Wednesday, 

December 29, 2010 

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 


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82148 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 317 and 381 

[Docket No. FSIS–2005–0018] 

RIN 0583–AC60 

Nutrition Labeling of Single-Ingredient 

Products and Ground or Chopped 

Meat and Poultry Products 

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-ofpurchase, unless an exemption applies. 

FSIS is also amending its regulations to 

require nutrition labels on all ground or 

chopped meat and poultry products, 

with or without added seasonings, 

unless an exemption applies. In 

addition, the rule provides that, when a 

ground or chopped product does not 

meet the regulatory criteria to be labeled 

‘‘low fat,’’ a lean percentage statement 

may be included on the label or in 

labeling as long as a statement of the fat 

percentage that meets the specified 

criteria also is displayed on the label or 

in labeling. 

DATES: Effective Date: This final rule is 

effective on January 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Rosalyn Murphy-Jenkins, Director, 

Labeling and Program Delivery Division, 

Office of Policy and Program 

Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, Beltsville, MD 20705; (301) 

504–0878. 

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 singleingredient, raw meat and poultry 

products would include the number of 

calories and the grams of total fat and 

saturated fat the product contains. The 

information FSIS is requiring would, 

therefore, assist consumers in following 

the advice in the Dietary Guidelines for 

Americans, 2005. 

Major cuts: This final rule requires 

nutrition labeling of the major cuts of 

single-ingredient, raw meat and poultry 

products identified in §§ 317.344 and 

381.444 that are not ground or chopped, 

except for certain exemptions. For these 

products, the final rule requires that 

nutrition information be provided on 

the label or at point-of-purchase, unless 

an exemption applies. 

In its two most recent surveys of the 

voluntary nutrition labeling of singleingredient, raw products, FSIS found 

that significant participation in the 

voluntary nutrition labeling program 

did not exist (66 FR 4972, January 18, 

2001). Under 9 CFR 317.343 and 9 CFR 

381.443, if FSIS finds that there is not 

significant participation by retail stores 

in the voluntary nutrition labeling 

program to provide nutrition labeling 

for the major cuts of single-ingredient, 

raw meat and poultry products, FSIS is 

obligated to institute rulemaking to 

require that such labeling be provided. 

FSIS regulations provide that a food 

retailer participates at a significant level 

(1) if the retailer provides nutrition 

labeling information for at least 90 

percent of the major cuts of singleingredient, raw meat and poultry 

products it sells; and (2) if the nutrition 

label on these products is consistent in 

content and format with the mandatory 

program, or if nutrition information is 

displayed at point-of-purchase in an 

appropriate manner. Significant 

participation by food retailers exists if at 

least 60 percent of all companies that 

were evaluated were participating in 

accordance with the guidelines. Based 

on the survey data from the two most 

recent surveys from 1996 and 1999, less 

than 60 percent of stores evaluated were 

participating in accordance with the 

guidelines. Therefore, significant 

participation in the voluntary nutrition 

labeling program did not exist, and FSIS 

proceeded with rulemaking. 

Under § 317.4, FSIS’s Labeling and 

Program Delivery Division (LPDD) 

reviews labels on meat and poultry 

products that have been submitted for 

approval. Based on its label review, 

FSIS has not seen an increase in 

nutrition labeling of the major cuts of 

single-ingredient raw, meat and poultry 

products since the surveys were 

conducted. Compliance investigators in 

FSIS’s Office of Program Evaluation, 

Enforcement & Review (OPEER) also 

have not seen an increase in the number 

of packages of the major cuts of singleingredient, raw meat and poultry 

products that have nutrition facts panels 

on their labels at retail or an increase in 

the availability of point-of-purchase 

materials that provide nutrition 

information for such products at retail 

since the last compliance surveys were 

conducted. For these reasons and 

because no other evidence has been 

submitted to FSIS that significant 

participation in the voluntary program 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 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 pointof-purchase materials. Further, FSIS has 

determined that point-of-purchase 

labeling is appropriate because 

consumers can generally estimate the fat 

content in these products, and because 

the nutrient content of any given major 

cut is relatively uniform across the 

market. 

Ground or Chopped Products: This 

final rule requires that nutrition labels 

be provided for all ground or chopped 

products (livestock species) and 

hamburger, with or without added 

seasonings, unless an exemption 

applies. Similarly, this final rule 

requires that nutrition labels be 

provided for all ground or chopped 

poultry (kind), with or without added 

seasonings, unless an exemption 

applies. Under this final rule, products 

that would be required to bear nutrition 

labels include single-ingredient, raw 

hamburger, ground beef, ground beef 

patties, ground chicken, ground turkey, 

ground chicken patties, ground pork, 

and ground lamb. 

Unlike other single-ingredient, raw 

products, producers are able to 

formulate precisely the fat content of 

ground or chopped products. Therefore, 

in this respect, these products are 

similar to products in the existing 

mandatory program that are required to 

bear nutrition labels. Other singleingredient, raw products cannot be 

formulated in the same manner or to the 

same degree as ground products. 

In ground or chopped products, the 

fat is uniformly distributed throughout 

the product and is not clearly 

distinguishable on the surface of the 

product. The Agency has concluded that 

consumers cannot estimate the level of 

fat in these products and cannot 

compare the levels of fat in these 

products to those in other products. 

Additionally, producers sometimes use 

meat from advanced meat recovery 

(AMR) systems and low temperature 

rendering (LTR) in ground or chopped 

beef or pork products, which can affect 

their nutrient content. For these reasons, 

FSIS has concluded that ground or 

chopped meat and poultry products that 

do not bear nutrition information will 

be misbranded under section 1(n)(1) of 

the FMIA and section 4(h)(1) of the 

PPIA. 

FSIS is requiring that nutrition 

information for ground or chopped 

products appear on the label of these 

products (unless an exemption applies), 

as is required for multi-ingredient and 

heat processed products, rather than on 

point-of-purchase materials. Because 

there are numerous formulations of 

ground or chopped products, it would 

be difficult for producers or retailers to 

develop point-of-purchase materials that 

would address all the different 

formulations that exist for these 

products. Furthermore, it would be 

difficult for consumers to find the 

correct information for a specific ground 

or chopped product on point-ofpurchase materials that include 

information concerning numerous 

formulations of these products. 

Non-major Cuts of Single-Ingredient, 

Raw Meat and Poultry Products that are 

not Ground or Chopped: FSIS is not 

requiring nutrition information for 

single-ingredient, raw meat and poultry 

products that are not major cuts and that 

are not ground or chopped. But, if 

nutrition information is provided for 

these products, it must be provided in 

accordance with the nutrition labeling 

requirements for the major cuts. 

Therefore, under the final rule, if 

establishments or retail facilities choose 

to provide nutrition information for 

these products, they will either provide 

it at point-of-purchase, in accordance 

with § 317.345 or § 381.445, or on their 

label, in accordance with § 317.309 or 

§ 381.409. Thus, the nutrition labeling 

provisions for these products will be 

consistent with those for the voluntary 

nutrition labeling program. 

Permitting Percent Lean Statements 

on labels or in labeling of ground or 

chopped products: The final rule 

permits a statement of lean percentage 

on the label or in labeling of ground or 

chopped meat and poultry products that 

do not meet the regulatory criteria for 

‘‘low fat,’’ provided that a statement of 

the fat percentage is also displayed on 

the label or in labeling. The required 

statement of fat percentage must be 

contiguous to, in lettering of the same 

color, size, and type as, and on the same 

color background as, the statement of 

lean percentage. Many consumers have 

become accustomed to this labeling on 

ground beef products, and FSIS has 

concluded that this labeling provides a 

quick, simple, and accurate means of 

comparing ground or chopped meat and 

poultry products. 

Exemptions: Under this final rule, the 

following exemptions from nutrition 

labeling requirements will apply to the 

major cuts of single-ingredient, raw 

meat and poultry products and ground 

or chopped meat and poultry products: 

• Products intended for further 

processing, provided that the labels for 

these products bear no nutrition claim 

or nutrition information, 

• Products that are not for sale to 

consumers, provided that the labels for 

these products bear no nutrition claims 

or nutrition information, 

• Products in small packages that are 

individually wrapped packages of less 

than 1⁄2; ounce net weight, provided that 

the labels for these products bear no 

nutrition claims or nutrition 

information, 

• Products that are custom 

slaughtered or prepared, and 

• Products intended for export. 

This final rule also provides the 

following additional exemptions for 

ground or chopped products: 

• Ground or chopped products that 

qualify for the small business exemption 

in §§ 317.400(a)(1) and 381.500(a)(1), 

• Products that are ground or 

chopped at an individual customer’s 

request and that are prepared and 

served at retail, provided that the labels 

or labeling of these products bears no 

nutrition claims or nutrition 

information, 

• Ground or chopped products in 

packages that have a total surface area 

for labeling of less than 12 square 

inches, provided that the product’s 

labeling includes no nutrition claims or 


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82150 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

nutrition information and provided that 

an address or telephone number that a 

consumer can use to obtain the required 

information is included on the label, 

and 

• Ground products produced by small 

businesses that use statements of 

percent fat and percent lean on the label 

or in labeling of ground products, 

provided they include no other 

nutrition claims or nutrition 

information on the product labels or 

labeling. 

FSIS believes an exemption for 

ground or chopped products produced 

by small businesses is necessary 

because the burden of mandatory 

nutrition labeling may force some small 

firms to stop producing the product 

because of the cost of nutrition labeling 

and eventually force some small firms 

out of business. FSIS believes it would 

not be feasible for some small 

businesses to incur the additional costs 

of nutrition labeling because of their 

low volume of sales or low volume of 

ground product. FSIS believes it is 

feasible for larger businesses to incur 

the additional costs of nutrition labeling 

because of their higher volume of sales 

or larger levels of production of ground 

product. This final rule, with an 

exemption for ground or chopped 

products that qualify for the small 

business exemption in §§ 317.400(a)(1) 

and 381.500(a)(1), provides nutrition 

labeling on the maximum volume of 

ground or chopped product while 

assuring that small businesses 

producing low volumes of product are 

not at risk of going out of business or 

materially reducing the variety of 

products they deliver to their customers. 

Further, FSIS believes that the relatively 

small additional benefits of requiring 

small businesses to put nutrition labels 

on all ground or chopped products are 

outweighed by the larger additional 

costs. FSIS estimates that without the 

exemption there would be a $3 million 

reduction in annual average net benefit. 

Without the exemption, the projected 

compliance average total cost increase 

annually of $54 million would not be 

the only type of cost that would be 

incurred. FSIS believes that without the 

exemption many small businesses 

would have to close or substantially 

reduce the variety of products they now 

offer. Reductions in purchase options 

would be a cost to consumers that could 

not be quantified for FSIS’s analysis. 

Under this final rule, there is not a 

small business exemption for the major 

cuts of single-ingredient, raw meat and 

poultry products because nutrition 

information for these products may be 

provided on labels or, alternatively, at 

their point-of-purchase. Additionally, 

FSIS will make point-of-purchase 

materials available over the Internet free 

of charge. Therefore, the nutrition 

labeling requirement for major cuts of 

single-ingredient, raw products should 

not impose an economic hardship for 

small businesses, including those that 

are retail stores. 

Under the proposed rule, if small 

businesses produced ground or chopped 

product and included a statement of 

lean percentage and fat percentage on 

the product’s label, the small business 

would have been required to include 

nutrition information on the product 

label. These small businesses would not 

have qualified for the small business 

exemption because the labels for these 

products included nutrition claims. 

Based on the National Cattleman’s Beef 

Association (NCBA) National Meat Case 

Study in 2004, 93 percent of ground 

beef packages had statements of lean or 

fat percentages (74 FR 67741). Sixtyeight percent of packages with such 

statements had nutrition facts panels 

and 25 percent did not (74 FR 67741). 

