[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Rules and Regulations]
[Pages 79044-79062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30472]
[[Page 79043]]
Vol. 79
Wednesday,
No. 250
December 31, 2014
Part IV
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 317 and 381
Descriptive Designation for Raw Meat and Poultry Products Containing
Added Solutions; Final Rule
Federal Register / Vol. 79 , No. 250 / Wednesday, December 31, 2014 /
Rules and Regulations
[[Page 79044]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. FSIS-2010-0012]
RIN 0583-AD43
Descriptive Designation for Raw Meat and Poultry Products
Containing Added Solutions
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
regulations to require the use of a descriptive designation as part of
the product name on the labels of raw meat and poultry products that
contain added solutions and that do not meet a standard of identity.
The descriptive designation will have to include the percentage of
added solution, and the individual ingredients or multi-ingredient
components in the solution listed in descending order of predominance
by weight. The print for all words in the product name, including the
descriptive designation, must appear in a single easy-to-read type
style and color and on a single-color contrasting background. The print
may appear in upper and lower case letters, with the lower case letters
not smaller than one-third (\1/3\) the size of the largest letter. The
percent solution must appear as a number (e.g., 15, 20, 30) with the
percentage sign (%) and may be declared with the word ``containing'' or
``contains.'' Under this final rule, the word ``enhanced'' is not
allowed in the product name. The Agency is also removing the standard
of identity regulation for ``ready-to-cook poultry products to which
solutions are added''.
DATES: Effective Date: January 1, 2016.
Applicability Date: The regulation that prescribes that the product
name appear with the lower case letters not smaller than one-third (\1/
3\) the size of the largest letter in the product name (9 CFR
317.2(e)(2)(iv) and 381.117(h)(4)) will be applicable on January 1,
2018.
FOR FURTHER INFORMATION CONTACT: Ms. Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery Staff, Office of Policy and Program
Development, FSIS, USDA; Telephone: (301)504-0879.
SUPPLEMENTARY INFORMATION:
Executive Summary
This rule requires a descriptive designation as part of the product
name for raw meat and poultry products that contain added solutions.
The Agency proposed changes to the labeling of these products on July
27, 2011, in response to two petitions that requested that the Agency
prevent consumers from being misled by the on-going marketing of added
solution poultry products.
FSIS, in response to the petitions and after evaluating its
experience in reviewing labels, determined that some added- solution
product labels that follow current labeling guidance and comply with
current regulations are misleading because they do not clearly and
conspicuously show that the product contains an added solution, and
that, without updated labeling regulations that require the conspicuous
labeling of the added solution, consumers likely cannot distinguish
between raw single-ingredient products versus similar raw products
containing added solution.
Under the Federal Meat Inspection Act (FMIA) and the Poultry
Products Inspection Act (PPIA), the labels of meat and poultry products
must be truthful and not misleading, and the labels must accurately
disclose to consumers what they are buying when they purchase any meat
or poultry product. The FMIA and PPIA give FSIS broad authority to
promulgate rules and regulations necessary to carry out the provisions
of the Acts.
To increase consumer awareness of the added solution and the amount
of the added solution in raw meat and poultry products, FSIS proposed
that the common or usual name of the product include the percentage and
the ingredients of the added solution. In addition, the Agency proposed
that the print for all of the words in the name, including the
percentage and ingredients in the solution, appear in a single font
size, color, and style of print and appear on a single-color
contrasting background.
This final rule requires a descriptive designation as part of the
product name, not as part of the common or usual name of the product.
FSIS made this change to make clear that the descriptive designation is
required to be part of the product name but does not need to be on the
same line as the rest of the name. The descriptive designation can be
above, below, or next to the product name (without intervening text or
graphics) on the principle display panel. FSIS also made this change to
make this labeling rule more consistent with the rule concerning the
labeling of mechanically tenderized beef products. This rule adopts all
of the proposed rule's provisions for the listing of the individual
ingredients or multi-ingredient components in the solution in
descending order of predominance by weight, with the clarification that
the added solution percentage must be a number and a percent symbol
(e.g., 15%), and that upper- and lower-case lettering may be used,
provided that the lower-case lettering is not smaller than one-third
(\1/3\) the size of the largest letter in the product name. The
requirements concerning type style, color, and background for the
product name (including the descriptive designation) are consistent
with those in the proposed rule. The final rule also prohibits the use
of the word ``enhanced'' in the product name (including the descriptive
designation) of meat and poultry products containing added solutions
that do not meet a standard of identity.
The final rule will result in one-time costs to establishments and
retail facilities that produce and package raw meat and poultry
products that contain added solutions and that do not meet a standard
of identity. All of the costs pertain to the label modification
procedures for the affected products, and are quantified below.
[[Page 79045]]
Table 1--Summary of Costs and Benefits
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Lower bound Upper bound
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Costs
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Annualized Cost (3% Discount Rate, 10 Year).............................
Annualized Cost (7% Discount Rate, 10 Year).............................
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Benefits
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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 preferences and dietary
needs through the added solutions descriptive designation. 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..................................
More complete label information may help consumers make more
informed decisions leading to an increase in consumer welfare..........
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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. 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 product 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 part 381, subpart N). On July 27, 2011, FSIS published a
proposed rule to amend the meat and poultry regulations to establish a
common or usual name for raw meat and poultry products that contain
added solutions that do not meet a standard of identity (76 FR 44855).
As FSIS explained in the proposed rule (76 FR 44856), the poultry
products regulations include labeling requirements for ready-to-cook,
bone-in poultry carcasses and parts with added solutions that increase
the weight by approximately 3 percent over the raw product after
chilling and washing (9 CFR 381.169). However, since 9 CFR 381.169 was
codified on May 16, 1972 (37 FR 9706), and subsequently amended on
October 7, 1974 (39 FR 36000), poultry processors developed new
technologies that could incorporate more solution into products. In an
effort to keep pace with industry practice and prevent false or
misleading labeling, FSIS issued labeling guidance for raw bone-in
poultry products that contain more than the 3 percent solution
permitted by 9 CFR 381.169, and for boneless poultry products that
contain added solutions. Policy Memo 042, ``Raw Bone-in Poultry
Products Containing Added Solutions,'' (issued February 1982) provided
that solutions may be added to raw bone-in poultry and poultry parts at
various levels if the product name contained an appropriate qualifying
statement. Policy Memo 044A, ``Labeling of Raw Boneless Poultry and
Poultry Parts to Which Solutions are Added,'' (issued September 1986)
provided for the addition of solution at any level to raw boneless
poultry and poultry parts if the addition and the amount of solution
were identified. FSIS also issued Policy Memo 066C, ``Uncooked Red Meat
Products Containing Added Substances,'' (November 2004) to provide
similar guidance for red meat products that contain added solutions.
As discussed in the proposal (76 FR 44856), the intent of the
policy memoranda guidance was to assist industry in developing
truthful, easy-to-read labeling information about the solutions added
to products, so that consumers would be aware of the added solutions
and could make informed purchasing decisions. However, it came to the
Agency's attention from petitions, comments submitted by the public,
and FSIS review of labels, that some product labels are misleading
because they do not clearly and conspicuously identify that the raw
meat or poultry products contain added solution, and that products that
contain added solution have the same product name as products that do
not contain added solution. For example, the name for both a single-
ingredient chicken breast and a chicken breast with added solution is
``chicken breast,'' even though one is 100 percent chicken, and the
other is not. Although the labeling of the product must include a
qualifying statement that reflects the fact that the product contains
added solution, this fact may not be readily apparent to consumers
because the statement is not part of the product name (76 FR 44857).
The petitions discussed in the proposed rule are found at http://www.fsis.usda.gov/wps/portal/searchhelp/sitemap/!ut/p/a0/04_Sj9CPykssy0xPLMnMz0vMAfGjzOINAg3MDC2dDbz8LQ3dDDz9wgL9vZ2dDdx9jfQLsh0VAcILpdM!/?1dmy¤t=true&urile=wcm%3Apath%3A%2Ffsis-content%2Fobsolete-archives%2Fproposed-rules%2Ffederal-proposed-rules-archive-2011.
Therefore, to ensure that labels adequately inform consumers that
those 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 proposed to establish a common or usual name for such raw
products. FSIS proposed 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.
After the publication of the proposed rule, the Agency received a
letter requesting a 60-day extension of the comment period, and the
information, data, and evidence the Agency
[[Page 79046]]
considered in developing the proposed rule. On November 8, 2011, in
response to the request to extend the comment period, the Agency
reopened the comment period for 60 days (76 FR 69146). The Agency's
letter responding to the request for additional information, including
links to data and specific labels of concern is posted on its Web site
at http://www.fsis.usda.gov/wps/wcm/connect/cf80e9a5-7e39-470f-90c9-0911402268b0/2010-0012_Response_to_AMI_508.pdf?MOD=AJPERES.
After review and consideration of all the comments submitted, FSIS
is amending and clarifying the July 2011 proposed amendments. As is
explained above, this rule is necessary because we have found that
under current regulations, some product labels are misleading because
they do not clearly and conspicuously identify to consumers that the
raw meat or poultry products contain added solution. Therefore under,
this final rule, such labels would be misbranded.
