, narrow, or slanted fonts at the smallest height permitted, and on
background of poor color contrast. While such labeling may be
consistent with existing Agency guidance, it may not clearly identify
to consumers that the products contain added solutions.
Petitions and Public Comments Related to Products That Contain Added
Solution
Since 2007, FSIS has received two petitions related to products
that contain added solution. In July 2007, the Truthful Labeling
Coalition (TLC) submitted a petition to the Agency requesting that it
``prevent the ongoing marketing of so-called `enhanced' (added
solution) fresh poultry products in all situations where ingredients
added to such products are not being adequately labeled to prevent the
consuming public from being misled.''
Included in the TLC petition were two consumer research
studies.1 2 Though these studies are not generalizable, they
provide anecdotal evidence that consumers read and use labels, and that
users of ``enhanced'' chicken are not aware that it contains additives
until specifically directed to look at the label. According to the
Sorenson study, even after looking at the label of an ``enhanced''
chicken product, about 20% participants in the study that purchase the
chicken failed to realize that the chicken contains additives.'' In
addition, almost one-third of these participants indicated that they
``care a lot that their chicken contains additives,'' and after being
informed about the additives, these participants said they probably or
definitely would not buy it again. Participants in the study were also
presented with the following label descriptions that communicated
additive ingredients in chicken: ``Contains up to 15% water, salt, and
sodium phosphate,'' ``Enhanced with up to 15% solution of water, salt,
and sodium phosphates,'' ``Contains up to 15% chicken broth,'' and
``Enhanced with up to fifteen percent chicken broth.'' Respondents
considered the wording ``Contains up to 15% water, salt, and sodium
phosphates'' as most accurately communicating additive ingredients in
chickens.
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\1\ Russell Research, Fresh Chicken Study Final Report, June
2006.
\2\ ``Enhanced'' Chicken, Consumer Research, November 2004, SAI
Project 04177, Sorensen Associates, Minneapolis, Minnesota
(888-616-0123), Portland, Oregon (800-542-4321).
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The TLC petition also pointed out health concerns associated with
the addition of salt to these products. TLC submitted a comparison of
the sodium content in 4 ounces of a single ingredient, raw poultry
product (45 mg sodium) to 4 ounces of a poultry product with added
solution (370 mg sodium), more than an eightfold increase in the amount
of sodium. TLC argued that many consumers do not realize that there may
be a significant difference in sodium content between a single-
ingredient, raw product and a similar-looking product with added
solution.
In March 2009, the California Agricultural Commissioners and
Sealers Association submitted a petition to revoke FSIS's September 9,
2008, Final Rule, ``Determining Net Weight Compliance for Meat and
Poultry Products'' (73 FR 52189), which eliminated wet tare provisions
for determining the net weight of packaged meat and poultry products.
The petition suggested that meat and poultry products with added
solution were misleading to the consumer because added liquids
represent a high percentage of product weight. The petition stated that
in 2006, California Weights and Measures officials conducted a study
that indicated that, in California alone, consumers spent an estimated
$246 million on solutions added to ready-to-cook poultry. The petition
further stated that, assuming California has approximately 12% of the
U.S. market share, the nationwide impact is projected at a cost of $2
billion annually for just the added solution.
In addition, after FSIS held a public meeting on December 12, 2006,
to solicit public input on ``natural'' claims, the Agency received more
than 12,000 comments from a write-in campaign sponsored by TLC that
objected to the use of ``natural'' claims in the labeling of poultry
product with added solutions (71 FR 70503). The Agency received similar
comments in response to its September 14, 2009, Advance Notice of
Proposed Rulemaking, ``Product Labeling: Use of the Voluntary Claim
`Natural' in the Labeling of Meat and Poultry Products'' (74 FR 46951).
