79044 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 317 and 381 

[Docket No. FSIS–2010–0012] 

RIN 0583–AD43 

Descriptive Designation for Raw Meat 

and Poultry Products Containing 

Added Solutions 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

its regulations to require the use of a 

descriptive designation as part of the 

product name on the labels of raw meat 

and poultry products that contain added 

solutions and that do not meet a 

standard of identity. The descriptive 

designation will have to include the 

percentage of added solution, and the 

individual ingredients or multiingredient components in the solution 

listed in descending order of 

predominance by weight. The print for 

all words in the product name, 

including the descriptive designation, 

must appear in a single easy-to-read 

type style and color and on a singlecolor contrasting background. The print 

may appear in upper and lower case 

letters, with the lower case letters not 

smaller than one-third (1⁄3) the size of 

the largest letter. The percent solution 

must appear as a number (e.g., 15, 20, 

30) with the percentage sign (%) and 

may be declared with the word 

‘‘containing’’ or ‘‘contains.’’ Under this 

final rule, the word ‘‘enhanced’’ is not 

allowed in the product name. The 

Agency is also removing the standard of 

identity regulation for ‘‘ready-to-cook 

poultry products to which solutions are 

added’’. 

DATES: Effective Date: January 1, 2016. 

Applicability Date: The regulation 

that prescribes that the product name 

appear with the lower case letters not 

smaller than one-third (1⁄3) the size of 

the largest letter in the product name (9 

CFR 317.2(e)(2)(iv) and 381.117(h)(4)) 

will be applicable on January 1, 2018. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Rosalyn Murphy-Jenkins, Director, 

Labeling and Program Delivery Staff, 

Office of Policy and Program 

Development, FSIS, USDA; Telephone: 

(301)504–0879. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

This rule requires a descriptive 

designation as part of the product name 

for raw meat and poultry products that 

contain added solutions. The Agency 

proposed changes to the labeling of 

these products on July 27, 2011, in 

response to two petitions that requested 

that the Agency prevent consumers from 

being misled by the on-going marketing 

of added solution poultry products. 

FSIS, in response to the petitions and 

after evaluating its experience in 

reviewing labels, determined that some 

added- solution product labels that 

follow current labeling guidance and 

comply with current regulations are 

misleading because they do not clearly 

and conspicuously show that the 

product contains an added solution, and 

that, without updated labeling 

regulations that require the conspicuous 

labeling of the added solution, 

consumers likely cannot distinguish 

between raw single-ingredient products 

versus similar raw products containing 

added solution. 

Under the Federal Meat Inspection 

Act (FMIA) and the Poultry Products 

Inspection Act (PPIA), the labels of meat 

and poultry products must be truthful 

and not misleading, and the labels must 

accurately disclose to consumers what 

they are buying when they purchase any 

meat or poultry product. The FMIA and 

PPIA give FSIS broad authority to 

promulgate rules and regulations 

necessary to carry out the provisions of 

the Acts. 

To increase consumer awareness of 

the added solution and the amount of 

the added solution in raw meat and 

poultry products, FSIS proposed that 

the common or usual name of the 

product include the percentage and the 

ingredients of the added solution. In 

addition, the Agency proposed that the 

print for all of the words in the name, 

including the percentage and 

ingredients in the solution, appear in a 

single font size, color, and style of print 

and appear on a single-color contrasting 

background. 

This final rule requires a descriptive 

designation as part of the product name, 

not as part of the common or usual 

name of the product. FSIS made this 

change to make clear that the 

descriptive designation is required to be 

part of the product name but does not 

need to be on the same line as the rest 

of the name. The descriptive 

designation can be above, below, or next 

to the product name (without 

intervening text or graphics) on the 

principle display panel. FSIS also made 

this change to make this labeling rule 

more consistent with the rule 

concerning the labeling of mechanically 

tenderized beef products. This rule 

adopts all of the proposed rule’s 

provisions for the listing of the 

individual ingredients or multiingredient components in the solution 

in descending order of predominance by 

weight, with the clarification that the 

added solution percentage must be a 

number and a percent symbol (e.g., 

15%), and that upper- and lower-case 

lettering may be used, provided that the 

lower-case lettering is not smaller than 

one-third (1⁄3) the size of the largest 

letter in the product name. The 

requirements concerning type style, 

color, and background for the product 

name (including the descriptive 

designation) are consistent with those in 

the proposed rule. The final rule also 

prohibits the use of the word 

‘‘enhanced’’ in the product name 

(including the descriptive designation) 

of meat and poultry products containing 

added solutions that do not meet a 

standard of identity. 