In response to comments, rather than requiring the added solution
information as part of the common or usual name, the final rule
requires a product name with a descriptive designation that clearly
indicates that the product contains added solutions. The descriptive
designation will need to appear as part of the product name on the
principal display panel and may be above, below, or next to the product
name (without intervening text or graphics).
All of the print and color requirements in the final rule, i.e., a
single easy-to-read type style and color and single-color contrasting
background are consistent with those from the proposed rule and are
applicable to the product name and the descriptive designation.
However, in the final rule, FSIS made changes to the regulatory text to
clarify that the percentage of added solution must be represented by a
number and a percent symbol (e.g., 15%), not words (e.g., fifteen
percent), and provide that upper and lower case lettering may be used
for the in the product name, provided that the lower case lettering is
not smaller than one-third (\1/3\) the size of the largest letter. Some
added solution product labels may comply with current guidance for the
labeling these products (Policy Memorandum 042, ``Raw Bone-In Poultry
Products Containing Solutions;'' Policy Memorandum 044A, ``Raw Boneless
Poultry Containing Solutions;'' and Policy Memorandum 066C, ``Uncooked
Red Meat Products Containing Added Substances''). The labeling guidance
provides that added solution statements must be one-fourth (\1/4\) the
size of the largest or most prominent letter in the product name. To
reduce costs to establishments that produce added solutions products,
the applicability date for the one-third (\1/3\) size requirement for
the descriptive designation is January 1, 2018.
The Agency is also providing for the use of the words
``containing'' or ``contains'' (e.g., ``containing 15% added solution
of water and salt'') and prohibiting the use of the word ``enhanced''
in the product name (including the descriptive designation) of meat and
poultry products containing added solutions that do not meet a standard
of identity. The amendments and clarifications are discussed in further
detail below in the summary of and response to comments.
Summary of and Response to Comments
FSIS received a total of 889 comments. These were from consumers; a
coalition representing poultry producers and consumers; consumer
advocacy organizations; health organizations; dieticians; State and
county departments of agriculture, weights and measures; trade
associations that represent meat and poultry processors; an association
of agricultural commissioners and sealers; a trade association that
represents ingredient manufacturers; a trade association that
represents food retailers and wholesalers; and poultry, beef, and pork
products manufacturers. The majority of comments were identical form
responses submitted electronically by individuals that identified their
organization as the coalition of poultry producers and consumers or one
of the poultry producers that belong to the coalition.
A. General Support for the Proposed Common or Usual Name Requirements
The majority of comments generally supported the proposed
amendments. Many commenters agreed that the current labels for meat and
poultry products containing added solutions are misleading. Many
commenters stated that the current solution statement is too small to
read, and that other claims or statements on the product label make it
difficult for consumers to differentiate between single-ingredient
products and those with added solutions. One meat association
acknowledged that containing statements can appear in fonts that are
tall, slanted, and difficult to read. Many commenters stated that
product labels should be truthful, clear, easy to read (e.g., clear
font, size, color, and style), and easily understandable, so that
consumers can compare products and make informed choices. These
commenters stated that the proposed regulations accomplish these goals.
Additionally, these commenters stated that the proposed regulations
would ensure fair competition among retailers and manufacturers.
B. Opposition to the Proposed Common or Usual Name Requirements
Comment: Several commenters stated that the petitions submitted by
the Truthful Labeling Coalition (TLC) (with attached research studies)
and the California Agriculture Commissioners and Sealers Association
(CACSA) did not support the need for the proposed amendments, and that
the research was limited and not compelling.
Response: FSIS acknowledged in the proposed rule that findings
included in the TLC petition were not generalizable but constituted
anecdotal evidence that consumers read and use labels (76 FR 44857).
The Sorensen Associates Research, included with the TLC petition, found
that consumers of ``enhanced'' chicken products were not aware that the
``enhanced'' product contained additives until they were specifically
directed to look at the label. Even after looking at the label, nearly
1 out of 5 ``enhanced'' chicken buyers didn't realize that the chicken
contained additives. The CACSA petition stated that in 2006, California
Weights and Measures officials conducted a study that indicated that
consumers, because they pay for the solution added to products, pay an
estimated $246 million for the added solution in California alone.
CASCA then estimated, assuming that California has an approximate
market share of 12 percent, that the impact to consumers nationwide is
projected at $2 billion annually. Also, information from FSIS's
Labeling and Program Delivery Staff's (LPDS), formerly the Labeling and
Program Delivery Division (LPDD), review of labels and compliance
activities indicated that some product labels do not clearly and
conspicuously identify that the raw meat or poultry products contain
added solution even though they meet current regulatory requirements
and follow current guidance. The findings, projected costs from the
CACSA petition, and label approval and compliance information were the
best data available to the Agency.
Comment: Several meat and poultry companies argued that the
proposed requirements would obscure the identity of the meat or poultry
component of their products and submitted labels to illustrate this
point.
[[Page 79047]]
Two companies conducted consumer surveys to compare consumer
understanding of labels that meet the current labeling requirements
versus those that meet the proposed labeling requirements. The two
companies stated that the surveys demonstrated that consumers preferred
the current added-solution product labeling to the proposed required
labeling.
One consumer survey compared a current meat with added solution
label with a meat with added solution label meeting the proposed
requirements. The results of the 66 respondent survey showed that the
79 percent of respondents agreed that the ``current'' label and the
``proposed'' label were ``easy to understand.'' The results also showed
that eighteen percent of the panelists responded that the current label
``could be confusing,'' in comparison with twenty-three percent of the
respondents that stated the proposed label was ``confusing'' (a five
percent increase).
The other consumer survey was conducted online with a panel of 857
respondents. The overall results of this survey showed that 65 percent
of the respondents preferred the current ``large'' font size label.
Response: The majority of the label examples submitted to
illustrate that the proposed amendments would obscure the identity of
the meat or poultry component of their products did not accurately
reflect the proposed requirements. The common or usual names included
superfluous text (e.g., ``tenderness and juiciness improved''), spelled
out percentages (e.g., ``twelve percent''), and contained only
uppercase letters.
The one consumer survey did not accurately represent the proposed
requirements, and the ``current'' label's containing statement was
considerably larger than the \1/4\ size provided in labeling guidance
and, therefore, may have been more conspicuous to survey participants
than product labels currently available at retail.
Another consumer survey, conducted online, did not offer
respondents labels that accurately represented the current labeling
guidance versus the proposed labeling requirements. The company
presented two versions of four different added solution product labels,
fresh chicken breast, frozen chicken wing sections, pork loin, and
beef. Respondents were asked to compare the labels that meet the
current labeling guidance with the labels that meet the proposed
requirements. Three of the four current labels appeared to have
containing statements larger than the minimum of \1/4\ size permitted
under the current regulation (9 CFR 381.169) and labeling guidance. The
containing statement on three of the four labels that represented the
proposed requirements is in upper case letters, which is not a proposed
requirement. FSIS proposed to require the added solutions statement in
the common or usual name. However, in response to these comments, the
Agency is amending this final rule to provide that a descriptive
designation that clearly indicates that the product contains added
solution will be required on the label as part of the product name, but
not as a part of the common or usual name. In addition, the product
name (including the descriptive designation) may appear in upper and
lower case letters, with the lower case letters not smaller than one-
third (\1/3\) the size of the largest letter (9 CFR 317.2(e)(2)(iii)
and 381.117(h)(3)). Current labeling guidance for added solutions
statements provide for a one-fourth (\1/4\) size requirement in
comparison to the largest letter in the product name. However, the one-
third (\1/3\) size requirement is based on several regulatory
requirements (9 CFR 319.104 and 319.105) and is consistent with the
requirements in the Descriptive Designation for Needle- or Blade-
Tenderized (Mechanically Tenderized) Beef Products final rule.
FSIS is also amending this final rule to require that the percent
solution must appear as a number (such as, 15, 20, 30) and the percent
symbol (%) (9 CFR 317.2(e)(2)(i) and 381.117(h)(1)). These amendments
will ensure that the descriptive designation is easy to recognize and
understand, and that the meat or poultry component of the product is
not obscured. Also, the product name (including the descriptive
designation) must be printed in a single easy-to-read type style and
color and must appear on a single-color contrasting background, which
will ensure the overall prominence of the descriptive designation on
the label (9 CFR 317.2(e)(2)(v) and 381.117(h)(5)).
Examples of labels that met the proposed labeling requirements were
included in the proposed rule (76 FR 44860 and 44861). Label examples
are included again in this final rule as guidance (Figures 1, 2, and
3). The label in Figure 1 is an example of a product with a descriptive
designation that includes a multi-ingredient component. The ingredients
of the component are not declared in the descriptive designation but
are declared in a separate ingredients statement along with all of the
ingredients in the product (9 CFR 317.2(e)(2)(iii) and 381.117(h)(3)).
The label in Figure 2 is an example of a product with a descriptive
designation that includes the term ``contains'' and lists the
individual ingredients in the added solution in descending order of
predominance by weight (9 CFR 317.2(e)(2)(i), 317.2(e)(2)(ii),
381.117(h)(1), and 381.117(h)(2)). The label in Figure 3 is an example
of a descriptive designation that includes the term ``flavored with''
and lists the individual ingredients in the solution in descending
order of predominance by weight (9 CFR 317.2(e)(2)(ii) and
381.117(h)(2)).