Although the current proposed rule does not address ``natural'' claims
in product labeling, we note that almost all of the comments submitted
as part of the TLC write-in campaign also requested that FSIS require
poultry products with added solution to bear a prominent label that
clearly reflects the products' true composition. This proposed rule
addresses the labeling of products that contain added solution and does
not affect FSIS's ``natural'' claims policy. The Agency intends to
pursue separate rulemaking to address issues associated with
``natural'' claims.
Proposed Amendments
After considering the comments submitted in response to the 2006
public meeting and the 2009 advanced notice of proposed rulemaking, and
the information presented in the petitions described above, along with
the Agency's experience in reviewing labels of meat and poultry
products with added solution, the Agency has tentatively concluded that
without specific, clear, and conspicuous information about the
percentage of added solution incorporated into the product, the
labeling of these raw meat or poultry products that do not meet a
standard of identity is likely to be misleading to consumers.
As noted above, raw products that have added solution and single-
ingredient raw products currently have the same product name, and the
qualifying statement required for products with added solution may not
be readily apparent to consumers. Thus, the labeling of meat and
poultry products with added solution that do not meet a regulatory
standard of identity often does not adequately reveal a significant
material fact about the nature of the product.
FSIS agrees with the petitions discussed above, the comments
submitted in response to the 2006 public meeting on ``natural'' claims,
and the 2009 Advance Notice of Proposed Rulemaking on ``natural''
claims that without adequate information, consumers likely cannot
distinguish between single-ingredient raw meat and poultry products
versus similar raw meat and poultry products containing added solution
that do not meet a standard of identity. The added solution in a raw
meat and poultry product is a characterizing component of the product,
and, as suggested by the consumer research discussed above, is likely
to affect consumers' purchasing decisions. Furthermore, as noted in the
TLC petition, the presence of added solutions affects the product's
nutrition profile because there may be a significant difference in
sodium content between a single-ingredient raw product
[[Page 44858]]
and a similar-looking product containing added solution. The effect of
excess sodium may be compounded if consumers unknowingly purchase a
product with added solution, believe it to be a single-ingredient
product, and add salt during preparation or prior to consumption.
Therefore, to ensure that labels adequately inform consumers that
raw products that do not meet a standard of identity in 9 CFR part 319
or 9 CFR part 381, subpart P, contain added solutions, the Agency is
proposing to establish a common or usual name for such raw products.
FSIS is proposing that the common or usual name of such product consist
of the following: an accurate description of the raw meat or poultry
component; the percentage of any added solution incorporated into the
raw meat or poultry product (total weight of solution ingredients
divided by the weight of the raw meat or poultry without solution or
any other added ingredients, multiplied by 100) using numerical
representation and the percent symbol ``%;'' and the common or usual
name of all individual ingredients or multi-ingredient components in
the solution listed in descending order of predominance by weight. For
example, an applicable product could be labeled as ``chicken breast--
40% added solution of water, salt and sodium phosphate'' or ``chicken
breast--40% added solution of water, teriyaki sauce, and salt.'' If the
poultry component of a poultry product is represented by a standard cut
for raw poultry prescribed in 9 CFR 381.170, the common or usual name
of the product would include the name of the standard poultry cut, the
percentage of added solution, and the common or usual names of the
ingredients in the solution.
Under this proposal all of the letters in the name would be
required to appear in a single font size, color, and style of print and
appear on a single-color contrasting background, as opposed to the
smaller type and differing style that is currently permitted for the
qualifying statement. This approach will clearly disclose that the
product has been formulated with added solution, and it will clearly
distinguish raw meat and poultry products that have added solution from
single-ingredient raw meat and poultry products.
The Agency would like to receive any consumer research information
that evaluates whether the proposed product name requirements described
above would better inform consumers and affect their purchasing habits.
