Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products, 82148-82167 [2010-32485]
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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. FSIS–2005–0018]
RIN 0583–AC60
Nutrition Labeling of Single-Ingredient
Products and Ground or Chopped
Meat and Poultry Products
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is amending
the Federal meat and poultry products
inspection regulations to require
nutrition labeling of the major cuts of
single-ingredient, raw meat and poultry
products on labels or at point-ofpurchase, unless an exemption applies.
FSIS is also amending its regulations to
require nutrition labels on all ground or
chopped meat and poultry products,
with or without added seasonings,
unless an exemption applies. In
addition, the rule provides that, when a
ground or chopped product does not
meet the regulatory criteria to be labeled
‘‘low fat,’’ a lean percentage statement
may be included on the label or in
labeling as long as a statement of the fat
percentage that meets the specified
criteria also is displayed on the label or
in labeling.
DATES: Effective Date: This final rule is
effective on January 1, 2012.
FOR FURTHER INFORMATION CONTACT:
Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery Division,
Office of Policy and Program
Development, Food Safety and
Inspection Service, U.S. Department of
Agriculture, Beltsville, MD 20705; (301)
504–0878.
SUMMARY:
Section I.
SUPPLEMENTARY INFORMATION:
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Background
The Nutrition Labeling and Education
Act (NLEA) of 1990 required nutrition
labeling of most foods regulated by the
Food and Drug Administration (FDA).
Because FSIS is committed to providing
consumers with the most informative
labeling system possible, FSIS
published regulations establishing
comparable nutrition labeling
requirements for meat and poultry
products. FSIS published an advance
notice of proposed rulemaking on
nutrition labeling of meat and poultry
products on April 2, 1991 (56 FR
13564), a proposed rule on November
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27, 1991 (56 FR 60302), a final rule on
January 6, 1993 (58 FR 632), and
subsequently other amendments to the
rule.
The Agency’s regulations currently
require nutrition labels on the packages
of all multi-ingredient and heat
processed meat and poultry products,
unless an exemption applied. The
required nutrition labeling provisions
are referred to as ‘‘the mandatory
nutrition labeling program.’’ The
Agency’s 1993 regulations also
established guidelines for voluntary
nutrition labeling of single-ingredient,
raw meat and poultry products,
including single-ingredient, raw ground
or chopped products.
On January 18, 2001, FSIS published
a proposed rule in the Federal Register
entitled, ‘‘Nutrition Labeling of Ground
or Chopped Meat and Poultry Products
and Single-Ingredient Products’’ (66 FR
4969). Because of the length of time
since the publication of the proposed
rule, FSIS published a supplemental
proposed rule on December 18, 2009, to
provide the public an additional
opportunity to comment (74 FR 67736).
This final rule is consistent with the
provisions in the supplemental
proposed rule.
Nutrition labeling continues to be an
integral part of USDA’s efforts to
educate consumers concerning nutrition
and diets. Since 1980 USDA and the
Department of Health and Human
Services (HHS) have jointly published
the Dietary Guidelines for Americans
every five years. The Dietary Guidelines
provide advice concerning food choices
that promote health and prevent
disease. The Dietary Guidelines for
Americans, 2005, advises consumers to
aim for a total fat intake between 20 to
35 percent of calories (page viii). In
addition, the Dietary Guidelines for
Americans, 2005, includes a chart
showing the recommended upper limits
for grams of saturated fat per day for a
range of total calories per day (page 31).
The nutrition information that FSIS is
requiring in this final rule on the labels
of ground or chopped products and on
either labels or point-of-purchase
materials for the major cuts of singleingredient, raw meat and poultry
products would include the number of
calories and the grams of total fat and
saturated fat the product contains. The
information FSIS is requiring would,
therefore, assist consumers in following
the advice in the Dietary Guidelines for
Americans, 2005.
Major cuts: This final rule requires
nutrition labeling of the major cuts of
single-ingredient, raw meat and poultry
products identified in §§ 317.344 and
381.444 that are not ground or chopped,
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except for certain exemptions. For these
products, the final rule requires that
nutrition information be provided on
the label or at point-of-purchase, unless
an exemption applies.
In its two most recent surveys of the
voluntary nutrition labeling of singleingredient, raw products, FSIS found
that significant participation in the
voluntary nutrition labeling program
did not exist (66 FR 4972, January 18,
2001). Under 9 CFR 317.343 and 9 CFR
381.443, if FSIS finds that there is not
significant participation by retail stores
in the voluntary nutrition labeling
program to provide nutrition labeling
for the major cuts of single-ingredient,
raw meat and poultry products, FSIS is
obligated to institute rulemaking to
require that such labeling be provided.
FSIS regulations provide that a food
retailer participates at a significant level
(1) if the retailer provides nutrition
labeling information for at least 90
percent of the major cuts of singleingredient, raw meat and poultry
products it sells; and (2) if the nutrition
label on these products is consistent in
content and format with the mandatory
program, or if nutrition information is
displayed at point-of-purchase in an
appropriate manner. Significant
participation by food retailers exists if at
least 60 percent of all companies that
were evaluated were participating in
accordance with the guidelines. Based
on the survey data from the two most
recent surveys from 1996 and 1999, less
than 60 percent of stores evaluated were
participating in accordance with the
guidelines. Therefore, significant
participation in the voluntary nutrition
labeling program did not exist, and FSIS
proceeded with rulemaking.
Under § 317.4, FSIS’s Labeling and
Program Delivery Division (LPDD)
reviews labels on meat and poultry
products that have been submitted for
approval. Based on its label review,
FSIS has not seen an increase in
nutrition labeling of the major cuts of
single-ingredient raw, meat and poultry
products since the surveys were
conducted. Compliance investigators in
FSIS’s Office of Program Evaluation,
Enforcement & Review (OPEER) also
have not seen an increase in the number
of packages of the major cuts of singleingredient, raw meat and poultry
products that have nutrition facts panels
on their labels at retail or an increase in
the availability of point-of-purchase
materials that provide nutrition
information for such products at retail
since the last compliance surveys were
conducted. For these reasons and
because no other evidence has been
submitted to FSIS that significant
participation in the voluntary program
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now exists, FSIS has concluded that this
final rule is necessary.
FSIS has determined that major cuts
of single-ingredient raw, meat and
poultry products that do not bear
nutrition information on their labels or
on point-of-purchase materials will be
misbranded, under section 1(n) of the
Federal Meat Inspection Act (FMIA) (21
U.S.C. 601(n)(1)) and section 4(h)(1) of
the Poultry Products Inspection Act
(PPIA) (21 U.S.C. 453(h)(1)). Without
nutrition information on their labeling,
FSIS has concluded that the labeling of
these products will be false or
misleading because it will not provide
consumers with sufficient information
to assess the nutrient content of the
major cuts and will not enable
consumers to select major cuts that fit
into a healthy diet that meets their
individual needs.
Consumers are given a rough
indication of the fat content of major
cuts of poultry based on whether the
product has skin and based on the levels
of attached fat in the product. Similarly,
consumers are given a rough indication
of the fat content of major cuts of meat
products based on internal marbling and
attached fat. However, without nutrition
labeling for the major cuts, consumers
cannot assess precise levels of fat (e.g.,
10 grams vs. 20 grams of fat per serving)
and cannot know the levels of specific
nutrients, such as saturated fat, in these
products. Therefore, without nutrition
labeling of these products, consumers
cannot make educated choices about
consuming the major cuts.
To provide flexibility, the rule allows
nutrition information to be provided on
the labels of individual packages of the
major cuts of single-ingredient, raw
products and, to be provided on pointof-purchase materials. Further, FSIS has
determined that point-of-purchase
labeling is appropriate because
consumers can generally estimate the fat
content in these products, and because
the nutrient content of any given major
cut is relatively uniform across the
market.
Ground or Chopped Products: This
final rule requires that nutrition labels
be provided for all ground or chopped
products (livestock species) and
hamburger, with or without added
seasonings, unless an exemption
applies. Similarly, this final rule
requires that nutrition labels be
provided for all ground or chopped
poultry (kind), with or without added
seasonings, unless an exemption
applies. Under this final rule, products
that would be required to bear nutrition
labels include single-ingredient, raw
hamburger, ground beef, ground beef
patties, ground chicken, ground turkey,
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ground chicken patties, ground pork,
and ground lamb.
Unlike other single-ingredient, raw
products, producers are able to
formulate precisely the fat content of
ground or chopped products. Therefore,
in this respect, these products are
similar to products in the existing
mandatory program that are required to
bear nutrition labels. Other singleingredient, raw products cannot be
formulated in the same manner or to the
same degree as ground products.
In ground or chopped products, the
fat is uniformly distributed throughout
the product and is not clearly
distinguishable on the surface of the
product. The Agency has concluded that
consumers cannot estimate the level of
fat in these products and cannot
compare the levels of fat in these
products to those in other products.
Additionally, producers sometimes use
meat from advanced meat recovery
(AMR) systems and low temperature
rendering (LTR) in ground or chopped
beef or pork products, which can affect
their nutrient content. For these reasons,
FSIS has concluded that ground or
chopped meat and poultry products that
do not bear nutrition information will
be misbranded under section 1(n)(1) of
the FMIA and section 4(h)(1) of the
PPIA.
FSIS is requiring that nutrition
information for ground or chopped
products appear on the label of these
products (unless an exemption applies),
as is required for multi-ingredient and
heat processed products, rather than on
point-of-purchase materials. Because
there are numerous formulations of
ground or chopped products, it would
be difficult for producers or retailers to
develop point-of-purchase materials that
would address all the different
formulations that exist for these
products. Furthermore, it would be
difficult for consumers to find the
correct information for a specific ground
or chopped product on point-ofpurchase materials that include
information concerning numerous
formulations of these products.
Non-major Cuts of Single-Ingredient,
Raw Meat and Poultry Products that are
not Ground or Chopped: FSIS is not
requiring nutrition information for
single-ingredient, raw meat and poultry
products that are not major cuts and that
are not ground or chopped. But, if
nutrition information is provided for
these products, it must be provided in
accordance with the nutrition labeling
requirements for the major cuts.
Therefore, under the final rule, if
establishments or retail facilities choose
to provide nutrition information for
these products, they will either provide
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it at point-of-purchase, in accordance
with § 317.345 or § 381.445, or on their
label, in accordance with § 317.309 or
§ 381.409. Thus, the nutrition labeling
provisions for these products will be
consistent with those for the voluntary
nutrition labeling program.
Permitting Percent Lean Statements
on labels or in labeling of ground or
chopped products: The final rule
permits a statement of lean percentage
on the label or in labeling of ground or
chopped meat and poultry products that
do not meet the regulatory criteria for
‘‘low fat,’’ provided that a statement of
the fat percentage is also displayed on
the label or in labeling. The required
statement of fat percentage must be
contiguous to, in lettering of the same
color, size, and type as, and on the same
color background as, the statement of
lean percentage. Many consumers have
become accustomed to this labeling on
ground beef products, and FSIS has
concluded that this labeling provides a
quick, simple, and accurate means of
comparing ground or chopped meat and
poultry products.
Exemptions: Under this final rule, the
following exemptions from nutrition
labeling requirements will apply to the
major cuts of single-ingredient, raw
meat and poultry products and ground
or chopped meat and poultry products:
• Products intended for further
processing, provided that the labels for
these products bear no nutrition claim
or nutrition information,
• Products that are not for sale to
consumers, provided that the labels for
these products bear no nutrition claims
or nutrition information,
• Products in small packages that are
individually wrapped packages of less
than 1⁄2; ounce net weight, provided that
the labels for these products bear no
nutrition claims or nutrition
information,
• Products that are custom
slaughtered or prepared, and
• Products intended for export.
This final rule also provides the
following additional exemptions for
ground or chopped products:
• Ground or chopped products that
qualify for the small business exemption
in §§ 317.400(a)(1) and 381.500(a)(1),
• Products that are ground or
chopped at an individual customer’s
request and that are prepared and
served at retail, provided that the labels
or labeling of these products bears no
nutrition claims or nutrition
information,
• Ground or chopped products in
packages that have a total surface area
for labeling of less than 12 square
inches, provided that the product’s
labeling includes no nutrition claims or
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nutrition information and provided that
an address or telephone number that a
consumer can use to obtain the required
information is included on the label,
and
• Ground products produced by small
businesses that use statements of
percent fat and percent lean on the label
or in labeling of ground products,
provided they include no other
nutrition claims or nutrition
information on the product labels or
labeling.
FSIS believes an exemption for
ground or chopped products produced
by small businesses is necessary
because the burden of mandatory
nutrition labeling may force some small
firms to stop producing the product
because of the cost of nutrition labeling
and eventually force some small firms
out of business. FSIS believes it would
not be feasible for some small
businesses to incur the additional costs
of nutrition labeling because of their
low volume of sales or low volume of
ground product. FSIS believes it is
feasible for larger businesses to incur
the additional costs of nutrition labeling
because of their higher volume of sales
or larger levels of production of ground
product. This final rule, with an
exemption for ground or chopped
products that qualify for the small
business exemption in §§ 317.400(a)(1)
and 381.500(a)(1), provides nutrition
labeling on the maximum volume of
ground or chopped product while
assuring that small businesses
producing low volumes of product are
not at risk of going out of business or
materially reducing the variety of
products they deliver to their customers.
Further, FSIS believes that the relatively
small additional benefits of requiring
small businesses to put nutrition labels
on all ground or chopped products are
outweighed by the larger additional
costs. FSIS estimates that without the
exemption there would be a $3 million
reduction in annual average net benefit.
Without the exemption, the projected
compliance average total cost increase
annually of $54 million would not be
the only type of cost that would be
incurred. FSIS believes that without the
exemption many small businesses
would have to close or substantially
reduce the variety of products they now
offer. Reductions in purchase options
would be a cost to consumers that could
not be quantified for FSIS’s analysis.
Under this final rule, there is not a
small business exemption for the major
cuts of single-ingredient, raw meat and
poultry products because nutrition
information for these products may be
provided on labels or, alternatively, at
their point-of-purchase. Additionally,
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FSIS will make point-of-purchase
materials available over the Internet free
of charge. Therefore, the nutrition
labeling requirement for major cuts of
single-ingredient, raw products should
not impose an economic hardship for
small businesses, including those that
are retail stores.
Under the proposed rule, if small
businesses produced ground or chopped
product and included a statement of
lean percentage and fat percentage on
the product’s label, the small business
would have been required to include
nutrition information on the product
label. These small businesses would not
have qualified for the small business
exemption because the labels for these
products included nutrition claims.
Based on the National Cattleman’s Beef
Association (NCBA) National Meat Case
Study in 2004, 93 percent of ground
beef packages had statements of lean or
fat percentages (74 FR 67741). Sixtyeight percent of packages with such
statements had nutrition facts panels
and 25 percent did not (74 FR 67741).
Because about 95 percent of grinders are
small businesses, FSIS concluded that
many of the 25 percent of packages that
included lean or fat percentage
statements without nutrition facts
panels were produced by small
businesses. Therefore, FSIS believes
many small businesses include
statements of lean or fat percentage on
the label of their ground products but
not the nutrition facts panel. Also,
because of the longstanding use of the
statements of percent fat and percent
lean on the label or in labeling of
ground beef and hamburger products,
FSIS believes that such statements on
the label or in labeling of ground
products produced by small businesses
will not mislead consumers, even if the
small businesses do not include
nutrition information on the products’
labels (74 FR 67741). Many consumers
have become accustomed to this
labeling on ground beef products, and
FSIS believes that this labeling provides
a quick, simple, and accurate means of
comparing ground or chopped meat and
poultry products. Therefore under the
final rule, small businesses that use
statements of percent fat and percent
lean on the label of ground products,
provided they include no other
nutrition claims or nutrition
information on the product labels or
labeling, are exempted from the
nutrition labeling requirements.
Additionally, under this final rule,
any ground or chopped product or
major cut of single-ingredient, raw
product represented or purported to be
specifically for infants and children less
than 4 years of age will not be allowed
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to include certain nutrient content
declarations because infants and
children less than 4 years of age have
different nutrition needs than adults
and children older than 4 years of age.
Finally, this final rule makes clear
that the current regulatory exemptions
for ready-to-eat (RTE) product packaged
or portioned at retail and multiingredient product processed at retail do
not apply to RTE ground or chopped
products packaged or portioned at retail
or multi-ingredient ground or chopped
products that are processed at retail
because there may be a significant
amount of multi-ingredient ground beef
retail processed products or RTE retail
packaged products (66 FR 4979, January
18, 2001). For further explanation of the
reasons for the foregoing exemptions,
see 58 FR 638–639; 66 FR 4978–4979;
and 75 FR 67740–67741.
Enforcement and Compliance: After
the final rule is implemented, FSIS will
collect samples of ground product at
retail for nutrient analysis. In addition,
FSIS will assess whether nutrition
information is available for the major
cuts, either on package labels or at the
point-of-purchase.
Under this final rule, the procedures
set forth for FSIS product sampling and
nutrient analysis in §§ 317.309(h)(1)–(8)
and 381.409(h)(1)–(8) will be applicable
to ground or chopped meat and to
ground or chopped poultry products,
respectively. FSIS will sample and
conduct nutrient analysis of ground or
chopped products to verify compliance
with nutrition labeling requirements,
even if nutrition labeling on these
products is based on the most current
representative database values
contained in USDA’s National Nutrient
Data Bank or the USDA National
Nutrient Database for Standard
Reference and there are no claims on the
labeling. Therefore, FSIS will treat these
products as it treats other products
required to bear nutrition labels.
FSIS will treat ground or chopped
products in this way because the fat
content of these products can vary
significantly. FSIS employees cannot
visually assess whether nutrition
information on the label of ground or
chopped products accurately reflects the
labeled products’ contents because, in
most cases, it is not possible to visually
assess the level of fat in a ground or
chopped product.
If nutrition labeling of the major cuts
of single-ingredient, raw products (other
than ground beef or ground pork) is
based on USDA’s National Nutrient Data
Bank or the USDA’s National Nutrient
Database for Standard Reference, and
there are no nutrition claims on the
labeling, FSIS will not sample and
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conduct a nutrient analysis of the
products because FSIS personnel can
visually identify the particular cut. If
the nutrition information for these
products is based on USDA’s National
Nutrient Data Bank or the USDA
National Nutrient Database for Standard
Reference, and there are no nutrition
claims on the labeling, it is not
necessary for FSIS to verify the accuracy
of the data because they are USDA data.
USDA has already evaluated these data
and determined that they are valid (66
FR 4980, January 18, 2001).
Outreach: FSIS personnel will
conduct meetings and Webinars on the
final rule and will provide additional
information and guidance as needed. If
retailers cannot obtain point-ofpurchase materials over the Internet,
FSIS personnel will have copies of the
information to provide to retailers.
Six months prior to the effective date,
FSIS intends to make available nutrition
labeling materials that can be used at
the point-of-purchase of the major cuts
at the following Internet address:
https://www.fsis.usda.gov. Also, the Food
Marketing Institute (FMI) has made
available materials that can be used at
the point-of-purchase at the following
Internet address: https://www.fmi.org/
consumer/nutrifacts/.
In addition, the USDA National
Nutrient Database for Standard
Reference is developed and maintained
by the Agricultural Research Service
(ARS) and can be found on the Internet
at the following address: https://
www.ars.usda.gov\nutrientdata.
Information is available at this site for
ground beef products containing 5%,
10%, 15%, 20%, 25%, and 30% fat. In
addition, ARS has included a calculator
on the Internet, with the Database.
Parties can enter the amount of fat (5%
to 30% percent fat) or lean (70% to 95%
lean) in a particular raw ground beef
product, and the calculator will
calculate the nutrient values for the
product based on the fat value entered.
The USDA National Nutrient Database
for Standard Reference also includes a
set of tables with nutrient values for
ground pork with fat levels from 4% to
28%, in one percent increments. The
USDA Nutrient Database also includes
nutrient values for raw and cooked
ground chicken but does not include
nutrient values for such product at
varying fat levels. ARS also has
published nutrient values for ground
turkey with fat levels of 0%, 7%, and
15%. In the supplemental proposed
rule, FSIS provided examples of
nutrition labels for ground or chopped
products that would meet the
requirements of the final rule (74 FR
67742). Six months prior to the effective
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date, FSIS will make additional
examples of acceptable labels for such
products available on the Agency’s Web
site.
Effective Dates: The requirements for
ground or chopped products will
become effective on January 1, 2012.