Because about 95 percent of grinders are 

small businesses, FSIS concluded that 

many of the 25 percent of packages that 

included lean or fat percentage 

statements without nutrition facts 

panels were produced by small 

businesses. Therefore, FSIS believes 

many small businesses include 

statements of lean or fat percentage on 

the label of their ground products but 

not the nutrition facts panel. Also, 

because of the longstanding use of the 

statements of percent fat and percent 

lean on the label or in labeling of 

ground beef and hamburger products, 

FSIS believes that such statements on 

the label or in labeling of ground 

products produced by small businesses 

will not mislead consumers, even if the 

small businesses do not include 

nutrition information on the products’ 

labels (74 FR 67741). Many consumers 

have become accustomed to this 

labeling on ground beef products, and 

FSIS believes that this labeling provides 

a quick, simple, and accurate means of 

comparing ground or chopped meat and 

poultry products. Therefore under the 

final rule, small businesses that use 

statements of percent fat and percent 

lean on the label of ground products, 

provided they include no other 

nutrition claims or nutrition 

information on the product labels or 

labeling, are exempted from the 

nutrition labeling requirements. 

Additionally, under this final rule, 

any ground or chopped product or 

major cut of single-ingredient, raw 

product represented or purported to be 

specifically for infants and children less 

than 4 years of age will not be allowed 

to include certain nutrient content 

declarations because infants and 

children less than 4 years of age have 

different nutrition needs than adults 

and children older than 4 years of age. 

Finally, this final rule makes clear 

that the current regulatory exemptions 

for ready-to-eat (RTE) product packaged 

or portioned at retail and multiingredient product processed at retail do 

not apply to RTE ground or chopped 

products packaged or portioned at retail 

or multi-ingredient ground or chopped 

products that are processed at retail 

because there may be a significant 

amount of multi-ingredient ground beef 

retail processed products or RTE retail 

packaged products (66 FR 4979, January 

18, 2001). For further explanation of the 

reasons for the foregoing exemptions, 

see 58 FR 638–639; 66 FR 4978–4979; 

and 75 FR 67740–67741. 

Enforcement and Compliance: After 

the final rule is implemented, FSIS will 

collect samples of ground product at 

retail for nutrient analysis. In addition, 

FSIS will assess whether nutrition 

information is available for the major 

cuts, either on package labels or at the 

point-of-purchase. 

Under this final rule, the procedures 

set forth for FSIS product sampling and 

nutrient analysis in §§ 317.309(h)(1)–(8) 

and 381.409(h)(1)–(8) will be applicable 

to ground or chopped meat and to 

ground or chopped poultry products, 

respectively. FSIS will sample and 

conduct nutrient analysis of ground or 

chopped products to verify compliance 

with nutrition labeling requirements, 

even if nutrition labeling on these 

products is based on the most current 

representative database values 

contained in USDA’s National Nutrient 

Data Bank or the USDA National 

Nutrient Database for Standard 

Reference and there are no claims on the 

labeling. Therefore, FSIS will treat these 

products as it treats other products 

required to bear nutrition labels. 

FSIS will treat ground or chopped 

products in this way because the fat 

content of these products can vary 

significantly. FSIS employees cannot 

visually assess whether nutrition 

information on the label of ground or 

chopped products accurately reflects the 

labeled products’ contents because, in 

most cases, it is not possible to visually 

assess the level of fat in a ground or 

chopped product. 

If nutrition labeling of the major cuts 

of single-ingredient, raw products (other 

than ground beef or ground pork) is 

based on USDA’s National Nutrient Data 

Bank or the USDA’s National Nutrient 

Database for Standard Reference, and 

there are no nutrition claims on the 

labeling, FSIS will not sample and 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 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-ofpurchase materials over the Internet, 

FSIS personnel will have copies of the 

information to provide to retailers. 

Six months prior to the effective date, 

FSIS intends to make available nutrition 

labeling materials that can be used at 

the point-of-purchase of the major cuts 

at the following Internet address: 

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 onpackage labels. Because this final rule 

allows for the presentation of nutrition 

information for the major cuts of singleingredient, raw meat and poultry 

products at their point-of-purchase, no 

change in on-package labels will be 

necessary to effect this aspect of this 

final rule. Thus, in the supplemental 

proposed rule, FSIS proposed that the 

labeling requirements for the major cuts 

would be effective one year from the 

date of publication of the final rule. 

Because one year from the date of 

publication will only be a few days 

before the effective date for ground and 

chopped products, January 1, 2012, 

FSIS is also establishing January 1, 2012 

as the effective date for the labeling 

requirements for the major cuts. 

Summary of and Response to 

Comments 

FSIS received 33 comments on the 

supplemental proposed rule from 

individuals, a consumer organization, 

members of the regulated industry, trade 

and professional associations, and a city 

health department. 

A summary of issues raised by 

commenters and the Agency responses 

follows. 

Nutrition Labeling for the Major Cuts of 

Single-Ingredient, Raw Meat and 

Poultry Products 

Comment: Many individuals, several 

trade associations, a city health 

department, a perishable items tracking 

company, and an industry commenter 

all generally supported required 

nutrition information for the major cuts, 

either on their label or at their point-ofpurchase. Several individuals and the 

city health department stated that 

providing this nutrition information 

will help consumers make healthier, 

informed food choices and will allow 

them to monitor the amount of fat, 

cholesterol, and sodium that they 

consume. According to the city health 

department, cardiovascular disease, 

diabetes, and cancer are the leading 

causes of death, disability, and 

compromised quality of life in the 

United States. This commenter also 

argued that these illnesses are 

connected with nutrition, and improved 

access to nutrition information through 

nutrition labeling can help people 

reduce their risk of developing these 

illnesses. A trade association stated that 

nutrition labeling allows consumers to 

quickly differentiate between meat 

products and identify leaner choices. 

One individual stated that many people 

need to check the specific nutritional 

content of foods for medical reasons. 

One individual stated that most 

retailers do not participate in the 

voluntary nutrition labeling program at 

a significant level because the program 

is voluntary. 

A consumer organization, a city 

health department, and an individual 

supported the proposed rule but argued 

that the final rule should mandate that 

nutrition information for major cuts of 

meat be provided through on-package 

labels rather than point-of-purchase 

materials. These commenters stated that 

on-package labeling helps people make 

more informed decisions. The consumer 

organization noted that a recent 

telephone survey showed an 

overwhelming percentage (86%) of the 

respondents preferred nutrition facts 

labels on meat packages rather than 

nutrition information on wall posters or 

signs. The city health department and 

the consumer organization argued that 

point-of-purchase materials are not an 

effective means of communication 

because their success depends on 

external factors, such as the retailer’s 

placement of the point-of-purchase 

materials and layout limitations in small 

stores. The consumer organization and 

one individual stated that some of the 

disadvantages to using point-ofpurchase materials are that they are 

hard to find, inconvenient to use, and 

difficult to read and comprehend. One 

individual also believed it was timeconsuming and embarrassing for 

shoppers to read posters regarding 

nutrition information. Another 

individual stated that on-package 

labeling allows consumers to quickly 

compare products and provides the 

nutrition information to other 

consumers at home. 

The consumer organization stated that 

point-of-purchase materials are not 

subject to any formal requirements 

under the supplemental rule. The 

consumer organization stated that FSIS 

should specify format and placement 

requirements for point-of-purchase 

materials. This organization stated that 

the USDA should work with the FDA to 

update format and readability 

requirements for posters. This 

organization believed that posters are 


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82152 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

likely to omit many cuts or give them 

a different name than what appears on 

the package. The organization also 

stated that USDA should conduct a 

survey to determine whether consumers 

are better served by on-package 

nutrition labels than point-of-purchase 

materials. According to this consumer 

organization, many companies and 

grocery chains already use on-package 

nutrition labeling. Additionally, the 

consumer organization stated that if 

similar nutrition labels and labeling 

equipment are required for ground 

products, then retailers would not incur 

substantial additional costs by adding 

nutrition labels to major cuts. 

The consumer organization disagreed 

with FSIS’s position that consumers can 

visually determine the difference in fat 

content between various cuts. This 

organization noted that a recent 

telephone survey showed an 

overwhelming percentage (80%) of 

respondents could not determine which 

cuts of meat had the least amount of fat. 

The consumer organization suggested 

that the USDA does not have any data 

to support its assumption that 

consumers can visually determine the 

difference in fat content between 

various cuts. 

Several trade associations, an industry 

commenter, and the food marketing 

organization supported the option of 

providing nutrition information for the 

major cuts through point-of-purchase 

materials. According to one trade 

association, their retailer customers 

believe nutrition labeling for meat is 

more efficiently displayed via point-ofpurchase materials than on the product. 

Response: As FSIS proposed, this 

final rule will require that nutrition 

information be provided for the major 

cuts of single-ingredient, raw meat and 

poultry products, either on the label or 

at the point-of-purchase. FSIS agrees 

that the final rule will produce health 

benefits, including projected reductions 

in the incidence of coronary heart 

disease and three types of cancer that 

may accrue as consumers improve their 

diet quality through increased use of 

nutrition information generated by the 

final rule. 

FSIS agrees with the individual that 

stated that most retailers do not 

participate at a significant level when 

labeling is voluntary. In the two most 

recent surveys from 1996 and 1999, 

FSIS found that significant participation 

in the voluntary nutrition labeling 

program did not exist (see 66 FR 4973, 

January 18, 2001; 74 FR 67736–67737, 

December 18, 2009). In addition, since 

the surveys were conducted, FSIS’s 

LPDD has not seen an increase in the 

number of labels that include nutrition 

information for the major cuts of singleingredient, raw meat and poultry 

products. Further, FSIS’s OPEER also 

has not seen an increase in the number 

of packages of the major cuts of singleingredient, raw meat and poultry 

products that have nutrition facts panels 

on their labels at retail or an increase in 

the availability of point-of-purchase 

materials that provide nutrition 

information for such products at retail 

since the last compliance surveys were 

conducted. These observations do not 

constitute survey data but provide 

additional meaningful information 

based on the experience of FSIS’s LPDD 

and OPEER. No evidence has been 

submitted to FSIS that significant 

participation in the voluntary program 

now exists. 

FSIS agrees that many consumers 

cannot accurately assess the nutritional 

content of the major cuts of singleingredient, raw products; however, we 

continue to believe that point-ofpurchase nutritional information is 

appropriate for these products. 

While consumers cannot accurately 

assess the nutritional content of the 

major cuts of single-ingredient, raw 

products, their ability to do so is greater 

than in the case of ground products. 

Ground products are processed in such 

a way that fat content is very difficult 

to visually ascertain. Internal marbling, 

attached fat, and whether the product 

has skin gives consumers some rough 

indication of the fat content of the major 

cuts of single-ingredient, raw products, 

which leads FSIS to believe that the 

benefits of on-package labeling may be 

slightly less than with ground product. 

FSIS notes, however, that consumers 

still need nutrition information on 

point-of-purchase materials for the 

major cuts because consumers cannot 

assess precise levels of fat (e.g., 10 

grams vs. 20 grams of fat per serving) 

and cannot know the levels of calories 

or other specific nutrients, such as 

saturated fat, in these products. 

Based on comments received and the 

Supplemental Proposed Rule Regulatory 

Impact Analysis, FSIS believes that 

requiring on-package labeling for the 

major cuts of single-ingredient, raw 

products is also likely to be significantly 

more costly than for ground products 

because it would require on-package 

labeling on a larger volume of product. 

In the Supplemental Proposed Rule 

Regulatory Impact Analysis, FSIS 

estimated that the annualized average 

present value of the costs of requiring 

nutrition labels on the major cuts of 

single-ingredient, raw meat and poultry 

products would be $16.48 million more 

than the annualized average present 

value of the costs of requiring nutrition 

labels on all ground or chopped 

products, without taking into account 

the current level of voluntary 

compliance (74 FR 67789). 

As discussed in the proposed rule and 

in the supplemental proposed rule, FSIS 

believes it will be relatively easy to 

prepare point-of-purchase materials for 

the major cuts because the nutrient 

content of a given major cut is relatively 

uniform across the market, and these 

products are not formulated in the 

manner of ground or chopped products 

(66 FR 4974, January 18, 2001) (74 FR 

67737, December 18, 2009). To ensure 

that this is the case, FSIS is making 

available nutrition labeling materials 

that can be used at point-of-purchase 

over the Internet free of charge. 