Comment: One commenter agreed that it is important to inform
consumers when differences exist between single-ingredient raw meat and
poultry products and similar raw meat and poultry products containing
added solutions, but it did not agree with establishing a common or
usual name to describe these differences. The commenter stated that
there should be a general common or usual naming convention for all
meat and poultry products. In addition, the commenter stated the
proposed requirements would change the product names and ingredient
declarations of secondary products in which these added solution
products are used, resulting in complicated naming conventions for
ordinary foods and expanding ingredient declarations.
Response: The intent of this rule is to ensure that consumers have
specific, clear, and conspicuous information about the percentage of
added solution. As discussed above, although FSIS proposed to require
that the percentage and ingredients of the added solution as part of
the common or usual name, in response to comments, in this final rule,
FSIS is requiring a descriptive designation as part of the product
name, consistent with prior labeling guidance FSIS has provided in
Policy Memoranda. The declaration of the secondary product's name and
the product's ingredients will continue to follow the applicable
labeling regulations.
C. Comments Opposed to Removing Ready-To-Cook Poultry Products
Regulatory Requirements (9 CFR 381.169) and Rescinding Policy Memoranda
for Products With Added Solutions
Comment: Several commenters opposed removing the regulatory
requirements and policy guidance for products with added solutions (9
CFR 381.169; Policy Memorandum 042, ``Raw Bone-In Poultry Products
Containing Solutions;'' Policy Memorandum 044A, ``Raw Boneless Poultry
Containing Solutions;'' and Policy Memorandum 066C, ``Uncooked
[[Page 79048]]
Red Meat Products Containing Added Substances''). These commenters were
specifically concerned about removing the requirement in 9 CFR
381.169(a) that states that the added materials shall increase the
weight of the poultry product by approximately 3 percent over the
weight of the raw product, and the policy guidance limiting the amount
of solution used in products labeled with the terms ``basted,''
``marinated,'' or ``for flavoring,'' because removing these provisions
would result in the unbridled addition of solutions. The commenters
also objected to removing the regulatory requirement in 9 CFR
381.169(c) for processors to control the finished product within a
range of three-tenths of 1 percent accuracy, using an approved plant
control procedure.
Response: As discussed above, FSIS explained in the proposed rule
(76 FR 44856) that after the regulation for ready-to-cook, bone-in
poultry (9 CFR 381.169) was codified and amended in the 1970's, poultry
processors developed technologies, such as injecting solutions deep
into muscle tissue, that increased the amount of solution that could be
incorporated into products. Therefore, to provide labeling guidance for
ready-to-cook, bone-in poultry products that contained more than the
approximate 3 percent added solution and ready-to-cook, boneless
poultry products with added solution, the Agency issued Policy
Memoranda for the industry to develop truthful, easy-to-read labeling
information so that consumers could make informed purchasing decisions.
The Agency also later issued labeling guidance for raw red meat
products with added solutions. The regulatory requirements provided in
9 CFR 381.169(c) for processors to control the finished product within
a specified range are only applicable to ready-to-cook, bone-in poultry
products with approximately 3 percent added solution. Raw meat and
ready-to-cook, boneless poultry products that contain added solutions,
and ready-to-cook, bone-in poultry products that contain more than
approximately 3 percent added solution follow the labeling guidance
provided in the Policy Memoranda.
FSIS does not believe, and the comments did not provide any
evidence, that the terms ``marinated,'' ``basted,'' and ``for
flavoring,'' provided in Policy Memoranda imply to today's consumers a
specific level of added solution in the product. This final rule
establishes consistent regulatory requirements for a descriptive
designation as part of the product name for all raw meat and poultry
products containing added solutions that do not have a standard of
identity (9 CFR 317.2(e)(2) and 381.117(h)), regardless of the amount
of solution or other information provided on the label. For this
reason, the requirements in 9 CFR 381.169 are no longer needed, and
will be deleted with this final rule. In addition, when this rule
becomes effective, FSIS will eliminate the Policy Memoranda that
provides labeling guidance for meat and poultry products with added
solutions. The terms ``marinated,'' ``basted,'' ``for flavor,'' and
``flavored with,'' may be used with any level of solution, provided
that the product labeling contains a descriptive designation. The final
rule includes an example of added solution product label (Figure 3)
that uses the term ``flavored with'' in the descriptive designation.
Comment: The commenters that opposed removing 9 CFR 381.169 and the
FSIS Policy Memoranda for products with added solution wanted the
Agency to retain the requirement of the method of solution introduction
and the function of the added materials. In addition, approximately 133
comments that had been submitted as part of a write-in campaign stated
that FSIS should require that the method by which solutions are added
to the product be included in the product name.
Response: As discussed above, FSIS is deleting 9 CFR 381.169
because it contains regulatory requirements that are outdated and
inconsistent with industry practice. Also, FSIS has never required the
method of addition or function of the added solution in the labeling of
meat products or boneless poultry products. Companies use various
methods to add solutions to meat and poultry products, and the
solutions can have various functions. The Agency does not have any data
suggesting that including the method of addition and function of the
added solution in the product name provides useful information to
consumers. Therefore, FSIS has concluded that the product name does not
have to refer to the method of addition or the function of the added
solution.
Comment: Some commenters were concerned that when Policy Memorandum
066C, ``Uncooked Red Meat Products Containing Added Substances,'' is
rescinded, it will eliminate the limit on the addition of enzyme
solutions (3 percent) to meat products.
Response: The 3 percent limit for tenderizing solutions is a
regulatory requirement (9 CFR 424.21 and 381.87(b)(25)) that is not
affected by this final rule.
Comment: Several commenters stated that many products with added
solutions currently in the marketplace do not meet regulatory
requirements or comply with labeling guidance. The commenters stated
that the LPDS should be reviewing and ensuring the accuracy of labels
during label review.
Response: The LPDS reviews labels that are submitted to ensure
compliance with the labeling regulations in 9 CFR parts 317 and 381.
However, as provided by 9 CFR 412.2, FSIS authorizes establishments to
use generically approved labels without submitting them for approval.
Generically approved labels must bear all applicable mandatory labeling
features in a prominent manner in compliance with part 317 or part 381,
and is not otherwise false or misleading. Inspection program personnel
periodically review products with these labels to ensure compliance
with labeling requirements. When the LPDS receives a labeling complaint
and determines that a label is false or misleading, FSIS contacts the
company and advises it to make corrections. If the company does not
make corrections, FSIS may rescind or refuse label approval under 9 CFR
500.8, ``Procedures for Rescinding or Refusing Approval of Marks,
Labels, and Containers.''
D. Use of the Term ``Enhanced''
Comment: Several commenters stated that FSIS should not allow the
use of the term ``enhanced'' in the product name of raw meat or poultry
products that contain added solutions. These commenters stated that the
term ``enhanced'' suggests the meat is a higher quality or that the
meat has been improved by added solutions when it actually may contain
increased levels of sodium, which is a concern for consumers trying to
limit their sodium intake. These commenters also asserted that the word
``contains'' does not imply a judgment about the product. One commenter
recommended that FSIS prohibit the use of the word ``enhanced'' (or
similar terms) anywhere on products containing added solutions.
One commenter argued that the term ``enhanced'' should be permitted
because the added solution results in a product that is juicier and has
an improved value, quality, desirability, and attractiveness over non-
enhanced products.
Response: FSIS agrees that the term ``enhanced'' suggests that the
product has been increased or improved in value, quality, desirability,
or attractiveness, based on the Merriam-
[[Page 79049]]
Webster dictionary definition.\1\ A product with added solution may or
may not be ``juicier'' when consumed, depending on the way it is cooked
or used. Whether or not a product with added solution is of improved
value, quality, desirability, or attractiveness is dependent on
individual preference. FSIS stated in the proposed rule that it
recognized that the term ``enhanced'' could imply a judgment about the
value of the product; for this reason, the Agency did not propose to
include the term ``enhanced'' in the common or usual name for products
containing added solutions (76 FR 44858). The Agency has concluded the
term ``enhanced'' is not appropriate in the product name (including the
descriptive designation) for raw meat and poultry products containing
added solution and is stating in the regulatory text that the term
``enhanced'' must not be used in the product name of meat and poultry
products containing added solutions that do not meet a standard of
identity. The term ``enhanced,'' however, can be used elsewhere on the
label, e.g., in a starburst, or in advertising language.
---------------------------------------------------------------------------
\1\ http://www.merriam-webster.com/dictionary/enhance.
---------------------------------------------------------------------------
The Agency agrees that the word ``contains'' does not imply a
judgment about the product, and, to provide additional clarification
and flexibility to producers, FSIS is clarifying in this final rule
that the words ``containing'' or ``contains'' may be used in the
descriptive designation of raw meat and poultry products containing
added solutions, e.g., ``containing 15% Added Solution of Water and
Salt,'' or ``contains 15% Added Solution of Water or Teriyaki Sauce.''
Other terms that may be used in the descriptive designation include
``basted'' or ``marinated,'' as listed in the foregoing sections.