FSIS issued a final rule to establish this
date as the uniform compliance date for
new food labeling regulations that are
issued between January 1, 2009, and
December 31, 2010 (73 FR 75564;
December 12, 2008). FSIS established
the uniform compliance date to
minimize costs associated with onpackage labels. Because this final rule
allows for the presentation of nutrition
information for the major cuts of singleingredient, raw meat and poultry
products at their point-of-purchase, no
change in on-package labels will be
necessary to effect this aspect of this
final rule. Thus, in the supplemental
proposed rule, FSIS proposed that the
labeling requirements for the major cuts
would be effective one year from the
date of publication of the final rule.
Because one year from the date of
publication will only be a few days
before the effective date for ground and
chopped products, January 1, 2012,
FSIS is also establishing January 1, 2012
as the effective date for the labeling
requirements for the major cuts.
Summary of and Response to
Comments
FSIS received 33 comments on the
supplemental proposed rule from
individuals, a consumer organization,
members of the regulated industry, trade
and professional associations, and a city
health department.
A summary of issues raised by
commenters and the Agency responses
follows.
Nutrition Labeling for the Major Cuts of
Single-Ingredient, Raw Meat and
Poultry Products
Comment: Many individuals, several
trade associations, a city health
department, a perishable items tracking
company, and an industry commenter
all generally supported required
nutrition information for the major cuts,
either on their label or at their point-ofpurchase. Several individuals and the
city health department stated that
providing this nutrition information
will help consumers make healthier,
informed food choices and will allow
them to monitor the amount of fat,
cholesterol, and sodium that they
consume. According to the city health
department, cardiovascular disease,
diabetes, and cancer are the leading
causes of death, disability, and
compromised quality of life in the
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United States. This commenter also
argued that these illnesses are
connected with nutrition, and improved
access to nutrition information through
nutrition labeling can help people
reduce their risk of developing these
illnesses. A trade association stated that
nutrition labeling allows consumers to
quickly differentiate between meat
products and identify leaner choices.
One individual stated that many people
need to check the specific nutritional
content of foods for medical reasons.
One individual stated that most
retailers do not participate in the
voluntary nutrition labeling program at
a significant level because the program
is voluntary.
A consumer organization, a city
health department, and an individual
supported the proposed rule but argued
that the final rule should mandate that
nutrition information for major cuts of
meat be provided through on-package
labels rather than point-of-purchase
materials. These commenters stated that
on-package labeling helps people make
more informed decisions. The consumer
organization noted that a recent
telephone survey showed an
overwhelming percentage (86%) of the
respondents preferred nutrition facts
labels on meat packages rather than
nutrition information on wall posters or
signs. The city health department and
the consumer organization argued that
point-of-purchase materials are not an
effective means of communication
because their success depends on
external factors, such as the retailer’s
placement of the point-of-purchase
materials and layout limitations in small
stores. The consumer organization and
one individual stated that some of the
disadvantages to using point-ofpurchase materials are that they are
hard to find, inconvenient to use, and
difficult to read and comprehend. One
individual also believed it was timeconsuming and embarrassing for
shoppers to read posters regarding
nutrition information. Another
individual stated that on-package
labeling allows consumers to quickly
compare products and provides the
nutrition information to other
consumers at home.
The consumer organization stated that
point-of-purchase materials are not
subject to any formal requirements
under the supplemental rule. The
consumer organization stated that FSIS
should specify format and placement
requirements for point-of-purchase
materials. This organization stated that
the USDA should work with the FDA to
update format and readability
requirements for posters. This
organization believed that posters are
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likely to omit many cuts or give them
a different name than what appears on
the package. The organization also
stated that USDA should conduct a
survey to determine whether consumers
are better served by on-package
nutrition labels than point-of-purchase
materials. According to this consumer
organization, many companies and
grocery chains already use on-package
nutrition labeling. Additionally, the
consumer organization stated that if
similar nutrition labels and labeling
equipment are required for ground
products, then retailers would not incur
substantial additional costs by adding
nutrition labels to major cuts.
The consumer organization disagreed
with FSIS’s position that consumers can
visually determine the difference in fat
content between various cuts. This
organization noted that a recent
telephone survey showed an
overwhelming percentage (80%) of
respondents could not determine which
cuts of meat had the least amount of fat.
The consumer organization suggested
that the USDA does not have any data
to support its assumption that
consumers can visually determine the
difference in fat content between
various cuts.
Several trade associations, an industry
commenter, and the food marketing
organization supported the option of
providing nutrition information for the
major cuts through point-of-purchase
materials. According to one trade
association, their retailer customers
believe nutrition labeling for meat is
more efficiently displayed via point-ofpurchase materials than on the product.
Response: As FSIS proposed, this
final rule will require that nutrition
information be provided for the major
cuts of single-ingredient, raw meat and
poultry products, either on the label or
at the point-of-purchase. FSIS agrees
that the final rule will produce health
benefits, including projected reductions
in the incidence of coronary heart
disease and three types of cancer that
may accrue as consumers improve their
diet quality through increased use of
nutrition information generated by the
final rule.
FSIS agrees with the individual that
stated that most retailers do not
participate at a significant level when
labeling is voluntary. In the two most
recent surveys from 1996 and 1999,
FSIS found that significant participation
in the voluntary nutrition labeling
program did not exist (see 66 FR 4973,
January 18, 2001; 74 FR 67736–67737,
December 18, 2009). In addition, since
the surveys were conducted, FSIS’s
LPDD has not seen an increase in the
number of labels that include nutrition
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information for the major cuts of singleingredient, raw meat and poultry
products. Further, FSIS’s OPEER also
has not seen an increase in the number
of packages of the major cuts of singleingredient, raw meat and poultry
products that have nutrition facts panels
on their labels at retail or an increase in
the availability of point-of-purchase
materials that provide nutrition
information for such products at retail
since the last compliance surveys were
conducted. These observations do not
constitute survey data but provide
additional meaningful information
based on the experience of FSIS’s LPDD
and OPEER. No evidence has been
submitted to FSIS that significant
participation in the voluntary program
now exists.
FSIS agrees that many consumers
cannot accurately assess the nutritional
content of the major cuts of singleingredient, raw products; however, we
continue to believe that point-ofpurchase nutritional information is
appropriate for these products.
While consumers cannot accurately
assess the nutritional content of the
major cuts of single-ingredient, raw
products, their ability to do so is greater
than in the case of ground products.
Ground products are processed in such
a way that fat content is very difficult
to visually ascertain. Internal marbling,
attached fat, and whether the product
has skin gives consumers some rough
indication of the fat content of the major
cuts of single-ingredient, raw products,
which leads FSIS to believe that the
benefits of on-package labeling may be
slightly less than with ground product.
FSIS notes, however, that consumers
still need nutrition information on
point-of-purchase materials for the
major cuts because consumers cannot
assess precise levels of fat (e.g., 10
grams vs. 20 grams of fat per serving)
and cannot know the levels of calories
or other specific nutrients, such as
saturated fat, in these products.
Based on comments received and the
Supplemental Proposed Rule Regulatory
Impact Analysis, FSIS believes that
requiring on-package labeling for the
major cuts of single-ingredient, raw
products is also likely to be significantly
more costly than for ground products
because it would require on-package
labeling on a larger volume of product.
In the Supplemental Proposed Rule
Regulatory Impact Analysis, FSIS
estimated that the annualized average
present value of the costs of requiring
nutrition labels on the major cuts of
single-ingredient, raw meat and poultry
products would be $16.48 million more
than the annualized average present
value of the costs of requiring nutrition
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labels on all ground or chopped
products, without taking into account
the current level of voluntary
compliance (74 FR 67789).
As discussed in the proposed rule and
in the supplemental proposed rule, FSIS
believes it will be relatively easy to
prepare point-of-purchase materials for
the major cuts because the nutrient
content of a given major cut is relatively
uniform across the market, and these
products are not formulated in the
manner of ground or chopped products
(66 FR 4974, January 18, 2001) (74 FR
67737, December 18, 2009). To ensure
that this is the case, FSIS is making
available nutrition labeling materials
that can be used at point-of-purchase
over the Internet free of charge.
FSIS acknowledges the concern
expressed by an individual and by the
consumer organization about the
location of point-of-purchase materials,
but believes that it is currently
addressed in the regulations (9 CFR
317.345(a)(3) and 381.445(a)(3)) which
require that point-of-purchase materials
be made available in close proximity to
the food. In addition, FSIS personnel
will also visit stores to verify that they
are following this and the other
requirements.
In response to the comment that noted
that an advantage of including nutrition
information on the label is that
consumers can review the nutrient
content of the product once the product
is taken home, and that others besides
the primary food purchaser would have
better access to this information,
surveys, including the Diet and Health
Knowledge Survey (DHKS), show that a
majority of individuals report using
labels while buying foods. Although the
DHKS shows that adults who are not
main household shoppers use labels, the
survey shows that the main shoppers
use labels at a higher rate than those
who are not main household shoppers.
If individuals in a household have
certain nutrition practices and needs,
the person who purchases food for the
household would likely take other
household members’ needs and
preferences into account. In this case,
the entire household would ultimately
receive the benefits of the nutrition
information. Further, other household
members besides the primary food
purchaser will be able to obtain
nutrition information for the major cuts
on the Internet on FSIS’s Web site,
ARS’s Web site, and FMI’s Web site.
FSIS agrees that consumers cannot
accurately judge the nutritional content
of the major cuts of single-ingredient,
raw products, and that the mandatory
provision of this information to
consumers is warranted and
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appropriate. However, for the reasons
described above, we believe that pointof-purchase information is appropriate
for these products.
Comment: Several individuals and
trade associations, one food marketing
organization, and an industry
commenter opposed the proposed rule
to require nutrition information for the
major cuts, either on their label or at
their point-of-purchase. These trade
associations and the food marketing
organization stated that FSIS should
maintain its existing voluntary program.
One trade association and the food
marketing organization advocated that
the USDA should conduct a new
compliance survey because it is likely
that the level of participation in the
voluntary nutrition labeling program
has increased beyond the ‘‘significant
participation’’ threshold because of
changes in the composition of the retail
sector over the past decade, and because
of efforts by FMI to encourage the
widespread use and dissemination of
Nutri-Facts materials. These
organizations stated that the last USDA
survey for compliance is outdated
because it was conducted in 1999, and
should not be the basis for promulgating
the rule. The food marketing
organization noted that the regulations
that require FSIS to evaluate the level of
participation in the voluntary nutrition
labeling program every two years
remain in effect. One trade association
stated that maintaining the voluntary
program will be less costly and will
help the industry. According to this
trade association, FSIS could increase
voluntary compliance by making the
same updated nutrition information
available free of charge to retailers as it
planned to make available under the
proposed rule. Several trade
associations stated that if individual
consumers wanted more specific
nutrition information about a particular
product, they could access it through
other sources like the Internet. An
industry commenter noted that if there
was sufficient consumer demand for
more nutrition information, then
retailers would have an economic
incentive to voluntarily supply it.
One trade association did not agree
with FSIS’s position that major cuts of
single-ingredient raw, meat and poultry
products that do not bear nutrition
information on their labels or on pointof-purchase materials are misbranded.
Another trade association believed that
there were few significant differences in
the nutritional values among the various
brands of young chicken, and that
nutrition information for singleingredient chicken is not that useful
because most people add ingredients to
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it during cooking that alter the calories,
fat, and protein. For those reasons, the
poultry trade association stated that
there is no need to mandate nutrition
labeling for the major cuts, and FSIS
should maintain its existing voluntary
nutrition labeling program for the major
cuts. Several individuals stated that
consumers already have a general idea
of the average nutritional value of major
cuts of meat and poultry products.
Response: FSIS encouraged
participation in the voluntary nutrition
labeling program through meetings with
industry. Additionally, nutrition
labeling materials for the major cuts
have been available on FMI’s Web site
for several years (https://www.fmi.org).
Despite this, and FSIS’s encouragement
of the use of such materials, the 1999
voluntary nutrition labeling survey
found a lower rate of participation than
the 1996 survey found. Thus, the fact
that nutrition information was available
was insufficient to ensure that
consumers received this necessary
nutrition information. By making the
guidelines for the voluntary nutrition
labeling program mandatory, FSIS will
ensure that consumers are provided
with sufficient information to assess the
nutrient content of the major cuts and
enable them to select foods that fit into
a healthy diet that meets their
individual needs.
FSIS’s regulations provide that the
Agency would evaluate significant
participation every 2 years
(§§ 317.343(e) and 381.443(e)). Although
FSIS did not conduct the surveys
precisely 2 years apart, the Agency did
conduct the surveys approximately
every two years until 1999 (74 FR
67748, December 18, 2009), and the
surveys failed to show significant
participation. Because significant
participation did not exist, FSIS
proceeded with rulemaking.
Under § 317.4, FSIS’s LPDD reviews
labels on meat and poultry products that
have been submitted for approval. Based
on its label review, FSIS has not seen an
increase in nutrition labeling of the
major cuts of single-ingredient raw,
meat and poultry products since the
surveys were conducted. Compliance
investigators in FSIS’s OPEER also have
not seen an increase in the number of
packages of the major cuts of singleingredient, raw meat and poultry
products that have nutrition facts panels
on their labels at retail or an increase in
the availability of point-of-purchase
materials that provide nutrition
information for such products at retail
since the last compliance surveys were
conducted. Because (i) the most recent
surveys showed that significant
participation in the voluntary nutrition
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labeling program did not exist, (ii)
FSIS’s LPDD has not seen an increase in
nutrition labeling of the major cuts of
single-ingredient raw, meat and poultry
products and ground or chopped meat
and poultry products since the surveys
were conducted, (iii) FSIS’s OPPER has
not seen an increase in nutrition
labeling of the major cuts of singleingredient raw, meat and poultry
products at retail or an increase in the
availability of point-of-purchase
materials that provide nutrition
information for the major cuts at retail
since the last compliance surveys were
conducted, and (iv) no other evidence
has been submitted to FSIS that
significant participation in the
voluntary program now exists, FSIS has
concluded that this final rule is
necessary.
In response to the comment that
maintaining the voluntary program will
be less costly and will help the industry,
this final rule makes the guidelines for
the voluntary nutrition labeling program
mandatory, so the costs for the industry
should not increase for stores that are
following the guidelines.
In response to the statement that if
there was sufficient consumer demand
for more nutrition information, then
retailers would have an economic
incentive to voluntarily supply it,
market forces have not been great
enough to ensure significant
participation in the voluntary nutrition
labeling program. This fact could be
evidence that consumers are not willing
to pay for this information. However, as
is explained above, FSIS believes that
consumers can generally estimate the fat
content of the major cuts of meat and
poultry products, but nonetheless, they
need more precise information about the
nutrient content of the major cuts in
order to make a fully informed
comparative judgment about the various
cuts.
FSIS has concluded that without
nutrition information for the major cuts
of single-ingredient, raw meat and
poultry products, these products will be
misbranded under the FMIA and the
PPIA (21 U.S.C. 601(n)(1) and 453
(h)(1)). Without nutrition information
on their labeling, FSIS has concluded
that the labeling of these products will
be false or misleading because it will
not provide consumers with sufficient
information to assess the nutrient
content of the major cuts and will not
enable consumers to select major cuts
that fit into a healthy diet that meets
their individual needs.
In response to the comment that
nutrition information for singleingredient chicken is not that useful
because most people add ingredients to
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it during cooking that alter the calories,
fat, and protein, the final rule allows
nutrition information to be declared on
either an ‘‘as packaged’’ basis or an ‘‘as
consumed’’ basis. The point-of-purchase
materials and the labels clearly inform
consumers whether the nutrition
information provided is ‘‘as packaged’’
or ‘‘as consumed.’’ Consistent with the
provisions in the voluntary nutrition
labeling program, when nutrition
information is presented on an ‘‘as
consumed’’ basis, retailers or
manufacturers will be required to
specify a method of cooking that will
not add nutrients from other ingredients
such as flour, breading, and salt
(§§ 317.345(d) and 381.445(d)).
Comment: Several trade associations
asserted that the list of major cuts needs
to be updated. One trade association
stated that, according to The National
Pork Board meat scanner data, pork
whole loin, pork shoulder picnic, pork
shoulder Boston butt, pork sirloin chop,
pork center chop, and pork rib roast
should be added to the list of major
cuts. One trade association stated that
FSIS should review the list of major cuts
based on market share and availability
because there are still cuts on the list of
major cuts for which data reflective of
trim levels sold at retail is not currently
available. One trade association was
concerned that if the USDA does not
update the list, but rather makes a
change to the list later, then retailers
will incur the $5.67 million cost to
purchase and install posters again.
Response: Because FSIS did not
propose to amend the codified list of
major cuts in the regulations and did
not provide an opportunity for the
public to comment on proposed changes
to the list, FSIS is not amending the list
of major cuts in the regulations at this
time. FSIS acknowledges that the
codified list of major cuts may need to
be updated. FSIS intends to assess the
need to update the list and to update it
as necessary when resources permit.
Establishments or retail facilities may
choose to provide nutrition information
for the non-major cuts, either at pointof-purchase, in accordance with
§ 317.345 or § 381.445, or on their label,
in accordance with § 317.309 or
§ 381.409.
Comment: The consumer organization
argued that the number of servings
should be required on all major cuts.
This organization stated that many
retailers now have the ability to
calculate the number of servings in a
package. As an example, this
organization suggested that companies
could determine the number of servings
for the major cuts based on the number
of pieces of meat in the package and
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their average weights. According to this
organization, the number of servings
reminds consumers that a package has
multiple servings, and that if someone
eats more than one serving, the
nutrients consumed will increase. This
commenter stated that most consumers
eat more than the USDA standard
serving size of 4 oz. of meat or poultry,
and single-serving packages of meat or
poultry contain more than 4 oz. This
commenter also stated that nutrition
facts should be provided for the entire
package if the single serving package
exceeds 4 oz. Alternatively, the
commenter stated that the package
should be required to include a
disclaimer such as: ‘‘Nutrition Facts are
based on a 4 oz. serving. This package
may contain a serving larger than 4 oz.’’
Finally, the commenter stated that the
USDA also needs to update its standard
serving size upward to reflect actual
consumption.
Response: The number of servings per
container is not necessary information
on the nutrition labels or point-ofpurchase materials of the major cuts or
non-major cuts of single-ingredient, raw
products because these products are
typically random weight products. For
multi-ingredient and heat-processed
products that must bear nutrition labels,
the number of servings is not required
on random weight products because the
weight statement is applied at retail.
The weight of such products varies from
package to package
(§§ 317.309(b)(10)(iii),
381.409(b)(10)(iii), 317.2(h)(9) and
381.121(c)(9)) (74 FR 67747, December
18, 2009).
The request to change and update
USDA’s standard serving size is outside
the scope of this regulation.
Comment: One individual and a trade
association were concerned that
consumers would not understand that
the nutrition information for the major
cuts will be based on averages of
nutrient content data for that cut of meat
or poultry. The trade association
questioned whether there should be an
explanation on the package regarding
the potential variation from the average,
so consumers will not be misled. The
individual suggested that there should
be a disclaimer on the label regarding
the potential variation from the average.
Response: FSIS does not believe an
explanation regarding potential
variability of nutrition information is
necessary for single-ingredient cuts. All
nutrition information is based on
average values. Compliance
requirements in 9 CFR 317.309 and
381.409 allow for a twenty percent
variation before regulatory action is
taken against products.
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Comment: The consumer organization
stated that nutrition facts should be
provided on an ‘‘as packaged’’ basis
rather than on an ‘‘as consumed basis’’
because consumers may alter the
product in ways that could affect the
nutrient content before eating.
Response: As proposed, for the major
cuts and non-major cuts of singleingredient, raw products, this final rule
will allow nutrition information on the
label or on point-of-purchase materials
to be declared on either an ‘‘as
packaged’’ basis or an ‘‘as consumed’’
basis because most of these products
will not be subject to FSIS nutrient
analysis. If nutrition information for
these products is based on USDA’s
National Nutrient Database for Standard
Reference, and there are no claims on
the labeling, FSIS will not conduct a
nutrient analysis of these raw products
and, therefore, will not evaluate ‘‘as
packaged’’ nutrition labeling
information for these products.
Consistent with the provisions in the
voluntary nutrition labeling program,
when nutrition information is presented
on an ‘‘as consumed’’ basis, retailers or
manufacturers will be required to
specify a method of cooking that will
not add nutrients from other ingredients
such as flour, breading, and salt
(§§ 317.345(d) and 381.445(d)) (74 FR
67747, December 18, 2009).