FSIS acknowledges the concern 

expressed by an individual and by the 

consumer organization about the 

location of point-of-purchase materials, 

but believes that it is currently 

addressed in the regulations (9 CFR 

317.345(a)(3) and 381.445(a)(3)) which 

require that point-of-purchase materials 

be made available in close proximity to 

the food. In addition, FSIS personnel 

will also visit stores to verify that they 

are following this and the other 

requirements. 

In response to the comment that noted 

that an advantage of including nutrition 

information on the label is that 

consumers can review the nutrient 

content of the product once the product 

is taken home, and that others besides 

the primary food purchaser would have 

better access to this information, 

surveys, including the Diet and Health 

Knowledge Survey (DHKS), show that a 

majority of individuals report using 

labels while buying foods. Although the 

DHKS shows that adults who are not 

main household shoppers use labels, the 

survey shows that the main shoppers 

use labels at a higher rate than those 

who are not main household shoppers. 

If individuals in a household have 

certain nutrition practices and needs, 

the person who purchases food for the 

household would likely take other 

household members’ needs and 

preferences into account. In this case, 

the entire household would ultimately 

receive the benefits of the nutrition 

information. Further, other household 

members besides the primary food 

purchaser will be able to obtain 

nutrition information for the major cuts 

on the Internet on FSIS’s Web site, 

ARS’s Web site, and FMI’s Web site. 

FSIS agrees that consumers cannot 

accurately judge the nutritional content 

of the major cuts of single-ingredient, 

raw products, and that the mandatory 

provision of this information to 

consumers is warranted and 


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appropriate. However, for the reasons 

described above, we believe that pointof-purchase information is appropriate 

for these products. 

Comment: Several individuals and 

trade associations, one food marketing 

organization, and an industry 

commenter opposed the proposed rule 

to require nutrition information for the 

major cuts, either on their label or at 

their point-of-purchase. These trade 

associations and the food marketing 

organization stated that FSIS should 

maintain its existing voluntary program. 

One trade association and the food 

marketing organization advocated that 

the USDA should conduct a new 

compliance survey because it is likely 

that the level of participation in the 

voluntary nutrition labeling program 

has increased beyond the ‘‘significant 

participation’’ threshold because of 

changes in the composition of the retail 

sector over the past decade, and because 

of efforts by FMI to encourage the 

widespread use and dissemination of 

Nutri-Facts materials. These 

organizations stated that the last USDA 

survey for compliance is outdated 

because it was conducted in 1999, and 

should not be the basis for promulgating 

the rule. The food marketing 

organization noted that the regulations 

that require FSIS to evaluate the level of 

participation in the voluntary nutrition 

labeling program every two years 

remain in effect. One trade association 

stated that maintaining the voluntary 

program will be less costly and will 

help the industry. According to this 

trade association, FSIS could increase 

voluntary compliance by making the 

same updated nutrition information 

available free of charge to retailers as it 

planned to make available under the 

proposed rule. Several trade 

associations stated that if individual 

consumers wanted more specific 

nutrition information about a particular 

product, they could access it through 

other sources like the Internet. An 

industry commenter noted that if there 

was sufficient consumer demand for 

more nutrition information, then 

retailers would have an economic 

incentive to voluntarily supply it. 

One trade association did not agree 

with FSIS’s position that major cuts of 

single-ingredient raw, meat and poultry 

products that do not bear nutrition 

information on their labels or on pointof-purchase materials are misbranded. 

Another trade association believed that 

there were few significant differences in 

the nutritional values among the various 

brands of young chicken, and that 

nutrition information for singleingredient chicken is not that useful 

because most people add ingredients to 

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 

(§§ 317.343(e) and 381.443(e)). Although 

FSIS did not conduct the surveys 

precisely 2 years apart, the Agency did 

conduct the surveys approximately 

every two years until 1999 (74 FR 

67748, December 18, 2009), and the 

surveys failed to show significant 

participation. Because significant 

participation did not exist, FSIS 

proceeded with rulemaking. 

Under § 317.4, FSIS’s LPDD reviews 

labels on meat and poultry products that 

have been submitted for approval. Based 

on its label review, FSIS has not seen an 

increase in nutrition labeling of the 

major cuts of single-ingredient raw, 

meat and poultry products since the 

surveys were conducted. Compliance 

investigators in FSIS’s OPEER also have 

not seen an increase in the number of 

packages of the major cuts of singleingredient, raw meat and poultry 

products that have nutrition facts panels 

on their labels at retail or an increase in 

the availability of point-of-purchase 

materials that provide nutrition 

information for such products at retail 

since the last compliance surveys were 

conducted. Because (i) the most recent 

surveys showed that significant 

participation in the voluntary nutrition 

labeling program did not exist, (ii) 

FSIS’s LPDD has not seen an increase in 

nutrition labeling of the major cuts of 

single-ingredient raw, meat and poultry 

products and ground or chopped meat 

and poultry products since the surveys 

were conducted, (iii) FSIS’s OPPER has 

not seen an increase in nutrition 

labeling of the major cuts of singleingredient raw, meat and poultry 

products at retail or an increase in the 

availability of point-of-purchase 

materials that provide nutrition 

information for the major cuts at retail 

since the last compliance surveys were 

conducted, and (iv) no other evidence 

has been submitted to FSIS that 

significant participation in the 

voluntary program now exists, FSIS has 

concluded that this final rule is 

necessary. 

In response to the comment that 

maintaining the voluntary program will 

be less costly and will help the industry, 

this final rule makes the guidelines for 

the voluntary nutrition labeling program 

mandatory, so the costs for the industry 

should not increase for stores that are 

following the guidelines. 

In response to the statement that if 

there was sufficient consumer demand 

for more nutrition information, then 

retailers would have an economic 

incentive to voluntarily supply it, 

market forces have not been great 

enough to ensure significant 

participation in the voluntary nutrition 

labeling program. This fact could be 

evidence that consumers are not willing 

to pay for this information. However, as 

is explained above, FSIS believes that 

consumers can generally estimate the fat 

content of the major cuts of meat and 

poultry products, but nonetheless, they 

need more precise information about the 

nutrient content of the major cuts in 

order to make a fully informed 

comparative judgment about the various 

cuts. 

FSIS has concluded that without 

nutrition information for the major cuts 

of single-ingredient, raw meat and 

poultry products, these products will be 

misbranded under the FMIA and the 

PPIA (21 U.S.C. 601(n)(1) and 453 

(h)(1)). Without nutrition information 

on their labeling, FSIS has concluded 

that the labeling of these products will 

be false or misleading because it will 

not provide consumers with sufficient 

information to assess the nutrient 

content of the major cuts and will not 

enable consumers to select major cuts 

that fit into a healthy diet that meets 

their individual needs. 

In response to the comment that 

nutrition information for singleingredient chicken is not that useful 

because most people add ingredients to 


jlentini on DSKJ8SOYB1PROD with RULES2
82154 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

it during cooking that alter the calories, 

fat, and protein, the final rule allows 

nutrition information to be declared on 

either an ‘‘as packaged’’ basis or an ‘‘as 

consumed’’ basis. The point-of-purchase 

materials and the labels clearly inform 

consumers whether the nutrition 

information provided is ‘‘as packaged’’ 

or ‘‘as consumed.’’ Consistent with the 

provisions in the voluntary nutrition 

labeling program, when nutrition 

information is presented on an ‘‘as 

consumed’’ basis, retailers or 

manufacturers will be required to 

specify a method of cooking that will 

not add nutrients from other ingredients 

such as flour, breading, and salt 

(§§ 317.345(d) and 381.445(d)). 

Comment: Several trade associations 

asserted that the list of major cuts needs 

to be updated. One trade association 

stated that, according to The National 

Pork Board meat scanner data, pork 

whole loin, pork shoulder picnic, pork 

shoulder Boston butt, pork sirloin chop, 

pork center chop, and pork rib roast 

should be added to the list of major 

cuts. One trade association stated that 

FSIS should review the list of major cuts 

based on market share and availability 

because there are still cuts on the list of 

major cuts for which data reflective of 

trim levels sold at retail is not currently 

available. One trade association was 

concerned that if the USDA does not 

update the list, but rather makes a 

change to the list later, then retailers 

will incur the $5.67 million cost to 

purchase and install posters again. 

Response: Because FSIS did not 

propose to amend the codified list of 

major cuts in the regulations and did 

not provide an opportunity for the 

public to comment on proposed changes 

to the list, FSIS is not amending the list 

of major cuts in the regulations at this 

time. FSIS acknowledges that the 

codified list of major cuts may need to 

be updated. FSIS intends to assess the 

need to update the list and to update it 

as necessary when resources permit. 

Establishments or retail facilities may 

choose to provide nutrition information 

for the non-major cuts, either at pointof-purchase, in accordance with 

§ 317.345 or § 381.445, or on their label, 

in accordance with § 317.309 or 

§ 381.409. 

Comment: The consumer organization 

argued that the number of servings 

should be required on all major cuts. 

This organization stated that many 

retailers now have the ability to 

calculate the number of servings in a 

package. As an example, this 

organization suggested that companies 

could determine the number of servings 

for the major cuts based on the number 

of pieces of meat in the package and 

their average weights. According to this 

organization, the number of servings 

reminds consumers that a package has 

multiple servings, and that if someone 

eats more than one serving, the 

nutrients consumed will increase. This 

commenter stated that most consumers 

eat more than the USDA standard 

serving size of 4 oz. of meat or poultry, 

and single-serving packages of meat or 

poultry contain more than 4 oz. This 

commenter also stated that nutrition 

facts should be provided for the entire 

package if the single serving package 

exceeds 4 oz. Alternatively, the 

commenter stated that the package 

should be required to include a 

disclaimer such as: ‘‘Nutrition Facts are 

based on a 4 oz. serving. This package 

may contain a serving larger than 4 oz.’’ 

Finally, the commenter stated that the 

USDA also needs to update its standard 

serving size upward to reflect actual 

consumption. 

Response: The number of servings per 

container is not necessary information 

on the nutrition labels or point-ofpurchase materials of the major cuts or 

non-major cuts of single-ingredient, raw 

products because these products are 

typically random weight products. For 

multi-ingredient and heat-processed 

products that must bear nutrition labels, 

the number of servings is not required 

on random weight products because the 

weight statement is applied at retail. 

The weight of such products varies from 

package to package 

(§§ 317.309(b)(10)(iii), 

381.409(b)(10)(iii), 317.2(h)(9) and 

381.121(c)(9)) (74 FR 67747, December 

18, 2009). 

The request to change and update 

USDA’s standard serving size is outside 

the scope of this regulation. 

Comment: One individual and a trade 

association were concerned that 

consumers would not understand that 

the nutrition information for the major 

cuts will be based on averages of 

nutrient content data for that cut of meat 

or poultry. The trade association 

questioned whether there should be an 

explanation on the package regarding 

the potential variation from the average, 

so consumers will not be misled. The 

individual suggested that there should 

be a disclaimer on the label regarding 

the potential variation from the average. 

Response: FSIS does not believe an 

explanation regarding potential 

variability of nutrition information is 

necessary for single-ingredient cuts. All 

nutrition information is based on 

average values. Compliance 

requirements in 9 CFR 317.309 and 

381.409 allow for a twenty percent 

variation before regulatory action is 

taken against products. 

Comment: The consumer organization 

stated that nutrition facts should be 

provided on an ‘‘as packaged’’ basis 

rather than on an ‘‘as consumed basis’’ 

because consumers may alter the 

product in ways that could affect the 

nutrient content before eating. 

Response: As proposed, for the major 

cuts and non-major cuts of singleingredient, raw products, this final rule 

will allow nutrition information on the 

label or on point-of-purchase materials 

to be declared on either an ‘‘as 

packaged’’ basis or an ‘‘as consumed’’ 

basis because most of these products 

will not be subject to FSIS nutrient 

analysis. If nutrition information for 

these products is based on USDA’s 

National Nutrient Database for Standard 

Reference, and there are no claims on 

the labeling, FSIS will not conduct a 

nutrient analysis of these raw products 

and, therefore, will not evaluate ‘‘as 

packaged’’ nutrition labeling 

information for these products. 

Consistent with the provisions in the 

voluntary nutrition labeling program, 

when nutrition information is presented 

on an ‘‘as consumed’’ basis, retailers or 

manufacturers will be required to 

specify a method of cooking that will 

not add nutrients from other ingredients 

such as flour, breading, and salt 

(§§ 317.345(d) and 381.445(d)) (74 FR 

67747, December 18, 2009). 