The final rule will result in one-time 

costs to establishments and retail 

facilities that produce and package raw 

meat and poultry products that contain 

added solutions and that do not meet a 

standard of identity. All of the costs 

pertain to the label modification 

procedures for the affected products, 

and are quantified below. 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79045 

TABLE 1—SUMMARY OF COSTS AND BENEFITS

Lower bound Upper bound 

Costs 

Annualized Cost (3% Discount Rate, 10 Year) ....................................................................................................... $5,897,722 $9,555,104 

Annualized Cost (7% Discount Rate, 10 Year) ....................................................................................................... 6,895,066 11,170,937 

Benefits 

• Improved public awareness of product identities by providing truthful and accurate labeling of meat and poultry products to clearly differentiate 

products containing added solutions from single-ingredient products. 

• Consumers can better determine whether products containing added solutions are suitable for their personal preferences and dietary needs 

through the added solutions descriptive designation. For example, consumers’ choices of meat and poultry products with added solutions with 

a high sodium content could have unintended health consequences if labels of these products were inadequate in revealing the information of 

added ingredients to the consumers. 

• More complete label information may help consumers make more informed decisions leading to an increase in consumer welfare. 

Background 

The Federal Meat Inspection Act 

(FMIA) (21 U.S.C. 601–695) and Poultry 

Products Inspection Act (PPIA) (21 

U.S.C. 451–470) (‘‘the Acts’’) provide 

that the labels of meat and poultry 

products must be approved by the 

Secretary of Agriculture, who has 

delegated this authority to FSIS, before 

these products can enter commerce. The 

Acts also prohibit the distribution incommerce of meat or poultry products 

that are adulterated or misbranded. The 

FMIA and PPIA give FSIS broad 

authority to promulgate such rules and 

regulations as are necessary to carry out 

the provisions of the Acts (21 U.S.C. 621 

and 463(b)). 

To prevent meat and poultry products 

from being misbranded, the meat and 

poultry product inspection regulations 

require that the labels of meat and 

poultry products contain specific 

information, and that such information 

be displayed as prescribed in the 

regulations (9 CFR part 317 and part 

381, subpart N). On July 27, 2011, FSIS 

published a proposed rule to amend the 

meat and poultry regulations to 

establish a common or usual name for 

raw meat and poultry products that 

contain added solutions that do not 

meet a standard of identity (76 FR 

44855). As FSIS explained in the 

proposed rule (76 FR 44856), the 

poultry products regulations include 

labeling requirements for ready-to-cook, 

bone-in poultry carcasses and parts with 

added solutions that increase the weight 

by approximately 3 percent over the raw 

product after chilling and washing (9 

CFR 381.169). However, since 9 CFR 

381.169 was codified on May 16, 1972 

(37 FR 9706), and subsequently 

amended on October 7, 1974 (39 FR 

36000), poultry processors developed 

new technologies that could incorporate 

more solution into products. In an effort 

to keep pace with industry practice and 

prevent false or misleading labeling, 

FSIS issued labeling guidance for raw 

bone-in poultry products that contain 

more than the 3 percent solution 

permitted by 9 CFR 381.169, and for 

boneless poultry products that contain 

added solutions. Policy Memo 042, 

‘‘Raw Bone-in Poultry Products 

Containing Added Solutions,’’ (issued 

February 1982) provided that solutions 

may be added to raw bone-in poultry 

and poultry parts at various levels if the 

product name contained an appropriate 

qualifying statement. Policy Memo 

044A, ‘‘Labeling of Raw Boneless 

Poultry and Poultry Parts to Which 

Solutions are Added,’’ (issued 

September 1986) provided for the 

addition of solution at any level to raw 

boneless poultry and poultry parts if the 

addition and the amount of solution 

were identified. FSIS also issued Policy 

Memo 066C, ‘‘Uncooked Red Meat 

Products Containing Added 

Substances,’’ (November 2004) to 

provide similar guidance for red meat 

products that contain added solutions. 