Mandatory Nutrition Labeling for
Ground or Chopped Products
Comment: Many individuals, several
trade associations, a city health
department, an industry commenter,
and a perishable items tracking
company supported mandatory onpackage nutrition labeling for ground or
chopped products. Several of those
trade associations and the city health
department specifically supported
FSIS’s proposal to require on-package
labeling as opposed to allowing for
nutrition information at point-ofpurchase. One of these trade
associations stated that on-package
labeling is needed because fat content is
difficult to see in ground products. Two
of the trade associations noted that
plants produce ground meats at specific
lean/fat ratios, and that the amount of
fat is easy to control. One trade
association stated that plants provide
nutritional data to retailers, and that
data can easily be added to a nutrition
facts panel.
Two trade associations and the city
health department believed that onpackage labeling is the most beneficial
for consumers. One of the trade
associations questioned whether
consumers actually use point-ofpurchase materials for ground or
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chopped products and questioned the
feasibility of developing point-ofpurchase materials for such products.
The city health department argued that
point-of-purchase materials for ground
or chopped products are not an effective
means of communication because their
success depends on external factors
such as the retailer’s placement of the
point-of-purchase materials and layout
limitations in small stores. One trade
association stated that point-of-purchase
materials increase redundancy and cost
because most retailers have nutrition
data that can be easily distributed
among retailers and added to a nutrition
facts panel.
Several trade associations and the
food marketing organization supported
the option to provide nutrition
information for ground and chopped
products at point-of-purchase. One of
the trade associations believed that
point-of-purchase materials allow
consumers to make more informed
choices concerning the purchase of
ground or chopped products because
they are consistently displayed and
more efficient than on-package labeling.
This commenter stated that retailers are
limited because of the small number of
meat case staff and the available space
on ground or chopped product
packages. According to the food
marketing organization, point-ofpurchase materials allow consumers to
easily compare products. The
organization also was concerned that
consumers would not be able to visually
inspect the product because of the large
label required to be able to list the
nutrition information, food safety
information, and cooking instructions.
This organization also suggested that
important food safety information
would not be as prominent once
nutrition information is added to the
label.
One trade association and the food
marketing organization asserted that
allowing the use of point-of-purchase
materials will reduce the financial
burden on retailers and benefit
consumers. These commenters stated
that FSIS underestimated the cost of
providing nutrition labels on ground
and chopped products. According to
these commenters, FSIS did not account
for the number of retailers that would
have to buy new printer or scale systems
at the store level. Additionally, one
trade association stated that retailers
that provide on-site custom services
would have to increase prices or only
sell case-ready meat because of the
increased costs. The food marketing
organization was concerned that
retailers may be forced to eliminate
some of their product choices because of
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the cost of testing and verifying the
nutrient values for each nutrition label.
The food marketing organization
claimed that effective point-of-purchase
materials for ground and chopped
products could be developed. One trade
association suggested that there could
be standardized posters for other ground
or chopped products, similar to the ones
currently used for ground beef. An
industry commenter noted that
producers supply retailers with ground
products based on established finished
lean/fat ratios, which do not differ
among retailers. The industry
commenter suggested that nutrition
information for these lean/fat ratios
could be used on point-of-purchase
materials, and consumers could match
the lean/fat ratio on their ground
product with the nutrition information
for that lean/fat ratio on the point-ofpurchase materials. The commenter also
stated that if a retailer uses a different
lean/fat ratio than is provided on the
point-of-purchase materials, it would
have to put the nutrition information on
the individual package.
A trade association, an industry
commenter, and the food marketing
organization stated that FSIS should
maintain its existing voluntary program
for nutrition labeling of ground or
chopped products. The food marketing
organization believed that there was no
need to require mandatory on-package
labeling for ground and chopped
products.
Response: FSIS will require onpackage nutrition information for these
products rather than allowing nutrition
information to be provided at their
point-of-purchase for the reasons stated
above. Because there are numerous
formulations of ground or chopped
products, as a practical matter, it would
be difficult for producers or retailers to
develop point-of-purchase materials that
would address all the different
formulations that exist for these
products. Furthermore, it would be
difficult for consumers to find the
correct information for a specific ground
or chopped product on point-ofpurchase materials that include
information concerning numerous
formulations of these products (66 FR
4977, January 18, 2001). If a statement
of the fat percentage and lean
percentage is not included on a package
of ground product, consumers would
not know which nutrient data
concerning ground product on point-ofpurchase materials would apply to that
particular ground product.
Establishments and retailers are not
required to provide such a statement
and will not be required to provide such
a statement when this rule becomes
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effective (74 FR 67750, December 18,
2009).
Information concerning the
nutritional qualities of ground or
chopped meat and poultry products is
particularly important because these
products, especially ground beef, are
widely consumed. Based on a Beef Sales
Survey at retail markets in the United
States over 52 weeks ending March 23,
2010, ground beef sales were about $5.6
billion for about 2.1 billion pounds,
excluding the ‘‘other’’ category of ground
beef for chili, meatloaf, meat balls, and
trim (source: FreshLook Marketing,
available at https://beefretail.org/
GroundBeefCategoryBreakdown.aspx).
According to the summary of results on
the National Cattleman’s Beef
Association Web site, ground beef
accounts for about 66 percent of all
fresh beef eatings (servings) in-home
(source: NPD National Eating Trends
(NET) Research, Two Years Rolling
August 2009, available at https://
beefretail.org/
individualpenetrationbybeefcut.aspx).
Additional information about the
nutrient values of ground or chopped
meat and poultry products will enable
consumers to make informed decisions
about including these products in their
diets and will, therefore, help
consumers to construct healthy diets (74
FR 67750, December 18, 2009).
Thus, this final rule will require
nutrition labels on all ground or
chopped meat and poultry products,
with or without added seasonings,
unless an exemption applies. These
products are similar to multi-ingredient
products in the mandatory nutrition
labeling program (which requires
nutrition information to be on the label
of individual packages). Just as
producers can control the incoming
ingredients and levels of such
ingredients in multi-ingredient
products, producers can precisely
control the fat content of ground or
chopped products to obtain the desired
product. In addition, just as consumers
cannot often see all the ingredients in
multi-ingredient products, consumers
cannot easily see the fat in ground or
chopped products. The fat is uniformly
distributed throughout the product and
is not clearly distinguishable on the
surface of the product. Therefore,
consumers cannot estimate the fat levels
in these products and cannot compare
the fat levels in these products to those
in other products. Thus, it is difficult for
consumers to have a reasonable
understanding of the nutritional quality
of these products (74 FR 67750,
December 18, 2009).
Many grocers and manufacturers
provide nutrition facts panels on ground
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beef products. Therefore, FSIS questions
why certain commenters stated that
there is not sufficient room on the label
of these products for nutrition
information (74 FR 67750, December 18,
2009). FSIS disagrees with the comment
that consumers will not be able to
visually inspect the product because of
the large label required to list the
nutrition information, food safety
information, and cooking instructions.
As with the Safe Handling Instructions
(SHI) and cooking instructions,
nutrition labeling information can
appear off the principal display panel
(PDP). Many retailers place SHI on the
bottom or side panels of packages to
allow consumers to visually inspect the
largest amount of product. There should
be sufficient space available on these
panels for nutrition facts information to
appear off the PDP.
Additionally, the nutrition labeling
requirements for ground or chopped
products should not be particularly
difficult for small operations, since
ground or chopped product produced
by retail establishments and Federal
establishments that meet specific small
business criteria will be exempt from
nutrition labeling requirements
(§§ 317.400(a)(1) and 381.500(a)(1)) (74
FR 67750, December 18, 2009).
Moreover, an exemption from the
nutrition labeling requirements, which
is provided in this final rule, should
alleviate any concerns that nutrition
labeling requirements will discourage
retailers from grinding product based on
customers’ requests. This final rule
provides an exemption from nutrition
labeling requirements for ground or
chopped products that are ground or
chopped at an individual customer’s
request and that are prepared and
served or sold at retail, provided that
the labels or labeling of these products
bear no nutrition claims or nutrition
information (74 FR 67750, December 18,
2009).
If a customer selects an intact product
for purchase and requests that the
product be ground at the retail facility,
FSIS has determined that nutrition
information on the package of the
ground product would not be necessary.
In this instance, the customer has made
the decision to purchase the product
before it was ground. The customer is
not selecting the product from among
various, formulated, ground or chopped
product, and thus the reasons for
requiring a nutrition label on such a
product would not be applicable here
(74 FR 67750, December 18, 2009).
Moreover, the product selected may
already be the subject of nutrition
labeling as a raw, single ingredient
product.
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Many of the suppliers of coarse
ground products that are then ground
and packaged at retail have supplied, or
can supply, the nutrition facts panels for
the retailers. Most retailers offer a
limited selection of ground beef
products. Thus, dozens of different
nutrition labels for each retailer will not
be necessary. In addition, information
for ground beef and other products is
available through the National Nutrient
Database for Standard Reference.
Finally, the requirements for on-package
nutrition labeling for ground or chopped
products will not be effective until
January 1, 2012 (74 FR 67753, December
18, 2009).
In response to the comments that FSIS
underestimated the costs of developing
and providing nutrition labels for
ground and chopped products, FSIS
does not believe that it has
underestimated the costs. Since the
Supplemental Proposed Rule Regulatory
Impact Analysis was done, the total
costs of labeling may have even
decreased because of more cost-effective
technology, such as less expensive
computerized flexography and scalelabel printers. The additional costs of
labeling would be relatively low for the
affected businesses. In addition, this
final rule exempts small businesses that
produce ground or chopped product
from nutrition labeling requirements.
Comment: The consumer organization
argued that nutrition labels for ground
meats should list the number of servings
in the package. In the alternative, the
commenter stated that the package
should be required to include a
disclaimer such as: ‘‘Nutrition Facts are
based on a 4 oz. serving. This package
may contain two or more servings, some
or all of which exceed 4 oz.’’
Response: As discussed above, FSIS is
not requiring that the number of
servings per container be declared for
the major cuts of single-ingredient, raw
meat and poultry products because all
of these products are random weight
products, and the number of servings is
not required on random weight products
(see §§ 317.309(b)(10)(iii) and
381.409(b)(10)(iii)) (66 FR 4974, January
18, 2001). FSIS is not requiring that the
number of servings per container be
declared for ground or chopped meat
and poultry products because these are
also random weight products. Even
though the number of servings per
container are not declared on ground or
chopped products, FSIS believes that
on-package nutrition information is still
meaningful to consumers because it is
based on a stated serving size and
allows consumers to make comparisons
among products.
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Comment: One trade association
opposed requiring nutrition labels on
multi-ingredient ground beef retail
processed products or ready-to-eat-retail
packaged products.
Response: FSIS believes that all
ground beef and hamburger products,
unless an exemption applies, should be
required to include nutrition facts
information. If multi-ingredient ground
beef products were permitted an
exemption, it would encourage firms to
add seasoning to ground beef and
hamburger products as a way to avoid
providing nutrition facts information.
Seasonings often include substances,
such as salt and sugar, that can
significantly alter the nutritional profile.
Thus, there is a need for nutrition
labeling information on such products.
Comment: One industry commenter
noted that there is no significant change
in calcium and iron values for finished
ground products that contain common
industry levels of AMR or low
temperature rendered product from that
of finished ground products that do not
contain these products. This commenter
asserted that additional testing should
not be required for products that contain
AMR or LTR products.
Response: No additional testing will
be required for products that contain
meat derived from advance meat
recovery systems or low temperature
rendered products, such as finely
textured beef (FTB) or lean finely
textured beef (LFTB). 9 CFR 318.24(c)
limits the calcium and iron content of
meat derived from AMR systems. In
comparison, meat trimmings only need
a minimum of 12% lean tissue to be
considered ‘‘meat,’’ and the standard of
identity for ground beef and hamburger
(9 CFR 319.15(a) and (b), respectively)
limit the fat content to no more than
30%. There is also no upper regulatory
limit on the use of meat derived from
AMR systems or the use of FTB or LFTB
in ground beef. Therefore, a wide range
of possible formulations for ground beef
and hamburger exist that could result in
significant differences in the fat content.
These facts support the need for
nutrition labeling.
Comment: One farmer did not believe
FSIS should treat ground or chopped
beef as a ‘‘single ingredient’’ product
because it normally comes from a large
number of animals. According to the
commenter, if FSIS continues to treat
ground or chopped beef as a ‘‘single
ingredient’’ product, then the label
should be required to indicate the
sources of each and all animals
contained in the package.
Response: Ground beef production
does typically involve multiple animals.
However, all animals are from the same
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species. Previous regulations defined
certain ground beef products as major
cuts of single-ingredient raw products (9
CFR 317.344). FSIS is not re-defining
ground beef products that do not
include ingredients in addition to
ground beef as multi-ingredient
products. However, as is explained in
this preamble, FSIS considers ground
beef products to be formulated products.
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No Requirements for Non-Major Cuts
Comment: Several trade associations
supported the proposal not to require
nutrition labeling on non-major cuts
that are not ground or chopped. One of
those trade associations questioned
whether it would be misleading for
consumers to see nutrition information
about one product, but no nutrition
information on another product within
the same retail case. Additionally, one
individual and the city health
department argued that nutrition
labeling should be mandatory for all
products, including meat and poultry
products.
Response: At this time, FSIS is not
requiring that nutrition information be
provided for non-major cuts of singleingredient, raw products that are not
ground or chopped. The Agency has
concluded that it is not necessary to do
so at this time. FSIS stated in the
proposed rule that it intended to
examine the current state of nutrition
labeling for single-ingredient, raw
products that are not ground or chopped
and that are not considered to be major
cuts (66 FR 4974, January 18, 2001).
FSIS still intends to conduct this
assessment. Once this rule is effective,
FSIS will examine and assess the
adequacy of the nutrition information
provided for the major cuts and will
also determine whether and to what
extent nutrition information is being
made available for the non-major cuts
and whether it is necessary to consider
a rule requiring such information be
provided.
Permitting Percent Lean Statements on
Labels or in Labeling of Ground or
Chopped Products
Comment: The majority of
commenters on this issue supported the
proposal to permit the use of the
statements of lean percentages on the
label or in labeling of ground or
chopped products that do not meet the
regulatory criteria for ‘‘low fat.’’
According to several consumer survey
results provided by trade associations,
consumers use both lean and fat
percentages to determine the type of
product to buy. Several trade
associations stated that consumers need
the lean and fat percentages to quickly
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determine whether the product is
suitable for their needs. An industry
commenter and the food marketing
organization noted that recipes, child
nutrition programs, and health and
dietary requirements identify and refer
to ground products by their lean
percentage. The food marketing
organization believed lean statements
were complementary, not redundant. A
trade association believed that not
allowing lean percentage statements
will omit key information. According to
one trade association, the industry
would be unlikely to use only a fat
percentage statement because the
majority of beef is sold using lean/fat
ratios.
One trade association stated that,
based on a consumer survey, consumers
are not misled by %lean/%fat
statements. An industry commenter
stated that consumers were confused in
1993 when FSIS’s nutrition labeling
regulation did not allow %lean to be
used on ground products that did not
meet the regulatory criteria for ‘‘low fat.’’
Also, a trade association noted that
%lean/%fat ratios are needed on the
label to avoid confusion with %lean
claims, which are defined differently
and used for other products.
Additionally, the food marketing
organization argued that consumers may
purchase products higher in fat because
they would be provided with less
information if only ‘‘low fat’’ products
could have lean/fat percentages.
Moreover, a trade association stated that
consumers benefit from consistent
labeling and purchasing options.
One individual argued that if lean
percentages are maintained, they should
follow the fat percentages in a smaller
letter size to reduce consumer
confusion. Also, the individual noted
that this labeling would ensure that
people do not focus on only the lean
percentage statement without regard to
the fat percentage statement. According
to this individual, all of the examples of
nutrition labels in the Federal Register
begin with the fat percentage. However,
one trade association suggested that the
use of %fat/%lean claims be an option
for manufacturers, not a regulatory
requirement.
A poultry trade association and the
consumer organization did not support
the use of statements of lean percentages
on the label or in labeling of ground or
chopped products that do not meet the
regulatory criteria for ‘‘low fat.’’ These
commenters stated that the use of a lean
statement is misleading to consumers if
the product does not also qualify as
‘‘low fat.’’ According to the consumer
organization, FSIS’s policy would be
inconsistent with FDA’s policy that
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prohibits the term ‘‘_ percent fat free’’ on
all foods that are not low in fat to
prevent consumers from being misled.
The trade association stated that FSIS
should maintain a consistent policy for
use of the phrase ‘‘low fat’’ and similar
statements.
One individual and the consumer
organization argued that lean percentage
statements should not be permitted on
labels or labeling of ground or chopped
products because they are redundant
and misleading. According to the
consumer organization and its consumer
survey data, percent lean claims are
misleading because they imply that the
product is low in fat and leaner than
other meat and poultry products. This
consumer organization noted that the
use of fat percent claims with lean
percent claims does not prevent
consumers from being misled.
According to the commenter, consumers
cannot compare lean and fat percentage
statements on ground products to other
food products because only milk
products use percent fat statements.
This consumer organization believed
that if lean percent claims are used,
many people will only look at them and
will not look at the nutrition facts panel.
This consumer organization stated that
consumers do not need lean percent
claims because they can get all the
necessary information from the fat
percent claims.
Response: The final regulations
permit a statement of lean percentage on
the label or in labeling of ground or
chopped meat and poultry products that
do not meet the regulatory criteria for
‘‘low fat.’’ The regulations require that a
statement of fat percentage be
contiguous to, in lettering of the same
color, size, and type as, and on the same
color background as, the statement of
lean percentage. The regulations permit
the use of %lean/%fat statements or
%fat/%lean statements on the label or
in the labeling of ground or chopped
meat and poultry products. (74 FR
67752, December 18, 2009).
Trade associations presented
information from consumer surveys that
showed that consumers understood the
meaning of statements of lean and fat
percentages on ground beef and
supported the use of these statements.
Based on the survey information
provided, the majority of consumers
believe %lean/%fat designations are
important information and use them
when choosing which ground beef
products to purchase.
Producers, according to industry,
have been using lean percentage
statements on the labeling of ground
beef and hamburger products for over 30
years (59 FR 26917, May 24, 1994).
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Because the percent fat statement must
be contiguous to the percent lean
statement and must be in lettering of the
same color, size, and type as, and on the
same color background as, the lean
percentage statement, FSIS believes that
the percent lean statements will not
mislead consumers, even if they are
used on products that do not qualify as
‘‘low fat’’ under the regulatory criteria
(74 FR 67752, December 18, 2009).
Lean/fat ratios allow consumers to
readily identify and differentiate
between all ground or chopped meat
and poultry products and will assist
consumers in selecting leaner versions
of these products and will provide an
incentive for manufacturers to market
products lower in fat (66 FR 4972,
January 18, 2001).
As one trade association stated,
producers may include a percent fat
statement on the label or in labeling of
ground products without including a
percent lean statement, though unlikely.
A percent fat statement on ground or
chopped products would be an
acceptable alternative to a statement of
lean and fat percentage. Because of the
longstanding use of the statements of
percent fat and percent lean on the label
or in labeling of ground beef and
hamburger products, FSIS believes such
statements on the label or in labeling of
ground products will not mislead
consumers (74 FR 67752, December 18,
2009).
Comment: A trade association and the
food marketing organization supported
the proposal that small businesses that
produce ground or chopped product
and include a statement of lean
percentage and fat percentage on the
product’s label or in the labeling would
not be required to include nutrition
information on the product label, unless
they include other nutrition claims or
information on the product label. The
food marketing organization stated that
the flexibility for small businesses
should be maintained. Otherwise,
according to the commenter, an undue
economic hardship on small businesses
could result in a competitive
disadvantage for small businesses. This
food marketing organization also did not
believe this proposed exemption from
nutrition labeling requirements would
mislead consumers.
Several trade associations and an
industry commenter stated that
nutrition information should be
required on the labels of any ground or
chopped product for which a lean
percentage and a fat percentage
statement is provided on the label or in
the labeling, regardless of the size of the
business making the product. The
industry commenter also believed that
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all ground or chopped products should
be labeled with a percent lean statement
because consumers need consistent
information to compare products and
make informed decisions. One trade
association argued that there is no need
for a small business exemption because
small businesses purchase raw materials
from larger businesses, which provide
nutrition labeling in the proper format
for all fat contents of bulk coarse or fine
ground products to any store that
purchases their products. According to
this trade association, the labels are
provided for use at point-of-purchase at
no cost to the retailer or distributor.
Another trade association expressed
concern because small businesses can
produce a significant quantity of meat
and poultry products per year. This
trade association believed there should
only be exemptions for very, very small
companies that receive Federal
inspection and market to a local
customer base.