E. Comments on Sodium and Salt
Comment: Many commenters expressed the opinion that the current
labeling of products with added solutions does not sufficiently alert
consumers to the fact that the products contain added solutions, or the
fact that salt is almost always included in the added solutions. One
commenter recommended that the labels of products with added salt and
sodium solutions contain a disclosure statement such as ``Contains
SALT: See sodium content on the Nutrition Facts Panel.'' Another
commenter recommended that a similar statement be displayed on raw,
partially-heat treated, and fully cooked meat and poultry products with
added solutions.
However, other commenters indicated that the appropriate place for
nutrition information, and where consumers will look for that
information, is the Nutrition Facts panel. Additionally, some
commenters stated that the proposed amendments would provide improved
consumer awareness of the added ingredients, and that consumers would
look at the ingredients statement for ingredients of concern, such as
salt.
Response: FSIS agrees that the Nutrition Facts panel is the
appropriate place for the sodium content to be displayed and is where
consumers will look for that information. This conclusion is supported
by the 2010 Food and Health Survey conducted by the International Food
Information Council (IFIC) Foundation,\2\ which found that 68 percent
of consumers use the Nutrition Facts panel to obtain nutrition
information. Additionally, the survey reported that, when asked which
specific elements consumers use on the Nutrition Facts panel, 63
percent of consumers mentioned the statement of sodium content. FSIS
also agrees that the proposed amendments will alert consumers to
products containing added solutions, and that, being so alerted,
consumers are likely to look at the Nutrition Facts panel and the
ingredients statement where all ingredients must be listed.
---------------------------------------------------------------------------
\2\ Available at http://www.foodinsight.org/Content/3651/2010FinalFullReport.pdf.
---------------------------------------------------------------------------
F. Comments on Fully-Cooked or Partially Heat-Treated Products
Containing Added Solutions
Comment: A few commenters stated that FSIS should establish common
or usual name requirements for non-standardized fully-cooked or
partially-heat treated products that contain added solutions. One of
the commenters argued that consumers need this information to make
informed choices, because consumers will not be aware that a solution
was added that could make up a significant portion of the product
weight or contain significant amounts of other ingredients.
Other commenters stated that FSIS should not establish a common or
usual name for non-standardized fully cooked or partially-heat treated
products that contain added solutions. The commenters stated that
consumers understand that fully cooked or partially heat-treated
products are not single-ingredient products, and that the required
qualifiers, e.g., ``Breaded,'' ``Coated,'' and ``Glazed,'' alert
consumers to any added ingredients in the products or that the products
have been further processed in some way. One commenter expressed
concern that it would not be appropriate to require that the common or
usual name for these types of products include a listing of
ingredients. One commenter suggested that FSIS, in the regulatory text,
specifically exclude these products.
Response: FSIS agrees with the commenters that non-standardized
fully-cooked or partially heat-treated products, which are typically
breaded, coated, and glazed, are obviously not single-ingredient
products, and that consumers understand that these products may contain
ingredients that affect the products' weight. These commenters support
the Agency's tentative conclusion, stated in the proposed rule (FR 76
44858), that consumers are unlikely to be misled into thinking that
non-standardized fully cooked or partially-heated treated products that
contain added solutions are single-ingredient products.
The regulatory text clearly states that the requirements are for
raw meat and poultry products that contain added solutions and that do
not meet a regulatory standard (9 CFR 317.2(e)(2) and 381.117(h)).
Therefore, the Agency sees no need to add regulatory text to exclude
fully-cooked or partially-heat treated products that contain added
solutions.
G. Comments on Retail Labeling of Products With Added Solutions
Comment: A trade association that represents food retailers and
wholesalers commented that the proposed rule would impose a burden on
the supermarket industry. The association stated that retailers would
be affected directly because it is not feasible to calculate marinade
absorption rates at the retail level because they do not operate in the
same manner as a Federal establishment and do not have precise
marination times, temperatures, or solution composition; that retail
signage would have to be altered; and that retailers would have to
redesign labels at a very significant cost. The trade association also
stated that the $1,557 per label cost estimate was too low.
Response: As discussed in the proposed rule (76 FR 44859), 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)). Therefore, these
regulations 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
[[Page 79050]]
processing. Retail stores must comply with amendments in this final
rule, including determining marinade absorption rates, redesigning
labels, and altering retail signage.
FSIS requested comment on the number of retail facilities that
produce product containing added solution and the volume of such
product that would be subject to the proposed requirements (76 FR
44862). The Agency did not receive any comments addressing the number
of facilities or the volume of product produced at retail. As discussed
in the ``Cost and Benefits'' section below, to acquire a better cost
estimate, the Agency utilized the March 2011 FDA labeling cost model
and contracted for an expert elicitation on the market shares for raw
meat and poultry products containing added solutions, including
products produced at retail, and has adjusted the per-label cost
estimate to $310 per label for a coordinated minor change and $4,380
for an uncoordinated minor change. The expert elicitation concluded
that very few products containing added solutions are produced at
retail establishments (<5%). FSIS believes the revised label change
cost, provided from the March 2011 labeling cost estimate, is a
superior estimate as it represents the most detailed study available on
the costs associated with labeling of consumer products. FSIS included
the expected costs borne by the retailers in the final estimate.
H. Use of the Term ``Natural''
Comment: Numerous consumers commented that products with added
solutions should not be labeled as ``natural.'' Several commenters
wanted FSIS to take immediate action or quickly move forward on a
proposed rule.
Response: Products with added solutions may meet the current FSIS
labeling policy guidance for the term ``natural'' if (1) the product
does not contain any artificial flavor or flavoring, coloring
ingredient, or chemical preservative (as defined in 21 CFR 101.22), or
any other artificial or synthetic ingredient; and (2) the product and
its ingredients are not more than minimally processed (the practice of
marinating or tenderizing products prior to consumption is a minimal
process).
The Agency is developing a proposed rule to define the ``natural''
claim in response to comments received on the 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).
I. Compliance Date and Label Review Time
Comment: One commenter stated that the proposed January 1, 2014,
compliance date was excessive and unnecessary. The commenter believed
that immediate action should be taken, and that the effective date of
the final rule could be 30-60 days after publication of the final rule
because labeling changes can be easily implemented by industry at a
minimal cost.
Another commenter stated that processors need ample time to get
through their label inventories and requested that the status of
products in-commerce on the effective date of the final rule be
clarified by the Agency.
Response: The January 1, 2014, uniform compliance date was
applicable for meat and poultry product labeling final rules published
between January 1, 2011 and December 31, 2012. On December 31, 2012,
FSIS published a final rule establishing January 1, 2016, as the
uniform compliance date for meat and poultry product labeling
regulations issued between January 1, 2013, and December 31, 2014 (77
FR 76824). Therefore, the effective date of this final rule is January
1, 2016. However, as discussed above, the Agency is providing an
applicability date of January 1, 2018 for the one-third (\1/3\) type
size requirement for the descriptive designation to provide additional
time and flexibility for establishments to make labeling changes. Based
on current guidance for the labeling of these products, many
establishments likely use one-fourth (\1/4\) type size for the
descriptive designations or qualifying statements for products with
added solutions. Establishments may continue to do so until January 1,
2018.
Comment: Several commenters expressed concern that the proposed
amendments would overly burden the Agency's label approval process,
especially since the proposed labeling changes could not be generically
approved within the parameters of 9 CFR 317.5 and 381.133.
Response: On November 7, 2013, FSIS published the final rule,
``Prior Label Approval System: Generic Label Approval'' (78 FR 66826)
that expands the circumstances in which FSIS generically approves meat
and poultry labels. The labels of meat and poultry products containing
added solutions can be generically approved, i.e., the labels do not
have to be submitted to FSIS for approval, provided that they display
all mandatory features in a prominent manner in compliance with part
317 or part 381, and are not otherwise false or misleading in any
particular (9 CFR 412.2). In addition, in May 2012, the Agency launched
the Label Submission and Approval System (LSAS). The LSAS will have a
significant impact on the speed and accuracy of label review.
J. Comments on Costs and Benefits of the Proposal
Comment: A number of commenters suggested that FSIS underestimated
the costs to the industry of the proposed amendments and did not
accurately identify the proportion of products with added solution in
the marketplace.
Response: FSIS used the more up-to-date model \3\ from the
secondary cost analysis in the proposed rule to estimate the cost of
label changes for the industry. Although a few commenters provided
additional cost estimates for label plates, FSIS did not receive any
additional numbers that contradict the cost estimates presented in the
proposed rule. FSIS continues to believe that these cost estimates are
accurate because they represent the most detailed study available on
the costs associated with the labeling of consumer products.
---------------------------------------------------------------------------
\3\ 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).
---------------------------------------------------------------------------
In the proposed rule, FSIS estimated that the proportion of
products containing added solutions to be about 39 percent of all raw
meat and poultry products sold (76 FR 44862). This percentage was based
on FSIS's label review process estimates and the pounds of poultry,
beef, and pork consumed by households. The sources cited for the pounds
of poultry, beef, and pork consumed by household were the U.S. Poultry
& Egg Association: Poultry Statistics, 2007; the Economic Research
Service, USDA, U.S. Beef and Cattle Industry: Background Statistics and
Information, 2007; and the National Pork Producers Council: Background
Statistics and Information, 2007. However, the source of the
information for the pounds of poultry, beef, and pork consumed by
households should have been ``Livestock, Dairy, and Poultry Outlook,''
Dec. 17, 2009. The proposed rule also stated that the number of pounds
of poultry consumed by households was 49.2 billion (76 FR 44862), that
number, based on the corrected source information, should have been
42.7 billion pounds.