As discussed in the proposal (76 FR 

44856), the intent of the policy 

memoranda guidance was to assist 

industry in developing truthful, easy-toread labeling information about the 

solutions added to products, so that 

consumers would be aware of the added 

solutions and could make informed 

purchasing decisions. However, it came 

to the Agency’s attention from petitions, 

comments submitted by the public, and 

FSIS review of labels, that some product 

labels are misleading because they do 

not clearly and conspicuously identify 

that the raw meat or poultry products 

contain added solution, and that 

products that contain added solution 

have the same product name as 

products that do not contain added 

solution. For example, the name for 

both a single-ingredient chicken breast 

and a chicken breast with added 

solution is ‘‘chicken breast,’’ even 

though one is 100 percent chicken, and 

the other is not. Although the labeling 

of the product must include a qualifying 

statement that reflects the fact that the 

product contains added solution, this 

fact may not be readily apparent to 

consumers because the statement is not 

part of the product name (76 FR 44857). 

The petitions discussed in the proposed 

rule are found at http://

www.fsis.usda.gov/wps/portal/

searchhelp/sitemap/!ut/p/a0/04_

Sj9CPykssy0xPLMnMz0vMAfGjzOINA

g3MDC2dDbz8LQ3dDDz9wgL9v

Z2dDdx9jfQLsh0VAcILpdM!/

?1dmy¤t=true&urile=wcm%3

Apath%3A%2Ffsis-content%2

Fobsolete-archives%2Fproposedrules%2Ffederal-proposed-rulesarchive-2011. 

Therefore, to ensure that labels 

adequately inform consumers that those 

raw products that do not meet a 

standard of identity in 9 CFR part 319 

or 9 CFR part 381, subpart P, contain 

added solutions, the Agency proposed 

to establish a common or usual name for 

such raw products. FSIS proposed that 

the common or usual name of such 

product consist of the following: an 

accurate description of the raw meat or 

poultry component; the percentage of 

any added solution incorporated into 

the raw meat or poultry product (total 

weight of solution ingredients divided 

by the weight of the raw meat or poultry 

without solution or any other added 

ingredients, multiplied by 100) using 

numerical representation and the 

percent symbol ‘‘%;’’ and the common 

or usual name of all individual 

ingredients or multi-ingredient 

components in the solution listed in 

descending order of predominance by 

weight. 

After the publication of the proposed 

rule, the Agency received a letter 

requesting a 60-day extension of the 

comment period, and the information, 

data, and evidence the Agency 


tkelley on DSK3SPTVN1PROD with RULES4
79046 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

considered in developing the proposed 

rule. On November 8, 2011, in response 

to the request to extend the comment 

period, the Agency reopened the 

comment period for 60 days (76 FR 

69146). The Agency’s letter responding 

to the request for additional 

information, including links to data and 

specific labels of concern is posted on 

its Web site at http://www.fsis.usda.gov/ 

wps/wcm/connect/cf80e9a5-7e39-470f90c9-0911402268b0/2010-0012_

Response_to_AMI_

508.pdf?MOD=AJPERES. 

After review and consideration of all 

the comments submitted, FSIS is 

amending and clarifying the July 2011 

proposed amendments. As is explained 

above, this rule is necessary because we 

have found that under current 

regulations, some product labels are 

misleading because they do not clearly 

and conspicuously identify to 

consumers that the raw meat or poultry 

products contain added solution. 

Therefore under, this final rule, such 

labels would be misbranded. 