Response: This final rule maintains
that small businesses that use
statements of percent fat and percent
lean on the label or in labeling of
ground products would be exempt from
nutrition labeling requirements,
provided they include no other
nutrition claims or nutrition
information on the product labels or
labeling. As discussed in the
supplemental proposed rule, based on
the National Cattleman’s Beef
Association (NCBA) National Meat Case
Study in 2004, 93 percent of ground
beef packages had statements of lean or
fat percentages (74 FR 67741). Sixtyeight percent of packages with such
statements had nutrition facts panels
and 25 percent did not have nutrition
facts panels but had lean or fat
percentages (74 FR 67741). Seven
percent did not have any statements of
lean or fat percentages. Because about
95 percent of grinders are small
businesses, FSIS concluded that many
of the 25 percent of packages that
included lean or fat percentage
statements without nutrition facts
panels were produced by small
businesses. Therefore, FSIS believes
many small businesses include
statements of lean or fat percentage on
the label of their ground products but
not the nutrition facts panel. Also,
because of the longstanding use of the
statements of percent fat and percent
lean on the label or in labeling of
ground beef and hamburger products,
FSIS believes that such statements on
the label or in labeling of ground
products produced by small businesses
will not mislead consumers, even if the
small businesses do not include
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nutrition information on the products’
labels (74 FR 67741). Many consumers
have become accustomed to this
labeling on ground beef products, and
FSIS believes that this labeling provides
a quick, simple, and accurate means of
comparing ground or chopped meat and
poultry products. Based on the survey
information provided, the majority of
consumers believe %lean/%fat
designations are important information
and use them when choosing which
ground beef products to purchase.
Therefore under the final rule, small
businesses that use statements of
percent fat and percent lean on the label
of ground products, provided they
include no other nutrition claims or
nutrition information on the product
labels or labeling, are exempted from
the nutrition labeling requirements.
To qualify for the small business
exemption from the nutrition labeling
requirements under §§ 317.400(a)(1) and
381.500(a)(1), a meat or poultry product
must be produced by a single-plant
facility or multi-plant company/firm
that employs 500 or fewer people and
produces no more than 100,000 pounds
of the product annually, provided that
the label for the product bears no
nutrition claims or nutrition
information. In response to the
comment that small businesses can
produce a significant amount of meat
and poultry products per year, if a small
business produces more than 100,000
pounds of a particular product, then the
small business no longer qualifies for
the exemption from nutrition labeling
requirements for that product. In
connection with the 1993 final rule on
nutrition labeling of meat and poultry
products, FSIS evaluated several
options in establishing a poundage limit
for the small business exemption (58 FR
633). Based on that evaluation, FSIS
continues to believe that an annual
production poundage level of 100,000
pounds sets the limit high enough so
that the risk that any small business
would have to close would be minimal,
and sets the limit low enough so that the
maximum volume of total production
would bear nutrition labeling (see 58 FR
633, 638 for more discussion of the
analysis of the poundage limits). The
limit on the number of employees at a
firm is set at 500 or fewer employees,
which is the Small Business
Administration’s definition of a small
meat or poultry processing firm. This
approach allows the Small Business
Administration to assist in determining
which firms would qualify for the small
business exemption based on the
number of employees (58 FR 638).
Comment: One trade association
stated that %lean/%fat claims should
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only be allowed on ground products,
and that %Lean, Lean, and Extra Lean
claims should be applied across all meat
and poultry products.
Response: Current regulations address
the use of these claims (9 CFR
317.362(b)(6) and 381.462(b)(6)). An
exemption is being included for ground
species and ground (kind) to allow for
the %lean/%fat declarations on ground
species and ground (kind) that do not
meet the regulatory criteria for ‘‘low fat’’
because of the long and successful
history of the use of %lean/%fat
declarations in the ground beef
industry. The %lean/%fat declaration
has been used historically by consumers
wishing to make quick purchase
decisions based on the fat level of the
ground products. However, in most
cases the nutrition facts information is
necessary for consumers to take into
account additional nutrients in
formulating healthy diets.
Comment: The consumer organization
argued that the USDA should prohibit
misleading health and structure/
function claims and require that
nutrient content claims bear disclosure
statements similar to the FDA
requirements. This consumer
organization also stated that the USDA
should create a list of permissible
structure/function claims to ensure that
they do not undermine the mandatory
disclosure of nutrition information.
Response: This comment is outside
the scope of the regulation.
Exemptions for Nutrition Labeling
Comment: One individual supported
all of the exemptions in the proposed
rule because he believed they ensure
that the rule will not be unduly
burdensome.
One trade association stated that the
small business exemption should apply
to all products for nutrition labeling
purposes because excluding singleingredient raw products that are not
ground or chopped confuses small
businesses that have to comply with the
different requirements. According to
this trade association, small businesses
that increase prices in order to provide
nutrition facts on the label will be at a
disadvantage against their competitors
that do not provide the nutrition
information on the labels. This
commenter supported a small business
exemption from the nutrition labeling
requirements for the major cuts because
of the time necessary for small
businesses to access and display the free
nutrition information.
One trade association believed the
small business exemption pound limit
should be increased to 150,000 pounds.
According to this trade association, if
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the limit remains at 100,000 pounds,
only retailers who sell fewer than 700
packages of each product a week will be
exempt (based on USDA’s estimate that
the average ground product package
weighs 2.7 pounds). This commenter
stated that small businesses that only
sell a limited variety of popular
products would likely not be exempt
under the current proposal.
One individual stated that small
businesses should not be exempt from
the proposed rule.
Response: As discussed above, FSIS
believes an exemption for ground or
chopped products produced by small
businesses is necessary because the
burden of mandatory nutrition labeling
may force some small firms to stop
producing the product because of the
cost of nutrition labeling and eventually
force some small firms out of business.
FSIS believes it would not be feasible
for some small businesses to incur the
additional costs of nutrition labeling
because of their low volume of sales or
low volume of ground product. FSIS
believes it is feasible for larger
businesses to incur the additional costs
of nutrition labeling because of their
higher volume of sales or larger levels
of production of ground product. This
final rule, with an exemption for ground
or chopped products that qualify for the
small business exemption in
§§ 317.400(a)(1) and 381.500(a)(1),
provides nutrition labeling on the
maximum volume of ground or chopped
product while assuring that small
businesses producing low volumes of
product are not at risk of going out of
business or materially reducing the
variety of products they deliver to their
customers. Further, as discussed above,
FSIS believes that the relatively small
additional benefits of requiring small
businesses to put nutrition labels on all
ground or chopped products are
outweighed by the larger additional
costs.
As explained in more detail above,
even if the products produced by small
businesses bear a %fat/%lean statement,
they will still be exempt under the small
business exemption. Consumers use
these statements to identify their
desired product and are not misled by
these statements, even if small
businesses do not include nutrition
information on the products’ labels.
To qualify for the exemption, a retail
store must either be a single retail store
that employs 500 or fewer people or a
multi-retail store operation that employs
500 or fewer people and that produces
no more than 100,000 pounds of each
ground product per year. For an official
establishment to qualify for the
exemption, it must be either a single-
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plant facility that employs 500 or fewer
people, or a multi-plant company/firm
that employs 500 or fewer people and
produces no more than 100,000 pounds
per year of each ground product. As
explained in the preamble to the
proposed rule, ground or chopped
products formulated to have different
levels of fat would be considered
different food products for the purposes
of the small business exemption (66 FR
4978, January 18, 2001; 74 FR 67753,
December 18, 2009). As stated above
and in the supplemental proposed rule,
there is no small business exemption
from the nutrition labeling requirements
for the major cuts of single-ingredient,
raw meat and poultry products because
the requirements should not impose an
economic hardship on small businesses
(74 FR 67738). Nutrition information for
the major cuts can be displayed either
on the labels or on point-of-purchase
materials. FSIS will make point-ofpurchase materials available over the
Internet free of charge. Therefore, small
businesses will not incur significant
costs to provide nutrition information
for the major cuts of single-ingredient,
raw meat and poultry products.
FSIS finds that the 100,000 pound
limit in the small business exemption is
appropriate because it has been
successfully applied for over a decade
for other nutrition labeling exemptions.
Furthermore, the Agency received no
compelling data to support raising the
limit to 150,000 pounds for this
exemption. A consistent poundage limit
will be easier to apply across all meat
and poultry products.
Comment: Two trade associations
stated that it was necessary to provide
outreach resources to the industry
through meetings and materials such as
compliance guidelines. One of the trade
associations noted that many small
businesses do not have Internet access,
so FSIS’s Office of Outreach, Employee
Education and Training (OOEET) will
need to develop hard copy materials.
Response: If retailers cannot obtain
the point-of-purchase materials over the
Internet, FSIS personnel will have
copies of the information to provide to
retailers. FSIS personnel will also
conduct meetings on the final rule. For
retailers that have access to the Internet,
FSIS will conduct Webinars on the final
rule.
Comment: The city health department
asserted that nutrition labeling should
be mandatory for all meat and poultry
products that are sold to the food
service sector to enable restaurants and
food service companies to make more
healthful choices, which will ultimately
benefit consumer health.
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Response: Existing regulations
provide that products intended for
further processing and products not for
sale to consumers are exempt from
nutrition labeling requirements (9 CFR
§ 317.400). Such products are exempt
from nutrition labeling requirements
because consumers do not see the
nutrition information on products used
for further processing or products that
are not for sale to consumers.
Enforcement & Compliance
Comment: Several trade associations
stated that there should be some
flexibility in variations from estimated
nutritional values in sampling and in
nutrient analysis if the nutrition
labeling information is based on the
most current USDA National Nutrient
Data Bank or the USDA National
Nutrient Database for Standard
Reference. One trade association
questioned whether reliance on the
USDA National Nutrient Database for
Standard Reference or the Agricultural
Research Service (ARS) calculator is
considered a valid response to USDA
nutrition test results. Another trade
association believed that the use of the
Nutrient Database for Standard
Reference should be acceptable for
providing nutritional values for all
products. Further, the commenter stated
that the nutritional values should be
based on the analyzed fat content
because it would minimize the number
and costs of expensive analysis
required.
One trade association stated that all
entries in the Nutrient Database for
Standard Reference that are added or
removed should go through the rulemaking process to ensure that all groups
using these entries are considered. For
example, this trade association stated
that commodity type cuts and items
with more than 1⁄8 inch fat need to be
added to the Nutrient Database for
Standard Reference because these
products are still sold through food
service channels, and it is costly for
producers to provide nutrition
information via nutrient analysis to
commodity type customers.
One trade association stated that the
ARS calculator should be updated to
provide nutrition information for
turkey, pork, and chicken.
One trade association suggested that
the Nutrient Database for Standard
Reference be split into two databases,
one for retail type products and one for
commodity type products. One trade
association questioned how
enforcement of nutrition labeling
requirements will work at retail
establishments and farmer’s markets.
The trade association further questioned
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whether there will be fines for noncompliance. Additionally, in order to
prevent inconsistent Agency
enforcement actions, the commenter
stated that FSIS needs to ensure all
businesses are in compliance.
Response: As FSIS stated in the
preamble to the proposal, the fat content
of different ground or chopped products
can vary significantly, depending upon
the level of fat in the product being
ground and depending on whether
product from AMR systems is used (66
FR 4980, January 18, 2001). As FSIS
explained in the supplemental proposed
rule, the procedures set forth for FSIS
product sampling and nutrient analysis
in 9 CFR 317.309(h)(1)–(8) and
381.409(h)(1)–(8) will be applicable to
ground or chopped meat and to ground
or chopped poultry products,
respectively. FSIS will not analyze
ground or chopped products for fat
only, because if the ground product
includes AMR product or product from
low temperature rendering (e.g., finely
textured beef or lean finely textured
beef), the use of these materials could
affect other nutrient values in the
product. (74 FR 67754, December 18,
2009).
FSIS will sample and conduct
nutrient analysis of ground or chopped
products to verify compliance with
nutrition labeling requirements, even if
nutrition labeling on these products is
based on the most current representative
database values contained in USDA’s
National Nutrient Data Bank or the
USDA National Nutrient Database for
Standard Reference and there are no
claims on the labeling. FSIS will treat
ground or chopped products in this way
because the fat content of these products
can vary significantly. FSIS employees
cannot visually assess whether nutrition
information on the label of ground or
chopped products accurately reflects the
labeled products’ contents because, in
most cases, it is not possible to visually
assess the level of fat in a ground or
chopped product. For example, FSIS
employees cannot visually determine
whether product that is labeled 17
percent fat ground beef is actually 17
percent fat ground beef as opposed to 27
percent fat (or another percentage of fat)
ground beef (66 FR 4980, January 18,
2001) (74 FR 67755, December 18,
2009). Therefore, FSIS will treat ground
or chopped products as it treats all other
products for which the regulations
require nutrition information on their
package. In the event that FSIS samples
and conducts nutrient analysis of
ground or chopped beef, if producers
know the fat content of their product
and have used USDA database values on
the nutrition labels, FSIS would likely
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find the product’s label in compliance
with nutrition labeling requirements,
unless the product’s source materials
contain a significant amount of AMR
product or product from low
temperature rendering (74 FR 67755,
December 18, 2009).
If nutrition labeling of the major cuts
of single-ingredient, raw products (other
than ground beef or ground pork) is
based on USDA’s National Nutrient Data
Bank or the USDA’s National Nutrient
Database for Standard Reference, and
there are no nutrition claims on the
labeling, FSIS will not sample and
conduct a nutrient analysis of the
products. The preamble to the
supplemental proposed rule explained
that, for the major cuts, FSIS personnel
can visually identify the particular cut.
FSIS further explained that, if the
nutrition information for these products
is based on USDA’s National Nutrient
Data Bank or the USDA National
Nutrient Database for Standard
Reference, and there are no nutrition
claims on the labeling, it is not
necessary for FSIS to verify the accuracy
of the data because they are USDA data.
USDA has already evaluated these
USDA data and determined that they are
valid (66 FR 4980, January 18, 2001).
The USDA National Nutrient Database
for Standard Reference is developed and
maintained by the Agricultural Research
Service (ARS) and can be found on the
Internet at the following address:
https://www.ars.usda.gov\nutrientdata.
Information is available at this site for
ground beef products containing 5%,
10%, 15%, 20%, 25%, and 30% fat. In
addition, ARS has included a calculator
on the Internet, with the Database.
Parties can enter the amount of fat (5%
to 30% percent fat) or lean (70% to 95%
lean) in a particular raw ground beef
product, and the calculator will
calculate the nutrient values for the
product based on the fat value entered.
The USDA National Nutrient Database
for Standard Reference also includes a
set of tables with nutrient values for
ground pork with fat levels from 4% to
28%, in one percent increments. ARS
did not develop a calculator because, at
this time, labeling for ground pork at
retail does not include statements of
percentage fat or percentage lean. One
trade association comment to the
supplemental proposed rule stated that
nutritional tables will be sufficient for
retailers to create nutrition labels for
ground pork.
The USDA Nutrient Database also
includes nutrient values for raw and
cooked ground chicken but does not
include nutrient values for such product
at varying fat levels. Ground chicken is
not typically produced over a wide
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jlentini on DSKJ8SOYB1PROD with RULES2
range of fat levels. ARS also has nutrient
data for three types of commonly
marketed ground turkey products. ARS
also has published nutrient values for
ground turkey with fat levels of 0%, 7%,
and 15%. Most ground poultry products
are produced and labeled at Federal
establishments rather than at retail.
Commodity products are exempt from
nutrition labeling requirements under 9
CFR 317.400 and 381.500 because they
are not offered for sale. If commodity
products bear nutrition claims or
information, then they will be subject to
the nutrition labeling requirements.
Producers that sell product at farmers
markets would typically be exempt from
nutrition labeling requirements under
the small business exemption.
FSIS will explore its regulatory
options, including seeking criminal
penalties, if it discovers a violation of
the nutrition labeling requirements.
FSIS is not authorized to impose civil
penalties, including fines, under the
FMIA or PPIA. For more discussion of
possible enforcement actions following
implementation of the rule, see the
supplemental proposed rule (74 FR
67754, December 18, 2009).
Effective Date
Comment: Several trade associations
stated that the requirements for major
cuts of single-ingredient, raw meat and
poultry products and ground or
chopped products should become
effective on the uniform compliance
date, January 1, 2012. One of the trade
associations believed that different
implementation dates for the two types
of products would be confusing to
consumers and may require two
outreach programs. The other trade
association argued that establishments
need as much time as possible to
understand the new requirements and
develop new labels and point-ofpurchase materials before the
requirements become effective. The food
marketing organization agreed that there
should be additional time prior to
implementation of the nutrition labeling
requirements for the major cuts because
of the burden on the retailers.
One trade association stated that an
18–24 month period was needed for
implementation.
The food marketing organization
argued that the final rule should include
a provision allowing an extension of the
effective dates of up to six months if
there is evidence of difficulties with
compliance. One trade association
agreed with a six month or a twelve
month extension period before the
effective date of the rule.
Response: As FSIS stated in the
supplemental proposed rule,
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requirements for ground or chopped
products will become effective on
January 1, 2012, the uniform
compliance date for new food labeling
regulations that are issued between
January 1, 2009, and December 31, 2010,
to minimize costs associated with onpackage labels. In the supplemental
proposed rule, FSIS proposed that the
labeling requirements for the major cuts
be effective one year from the date of
publication of the final rule because the
final rule allows for the presentation of
nutrition information for the major cuts
of single-ingredient, raw meat and
poultry products at their point-ofpurchase and will not require changes
to product labels (74 FR 67741,
December 18, 2009). But, because one
year from the date of publication will
only be a few days before the effective
date for ground and chopped products,
January 1, 2012, FSIS is also
establishing January 1, 2012, as the
effective date for the labeling
requirements for the major cuts.
Costs and Benefits
Comment: One trade association
stated that the proposed rule was
discriminatory because it would have a
disproportionate effect on retailers with
service meat departments. This trade
association also noted that under this
rule, retailers will have a more costly
burden compared to restaurant
competitors.
One trade association argued that
FSIS should finalize the regulation with
the least amount of economic impact on
the meat industry.
Several individuals and an industry
commenter were concerned that the rule
would increase costs to producers and
consumers and increase taxes.
Response: The Regulatory Flexibility
Act requires Federal Agencies to
consider the effect of regulations on
small entities in developing regulations
(74 FR 67757, December 18, 2009).
However, FSIS has sought to make this
rule as fair and equitable as possible,
regardless of the size of the company
involved.
Thus, to minimize the burden on
small businesses, the final rule provides
a small business exemption. In addition,
the final rule provides an exemption
from nutrition labeling requirements for
ground or chopped products that are
ground or chopped at an individual
customer’s request and that are prepared
and served or sold at retail, provided
that the labels or labeling of these
products bear no nutrition claims or
nutrition information. FSIS will also
provide nutrition labeling materials for
the major cuts of single-ingredient, raw
products and for ground or chopped
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82161
products on a free basis through its Web
site. Retailers can display these
materials at the point-of-purchase for
the major cuts. Also, retailers and
official establishments can obtain
nutrition information for ground or
chopped products at the following Web
site: https://www.ars.usda.gov. (74 FR
67757, December 18, 2009).
As FSIS explained in the proposed
rule, restaurant menus generally do not
fall within the scope of the nutrition
labeling regulations. See 9 CFR
317.400(b) and 381.500(b). Similarly,
although a restaurant menu would most
likely not include a major cut of singleingredient, raw product, if it did, the
menu would not fall within the scope of
the proposed regulations. (66 FR 4979,
January 18, 2001).
FSIS does not believe that it has
underestimated the costs of the final
rule. Since the Supplemental Proposed
Rule Regulatory Impact Analysis was
done, the total costs of labeling may
have even decreased because of more
cost-effective technology, such as less
expensive computerized flexography
and scale-label printers. The additional
costs of labeling would be relatively low
for the affected businesses. Furthermore,
the final rule will exempt small
businesses that produce ground or
chopped product from nutrition labeling
requirements. As FSIS explained in the
proposed rule and supplemental
proposed rule, this rule will not
significantly increase costs to affected
producers and retailers because the
additional cost of this rule is a relatively
small proportion of the total costs of
production or retail marketing of
affected businesses. The estimated cost
of the rule on a per pound basis is about
$0.006, for ground or chopped products.
This increase in cost should not affect
consumer costs or purchases.
Comment: According to a case study,
one individual stated that the proposed
rule may produce benefits of $62 to
$125 million annually.
