Descriptive Designation for Raw Meat and Poultry Products Containing Added Solutions, 79043-79062 [2014-30472]
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Vol. 79
Wednesday,
No. 250
December 31, 2014
Part IV
Department of Agriculture
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Food Safety and Inspection Service
9 CFR Parts 317 and 381
Descriptive Designation for Raw Meat and Poultry Products Containing
Added Solutions; Final Rule
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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations
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:
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
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
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 multiingredient 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 singlecolor 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
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SUMMARY:
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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
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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 multiingredient 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.
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TABLE 1—SUMMARY OF COSTS AND BENEFITS
Lower bound
Upper bound
Costs
Annualized Cost (3% Discount Rate, 10 Year) .......................................................................................................
Annualized Cost (7% Discount Rate, 10 Year) .......................................................................................................
$5,897,722
6,895,066
$9,555,104
11,170,937
Benefits
• 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 incommerce 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
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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-toread 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
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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 https://
www.fsis.usda.gov/wps/portal/
searchhelp/sitemap/!ut/p/a0/04_
Sj9CPykssy0xPLMnMz0vMAfGjzOINA
g3MDC2dDbz8LQ3dDDz9wgL9v
Z2dDdx9jfQLsh0VAcILpdM!/
?1dmy¤t=true&urile=wcm%3
Apath%3A%2Ffsis-content%2
Fobsolete-archives%2Fproposedrules%2Ffederal-proposed-rulesarchive-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
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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 https://www.fsis.usda.gov/
wps/wcm/connect/cf80e9a5-7e39-470f90c9-0911402268b0/2010-0012_
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 onethird (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
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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
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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.
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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 addedsolution 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
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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
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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 singleingredient 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
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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 threetenths 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
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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.
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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-
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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.
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.
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.
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 nonstandardized fully-cooked or partiallyheat 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 singleingredient 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.
1 https://www.merriam-webster.com/dictionary/
enhance.
2 Available at https://www.foodinsight.org/
Content/3651/2010FinalFullReport.pdf.
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
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.
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.
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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.
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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).
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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 incommerce 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
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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-todate 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.
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
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).
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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
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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.
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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
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Figure 1. Label example - The product name includes a descriptive designation at one-third
(113t the size ofthe largest letter (9 CFR 317.2(e)(2)(iv)), a multi-ingredient component
(Teriyaki Sauce), all ingredients in the product are declared in a separate ingredients statement (9
CFR 317.2(e)(2)(iii)).
Pork Tenderloin - 15% Added solution of
Water and Teriyaki Sauce
Safe Handling
Instructions
4
Label shown using the one-third (1/3) font size requirement applicable January 1, 2018.
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79053
Figure 2. Label example - The product name includes a descriptive designation at one-third
(113i the size ofthe largest letter (9 CFR 317.2(e)(2)(iv)), includes the word "contains" (9 CFR
317 .2( e)(2)(i) ), the individual ingredients in the solution listed in descending order of
predominance by weight (9 CFR 317 .2( e)(2)(ii), followed by a vignette of the product.
Nutrition Facts
Panel
Safe Handling
Instructions
5
Label shown using the one-third {1/3) font size requirement applicable effective January 1, 2018.
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AND PASSED BY
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Figure 3. Label example- The product name includes a descriptive designation at one-third
(113/ the size ofthe largest letter (9 CFR 381.117(h)(4)), includes the term "flavored with," the
individual ingredients in the solution listed in descending order of predominance by weight (9
CFR 381.117 (h)(2)).
Chicken Breast Flavored with 15% Added
Solution of Water, Salt, Spices, and Sodium Phosphate
Safe Handling
Instructions
6
Label shown using the one-third (1/3) font size requirement applicable effective January 1, 2018.
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BILLING CODE 3410–DM–C
Executive Orders 12866 and 13563 and
the Regulatory Flexibility Act
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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 incommerce 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
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.
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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.
• 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
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
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.
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79055
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 singleingredient 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:
https://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.
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TABLE 1—ESTIMATED NUMBER OF ESTABLISHMENTS THAT PRODUCE EACH TYPE OF PRODUCT BY SPECIES AND
ESTABLISHMENT SIZE 14
Species
Product
Beef ...............................