In response to comments, rather than 

requiring the added solution 

information as part of the common or 

usual name, the final rule requires a 

product name with a descriptive 

designation that clearly indicates that 

the product contains added solutions. 

The descriptive designation will need to 

appear as part of the product name on 

the principal display panel and may be 

above, below, or next to the product 

name (without intervening text or 

graphics). 

All of the print and color 

requirements in the final rule, i.e., a 

single easy-to-read type style and color 

and single-color contrasting background 

are consistent with those from the 

proposed rule and are applicable to the 

product name and the descriptive 

designation. However, in the final rule, 

FSIS made changes to the regulatory 

text to clarify that the percentage of 

added solution must be represented by 

a number and a percent symbol (e.g., 

15%), not words (e.g., fifteen percent), 

and provide that upper and lower case 

lettering may be used for the in the 

product name, provided that the lower 

case lettering is not smaller than onethird (1⁄3) the size of the largest letter. 

Some added solution product labels 

may comply with current guidance for 

the labeling these products (Policy 

Memorandum 042, ‘‘Raw Bone-In 

Poultry Products Containing Solutions;’’ 

Policy Memorandum 044A, ‘‘Raw 

Boneless Poultry Containing Solutions;’’ 

and Policy Memorandum 066C, 

‘‘Uncooked Red Meat Products 

Containing Added Substances’’). The 

labeling guidance provides that added 

solution statements must be one-fourth 

(1⁄4) the size of the largest or most 

prominent letter in the product name. 

To reduce costs to establishments that 

produce added solutions products, the 

applicability date for the one-third (1⁄3) 

size requirement for the descriptive 

designation is January 1, 2018. 

The Agency is also providing for the 

use of the words ‘‘containing’’ or 

‘‘contains’’ (e.g., ‘‘containing 15% added 

solution of water and salt’’) and 

prohibiting the use of the word 

‘‘enhanced’’ in the product name 

(including the descriptive designation) 

of meat and poultry products containing 

added solutions that do not meet a 

standard of identity. The amendments 

and clarifications are discussed in 

further detail below in the summary of 

and response to comments. 

Summary of and Response to 

Comments 

FSIS received a total of 889 

comments. These were from consumers; 

a coalition representing poultry 

producers and consumers; consumer 

advocacy organizations; health 

organizations; dieticians; State and 

county departments of agriculture, 

weights and measures; trade 

associations that represent meat and 

poultry processors; an association of 

agricultural commissioners and sealers; 

a trade association that represents 

ingredient manufacturers; a trade 

association that represents food retailers 

and wholesalers; and poultry, beef, and 

pork products manufacturers. The 

majority of comments were identical 

form responses submitted electronically 

by individuals that identified their 

organization as the coalition of poultry 

producers and consumers or one of the 

poultry producers that belong to the 

coalition. 

A. General Support for the Proposed 

Common or Usual Name Requirements 

The majority of comments generally 

supported the proposed amendments. 

Many commenters agreed that the 

current labels for meat and poultry 

products containing added solutions are 

misleading. Many commenters stated 

that the current solution statement is too 

small to read, and that other claims or 

statements on the product label make it 

difficult for consumers to differentiate 

between single-ingredient products and 

those with added solutions. One meat 

association acknowledged that 

containing statements can appear in 

fonts that are tall, slanted, and difficult 

to read. Many commenters stated that 

product labels should be truthful, clear, 

easy to read (e.g., clear font, size, color, 

and style), and easily understandable, so 

that consumers can compare products 

and make informed choices. These 

commenters stated that the proposed 

regulations accomplish these goals. 

Additionally, these commenters stated 

that the proposed regulations would 

ensure fair competition among retailers 

and manufacturers. 

B. Opposition to the Proposed Common 

or Usual Name Requirements 

Comment: Several commenters stated 

that the petitions submitted by the 

Truthful Labeling Coalition (TLC) (with 

attached research studies) and the 

California Agriculture Commissioners 

and Sealers Association (CACSA) did 

not support the need for the proposed 

amendments, and that the research was 

limited and not compelling. 