For a better estimate of the amount of product with added solution
purchased, FSIS contracted for an expert elicitation on the market
shares for raw meat and poultry products containing added
[[Page 79051]]
solutions. The results of that elicitation showed that the amount of
product with added solution purchased is approximately 60 percent of
the total. The cost analysis in this final rule uses this market share
analysis.
Comment: A number of commenters suggested that the costs associated
for the rule would be borne by the consumer in a time of economic
uncertainty. Conversely, a number of commenters also suggested that
consumers unfairly pay a premium price for products with added
solutions. Some commenters suggested that this rule will place products
with added solutions at a competitive disadvantage to products without
the solution.
Response: The overall impact of the final rule on costs to the
consumer is expected to be minimal. The estimated additional cost per
package is between $0.0013 and $0.003. Thus, the increase in cost of
buying two packages per week is between $.13 and $0.36 per year, and
the consumer will only pay a portion of the this cost based on the
relative elasticity of demand. Given the high elasticity of demand for
this product because of the availability of close substitutes, the
minimal cost imposed may be borne more by the producers than the
consumers.
FSIS has no data to determine that this rule places products with
added solutions at a competitive disadvantage to products without the
solution and has no evidence to suggest that the market for these
products will be adversely impacted.
Comment: One commenter suggested that the current labeling
practices will result in higher health care costs.
Response: This rule does not provide new nutrition information.
FSIS did not quantify the health care costs and benefits of this rule.
K. Miscellaneous Comments
Comment: One commenter recommended that all of the proposed
requirements apply to meat and poultry products that meet standards of
identity.
Response: As explained in the preamble to the proposed rule, under
this 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 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 would need to
be labeled with a descriptive designation.
Standard of identity regulations provide requirements for added
solutions for standardized products. Therefore, consumers likely
understand and are aware that products with a standard of identity,
such as corned beef or poultry roast, include solutions. The intent of
this final rule is to eliminate confusion between single-ingredient
products and those similar types of products that contain additional
ingredients and solutions. Therefore, the Agency will not include
products with a standard of identity in this rulemaking.
Comment: FSIS received numerous comments on an array of issues
including: Country of origin labeling for all meat, poultry, fruits,
and vegetables; the labeling of genetically modified foods; organic
claims; concerns over raising conditions of animals and the use of
hormone implants; pesticides and herbicides; mandatory nutrition
labeling for liquor products; mandatory declaration of potassium and
phosphorus in the Nutrition Facts panel; healthy eating; and nutrition
education.
Response: These comments are outside the scope of this rulemaking.
Compliance With This Final Rule
To facilitate Agency verification of compliance with regulatory
labeling requirements, FSIS requires that establishments make labeling
records available to any authorized USDA official upon request (9 CFR
320.4). Inspection program personnel will perform labeling verification
activities to ensure that establishments are complying with the
requirements of this final rule. FSIS also performs verification and
post-market surveillance activities in-commerce to ensure that meat and
poultry product labels comply with all applicable regulations. The
Agency will provide guidance on its Web site to assist establishments
in meeting the requirements in this final rule. Figures 1 and 2 (below)
are examples of labels of pork product containing added solutions and
Figure 3 (below) is an example of poultry product containing added
solution, all three examples meet the labeling requirements of this
final rule.
BILLING CODE 3410-DM-P
[[Page 79052]]
[GRAPHIC] [TIFF OMITTED] TR31DE14.000
[[Page 79053]]
[GRAPHIC] [TIFF OMITTED] TR31DE14.001
[[Page 79054]]
[GRAPHIC] [TIFF OMITTED] TR31DE14.002
[[Page 79055]]
BILLING CODE 3410-DM-C
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. This final rule has been reviewed under E.O. 12866. The
Office of Management and Budget (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 OMB.
The final rule will apply to all in-commerce raw meat and poultry
products containing added solution that do not meet a standard of
identity. The labeling requirements would apply to such products that
are produced at federal establishments, retail facilities, such as
grocery stores, and products produced in countries deemed equivalent
under 9 CFR 327.2 and 381.196.
FSIS updated the Regulatory Impact Analysis to take into account
recently updated source data and modified timelines for implementation
of the final rule. The changes to the costs and benefits sections
incorporate the following factors:
Information Resources, Inc., (IRI) scanner data was used
to calculate the number of raw meat and poultry products in the retail
market and the number of private and branded products. IRI gathers data
by scanners in supermarkets, drugstores, and mass merchandisers and
maintains a panel of consumer households that record purchases at
outlets by scanning UPC codes on the products purchased.
FSIS used the FDA March 2011 labeling cost model \7\ from
the secondary cost analysis in the proposed rule to estimate the cost
of label changes for the industry. FSIS believes the FDA March 2011
labeling cost model represents the most detailed study available on the
costs associated with labeling of consumer products and reflects more
recent data than the primary analysis used in the proposed rule, and
therefore is used in the final rule.
---------------------------------------------------------------------------
\7\ FDA March 2011 labeling cost model: A copy of the document
is available in the FSIS Docket Room, Patriots Plaza 3, 355 E.
Street SW., Room 8-164, Washington, DC 20250-3700.
---------------------------------------------------------------------------
In response to the change in compliance period when
calculating the relabeling cost, FSIS adjusted the percentage of
coordinated and uncoordinated label changes.
Need for the Rule
Under FSIS's current regulatory approach, some raw products are not
conspicuously identifying that they contain added solution. A survey
\8\ submitted during the comment period found that only 40 percent of
all consumers are aware that the products they purchase may contain
added solutions, and therefore, FSIS assumes that current regulations
are insufficient to fully inform consumers about the nature of the
product they purchase. It is important for consumers to have readily
available information on meat and poultry products with added solutions
as 87 percent of chicken purchasers care if their chicken contains
additives (Sorensen, November 2004).\9\ Fifty-four percent of the
respondents in this study indicated they felt deceived at the
disclosure that some chicken products include additives and 10 percent
indicated they felt angry. This research has some limitations such as
no reported peer review and some methodological weakness. The research
did not provide information on response rate or sample selection which
could contribute to survey bias. On the other hand, this study is
strengthened by the diversity of the six primary sampling units \10\
and a significant sample size; moreover, its results are similar to
those of other consumer studies.\11\
---------------------------------------------------------------------------
\8\ Label Contaminant Statement Package Test: Study Results,
Prepared for: Tyson Foods, Inc. by Lunt Associates. Question 10. May
2011.
\9\ ``Enhanced'' Chicken, Consumer Research, November 2004, SAI
Project 04177, Sorensen Associates, Minneapolis, Minnesota (888-616-
0123), Portland, Oregon (800-542-4321).
\10\ The research in the Sorensen Study was conducted in six
primary sampling units; Atlanta, Chicago, San Francisco, Kansas
City, Dallas and Seattle.
\11\ Label Contaminant Statement Package Test: Study Results,
Prepared for: Tyson Foods, Inc. by Lunt Associates. May 2011.
---------------------------------------------------------------------------
FSIS, in response to stakeholder petitions and after evaluating its
experience in reviewing labels, determined that some added-solution
product labels that follow current labeling guidance and comply with
current regulations are misleading because they do not clearly and
conspicuously show that the product contains an added solution, and
that, without updated labeling regulations that require the conspicuous
qualifying statement, consumers likely cannot distinguish between raw
single-ingredient products versus similar raw products containing added
solution. A market failure exists when raw products with added
solutions are misbranded and information is not readily available for
the consumer. This market failure results from inadequate information
in misbranded products and information asymmetry between producers and
retail consumers and leads to suboptimal equilibrium quantities for
both products containing solutions and products not containing
solutions because consumers cannot readily identify the differences
between the two groups. 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 breast and one may be
60 percent chicken breast and 40 percent solution. The new regulation
presented in the final rule addresses the market failure by requiring
that all labels for these types of products provide clear and
conspicuous labeling.
Baseline
FSIS contracted for an expert elicitation on the market shares for
raw meat and poultry products containing added solutions (February 2012
report).\12\ The February 2012 report, using FSIS data on the number of
establishments that produce each type of product by species and
establishment size and the 2010 total volume,\13\ provided estimates of
numbers of establishments that produce products with added solutions
only (i.e., without mechanical tenderization) and establishments that
produce mechanically tenderized products with added solutions and
estimates of the total volume of these products.
---------------------------------------------------------------------------
\12\ Expert Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and Mechanically
Tenderized Raw Meat and Poultry Products. Final Report. Research
Triangle Institute. February 2012. Available at: http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.
\13\ FSIS data estimated the 2010 total volume by multiplying
slaughter volumes by average carcass weights.
[[Page 79056]]
Table 1--Estimated Number of Establishments That Produce Each Type of Product by Species and Establishment Size \14\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Species Product Very small Small Large Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beef........................................... Containing added solutions only \15\... 181 218 21 420
Mechanically tenderized with added 251 218 21 490
solutions.
Pork........................................... Containing added solutions only........ 285 439 34 758
Mechanically tenderized with added 256 293 27 576
solutions.
Lamb and Goat.................................. Containing added solutions only........ 24 29 0 53
Mechanically tenderized with added 35 34 0 69
solutions.