Mandatory Nutrition Labeling for 

Ground or Chopped Products 

Comment: Many individuals, several 

trade associations, a city health 

department, an industry commenter, 

and a perishable items tracking 

company supported mandatory onpackage nutrition labeling for ground or 

chopped products. Several of those 

trade associations and the city health 

department specifically supported 

FSIS’s proposal to require on-package 

labeling as opposed to allowing for 

nutrition information at point-ofpurchase. One of these trade 

associations stated that on-package 

labeling is needed because fat content is 

difficult to see in ground products. Two 

of the trade associations noted that 

plants produce ground meats at specific 

lean/fat ratios, and that the amount of 

fat is easy to control. One trade 

association stated that plants provide 

nutritional data to retailers, and that 

data can easily be added to a nutrition 

facts panel. 

Two trade associations and the city 

health department believed that onpackage labeling is the most beneficial 

for consumers. One of the trade 

associations questioned whether 

consumers actually use point-ofpurchase materials for ground or 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 82155 

chopped products and questioned the 

feasibility of developing point-ofpurchase materials for such products. 

The city health department argued that 

point-of-purchase materials for ground 

or chopped products are not an effective 

means of communication because their 

success depends on external factors 

such as the retailer’s placement of the 

point-of-purchase materials and layout 

limitations in small stores. One trade 

association stated that point-of-purchase 

materials increase redundancy and cost 

because most retailers have nutrition 

data that can be easily distributed 

among retailers and added to a nutrition 

facts panel. 

Several trade associations and the 

food marketing organization supported 

the option to provide nutrition 

information for ground and chopped 

products at point-of-purchase. One of 

the trade associations believed that 

point-of-purchase materials allow 

consumers to make more informed 

choices concerning the purchase of 

ground or chopped products because 

they are consistently displayed and 

more efficient than on-package labeling. 

This commenter stated that retailers are 

limited because of the small number of 

meat case staff and the available space 

on ground or chopped product 

packages. According to the food 

marketing organization, point-ofpurchase materials allow consumers to 

easily compare products. The 

organization also was concerned that 

consumers would not be able to visually 

inspect the product because of the large 

label required to be able to list the 

nutrition information, food safety 

information, and cooking instructions. 

This organization also suggested that 

important food safety information 

would not be as prominent once 

nutrition information is added to the 

label. 

One trade association and the food 

marketing organization asserted that 

allowing the use of point-of-purchase 

materials will reduce the financial 

burden on retailers and benefit 

consumers. These commenters stated 

that FSIS underestimated the cost of 

providing nutrition labels on ground 

and chopped products. According to 

these commenters, FSIS did not account 

for the number of retailers that would 

have to buy new printer or scale systems 

at the store level. Additionally, one 

trade association stated that retailers 

that provide on-site custom services 

would have to increase prices or only 

sell case-ready meat because of the 

increased costs. The food marketing 

organization was concerned that 

retailers may be forced to eliminate 

some of their product choices because of 

the cost of testing and verifying the 

nutrient values for each nutrition label. 

The food marketing organization 

claimed that effective point-of-purchase 

materials for ground and chopped 

products could be developed. One trade 

association suggested that there could 

be standardized posters for other ground 

or chopped products, similar to the ones 

currently used for ground beef. An 

industry commenter noted that 

producers supply retailers with ground 

products based on established finished 

lean/fat ratios, which do not differ 

among retailers. The industry 

commenter suggested that nutrition 

information for these lean/fat ratios 

could be used on point-of-purchase 

materials, and consumers could match 

the lean/fat ratio on their ground 

product with the nutrition information 

for that lean/fat ratio on the point-ofpurchase materials. The commenter also 

stated that if a retailer uses a different 

lean/fat ratio than is provided on the 

point-of-purchase materials, it would 

have to put the nutrition information on 

the individual package. 

A trade association, an industry 

commenter, and the food marketing 

organization stated that FSIS should 

maintain its existing voluntary program 

for nutrition labeling of ground or 

chopped products. The food marketing 

organization believed that there was no 

need to require mandatory on-package 

labeling for ground and chopped 

products. 

Response: FSIS will require onpackage nutrition information for these 

products rather than allowing nutrition 

information to be provided at their 

point-of-purchase for the reasons stated 

above. Because there are numerous 

formulations of ground or chopped 

products, as a practical matter, it would 

be difficult for producers or retailers to 

develop point-of-purchase materials that 

would address all the different 

formulations that exist for these 

products. Furthermore, it would be 

difficult for consumers to find the 

correct information for a specific ground 

or chopped product on point-ofpurchase materials that include 

information concerning numerous 

formulations of these products (66 FR 

4977, January 18, 2001). If a statement 

of the fat percentage and lean 

percentage is not included on a package 

of ground product, consumers would 

not know which nutrient data 

concerning ground product on point-ofpurchase materials would apply to that 

particular ground product. 

Establishments and retailers are not 

required to provide such a statement 

and will not be required to provide such 

a statement when this rule becomes 

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 


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82156 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

beef products. Therefore, FSIS questions 

why certain commenters stated that 

there is not sufficient room on the label 

of these products for nutrition 

information (74 FR 67750, December 18, 

2009). FSIS disagrees with the comment 

that consumers will not be able to 

visually inspect the product because of 

the large label required to list the 

nutrition information, food safety 

information, and cooking instructions. 

As with the Safe Handling Instructions 

(SHI) and cooking instructions, 

nutrition labeling information can 

appear off the principal display panel 

(PDP). Many retailers place SHI on the 

bottom or side panels of packages to 

allow consumers to visually inspect the 

largest amount of product. There should 

be sufficient space available on these 

panels for nutrition facts information to 

appear off the PDP. 

Additionally, the nutrition labeling 

requirements for ground or chopped 

products should not be particularly 

difficult for small operations, since 

ground or chopped product produced 

by retail establishments and Federal 

establishments that meet specific small 

business criteria will be exempt from 

nutrition labeling requirements 

(§§ 317.400(a)(1) and 381.500(a)(1)) (74 

FR 67750, December 18, 2009). 

Moreover, an exemption from the 

nutrition labeling requirements, which 

is provided in this final rule, should 

alleviate any concerns that nutrition 

labeling requirements will discourage 

retailers from grinding product based on 

customers’ requests. This final rule 

provides an exemption from nutrition 

labeling requirements for ground or 

chopped products that are ground or 

chopped at an individual customer’s 

request and that are prepared and 

served or sold at retail, provided that 

the labels or labeling of these products 

bear no nutrition claims or nutrition 

information (74 FR 67750, December 18, 

2009). 

If a customer selects an intact product 

for purchase and requests that the 

product be ground at the retail facility, 

FSIS has determined that nutrition 

information on the package of the 

ground product would not be necessary. 

In this instance, the customer has made 

the decision to purchase the product 

before it was ground. The customer is 

not selecting the product from among 

various, formulated, ground or chopped 

product, and thus the reasons for 

requiring a nutrition label on such a 

product would not be applicable here 

(74 FR 67750, December 18, 2009). 

Moreover, the product selected may 

already be the subject of nutrition 

labeling as a raw, single ingredient 

product. 

Many of the suppliers of coarse 

ground products that are then ground 

and packaged at retail have supplied, or 

can supply, the nutrition facts panels for 

the retailers. Most retailers offer a 

limited selection of ground beef 

products. Thus, dozens of different 

nutrition labels for each retailer will not 

be necessary. In addition, information 

for ground beef and other products is 

available through the National Nutrient 

Database for Standard Reference. 

Finally, the requirements for on-package 

nutrition labeling for ground or chopped 

products will not be effective until 

January 1, 2012 (74 FR 67753, December 

18, 2009). 

In response to the comments that FSIS 

underestimated the costs of developing 

and providing nutrition labels for 

ground and chopped products, FSIS 

does not believe that it has 

underestimated the costs. Since the 

Supplemental Proposed Rule Regulatory 

Impact Analysis was done, the total 

costs of labeling may have even 

decreased because of more cost-effective 

technology, such as less expensive 

computerized flexography and scalelabel printers. The additional costs of 

labeling would be relatively low for the 

affected businesses. In addition, this 

final rule exempts small businesses that 

produce ground or chopped product 

from nutrition labeling requirements. 

Comment: The consumer organization 

argued that nutrition labels for ground 

meats should list the number of servings 

in the package. In the alternative, the 

commenter stated that the package 

should be required to include a 

disclaimer such as: ‘‘Nutrition Facts are 

based on a 4 oz. serving. This package 

may contain two or more servings, some 

or all of which exceed 4 oz.’’ 

Response: As discussed above, FSIS is 

not requiring that the number of 

servings per container be declared for 

the major cuts of single-ingredient, raw 

meat and poultry products because all 

of these products are random weight 

products, and the number of servings is 

not required on random weight products 

(see §§ 317.309(b)(10)(iii) and 

381.409(b)(10)(iii)) (66 FR 4974, January 

18, 2001). FSIS is not requiring that the 

number of servings per container be 

declared for ground or chopped meat 

and poultry products because these are 

also random weight products. Even 

though the number of servings per 

container are not declared on ground or 

chopped products, FSIS believes that 

on-package nutrition information is still 

meaningful to consumers because it is 

based on a stated serving size and 

allows consumers to make comparisons 

among products. 

Comment: One trade association 

opposed requiring nutrition labels on 

multi-ingredient ground beef retail 

processed products or ready-to-eat-retail 

packaged products. 

Response: FSIS believes that all 

ground beef and hamburger products, 

unless an exemption applies, should be 

required to include nutrition facts 

information. If multi-ingredient ground 

beef products were permitted an 

exemption, it would encourage firms to 

add seasoning to ground beef and 

hamburger products as a way to avoid 

providing nutrition facts information. 

Seasonings often include substances, 

such as salt and sugar, that can 

significantly alter the nutritional profile. 

Thus, there is a need for nutrition 

labeling information on such products. 

Comment: One industry commenter 

noted that there is no significant change 

in calcium and iron values for finished 

ground products that contain common 

industry levels of AMR or low 

temperature rendered product from that 

of finished ground products that do not 

contain these products. This commenter 

asserted that additional testing should 

not be required for products that contain 

AMR or LTR products. 

Response: No additional testing will 

be required for products that contain 

meat derived from advance meat 

recovery systems or low temperature 

rendered products, such as finely 

textured beef (FTB) or lean finely 

textured beef (LFTB). 9 CFR 318.24(c) 

limits the calcium and iron content of 

meat derived from AMR systems. In 

comparison, meat trimmings only need 

a minimum of 12% lean tissue to be 

considered ‘‘meat,’’ and the standard of 

identity for ground beef and hamburger 

(9 CFR 319.15(a) and (b), respectively) 

limit the fat content to no more than 

30%. There is also no upper regulatory 

limit on the use of meat derived from 

AMR systems or the use of FTB or LFTB 

in ground beef. Therefore, a wide range 

of possible formulations for ground beef 

and hamburger exist that could result in 

significant differences in the fat content. 

These facts support the need for 

nutrition labeling. 

Comment: One farmer did not believe 

FSIS should treat ground or chopped 

beef as a ‘‘single ingredient’’ product 

because it normally comes from a large 

number of animals. According to the 

commenter, if FSIS continues to treat 

ground or chopped beef as a ‘‘single 

ingredient’’ product, then the label 

should be required to indicate the 

sources of each and all animals 

contained in the package. 

Response: Ground beef production 

does typically involve multiple animals. 

However, all animals are from the same 


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species. Previous regulations defined 

certain ground beef products as major 

cuts of single-ingredient raw products (9 

CFR 317.344). FSIS is not re-defining 

ground beef products that do not 

include ingredients in addition to 

ground beef as multi-ingredient 

products. However, as is explained in 

this preamble, FSIS considers ground 

beef products to be formulated products. 

No Requirements for Non-Major Cuts 

Comment: Several trade associations 

supported the proposal not to require 

nutrition labeling on non-major cuts 

that are not ground or chopped. One of 

those trade associations questioned 

whether it would be misleading for 

consumers to see nutrition information 

about one product, but no nutrition 

information on another product within 

the same retail case. Additionally, one 

individual and the city health 

department argued that nutrition 

labeling should be mandatory for all 

products, including meat and poultry 

products. 

