[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Rules and Regulations]
[Pages 82148-82167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32485]



[[Page 82147]]

-----------------------------------------------------------------------

Part II





Department of Agriculture





-----------------------------------------------------------------------



Food Safety and Inspection Service



-----------------------------------------------------------------------



9 CFR Parts 317 and 381



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

  Federal Register / Vol. 75 , No. 249 / Wednesday, December 29, 2010 / 
Rules and Regulations  

[[Page 82148]]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. FSIS-2005-0018]
RIN 0583-AC60


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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations to require 
nutrition labeling of the major cuts of single-ingredient, raw meat and 
poultry products on labels or at point-of-purchase, unless an exemption 
applies. FSIS is also amending its regulations to require nutrition 
labels on all ground or chopped meat and poultry products, with or 
without added seasonings, unless an exemption applies. In addition, the 
rule provides that, when a ground or chopped product does not meet the 
regulatory criteria to be labeled ``low fat,'' a lean percentage 
statement may be included on the label or in labeling as long as a 
statement of the fat percentage that meets the specified criteria also 
is displayed on the label or in labeling.

DATES: Effective Date: This final rule is effective on January 1, 2012.

FOR FURTHER INFORMATION CONTACT: Rosalyn Murphy-Jenkins, Director, 
Labeling and Program Delivery Division, Office of Policy and Program 
Development, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Beltsville, MD 20705; (301) 504-0878.

Section I.

SUPPLEMENTARY INFORMATION:

Background

    The Nutrition Labeling and Education Act (NLEA) of 1990 required 
nutrition labeling of most foods regulated by the Food and Drug 
Administration (FDA). Because FSIS is committed to providing consumers 
with the most informative labeling system possible, FSIS published 
regulations establishing comparable nutrition labeling requirements for 
meat and poultry products. FSIS published an advance notice of proposed 
rulemaking on nutrition labeling of meat and poultry products on April 
2, 1991 (56 FR 13564), a proposed rule on November 27, 1991 (56 FR 
60302), a final rule on January 6, 1993 (58 FR 632), and subsequently 
other amendments to the rule.
    The Agency's regulations currently require nutrition labels on the 
packages of all multi-ingredient and heat processed meat and poultry 
products, unless an exemption applied. The required nutrition labeling 
provisions are referred to as ``the mandatory nutrition labeling 
program.'' The Agency's 1993 regulations also established guidelines 
for voluntary nutrition labeling of single-ingredient, raw meat and 
poultry products, including single-ingredient, raw ground or chopped 
products.
    On January 18, 2001, FSIS published a proposed rule in the Federal 
Register entitled, ``Nutrition Labeling of Ground or Chopped Meat and 
Poultry Products and Single-Ingredient Products'' (66 FR 4969). Because 
of the length of time since the publication of the proposed rule, FSIS 
published a supplemental proposed rule on December 18, 2009, to provide 
the public an additional opportunity to comment (74 FR 67736). This 
final rule is consistent with the provisions in the supplemental 
proposed rule.
    Nutrition labeling continues to be an integral part of USDA's 
efforts to educate consumers concerning nutrition and diets. Since 1980 
USDA and the Department of Health and Human Services (HHS) have jointly 