Under the current regulations, as noted above, the product label is
required to show the product name, which, for a non-standardized
product with a common or usual name, would be the common or usual name
of the food (9 CFR 317.2(c)(1) and 381.117). Thus, if finalized, the
common or usual name for raw meat and poultry products containing added
solution subject to this proposed rule would be different from the name
for similar raw products without added solution. If this proposal is
finalized, raw products containing added solution subject to the rule
that are not labeled with the prescribed common or usual name would be
considered misbranded because their labeling would be false or
misleading and they would be offered for sale under the name of another
food (21 U.S.C. 601(n)(1), 453(h)(1), 601(n)(2), and 453(h)(2)).
The Agency seeks to ensure that the common or usual name
consistently conveys to consumers that these products contain added
solutions. Various methods are used to add solutions to meat and
poultry products (e.g., injecting, marinating, or tumbling). The term
``enhanced'' is commonly used to describe products with added
solutions, regardless of the method used to incorporate solution into
the product, and was the term used in the petitions submitted to the
Agency. However, FSIS recognizes that the term ``enhanced'' could imply
a judgment about the value of the product. As such, the Agency did not
propose to include the term ``enhanced'' in the common or usual name
for products containing added solutions.
In addition, FSIS is proposing that the common or usual name of
such products that contain added solution include the common or usual
name of individual ingredients or multi-ingredient components in the
solution listed in descending order of predominance. FSIS is proposing
to require this information in the product name to ensure that
consumers are aware of the ingredients in the solution. FSIS is
proposing that the common or usual names of applicable multi-ingredient
components, rather than the components' individual ingredients, may be
listed in the common or usual name to simplify the product name for raw
products that may contain numerous ingredients. FSIS requests comment
on whether the common or usual name of a multi-ingredient component in
the product name sufficiently alerts consumers concerning the content
of the added solution. FSIS acknowledges that many solutions include
salt and requests comment on whether consumers are aware of that. Under
this proposal, when the common or usual name includes the individual
ingredients in the solution, those ingredients would not need to be
listed in a separate ingredients statement on the label. However, when
the common or usual name includes multi-ingredient components, all
ingredients in the product would be required to be declared in a
separate ingredients statement on the label. Regulations currently
require that ingredients in the ingredients statement on the label be
listed in descending order of predominance (9 CFR 317.2(c)(2),(f) and
381.118(a)(1)).
Raw products are products that have not received any type of heat
treatment or full lethality treatment to destroy harmful bacteria. FSIS
agrees with the petitions and comments that without adequate
information, consumers have difficulty distinguishing between single-
ingredient raw meat and poultry products and raw meat and poultry
products containing added solution.
FSIS has not received information indicating that consumers lack
adequate ingredient information for fully cooked or partially heat-
treated products containing added solution. An example of a partially
heat-treated product containing added solution is a raw chicken strip
with an added solution that is breaded, and then immersed in hot oil to
set the breading. This product and other similar products would not be
subject to the common or usual name requirements proposed in this
rulemaking because FSIS has tentatively concluded that consumers are
unlikely to be misled into thinking that these are single-ingredient
products based on the product appearance. For example, breaded products
are obviously not single-ingredient. Furthermore, the petitions and
comments submitted on products containing added solution expressed
concern that without adequate labeling consumers would have difficulty
distinguishing raw products with solutions from single-ingredient raw
products. They did not express the same concern regarding partially
heat-treated or cooked products. FSIS requests comments on whether it
should establish a common or usual name for non-standardized fully
cooked or partially-heated treated products that contain added
solutions.
Under this proposed rule, meat and poultry products that comply
with a standard of identity in the regulations will continue to be
labeled as the named food specified in the standard. For example,
``corned beef,'' which includes curing solution, is allowed up to a 10
percent gain from the fresh weight of the uncured beef in accordance
with the 9 CFR 319.100 standard of identity for
[[Page 44859]]
corned beef. Products that comply with this standard would be named and
labeled as ``corned beef.'' However, if a product similar to ``corned
beef'' includes a solution amount that is greater than the standard
allows, the product is no longer a standardized product and, under this
proposed rule, it must be labeled with the common or usual name,
``corned beef containing up to 15% of a solution.'' The name would
follow the labeling requirements for font size, color, and style and
background color as proposed.
