Docket No. FSIS-2005-0018

[Federal Register: December 29, 2010 (Volume 75, Number 249)]
[Rules and Regulations]
[Page 82147-82167]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de10-27]

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Part II

Department of Agriculture

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Food Safety and Inspection Service

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9 CFR Parts 317 and 381

Nutrition Labeling of Single-Ingredient Products and Ground or Chopped
Meat and Poultry Products; Final Rule

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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.

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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

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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 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

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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 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

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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-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: http:/
/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: http://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: http://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

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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-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 (http://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

[[Page 82154]]

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 http://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 http://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 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 scale-label 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 Sec. Sec. 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.
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

[[Page 82157]]

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.

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 single-ingredient, 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 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 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).

[[Page 82158]]

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 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). Sixty-eight 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 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 Sec. Sec. 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

[[Page 82159]]

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 single-ingredient 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 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
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, 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-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-of-purchase 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.

[[Page 82160]]

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 Sec. 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 rule-making 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 whether there will be fines for non-compliance.
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 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: http://
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

[[Page 82161]]

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-of-purchase 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,
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 on-package 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-of-purchase
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 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: http://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 single-ingredient, 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

[[Page 82162]]

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 single-ingredient 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

Executive Order 12866--Final Rule Regulatory Impact Analysis (FRIA) and
Final Regulatory Flexibility Act (RFA) Assessment

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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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 located at http://
www.fsis.usda.gov/Regulations_&_Policies/2009_Proposed_Rules_
Index/index.asp.

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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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.

[[Page 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]
----------------------------------------------------------------------------------------------------------------
UNITS
Primary or Low High -------------------------------------------
Category average estimate estimate Year
estimate dollars Discount Period covered
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized................... 75.5 68.1 84.8 2002 7% 20 years
Monetized* $million/year..... 91.3 83.9 100.6 2002 3% 20 years
Qualitative.................. Consumers might also choose to use nutritional information to enhance enjoyment
of food, and not just to raise their health status.
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized................... 10.9 8.9 14.7 2002 7% 20 years
Monetized $million/year...... 10.5 8.6 14.4 2002 3% 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

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 single-ingredient, 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 $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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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 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.

[[Page 82164]]

The exemption for small businesses affects about 1.238 billion
pounds of meat or poultry product affected by the final rule.

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 Sec. Sec. 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 and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.

USDA Nondiscrimination Statement

The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue,
SW, Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.

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 http://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 http://www.fsis.usda.gov/
News_&_Events/Email_Subscription/. Options range from recalls to
export information to regulations, directives and notices. Customers
can add or delete subscriptions themselves, and have the option to
password protect their accounts.

Section III

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.

0
For the reasons stated in the preamble, FSIS is amending 9 CFR Chapter
III, as follows:

PART 317--LABELING, MARKING DEVICES AND CONTAINERS

0
1. The authority citation for part 317 continues to read as follows:

Authority: 21 U.S.C 601-695; 7 CFR 2.18, 2.53.

0
2. Section 317.300 is revised to read as follows:

Sec. 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 Sec. 317.301 and are not major cuts of
single-ingredient, raw meat products identified in Sec. 317.344,
unless the product is exempted under Sec. 317.400 . Nutrition labeling
must be provided for the major cuts of single-ingredient, raw meat
products identified in Sec. 317.344, either in accordance with the
provisions of Sec. 317.309 for nutrition labels, or in accordance with
the provisions of Sec. 317.345 for point-of-purchase materials, except
as exempted under Sec. 317.400. For all other products for which
nutrition labeling is required, including ground or chopped meat
products described in Sec. 317.301, nutrition labeling must be
provided in accordance with the provisions of Sec. 317.309, except as
exempted under Sec. 317.400.
(b) Nutrition labeling may be provided for single-ingredient, raw
meat products that are not ground or chopped meat products described in
Sec. 317.301 and that are not major cuts of single-ingredient, raw
meat products identified

[[Page 82165]]

in Sec. 317.344, either in accordance with the provisions of Sec.
317.309 for nutrition labels, or in accordance with the provisions of
Sec. 317.345 for point-of-purchase materials.