published the Dietary Guidelines for Americans every five years. The 
Dietary Guidelines provide advice concerning food choices that promote 
health and prevent disease. The Dietary Guidelines for Americans, 2005, 
advises consumers to aim for a total fat intake between 20 to 35 
percent of calories (page viii). In addition, the Dietary Guidelines 
for Americans, 2005, includes a chart showing the recommended upper 
limits for grams of saturated fat per day for a range of total calories 
per day (page 31). The nutrition information that FSIS is requiring in 
this final rule on the labels of ground or chopped products and on 
either labels or point-of-purchase materials for the major cuts of 
single-ingredient, raw meat and poultry products would include the 
number of calories and the grams of total fat and saturated fat the 
product contains. The information FSIS is requiring would, therefore, 
assist consumers in following the advice in the Dietary Guidelines for 
Americans, 2005.
    Major cuts: This final rule requires nutrition labeling of the 
major cuts of single-ingredient, raw meat and poultry products 
identified in Sec. Sec.  317.344 and 381.444 that are not ground or 
chopped, except for certain exemptions. For these products, the final 
rule requires that nutrition information be provided on the label or at 
point-of-purchase, unless an exemption applies.
    In its two most recent surveys of the voluntary nutrition labeling 
of single-ingredient, raw products, FSIS found that significant 
participation in the voluntary nutrition labeling program did not exist 
(66 FR 4972, January 18, 2001). Under 9 CFR 317.343 and 9 CFR 381.443, 
if FSIS finds that there is not significant participation by retail 
stores in the voluntary nutrition labeling program to provide nutrition 
labeling for the major cuts of single-ingredient, raw meat and poultry 
products, FSIS is obligated to institute rulemaking to require that 
such labeling be provided. FSIS regulations provide that a food 
retailer participates at a significant level (1) if the retailer 
provides nutrition labeling information for at least 90 percent of the 
major cuts of single-ingredient, raw meat and poultry products it 
sells; and (2) if the nutrition label on these products is consistent 
in content and format with the mandatory program, or if nutrition 
information is displayed at point-of-purchase in an appropriate manner. 
Significant participation by food retailers exists if at least 60 
percent of all companies that were evaluated were participating in 
accordance with the guidelines. Based on the survey data from the two 
most recent surveys from 1996 and 1999, less than 60 percent of stores 
evaluated were participating in accordance with the guidelines. 
Therefore, significant participation in the voluntary nutrition 
labeling program did not exist, and FSIS proceeded with rulemaking.
    Under Sec.  317.4, FSIS's Labeling and Program Delivery Division 
(LPDD) reviews labels on meat and poultry products that have been 
submitted for approval. Based on its label review, FSIS has not seen an 
increase in nutrition labeling of the major cuts of single-ingredient 
raw, meat and poultry products since the surveys were conducted. 
Compliance investigators in FSIS's Office of Program Evaluation, 
Enforcement & Review (OPEER) also have not seen an increase in the 
number of packages of the major cuts of single-ingredient, raw meat and 
poultry products that have nutrition facts panels on their labels at 
retail or an increase in the availability of point-of-purchase 
materials that provide nutrition information for such products at 
retail since the last compliance surveys were conducted. For these 
reasons and because no other evidence has been submitted to FSIS that 
significant participation in the voluntary program