Response: FSIS acknowledged in the 

proposed rule that findings included in 

the TLC petition were not generalizable 

but constituted anecdotal evidence that 

consumers read and use labels (76 FR 

44857). The Sorensen Associates 

Research, included with the TLC 

petition, found that consumers of 

‘‘enhanced’’ chicken products were not 

aware that the ‘‘enhanced’’ product 

contained additives until they were 

specifically directed to look at the label. 

Even after looking at the label, nearly 1 

out of 5 ‘‘enhanced’’ chicken buyers 

didn’t realize that the chicken contained 

additives. The CACSA petition stated 

that in 2006, California Weights and 

Measures officials conducted a study 

that indicated that consumers, because 

they pay for the solution added to 

products, pay an estimated $246 million 

for the added solution in California 

alone. CASCA then estimated, assuming 

that California has an approximate 

market share of 12 percent, that the 

impact to consumers nationwide is 

projected at $2 billion annually. Also, 

information from FSIS’s Labeling and 

Program Delivery Staff’s (LPDS), 

formerly the Labeling and Program 

Delivery Division (LPDD), review of 

labels and compliance activities 

indicated that some product labels do 

not clearly and conspicuously identify 

that the raw meat or poultry products 

contain added solution even though 

they meet current regulatory 

requirements and follow current 

guidance. The findings, projected costs 

from the CACSA petition, and label 

approval and compliance information 

were the best data available to the 

Agency. 

Comment: Several meat and poultry 

companies argued that the proposed 

requirements would obscure the 

identity of the meat or poultry 

component of their products and 

submitted labels to illustrate this point. 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79047 

Two companies conducted consumer 

surveys to compare consumer 

understanding of labels that meet the 

current labeling requirements versus 

those that meet the proposed labeling 

requirements. The two companies stated 

that the surveys demonstrated that 

consumers preferred the current addedsolution product labeling to the 

proposed required labeling. 

One consumer survey compared a 

current meat with added solution label 

with a meat with added solution label 

meeting the proposed requirements. The 

results of the 66 respondent survey 

showed that the 79 percent of 

respondents agreed that the ‘‘current’’ 

label and the ‘‘proposed’’ label were 

‘‘easy to understand.’’ The results also 

showed that eighteen percent of the 

panelists responded that the current 

label ‘‘could be confusing,’’ in 

comparison with twenty-three percent 

of the respondents that stated the 

proposed label was ‘‘confusing’’ (a five 

percent increase). 

The other consumer survey was 

conducted online with a panel of 857 

respondents. The overall results of this 

survey showed that 65 percent of the 

respondents preferred the current 

‘‘large’’ font size label. 

Response: The majority of the label 

examples submitted to illustrate that the 

proposed amendments would obscure 

the identity of the meat or poultry 

component of their products did not 

accurately reflect the proposed 

requirements. The common or usual 

names included superfluous text (e.g., 

‘‘tenderness and juiciness improved’’), 

spelled out percentages (e.g., ‘‘twelve 

percent’’), and contained only 

uppercase letters. 

The one consumer survey did not 

accurately represent the proposed 

requirements, and the ‘‘current’’ label’s 

containing statement was considerably 

larger than the 1⁄4 size provided in 

labeling guidance and, therefore, may 

have been more conspicuous to survey 

participants than product labels 

currently available at retail. 

Another consumer survey, conducted 

online, did not offer respondents labels 

that accurately represented the current 

labeling guidance versus the proposed 

labeling requirements. The company 

presented two versions of four different 

added solution product labels, fresh 

chicken breast, frozen chicken wing 

sections, pork loin, and beef. 