Response: At this time, FSIS is not 

requiring that nutrition information be 

provided for non-major cuts of singleingredient, raw products that are not 

ground or chopped. The Agency has 

concluded that it is not necessary to do 

so at this time. FSIS stated in the 

proposed rule that it intended to 

examine the current state of nutrition 

labeling for single-ingredient, raw 

products that are not ground or chopped 

and that are not considered to be major 

cuts (66 FR 4974, January 18, 2001). 

FSIS still intends to conduct this 

assessment. Once this rule is effective, 

FSIS will examine and assess the 

adequacy of the nutrition information 

provided for the major cuts and will 

also determine whether and to what 

extent nutrition information is being 

made available for the non-major cuts 

and whether it is necessary to consider 

a rule requiring such information be 

provided. 

Permitting Percent Lean Statements on 

Labels or in Labeling of Ground or 

Chopped Products 

Comment: The majority of 

commenters on this issue supported the 

proposal to permit the use of the 

statements of lean percentages on the 

label or in labeling of ground or 

chopped products that do not meet the 

regulatory criteria for ‘‘low fat.’’ 

According to several consumer survey 

results provided by trade associations, 

consumers use both lean and fat 

percentages to determine the type of 

product to buy. Several trade 

associations stated that consumers need 

the lean and fat percentages to quickly 

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). 


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Because the percent fat statement must 

be contiguous to the percent lean 

statement and must be in lettering of the 

same color, size, and type as, and on the 

same color background as, the lean 

percentage statement, FSIS believes that 

the percent lean statements will not 

mislead consumers, even if they are 

used on products that do not qualify as 

‘‘low fat’’ under the regulatory criteria 

(74 FR 67752, December 18, 2009). 

Lean/fat ratios allow consumers to 

readily identify and differentiate 

between all ground or chopped meat 

and poultry products and will assist 

consumers in selecting leaner versions 

of these products and will provide an 

incentive for manufacturers to market 

products lower in fat (66 FR 4972, 

January 18, 2001). 

As one trade association stated, 

producers may include a percent fat 

statement on the label or in labeling of 

ground products without including a 

percent lean statement, though unlikely. 

A percent fat statement on ground or 

chopped products would be an 

acceptable alternative to a statement of 

lean and fat percentage. Because of the 

longstanding use of the statements of 

percent fat and percent lean on the label 

or in labeling of ground beef and 

hamburger products, FSIS believes such 

statements on the label or in labeling of 

ground products will not mislead 

consumers (74 FR 67752, December 18, 

2009). 

Comment: A trade association and the 

food marketing organization supported 

the proposal that small businesses that 

produce ground or chopped product 

and include a statement of lean 

percentage and fat percentage on the 

product’s label or in the labeling would 

not be required to include nutrition 

information on the product label, unless 

they include other nutrition claims or 

information on the product label. The 

food marketing organization stated that 

the flexibility for small businesses 

should be maintained. Otherwise, 

according to the commenter, an undue 

economic hardship on small businesses 

could result in a competitive 

disadvantage for small businesses. This 

food marketing organization also did not 

believe this proposed exemption from 

nutrition labeling requirements would 

mislead consumers. 

Several trade associations and an 

industry commenter stated that 

nutrition information should be 

required on the labels of any ground or 

chopped product for which a lean 

percentage and a fat percentage 

statement is provided on the label or in 

the labeling, regardless of the size of the 

business making the product. The 

industry commenter also believed that 

all ground or chopped products should 

be labeled with a percent lean statement 

because consumers need consistent 

information to compare products and 

make informed decisions. One trade 

association argued that there is no need 

for a small business exemption because 

small businesses purchase raw materials 

from larger businesses, which provide 

nutrition labeling in the proper format 

for all fat contents of bulk coarse or fine 

ground products to any store that 

purchases their products. According to 

this trade association, the labels are 

provided for use at point-of-purchase at 

no cost to the retailer or distributor. 

Another trade association expressed 

concern because small businesses can 

produce a significant quantity of meat 

and poultry products per year. This 

trade association believed there should 

only be exemptions for very, very small 

companies that receive Federal 

inspection and market to a local 

customer base. 

Response: This final rule maintains 

that small businesses that use 

statements of percent fat and percent 

lean on the label or in labeling of 

ground products would be exempt from 

nutrition labeling requirements, 

provided they include no other 

nutrition claims or nutrition 

information on the product labels or 

labeling. As discussed in the 

supplemental proposed rule, based on 

the National Cattleman’s Beef 

Association (NCBA) National Meat Case 

Study in 2004, 93 percent of ground 

beef packages had statements of lean or 

fat percentages (74 FR 67741). Sixtyeight percent of packages with such 

statements had nutrition facts panels 

and 25 percent did not have nutrition 

facts panels but had lean or fat 

percentages (74 FR 67741). Seven 

percent did not have any statements of 

lean or fat percentages. Because about 

95 percent of grinders are small 

businesses, FSIS concluded that many 

of the 25 percent of packages that 

included lean or fat percentage 

statements without nutrition facts 

panels were produced by small 

businesses. Therefore, FSIS believes 

many small businesses include 

statements of lean or fat percentage on 

the label of their ground products but 

not the nutrition facts panel. Also, 

because of the longstanding use of the 

statements of percent fat and percent 

lean on the label or in labeling of 

ground beef and hamburger products, 

FSIS believes that such statements on 

the label or in labeling of ground 

products produced by small businesses 

will not mislead consumers, even if the 

small businesses do not include 

nutrition information on the products’ 

labels (74 FR 67741). Many consumers 

have become accustomed to this 

labeling on ground beef products, and 

FSIS believes that this labeling provides 

a quick, simple, and accurate means of 

comparing ground or chopped meat and 

poultry products. Based on the survey 

information provided, the majority of 

consumers believe %lean/%fat 

designations are important information 

and use them when choosing which 

ground beef products to purchase. 

Therefore under the final rule, small 

businesses that use statements of 

percent fat and percent lean on the label 

of ground products, provided they 

include no other nutrition claims or 

nutrition information on the product 

labels or labeling, are exempted from 

the nutrition labeling requirements. 

To qualify for the small business 

exemption from the nutrition labeling 

requirements under §§ 317.400(a)(1) and 

381.500(a)(1), a meat or poultry product 

must be produced by a single-plant 

facility or multi-plant company/firm 

that employs 500 or fewer people and 

produces no more than 100,000 pounds 

of the product annually, provided that 

the label for the product bears no 

nutrition claims or nutrition 

information. In response to the 

comment that small businesses can 

produce a significant amount of meat 

and poultry products per year, if a small 

business produces more than 100,000 

pounds of a particular product, then the 

small business no longer qualifies for 

the exemption from nutrition labeling 

requirements for that product. In 

connection with the 1993 final rule on 

nutrition labeling of meat and poultry 

products, FSIS evaluated several 

options in establishing a poundage limit 

for the small business exemption (58 FR 

633). Based on that evaluation, FSIS 

continues to believe that an annual 

production poundage level of 100,000 

pounds sets the limit high enough so 

that the risk that any small business 

would have to close would be minimal, 

and sets the limit low enough so that the 

maximum volume of total production 

would bear nutrition labeling (see 58 FR 

633, 638 for more discussion of the 

analysis of the poundage limits). The 

limit on the number of employees at a 

firm is set at 500 or fewer employees, 

which is the Small Business 

Administration’s definition of a small 

meat or poultry processing firm. This 

approach allows the Small Business 

Administration to assist in determining 

which firms would qualify for the small 

business exemption based on the 

number of employees (58 FR 638). 

Comment: One trade association 

stated that %lean/%fat claims should 


jlentini on DSKJ8SOYB1PROD with RULES2
Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 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 singleingredient raw products that are not 

ground or chopped confuses small 

businesses that have to comply with the 

different requirements. According to 

this trade association, small businesses 

that increase prices in order to provide 

nutrition facts on the label will be at a 

disadvantage against their competitors 

that do not provide the nutrition 

information on the labels. This 

commenter supported a small business 

exemption from the nutrition labeling 

requirements for the major cuts because 

of the time necessary for small 

businesses to access and display the free 

nutrition information. 

One trade association believed the 

small business exemption pound limit 

should be increased to 150,000 pounds. 

According to this trade association, if 

the limit remains at 100,000 pounds, 

only retailers who sell fewer than 700 

packages of each product a week will be 

exempt (based on USDA’s estimate that 

the average ground product package 

weighs 2.7 pounds). This commenter 

stated that small businesses that only 

sell a limited variety of popular 

products would likely not be exempt 

under the current proposal. 

One individual stated that small 

businesses should not be exempt from 

the proposed rule. 

Response: As discussed above, FSIS 

believes an exemption for ground or 

chopped products produced by small 

businesses is necessary because the 

burden of mandatory nutrition labeling 

may force some small firms to stop 

producing the product because of the 

cost of nutrition labeling and eventually 

force some small firms out of business. 

FSIS believes it would not be feasible 

for some small businesses to incur the 

additional costs of nutrition labeling 

because of their low volume of sales or 

low volume of ground product. FSIS 

believes it is feasible for larger 

businesses to incur the additional costs 

of nutrition labeling because of their 

higher volume of sales or larger levels 

of production of ground product. This 

final rule, with an exemption for ground 

or chopped products that qualify for the 

small business exemption in 

§§ 317.400(a)(1) and 381.500(a)(1), 

provides nutrition labeling on the 

maximum volume of ground or chopped 

product while assuring that small 

businesses producing low volumes of 

product are not at risk of going out of 

business or materially reducing the 

variety of products they deliver to their 

customers. Further, as discussed above, 

FSIS believes that the relatively small 

additional benefits of requiring small 

businesses to put nutrition labels on all 

ground or chopped products are 

outweighed by the larger additional 

costs. 

As explained in more detail above, 

even if the products produced by small 

businesses bear a %fat/%lean statement, 

they will still be exempt under the small 

business exemption. Consumers use 

these statements to identify their 

desired product and are not misled by 

these statements, even if small 

businesses do not include nutrition 

information on the products’ labels. 

To qualify for the exemption, a retail 

store must either be a single retail store 

that employs 500 or fewer people or a 

multi-retail store operation that employs 

500 or fewer people and that produces 

no more than 100,000 pounds of each 

ground product per year. For an official 

establishment to qualify for the 

exemption, it must be either a singleplant facility that employs 500 or fewer 

people, or a multi-plant company/firm 

that employs 500 or fewer people and 

produces no more than 100,000 pounds 

per year of each ground product. As 

explained in the preamble to the 

proposed rule, ground or chopped 

products formulated to have different 

levels of fat would be considered 

different food products for the purposes 

of the small business exemption (66 FR 

4978, January 18, 2001; 74 FR 67753, 

December 18, 2009). As stated above 

and in the supplemental proposed rule, 

there is no small business exemption 

from the nutrition labeling requirements 

for the major cuts of single-ingredient, 

raw meat and poultry products because 

the requirements should not impose an 

economic hardship on small businesses 

(74 FR 67738). Nutrition information for 

the major cuts can be displayed either 

on the labels or on point-of-purchase 

materials. FSIS will make point-ofpurchase materials available over the 

Internet free of charge. Therefore, small 

businesses will not incur significant 

costs to provide nutrition information 

for the major cuts of single-ingredient, 

raw meat and poultry products. 

FSIS finds that the 100,000 pound 

limit in the small business exemption is 

appropriate because it has been 

successfully applied for over a decade 

for other nutrition labeling exemptions. 

Furthermore, the Agency received no 

compelling data to support raising the 

limit to 150,000 pounds for this 

exemption. A consistent poundage limit 

will be easier to apply across all meat 

and poultry products. 

Comment: Two trade associations 

stated that it was necessary to provide 

outreach resources to the industry 

through meetings and materials such as 

compliance guidelines. One of the trade 

associations noted that many small 

businesses do not have Internet access, 

so FSIS’s Office of Outreach, Employee 

Education and Training (OOEET) will 

need to develop hard copy materials. 