[[Page 82149]]

now exists, FSIS has concluded that this final rule is necessary.
    FSIS has determined that major cuts of single-ingredient raw, meat 
and poultry products that do not bear nutrition information on their 
labels or on point-of-purchase materials will be misbranded, under 
section 1(n) of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
601(n)(1)) and section 4(h)(1) of the Poultry Products Inspection Act 
(PPIA) (21 U.S.C. 453(h)(1)). Without nutrition information on their 
labeling, FSIS has concluded that the labeling of these products will 
be false or misleading because it will not provide consumers with 
sufficient information to assess the nutrient content of the major cuts 
and will not enable consumers to select major cuts that fit into a 
healthy diet that meets their individual needs.
    Consumers are given a rough indication of the fat content of major 
cuts of poultry based on whether the product has skin and based on the 
levels of attached fat in the product. Similarly, consumers are given a 
rough indication of the fat content of major cuts of meat products 
based on internal marbling and attached fat. However, without nutrition 
labeling for the major cuts, consumers cannot assess precise levels of 
fat (e.g., 10 grams vs. 20 grams of fat per serving) and cannot know 
the levels of specific nutrients, such as saturated fat, in these 
products. Therefore, without nutrition labeling of these products, 
consumers cannot make educated choices about consuming the major cuts.
    To provide flexibility, the rule allows nutrition information to be 
provided on the labels of individual packages of the major cuts of 
single-ingredient, raw products and, to be provided on point-of-
purchase materials. Further, FSIS has determined that point-of-purchase 
labeling is appropriate because consumers can generally estimate the 
fat content in these products, and because the nutrient content of any 
given major cut is relatively uniform across the market.
    Ground or Chopped Products: This final rule requires that nutrition 
labels be provided for all ground or chopped products (livestock 
species) and hamburger, with or without added seasonings, unless an 
exemption applies. Similarly, this final rule requires that nutrition 
labels be provided for all ground or chopped poultry (kind), with or 
without added seasonings, unless an exemption applies. Under this final 
rule, products that would be required to bear nutrition labels include 
single-ingredient, raw hamburger, ground beef, ground beef patties, 
ground chicken, ground turkey, ground chicken patties, ground pork, and 
ground lamb.
    Unlike other single-ingredient, raw products, producers are able to 
formulate precisely the fat content of ground or chopped products. 
Therefore, in this respect, these products are similar to products in 
the existing mandatory program that are required to bear nutrition 
labels. Other single-ingredient, raw products cannot be formulated in 
the same manner or to the same degree as ground products.
    In ground or chopped products, the fat is uniformly distributed 
throughout the product and is not clearly distinguishable on the 
surface of the product. The Agency has concluded that consumers cannot 
estimate the level of fat in these products and cannot compare the 
levels of fat in these products to those in other products. 
Additionally, producers sometimes use meat from advanced meat recovery 
(AMR) systems and low temperature rendering (LTR) in ground or chopped 
beef or pork products, which can affect their nutrient content. For 
these reasons, FSIS has concluded that ground or chopped meat and 
poultry products that do not bear nutrition information will be 
misbranded under section 1(n)(1) of the FMIA and section 4(h)(1) of the 
PPIA.
    FSIS is requiring that nutrition information for ground or chopped 
products appear on the label of these products (unless an exemption 
applies), as is required for multi-ingredient and heat processed 
products, rather than on point-of-purchase materials. Because there are 
numerous formulations of ground or chopped products, it would be 
difficult for producers or retailers to develop point-of-purchase 
materials that would address all the different formulations that exist 
for these products. Furthermore, it would be difficult for consumers to 
find the correct information for a specific ground or chopped product 
on point-of-purchase materials that include information concerning 
numerous formulations of these products.
    Non-major Cuts of Single-Ingredient, Raw Meat and Poultry Products 
that are not Ground or Chopped: FSIS is not requiring nutrition 
information for single-ingredient, raw meat and poultry products that 
are not major cuts and that are not ground or chopped. But, if 
nutrition information is provided for these products, it must be 
provided in accordance with the nutrition labeling requirements for the 
major cuts. Therefore, under the final rule, if establishments or 
retail facilities choose to provide nutrition information for these 
products, they will either provide it at point-of-purchase, in 
accordance with Sec.  317.345 or Sec.  381.445, or on their label, in 
accordance with Sec.  317.309 or Sec.  381.409. Thus, the nutrition 
labeling provisions for these products will be consistent with those 
for the voluntary nutrition labeling program.
    Permitting Percent Lean Statements on labels or in labeling of 
ground or chopped products: The final rule permits a statement of lean 
percentage on the label or in labeling of ground or chopped meat and 
poultry products that do not meet the regulatory criteria for ``low 
fat,'' provided that a statement of the fat percentage is also 
displayed on the label or in labeling. The required statement of fat 
percentage must be contiguous to, in lettering of the same color, size, 
and type as, and on the same color background as, the statement of lean 
percentage. Many consumers have become accustomed to this labeling on 
ground beef products, and FSIS has concluded that this labeling 
provides a quick, simple, and accurate means of comparing ground or 
chopped meat and poultry products.
    Exemptions: Under this final rule, the following exemptions from 
nutrition labeling requirements will apply to the major cuts of single-
ingredient, raw meat and poultry products and ground or chopped meat 
and poultry products:
     Products intended for further processing, provided that 
the labels for these products bear no nutrition claim or nutrition 
information,
     Products that are not for sale to consumers, provided that 
the labels for these products bear no nutrition claims or nutrition 
information,
     Products in small packages that are individually wrapped 
packages of less than \1/2\; ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information,
     Products that are custom slaughtered or prepared, and
     Products intended for export.
    This final rule also provides the following additional exemptions 
for ground or chopped products:
     Ground or chopped products that qualify for the small 
business exemption in Sec. Sec.  317.400(a)(1) and 381.500(a)(1),
     Products that are ground or chopped at an individual 
customer's request and that are prepared and served at retail, provided 
that the labels or labeling of these products bears no nutrition claims 
or nutrition information,
     Ground or chopped products in packages that have a total 
surface area for labeling of less than 12 square inches, provided that 
the product's labeling includes no nutrition claims or