This proposed rule is only applicable to raw meat and poultry
products that, after post-evisceration processing, have solutions
added. Raw, single-ingredient meat and poultry products that retain
water as the result of post-evisceration processing are subject to the
retained water regulations (9 CFR 441.10). The regulations at 9 CFR
441.10 also address retained water as a result of the use of anti-
microbial solutions (66 FR 1766). This proposal addresses most other
added solutions.
FSIS Directive 7620.3, ``Processing Inspectors' Calculations
Handbook,'' provides instructions to inspection personnel concerning
the method to use in determining the percent pickup of solutions added
to raw poultry and meat products. The National Institute of Standards
and Technology (NIST) Handbook 133 provides instructions to personnel
concerning the method to use in determining the net weight of enhanced
products. Should this rule become final, FSIS personnel will continue
to follow Directive 7620.3 when enforcing these labeling requirements
and the NIST Handbook 133 in order to determine the net weight of these
products.
In addition to proposing a common or usual name for raw meat and
poultry products containing added solution, FSIS is proposing to remove
9 CFR 381.169, the standard for ``ready-to-cook poultry products to
which solutions are added.'' The Agency has evaluated the provisions in
9 CFR 381.169 and has determined that the provisions are not necessary.
If this proposal is finalized, 9 CFR 381.169 will not be necessary
because the labeling of all poultry and meat products containing added
solution will be required to comply with the common or usual name
requirements. Likewise, when these proposed amendments are finalized,
Policy Memos 042,044A, and 066C will be rescinded and references to
these policy memoranda will be deleted from the FSIS Food Standards and
Labeling Policy Book. FSIS is requesting comments on removing all of
the regulatory requirements in 9 CFR 381.169.
The misbranding provisions of the Acts apply to all meat and
poultry products, including products that are not subject to the
inspection provisions of the Acts (21 U.S.C. 623(d) and 464(e)). Thus,
if finalized, these proposed regulations will apply to raw meat and
poultry products containing added solutions that do not meet a
regulatory standard of identity and that are sold for retail sale,
institutional use, or further processing. If retail facilities, such as
grocery stores, produce such products, the proposed labeling
requirements would apply to those products. The proposed regulations
would also apply to raw meat and poultry products containing added
solutions that have been sliced or cut up and re-packaged at retail or
another official establishment.
These proposed amendments, if finalized, will become effective on
January 1, 2014, the compliance date provided by the Uniform Compliance
Date for Food Labeling Regulations (75 FR 71344).
BILLING CODE 3410-DM-P
[[Page 44860]]
[GRAPHIC] [TIFF OMITTED] TP27JY11.018
[[Page 44861]]
[GRAPHIC] [TIFF OMITTED] TP27JY11.019
BILLING CODE 3410-DM-C
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this proposed rule: (1) All State and local
laws and regulations that are inconsistent with this rule will be
preempted, (2) no retroactive effect will be given to this rule, and
(3) no retroactive proceedings will be required before parties may file
suit in court challenging this rule.
[[Page 44862]]
Executive Orders 12866 and 13563 and the Regulatory Flexibility Act
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order (E.O.) 13563 emphasizes the importance of quantifying both costs
and benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Section 4 of E.O. 13563 emphasizes flexible approaches,
including ``provision of information to the public in a form that is
clear and intelligible.'' This proposed rule has been reviewed under
Executive Order (E.O.) 12866. OMB has determined that it is a
significant regulatory action under section 3(f) of E.O. 12866 and,
therefore, it has been reviewed by the Office of Management and Budget.