Response: FSIS projected that the
annualized average present value of the
benefit of the final rule is about $75.5
million, after accounting for assumed
levels of current compliance. For a
discussion of the methodology used to
estimate the benefits of the final rule,
please see the Final Regulatory Impact
Analysis below.
Other Comments
Comment: The consumer organization
believed nutrition labels should be
required to indicate the amount of trans
fat in the product similar to the FDA’s
policy. According to the consumer
organization, the trans fat in beef and
dairy products has the same harmful
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located at https://www.fsis.usda.gov/
Regulations_&_Policies/
2009_Proposed_Rules_Index/index.asp.
This action has been reviewed for
compliance with Executive Order
12866. This rule was reviewed by the
Office of Management and Budget
(OMB) under Executive Order 12866
and was determined to be significant.
In this FRIA, FSIS is adopting the
compliance adjusted analysis (i.e.,
accounting for assumed levels of current
compliance with the final rule)
presented in Table 1 below and in Table
30c and Appendix C of the
supplemental Preliminary Regulatory
Impact Analysis (PRIA) and the
supplemental initial Regulatory
Flexibility Act (RFA) assessment as
final. This FRIA and final RFA
assessment do not finalize the
supplemental PRIA or the supplemental
initial RFA. The PRIA used both a
baseline before considering existing
compliance (i.e., assuming no
compliance) and a baseline after
considering an assumed compliance to
the rule. Then, in the supplemental
PRIA, FSIS compared the analyses that
used the two cases of different baselines
of compliance. FSIS used the analysis
that accounted for the assumed levels of
nutrition labeling in compliance with
this final rule here because FSIS thinks
that this baseline would best represent
the current state of the use of nutrition
labeling of these products before FSIS
implements the final rule.
The supplemental PRIA
overestimated the amounts of ground or
chopped products and major cuts that
would be impacted by the final rule by
not taking into account the assumed
level of voluntary compliance with the
nutrition labeling regulations that
currently exists—the 68 percent
compliance rate of voluntary nutrition
labeling of ground or chopped
products.1 and 54.8 percent level of
voluntary compliance of stores that
provide nutrition labeling for major
cuts.2 Thus, the averages and ranges of
benefits and costs used in the FRIA
reflect the supplemental PRIA baseline
that considered the assumed levels of
compliance.
OMB designated the supplemental
proposed rule economically significant
based on annual benefits that did not
take into account current benefits that
result from nutrition labeling
information that is currently available;
costs in the supplemental PRIA did not
reach the threshold for economically
significant regulations. In this FRIA,
after accounting for existing levels of
compliance, the additional benefits
were only ‘‘significant,’’ as were the
additional costs. The complete
supplemental PRIA and the complete
final RFA assessment can be found
online through the FSIS Web page
1 National Cattlemen’s Beef Association, 2004.
National Meat Case Study.
2 U.S. Department of Agriculture, October 1999.
Nutrition Labeling/Safety Handling Information
Study-Raw Meat and Poultry. Prepared by Retail
Diagnostic, Inc., Oradell, New Jersey. Final Report
2000.
3 The impacts of a 68 percent compliance rate for
nutrition labeling of ground or chopped products
(NCBA, 2004) and a 54.8 percent compliance rate
for major cuts (USDA, 1999) are included in this
RIA of the Final Rule.
impact on LDL cholesterol as the trans
fat in partially hydrogenated oils.
Response: FSIS does not require the
mandatory labeling of trans fats as
required by FDA. However, through
routine label approval, FSIS estimates
75% to 80% of FSIS nutrition labels do
voluntarily include trans fat in the
nutrition facts information. FSIS
anticipates many companies will
voluntarily include trans fat in the
nutrition facts information on singleingredient and ground products.
Comment: The city health department
stated that nutrition labels for meat and
poultry products should be consistent
with the Nutrition Labeling and
Education Act and the majority of
packaged foods.
Response: Products under FSIS
jurisdiction are not subject to the
Nutrition Labeling and Education Act
(74 FR 67754, December 18, 2009). But,
FSIS believes that the requirements of
this final rule are consistent with the
Nutrition Labeling and Education Act.
Comments: FSIS also received
comments on issues outside the scope of
these regulations. One trade association
stated that all nutrition labels should
specify all the nutrients found in meat
products. One individual suggested that
approximate cook times for chicken and
pork products should be placed on their
labels. One individual stated that meat
and poultry product labels should
include information such as date
butchered, date preserved/frozen, any
hormones or antibiotics in the product,
and genetic engineering used in the
creation of the product. One perishable
items tracking company argued that
tracers like radio frequency
identification tags should be mandated
in all meat and poultry shipping
containers to record the shipping times
and ensure the products were kept at
safe temperatures similar to the
TEDSBOX system. Further, the tracing
information should be provided on all
product labels.
Section II
jlentini on DSKJ8SOYB1PROD with RULES2
Executive Order 12866—Final Rule
Regulatory Impact Analysis (FRIA) and
Final Regulatory Flexibility Act (RFA)
Assessment
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A. Costs and Benefits of the Final Rule
The FRIA assumes that some
establishments or retail facilities have
incurred costs associated with the
requirements of this regulation prior to
its effective date, and many firms have
already been providing the information
that is being required.3 Hence, the
discounted average present value of the
total costs, over a 20-year period, are
estimated to be about $115.4 million
using a 7 percent discount rate and
about $156.7 million using a 3 percent
discount rate. The corresponding
annualized present values of the average
total costs are $10.9 million, using a 7
percent discount rate, and $10.5
million, using a 3 percent discount rate
(see Table 1). For point-of-purchase
(POP) nutrition information for major
cuts of single ingredient, raw products,
the annualized present values of the
average total costs are $1.32 million,
using a 7 percent discount rate, and
$1.30 million, using a 3 percent
discount rate. For on-package nutrition
labels for ground or chopped products,
the annualized present values of the
average total costs are $9.6 million,
using a 7 percent discount rate, and 9.2
million, using a 3 percent discount rate.
For POP nutrition information for major
cuts of single ingredient, raw products,
the estimated additional annual cost of
the rule on a per pound basis is about
$0.0002 ($1.3 million/7,548 million
pounds). For ground or chopped
products, the estimated additional
annual cost of the rule on a per pound
basis is about $0.006 ($9.6 million/1,568
million pounds). However, the
additional cost of nutrition labeling for
ground or chopped products may be
overstated because firms can use their
existing stock of labels before incurring
additional costs of new labeling, under
the Uniform Compliance Date for Food
Labeling Regulations.
The average present values of the
benefits are about $800 million and
about $1,358 million, using 7 and 3
percent discount rates, respectively. The
corresponding annualized average
present values of the benefits are about
$75.5 million and about $91.3 million,
using 7 and 3 percent discount rates,
respectively. Table 1 provides a
summary of these annualized net
present values of costs and benefits.
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82163
TABLE 1—SUMMARY OF ANNUALIZED NET PRESENT VALUES OF COSTS AND BENEFITS, AFTER ACCOUNTING FOR
ASSUMED LEVELS OF CURRENT COMPLIANCE TO THE FINAL RULE.
[$million/year]
Primary
or
average
estimate
Category
Benefits:
Annualized .......................................................
Monetized* $million/year .................................
Qualitative .......................................................
UNITS
Low
estimate
High
estimate
Year
dollars
Discount
Period
covered
75.5
68.1
84.8
2002
7% 20 years
91.3
83.9
100.6
2002
3% 20 years
Consumers might also choose to use nutritional information to enhance enjoyment of food, and
not just to raise their health status.
Costs:
Annualized .......................................................
Monetized $million/year ..................................
10.9
10.5
8.9
8.6
14.7
14.4
2002
2002
7%
3%
20 years
20 years
NOTES:
* Monetized benefits of potential lives saved
NOTE: These estimates take into account assumed levels of voluntary compliance with the nutrition labeling requirements for ground or
chopped products that currently exists—the 68 percent compliance rate (NCBA, 2004) of voluntary nutrition labeling of ground or chopped products and 54.8 percent level of voluntary compliance (USDA, 1999) of stores that provide nutrition labeling for major cuts
jlentini on DSKJ8SOYB1PROD with RULES2
The projected annualized average net
present values of costs of the rule’s
nutrition labeling requirements appear
to be justified by the larger projected
annualized average net present values of
benefits.
B. Regulatory Flexibility Act (RFA)—
Assessment
This final Regulatory Flexibility Act
(RFA) assessment is not changed from
the supplemental preliminary RFA
assessment that was published in the
supplemental proposed rule on 18
December 2009.
Based on the cost analysis, FSIS
certifies that this final rule would not
have a significant economic impact on
a substantial number of small entities,
as defined by the Regulatory Flexibility
Act (5 U.S.C. 601).
FSIS does not believe that any very
small processing operations (grinding
firms) would be affected by the
regulation because very small meat and
poultry operations employ nine or fewer
employees. These establishments would
find it difficult to produce over 100,000
pounds per ground product annually
because these employees also process
other products.
Small retail stores would incur the
additional cost of providing POP
nutrition information for the major cuts
of single-ingredient, raw products.
There are about 47,422 small retail firms
that own about 51,431 small retail stores
that would be required to provide POP
information for the major cuts of singleingredient, raw products. FSIS estimates
that the cost to a retail store for placards
would be $10.56 for labor plus $65.17
for materials or approximately $75.73
per store. The annualized cost,
assuming that the placards have to be
replaced every two years, is about
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$41.88 using a 7 percent discount rate.
All the retail stores, including small and
very small businesses would incur these
additional costs in either the first year,
if the store is not currently providing
POP nutrition information for the major
cuts of single-ingredient, raw products,
or in the third year, if the store is
currently providing this information.
FSIS believes that these additional costs
are not significant even for very small
businesses.
Retail stores would also incur
additional costs related to required
nutrition labels for ground or chopped
products. A total of 74,910 stores owned
by 47,688 firms could be affected.
However, 23,479 stores owned by 266
firms are considered to be large
according to the 2002 Economic Census.
If they grind or chop over 100,000
pounds of a particular product annually,
then, in the worst case scenario, as
many as 51,431 small establishments
owned by 47,422 firms could be
affected.4
FSIS estimates that using a 7 percent
discount rate the sum of the annualized
average cost to each retail store that is
not currently providing nutrition
information for the major cuts or ground
or chopped products would be $42 for
nutrition information placards, $486 for
upgrading and maintaining scale-printer
systems, $969 for redesigning larger
store logo labels, and $40 for using
larger labels. For a store that is not
currently providing nutrition
information for the major cuts or ground
4 RTI believes that all of these businesses will be
exempt from nutrition labeling requirements. For
purposes of conducting a sensitivity analysis, this
analysis assumes that they are all small for
purposes of the Regulatory Flexibility Act and that
they will not qualify for the small business
exemption.
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or chopped product, the annualized
total cost over 20 years, using a 7
percent discount rate, would be about
$1,537, per store. In summary, FSIS
concludes that this final rule would not
have a significant impact on a
substantial number of small entities.
Based on the 2002 Economic Census
of the U.S. Department of Commerce,
meat and poultry processing
establishments that are small entities
had annual revenues from total value of
shipments that ranged from $0.454
million to $96.038 million. For each
processing (grinding) establishment
affected that is not currently providing
nutrition information for ground or
chopped products, the additional
annualized average total cost is about
$1,402. Then, for each such processing
(grinding) establishment, additional
annualized average total costs as a
percent of revenues range from a lower
bound of 0.001 percent ($1,402/$96.038
million) to an upper bound of 0.3
percent ($1,402/$0.454 million).
Further, small entity retail stores,
supermarkets and other grocery (except
convenience) stores and meat market
stores, had annual revenues from sales
that ranged from $0.343 million to
$8.873 million. Also, the companies or
firms of the small retail stores had
annual revenues from sales that ranged
from $0.343 million to $48.342 million.
Additional annualized total costs as a
percent of revenues range from the
lower bound of 0.02 percent ($1,537/
$8.873 million) to the upper bound of
0.4 percent ($1,537/$0.343 million).
Many of these retail firms that are small
entities own multiple retail stores that
are small entity supermarkets and other
grocery (except convenience) stores.
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The exemption for small businesses
affects about 1.238 billion pounds of
meat or poultry product affected by the
final rule.
jlentini on DSKJ8SOYB1PROD with RULES2
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. States and local
jurisdictions are preempted by the
Federal Meat Inspection Act (FMIA) and
the Poultry Products Inspection Act
(PPIA) from imposing any marking,
labeling, packaging, or ingredient
requirements on Federally inspected
meat and poultry products that are in
addition to, or different than, those
imposed under the FMIA or the PPIA.
However, States and local jurisdictions
may exercise concurrent jurisdiction
over meat and poultry products that are
outside official establishments for the
purpose of preventing the distribution
of meat and poultry products that are
misbranded or adulterated under the
FMIA or PPIA, or, in the case of
imported articles, which are not at such
an establishment, after their entry into
the United States.
This final rule does not have
retroactive effect.
Administrative proceedings would
not be required before parties may file
suit in court challenging this rule.
However, the administrative procedures
specified in §§ 306.5 and 381.35 must be
exhausted before there is any judicial
challenge of the application of the rule,
if the challenge involves any decision of
an FSIS employee relating to inspection
services provided under FMIA and
PPIA.
Paperwork Requirements
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection 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 John
O’Connell, Paperwork Reduction Act
Coordinator, Food Safety and Inspection
Service, USDA, 1400 Independence
Ave., SW., Room 60853 South Building,
Washington, DC 20250–3700; (202) 720–
0345.
Executive Order 13175
This final rule has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
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and Coordination with Indian Tribal
Governments. The review reveals that
this regulation will not have substantial
and direct effects on Tribal governments
and will not have significant Tribal
implications.
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
The U.S. Department of Agriculture
(USDA) prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.)
Persons with disabilities who require
alternative means for communication of
program information (Braille, large
print, audiotape, etc.) should contact
USDA’s Target Center at 202–720–2600
(voice and TTY).
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue, SW,
Washington, DC 20250–9410 or call
202–720–5964 (voice and TTY). USDA
is an equal opportunity provider and
employer.
Section III
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
ensure that minorities, women, and
persons with disabilities are aware of
this final rule, FSIS will announce it
online through the FSIS Web page
located at https://www.fsis.usda.gov/
regulations_&_policies/
2010_Interim_&_Final_Rules_Index/
index.asp. FSIS also will 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 available on the
FSIS Web page. Through the Listserv
and the Web page, FSIS is able to
provide information to a much broader
and more diverse audience.
In addition, FSIS offers an e-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/
News_&_Events/Email_Subscription/.
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List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Meat
Inspection, Nutrition, Reporting and
recordkeeping requirements.
9 CFR Part 381
Food labeling, Food packaging,
Nutrition, Poultry and poultry products,
Reporting and recordkeeping
requirements.
■ For the reasons stated 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. Section 317.300 is revised to read
as follows:
■
§ 317.300 Nutrition labeling of meat and
meat food products.
(a) Nutrition labeling must be
provided for all meat and meat food
products intended for human
consumption and offered for sale,
except single-ingredient, raw meat
products that are not ground or chopped
meat products described in § 317.301
and are not major cuts of singleingredient, raw meat products identified
in § 317.344, unless the product is
exempted under § 317.400 . Nutrition
labeling must be provided for the major
cuts of single-ingredient, raw meat
products identified in § 317.344, either
in accordance with the provisions of
§ 317.309 for nutrition labels, or in
accordance with the provisions of
§ 317.345 for point-of-purchase
materials, except as exempted under
§ 317.400. For all other products for
which nutrition labeling is required,
including ground or chopped meat
products described in § 317.301,
nutrition labeling must be provided in
accordance with the provisions of
§ 317.309, except as exempted under
§ 317.400.
(b) Nutrition labeling may be
provided for single-ingredient, raw meat
products that are not ground or chopped
meat products described in § 317.301
and that are not major cuts of singleingredient, raw meat products identified
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in § 317.344, either in accordance with
the provisions of § 317.309 for nutrition
labels, or in accordance with the
provisions of § 317.345 for point-ofpurchase materials.
3. A new § 317.301 is added to read
as follows:
■
§ 317.301 Required nutrition labeling of
ground or chopped meat products.
(a) Nutrition labels must be provided
for all ground or chopped products
(livestock species) and hamburger with
or without added seasonings (including,
but not limited to, ground beef, ground
beef patties, ground sirloin, ground
pork, and ground lamb) that are
intended for human consumption and
offered for sale, in accordance with the
provisions of § 317.309, except as
exempted under § 317.400.
(b) [Reserved]
4. Section 317.309 is amended as
follows:
■ a. In paragraph (b)(3), the first
sentence is amended by adding ‘‘that are
not ground or chopped meat products
described in § 317.301’’ after the phrase
‘‘single-ingredient, raw products’’, and
by removing ‘‘as set forth in
§ 317.345(a)(1)’’; the second sentence is
amended by adding, ‘‘that are not
ground or chopped meat products
described in § 317.301’’ after the phrase
‘‘single-ingredient, raw products’’, and
the following new sentence is added
after the first sentence: ‘‘For singleingredient, raw products that are not
ground or chopped meat products
described in § 317.301, if data are based
on the product ‘as consumed,’ the data
must be presented in accordance with
§ 317.345(d)’’;
■ b. Amend paragraph (b)(10) by adding
the following new sentence at the end
of the paragraph: ‘‘The declaration of the
number of servings per container need
not be included in nutrition labeling of
single-ingredient, raw meat products
that are not ground or chopped meat
products described in § 317.301,
including those that have been
previously frozen.’’;
■ c. Amend paragraph (b)(11) by adding
the phrase ‘‘single-ingredient, raw
products that are not ground or chopped
meat products described in § 317.301
and’’ after ‘‘exception of’’;
■ d. Amend paragraph (d)(3)(ii) by
removing the period and adding ‘‘or on
single-ingredient, raw meat products
that are not ground or chopped meat
products described in § 317.301.’’ at the
end of the paragraph;
■ e. Amend paragraph (e)(3) by adding
‘‘, but may be on the basis of ‘as
consumed’ for single-ingredient, raw
meat products that are not ground or
jlentini on DSKJ8SOYB1PROD with RULES2
■
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chopped meat products described in
§ 317.301,’’ after ‘‘as packaged’’; and
■ f. Amend paragraph (h)(9) by
removing the phrase ‘‘(including ground
beef)’’, by adding, ‘‘that are not ground
or chopped meat products described in
§ 317.301’’ after ‘‘products’’, by removing
the phrase, ‘‘its published form, the
Agriculture Handbook No. 8 series
available from the Government Printing
Office’’, and by adding, in its place, ‘‘its
released form, the USDA National
Nutrient Database for Standard
Reference’’, and by removing the period
and adding the following at the end of
the paragraph: ’’ as provided in
§ 317.345(e) and (f).’’
§ 317.343
[Removed]
5. Section 317.343 is removed.
6. Section 317.344 is amended by
removing the phrases ‘‘ground beef
regular without added seasonings,
ground beef about 17% fat,’’ and
‘‘ground pork’’.
■ 7. Section 317.345 is amended as
follows:
■ a. Revise the section heading and
paragraphs (a) and (c);
■ b. Amend paragraph (d) by removing
‘‘should’’ and adding, in its place, ‘‘for
products covered in paragraphs (a)(1)
and (a)(2) must’’;
■ c. Amend paragraph (e) by removing
‘‘its published form, the Agriculture
Handbook No. 8 series’’ and by adding,
in its place, ‘‘its released form, the
USDA National Nutrient Database for
Standard Reference’’, and by removing
‘‘(including ground beef)’’;
■ d. Amend paragraph (f) by adding
‘‘provided’’ after ‘‘nutrition information
is’’; and
■ e. Amend paragraph (g) by removing
the phrase ‘‘(including ground beef)’’.
The revisions read as follows:
■
■
§ 317.345 Nutrition labeling of singleingredient, raw meat products that are not
ground or chopped products described in
§ 317.301.
(a)(1) Nutrition information on the
major cuts of single-ingredient, raw
meat products identified in § 317.344,
including those that have been
previously frozen, is required, either on
their label or at their point-of-purchase,
unless exempted under § 317.400. If
nutrition information is presented on
the label, it must be provided in
accordance with § 317.309. If nutrition
information is presented at the point-ofpurchase, it must be provided in
accordance with the provisions of this
section.
(2) Nutrition information on singleingredient, raw meat products that are
not ground or chopped meat products
described in § 317.301 and are not major
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82165
cuts of single-ingredient, raw meat
products identified in § 317.344,
including those that have been
previously frozen, may be provided at
their point-of-purchase in accordance
with the provisions of this section or on
their label, in accordance with the
provisions of § 317.309.