[[Page 82150]]

nutrition information and provided that an address or telephone number 
that a consumer can use to obtain the required information is included 
on the label, and
     Ground products produced by small businesses that use 
statements of percent fat and percent lean on the label or in labeling 
of ground products, provided they include no other nutrition claims or 
nutrition information on the product labels or labeling.
    FSIS believes an exemption for ground or chopped products produced 
by small businesses is necessary because the burden of mandatory 
nutrition labeling may force some small firms to stop producing the 
product because of the cost of nutrition labeling and eventually force 
some small firms out of business. FSIS believes it would not be 
feasible for some small businesses to incur the additional costs of 
nutrition labeling because of their low volume of sales or low volume 
of ground product. FSIS believes it is feasible for larger businesses 
to incur the additional costs of nutrition labeling because of their 
higher volume of sales or larger levels of production of ground 
product. This final rule, with an exemption for ground or chopped 
products that qualify for the small business exemption in Sec. Sec.  
317.400(a)(1) and 381.500(a)(1), provides nutrition labeling on the 
maximum volume of ground or chopped product while assuring that small 
businesses producing low volumes of product are not at risk of going 
out of business or materially reducing the variety of products they 
deliver to their customers. Further, FSIS believes that the relatively 
small additional benefits of requiring small businesses to put 
nutrition labels on all ground or chopped products are outweighed by 
the larger additional costs. FSIS estimates that without the exemption 
there would be a $3 million reduction in annual average net benefit. 
Without the exemption, the projected compliance average total cost 
increase annually of $54 million would not be the only type of cost 
that would be incurred. FSIS believes that without the exemption many 
small businesses would have to close or substantially reduce the 
variety of products they now offer. Reductions in purchase options 
would be a cost to consumers that could not be quantified for FSIS's 
analysis.
    Under this final rule, there is not a small business exemption for 
the major cuts of single-ingredient, raw meat and poultry products 
because nutrition information for these products may be provided on 
labels or, alternatively, at their point-of-purchase. Additionally, 
FSIS will make point-of-purchase materials available over the Internet 
free of charge. Therefore, the nutrition labeling requirement for major 
cuts of single-ingredient, raw products should not impose an economic 
hardship for small businesses, including those that are retail stores.
    Under the proposed rule, if small businesses produced ground or 
chopped product and included a statement of lean percentage and fat 
percentage on the product's label, the small business would have been 
required to include nutrition information on the product label. These 
small businesses would not have qualified for the small business 
exemption because the labels for these products included nutrition 
claims. Based on the National Cattleman's Beef Association (NCBA) 
National Meat Case Study in 2004, 93 percent of ground beef packages 
had statements of lean or fat percentages (74 FR 67741). Sixty-eight 
percent of packages with such statements had nutrition facts panels and 
25 percent did not (74 FR 67741). Because about 95 percent of grinders 
are small businesses, FSIS concluded that many of the 25 percent of 
packages that included lean or fat percentage statements without 
nutrition facts panels were produced by small businesses. Therefore, 
FSIS believes many small businesses include statements of lean or fat 
percentage on the label of their ground products but not the nutrition 
facts panel. Also, because of the longstanding use of the statements of 
percent fat and percent lean on the label or in labeling of ground beef 
and hamburger products, FSIS believes that such statements on the label 
or in labeling of ground products produced by small businesses will not 
mislead consumers, even if the small businesses do not include 
nutrition information on the products' labels (74 FR 67741). Many 
consumers have become accustomed to this labeling on ground beef 
products, and FSIS believes that this labeling provides a quick, 
simple, and accurate means of comparing ground or chopped meat and 
poultry products. Therefore under the final rule, small businesses that 
use statements of percent fat and percent lean on the label of ground 
products, provided they include no other nutrition claims or nutrition 
information on the product labels or labeling, are exempted from the 
nutrition labeling requirements.
    Additionally, under this final rule, any ground or chopped product 
or major cut of single-ingredient, raw product represented or purported 
to be specifically for infants and children less than 4 years of age 
will not be allowed to include certain nutrient content declarations 
because infants and children less than 4 years of age have different 
nutrition needs than adults and children older than 4 years of age.
    Finally, this final rule makes clear that the current regulatory 
exemptions for ready-to-eat (RTE) product packaged or portioned at 
retail and multi-ingredient product processed at retail do not apply to 
RTE ground or chopped products packaged or portioned at retail or 
multi-ingredient ground or chopped products that are processed at 
retail because there may be a significant amount of multi-ingredient 
ground beef retail processed products or RTE retail packaged products 
(66 FR 4979, January 18, 2001). For further explanation of the reasons 
for the foregoing exemptions, see 58 FR 638-639; 66 FR 4978-4979; and 
75 FR 67740-67741.
    Enforcement and Compliance: After the final rule is implemented, 
FSIS will collect samples of ground product at retail for nutrient 
analysis. In addition, FSIS will assess whether nutrition information 
is available for the major cuts, either on package labels or at the 
point-of-purchase.
    Under this final rule, the procedures set forth for FSIS product 
sampling and nutrient analysis in Sec. Sec.  317.309(h)(1)-(8) and 
381.409(h)(1)-(8) will be applicable to ground or chopped meat and to 
ground or chopped poultry products, respectively. FSIS will sample and 
conduct nutrient analysis of ground or chopped products to verify 
compliance with nutrition labeling requirements, even if nutrition 
labeling on these products is based on the most current representative 
database values contained in USDA's National Nutrient Data Bank or the 
USDA National Nutrient Database for Standard Reference and there are no 
claims on the labeling. Therefore, FSIS will treat these products as it 
treats other products required to bear nutrition labels.
    FSIS will treat ground or chopped products in this way because the 
fat content of these products can vary significantly. FSIS employees 
cannot visually assess whether nutrition information on the label of 
ground or chopped products accurately reflects the labeled products' 
contents because, in most cases, it is not possible to visually assess 
the level of fat in a ground or chopped product.
    If nutrition labeling of the major cuts of single-ingredient, raw 
products (other than ground beef or ground pork) is based on USDA's 
National Nutrient Data Bank or the USDA's National Nutrient Database 
for Standard Reference, and there are no nutrition claims on the 
labeling, FSIS will not sample and