FSIS estimated that the proportion of products containing added
solutions is about 39 percent of all raw meat and poultry products
sold. Based on FSIS's label review process estimates, 30 percent of the
49.2 billion pounds of poultry \3\ consumed by households (14.8 billion
pounds), 15 percent of the 27.3 billion pounds of beef \4\ consumed by
households (4.1 billion pounds), and 90 percent of the 21 billion
pounds of pork \5\ consumed by household (18.9 billion pounds) contain
added solutions. As a result, approximately 37.8 billion pounds, or
about 39 percent of the 97.5 billion pounds of meat and poultry
products consumed by households in the U.S. contain added solutions.\6\
FSIS requests comments on these estimates.
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\3\ U.S. Poultry & Egg Association: Poultry Statistics, 2007.
\4\ Economic Research Service, USDA. U.S. Beef and Cattle
Industry: Background Statistics and Information, 2007.
\5\ National Pork Producers Council: Background Statistics and
Information, 2007.
\6\ Totals do not necessarily add up due to rounding.
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This rule will affect foreign establishments that manufacture and
export products containing added solutions to the United States,
because foreign establishments that manufacture and export products
containing added solutions to the United States will be required to
follow these same labeling requirements. FSIS requests information on
the number of foreign establishments that may be affected by this
proposed rule.
If finalized, the proposed regulations will apply to all raw meat
and poultry products containing added solution that do not meet a
standard of identity that are produced at federal establishments. The
proposed labeling requirements also apply to such products that are
produced at retail facilities, such as grocery stores. FSIS requests
comment on the number of retail facilities that produce product
containing added solution and the volume of such product that would be
subject to these regulations.
Alternatives considered:
1. No Action.
FSIS considered taking no action but did not select this
alternative because of evidence (Sorenson, November 2004) \7\ that
consumers view information about these additives as important factors
in their purchasing decision.
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\7\ See footnote 2, page 8.
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2. Propose to require the word ``enhanced'' in the product's common
or usual name, or propose the use of the term ``enhanced'' in the
containing statement, e.g., ``enhanced with a 15% solution * * *''.
FSIS did not select the alternative of proposing to require the
word ``enhanced'' in the product's common or usual name because the
word implies that the product is improved by the addition of the
solution. The intent of this proposal is to increase transparency to
consumers, not to suggest that the product is either better or worse
than a raw product without the added solution.
In addition, consumer research (Sorenson, November 2004) \8\ showed
that the containing statement, ``enhanced with up to 15% solution of
water, salt, and sodium phosphates'' was preferred by fewer study
participants (about 10% fewer) \9\ than the use of the description
``contains up to 15% water, salt, and sodium phosphates.''
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\8\ See footnote 2, page 8.
\9\ The Sorenson study did not report statistical significance.
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3. Propose to require that the common or usual name of the product
include an accurate description of the raw meat or poultry component,
the percentage of added solution, and the common or usual names of the
ingredients in the solution, with all of the print in a single font
size, color, and style on a single-color contrasting background (the
proposed amendments).
FSIS selected this alternative because it is likely to improve
consumer awareness and understanding that the raw meat or poultry
product contains an added solution. FSIS believes proposing to require
the percentage of the solution and the ingredients of the solution as
part of the common or usual name is information consumers need to make
informed purchasing decisions.
Expected Cost of the Proposed Rule
The proposed rule will result in one-time costs to establishments
and retail facilities that produce and package enhanced products
pertaining to modifying labels of products. The estimated costs of
modifying labels are determined by the number of label plates or
digitalized label templates required to be modified and the average
cost of modifying labels. This methodology provides an estimated cost
for all labels of products with added solution in commerce, including
those for retailers and foreign entities that sell meat and poultry in
the United States. Based on the Agency's Labeling Information System
database, FSIS estimates that there were approximately 121,350 \10\ raw
meat and poultry product unique labels submitted by official
establishments and approved by the Agency in 2009. Therefore, FSIS
estimates that there are 46,990 (121,350 * 39%) unique labels for meat
and poultry raw products containing added solution in commerce.