(3) A retailer may provide nutrition
information at the point-of-purchase by
various methods, such as by posting a
sign or by making the information
readily available in brochures,
notebooks, or leaflet form in close
proximity to the food. The nutrition
labeling information may also be
supplemented by a video, live
demonstration, or other media. If a
nutrition claim is made on point-ofpurchase materials, all of the format and
content requirements of § 317.309
apply. However, if only nutrition
information—and not a nutrition
claim—is supplied on point-of-purchase
materials, the requirements of § 317.309
apply, provided, however:
(i) The listing of percent of Daily
Value for the nutrients (except vitamins
and minerals specified in
§ 317.309(c)(8)) and footnote required by
§ 317.309(d)(9) may be omitted; and
(ii) The point-of-purchase materials
are not subject to any of the format
requirements.
*
*
*
*
*
(c) For the point-of-purchase
materials, the declaration of nutrition
information may be presented in a
simplified format as specified in
§ 317.309(f).
*
*
*
*
*
■ 8. Section 317.362 is amended by
adding a new paragraph (f) to read as
follows:
§ 317.362 Nutrient content claims for fat,
fatty acids, and cholesterol content.
*
*
*
*
*
(f) A statement of the lean percentage
may be used on the label or in labeling
of ground or chopped meat products
described in § 317.301 when the
product does not meet the criteria for
‘‘low fat,’’ defined in § 317.362(b)(2),
provided that a statement of the fat
percentage is contiguous to and in
lettering of the same color, size, type,
and on the same color background, as
the statement of the lean percentage.
*
*
*
*
*
■ 9. Section 317.400 is amended by:
■ a. Revising paragraph (a)(1)
introductory text;
■ b. Amending paragraph (a)(1)(ii) by
adding ‘‘, including a single retail store,’’
after the phrase ‘‘single-plant facility,’’
and by adding, ‘‘, including a multi-
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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations
retail store operation,’’ after ‘‘company/
firm’’;
■ c. Amending paragraph (a)(7)(i) by
removing the semi-colon and ‘‘and’’ and
by adding the following at the end of the
paragraph: ‘‘, provided, however, that
this exemption does not apply to readyto-eat ground or chopped meat products
described in § 317.301 that are packaged
or portioned at a retail establishment,
unless the establishment qualifies for an
exemption under (a)(1);’’;
■ d. Amending paragraph (a)(7)(ii) by
removing the period and by adding the
following at the end of the paragraph: ‘‘,
provided, however, that this exemption
does not apply to multi-ingredient
ground or chopped meat products
described in § 317.301 that are
processed at a retail establishment,
unless the establishment qualifies for an
exemption under (a)(1); and’’;
■ e. Adding a new paragraph (a)(7)(iii);
and
■ f. Paragraph (d)(1) is amended by
removing the period at the end of the
first sentence, and by adding the
following to the end of the first
sentence: ‘‘, except that this exemption
does not apply to the major cuts of
single-ingredient, raw meat products
identified in § 317.344.’’
The revision and additions read as
follows:
§ 317.400
labeling.
Exemption from nutrition
jlentini on DSKJ8SOYB1PROD with RULES2
(a) * * *
(1) Food products produced by small
businesses, other than the major cuts of
single-ingredient, raw meat products
identified in § 317.344 produced by
small businesses, provided that the
labels for these products bear no
nutrition claims or nutrition
information, and ground or chopped
products described in § 317.301
produced by small businesses that bear
a statement of the lean percentage and
fat percentage on the label or in labeling
in accordance with § 317.362(f),
provided that labels or labeling for these
products bear no other nutrition claims
or nutrition information,
*
*
*
*
*
(7) * * *
(iii) Products that are ground or
chopped at an individual customer’s
request.
*
*
*
*
*
PART 381—POULTRY PRODUCTS
INSPECTION REGULATIONS
10. 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 2.18, 2.53.
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Jkt 223001
11. Section 381.400 is revised to read
as follows:
■
§ 381.400 Nutrition labeling of poultry
products.
(a) Nutrition labeling must be
provided for all poultry products
intended for human consumption and
offered for sale, except singleingredient, raw poultry products that
are not ground or chopped poultry
products described in § 381.401 and are
not major cuts of single-ingredient, raw
poultry products identified in § 381.444,
unless the product is exempted under
§ 381.500. Nutrition labeling must be
provided for the major cuts of singleingredient, raw poultry products
identified in § 381.444, either in
accordance with the provisions of
§ 381.409 for nutrition labels, or in
accordance with the provisions of
§ 381.445 for point-of-purchase
materials, except as exempted under
§ 381.500. For all other products that
require nutrition labeling, including
ground or chopped poultry products
described in § 381.401, nutrition
labeling must be provided in accordance
with the provisions of § 381.409, except
as exempted under § 381.500.
(b) Nutrition labeling may be
provided for single-ingredient, raw
poultry products that are not ground or
chopped poultry products described in
§ 381.401 and that are not major cuts of
single-ingredient, raw poultry products
identified in § 381.444, either in
accordance with the provisions of
§ 381.409 for nutrition labels, or in
accordance with the provisions of
§ 381.445 for point-of-purchase
materials.
*
*
*
*
*
■ 12. A new § 381.401 is added to read
as follows:
§ 381.401 Required nutrition labeling of
ground or chopped poultry products.
Nutrition labels must be provided for
all ground or chopped poultry (kind)
with or without added seasonings
(including, but not limited to, ground
chicken, ground turkey, and (kind)
burgers) that are intended for human
consumption and offered for sale, in
accordance with the provisions of
§ 381.409, except as exempted under
§ 381.500.
13. Section 381.409 is amended as
follows:
■ a. Revise paragraph (b)(3);
■ b. Amend paragraph (b)(10) by adding
the following new sentence at the end
of the paragraph: ‘‘The declaration of the
number of servings per container need
not be included in nutrition labeling of
single-ingredient, raw poultry products
■
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
that are not ground or chopped poultry
products described in § 381.401,
including those that have been
previously frozen.’’;
■ c. Amend paragraph (b)(11) by adding
the phrase ‘‘single-ingredient, raw
products that are not ground or chopped
poultry products described in § 381.401
and’’ after ‘‘exception of’’;
■ d. Amend paragraph (d)(3)(ii) by
removing the period and adding ‘‘or on
single-ingredient, raw poultry products
that are not ground or chopped poultry
products described in § 381.401.’’ at the
end of the paragraph;
■ e. Amend paragraph (e)(3) by adding
‘‘, but may be on the basis of ‘as
consumed’ for single-ingredient, raw
poultry products that are not ground or
chopped poultry products described in
§ 381.401,’’ after ‘‘as packaged’’; and
■ f. Amend paragraph (h)(9) by adding,
‘‘that are not ground or chopped poultry
products described in § 381.401’’ after
‘‘products’’, by removing the phrase, ‘‘its
published form, the Agriculture
Handbook No. 8 series’’, and by adding,
in its place, ‘‘its released form, the
USDA National Nutrient Database for
Standard Reference’’, and by removing
the period and adding the following at
the end of the paragraph: ‘‘, as provided
in § 381.445(e) and (f).’’
The revision reads as follows:
§ 381.409
Nutrition label content.
*
*
*
*
*
(b) * * *
(3) The declaration of nutrient and
food component content shall be on the
basis of the product ‘‘as packaged’’ for all
products, except that single-ingredient,
raw products that are not ground or
chopped poultry products as described
in § 381.401 may be declared on the
basis of the product ‘‘as consumed.’’ For
single-ingredient, raw products that are
not ground or chopped poultry products
described in § 381.401, if data are based
on the product ‘‘as consumed,’’ the data
must be presented in accordance with
§ 381.445(d). In addition to the required
declaration on the basis of ‘‘as packaged’’
for products other than singleingredient, raw products that are not
ground or chopped poultry products as
described in § 381.401, the declaration
may also be made on the basis of ‘‘as
consumed,’’ provided that preparation
and cooking instructions are clearly
stated.
*
*
*
*
*
§ 381.443
[Removed]
14. Section 381.443 is removed.
15. Section 381.445 is amended as
follows:
■ a. Revise the section heading and
paragraph (a) and (c);
■
■
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b. Amend paragraph (d) by removing
‘‘should’’ and adding, in its place, ‘‘for
products covered in paragraphs (a)(1)
and (a)(2) must’’;
■ c. Amend paragraph (e) by removing
‘‘its published form, the Agriculture
Handbook No. 8 series’’ and by adding,
in its place, ‘‘its released form, the
USDA National Nutrient Database for
Standard Reference.’’; and
■ d. Amend paragraph (f) by adding
‘‘provided’’ after ‘‘nutrition information
is’’.
The revisions read as follows:
■
§ 381.445 Nutrition labeling of singleingredient, raw poultry products that are
not ground or chopped products described
in § 381.401.
jlentini on DSKJ8SOYB1PROD with RULES2
(a)(1) Nutrition information on the
major cuts of single-ingredient, raw
poultry products identified in § 381.444,
including those that have been
previously frozen, is required, either on
their label or at their point-of-purchase,
unless exempted under § 381.500. If
nutrition information is presented on
the label, it must be provided in
accordance with the provisions of
§ 381.409. If nutrition information is
presented at the point-of-purchase, it
must be provided in accordance with
the provisions of this section.
(2) Nutrition information on singleingredient, raw poultry products that
are not ground or chopped poultry
products described in § 381.401 and are
not major cuts of single-ingredient, raw
poultry products identified in § 381.444,
including those that have been
previously frozen, may be provided at
their point-of-purchase in accordance
with the provisions of this section or on
their label, in accordance with the
provisions of § 381.409.
(3) A retailer may provide nutrition
information at the point-of-purchase by
various methods, such as by posting a
sign or by making the information
readily available in brochures,
notebooks, or leaflet form in close
proximity to the food. The nutrition
labeling information may also be
supplemented by a video, live
demonstration, or other media. If a
nutrition claim is made on point-ofpurchase materials, all of the format and
content requirements of § 381.409
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82167
apply. However, if only nutrition
information—and not a nutrition
claim—is supplied on point-of-purchase
materials, the requirements of § 381.409
apply, provided, however:
(i) The listing of percent of Daily
Value for the nutrients (except vitamins
and minerals specified in
§ 381.409(c)(8)) and footnote required by
§ 381.409(d)(9) may be omitted; and
(ii) The point-of-purchase materials
are not subject to any of the format
requirements.
*
*
*
*
*
(c) For the point-of-purchase
materials, the declaration of nutrition
information may be presented in a
simplified format as specified in
§ 381.409(f).
*
*
*
*
*
■ 16. Section 381.462 is amended by
adding a new paragraph (f) to read as
follows:
establishment, unless the establishment
qualifies for an exemption under (a)(1);’’;
■ d. Amending paragraph (a)(7)(ii) by
removing the period and adding the
following at the end of the paragraph: ‘‘,
provided, however, that this exemption
does not apply to multi-ingredient
ground or chopped poultry products
described in § 381.401 that are
processed at a retail establishment,
unless the establishment qualifies for an
exemption under (a)(1); and’’;
■ e. Adding a new paragraph (a)(7)(iii);
and
■ f. Amending paragraph (d)(1) by
removing the period at the end of the
sentence, and by adding the following to
the end of the sentence: ‘‘except that this
exemption does not apply to the major
cuts of single-ingredient, raw poultry
products identified in § 381.444.’’
The revision and additions read as
follows:
§ 381.462 Nutrient content claims for fat,
fatty acids, and cholesterol content.
§ 381.500
labeling.
*
(a) * * *
(1) Food products produced by small
businesses other than the major cuts of
single-ingredient, raw poultry products
identified in § 381.444 produced by
small businesses, provided that the
labels for these products bear no
nutrition claims or nutrition
information, and ground or chopped
products described in § 381.401
produced by small businesses that bear
a statement of the lean percentage and
fat percentage on the label or in labeling
in accordance with § 381.462(f),
provided that labels or labeling for these
products bear no other nutrition claims
or nutrition information,
*
*
*
*
*
(7) * * *
(iii) Products that are ground or
chopped at an individual customer’s
request.
*
*
*
*
*
*
*
*
*
(f) A statement of the lean percentage
may be used on the label or in labeling
of ground or chopped poultry products
described in § 381.401 when the
product does not meet the criteria for
‘‘low fat,’’ defined in § 381.462(b)(2),
provided that a statement of the fat
percentage is contiguous to and in
lettering of the same color, size, type,
and on the same color background, as
the statement of the lean percentage.
*
*
*
*
*
■ 17. Section 381.500 is amended by:
■ a. Revising paragraph (a)(1)
introductory text;
■ b. Amending paragraph (a)(1)(ii) by
adding, ‘‘, including a single retail
store,’’ after the phrase ‘‘single-plant
facility,’’ and by adding ‘‘,including a
multi-retail store operation’’ after
‘‘company/firm’’;
■ c. Amending paragraph (a)(7)(i) by
removing the semi-colon and ‘‘and’’ and
adding the following at the end of the
paragraph: ‘‘, provided, however, that
this exemption does not apply to readyto-eat ground or chopped poultry
products described in § 381.401 that are
packaged or portioned at a retail
PO 00000
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Fmt 4701
Sfmt 9990
Exemption from nutrition
Done in Washington, DC on December 21,
2010.
Alfred V. Almanza,
Administrator.
[FR Doc. 2010–32485 Filed 12–28–10; 8:45 am]
BILLING CODE 3410–DM–P
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[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Rules and Regulations]
[Pages 82148-82167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32485]
[[Page 82147]]
-----------------------------------------------------------------------
Part II
Department of Agriculture
-----------------------------------------------------------------------
Food Safety and Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 317 and 381
Nutrition Labeling of Single-Ingredient Products and Ground or Chopped
Meat and Poultry Products; Final Rule
Federal Register / Vol. 75 , No. 249 / Wednesday, December 29, 2010 /
Rules and Regulations
[[Page 82148]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. FSIS-2005-0018]
RIN 0583-AC60
Nutrition Labeling of Single-Ingredient Products and Ground or
Chopped Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to require
nutrition labeling of the major cuts of single-ingredient, raw meat and
poultry products on labels or at point-of-purchase, unless an exemption
applies. FSIS is also amending its regulations to require nutrition
labels on all ground or chopped meat and poultry products, with or
without added seasonings, unless an exemption applies. In addition, the
rule provides that, when a ground or chopped product does not meet the
regulatory criteria to be labeled ``low fat,'' a lean percentage
statement may be included on the label or in labeling as long as a
statement of the fat percentage that meets the specified criteria also
is displayed on the label or in labeling.
DATES: Effective Date: This final rule is effective on January 1, 2012.
FOR FURTHER INFORMATION CONTACT: Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery Division, Office of Policy and Program
Development, Food Safety and Inspection Service, U.S. Department of
Agriculture, Beltsville, MD 20705; (301) 504-0878.
Section I.
SUPPLEMENTARY INFORMATION:
Background
The Nutrition Labeling and Education Act (NLEA) of 1990 required
nutrition labeling of most foods regulated by the Food and Drug
Administration (FDA). Because FSIS is committed to providing consumers
with the most informative labeling system possible, FSIS published
regulations establishing comparable nutrition labeling requirements for
meat and poultry products. FSIS published an advance notice of proposed
rulemaking on nutrition labeling of meat and poultry products on April
2, 1991 (56 FR 13564), a proposed rule on November 27, 1991 (56 FR
60302), a final rule on January 6, 1993 (58 FR 632), and subsequently
other amendments to the rule.
The Agency's regulations currently require nutrition labels on the
packages of all multi-ingredient and heat processed meat and poultry
products, unless an exemption applied. The required nutrition labeling
provisions are referred to as ``the mandatory nutrition labeling
program.'' The Agency's 1993 regulations also established guidelines
for voluntary nutrition labeling of single-ingredient, raw meat and
poultry products, including single-ingredient, raw ground or chopped
products.
On January 18, 2001, FSIS published a proposed rule in the Federal
Register entitled, ``Nutrition Labeling of Ground or Chopped Meat and
Poultry Products and Single-Ingredient Products'' (66 FR 4969). Because
of the length of time since the publication of the proposed rule, FSIS
published a supplemental proposed rule on December 18, 2009, to provide
the public an additional opportunity to comment (74 FR 67736). This
final rule is consistent with the provisions in the supplemental
proposed rule.
Nutrition labeling continues to be an integral part of USDA's
efforts to educate consumers concerning nutrition and diets. Since 1980
USDA and the Department of Health and Human Services (HHS) have jointly
published the Dietary Guidelines for Americans every five years. The
Dietary Guidelines provide advice concerning food choices that promote
health and prevent disease. The Dietary Guidelines for Americans, 2005,
advises consumers to aim for a total fat intake between 20 to 35
percent of calories (page viii). In addition, the Dietary Guidelines
for Americans, 2005, includes a chart showing the recommended upper
limits for grams of saturated fat per day for a range of total calories
per day (page 31). The nutrition information that FSIS is requiring in
this final rule on the labels of ground or chopped products and on
either labels or point-of-purchase materials for the major cuts of
single-ingredient, raw meat and poultry products would include the
number of calories and the grams of total fat and saturated fat the
product contains. The information FSIS is requiring would, therefore,
assist consumers in following the advice in the Dietary Guidelines for
Americans, 2005.
Major cuts: This final rule requires nutrition labeling of the
major cuts of single-ingredient, raw meat and poultry products
identified in Sec. Sec. 317.344 and 381.444 that are not ground or
chopped, except for certain exemptions. For these products, the final
rule requires that nutrition information be provided on the label or at
point-of-purchase, unless an exemption applies.
In its two most recent surveys of the voluntary nutrition labeling
of single-ingredient, raw products, FSIS found that significant
participation in the voluntary nutrition labeling program did not exist
(66 FR 4972, January 18, 2001). Under 9 CFR 317.343 and 9 CFR 381.443,
if FSIS finds that there is not significant participation by retail
stores in the voluntary nutrition labeling program to provide nutrition
labeling for the major cuts of single-ingredient, raw meat and poultry
products, FSIS is obligated to institute rulemaking to require that
such labeling be provided. FSIS regulations provide that a food
retailer participates at a significant level (1) if the retailer
provides nutrition labeling information for at least 90 percent of the
major cuts of single-ingredient, raw meat and poultry products it
sells; and (2) if the nutrition label on these products is consistent
in content and format with the mandatory program, or if nutrition
information is displayed at point-of-purchase in an appropriate manner.
Significant participation by food retailers exists if at least 60
percent of all companies that were evaluated were participating in
accordance with the guidelines. Based on the survey data from the two
most recent surveys from 1996 and 1999, less than 60 percent of stores
evaluated were participating in accordance with the guidelines.
Therefore, significant participation in the voluntary nutrition
labeling program did not exist, and FSIS proceeded with rulemaking.
Under Sec. 317.4, FSIS's Labeling and Program Delivery Division
(LPDD) reviews labels on meat and poultry products that have been
submitted for approval. Based on its label review, FSIS has not seen an
increase in nutrition labeling of the major cuts of single-ingredient
raw, meat and poultry products since the surveys were conducted.
Compliance investigators in FSIS's Office of Program Evaluation,
Enforcement & Review (OPEER) also have not seen an increase in the
number of packages of the major cuts of single-ingredient, raw meat and
poultry products that have nutrition facts panels on their labels at
retail or an increase in the availability of point-of-purchase
materials that provide nutrition information for such products at
retail since the last compliance surveys were conducted. For these
reasons and because no other evidence has been submitted to FSIS that
significant participation in the voluntary program
[[Page 82149]]
now exists, FSIS has concluded that this final rule is necessary.
FSIS has determined that major cuts of single-ingredient raw, meat
and poultry products that do not bear nutrition information on their
labels or on point-of-purchase materials will be misbranded, under
section 1(n) of the Federal Meat Inspection Act (FMIA) (21 U.S.C.
601(n)(1)) and section 4(h)(1) of the Poultry Products Inspection Act
(PPIA) (21 U.S.C. 453(h)(1)). Without nutrition information on their
labeling, FSIS has concluded that the labeling of these products will
be false or misleading because it will not provide consumers with
sufficient information to assess the nutrient content of the major cuts
and will not enable consumers to select major cuts that fit into a
healthy diet that meets their individual needs.
Consumers are given a rough indication of the fat content of major
cuts of poultry based on whether the product has skin and based on the
levels of attached fat in the product. Similarly, consumers are given a
rough indication of the fat content of major cuts of meat products
based on internal marbling and attached fat. However, without nutrition
labeling for the major cuts, consumers cannot assess precise levels of
fat (e.g., 10 grams vs. 20 grams of fat per serving) and cannot know
the levels of specific nutrients, such as saturated fat, in these
products. Therefore, without nutrition labeling of these products,
consumers cannot make educated choices about consuming the major cuts.