[[Page 82151]]

conduct a nutrient analysis of the products because FSIS personnel can 
visually identify the particular cut. If the nutrition information for 
these products is based on USDA's National Nutrient Data Bank or the 
USDA National Nutrient Database for Standard Reference, and there are 
no nutrition claims on the labeling, it is not necessary for FSIS to 
verify the accuracy of the data because they are USDA data. USDA has 
already evaluated these data and determined that they are valid (66 FR 
4980, January 18, 2001).
    Outreach: FSIS personnel will conduct meetings and Webinars on the 
final rule and will provide additional information and guidance as 
needed. If retailers cannot obtain point-of-purchase materials over the 
Internet, FSIS personnel will have copies of the information to provide 
to retailers.
    Six months prior to the effective date, FSIS intends to make 
available nutrition labeling materials that can be used at the point-
of-purchase of the major cuts at the following Internet address: 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

[[Page 82152]]

likely to omit many cuts or give them a different name than what 
appears on the package. The organization also stated that USDA should 
conduct a survey to determine whether consumers are better served by 
on-package nutrition labels than point-of-purchase materials. According 
to this consumer organization, many companies and grocery chains 
already use on-package nutrition labeling. Additionally, the consumer 
organization stated that if similar nutrition labels and labeling 
equipment are required for ground products, then retailers would not 
incur substantial additional costs by adding nutrition labels to major 
cuts.
    The consumer organization disagreed with FSIS's position that 
consumers can visually determine the difference in fat content between 
various cuts. This organization noted that a recent telephone survey 
showed an overwhelming percentage (80%) of respondents could not 
determine which cuts of meat had the least amount of fat. The consumer 
organization suggested that the USDA does not have any data to support 
its assumption that consumers can visually determine the difference in 
fat content between various cuts.
    Several trade associations, an industry commenter, and the food 
marketing organization supported the option of providing nutrition 
information for the major cuts through point-of-purchase materials. 
According to one trade association, their retailer customers believe 
nutrition labeling for meat is more efficiently displayed via point-of-
purchase materials than on the product.
    Response: As FSIS proposed, this final rule will require that 
nutrition information be provided for the major cuts of single-
ingredient, raw meat and poultry products, either on the label or at 
the point-of-purchase. FSIS agrees that the final rule will produce 
health benefits, including projected reductions in the incidence of 
coronary heart disease and three types of cancer that may accrue as 
consumers improve their diet quality through increased use of nutrition 
information generated by the final rule.
    FSIS agrees with the individual that stated that most retailers do 
not participate at a significant level when labeling is voluntary. In 
the two most recent surveys from 1996 and 1999, FSIS found that 
significant participation in the voluntary nutrition labeling program 
did not exist (see 66 FR 4973, January 18, 2001; 74 FR 67736-67737, 
December 18, 2009). In addition, since the surveys were conducted, 
FSIS's LPDD has not seen an increase in the number of labels that 
include nutrition information for the major cuts of single-ingredient, 
raw meat and poultry products. Further, FSIS's OPEER also has not seen 
an increase in the number of packages of the major cuts of single-
ingredient, raw meat and poultry products that have nutrition facts 
panels on their labels at retail or an increase in the availability of 
point-of-purchase materials that provide nutrition information for such 
products at retail since the last compliance surveys were conducted. 
These observations do not constitute survey data but provide additional 
meaningful information based on the experience of FSIS's LPDD and 
OPEER. No evidence has been submitted to FSIS that significant 
participation in the voluntary program now exists.