0
3. A new Sec. 317.301 is added to read as follows:

Sec. 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 Sec. 317.309, except as exempted under Sec.
317.400.
(b) [Reserved]

0
4. Section 317.309 is amended as follows:
0
a. In paragraph (b)(3), the first sentence is amended by adding ``that
are not ground or chopped meat products described in Sec. 317.301''
after the phrase ``single-ingredient, raw products'', and by removing
``as set forth in Sec. 317.345(a)(1)''; the second sentence is amended
by adding, ``that are not ground or chopped meat products described in
Sec. 317.301'' after the phrase ``single-ingredient, raw products'',
and the following new sentence is added after the first sentence: ``For
single-ingredient, raw products that are not ground or chopped meat
products described in Sec. 317.301, if data are based on the product
`as consumed,' the data must be presented in accordance with Sec.
317.345(d)'';
0
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 Sec. 317.301, including those that have been
previously frozen.'';
0
c. Amend paragraph (b)(11) by adding the phrase ``single-ingredient,
raw products that are not ground or chopped meat products described in
Sec. 317.301 and'' after ``exception of'';
0
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 Sec. 317.301.'' at the end of the
paragraph;
0
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 chopped meat products described in Sec. 317.301,'' after ``as
packaged''; and
0
f. Amend paragraph (h)(9) by removing the phrase ``(including ground
beef)'', by adding, ``that are not ground or chopped meat products
described in Sec. 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 Sec.
317.345(e) and (f).''

Sec. 317.343 [Removed]

0
5. Section 317.343 is removed.
0
6. Section 317.344 is amended by removing the phrases ``ground beef
regular without added seasonings, ground beef about 17% fat,'' and
``ground pork''.
0
7. Section 317.345 is amended as follows:
0
a. Revise the section heading and paragraphs (a) and (c);
0
b. Amend paragraph (d) by removing ``should'' and adding, in its place,
``for products covered in paragraphs (a)(1) and (a)(2) must'';
0
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)'';
0
d. Amend paragraph (f) by adding ``provided'' after ``nutrition
information is''; and
0
e. Amend paragraph (g) by removing the phrase ``(including ground
beef)''.
The revisions read as follows:

Sec. 317.345 Nutrition labeling of single-ingredient, raw meat
products that are not ground or chopped products described in Sec.
317.301.

(a)(1) Nutrition information on the major cuts of single-
ingredient, raw meat products identified in Sec. 317.344, including
those that have been previously frozen, is required, either on their
label or at their point-of-purchase, unless exempted under Sec.
317.400. If nutrition information is presented on the label, it must be
provided in accordance with Sec. 317.309. 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 single-ingredient, raw meat products
that are not ground or chopped meat products described in Sec. 317.301
and are not major cuts of single-ingredient, raw meat products
identified in Sec. 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 Sec. 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-of-purchase materials, all of the
format and content requirements of Sec. 317.309 apply. However, if
only nutrition information--and not a nutrition claim--is supplied on
point-of-purchase materials, the requirements of Sec. 317.309 apply,
provided, however:
(i) The listing of percent of Daily Value for the nutrients (except
vitamins and minerals specified in Sec. 317.309(c)(8)) and footnote
required by Sec. 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 Sec. 317.309(f).
* * * * *

0
8. Section 317.362 is amended by adding a new paragraph (f) to read as
follows:

Sec. 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 Sec.
317.301 when the product does not meet the criteria for ``low fat,''
defined in Sec. 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.
* * * * *

0
9. Section 317.400 is amended by:
0
a. Revising paragraph (a)(1) introductory text;
0
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-

[[Page 82166]]

retail store operation,'' after ``company/firm'';
0
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 ready-to-eat ground or
chopped meat products described in Sec. 317.301 that are packaged or
portioned at a retail establishment, unless the establishment qualifies
for an exemption under (a)(1);'';
0
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 Sec. 317.301 that are processed at a retail
establishment, unless the establishment qualifies for an exemption
under (a)(1); and'';
0
e. Adding a new paragraph (a)(7)(iii); and
0
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 Sec.
317.344.''
The revision and additions read as follows:

Sec. 317.400 Exemption from nutrition labeling.

(a) * * *
(1) Food products produced by small businesses, other than the
major cuts of single-ingredient, raw meat products identified in Sec.
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 Sec. 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 Sec.
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

0
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.