To provide flexibility, the rule allows nutrition information to be
provided on the labels of individual packages of the major cuts of
single-ingredient, raw products and, to be provided on point-of-
purchase materials. Further, FSIS has determined that point-of-purchase
labeling is appropriate because consumers can generally estimate the
fat content in these products, and because the nutrient content of any
given major cut is relatively uniform across the market.
Ground or Chopped Products: This final rule requires that nutrition
labels be provided for all ground or chopped products (livestock
species) and hamburger, with or without added seasonings, unless an
exemption applies. Similarly, this final rule requires that nutrition
labels be provided for all ground or chopped poultry (kind), with or
without added seasonings, unless an exemption applies. Under this final
rule, products that would be required to bear nutrition labels include
single-ingredient, raw hamburger, ground beef, ground beef patties,
ground chicken, ground turkey, ground chicken patties, ground pork, and
ground lamb.
Unlike other single-ingredient, raw products, producers are able to
formulate precisely the fat content of ground or chopped products.
Therefore, in this respect, these products are similar to products in
the existing mandatory program that are required to bear nutrition
labels. Other single-ingredient, raw products cannot be formulated in
the same manner or to the same degree as ground products.
In ground or chopped products, the fat is uniformly distributed
throughout the product and is not clearly distinguishable on the
surface of the product. The Agency has concluded that consumers cannot
estimate the level of fat in these products and cannot compare the
levels of fat in these products to those in other products.
Additionally, producers sometimes use meat from advanced meat recovery
(AMR) systems and low temperature rendering (LTR) in ground or chopped
beef or pork products, which can affect their nutrient content. For
these reasons, FSIS has concluded that ground or chopped meat and
poultry products that do not bear nutrition information will be
misbranded under section 1(n)(1) of the FMIA and section 4(h)(1) of the
PPIA.
FSIS is requiring that nutrition information for ground or chopped
products appear on the label of these products (unless an exemption
applies), as is required for multi-ingredient and heat processed
products, rather than on point-of-purchase materials. Because there are
numerous formulations of ground or chopped products, it would be
difficult for producers or retailers to develop point-of-purchase
materials that would address all the different formulations that exist
for these products. Furthermore, it would be difficult for consumers to
find the correct information for a specific ground or chopped product
on point-of-purchase materials that include information concerning
numerous formulations of these products.
Non-major Cuts of Single-Ingredient, Raw Meat and Poultry Products
that are not Ground or Chopped: FSIS is not requiring nutrition
information for single-ingredient, raw meat and poultry products that
are not major cuts and that are not ground or chopped. But, if
nutrition information is provided for these products, it must be
provided in accordance with the nutrition labeling requirements for the
major cuts. Therefore, under the final rule, if establishments or
retail facilities choose to provide nutrition information for these
products, they will either provide it at point-of-purchase, in
accordance with Sec. 317.345 or Sec. 381.445, or on their label, in
accordance with Sec. 317.309 or Sec. 381.409. Thus, the nutrition
labeling provisions for these products will be consistent with those
for the voluntary nutrition labeling program.
Permitting Percent Lean Statements on labels or in labeling of
ground or chopped products: The final rule permits a statement of lean
percentage on the label or in labeling of ground or chopped meat and
poultry products that do not meet the regulatory criteria for ``low
fat,'' provided that a statement of the fat percentage is also
displayed on the label or in labeling. The required statement of fat
percentage must be contiguous to, in lettering of the same color, size,
and type as, and on the same color background as, the statement of lean
percentage. Many consumers have become accustomed to this labeling on
ground beef products, and FSIS has concluded that this labeling
provides a quick, simple, and accurate means of comparing ground or
chopped meat and poultry products.
Exemptions: Under this final rule, the following exemptions from
nutrition labeling requirements will apply to the major cuts of single-
ingredient, raw meat and poultry products and ground or chopped meat
and poultry products:
Products intended for further processing, provided that
the labels for these products bear no nutrition claim or nutrition
information,
Products that are not for sale to consumers, provided that
the labels for these products bear no nutrition claims or nutrition
information,
Products in small packages that are individually wrapped
packages of less than \1/2\; ounce net weight, provided that the labels
for these products bear no nutrition claims or nutrition information,
Products that are custom slaughtered or prepared, and
Products intended for export.
This final rule also provides the following additional exemptions
for ground or chopped products:
Ground or chopped products that qualify for the small
business exemption in Sec. Sec. 317.400(a)(1) and 381.500(a)(1),
Products that are ground or chopped at an individual
customer's request and that are prepared and served at retail, provided
that the labels or labeling of these products bears no nutrition claims
or nutrition information,
Ground or chopped products in packages that have a total
surface area for labeling of less than 12 square inches, provided that
the product's labeling includes no nutrition claims or
[[Page 82150]]
nutrition information and provided that an address or telephone number
that a consumer can use to obtain the required information is included
on the label, and
Ground products produced by small businesses that use
statements of percent fat and percent lean on the label or in labeling
of ground products, provided they include no other nutrition claims or
nutrition information on the product labels or labeling.
FSIS believes an exemption for ground or chopped products produced
by small businesses is necessary because the burden of mandatory
nutrition labeling may force some small firms to stop producing the
product because of the cost of nutrition labeling and eventually force
some small firms out of business. FSIS believes it would not be
feasible for some small businesses to incur the additional costs of
nutrition labeling because of their low volume of sales or low volume
of ground product. FSIS believes it is feasible for larger businesses
to incur the additional costs of nutrition labeling because of their
higher volume of sales or larger levels of production of ground
product. This final rule, with an exemption for ground or chopped
products that qualify for the small business exemption in Sec. Sec.
317.400(a)(1) and 381.500(a)(1), provides nutrition labeling on the
maximum volume of ground or chopped product while assuring that small
businesses producing low volumes of product are not at risk of going
out of business or materially reducing the variety of products they
deliver to their customers. Further, FSIS believes that the relatively
small additional benefits of requiring small businesses to put
nutrition labels on all ground or chopped products are outweighed by
the larger additional costs. FSIS estimates that without the exemption
there would be a $3 million reduction in annual average net benefit.
Without the exemption, the projected compliance average total cost
increase annually of $54 million would not be the only type of cost
that would be incurred. FSIS believes that without the exemption many
small businesses would have to close or substantially reduce the
variety of products they now offer. Reductions in purchase options
would be a cost to consumers that could not be quantified for FSIS's
analysis.
Under this final rule, there is not a small business exemption for
the major cuts of single-ingredient, raw meat and poultry products
because nutrition information for these products may be provided on
labels or, alternatively, at their point-of-purchase. Additionally,
FSIS will make point-of-purchase materials available over the Internet
free of charge. Therefore, the nutrition labeling requirement for major
cuts of single-ingredient, raw products should not impose an economic
hardship for small businesses, including those that are retail stores.
Under the proposed rule, if small businesses produced ground or
chopped product and included a statement of lean percentage and fat
percentage on the product's label, the small business would have been
required to include nutrition information on the product label. These
small businesses would not have qualified for the small business
exemption because the labels for these products included nutrition
claims. Based on the National Cattleman's Beef Association (NCBA)
National Meat Case Study in 2004, 93 percent of ground beef packages
had statements of lean or fat percentages (74 FR 67741). Sixty-eight
percent of packages with such statements had nutrition facts panels and
25 percent did not (74 FR 67741). Because about 95 percent of grinders
are small businesses, FSIS concluded that many of the 25 percent of
packages that included lean or fat percentage statements without
nutrition facts panels were produced by small businesses. Therefore,
FSIS believes many small businesses include statements of lean or fat
percentage on the label of their ground products but not the nutrition
facts panel. Also, because of the longstanding use of the statements of
percent fat and percent lean on the label or in labeling of ground beef
and hamburger products, FSIS believes that such statements on the label
or in labeling of ground products produced by small businesses will not
mislead consumers, even if the small businesses do not include
nutrition information on the products' labels (74 FR 67741). Many
consumers have become accustomed to this labeling on ground beef
products, and FSIS believes that this labeling provides a quick,
simple, and accurate means of comparing ground or chopped meat and
poultry products. Therefore under the final rule, small businesses that
use statements of percent fat and percent lean on the label of ground
products, provided they include no other nutrition claims or nutrition
information on the product labels or labeling, are exempted from the
nutrition labeling requirements.
Additionally, under this final rule, any ground or chopped product
or major cut of single-ingredient, raw product represented or purported
to be specifically for infants and children less than 4 years of age
will not be allowed to include certain nutrient content declarations
because infants and children less than 4 years of age have different
nutrition needs than adults and children older than 4 years of age.
Finally, this final rule makes clear that the current regulatory
exemptions for ready-to-eat (RTE) product packaged or portioned at
retail and multi-ingredient product processed at retail do not apply to
RTE ground or chopped products packaged or portioned at retail or
multi-ingredient ground or chopped products that are processed at
retail because there may be a significant amount of multi-ingredient
ground beef retail processed products or RTE retail packaged products
(66 FR 4979, January 18, 2001). For further explanation of the reasons
for the foregoing exemptions, see 58 FR 638-639; 66 FR 4978-4979; and
75 FR 67740-67741.
Enforcement and Compliance: After the final rule is implemented,
FSIS will collect samples of ground product at retail for nutrient
analysis. In addition, FSIS will assess whether nutrition information
is available for the major cuts, either on package labels or at the
point-of-purchase.
Under this final rule, the procedures set forth for FSIS product
sampling and nutrient analysis in Sec. Sec. 317.309(h)(1)-(8) and
381.409(h)(1)-(8) will be applicable to ground or chopped meat and to
ground or chopped poultry products, respectively. FSIS will sample and
conduct nutrient analysis of ground or chopped products to verify
compliance with nutrition labeling requirements, even if nutrition
labeling on these products is based on the most current representative
database values contained in USDA's National Nutrient Data Bank or the
USDA National Nutrient Database for Standard Reference and there are no
claims on the labeling. Therefore, FSIS will treat these products as it
treats other products required to bear nutrition labels.
FSIS will treat ground or chopped products in this way because the
fat content of these products can vary significantly. FSIS employees
cannot visually assess whether nutrition information on the label of
ground or chopped products accurately reflects the labeled products'
contents because, in most cases, it is not possible to visually assess
the level of fat in a ground or chopped product.
If nutrition labeling of the major cuts of single-ingredient, raw
products (other than ground beef or ground pork) is based on USDA's
National Nutrient Data Bank or the USDA's National Nutrient Database
for Standard Reference, and there are no nutrition claims on the
labeling, FSIS will not sample and
[[Page 82151]]
conduct a nutrient analysis of the products because FSIS personnel can
visually identify the particular cut. If the nutrition information for
these products is based on USDA's National Nutrient Data Bank or the
USDA National Nutrient Database for Standard Reference, and there are
no nutrition claims on the labeling, it is not necessary for FSIS to
verify the accuracy of the data because they are USDA data. USDA has
already evaluated these data and determined that they are valid (66 FR
4980, January 18, 2001).
Outreach: FSIS personnel will conduct meetings and Webinars on the
final rule and will provide additional information and guidance as
needed. If retailers cannot obtain point-of-purchase materials over the
Internet, FSIS personnel will have copies of the information to provide
to retailers.
Six months prior to the effective date, FSIS intends to make
available nutrition labeling materials that can be used at the point-
of-purchase of the major cuts at the following Internet address: https://www.fsis.usda.gov. Also, the Food Marketing Institute (FMI) has made
available materials that can be used at the point-of-purchase at the
following Internet address: https://www.fmi.org/consumer/nutrifacts/.
In addition, the USDA National Nutrient Database for Standard
Reference is developed and maintained by the Agricultural Research
Service (ARS) and can be found on the Internet at the following
address: https://www.ars.usda.gov\nutrientdata. Information is available
at this site for ground beef products containing 5%, 10%, 15%, 20%,
25%, and 30% fat. In addition, ARS has included a calculator on the
Internet, with the Database. Parties can enter the amount of fat (5% to
30% percent fat) or lean (70% to 95% lean) in a particular raw ground
beef product, and the calculator will calculate the nutrient values for
the product based on the fat value entered.
The USDA National Nutrient Database for Standard Reference also
includes a set of tables with nutrient values for ground pork with fat
levels from 4% to 28%, in one percent increments. The USDA Nutrient
Database also includes nutrient values for raw and cooked ground
chicken but does not include nutrient values for such product at
varying fat levels. ARS also has published nutrient values for ground
turkey with fat levels of 0%, 7%, and 15%. In the supplemental proposed
rule, FSIS provided examples of nutrition labels for ground or chopped
products that would meet the requirements of the final rule (74 FR
67742). Six months prior to the effective date, FSIS will make
additional examples of acceptable labels for such products available on
the Agency's Web site.
Effective Dates: The requirements for ground or chopped products
will become effective on January 1, 2012. FSIS issued a final rule to
establish this date as the uniform compliance date for new food
labeling regulations that are issued between January 1, 2009, and
December 31, 2010 (73 FR 75564; December 12, 2008). FSIS established
the uniform compliance date to minimize costs associated with on-
package labels. Because this final rule allows for the presentation of
nutrition information for the major cuts of single-ingredient, raw meat
and poultry products at their point-of-purchase, no change in on-
package labels will be necessary to effect this aspect of this final
rule. Thus, in the supplemental proposed rule, FSIS proposed that the
labeling requirements for the major cuts would be effective one year
from the date of publication of the final rule. Because one year from
the date of publication will only be a few days before the effective
date for ground and chopped products, January 1, 2012, FSIS is also
establishing January 1, 2012 as the effective date for the labeling
requirements for the major cuts.
Summary of and Response to Comments
FSIS received 33 comments on the supplemental proposed rule from
individuals, a consumer organization, members of the regulated
industry, trade and professional associations, and a city health
department.
A summary of issues raised by commenters and the Agency responses
follows.
Nutrition Labeling for the Major Cuts of Single-Ingredient, Raw Meat
and Poultry Products
Comment: Many individuals, several trade associations, a city
health department, a perishable items tracking company, and an industry
commenter all generally supported required nutrition information for
the major cuts, either on their label or at their point-of-purchase.
Several individuals and the city health department stated that
providing this nutrition information will help consumers make
healthier, informed food choices and will allow them to monitor the
amount of fat, cholesterol, and sodium that they consume. According to
the city health department, cardiovascular disease, diabetes, and
cancer are the leading causes of death, disability, and compromised
quality of life in the United States. This commenter also argued that
these illnesses are connected with nutrition, and improved access to
nutrition information through nutrition labeling can help people reduce
their risk of developing these illnesses. A trade association stated
that nutrition labeling allows consumers to quickly differentiate
between meat products and identify leaner choices. One individual
stated that many people need to check the specific nutritional content
of foods for medical reasons.
One individual stated that most retailers do not participate in the
voluntary nutrition labeling program at a significant level because the
program is voluntary.
A consumer organization, a city health department, and an
individual supported the proposed rule but argued that the final rule
should mandate that nutrition information for major cuts of meat be
provided through on-package labels rather than point-of-purchase
materials. These commenters stated that on-package labeling helps
people make more informed decisions. The consumer organization noted
that a recent telephone survey showed an overwhelming percentage (86%)
of the respondents preferred nutrition facts labels on meat packages
rather than nutrition information on wall posters or signs. The city
health department and the consumer organization argued that point-of-
purchase materials are not an effective means of communication because
their success depends on external factors, such as the retailer's
placement of the point-of-purchase materials and layout limitations in
small stores. The consumer organization and one individual stated that
some of the disadvantages to using point-of-purchase materials are that
they are hard to find, inconvenient to use, and difficult to read and
comprehend. One individual also believed it was time-consuming and
embarrassing for shoppers to read posters regarding nutrition
information. Another individual stated that on-package labeling allows
consumers to quickly compare products and provides the nutrition
information to other consumers at home.
The consumer organization stated that point-of-purchase materials
are not subject to any formal requirements under the supplemental rule.
The consumer organization stated that FSIS should specify format and
placement requirements for point-of-purchase materials. This
organization stated that the USDA should work with the FDA to update
format and readability requirements for posters. This organization
believed that posters are
[[Page 82152]]
likely to omit many cuts or give them a different name than what
appears on the package. The organization also stated that USDA should
conduct a survey to determine whether consumers are better served by
on-package nutrition labels than point-of-purchase materials. According
to this consumer organization, many companies and grocery chains
already use on-package nutrition labeling. Additionally, the consumer
organization stated that if similar nutrition labels and labeling
equipment are required for ground products, then retailers would not
incur substantial additional costs by adding nutrition labels to major
cuts.
The consumer organization disagreed with FSIS's position that
consumers can visually determine the difference in fat content between
various cuts. This organization noted that a recent telephone survey
showed an overwhelming percentage (80%) of respondents could not
determine which cuts of meat had the least amount of fat. The consumer
organization suggested that the USDA does not have any data to support
its assumption that consumers can visually determine the difference in
fat content between various cuts.
Several trade associations, an industry commenter, and the food
marketing organization supported the option of providing nutrition
information for the major cuts through point-of-purchase materials.
According to one trade association, their retailer customers believe
nutrition labeling for meat is more efficiently displayed via point-of-
purchase materials than on the product.
Response: As FSIS proposed, this final rule will require that
nutrition information be provided for the major cuts of single-
ingredient, raw meat and poultry products, either on the label or at
the point-of-purchase. FSIS agrees that the final rule will produce
health benefits, including projected reductions in the incidence of
coronary heart disease and three types of cancer that may accrue as
consumers improve their diet quality through increased use of nutrition
information generated by the final rule.
FSIS agrees with the individual that stated that most retailers do
not participate at a significant level when labeling is voluntary. In
the two most recent surveys from 1996 and 1999, FSIS found that
significant participation in the voluntary nutrition labeling program
did not exist (see 66 FR 4973, January 18, 2001; 74 FR 67736-67737,
December 18, 2009). In addition, since the surveys were conducted,
FSIS's LPDD has not seen an increase in the number of labels that
include nutrition information for the major cuts of single-ingredient,
raw meat and poultry products. Further, FSIS's OPEER also has not seen
an increase in the number of packages of the major cuts of single-
ingredient, raw meat and poultry products that have nutrition facts
panels on their labels at retail or an increase in the availability of
point-of-purchase materials that provide nutrition information for such
products at retail since the last compliance surveys were conducted.
These observations do not constitute survey data but provide additional
meaningful information based on the experience of FSIS's LPDD and
OPEER. No evidence has been submitted to FSIS that significant
participation in the voluntary program now exists.
FSIS agrees that many consumers cannot accurately assess the
nutritional content of the major cuts of single-ingredient, raw
products; however, we continue to believe that point-of-purchase
nutritional information is appropriate for these products.
While consumers cannot accurately assess the nutritional content of
the major cuts of single-ingredient, raw products, their ability to do
so is greater than in the case of ground products. Ground products are
processed in such a way that fat content is very difficult to visually
ascertain. Internal marbling, attached fat, and whether the product has
skin gives consumers some rough indication of the fat content of the
major cuts of single-ingredient, raw products, which leads FSIS to
believe that the benefits of on-package labeling may be slightly less
than with ground product. FSIS notes, however, that consumers still
need nutrition information on point-of-purchase materials for the major
cuts because consumers cannot assess precise levels of fat (e.g., 10
grams vs. 20 grams of fat per serving) and cannot know the levels of
calories or other specific nutrients, such as saturated fat, in these
products.
Based on comments received and the Supplemental Proposed Rule
Regulatory Impact Analysis, FSIS believes that requiring on-package
labeling for the major cuts of single-ingredient, raw products is also
likely to be significantly more costly than for ground products because
it would require on-package labeling on a larger volume of product. In
the Supplemental Proposed Rule Regulatory Impact Analysis, FSIS
estimated that the annualized average present value of the costs of
requiring nutrition labels on the major cuts of single-ingredient, raw
meat and poultry products would be $16.48 million more than the
annualized average present value of the costs of requiring nutrition
labels on all ground or chopped products, without taking into account
the current level of voluntary compliance (74 FR 67789).
As discussed in the proposed rule and in the supplemental proposed
rule, FSIS believes it will be relatively easy to prepare point-of-
purchase materials for the major cuts because the nutrient content of a
given major cut is relatively uniform across the market, and these
products are not formulated in the manner of ground or chopped products
(66 FR 4974, January 18, 2001) (74 FR 67737, December 18, 2009). To
ensure that this is the case, FSIS is making available nutrition
labeling materials that can be used at point-of-purchase over the
Internet free of charge.