Chicken........................................ Containing added solutions only........ 282 371 131 784
Mechanically tenderized with added 267 346 116 729
solutions.
Turkey......................................... Containing added solutions only........ 80 123 21 224
Mechanically tenderized with added 75 127 21 223
solutions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Establishments may produce multiple types of products and species and, therefore, may be represented in more than one row of the table.
The February 2012 report also provided updated estimates for the
proportion of products containing added solutions. The preliminary
regulatory impact analysis estimated that the proportion of products
containing added solutions was 39 percent (76 FR 44855-44865). Based on
the findings of the February 2012 report, FSIS estimates that
approximately 60 percent of all raw meat and poultry products sold
contain added solutions. The proportions and volumes for specific
product classes are found in Table 2.
---------------------------------------------------------------------------
\14\ Expert Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and Mechanically
Tenderized Raw Meat and Poultry Products. Final Report. Table 3-11
and 3-16. Available at: http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.
\15\ The expert elicitation report referred to products
``containing added solutions'' as ``enhanced.''
Table 2--Proportion of Raw Products Containing Added Solutions in Millions of Pounds by Species
----------------------------------------------------------------------------------------------------------------
Estimated
Proportion of amount of raw
product product
Volume containing containing
Product category produced added added
(2010) \1\ solutions (%) solutions
\2\ (volume *
proportion)
----------------------------------------------------------------------------------------------------------------
Beef............................................................ 24,300 21 5,127
Pork............................................................ 21,400 57 12,134
Lamb and Goat................................................... 185 30 55
Chicken......................................................... 49,400 78 38,532
Turkey.......................................................... 7,000 74 5,194
-----------------------------------------------
Total....................................................... 102,285 60 61,042
----------------------------------------------------------------------------------------------------------------
\1\ Numbers derived from FSIS data, as reported in the Expert Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and Mechanically Tenderized Raw Meat and Poultry Products. Final
Report. Research Triangle Institute. February 2012. Section 3.2.1 Available at http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.
\2\ Id., Table 3.6. Derived by summing median estimates for ``enhanced only'' and ``mechanically tenderized and
enhanced.''
* Totals in Estimated Amount do not necessarily add up due to rounding in Proportion of Product Containing Added
Solutions.
Currently, although labeling regulations and guidance state that
the labeling of products must include a qualifying statement that
reflects the fact that the product contains added solution, the
statement may not be readily apparent to consumers. This is because the
statement is not conspicuous. For example, through label review, FSIS
has found product labels contain product names in bold fonts with
strong contrasting backgrounds, with the qualifying statement on added
solution printed in 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 regulations and
guidance, it does not clearly identify to consumers that the product
contains added solutions. This rule addresses these issues.
The final rule will apply to all in-commerce raw meat and poultry
products containing added solution that do not meet a standard of
identity. These products will require a new label in order to comply
with the final rule.
A March 2011 FDA report \16\ 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
[[Page 79057]]
package surface area. FSIS estimates the cost of label modification to
accommodate the requirements of this final rule to fall into the minor
category.
---------------------------------------------------------------------------
\16\ 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 March 2011 FDA Report divides the minor category into minor
coordinated and minor uncoordinated changes based on the assumption
that all products are typically relabeled at least as often as every 3
to 4 years. The cost estimate is $310 per label (with a range of $170
to $440) for minor coordinated changes and $4,380 per label (with a
range of $2,417 to $7,330) for minor uncoordinated changes.\17\ The
model, defined in the report, assigns additional costs, e.g. labor, to
any change that does not fall into this 3 to 4 year period and is
designated to be an uncoordinated change that requires additional cost
attributes.
---------------------------------------------------------------------------
\17\ FDA March 2011 labeling cost model: A copy of the document
is available in the FSIS Docket Room, Patriots Plaza 3, 355 E.
Street SW., Room 8-164, Washington, DC 20250-3700.
---------------------------------------------------------------------------
This rule will affect foreign establishments that manufacture and
export raw meat or poultry products containing added solutions to the
United States, the same as it affects U.S. establishments. The labeling
costs for the affected foreign establishments are captured in the total
costs outlined later in this analysis. However, these products are not
typically imported; based on label review data,\18\ the amount of raw
meat and poultry products containing added solutions imported into the
United States is estimated to be less than 1 percent of the products
imported into the United States. For the purposes of this analysis,
FSIS assumes that the majority (>99.0 percent) of the affected products
are domestically produced.
---------------------------------------------------------------------------
\18\ Source: FSIS Labeling and Program Delivery Staff.
---------------------------------------------------------------------------
Regulatory Alternatives
We have identified three regulatory options for this rule.
1. Require or propose the use of ``enhanced'' in the containing
statement;
2. The final rule, except no requirement on background color for
the qualifying statement;
3. Amend FSIS regulations to establish a common or usual name
for raw meat and poultry products that contain added solutions; and
4. The final rule.
1. Require the Use of ``Enhanced'' in the Containing Statement
Under this alternative, FSIS would require the word ``enhanced'' in
the qualifying statement, or propose the use of the term ``enhanced''
in the containing statement, e.g., ``enhanced with a 15% solution . .
.''
FSIS did not select this alternative to require the word
``enhanced'' in the qualifying statement because the word implies that
the product is improved by the addition of the solution. The intent of
this rule 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. The cost for this alternative is the same or slightly
less than the preferred alternative; however benefits for consumers may
be reduced as a result of decreased transparency of products with and
without added solutions.
In addition, consumer research (Sorensen, November 2004)\19\ 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) than the use of the description
``contains up to 15% water, salt, and sodium phosphates.''
---------------------------------------------------------------------------
\19\ Enhanced'' Chicken, Consumer Research, November 2004, SAI
Project 04177, Sorensen Associates, Minneapolis, Minnesota (888-616-
0123), Portland, Oregon (800-542-4321).
---------------------------------------------------------------------------
2. Final Rule, Except No Requirement on Background Color for the
Qualifying Statement
Under this alternative, the color and style of the product's
qualifying statement is not required on a single-color contrasting
background. FSIS would still require the qualifying statement to
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.
FSIS did not select this alternative because the benefits would
likely be reduced. A benefit of this rule is to help consumers
determine whether products containing added solutions are suitable for
their personal preference and dietary needs. Removing the requirement
for background color choice would decrease transparency, as a result of
the reduction in contrast, to consumers.
The cost for this alternative is slightly less than the preferred
alternative because some existing labels already meet these
requirements. FSIS does not have supporting data to estimate the
precise number of labels in compliance with this alternative, but we
expect the number is minimal. FSIS expects reduced benefits from this
alternative as consumers are less likely to distinguish products with
and without added solutions, resulting in less informed decisions.
Consumers would not fully benefit from improved consumer awareness and
understanding that raw meat or poultry products may contain added
solutions.
3. Amend FSIS Regulations To Establish a Common or Usual Name for Raw
Meat and Poultry Products That Contain Added Solutions
Under this alternative, the common or usual name for a raw meat or
poultry product that contains an added solution would need to include
the percentage of added solution, and list the individual ingredients
or multi-ingredient components of the solution in descending order of
predominance by weight. Also, FSIS considered finalizing the proposed
provisions that would require that the print for all words in the
common or usual name appear in a single font size, color, and style of
print. As discussed above, after considering the comments, FSIS
concluded that the proposed requirements were more onerous and stricter
than necessary. Therefore, FSIS did not select this alternative and
made changes to the proposed rule to provide more flexibility and more
consistency with other labeling regulations.
4. The Final Rule
Under this alternative, FSIS would require that the qualifying
statement includes 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.
FSIS selected this alternative because it is preferred to the other
alternatives and is likely to improve consumer awareness and
understanding that the raw meat or poultry product contains an added
solution. The percentage of the solution and the ingredients of the
solution included in a qualifying statement is information consumers
need to make informed purchasing decisions.
Expected Cost of the Final Rule
The final rule will result in one-time costs to establishments and
retail facilities that produce and package raw meat and poultry
products containing added solutions. Producers may bear most of the
cost burden, not the consumers, given the high elasticity of demand for
this product because of the availability of close substitutes. All of
the costs pertain to the label modification procedures for the affected
products. The estimated cost of modifying labels is determined by the
number of label plates or digitized label
[[Page 79058]]
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.
Market Share
FSIS has updated the estimates for the proportion of products
containing added solutions to reflect the data received in the February
2012 report. Based on the findings of the report, FSIS estimates that
approximately 61.0 billion pounds or 60 percent of the 102.3 billion
pounds of meat and poultry products produced by federally inspected
establishments in the U.S. contain added solutions (Table 2). The
February 2012 report applies the estimate to the estimated pounds of
enhanced-only products and mechanically tenderized and enhanced
products by species, packaging, and labeling type. Based on this data,
FSIS is able to estimate (Table 3) the breakdown by percentage of
labels for products containing added solutions in the marketplace.\20\
---------------------------------------------------------------------------
\20\ Expert Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and Mechanically
Tenderized Raw Meat and Poultry Products. Final Report. Tables 3-15
and 3-16. Available at: http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.