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\10\ Source: FSIS Labeling and Program Delivery Division,
Labeling Information System Database, 2009.
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The Agency is providing a primary cost analysis based on the costs
published in the December 29, 2010, final rule, ``Nutrition Labeling of
Single-Ingredient Products and Ground or Chopped Meat and Poultry
Products'' (75 FR 82148). In May 2011, the Food and Drug Administration
(FDA) published a report, ``Model to Estimate Costs of Using Labeling
as a Risk Reduction Strategy for Consumer Products Regulated by the
Food and Drug Administration, FDA.'' A secondary cost analysis based on
the FDA report is also provided for comment. FSIS requests comment on
which cost analysis should be used for the economic analysis of the
final rule.
Primary Cost Analysis
The primary cost estimate for label modification reflects
administrative activities, graphic design, prepress activities, and
plate engraving costs and excludes nutrient analysis costs and all
other types of analysis. The mid-point label design modification cost
is an estimated $1,557 per label (75 FR 82148). This estimate assumes
separate label costs for every unique product containing added
solution. Because subsidiary establishments are owned by parent
companies, and subsidiaries
[[Page 44863]]
would likely use the same label, this estimate probably overestimates
the total cost. Using this estimate, total costs of modifying labels
for all federally inspected processors is $73 million as a central
estimate (46,990 * $1,557 label modification cost).
Secondary Cost Analysis
This secondary cost analysis uses the mid-point label design
modification costs for a minor coordinated label change, as provided in
a March 2011 FDA report.\11\ The Agency is requesting comment on
whether these costs estimates are applicable to the amendments in this
proposed rule. The mid-point label design modification costs for a
minor coordinated label change is an estimated $310 per label (with a
range of $170 to $440). A coordinated label change is when a regulatory
label change is coordinated with planned labeling changes by the firm.
In this case, only administrative and recordkeeping costs are
attributed to the regulation and all other costs are not. Using this
cost, FSIS estimates that the total costs of modifying labels for all
federally inspected processors is about $14.6 million as a central
estimate (46,990 labels * $310 label modification costs), with a range
of approximately $8.0 to $20.7 million).
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\11\ Model to Estimate Costs of Using Labeling as a Risk
Reduction Strategy for Consumer Products Regulated by the Food and
Drug Administration, FDA, March 2011 (Contract No. GS-10F-0097L,
Task Order 5). The labeling model defines all labeling changes as
minor, major, or extensive. A minor change is one in which only one
color is affected and the label does not need to be redesigned.
Examples of this type of change include changing an ingredient list
or adding a toll-free number. A major change requires multiple color
changes and label redesign. An example of a major change is adding a
facts panel or modifying the front of a package. An extensive change
is a major format change requiring a change to the product packaging
to accommodate labeling information. An example of an extensive
change is adding a peel-back label or otherwise increasing the
package surface area. We, therefore, conclude that the labeling
change that would be required by this proposed rule is a minor
change. FSIS expects that all label changes resulting from this
proposed rule will be coordinated with planned label changes.
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These estimated costs include the labeling costs of imported and
retailer-produced raw imported meat and poultry products containing
added solutions. Under either of the cost analyses presented above, the
compliance cost of this proposed rule will be negligible as the cost of
modifying labeling is small relative to the total sales of meat and
poultry products. The 2-year compliance increments defined in the FSIS
regulation titled ``Uniform Compliance Date for Food Labeling
Regulations'' (75 FR 71344) will help affected establishments minimize
the economic impact of labeling changes because affected establishments
possibly could incorporate multiple label redesigns required by
multiple Federal rules into one modification during the 2-year
increments. Moreover, the ``Uniform Compliance Date for Food Labeling
Regulations'' allows establishments time to use existing labels and
would, therefore, result in minimal loss of inventory of labels, if
any. The ``Uniform Compliance Date for Food Labeling Regulations'' also
allows establishments to incorporate the new requirements as a
coordinated change, which reduces the cost of complying with the
proposed regulation.