Response: If retailers cannot obtain 

the point-of-purchase materials over the 

Internet, FSIS personnel will have 

copies of the information to provide to 

retailers. FSIS personnel will also 

conduct meetings on the final rule. For 

retailers that have access to the Internet, 

FSIS will conduct Webinars on the final 

rule. 

Comment: The city health department 

asserted that nutrition labeling should 

be mandatory for all meat and poultry 

products that are sold to the food 

service sector to enable restaurants and 

food service companies to make more 

healthful choices, which will ultimately 

benefit consumer health. 


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Response: Existing regulations 

provide that products intended for 

further processing and products not for 

sale to consumers are exempt from 

nutrition labeling requirements (9 CFR 

§ 317.400). Such products are exempt 

from nutrition labeling requirements 

because consumers do not see the 

nutrition information on products used 

for further processing or products that 

are not for sale to consumers. 

Enforcement & Compliance 

Comment: Several trade associations 

stated that there should be some 

flexibility in variations from estimated 

nutritional values in sampling and in 

nutrient analysis if the nutrition 

labeling information is based on the 

most current USDA National Nutrient 

Data Bank or the USDA National 

Nutrient Database for Standard 

Reference. One trade association 

questioned whether reliance on the 

USDA National Nutrient Database for 

Standard Reference or the Agricultural 

Research Service (ARS) calculator is 

considered a valid response to USDA 

nutrition test results. Another trade 

association believed that the use of the 

Nutrient Database for Standard 

Reference should be acceptable for 

providing nutritional values for all 

products. Further, the commenter stated 

that the nutritional values should be 

based on the analyzed fat content 

because it would minimize the number 

and costs of expensive analysis 

required. 

One trade association stated that all 

entries in the Nutrient Database for 

Standard Reference that are added or 

removed should go through the rulemaking process to ensure that all groups 

using these entries are considered. For 

example, this trade association stated 

that commodity type cuts and items 

with more than 1⁄8 inch fat need to be 

added to the Nutrient Database for 

Standard Reference because these 

products are still sold through food 

service channels, and it is costly for 

producers to provide nutrition 

information via nutrient analysis to 

commodity type customers. 

One trade association stated that the 

ARS calculator should be updated to 

provide nutrition information for 

turkey, pork, and chicken. 

One trade association suggested that 

the Nutrient Database for Standard 

Reference be split into two databases, 

one for retail type products and one for 

commodity type products. One trade 

association questioned how 

enforcement of nutrition labeling 

requirements will work at retail 

establishments and farmer’s markets. 

The trade association further questioned 

whether there will be fines for noncompliance. Additionally, in order to 

prevent inconsistent Agency 

enforcement actions, the commenter 

stated that FSIS needs to ensure all 

businesses are in compliance. 

Response: As FSIS stated in the 

preamble to the proposal, the fat content 

of different ground or chopped products 

can vary significantly, depending upon 

the level of fat in the product being 

ground and depending on whether 

product from AMR systems is used (66 

FR 4980, January 18, 2001). As FSIS 

explained in the supplemental proposed 

rule, the procedures set forth for FSIS 

product sampling and nutrient analysis 

in 9 CFR 317.309(h)(1)–(8) and 

381.409(h)(1)–(8) will be applicable to 

ground or chopped meat and to ground 

or chopped poultry products, 

respectively. FSIS will not analyze 

ground or chopped products for fat 

only, because if the ground product 

includes AMR product or product from 

low temperature rendering (e.g., finely 

textured beef or lean finely textured 

beef), the use of these materials could 

affect other nutrient values in the 

product. (74 FR 67754, December 18, 

2009). 

FSIS will sample and conduct 

nutrient analysis of ground or chopped 

products to verify compliance with 

nutrition labeling requirements, even if 

nutrition labeling on these products is 

based on the most current representative 

database values contained in USDA’s 

National Nutrient Data Bank or the 

USDA National Nutrient Database for 

Standard Reference and there are no 

claims on the labeling. FSIS will treat 

ground or chopped products in this way 

because the fat content of these products 

can vary significantly. FSIS employees 

cannot visually assess whether nutrition 

information on the label of ground or 

chopped products accurately reflects the 

labeled products’ contents because, in 

most cases, it is not possible to visually 

assess the level of fat in a ground or 

chopped product. For example, FSIS 

employees cannot visually determine 

whether product that is labeled 17 

percent fat ground beef is actually 17 

percent fat ground beef as opposed to 27 

percent fat (or another percentage of fat) 

ground beef (66 FR 4980, January 18, 

2001) (74 FR 67755, December 18, 

2009). Therefore, FSIS will treat ground 

or chopped products as it treats all other 

products for which the regulations 

require nutrition information on their 

package. In the event that FSIS samples 

and conducts nutrient analysis of 

ground or chopped beef, if producers 

know the fat content of their product 

and have used USDA database values on 

the nutrition labels, FSIS would likely 

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 


jlentini on DSKJ8SOYB1PROD with RULES2
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range of fat levels. ARS also has nutrient 

data for three types of commonly 

marketed ground turkey products. ARS 

also has published nutrient values for 

ground turkey with fat levels of 0%, 7%, 

and 15%. Most ground poultry products 

are produced and labeled at Federal 

establishments rather than at retail. 

Commodity products are exempt from 

nutrition labeling requirements under 9 

CFR 317.400 and 381.500 because they 

are not offered for sale. If commodity 

products bear nutrition claims or 

information, then they will be subject to 

the nutrition labeling requirements. 

Producers that sell product at farmers 

markets would typically be exempt from 

nutrition labeling requirements under 

the small business exemption. 

FSIS will explore its regulatory 

options, including seeking criminal 

penalties, if it discovers a violation of 

the nutrition labeling requirements. 

FSIS is not authorized to impose civil 

penalties, including fines, under the 

FMIA or PPIA. For more discussion of 

possible enforcement actions following 

implementation of the rule, see the 

supplemental proposed rule (74 FR 

67754, December 18, 2009). 

Effective Date 

Comment: Several trade associations 

stated that the requirements for major 

cuts of single-ingredient, raw meat and 

poultry products and ground or 

chopped products should become 

effective on the uniform compliance 

date, January 1, 2012. One of the trade 

associations believed that different 

implementation dates for the two types 

of products would be confusing to 

consumers and may require two 

outreach programs. The other trade 

association argued that establishments 

need as much time as possible to 

understand the new requirements and 

develop new labels and point-ofpurchase materials before the 

requirements become effective. The food 

marketing organization agreed that there 

should be additional time prior to 

implementation of the nutrition labeling 

requirements for the major cuts because 

of the burden on the retailers. 

One trade association stated that an 

18–24 month period was needed for 

implementation. 

The food marketing organization 

argued that the final rule should include 

a provision allowing an extension of the 

effective dates of up to six months if 

there is evidence of difficulties with 

compliance. One trade association 

agreed with a six month or a twelve 

month extension period before the 

effective date of the rule. 

Response: As FSIS stated in the 

supplemental proposed rule, 

requirements for ground or chopped 

products will become effective on 

January 1, 2012, the uniform 

compliance date for new food labeling 

regulations that are issued between 

January 1, 2009, and December 31, 2010, 

to minimize costs associated with onpackage labels. In the supplemental 

proposed rule, FSIS proposed that the 

labeling requirements for the major cuts 

be effective one year from the date of 

publication of the final rule because the 

final rule allows for the presentation of 

nutrition information for the major cuts 

of single-ingredient, raw meat and 

poultry products at their point-ofpurchase and will not require changes 

to product labels (74 FR 67741, 

December 18, 2009). But, because one 

year from the date of publication will 

only be a few days before the effective 

date for ground and chopped products, 

January 1, 2012, FSIS is also 

establishing January 1, 2012, as the 

effective date for the labeling 

requirements for the major cuts. 

Costs and Benefits 

Comment: One trade association 

stated that the proposed rule was 

discriminatory because it would have a 

disproportionate effect on retailers with 

service meat departments. This trade 

association also noted that under this 

rule, retailers will have a more costly 

burden compared to restaurant 

competitors. 

One trade association argued that 

FSIS should finalize the regulation with 

the least amount of economic impact on 

the meat industry. 

Several individuals and an industry 

commenter were concerned that the rule 

would increase costs to producers and 

consumers and increase taxes. 

Response: The Regulatory Flexibility 

Act requires Federal Agencies to 

consider the effect of regulations on 

small entities in developing regulations 

(74 FR 67757, December 18, 2009). 

However, FSIS has sought to make this 

rule as fair and equitable as possible, 

regardless of the size of the company 

involved. 

Thus, to minimize the burden on 

small businesses, the final rule provides 

a small business exemption. In addition, 

the final rule provides an exemption 

from nutrition labeling requirements for 

ground or chopped products that are 

ground or chopped at an individual 

customer’s request and that are prepared 

and served or sold at retail, provided 

that the labels or labeling of these 

products bear no nutrition claims or 

nutrition information. FSIS will also 

provide nutrition labeling materials for 

the major cuts of single-ingredient, raw 

products and for ground or chopped 

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 singleingredient, raw product, if it did, the 

menu would not fall within the scope of 

the proposed regulations. (66 FR 4979, 

January 18, 2001). 

FSIS does not believe that it has 

underestimated the costs of the final 

rule. Since the Supplemental Proposed 

Rule Regulatory Impact Analysis was 

done, the total costs of labeling may 

have even decreased because of more 

cost-effective technology, such as less 

expensive computerized flexography 

and scale-label printers. The additional 

costs of labeling would be relatively low 

for the affected businesses. Furthermore, 

the final rule will exempt small 

businesses that produce ground or 

chopped product from nutrition labeling 

requirements. As FSIS explained in the 

proposed rule and supplemental 

proposed rule, this rule will not 

significantly increase costs to affected 

producers and retailers because the 

additional cost of this rule is a relatively 

small proportion of the total costs of 

production or retail marketing of 

affected businesses. The estimated cost 

of the rule on a per pound basis is about 

$0.006, for ground or chopped products. 

This increase in cost should not affect 

consumer costs or purchases. 

Comment: According to a case study, 

one individual stated that the proposed 

rule may produce benefits of $62 to 

$125 million annually. 

Response: FSIS projected that the 

annualized average present value of the 

benefit of the final rule is about $75.5 

million, after accounting for assumed 

levels of current compliance. For a 

discussion of the methodology used to 

estimate the benefits of the final rule, 

please see the Final Regulatory Impact 

Analysis below. 

Other Comments 

Comment: The consumer organization 

believed nutrition labels should be 

required to indicate the amount of trans 

fat in the product similar to the FDA’s 

policy. According to the consumer 

organization, the trans fat in beef and 

dairy products has the same harmful 


jlentini on DSKJ8SOYB1PROD with RULES2
82162 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

1National Cattlemen’s Beef Association, 2004. 

National Meat Case Study. 

2U.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. 

3The impacts of a 68 percent compliance rate for 

nutrition labeling of ground or chopped products 

(NCBA, 2004) and a 54.8 percent compliance rate 

for major cuts (USDA, 1999) are included in this 

RIA of the Final Rule. 

impact on LDL cholesterol as the trans 

fat in partially hydrogenated oils. 

Response: FSIS does not require the 

mandatory labeling of trans fats as 

required by FDA. However, through 

routine label approval, FSIS estimates 

75% to 80% of FSIS nutrition labels do 

voluntarily include trans fat in the 

nutrition facts information. FSIS 

anticipates many companies will 

voluntarily include trans fat in the 

nutrition facts information on singleingredient and ground products. 

Comment: The city health department 

stated that nutrition labels for meat and 

poultry products should be consistent 

with the Nutrition Labeling and 

Education Act and the majority of 

packaged foods. 

Response: Products under FSIS 

jurisdiction are not subject to the 

Nutrition Labeling and Education Act 

(74 FR 67754, December 18, 2009). But, 

FSIS believes that the requirements of 

this final rule are consistent with the 

Nutrition Labeling and Education Act. 