Containing added solutions only 15 .....................
Mechanically tenderized with added solutions ....
Containing added solutions only .........................
Mechanically tenderized with added solutions ....
Containing added solutions only .........................
Mechanically tenderized with added solutions ....
Containing added solutions only .........................
Mechanically tenderized with added solutions ....
Containing added solutions only .........................
Mechanically tenderized with added solutions ....
Pork ...............................
Lamb and Goat ..............
Chicken ..........................
Turkey ............................
Very small
Small
181
251
285
256
24
35
282
267
80
75
Large
218
218
439
293
29
34
371
346
123
127
Total
21
21
34
27
0
0
131
116
21
21
420
490
758
576
53
69
784
729
224
223
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.
TABLE 2—PROPORTION OF RAW PRODUCTS CONTAINING ADDED SOLUTIONS IN MILLIONS OF POUNDS BY SPECIES
Volume
produced
(2010) 1
Product category
Proportion of
product
containing
added
solutions
(%) 2
Estimated
amount of raw
product
containing
added
solutions
(volume *
proportion)
Beef ..............................................................................................................................................
Pork ..............................................................................................................................................
Lamb and Goat ............................................................................................................................
Chicken ........................................................................................................................................
Turkey ..........................................................................................................................................
24,300
21,400
185
49,400
7,000
21
57
30
78
74
5,127
12,134
55
38,532
5,194
Total ......................................................................................................................................
102,285
60
61,042
1 Numbers
tkelley on DSK3SPTVN1PROD with RULES4
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
https://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 incommerce 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
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: https://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.’’
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).
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package surface area. FSIS estimates the
cost of label modification to
accommodate the requirements of this
final rule to fall into the minor category.
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.
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.
Regulatory Alternatives
We have identified three regulatory
options for this rule.
tkelley on DSK3SPTVN1PROD with RULES4
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 . . .’’
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.
18 Source: FSIS Labeling and Program Delivery
Staff.
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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.’’
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 singlecolor 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
19 Enhanced’’ Chicken, Consumer Research,
November 2004, SAI Project 04177, Sorensen
Associates, Minneapolis, Minnesota (888–616–
0123), Portland, Oregon (800–542–4321).
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79057
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
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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
TABLE 3—PERCENT OF ENHANCED-ONLY AND MECHANICALLY TENDERIZED AND ENHANCED PRODUCTS BY SPECIES,
PACKAGING, AND LABELING TYPE
Beef
(percent)
Packaging or labeling type
Brand Name Label for Retail Sales .........
Private Label for Retail Sales ..................
Foodservice ..............................................
Retail ........................................................
Lamb and
goat*
(percent)
Pork*
(percent)
21
22
51
6
35
31
30
5
Chicken
(percent)
34
27
38
2
All*1
(percent)
Turkey
(percent)
36
22
37
5
38
22
35
5
35
24
37
5
1 Unweighted average.
* Totals do not necessarily add up due to rounding.
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.
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.)
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 onethird, 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,
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: https://www.fsis.usda.gov/
wps/wcm/connect/3a97f0b5-b523–4225–8387c56a1eeee189/Market_Shares_MTB_
0212.pdf?MOD=AJPERES.
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.
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.
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many products—including the ones
currently labeled with term
‘‘enhanced’’—will be subject to a 12month 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.
The relabeling cost estimate is an
overestimate for several reasons beyond
79059
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
10,907
2,138
Cost
Lower bound
Coor Chg ..............................................................................
Uncoor Chg ..........................................................................
1,200 11%
9,707 89%
Total Lower Bound Cost ...............................................
Annualized Cost (3% DR, 10 Year) .....................................
Annualized Cost (7% DR, 10 Year) .....................................
107
2,031
Lower
Mid
Upper
5%
95%
$222,129
28,371,037
$405,059
51,412,967
$574,922
71,154,236
........................
........................
28,593,166
51,818,026
71,729,158
........................
........................
........................
........................