FSIS Budgetary Impact of the Proposed Rule
This proposed rule will result in no impact on the Agency's
operational costs because the Agency will not need to add any staff or
incur any non-labor expenditures if the proposed rule is adopted.
FSIS is soliciting comments and data regarding any other potential
costs that might result from finalization of this rule.
Expected Benefits of the Proposed Rule
The expected benefits of this proposed rule are:
Improved public awareness of product identities by
providing truthful and accurate labeling of meat and poultry products
to clearly differentiate products containing added solutions from
single-ingredient products.
Consumers can better determine whether products containing
added solutions are suitable for their personal dietary needs through
increased product name prominence. For example, consumers' choices of
meat and poultry products with added solutions with a high sodium
content could have unintended health consequences if labels of these
products were inadequate in revealing the information of added
ingredients to the consumers.
This proposed action is not likely to result in a market demand
shift, relative to other products, for meat and poultry products, with
or without added solutions, because this proposed action is unlikely to
influence consumers' preference for meat and poultry products in
general. The proposed action, if adopted, will not add monetary
benefits to the meat and poultry industry. Instead, the rule will make
clearer product content information available to consumers of meat and
poultry products with added solutions.
This rule may also help consumers reduce their sodium intake
because the new product names will better alert consumers to the fact
that the products contain added solutions. The prominence and design of
the label on the front of the package may increase the likelihood that
consumers review the nutrition facts panel, including information on
sodium content, and make more healthful food choices. The benefits of
improved market information are not quantifiable due to lack of data.
FSIS is soliciting comments and data that would permit the
quantification of the expected benefits.
Regulatory Flexibility Analysis
The FSIS Administrator has made a preliminary determination that
this proposed rule would not have a significant economic impact on a
substantial number of small entities in the United States, as defined
by the Regulatory Flexibility Act (5 U.S.C. 601). There are about 5,719
small federally inspected establishments, of which 2,616 are small
(with 10 or more but less than 500 employees), and 3,103 are very small
(with fewer than 10 employees) based on Hazard Analysis Critical
Control Point (HACCP) classification. Because only a portion of all
meat and poultry products is sold with added solutions, a fraction of
small and very small establishments will be impacted by this proposed
rule at a negligible cost.
In the primary cost analysis above, FSIS estimated that the average
one-time cost of modifying labels per unique label is about $1,557 and
the total one-time cost for the industry is about $73 million (the
secondary cost analysis total cost is $14.6 million). This results in
an average one-time cost per establishment of about $11,969 ($73
million/6099 establishments). Because small and very small
establishments produce less output and fewer unique labels, their
average one-time cost per establishment will be lower. Therefore, FSIS
believes that the cost to small and very small establishments of
providing modified labels for the meat and poultry products with added
solutions will be negligible. FSIS requests comment on the average
number of labels of meat and poultry products with added solutions
produced by small and very small producers and invites small and very
small establishments to comment on the estimation of the compliance
cost of the proposed rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995, the information collection or
[[Page 44864]]
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Title: Product Labeling Requirements for Meat and Poultry
Containing Added Solutions.
Type of Collection: New.
Abstract: FSIS is proposing common or usual name labeling
requirements for raw meat and poultry products that do not meet
standard of identity regulations and to which solutions have been
added. The proposed amendments will require establishments that
manufacture products containing added solutions to modify or redesign
the product label. The proposed amendments will be effective on the
next compliance date provided by the Uniform Compliance Date for Food
Labeling Regulations.
Estimate of Burden: FSIS estimates that it will take a respondent
75 minutes per response to comply with the information collection
associated with product labeling requirements.
Respondents: Official establishments, retail stores, and foreign
firms.
Estimated Number of Respondents: 6,100.
Estimated Number of Responses per Respondent: 8.