Respondents were asked to compare the 

labels that meet the current labeling 

guidance with the labels that meet the 

proposed requirements. Three of the 

four current labels appeared to have 

containing statements larger than the 

minimum of 1⁄4 size permitted under the 

current regulation (9 CFR 381.169) and 

labeling guidance. The containing 

statement on three of the four labels that 

represented the proposed requirements 

is in upper case letters, which is not a 

proposed requirement. FSIS proposed to 

require the added solutions statement in 

the common or usual name. However, in 

response to these comments, the Agency 

is amending this final rule to provide 

that a descriptive designation that 

clearly indicates that the product 

contains added solution will be required 

on the label as part of the product name, 

but not as a part of the common or usual 

name. In addition, the product name 

(including the descriptive designation) 

may appear in upper and lower case 

letters, with the lower case letters not 

smaller than one-third (1⁄3) the size of 

the largest letter (9 CFR 317.2(e)(2)(iii) 

and 381.117(h)(3)). Current labeling 

guidance for added solutions statements 

provide for a one-fourth (1⁄4) size 

requirement in comparison to the largest 

letter in the product name. However, the 

one-third (1⁄3) size requirement is based 

on several regulatory requirements (9 

CFR 319.104 and 319.105) and is 

consistent with the requirements in the 

Descriptive Designation for Needle- or 

Blade-Tenderized (Mechanically 

Tenderized) Beef Products final rule. 

FSIS is also amending this final rule 

to require that the percent solution must 

appear as a number (such as, 15, 20, 30) 

and the percent symbol (%) (9 CFR 

317.2(e)(2)(i) and 381.117(h)(1)). These 

amendments will ensure that the 

descriptive designation is easy to 

recognize and understand, and that the 

meat or poultry component of the 

product is not obscured. Also, the 

product name (including the descriptive 

designation) must be printed in a single 

easy-to-read type style and color and 

must appear on a single-color 

contrasting background, which will 

ensure the overall prominence of the 

descriptive designation on the label (9 

CFR 317.2(e)(2)(v) and 381.117(h)(5)). 

Examples of labels that met the 

proposed labeling requirements were 

included in the proposed rule (76 FR 

44860 and 44861). Label examples are 

included again in this final rule as 

guidance (Figures 1, 2, and 3). The label 

in Figure 1 is an example of a product 

with a descriptive designation that 

includes a multi-ingredient component. 

The ingredients of the component are 

not declared in the descriptive 

designation but are declared in a 

separate ingredients statement along 

with all of the ingredients in the 

product (9 CFR 317.2(e)(2)(iii) and 

381.117(h)(3)). The label in Figure 2 is 

an example of a product with a 

descriptive designation that includes 

the term ‘‘contains’’ and lists the 

individual ingredients in the added 

solution in descending order of 

predominance by weight (9 CFR 

317.2(e)(2)(i), 317.2(e)(2)(ii), 

381.117(h)(1), and 381.117(h)(2)). The 

label in Figure 3 is an example of a 

descriptive designation that includes 

the term ‘‘flavored with’’ and lists the 

individual ingredients in the solution in 

descending order of predominance by 

weight (9 CFR 317.2(e)(2)(ii) and 

381.117(h)(2)). 

Comment: One commenter agreed that 

it is important to inform consumers 

when differences exist between singleingredient raw meat and poultry 

products and similar raw meat and 

poultry products containing added 

solutions, but it did not agree with 

establishing a common or usual name to 

describe these differences. The 

commenter stated that there should be 

a general common or usual naming 

convention for all meat and poultry 

products. In addition, the commenter 

stated the proposed requirements would 

change the product names and 

ingredient declarations of secondary 

products in which these added solution 

products are used, resulting in 

complicated naming conventions for 

ordinary foods and expanding 

ingredient declarations. 

Response: The intent of this rule is to 

ensure that consumers have specific, 

clear, and conspicuous information 

about the percentage of added solution. 

As discussed above, although FSIS 

proposed to require that the percentage 

and ingredients of the added solution as 

part of the common or usual name, in 

response to comments, in this final rule, 

FSIS is requiring a descriptive 

designation as part of the product name, 

consistent with prior labeling guidance 

FSIS has provided in Policy 

Memoranda. The declaration of the 

secondary product’s name and the 

product’s ingredients will continue to 

follow the applicable labeling 

regulations. 

