[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Proposed Rules]
[Pages 44855-44865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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[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