Comments: FSIS also received 

comments on issues outside the scope of 

these regulations. One trade association 

stated that all nutrition labels should 

specify all the nutrients found in meat 

products. One individual suggested that 

approximate cook times for chicken and 

pork products should be placed on their 

labels. One individual stated that meat 

and poultry product labels should 

include information such as date 

butchered, date preserved/frozen, any 

hormones or antibiotics in the product, 

and genetic engineering used in the 

creation of the product. One perishable 

items tracking company argued that 

tracers like radio frequency 

identification tags should be mandated 

in all meat and poultry shipping 

containers to record the shipping times 

and ensure the products were kept at 

safe temperatures similar to the 

TEDSBOX system. Further, the tracing 

information should be provided on all 

product labels. 

Section II 

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. 

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. 

The average present values of the 

benefits are about $800 million and 

about $1,358 million, using 7 and 3 

percent discount rates, respectively. The 

corresponding annualized average 

present values of the benefits are about 

$75.5 million and about $91.3 million, 

using 7 and 3 percent discount rates, 

respectively. Table 1 provides a 

summary of these annualized net 

present values of costs and benefits. 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 82163 

4RTI 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. 

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] 

Category 

Primary 

or 

average 

estimate 

Low 

estimate 

High 

estimate 

UNITS 

Year 

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 singleingredient, raw products. FSIS estimates 

that the cost to a retail store for placards 

would be $10.56 for labor plus $65.17 

for materials or approximately $75.73 

per store. The annualized cost, 

assuming that the placards have to be 

replaced every two years, is about 

$41.88 using a 7 percent discount rate. 

All the retail stores, including small and 

very small businesses would incur these 

additional costs in either the first year, 

if the store is not currently providing 

POP nutrition information for the major 

cuts of single-ingredient, raw products, 

or in the third year, if the store is 

currently providing this information. 

FSIS believes that these additional costs 

are not significant even for very small 

businesses. 

Retail stores would also incur 

additional costs related to required 

nutrition labels for ground or chopped 

products. A total of 74,910 stores owned 

by 47,688 firms could be affected. 

However, 23,479 stores owned by 266 

firms are considered to be large 

according to the 2002 Economic Census. 

If they grind or chop over 100,000 

pounds of a particular product annually, 

then, in the worst case scenario, as 

many as 51,431 small establishments 

owned by 47,422 firms could be 

affected.4

FSIS estimates that using a 7 percent 

discount rate the sum of the annualized 

average cost to each retail store that is 

not currently providing nutrition 

information for the major cuts or ground 

or chopped products would be $42 for 

nutrition information placards, $486 for 

upgrading and maintaining scale-printer 

systems, $969 for redesigning larger 

store logo labels, and $40 for using 

larger labels. For a store that is not 

currently providing nutrition 

information for the major cuts or ground 

or chopped product, the annualized 

total cost over 20 years, using a 7 

percent discount rate, would be about 

$1,537, per store. In summary, FSIS 

concludes that this final rule would not 

have a significant impact on a 

substantial number of small entities. 

Based on the 2002 Economic Census 

of the U.S. Department of Commerce, 

meat and poultry processing 

establishments that are small entities 

had annual revenues from total value of 

shipments that ranged from $0.454 

million to $96.038 million. For each 

processing (grinding) establishment 

affected that is not currently providing 

nutrition information for ground or 

chopped products, the additional 

annualized average total cost is about 

$1,402. Then, for each such processing 

(grinding) establishment, additional 

annualized average total costs as a 

percent of revenues range from a lower 

bound of 0.001 percent ($1,402/$96.038 

million) to an upper bound of 0.3 

percent ($1,402/$0.454 million). 

Further, small entity retail stores, 

supermarkets and other grocery (except 

convenience) stores and meat market 

stores, had annual revenues from sales 

that ranged from $0.343 million to 

$8.873 million. Also, the companies or 

firms of the small retail stores had 

annual revenues from sales that ranged 

from $0.343 million to $48.342 million. 

Additional annualized total costs as a 

percent of revenues range from the 

lower bound of 0.02 percent ($1,537/ 

$8.873 million) to the upper bound of 

0.4 percent ($1,537/$0.343 million). 

Many of these retail firms that are small 

entities own multiple retail stores that 

are small entity supermarkets and other 

grocery (except convenience) stores. 


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82164 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

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 §§ 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. 

■ For the reasons stated in the preamble, 

FSIS is amending 9 CFR Chapter III, as 

follows: 

PART 317—LABELING, MARKING 

DEVICES AND CONTAINERS 

■ 1. The authority citation for part 317 

continues to read as follows: 

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

2.53. 

■ 2. Section 317.300 is revised to read 

as follows: 

§ 317.300 Nutrition labeling of meat and 

meat food products. 

(a) Nutrition labeling must be 

provided for all meat and meat food 

products intended for human 

consumption and offered for sale, 

except single-ingredient, raw meat 

products that are not ground or chopped 

meat products described in § 317.301 

and are not major cuts of singleingredient, raw meat products identified 

in § 317.344, unless the product is 

exempted under § 317.400 . Nutrition 

labeling must be provided for the major 

cuts of single-ingredient, raw meat 

products identified in § 317.344, either 

in accordance with the provisions of 

§ 317.309 for nutrition labels, or in 

accordance with the provisions of 

§ 317.345 for point-of-purchase 

materials, except as exempted under 

§ 317.400. For all other products for 

which nutrition labeling is required, 

including ground or chopped meat 

products described in § 317.301, 

nutrition labeling must be provided in 

accordance with the provisions of 

§ 317.309, except as exempted under 

§ 317.400. 

(b) Nutrition labeling may be 

provided for single-ingredient, raw meat 

products that are not ground or chopped 

meat products described in § 317.301 

and that are not major cuts of singleingredient, raw meat products identified 


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Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 82165 

in § 317.344, either in accordance with 

the provisions of § 317.309 for nutrition 

labels, or in accordance with the 

provisions of § 317.345 for point-ofpurchase materials. 

■ 3. A new § 317.301 is added to read 

as follows: 

§ 317.301 Required nutrition labeling of 

ground or chopped meat products. 

(a) Nutrition labels must be provided 

for all ground or chopped products 

(livestock species) and hamburger with 

or without added seasonings (including, 

but not limited to, ground beef, ground 

beef patties, ground sirloin, ground 

pork, and ground lamb) that are 

intended for human consumption and 

offered for sale, in accordance with the 

provisions of § 317.309, except as 

exempted under § 317.400. 

(b) [Reserved] 

■ 4. Section 317.309 is amended as 

follows: 

■ a. In paragraph (b)(3), the first 

sentence is amended by adding ‘‘that are 

not ground or chopped meat products 

described in § 317.301’’ after the phrase 

‘‘single-ingredient, raw products’’, and 

by removing ‘‘as set forth in 

§ 317.345(a)(1)’’; the second sentence is 

amended by adding, ‘‘that are not 

ground or chopped meat products 

described in § 317.301’’ after the phrase 

‘‘single-ingredient, raw products’’, and 

the following new sentence is added 

after the first sentence: ‘‘For singleingredient, raw products that are not 

ground or chopped meat products 

described in § 317.301, if data are based 

on the product ‘as consumed,’ the data 

must be presented in accordance with 

§ 317.345(d)’’; 

■ b. Amend paragraph (b)(10) by adding 

the following new sentence at the end 

of the paragraph: ‘‘The declaration of the 

number of servings per container need 

not be included in nutrition labeling of 

single-ingredient, raw meat products 

that are not ground or chopped meat 

products described in § 317.301, 

including those that have been 

previously frozen.’’; 

■ c. Amend paragraph (b)(11) by adding 

the phrase ‘‘single-ingredient, raw 

products that are not ground or chopped 

meat products described in § 317.301 

and’’ after ‘‘exception of’’; 

■ d. Amend paragraph (d)(3)(ii) by 

removing the period and adding ‘‘or on 

single-ingredient, raw meat products 

that are not ground or chopped meat 

products described in § 317.301.’’ at the 

end of the paragraph; 

■ e. Amend paragraph (e)(3) by adding 

‘‘, but may be on the basis of ‘as 

consumed’ for single-ingredient, raw 

meat products that are not ground or 

chopped meat products described in 

§ 317.301,’’ after ‘‘as packaged’’; and 

■ f. Amend paragraph (h)(9) by 

removing the phrase ‘‘(including ground 

beef)’’, by adding, ‘‘that are not ground 

or chopped meat products described in 

§ 317.301’’ after ‘‘products’’, by removing 

the phrase, ‘‘its published form, the 

Agriculture Handbook No. 8 series 

available from the Government Printing 

Office’’, and by adding, in its place, ‘‘its 

released form, the USDA National 

Nutrient Database for Standard 

Reference’’, and by removing the period 

and adding the following at the end of 

the paragraph: ’’ as provided in 

§ 317.345(e) and (f).’’ 

§ 317.343 [Removed] 

■ 5. Section 317.343 is removed. 

■ 6. Section 317.344 is amended by 

removing the phrases ‘‘ground beef 

regular without added seasonings, 

ground beef about 17% fat,’’ and 

‘‘ground pork’’. 

■ 7. Section 317.345 is amended as 

follows: 

■ a. Revise the section heading and 

paragraphs (a) and (c); 

■ b. Amend paragraph (d) by removing 

‘‘should’’ and adding, in its place, ‘‘for 

products covered in paragraphs (a)(1) 

and (a)(2) must’’; 

■ c. Amend paragraph (e) by removing 

‘‘its published form, the Agriculture 

Handbook No. 8 series’’ and by adding, 

in its place, ‘‘its released form, the 

USDA National Nutrient Database for 

Standard Reference’’, and by removing 

‘‘(including ground beef)’’; 

■ d. Amend paragraph (f) by adding 

‘‘provided’’ after ‘‘nutrition information 

is’’; and 

■ e. Amend paragraph (g) by removing 

the phrase ‘‘(including ground beef)’’. 

The revisions read as follows: 

§ 317.345 Nutrition labeling of singleingredient, raw meat products that are not 

ground or chopped products described in 

§ 317.301. 

(a)(1) Nutrition information on the 

major cuts of single-ingredient, raw 

meat products identified in § 317.344, 

including those that have been 

previously frozen, is required, either on 

their label or at their point-of-purchase, 

unless exempted under § 317.400. If 

nutrition information is presented on 

the label, it must be provided in 

accordance with § 317.309. If nutrition 

information is presented at the point-ofpurchase, it must be provided in 

accordance with the provisions of this 

section. 

(2) Nutrition information on singleingredient, raw meat products that are 

not ground or chopped meat products 

described in § 317.301 and are not major 

cuts of single-ingredient, raw meat 

products identified in § 317.344, 

including those that have been 

previously frozen, may be provided at 

their point-of-purchase in accordance 

with the provisions of this section or on 

their label, in accordance with the 

provisions of § 317.309. 

(3) A retailer may provide nutrition 

information at the point-of-purchase by 

various methods, such as by posting a 

sign or by making the information 

readily available in brochures, 

notebooks, or leaflet form in close 

proximity to the food. The nutrition 

labeling information may also be 

supplemented by a video, live 

demonstration, or other media. If a 

nutrition claim is made on point-ofpurchase materials, all of the format and 

content requirements of § 317.309 

apply. However, if only nutrition 

information—and not a nutrition 

claim—is supplied on point-of-purchase 

materials, the requirements of § 317.309 

apply, provided, however: 

(i) The listing of percent of Daily 

Value for the nutrients (except vitamins 

and minerals specified in 

§ 317.309(c)(8)) and footnote required by 

§ 317.309(d)(9) may be omitted; and 

(ii) The point-of-purchase materials 

are not subject to any of the format 

requirements. 

* * * * * 

(c) For the point-of-purchase 

materials, the declaration of nutrition 

information may be presented in a 

simplified format as specified in 

§ 317.309(f). 

* * * * * 

■ 8. Section 317.362 is amended by 

adding a new paragraph (f) to read as 

follows: 

§ 317.362 Nutrient content claims for fat, 

fatty acids, and cholesterol content. 

* * * * * 

(f) A statement of the lean percentage 

may be used on the label or in labeling 

of ground or chopped meat products 

described in § 317.301 when the 

product does not meet the criteria for 

‘‘low fat,’’ defined in § 317.362(b)(2), 

provided that a statement of the fat 

percentage is contiguous to and in 

lettering of the same color, size, type, 

and on the same color background, as 

the statement of the lean percentage. 