FSIS acknowledges the concern expressed by an individual and by the
consumer organization about the location of point-of-purchase
materials, but believes that it is currently addressed in the
regulations (9 CFR 317.345(a)(3) and 381.445(a)(3)) which require that
point-of-purchase materials be made available in close proximity to the
food. In addition, FSIS personnel will also visit stores to verify that
they are following this and the other requirements.
In response to the comment that noted that an advantage of
including nutrition information on the label is that consumers can
review the nutrient content of the product once the product is taken
home, and that others besides the primary food purchaser would have
better access to this information, surveys, including the Diet and
Health Knowledge Survey (DHKS), show that a majority of individuals
report using labels while buying foods. Although the DHKS shows that
adults who are not main household shoppers use labels, the survey shows
that the main shoppers use labels at a higher rate than those who are
not main household shoppers. If individuals in a household have certain
nutrition practices and needs, the person who purchases food for the
household would likely take other household members' needs and
preferences into account. In this case, the entire household would
ultimately receive the benefits of the nutrition information. Further,
other household members besides the primary food purchaser will be able
to obtain nutrition information for the major cuts on the Internet on
FSIS's Web site, ARS's Web site, and FMI's Web site.
FSIS agrees that consumers cannot accurately judge the nutritional
content of the major cuts of single-ingredient, raw products, and that
the mandatory provision of this information to consumers is warranted
and
[[Page 82153]]
appropriate. However, for the reasons described above, we believe that
point-of-purchase information is appropriate for these products.
Comment: Several individuals and trade associations, one food
marketing organization, and an industry commenter opposed the proposed
rule to require nutrition information for the major cuts, either on
their label or at their point-of-purchase. These trade associations and
the food marketing organization stated that FSIS should maintain its
existing voluntary program. One trade association and the food
marketing organization advocated that the USDA should conduct a new
compliance survey because it is likely that the level of participation
in the voluntary nutrition labeling program has increased beyond the
``significant participation'' threshold because of changes in the
composition of the retail sector over the past decade, and because of
efforts by FMI to encourage the widespread use and dissemination of
Nutri-Facts materials. These organizations stated that the last USDA
survey for compliance is outdated because it was conducted in 1999, and
should not be the basis for promulgating the rule. The food marketing
organization noted that the regulations that require FSIS to evaluate
the level of participation in the voluntary nutrition labeling program
every two years remain in effect. One trade association stated that
maintaining the voluntary program will be less costly and will help the
industry. According to this trade association, FSIS could increase
voluntary compliance by making the same updated nutrition information
available free of charge to retailers as it planned to make available
under the proposed rule. Several trade associations stated that if
individual consumers wanted more specific nutrition information about a
particular product, they could access it through other sources like the
Internet. An industry commenter noted that if there was sufficient
consumer demand for more nutrition information, then retailers would
have an economic incentive to voluntarily supply it.
One trade association did not agree with FSIS's position that major
cuts of single-ingredient raw, meat and poultry products that do not
bear nutrition information on their labels or on point-of-purchase
materials are misbranded. Another trade association believed that there
were few significant differences in the nutritional values among the
various brands of young chicken, and that nutrition information for
single-ingredient chicken is not that useful because most people add
ingredients to it during cooking that alter the calories, fat, and
protein. For those reasons, the poultry trade association stated that
there is no need to mandate nutrition labeling for the major cuts, and
FSIS should maintain its existing voluntary nutrition labeling program
for the major cuts. Several individuals stated that consumers already
have a general idea of the average nutritional value of major cuts of
meat and poultry products.
Response: FSIS encouraged participation in the voluntary nutrition
labeling program through meetings with industry. Additionally,
nutrition labeling materials for the major cuts have been available on
FMI's Web site for several years (https://www.fmi.org). Despite this,
and FSIS's encouragement of the use of such materials, the 1999
voluntary nutrition labeling survey found a lower rate of participation
than the 1996 survey found. Thus, the fact that nutrition information
was available was insufficient to ensure that consumers received this
necessary nutrition information. By making the guidelines for the
voluntary nutrition labeling program mandatory, FSIS will ensure that
consumers are provided with sufficient information to assess the
nutrient content of the major cuts and enable them to select foods that
fit into a healthy diet that meets their individual needs.
FSIS's regulations provide that the Agency would evaluate
significant participation every 2 years (Sec. Sec. 317.343(e) and
381.443(e)). Although FSIS did not conduct the surveys precisely 2
years apart, the Agency did conduct the surveys approximately every two
years until 1999 (74 FR 67748, December 18, 2009), and the surveys
failed to show significant participation. Because significant
participation did not exist, FSIS proceeded with rulemaking.
Under Sec. 317.4, FSIS's LPDD reviews labels on meat and poultry
products that have been submitted for approval. Based on its label
review, FSIS has not seen an increase in nutrition labeling of the
major cuts of single-ingredient raw, meat and poultry products since
the surveys were conducted. Compliance investigators in FSIS's OPEER
also have not seen an increase in the number of packages of the major
cuts of single-ingredient, raw meat and poultry products that have
nutrition facts panels on their labels at retail or an increase in the
availability of point-of-purchase materials that provide nutrition
information for such products at retail since the last compliance
surveys were conducted. Because (i) the most recent surveys showed that
significant participation in the voluntary nutrition labeling program
did not exist, (ii) FSIS's LPDD has not seen an increase in nutrition
labeling of the major cuts of single-ingredient raw, meat and poultry
products and ground or chopped meat and poultry products since the
surveys were conducted, (iii) FSIS's OPPER has not seen an increase in
nutrition labeling of the major cuts of single-ingredient raw, meat and
poultry products at retail or an increase in the availability of point-
of-purchase materials that provide nutrition information for the major
cuts at retail since the last compliance surveys were conducted, and
(iv) no other evidence has been submitted to FSIS that significant
participation in the voluntary program now exists, FSIS has concluded
that this final rule is necessary.
In response to the comment that maintaining the voluntary program
will be less costly and will help the industry, this final rule makes
the guidelines for the voluntary nutrition labeling program mandatory,
so the costs for the industry should not increase for stores that are
following the guidelines.
In response to the statement that if there was sufficient consumer
demand for more nutrition information, then retailers would have an
economic incentive to voluntarily supply it, market forces have not
been great enough to ensure significant participation in the voluntary
nutrition labeling program. This fact could be evidence that consumers
are not willing to pay for this information. However, as is explained
above, FSIS believes that consumers can generally estimate the fat
content of the major cuts of meat and poultry products, but
nonetheless, they need more precise information about the nutrient
content of the major cuts in order to make a fully informed comparative
judgment about the various cuts.
FSIS has concluded that without nutrition information for the major
cuts of single-ingredient, raw meat and poultry products, these
products will be misbranded under the FMIA and the PPIA (21 U.S.C.
601(n)(1) and 453 (h)(1)). Without nutrition information on their
labeling, FSIS has concluded that the labeling of these products will
be false or misleading because it will not provide consumers with
sufficient information to assess the nutrient content of the major cuts
and will not enable consumers to select major cuts that fit into a
healthy diet that meets their individual needs.
In response to the comment that nutrition information for single-
ingredient chicken is not that useful because most people add
ingredients to
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it during cooking that alter the calories, fat, and protein, the final
rule allows nutrition information to be declared on either an ``as
packaged'' basis or an ``as consumed'' basis. The point-of-purchase
materials and the labels clearly inform consumers whether the nutrition
information provided is ``as packaged'' or ``as consumed.'' Consistent
with the provisions in the voluntary nutrition labeling program, when
nutrition information is presented on an ``as consumed'' basis,
retailers or manufacturers will be required to specify a method of
cooking that will not add nutrients from other ingredients such as
flour, breading, and salt (Sec. Sec. 317.345(d) and 381.445(d)).
Comment: Several trade associations asserted that the list of major
cuts needs to be updated. One trade association stated that, according
to The National Pork Board meat scanner data, pork whole loin, pork
shoulder picnic, pork shoulder Boston butt, pork sirloin chop, pork
center chop, and pork rib roast should be added to the list of major
cuts. One trade association stated that FSIS should review the list of
major cuts based on market share and availability because there are
still cuts on the list of major cuts for which data reflective of trim
levels sold at retail is not currently available. One trade association
was concerned that if the USDA does not update the list, but rather
makes a change to the list later, then retailers will incur the $5.67
million cost to purchase and install posters again.
Response: Because FSIS did not propose to amend the codified list
of major cuts in the regulations and did not provide an opportunity for
the public to comment on proposed changes to the list, FSIS is not
amending the list of major cuts in the regulations at this time. FSIS
acknowledges that the codified list of major cuts may need to be
updated. FSIS intends to assess the need to update the list and to
update it as necessary when resources permit. Establishments or retail
facilities may choose to provide nutrition information for the non-
major cuts, either at point-of-purchase, in accordance with Sec.
317.345 or Sec. 381.445, or on their label, in accordance with Sec.
317.309 or Sec. 381.409.
Comment: The consumer organization argued that the number of
servings should be required on all major cuts. This organization stated
that many retailers now have the ability to calculate the number of
servings in a package. As an example, this organization suggested that
companies could determine the number of servings for the major cuts
based on the number of pieces of meat in the package and their average
weights. According to this organization, the number of servings reminds
consumers that a package has multiple servings, and that if someone
eats more than one serving, the nutrients consumed will increase. This
commenter stated that most consumers eat more than the USDA standard
serving size of 4 oz. of meat or poultry, and single-serving packages
of meat or poultry contain more than 4 oz. This commenter also stated
that nutrition facts should be provided for the entire package if the
single serving package exceeds 4 oz. Alternatively, the commenter
stated that the package should be required to include a disclaimer such
as: ``Nutrition Facts are based on a 4 oz. serving. This package may
contain a serving larger than 4 oz.'' Finally, the commenter stated
that the USDA also needs to update its standard serving size upward to
reflect actual consumption.
Response: The number of servings per container is not necessary
information on the nutrition labels or point-of-purchase materials of
the major cuts or non-major cuts of single-ingredient, raw products
because these products are typically random weight products. For multi-
ingredient and heat-processed products that must bear nutrition labels,
the number of servings is not required on random weight products
because the weight statement is applied at retail. The weight of such
products varies from package to package (Sec. Sec.
317.309(b)(10)(iii), 381.409(b)(10)(iii), 317.2(h)(9) and
381.121(c)(9)) (74 FR 67747, December 18, 2009).
The request to change and update USDA's standard serving size is
outside the scope of this regulation.
Comment: One individual and a trade association were concerned that
consumers would not understand that the nutrition information for the
major cuts will be based on averages of nutrient content data for that
cut of meat or poultry. The trade association questioned whether there
should be an explanation on the package regarding the potential
variation from the average, so consumers will not be misled. The
individual suggested that there should be a disclaimer on the label
regarding the potential variation from the average.
Response: FSIS does not believe an explanation regarding potential
variability of nutrition information is necessary for single-ingredient
cuts. All nutrition information is based on average values. Compliance
requirements in 9 CFR 317.309 and 381.409 allow for a twenty percent
variation before regulatory action is taken against products.
Comment: The consumer organization stated that nutrition facts
should be provided on an ``as packaged'' basis rather than on an ``as
consumed basis'' because consumers may alter the product in ways that
could affect the nutrient content before eating.
Response: As proposed, for the major cuts and non-major cuts of
single-ingredient, raw products, this final rule will allow nutrition
information on the label or on point-of-purchase materials to be
declared on either an ``as packaged'' basis or an ``as consumed'' basis
because most of these products will not be subject to FSIS nutrient
analysis. If nutrition information for these products is based on
USDA's National Nutrient Database for Standard Reference, and there are
no claims on the labeling, FSIS will not conduct a nutrient analysis of
these raw products and, therefore, will not evaluate ``as packaged''
nutrition labeling information for these products. Consistent with the
provisions in the voluntary nutrition labeling program, when nutrition
information is presented on an ``as consumed'' basis, retailers or
manufacturers will be required to specify a method of cooking that will
not add nutrients from other ingredients such as flour, breading, and
salt (Sec. Sec. 317.345(d) and 381.445(d)) (74 FR 67747, December 18,
2009).
Mandatory Nutrition Labeling for Ground or Chopped Products
Comment: Many individuals, several trade associations, a city
health department, an industry commenter, and a perishable items
tracking company supported mandatory on-package nutrition labeling for
ground or chopped products. Several of those trade associations and the
city health department specifically supported FSIS's proposal to
require on-package labeling as opposed to allowing for nutrition
information at point-of-purchase. One of these trade associations
stated that on-package labeling is needed because fat content is
difficult to see in ground products. Two of the trade associations
noted that plants produce ground meats at specific lean/fat ratios, and
that the amount of fat is easy to control. One trade association stated
that plants provide nutritional data to retailers, and that data can
easily be added to a nutrition facts panel.
Two trade associations and the city health department believed that
on-package labeling is the most beneficial for consumers. One of the
trade associations questioned whether consumers actually use point-of-
purchase materials for ground or
[[Page 82155]]
chopped products and questioned the feasibility of developing point-of-
purchase materials for such products. The city health department argued
that point-of-purchase materials for ground or chopped products are not
an effective means of communication because their success depends on
external factors such as the retailer's placement of the point-of-
purchase materials and layout limitations in small stores. One trade
association stated that point-of-purchase materials increase redundancy
and cost because most retailers have nutrition data that can be easily
distributed among retailers and added to a nutrition facts panel.
Several trade associations and the food marketing organization
supported the option to provide nutrition information for ground and
chopped products at point-of-purchase. One of the trade associations
believed that point-of-purchase materials allow consumers to make more
informed choices concerning the purchase of ground or chopped products
because they are consistently displayed and more efficient than on-
package labeling. This commenter stated that retailers are limited
because of the small number of meat case staff and the available space
on ground or chopped product packages. According to the food marketing
organization, point-of-purchase materials allow consumers to easily
compare products. The organization also was concerned that consumers
would not be able to visually inspect the product because of the large
label required to be able to list the nutrition information, food
safety information, and cooking instructions. This organization also
suggested that important food safety information would not be as
prominent once nutrition information is added to the label.
One trade association and the food marketing organization asserted
that allowing the use of point-of-purchase materials will reduce the
financial burden on retailers and benefit consumers. These commenters
stated that FSIS underestimated the cost of providing nutrition labels
on ground and chopped products. According to these commenters, FSIS did
not account for the number of retailers that would have to buy new
printer or scale systems at the store level. Additionally, one trade
association stated that retailers that provide on-site custom services
would have to increase prices or only sell case-ready meat because of
the increased costs. The food marketing organization was concerned that
retailers may be forced to eliminate some of their product choices
because of the cost of testing and verifying the nutrient values for
each nutrition label.
The food marketing organization claimed that effective point-of-
purchase materials for ground and chopped products could be developed.
One trade association suggested that there could be standardized
posters for other ground or chopped products, similar to the ones
currently used for ground beef. An industry commenter noted that
producers supply retailers with ground products based on established
finished lean/fat ratios, which do not differ among retailers. The
industry commenter suggested that nutrition information for these lean/
fat ratios could be used on point-of-purchase materials, and consumers
could match the lean/fat ratio on their ground product with the
nutrition information for that lean/fat ratio on the point-of-purchase
materials. The commenter also stated that if a retailer uses a
different lean/fat ratio than is provided on the point-of-purchase
materials, it would have to put the nutrition information on the
individual package.
A trade association, an industry commenter, and the food marketing
organization stated that FSIS should maintain its existing voluntary
program for nutrition labeling of ground or chopped products. The food
marketing organization believed that there was no need to require
mandatory on-package labeling for ground and chopped products.
Response: FSIS will require on-package nutrition information for
these products rather than allowing nutrition information to be
provided at their point-of-purchase for the reasons stated above.
Because there are numerous formulations of ground or chopped products,
as a practical matter, it would be difficult for producers or retailers
to develop point-of-purchase materials that would address all the
different formulations that exist for these products. Furthermore, it
would be difficult for consumers to find the correct information for a
specific ground or chopped product on point-of-purchase materials that
include information concerning numerous formulations of these products
(66 FR 4977, January 18, 2001). If a statement of the fat percentage
and lean percentage is not included on a package of ground product,
consumers would not know which nutrient data concerning ground product
on point-of-purchase materials would apply to that particular ground
product. Establishments and retailers are not required to provide such
a statement and will not be required to provide such a statement when
this rule becomes effective (74 FR 67750, December 18, 2009).
Information concerning the nutritional qualities of ground or
chopped meat and poultry products is particularly important because
these products, especially ground beef, are widely consumed. Based on a
Beef Sales Survey at retail markets in the United States over 52 weeks
ending March 23, 2010, ground beef sales were about $5.6 billion for
about 2.1 billion pounds, excluding the ``other'' category of ground
beef for chili, meatloaf, meat balls, and trim (source: FreshLook
Marketing, available at https://beefretail.org/GroundBeefCategoryBreakdown.aspx). According to the summary of results
on the National Cattleman's Beef Association Web site, ground beef
accounts for about 66 percent of all fresh beef eatings (servings) in-
home (source: NPD National Eating Trends (NET) Research, Two Years
Rolling August 2009, available at https://beefretail.org/individualpenetrationbybeefcut.aspx). Additional information about the
nutrient values of ground or chopped meat and poultry products will
enable consumers to make informed decisions about including these
products in their diets and will, therefore, help consumers to
construct healthy diets (74 FR 67750, December 18, 2009).
Thus, this final rule will require nutrition labels on all ground
or chopped meat and poultry products, with or without added seasonings,
unless an exemption applies. These products are similar to multi-
ingredient products in the mandatory nutrition labeling program (which
requires nutrition information to be on the label of individual
packages). Just as producers can control the incoming ingredients and
levels of such ingredients in multi-ingredient products, producers can
precisely control the fat content of ground or chopped products to
obtain the desired product. In addition, just as consumers cannot often
see all the ingredients in multi-ingredient products, consumers cannot
easily see the fat in ground or chopped products. The fat is uniformly
distributed throughout the product and is not clearly distinguishable
on the surface of the product. Therefore, consumers cannot estimate the
fat levels in these products and cannot compare the fat levels in these
products to those in other products. Thus, it is difficult for
consumers to have a reasonable understanding of the nutritional quality
of these products (74 FR 67750, December 18, 2009).
Many grocers and manufacturers provide nutrition facts panels on
ground
[[Page 82156]]
beef products. Therefore, FSIS questions why certain commenters stated
that there is not sufficient room on the label of these products for
nutrition information (74 FR 67750, December 18, 2009). FSIS disagrees
with the comment that consumers will not be able to visually inspect
the product because of the large label required to list the nutrition
information, food safety information, and cooking instructions. As with
the Safe Handling Instructions (SHI) and cooking instructions,
nutrition labeling information can appear off the principal display
panel (PDP). Many retailers place SHI on the bottom or side panels of
packages to allow consumers to visually inspect the largest amount of
product. There should be sufficient space available on these panels for
nutrition facts information to appear off the PDP.
Additionally, the nutrition labeling requirements for ground or
chopped products should not be particularly difficult for small
operations, since ground or chopped product produced by retail
establishments and Federal establishments that meet specific small
business criteria will be exempt from nutrition labeling requirements
(Sec. Sec. 317.400(a)(1) and 381.500(a)(1)) (74 FR 67750, December 18,
2009).
Moreover, an exemption from the nutrition labeling requirements,
which is provided in this final rule, should alleviate any concerns
that nutrition labeling requirements will discourage retailers from
grinding product based on customers' requests. This final rule provides
an exemption from nutrition labeling requirements for ground or chopped
products that are ground or chopped at an individual customer's request
and that are prepared and served or sold at retail, provided that the
labels or labeling of these products bear no nutrition claims or
nutrition information (74 FR 67750, December 18, 2009).
If a customer selects an intact product for purchase and requests
that the product be ground at the retail facility, FSIS has determined
that nutrition information on the package of the ground product would
not be necessary. In this instance, the customer has made the decision
to purchase the product before it was ground. The customer is not
selecting the product from among various, formulated, ground or chopped
product, and thus the reasons for requiring a nutrition label on such a
product would not be applicable here (74 FR 67750, December 18, 2009).
Moreover, the product selected may already be the subject of nutrition
labeling as a raw, single ingredient product.
Many of the suppliers of coarse ground products that are then
ground and packaged at retail have supplied, or can supply, the
nutrition facts panels for the retailers. Most retailers offer a
limited selection of ground beef products. Thus, dozens of different
nutrition labels for each retailer will not be necessary. In addition,
information for ground beef and other products is avail