3,254,360
3,804,695
5,897,722
6,895,066
8,163,928
9,544,503
Branded
Private
7,670
3,464
Cost
Upper bound
1,944 11%
15,727 89%
Total Upper Bound Cost ...............................................
Upper
5%
95%
359,879
45,964,902
656,250
83,295,933
931,452
139,397,075
........................
........................
46,324,781
83,952,183
140,328,526
........................
........................
........................
........................
5,272,502
6,164,118
9,555,104
11,170,937
15,971,635
18,672,547
Minor Coordinated ...............................................................
Minor Uncoordinated ............................................................
........................
........................
........................
........................
170
2,417
310
4,380
440
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
24 All
costs are shown in 2010 Dollars.
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173
3,291
Mid
Annualized Cost (3% DR, 10 Year) .....................................
Annualized Cost (7% DR, 10 Year) .....................................
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Coor Chg ..............................................................................
Uncoor Chg ..........................................................................
Lower
and would be even smaller if
annualized (per package) over future
years.
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
25 2010 National Meat Case Study Executive
Summary. Accessed here: https://
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
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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
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
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:
https://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.
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).
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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.
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.
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
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: https://www.fda.gov/
Food/FoodScienceResearch/
ConsumerBehaviorResearch/ucm193895.htm.
33 NHANES. 2013 ‘‘Questionnaires, Datasets, and
Related Documentation’’ Center for Disease Control
and Prevention. Accessed on 6/16/2014. Available
at: https://www.cdc.gov/nchs/nhanes/nhanes_
questionnaires.htm.
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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.
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 onetime 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.
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: https://www.fsis.usda.gov/wps/wcm/
connect/3a97f0b5-b523-4225-8387-c56a1eeee189/
Market_Shares_MTB_0212.pdf?MOD=AJPERES.
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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations
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 EGovernment 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.
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Additional Public Notification
FSIS will announce this rule online
through the FSIS Web page located at
https://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
https://www.fsis.usda.gov/wps/portal/
fsis/programs-and-services/emailsubscription-service. Options range from
recalls to export information to
regulations, directives and notices.
Customers can add or delete
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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 https://
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: program.intake@usda.gov.
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
1. The authority citation for part 317
continues to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
2. Amend § 317.2 by redesignating
paragraph (e) as paragraph (e)(1) and
adding paragraph (e)(2) to read as
follows:
■
§ 317.2 Labels: definition; required
features.
*
*
*
*
*
(e) * * *
(2) The product name for a raw meat
product that contains added solution
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79061
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 multiingredient 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 multiingredient 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
§ 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
3. The authority citation for part 381
continues to read as follows:
■
Authority: 7 U.S.C. 138f, 450; 21 U.S.C.
451–470; 7 CFR 2.7, 2.18, 2.53.
4. Amend § 381.117 by adding
paragraph (h) to read as follows:
■
§ 381.117
labeling.
Name of product and other
*
*
*
*
*
(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
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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 multiingredient components in the solution
listed in descending order of
predominance by weight.
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(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 multiingredient 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
§ 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
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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.
§ 381.169
■
[Removed and Reserved]
5. Remove and reserve § 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
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]]>Agencies
[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Rules and Regulations]
[Pages 79043-79062]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Lower bound Upper bound
------------------------------------------------------------------------
Costs
========================================================================
Annualized Cost (3% Discount Rate, 10 Year).............................
Annualized Cost (7% Discount Rate, 10 Year).............................
------------------------------------------------------------------------
Benefits
------------------------------------------------------------------------
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..........
------------------------------------------------------------------------
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 https://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 https://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.
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\1\ https://www.merriam-webster.com/dictionary/enhance.
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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.
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\2\ Available at https://www.foodinsight.org/Content/3651/2010FinalFullReport.pdf.
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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: https://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: https://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 https://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: https://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.)
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\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.
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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.
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\25\ 2010 National Meat Case Study Executive Summary. Accessed
here: https://www.beefretail.org/CMDocs/BeefRetail/research/2010NationalMeatCaseStudy.pdf.
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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\
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\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: https://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.
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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.
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\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: https://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: https://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: https://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 https://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 https://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 https://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: program.intake@usda.gov.
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