    FSIS agrees that many consumers cannot accurately assess the 
nutritional content of the major cuts of single-ingredient, raw 
products; however, we continue to believe that point-of-purchase 
nutritional information is appropriate for these products.
    While consumers cannot accurately assess the nutritional content of 
the major cuts of single-ingredient, raw products, their ability to do 
so is greater than in the case of ground products. Ground products are 
processed in such a way that fat content is very difficult to visually 
ascertain. Internal marbling, attached fat, and whether the product has 
skin gives consumers some rough indication of the fat content of the 
major cuts of single-ingredient, raw products, which leads FSIS to 
believe that the benefits of on-package labeling may be slightly less 
than with ground product. FSIS notes, however, that consumers still 
need nutrition information on point-of-purchase materials for the major 
cuts because consumers cannot assess precise levels of fat (e.g., 10 
grams vs. 20 grams of fat per serving) and cannot know the levels of 
calories or other specific nutrients, such as saturated fat, in these 
products.
    Based on comments received and the Supplemental Proposed Rule 
Regulatory Impact Analysis, FSIS believes that requiring on-package 
labeling for the major cuts of single-ingredient, raw products is also 
likely to be significantly more costly than for ground products because 
it would require on-package labeling on a larger volume of product. In 
the Supplemental Proposed Rule Regulatory Impact Analysis, FSIS 
estimated that the annualized average present value of the costs of 
requiring nutrition labels on the major cuts of single-ingredient, raw 
meat and poultry products would be $16.48 million more than the 
annualized average present value of the costs of requiring nutrition 
labels on all ground or chopped products, without taking into account 
the current level of voluntary compliance (74 FR 67789).
    As discussed in the proposed rule and in the supplemental proposed 
rule, FSIS believes it will be relatively easy to prepare point-of-
purchase materials for the major cuts because the nutrient content of a 
given major cut is relatively uniform across the market, and these 
products are not formulated in the manner of ground or chopped products 
(66 FR 4974, January 18, 2001) (74 FR 67737, December 18, 2009). To 
ensure that this is the case, FSIS is making available nutrition 
labeling materials that can be used at point-of-purchase over the 
Internet free of charge.
    FSIS acknowledges the concern expressed by an individual and by the 
consumer organization about the location of point-of-purchase 
materials, but believes that it is currently addressed in the 
regulations (9 CFR 317.345(a)(3) and 381.445(a)(3)) which require that 
point-of-purchase materials be made available in close proximity to the 
food. In addition, FSIS personnel will also visit stores to verify that 
they are following this and the other requirements.
    In response to the comment that noted that an advantage of 
including nutrition information on the label is that consumers can 
review the nutrient content of the product once the product is taken 
home, and that others besides the primary food purchaser would have 
better access to this information, surveys, including the Diet and 
Health Knowledge Survey (DHKS), show that a majority of individuals 
report using labels while buying foods. Although the DHKS shows that 
adults who are not main household shoppers use labels, the survey shows 
that the main shoppers use labels at a higher rate than those who are 
not main household shoppers. If individuals in a household have certain 
nutrition practices and needs, the person who purchases food for the 
household would likely take other household members' needs and 
preferences into account. In this case, the entire household would 
ultimately receive the benefits of the nutrition information. Further, 
other household members besides the primary food purchaser will be able 
to obtain nutrition information for the major cuts on the Internet on 
FSIS's Web site, ARS's Web site, and FMI's Web site.
    FSIS agrees that consumers cannot accurately judge the nutritional 
content of the major cuts of single-ingredient, raw products, and that 
the mandatory provision of this information to consumers is warranted 
and