* * * * * 

■ 9. Section 317.400 is amended by: 

■ a. Revising paragraph (a)(1) 

introductory text; 

■ b. Amending paragraph (a)(1)(ii) by 

adding ‘‘, including a single retail store,’’ 

after the phrase ‘‘single-plant facility,’’ 

and by adding, ‘‘, including a multiVerDate Mar<15>2010 23:25 Dec 28, 2010 Jkt 223001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\29DER2.SGM 29DER2

jlentini on DSKJ8SOYB1PROD with RULES2
82166 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 

retail store operation,’’ after ‘‘company/ 

firm’’; 

■ c. Amending paragraph (a)(7)(i) by 

removing the semi-colon and ‘‘and’’ and 

by adding the following at the end of the 

paragraph: ‘‘, provided, however, that 

this exemption does not apply to readyto-eat ground or chopped meat products 

described in § 317.301 that are packaged 

or portioned at a retail establishment, 

unless the establishment qualifies for an 

exemption under (a)(1);’’; 

■ d. Amending paragraph (a)(7)(ii) by 

removing the period and by adding the 

following at the end of the paragraph: ‘‘, 

provided, however, that this exemption 

does not apply to multi-ingredient 

ground or chopped meat products 

described in § 317.301 that are 

processed at a retail establishment, 

unless the establishment qualifies for an 

exemption under (a)(1); and’’; 

■ e. Adding a new paragraph (a)(7)(iii); 

and 

■ f. Paragraph (d)(1) is amended by 

removing the period at the end of the 

first sentence, and by adding the 

following to the end of the first 

sentence: ‘‘, except that this exemption 

does not apply to the major cuts of 

single-ingredient, raw meat products 

identified in § 317.344.’’ 

The revision and additions read as 

follows: 

§ 317.400 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 § 317.344 produced by 

small businesses, provided that the 

labels for these products bear no 

nutrition claims or nutrition 

information, and ground or chopped 

products described in § 317.301 

produced by small businesses that bear 

a statement of the lean percentage and 

fat percentage on the label or in labeling 

in accordance with § 317.362(f), 

provided that labels or labeling for these 

products bear no other nutrition claims 

or nutrition information, 

* * * * * 

(7) * * * 

(iii) Products that are ground or 

chopped at an individual customer’s 

request. 

* * * * * 

PART 381—POULTRY PRODUCTS 

INSPECTION REGULATIONS 

■ 10. The authority citation for part 381 

continues to read as follows: 

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 

451–470; 7 CFR 2.18, 2.53. 

■ 11. Section 381.400 is revised to read 

as follows: 

§ 381.400 Nutrition labeling of poultry 

products. 

(a) Nutrition labeling must be 

provided for all poultry products 

intended for human consumption and 

offered for sale, except singleingredient, raw poultry products that 

are not ground or chopped poultry 

products described in § 381.401 and are 

not major cuts of single-ingredient, raw 

poultry products identified in § 381.444, 

unless the product is exempted under 

§ 381.500. Nutrition labeling must be 

provided for the major cuts of singleingredient, raw poultry products 

identified in § 381.444, either in 

accordance with the provisions of 

§ 381.409 for nutrition labels, or in 

accordance with the provisions of 

§ 381.445 for point-of-purchase 

materials, except as exempted under 

§ 381.500. For all other products that 

require nutrition labeling, including 

ground or chopped poultry products 

described in § 381.401, nutrition 

labeling must be provided in accordance 

with the provisions of § 381.409, except 

as exempted under § 381.500. 

(b) Nutrition labeling may be 

provided for single-ingredient, raw 

poultry products that are not ground or 

chopped poultry products described in 

§ 381.401 and that are not major cuts of 

single-ingredient, raw poultry products 

identified in § 381.444, either in 

accordance with the provisions of 

§ 381.409 for nutrition labels, or in 

accordance with the provisions of 

§ 381.445 for point-of-purchase 

materials. 

* * * * * 

■ 12. A new § 381.401 is added to read 

as follows: 

§ 381.401 Required nutrition labeling of 

ground or chopped poultry products. 

Nutrition labels must be provided for 

all ground or chopped poultry (kind) 

with or without added seasonings 

(including, but not limited to, ground 

chicken, ground turkey, and (kind) 

burgers) that are intended for human 

consumption and offered for sale, in 

accordance with the provisions of 

§ 381.409, except as exempted under 

§ 381.500. 

■ 13. Section 381.409 is amended as 

follows: 

■ a. Revise paragraph (b)(3); 

■ b. Amend paragraph (b)(10) by adding 

the following new sentence at the end 

of the paragraph: ‘‘The declaration of the 

number of servings per container need 

not be included in nutrition labeling of 

single-ingredient, raw poultry products 

that are not ground or chopped poultry 

products described in § 381.401, 

including those that have been 

previously frozen.’’; 

■ c. Amend paragraph (b)(11) by adding 

the phrase ‘‘single-ingredient, raw 

products that are not ground or chopped 

poultry products described in § 381.401 

and’’ after ‘‘exception of’’; 

■ d. Amend paragraph (d)(3)(ii) by 

removing the period and adding ‘‘or on 

single-ingredient, raw poultry products 

that are not ground or chopped poultry 

products described in § 381.401.’’ at the 

end of the paragraph; 

■ e. Amend paragraph (e)(3) by adding 

‘‘, but may be on the basis of ‘as 

consumed’ for single-ingredient, raw 

poultry products that are not ground or 

chopped poultry products described in 

§ 381.401,’’ after ‘‘as packaged’’; and 

■ f. Amend paragraph (h)(9) by adding, 

‘‘that are not ground or chopped poultry 

products described in § 381.401’’ after 

‘‘products’’, by removing the phrase, ‘‘its 

published form, the Agriculture 

Handbook No. 8 series’’, and by adding, 

in its place, ‘‘its released form, the 

USDA National Nutrient Database for 

Standard Reference’’, and by removing 

the period and adding the following at 

the end of the paragraph: ‘‘, as provided 

in § 381.445(e) and (f).’’ 

The revision reads as follows: 

§ 381.409 Nutrition label content. 

* * * * * 

(b) * * * 

(3) The declaration of nutrient and 

food component content shall be on the 

basis of the product ‘‘as packaged’’ for all 

products, except that single-ingredient, 

raw products that are not ground or 

chopped poultry products as described 

in § 381.401 may be declared on the 

basis of the product ‘‘as consumed.’’ For 

single-ingredient, raw products that are 

not ground or chopped poultry products 

described in § 381.401, if data are based 

on the product ‘‘as consumed,’’ the data 

must be presented in accordance with 

§ 381.445(d). In addition to the required 

declaration on the basis of ‘‘as packaged’’ 

for products other than singleingredient, raw products that are not 

ground or chopped poultry products as 

described in § 381.401, the declaration 

may also be made on the basis of ‘‘as 

consumed,’’ provided that preparation 

and cooking instructions are clearly 

stated. 

* * * * * 

§ 381.443 [Removed] 

■ 14. Section 381.443 is removed. 

■ 15. Section 381.445 is amended as 

follows: 

■ a. Revise the section heading and 

paragraph (a) and (c); 


jlentini on DSKJ8SOYB1PROD with RULES2
Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Rules and Regulations 82167 

■ b. Amend paragraph (d) by removing 

‘‘should’’ and adding, in its place, ‘‘for 

products covered in paragraphs (a)(1) 

and (a)(2) must’’; 

■ c. Amend paragraph (e) by removing 

‘‘its published form, the Agriculture 

Handbook No. 8 series’’ and by adding, 

in its place, ‘‘its released form, the 

USDA National Nutrient Database for 

Standard Reference.’’; and 

■ d. Amend paragraph (f) by adding 

‘‘provided’’ after ‘‘nutrition information 

is’’. 

The revisions read as follows: 

§ 381.445 Nutrition labeling of singleingredient, raw poultry products that are 

not ground or chopped products described 

in § 381.401. 

(a)(1) Nutrition information on the 

major cuts of single-ingredient, raw 

poultry products identified in § 381.444, 

including those that have been 

previously frozen, is required, either on 

their label or at their point-of-purchase, 

unless exempted under § 381.500. If 

nutrition information is presented on 

the label, it must be provided in 

accordance with the provisions of 

§ 381.409. If nutrition information is 

presented at the point-of-purchase, it 

must be provided in accordance with 

the provisions of this section. 

(2) Nutrition information on singleingredient, raw poultry products that 

are not ground or chopped poultry 

products described in § 381.401 and are 

not major cuts of single-ingredient, raw 

poultry products identified in § 381.444, 

including those that have been 

previously frozen, may be provided at 

their point-of-purchase in accordance 

with the provisions of this section or on 

their label, in accordance with the 

provisions of § 381.409. 

(3) A retailer may provide nutrition 

information at the point-of-purchase by 

various methods, such as by posting a 

sign or by making the information 

readily available in brochures, 

notebooks, or leaflet form in close 

proximity to the food. The nutrition 

labeling information may also be 

supplemented by a video, live 

demonstration, or other media. If a 

nutrition claim is made on point-ofpurchase materials, all of the format and 

content requirements of § 381.409 

apply. However, if only nutrition 

information—and not a nutrition 

claim—is supplied on point-of-purchase 

materials, the requirements of § 381.409 

apply, provided, however: 

(i) The listing of percent of Daily 

Value for the nutrients (except vitamins 

and minerals specified in 

§ 381.409(c)(8)) and footnote required by 

§ 381.409(d)(9) may be omitted; and 

(ii) The point-of-purchase materials 

are not subject to any of the format 

requirements. 

* * * * * 

(c) For the point-of-purchase 

materials, the declaration of nutrition 

information may be presented in a 

simplified format as specified in 

§ 381.409(f). 

* * * * * 

■ 16. Section 381.462 is amended by 

adding a new paragraph (f) to read as 

follows: 

§ 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 § 381.401 when the 

product does not meet the criteria for 

‘‘low fat,’’ defined in § 381.462(b)(2), 

provided that a statement of the fat 

percentage is contiguous to and in 

lettering of the same color, size, type, 

and on the same color background, as 

the statement of the lean percentage. 

* * * * * 

■ 17. Section 381.500 is amended by: 

■ a. Revising paragraph (a)(1) 

introductory text; 

■ b. Amending paragraph (a)(1)(ii) by 

adding, ‘‘, including a single retail 

store,’’ after the phrase ‘‘single-plant 

facility,’’ and by adding ‘‘,including a 

multi-retail store operation’’ after 

‘‘company/firm’’; 

■ c. Amending paragraph (a)(7)(i) by 

removing the semi-colon and ‘‘and’’ and 

adding the following at the end of the 

paragraph: ‘‘, provided, however, that 

this exemption does not apply to readyto-eat ground or chopped poultry 

products described in § 381.401 that are 

packaged or portioned at a retail 

establishment, unless the establishment 

qualifies for an exemption under (a)(1);’’; 

■ d. Amending paragraph (a)(7)(ii) by 

removing the period and adding the 

following at the end of the paragraph: ‘‘, 

provided, however, that this exemption 

does not apply to multi-ingredient 

ground or chopped poultry products 

described in § 381.401 that are 

processed at a retail establishment, 

unless the establishment qualifies for an 

exemption under (a)(1); and’’; 

■ e. Adding a new paragraph (a)(7)(iii); 

and 

■ f. Amending paragraph (d)(1) by 

removing the period at the end of the 

sentence, and by adding the following to 

the end of the sentence: ‘‘except that this 

exemption does not apply to the major 

cuts of single-ingredient, raw poultry 

products identified in § 381.444.’’ 

The revision and additions read as 

follows: 

§ 381.500 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 § 381.444 produced by 

small businesses, provided that the 

labels for these products bear no 

nutrition claims or nutrition 

information, and ground or chopped 

products described in § 381.401 

produced by small businesses that bear 

a statement of the lean percentage and 

fat percentage on the label or in labeling 

in accordance with § 381.462(f), 

provided that labels or labeling for these 

products bear no other nutrition claims 

or nutrition information, 

* * * * * 

(7) * * * 

(iii) Products that are ground or 

chopped at an individual customer’s 

request. 

* * * * * 

Done in Washington, DC on December 21, 

2010. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. 2010–32485 Filed 12–28–10; 8:45 am] 

BILLING CODE 3410–DM–P 


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