C. Comments Opposed to Removing 

Ready-To-Cook Poultry Products 

Regulatory Requirements (9 CFR 

381.169) and Rescinding Policy 

Memoranda for Products With Added 

Solutions 

Comment: Several commenters 

opposed removing the regulatory 

requirements and policy guidance for 

products with added solutions (9 CFR 

381.169; Policy Memorandum 042, 

‘‘Raw Bone-In Poultry Products 

Containing Solutions;’’ Policy 

Memorandum 044A, ‘‘Raw Boneless 

Poultry Containing Solutions;’’ and 

Policy Memorandum 066C, ‘‘Uncooked 


tkelley on DSK3SPTVN1PROD with RULES4
79048 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

Red Meat Products Containing Added 

Substances’’). These commenters were 

specifically concerned about removing 

the requirement in 9 CFR 381.169(a) 

that states that the added materials shall 

increase the weight of the poultry 

product by approximately 3 percent 

over the weight of the raw product, and 

the policy guidance limiting the amount 

of solution used in products labeled 

with the terms ‘‘basted,’’ ‘‘marinated,’’ 

or ‘‘for flavoring,’’ because removing 

these provisions would result in the 

unbridled addition of solutions. The 

commenters also objected to removing 

the regulatory requirement in 9 CFR 

381.169(c) for processors to control the 

finished product within a range of threetenths of 1 percent accuracy, using an 

approved plant control procedure. 

Response: As discussed above, FSIS 

explained in the proposed rule (76 FR 

44856) that after the regulation for 

ready-to-cook, bone-in poultry (9 CFR 

381.169) was codified and amended in 

the 1970’s, poultry processors 

developed technologies, such as 

injecting solutions deep into muscle 

tissue, that increased the amount of 

solution that could be incorporated into 

products. Therefore, to provide labeling 

guidance for ready-to-cook, bone-in 

poultry products that contained more 

than the approximate 3 percent added 

solution and ready-to-cook, boneless 

poultry products with added solution, 

the Agency issued Policy Memoranda 

for the industry to develop truthful, 

easy-to-read labeling information so that 

consumers could make informed 

purchasing decisions. The Agency also 

later issued labeling guidance for raw 

red meat products with added solutions. 

The regulatory requirements provided 

in 9 CFR 381.169(c) for processors to 

control the finished product within a 

specified range are only applicable to 

ready-to-cook, bone-in poultry products 

with approximately 3 percent added 

solution. Raw meat and ready-to-cook, 

boneless poultry products that contain 

added solutions, and ready-to-cook, 

bone-in poultry products that contain 

more than approximately 3 percent 

added solution follow the labeling 

guidance provided in the Policy 

Memoranda. 

FSIS does not believe, and the 

comments did not provide any 

evidence, that the terms ‘‘marinated,’’ 

‘‘basted,’’ and ‘‘for flavoring,’’ provided 

in Policy Memoranda imply to today’s 

consumers a specific level of added 

solution in the product. This final rule 

establishes consistent regulatory 

requirements for a descriptive 

designation as part of the product name 

for all raw meat and poultry products 

containing added solutions that do not 

have a standard of identity (9 CFR 

317.2(e)(2) and 381.117(h)), regardless 

of the amount of solution or other 

information provided on the label. For 

this reason, the requirements in 9 CFR 

381.169 are no longer needed, and will 

be deleted with this final rule. In 

addition, when this rule becomes 

effective, FSIS will eliminate the Policy 

Memoranda that provides labeling 

guidance for meat and poultry products 

with added solutions. The terms 

‘‘marinated,’’ ‘‘basted,’’ ‘‘for flavor,’’ and 

‘‘flavored with,’’ may be used with any 

level of solution, provided that the 

product labeling contains a descriptive 

designation. The final rule includes an 

example of added solution product label 

(Figure 3) that uses the term ‘‘flavored 

with’’ in the descriptive designation. 