Estimated Total Annual Burden on Respondents: 61,000 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue, SW., Room 6083,
South Building, Washington, DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both John O'Connell, Paperwork Reduction
Act Coordinator, at the address provided above, and the Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent to OMB within 60 days of the publication date
of this proposed rule.
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
proposed rule, FSIS will announce it online through the FSIS Web page
located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Publications_&_Related_Documents/index.asp.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. Through the Listserv and Web page, FSIS is able to provide
information to a much broader and more diverse audience. In addition,
FSIS offers an electronic mail subscription service which provides
automatic and customized access to selected food safety news and
information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range from recalls to
export information to regulations, directives and notices. Customers
can add or delete subscriptions themselves, and have the option to
password protect their accounts.
Executive Order 13175
This proposed rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue,
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Meat inspection, Nutrition,
Reporting and recordkeeping requirements.
9 CFR Part 381
Food labeling.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR Chapter III as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for Part 317 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Amend Sec. 317.2 by redesignating paragraph (e) as paragraph
(e)(1) and adding a new paragraph (e)(2) to read as follows:
Sec. 317.2 Labels: definition; required features.
* * * * *
(e) * * *
(2)(i) The common or usual name for a raw meat product that
contains added solution and does not meet a standard of identity in 9
CFR part 319 consists of:
(A) An accurate description of the raw meat component;
(B) The percentage of added solution (total weight of the solution
ingredients
[[Page 44865]]
divided by the weight of the raw meat without solution or any other
added ingredients multiplied by 100) using numerical representation and
the percent symbol ``%;'' and
(C) The common or usual name of individual ingredients or multi-
ingredient components in the solution listed in descending order of
predominance by weight (such as, ``pork tenderloin--15% added solution
of water and salt'' or ``beef--15% added solution of water and teriyaki
sauce'').
(ii) The common or usual name must be printed in a single font
size, color, and style of print and must appear on a single-color
contrasting background.
(iii) When the common or usual name includes all ingredients in the
solution, a separate ingredients statement is not required on the
label. When the common or usual name includes multi-ingredient
components and the ingredients of the component are not declared in the
product name, all ingredients in the product must be declared in a
separate ingredients statement on the label as required in Sec. Sec.
317.2(c)(2) and 317.2(f).
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority citation for Part 381 continues to read as
follows:
Authority: 7 U.S.C. 138F, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
4. A new Sec. 381.117(h) is added to read as follows:
Sec. 381.117 Name of product and other labeling.
* * * * *
(h) Common or usual name for raw products containing added
solution. (1) The common or usual name for a raw poultry product that
contains added solution and does not meet a standard of identity in 9
CFR part 381 consists of:
(i) An accurate description of the raw poultry component;
(ii) The percentage of added solution (total weight of the solution
ingredients divided by the weight of the raw poultry without solution
or any other added ingredients multiplied by 100) using numerical
representation and the percent symbol ``%;'' and
(iii) The common or usual name of all individual ingredients or
multi-ingredient components in the solution listed in descending order
of predominance by weight (such as, ``chicken breast--15% added
solution of water and salt'' or ``chicken breast--40% added solution of
water, teriyaki sauce, and salt'').
(2) The common or usual name must be printed in a single font size,
color, and style of print and must appear on a single-color contrasting
background.
(3) When the common or usual name includes all ingredients in the
solution, a separate ingredients statement is not required on the
label. When the common or usual name includes multi-ingredient
components and the ingredients of the component are not declared in the
product name, all ingredients in the product must be declared in a
separate ingredients statement on the label as required in Sec.
381.118.
Sec. 381.169 [Removed and reserved]
5. Remove and reserve Sec. 381.169.
Done at Washington, DC, on July 20, 2011.
Alfred Almanza,
Administrator.
[FR Doc. 2011-18793 Filed 7-26-11; 8:45 am]
BILLING CODE 3410-DM-P