Table 3--Percent of Enhanced-Only and Mechanically Tenderized and Enhanced Products by Species, Packaging, and Labeling Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pork* Lamb and goat* Chicken Turkey All*\1\
Packaging or labeling type Beef (percent) (percent) (percent) (percent) (percent) (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brand Name Label for Retail Sales....................... 21 35 34 36 38 35
Private Label for Retail Sales.......................... 22 31 27 22 22 24
Foodservice............................................. 51 30 38 37 35 37
Retail.................................................. 6 5 2 5 5 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Unweighted average.
* Totals do not necessarily add up due to rounding.
Costs for Label Modification
IRI scanner data indicate that there are 13,697 \21\ raw meat and
poultry labels in retail, 16.39 percent (or 2,245) of which are private
label, with the remainder (or 11,452) branded. Although IRI's
geographic coverage--which includes the largest urban areas in the U.S.
and a few whole states--may yield a reasonable estimate of the universe
of branded retail labels, a substantial number of chains that are large
enough to have their own private labels but that only serve small or
medium-sized cities may be missed. For this reason, the IRI results
will be used as a lower bound on the number of retail labels affected
by this rule. To estimate an upper bound, we make use of the estimates
in Table 3, to calculate that 37.5 percent (24%/[35% + 24% + 5%]) of
retail labels may be private label. In this case, there are an
estimated 6,871 private retail labels and 18,323 (11,452 + 6,871) total
retail labels. Because the IRI scanner data do not capture food service
labels, these estimates must be adjusted upward; based on the contents
of Table 3, about 37 percent of all meat and poultry products are for
food service. From this, FSIS estimates about 37 percent of meat and
poultry labels are for food service and the remaining 63 percent of
label are for retail, yielding estimates of 21,741 (13,697/63%]) to
29,084 (18323*/63%) raw meat and poultry product labels in the
marketplace. The market share of raw meat and poultry products that
contain added solutions is estimated to be 60 percent. Therefore, FSIS
estimates approximately 13,045 (21,741 * 60%) to 17,450 (29,084 * 60%)
unique labels for meat and poultry raw products containing added
solution in-commerce.
---------------------------------------------------------------------------
\21\ Information Resources, Inc, (IRI) scanner data was used to
calculate the number of raw meat and poultry products in the retail
market. IRI gathers data by scanners in supermarkets, drugstores,
and mass merchandisers and maintains a panel of consumer households
that record purchases at outlets by scanning UPC codes on the
products purchased.
---------------------------------------------------------------------------
This cost analysis uses the label design modification costs for a
minor coordinated label change and a minor uncoordinated label change
as defined in the March 2011 FDA Report.\22\ The use of the label
design modification costs for minor coordinated and uncoordinated label
changes are further supported by the 2-year compliance increments
defined in the FSIS regulation titled ``Uniform Compliance Date for
Food Labeling Regulations.'' \23\ That regulation helps 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. In other words, the ``Uniform Compliance
Date for Food Labeling Regulations'' increases the number of
establishments that can incorporate new requirements as a coordinated
change, which reduces the cost of complying with the final regulation.
(For example, FSIS is simultaneously developing a final rule that would
require additional labeling for beef products that are mechanically
tenderized. The cost associated with the labels for mechanically
tenderized beef products containing added solutions are lessened if
both rules' changes are required as of the same Uniform Compliance
Date.)
---------------------------------------------------------------------------
\22\ 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).
\23\ 77 FR 76824.
---------------------------------------------------------------------------
The labeling cost model states that the allocation of label changes
between coordinated and uncoordinated depends on the compliance period
allowed by the regulation under consideration. For some products
affected by this rule, the only necessary label change is an increase
in the formatting of the descriptive designation so that the size of
the smallest letter is at least one-third, rather than just one-fourth,
the size of the largest letter; the cost impact for such products would
be appropriately analyzed using the model's results for a 36-month
compliance period (100% of branded and 57% of private label changes
able to be coordinated). On the other hand,
[[Page 79059]]
many products--including the ones currently labeled with term
``enhanced''--will be subject to a 12-month compliance period (for
which the model shows 11% of branded and 5% of private label changes
can be coordinated). In the absence of data on the portion of products
that will need to have label changes in 12 months and the portion that
will need to have label changes in 36 months, we present results using
only the 12-month estimates, acknowledging that this approach leads to
an overstatement of the actual rule-induced costs.
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) and $4,380 per label (with a range of $2,417 and
$7,330) for a minor uncoordinated change.\24\ Using these costs for the
number of minor coordinated and uncoordinated changes in branded and
private modified labels from Table 4, FSIS estimates that the one-time
total cost of modifying labels for all federally inspected processors
is between $52 and $84 million as lower and upper bound estimates. Over
a ten year period, the lower and upper bound annualized cost for the
industry is $5.9 and $9.6 million at a 3 percent discount rate (DR)
over ten years and $6.9 and $11 million at a 7 percent DR over ten
years.
---------------------------------------------------------------------------
\24\ All costs are shown in 2010 Dollars.
---------------------------------------------------------------------------
The relabeling cost estimate is an overestimate for several reasons
beyond those already discussed. The model used to calculate the cost
for updating food labels encompasses all food labels products,
including FDA food labels. Information from FSIS's Labeling and Program
Delivery Staff's (LPDS) determined label changes for FSIS products
occur more frequently than the model indicates, resulting in an
overestimate of costly uncoordinated changes. Additionally, the
relabeling estimate includes all unique labels with added solutions
while many products with added solutions are already in compliance with
regulations provided in this rule. For these reasons, FSIS considers
the relabeling cost estimate an overestimate.
Table 4--Relabeling Cost for Meat and Poultry Products With Added Solutions, 12 Month Compliance Period
----------------------------------------------------------------------------------------------------------------
Branded Private Cost
Lower bound -------------------------------------------------------------------------------
10,907 2,138 Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
Coor Chg........................ 1,200 11% 107 5% $222,129 $405,059 $574,922
Uncoor Chg...................... 9,707 89% 2,031 95% 28,371,037 51,412,967 71,154,236
-------------------------------------------------------------------------------
Total Lower Bound Cost...... .............. .............. 28,593,166 51,818,026 71,729,158
===============================================================================
Annualized Cost (3% DR, 10 Year) .............. .............. 3,254,360 5,897,722 8,163,928
Annualized Cost (7% DR, 10 Year) .............. .............. 3,804,695 6,895,066 9,544,503
----------------------------------------------------------------------------------------------------------------
Branded Private Cost
Upper bound -------------------------------------------------------------------------------
7,670 3,464 Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
Coor Chg........................ 1,944 11% 173 5% 359,879 656,250 931,452
Uncoor Chg...................... 15,727 89% 3,291 95% 45,964,902 83,295,933 139,397,075
-------------------------------------------------------------------------------
Total Upper Bound Cost...... .............. .............. 46,324,781 83,952,183 140,328,526
===============================================================================
Annualized Cost (3% DR, 10 Year) .............. .............. 5,272,502 9,555,104 15,971,635
Annualized Cost (7% DR, 10 Year) .............. .............. 6,164,118 11,170,937 18,672,547
-------------------------------------------------------------------------------
Minor Coordinated............... .............. .............. 170 310 440
Minor Uncoordinated............. .............. .............. 2,417 4,380 7,330
----------------------------------------------------------------------------------------------------------------
The cost of modifying the labels is small relative to the total
volume of meat and poultry products. On a per pound basis, the upper
bound one-time cost for this rule is $.0014/per pound ($83 million/61.0
billion pounds). Further, the 2010 National Meat Case Study \25\ found
that the average number of pounds per package in the market place is 2
pounds. In the study, chicken and pork packages tended to be slightly
heavier at 2.5 and 2.1 pounds respectively. Therefore, by applying a
range of 1.5 to 2.5 pounds per package to the low and high range mid-
point cost estimates, the estimated additional cost per package is
between $.0013 and $.003. This cost is only incurred once and would be
even smaller if annualized (per package) over future years.
---------------------------------------------------------------------------
\25\ 2010 National Meat Case Study Executive Summary. Accessed
here: http://www.beefretail.org/CMDocs/BeefRetail/research/2010NationalMeatCaseStudy.pdf.
---------------------------------------------------------------------------
FSIS Budgetary Impact of the Final Rule
This final 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.
Expected Benefits of the Final Rule
FSIS anticipates benefits for the consumer such as improved
consumer awareness and understanding that raw meat or poultry products
may contain added solutions. This may increase consumer welfare.
The rule will likely improve 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. As noted in the need for rule
sections, nearly 60 percent of consumers are unaware that meat and
poultry products contain added solutions. Therefore, 60 percent of
consumers purchasing a chicken containing 15 percent added solution are
unaware they are purchasing a product that is 85 percent chicken and 15
percent added solution. Providing truthful and
[[Page 79060]]
accurate information on the label allows consumers to compare value
among such products and make a more informed purchasing decision.