0
11. Section 381.400 is revised to read as follows:

Sec. 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 single-
ingredient, raw poultry products that are not ground or chopped poultry
products described in Sec. 381.401 and are not major cuts of single-
ingredient, raw poultry products identified in Sec. 381.444, unless
the product is exempted under Sec. 381.500. Nutrition labeling must be
provided for the major cuts of single-ingredient, raw poultry products
identified in Sec. 381.444, either in accordance with the provisions
of Sec. 381.409 for nutrition labels, or in accordance with the
provisions of Sec. 381.445 for point-of-purchase materials, except as
exempted under Sec. 381.500. For all other products that require
nutrition labeling, including ground or chopped poultry products
described in Sec. 381.401, nutrition labeling must be provided in
accordance with the provisions of Sec. 381.409, except as exempted
under Sec. 381.500.
(b) Nutrition labeling may be provided for single-ingredient, raw
poultry products that are not ground or chopped poultry products
described in Sec. 381.401 and that are not major cuts of single-
ingredient, raw poultry products identified in Sec. 381.444, either in
accordance with the provisions of Sec. 381.409 for nutrition labels,
or in accordance with the provisions of Sec. 381.445 for point-of-
purchase materials.
* * * * *

0
12. A new Sec. 381.401 is added to read as follows:

Sec. 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 Sec. 381.409, except as exempted under Sec. 381.500.

0
13. Section 381.409 is amended as follows:
0
a. Revise paragraph (b)(3);
0
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 that are not ground or chopped poultry
products described in Sec. 381.401, including those that have been
previously frozen.'';
0
c. Amend paragraph (b)(11) by adding the phrase ``single-ingredient,
raw products that are not ground or chopped poultry products described
in Sec. 381.401 and'' after ``exception of'';
0
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 Sec. 381.401.'' at the end of the
paragraph;
0
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 Sec. 381.401,'' after
``as packaged''; and
0
f. Amend paragraph (h)(9) by adding, ``that are not ground or chopped
poultry products described in Sec. 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 Sec. 381.445(e) and (f).''
The revision reads as follows:

Sec. 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 Sec. 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
Sec. 381.401, if data are based on the product ``as consumed,'' the
data must be presented in accordance with Sec. 381.445(d). In addition
to the required declaration on the basis of ``as packaged'' for
products other than single-ingredient, raw products that are not ground
or chopped poultry products as described in Sec. 381.401, the
declaration may also be made on the basis of ``as consumed,'' provided
that preparation and cooking instructions are clearly stated.
* * * * *

Sec. 381.443 [Removed]

0
14. Section 381.443 is removed.
0
15. Section 381.445 is amended as follows:
0
a. Revise the section heading and paragraph (a) and (c);

[[Page 82167]]

0
b. Amend paragraph (d) by removing ``should'' and adding, in its place,
``for products covered in paragraphs (a)(1) and (a)(2) must'';
0
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
0
d. Amend paragraph (f) by adding ``provided'' after ``nutrition
information is''.
The revisions read as follows:

Sec. 381.445 Nutrition labeling of single-ingredient, raw poultry
products that are not ground or chopped products described in Sec.
381.401.

(a)(1) Nutrition information on the major cuts of single-
ingredient, raw poultry products identified in Sec. 381.444, including
those that have been previously frozen, is required, either on their
label or at their point-of-purchase, unless exempted under Sec.
381.500. If nutrition information is presented on the label, it must be
provided in accordance with the provisions of Sec. 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 single-ingredient, raw poultry
products that are not ground or chopped poultry products described in
Sec. 381.401 and are not major cuts of single-ingredient, raw poultry
products identified in Sec. 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 Sec. 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-of-purchase materials, all of the
format and content requirements of Sec. 381.409 apply. However, if
only nutrition information--and not a nutrition claim--is supplied on
point-of-purchase materials, the requirements of Sec. 381.409 apply,
provided, however:
(i) The listing of percent of Daily Value for the nutrients (except
vitamins and minerals specified in Sec. 381.409(c)(8)) and footnote
required by Sec. 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 Sec. 381.409(f).
* * * * *

0
16. Section 381.462 is amended by adding a new paragraph (f) to read as
follows:

Sec. 381.462 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 poultry products described in Sec.
381.401 when the product does not meet the criteria for ``low fat,''
defined in Sec. 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.
* * * * *

0
17. Section 381.500 is amended by:
0
a. Revising paragraph (a)(1) introductory text;
0
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'';
0
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 ready-to-eat ground or
chopped poultry products described in Sec. 381.401 that are packaged
or portioned at a retail establishment, unless the establishment
qualifies for an exemption under (a)(1);'';
0
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 Sec. 381.401 that are processed at a retail
establishment, unless the establishment qualifies for an exemption
under (a)(1); and'';
0
e. Adding a new paragraph (a)(7)(iii); and
0
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 Sec. 381.444.''
The revision and additions read as follows:

Sec. 381.500 Exemption from nutrition labeling.

(a) * * *
(1) Food products produced by small businesses other than the major
cuts of single-ingredient, raw poultry products identified in Sec.
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 Sec. 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 Sec.
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.
* * * * *

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