[[Page 82153]]

appropriate. However, for the reasons described above, we believe that 
point-of-purchase information is appropriate for these products.
    Comment: Several individuals and trade associations, one food 
marketing organization, and an industry commenter opposed the proposed 
rule to require nutrition information for the major cuts, either on 
their label or at their point-of-purchase. These trade associations and 
the food marketing organization stated that FSIS should maintain its 
existing voluntary program. One trade association and the food 
marketing organization advocated that the USDA should conduct a new 
compliance survey because it is likely that the level of participation 
in the voluntary nutrition labeling program has increased beyond the 
``significant participation'' threshold because of changes in the 
composition of the retail sector over the past decade, and because of 
efforts by FMI to encourage the widespread use and dissemination of 
Nutri-Facts materials. These organizations stated that the last USDA 
survey for compliance is outdated because it was conducted in 1999, and 
should not be the basis for promulgating the rule. The food marketing 
organization noted that the regulations that require FSIS to evaluate 
the level of participation in the voluntary nutrition labeling program 
every two years remain in effect. One trade association stated that 
maintaining the voluntary program will be less costly and will help the 
industry. According to this trade association, FSIS could increase 
voluntary compliance by making the same updated nutrition information 
available free of charge to retailers as it planned to make available 
under the proposed rule. Several trade associations stated that if 
individual consumers wanted more specific nutrition information about a 
particular product, they could access it through other sources like the 
Internet. An industry commenter noted that if there was sufficient 
consumer demand for more nutrition information, then retailers would 
have an economic incentive to voluntarily supply it.
    One trade association did not agree with FSIS's position that major 
cuts of single-ingredient raw, meat and poultry products that do not 
bear nutrition information on their labels or on point-of-purchase 
materials are misbranded. Another trade association believed that there 
were few significant differences in the nutritional values among the 
various brands of young chicken, and that nutrition information for 
single-ingredient chicken is not that useful because most people add 
ingredients to it during cooking that alter the calories, fat, and 
protein. For those reasons, the poultry trade association stated that 
there is no need to mandate nutrition labeling for the major cuts, and 
FSIS should maintain its existing voluntary nutrition labeling program 
for the major cuts. Several individuals stated that consumers already 
have a general idea of the average nutritional value of major cuts of 
meat and poultry products.
    Response: FSIS encouraged participation in the voluntary nutrition 
labeling program through meetings with industry. Additionally, 
nutrition labeling materials for the major cuts have been available on 
FMI's Web site for several years (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