Consumers can better determine whether products containing added
solutions are suitable for their personal preferences and dietary needs
through the added solutions qualifying statement. 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. For example, a raw chicken breast
containing added solutions averages an additional 333 mg of sodium than
chicken without added solutions, (122mg-455mg).\26\ High intakes of
sodium are directly associated with elevated blood pressure leading to
risks of cardiovascular disease (CVD) and stroke.\27\ While some
research \28\ suggests a U-shape relationship between sodium and health
with favorable sodium intake between 2,645 and 4,945 mgs, a Nutrition
Impact Model developed by Tim Dall estimates 1.5 million fewer cases of
hypertension with a potential annual savings of $2.3 billion if adults
with uncontrollable hypertension reduced their daily sodium intake by
400 mg.\29\
---------------------------------------------------------------------------
\26\ U.S. Department of Agriculture, Agricultural Research
Service. 2013. USDA National Nutrient Database for Standard
Reference, Release 26. Nutrient Data Laboratory Home Page, available
at: http://ndb.nal.usda.gov/ndb/.
\27\ Institute of Medicine (IOM) of the National Academies.
``Sodium Intake in Populations: Assessment of Evidence (2013),
Chapter 4: Sodium Intake and Health Outcomes,'' Washington, DC:
National Academies Press; 2013. pp.57.
\28\ N. Graudal, G. Jurgens, B. Baslund, M.H. Alderman. Compared
With Usual Sodium Intake, Low- and Excessive-Sodium Diets Are
Associated With Increased Mortality: A Meta-Analysis. American
Journal of Hypertension, 2014; DOI: 10.1093/ajh/hpu028.
\29\ Dall, T.M., V.L. Fulgoni III, Y. Zhang, K.J. Reimers, P.T.
Packard, and J.D. Astwood. 2009. Potential health benefits and
medical cost savings from calorie, sodium, and saturated fat
reductions in the American diet. American Journal of Health
Promotion. 23 (6), 12-22.
---------------------------------------------------------------------------
Additionally, it is estimated that there are about 3 million pre-
hypertensive and hypertensive persons in the US population.\30\ A
consumer research study indicates that 39% of consumers read but do not
understand current labels,\31\ and an FDA consumer study estimates that
49% of consumers would read and be able to understand new labels.\32\
Considering that difference and the estimates of pre-hypertensive and
hypertensive adults in the U.S. population, about 1 million individuals
may be able to better understand and apply the new label information
and, thereby, be better able to stay within their dietary salt intake
requirements.
---------------------------------------------------------------------------
\30\ Estimate is derived using U.S. Census Bureau, 2013
population estimates and studies that indicate that about 31% of
American adults have high blood pressure (CDC. Vital signs:
awareness and treatment of uncontrolled hypertension among adults--
United States, 2003-2010. MMWR. 2012;61(35):703-9) and an additional
one in three have prehypertension (Go AS, Mozaffarian D, Roger VL,
et al. Heart disease and stroke statistics--2013 update: a report
from the American Heart Association. Circulation. 2013;127:e6-245).
\31\ Label Contaminant Statement Package Test: Study Results,
Prepared for: Tyson Foods, Inc. by Lunt Associates. Question 10. May
2011.
\32\ FDA. ``Consumer Behavior Research 2008 Health and Diet
Survey'' Topline Frequencies. Question C3. Available at: http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.
---------------------------------------------------------------------------
More complete label information should increase consumer welfare.
Based on 2009-2010 National Health and Nutrition Examination Survey
data, NHANES, 46 percent of consumers rarely or never read food labels
when buying raw meat, poultry or fish products.\33\ Of the consumers
who rarely or never using food labels, 21 percent specified they are
not checking food labels because they did not know what to look for.
Results from the 2008 Health and Diet Survey indicated 29 percent of
respondents who never read food labels are not using labels because it
is hard to understand. The new requirements in this rule may make it
easier for consumers to understand the label and identify what to look
for. Providing more complete label information, currently unavailable
in the marketplace, will reduce transaction costs for consumers trying
to satisfy individual dietary or other preferences. Consumers with
complete information will be better able to discriminate between
products with added solutions and those without and select the products
they prefer, resulting in an increase in consumer welfare.
---------------------------------------------------------------------------
\33\ NHANES. 2013 ``Questionnaires, Datasets, and Related
Documentation'' Center for Disease Control and Prevention. Accessed
on 6/16/2014. Available at: http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
---------------------------------------------------------------------------
Regulatory Flexibility Analysis
The FSIS Administrator certifies that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not
have a significant economic impact on a substantial number of small
entities in the United States.
There are about 6,099 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 the
classifications outlined in the Pathogen Reduction; Hazard Analysis
Critical Control Point (HACCP) final rule (61 FR 38819). Hence, more
than 90 percent of the federal establishments \34\ that produce meat
and poultry products with added solutions which could possibly be
affected by this rule are small or very small according to the FSIS
HACCP definition.
---------------------------------------------------------------------------
\34\ Expert Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and Mechanically
Tenderized Raw Meat and Poultry Products. Final Report. Table 3-11.
Available at: http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
In the cost analysis above, FSIS estimated that the total upper and
lower bound one-time cost for the industry is about $52 to $84 million.
This results in an average one-time cost per establishment of about
$8496 ($52 million/6,099 establishments) to $13765 ($84 million/6,099)
or $967 to $1567 annualized (3 percent, 10 years). The small and very
small establishments produce less output and fewer unique labels, and
therefore their average one-time cost per establishment will be lower.
Thus, 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.
Executive Order 13175
This final rule has been reviewed in accordance with the
requirements of Executive Order 13175, ``Consultation and Coordination
with Indian Tribal Governments.'' FSIS has concluded, on the basis of
its evaluation, that this final rule will not have substantial and
direct effects on Indian Tribes, on the relationship between the
Federal Government and Indian Tribes, or on the distribution of power
or responsibilities between the Federal Government and Indian Tribes.
Nonetheless, FSIS will include Tribes and intertribal organizations,
involved in or interested in the meat and poultry sectors, in the
Agency's outreach efforts associated with implementation and
administration of this final rule.
Executive Order 12988 Civil Justice Reform
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under this 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 79061]]
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or record
keeping requirements included in this final rule have been submitted
for approval to the Office of Management and Budget (OMB). This
information collection request is at OMB awaiting approval. FSIS will
collect no information associated with this rule until the information
collection is approved by OMB.
Copies of this information collection assessment can be obtained
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083,
South Building, Washington, DC 20250-3700; (202) 690-6510.
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
FSIS will announce this rule online through the FSIS Web page
located at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.
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. 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/wps/portal/fsis/programs-and-services/email-subscription-service. 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.
USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.) should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
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 amending 9 CFR
chapter III as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
0
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.
0
2. Amend Sec. 317.2 by redesignating paragraph (e) as paragraph (e)(1)
and adding paragraph (e)(2) to read as follows:
Sec. 317.2 Labels: definition; required features.
* * * * *
(e) * * *
(2) The product name for a raw meat product that contains added
solution and does not meet a standard of identity in 9 CFR part 319
must contain a descriptive designation that includes:
(i) The percentage of added solution (total weight of the solution
ingredients divided by the weight of the raw meat without solution or
any other added ingredients multiplied by 100). The percentage of added
solution must appear as a number (such as, 15, 20, 30) and the percent
symbol (%). The percentage of added solution may be declared by the
words ``containing'' or ``contains'' (such as, ``contains 15% added
solution of water and salt,'' or ``containing 15% added solution of
water and teriyaki sauce'').
(ii) The common or usual name of all individual ingredients or
multi-ingredient components in the solution listed in descending order
of predominance by weight.
(iii) When the descriptive designation includes all ingredients in
the solution, a separate ingredients statement is not required on the
label. When the descriptive designation includes multi-ingredient
components and the ingredients of the component are not declared in the
descriptive designation, all ingredients in the product must be
declared in a separate ingredients statement on the label as required
in Sec. 317.2(c)(2) and (f).
(iv) The product name and the descriptive designation must be
printed in a single easy-to-read type style and color and must appear
on a single-color contrasting background. The print may appear in upper
and lower case letters, with the lower case letters not smaller than
one-third (\1/3\) the size of the largest letter.
(v) The word ``enhanced'' cannot be used in the product name.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
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.
0
4. Amend Sec. 381.117 by adding paragraph (h) to read as follows:
Sec. 381.117 Name of product and other labeling.
* * * * *
(h) The product name for a raw poultry product that contains added
solution and does not meet a standard of identity in this part must
contain a descriptive designation that includes:
(1) 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
[[Page 79062]]
ingredients multiplied by 100). The percentage of added solution must
appear as a number (such as, 15, 20, 30) and the percent symbol (%).
The percentage of added solution may be declared by the words
``containing'' or ``contains'' (such as, ``contains 15% added solution
of water and salt,'' or ``containing 15% added solution of water and
teriyaki sauce'').
(2) The common or usual name of all individual ingredients or
multi-ingredient components in the solution listed in descending order
of predominance by weight.
(3) When the descriptive designation includes all ingredients in
the solution, a separate ingredients statement is not required on the
label. When the descriptive designation 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.
(4) The product name and the descriptive designation must be
printed in a single easy-to-read type style and color and must appear
on a single-color contrasting background. The print may appear in upper
and lower case letters, with the lower case letters not smaller than
one-third (\1/3\) the size of the largest letter.
(5) The word ``enhanced'' cannot be used in the product name.
Sec. 381.169 [Removed and Reserved]
0
5. Remove and reserve Sec. 381.169.
Done at Washington, DC, on December 23, 2014.
Alfred Almanza,
Acting Administrator.
[FR Doc. 2014-30472 Filed 12-30-14; 8:45 am]
BILLING CODE 3410-DM-P