Comment: The commenters that 

opposed removing 9 CFR 381.169 and 

the FSIS Policy Memoranda for 

products with added solution wanted 

the Agency to retain the requirement of 

the method of solution introduction and 

the function of the added materials. In 

addition, approximately 133 comments 

that had been submitted as part of a 

write-in campaign stated that FSIS 

should require that the method by 

which solutions are added to the 

product be included in the product 

name. 

Response: As discussed above, FSIS is 

deleting 9 CFR 381.169 because it 

contains regulatory requirements that 

are outdated and inconsistent with 

industry practice. Also, FSIS has never 

required the method of addition or 

function of the added solution in the 

labeling of meat products or boneless 

poultry products. Companies use 

various methods to add solutions to 

meat and poultry products, and the 

solutions can have various functions. 

The Agency does not have any data 

suggesting that including the method of 

addition and function of the added 

solution in the product name provides 

useful information to consumers. 

Therefore, FSIS has concluded that the 

product name does not have to refer to 

the method of addition or the function 

of the added solution. 

Comment: Some commenters were 

concerned that when Policy 

Memorandum 066C, ‘‘Uncooked Red 

Meat Products Containing Added 

Substances,’’ is rescinded, it will 

eliminate the limit on the addition of 

enzyme solutions (3 percent) to meat 

products. 

Response: The 3 percent limit for 

tenderizing solutions is a regulatory 

requirement (9 CFR 424.21 and 

381.87(b)(25)) that is not affected by this 

final rule. 

Comment: Several commenters stated 

that many products with added 

solutions currently in the marketplace 

do not meet regulatory requirements or 

comply with labeling guidance. The 

commenters stated that the LPDS should 

be reviewing and ensuring the accuracy 

of labels during label review. 

Response: The LPDS reviews labels 

that are submitted to ensure compliance 

with the labeling regulations in 9 CFR 

parts 317 and 381. However, as 

provided by 9 CFR 412.2, FSIS 

authorizes establishments to use 

generically approved labels without 

submitting them for approval. 

Generically approved labels must bear 

all applicable mandatory labeling 

features in a prominent manner in 

compliance with part 317 or part 381, 

and is not otherwise false or misleading. 

Inspection program personnel 

periodically review products with these 

labels to ensure compliance with 

labeling requirements. When the LPDS 

receives a labeling complaint and 

determines that a label is false or 

misleading, FSIS contacts the company 

and advises it to make corrections. If the 

company does not make corrections, 

FSIS may rescind or refuse label 

approval under 9 CFR 500.8, 

‘‘Procedures for Rescinding or Refusing 

Approval of Marks, Labels, and 

Containers.’’ 

D. Use of the Term ‘‘Enhanced’’ 

Comment: Several commenters stated 

that FSIS should not allow the use of 

the term ‘‘enhanced’’ in the product 

name of raw meat or poultry products 

that contain added solutions. These 

commenters stated that the term 

‘‘enhanced’’ suggests the meat is a 

higher quality or that the meat has been 

improved by added solutions when it 

actually may contain increased levels of 

sodium, which is a concern for 

consumers trying to limit their sodium 

intake. These commenters also asserted 

that the word ‘‘contains’’ does not imply 

a judgment about the product. One 

commenter recommended that FSIS 

prohibit the use of the word ‘‘enhanced’’ 

(or similar terms) anywhere on products 

containing added solutions. 

One commenter argued that the term 

‘‘enhanced’’ should be permitted 

because the added solution results in a 

product that is juicier and has an 

improved value, quality, desirability, 

and attractiveness over non-enhanced 

products. 

Response: FSIS agrees that the term 

‘‘enhanced’’ suggests that the product 

has been increased or improved in 

value, quality, desirability, or 

attractiveness, based on the MerriamVerDate Sep<11>2014 20:40 Dec 30, 2014 Jkt 235001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\31DER4.SGM 31DER4

tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79049 

1http://www.merriam-webster.com/dictionary/

enhance. 

2Available at http://www.foodinsight.org/

Content/3651/2010FinalFullReport.pdf. 

Webster dictionary definition.1 A 

product with added solution may or 

may not be ‘‘juicier’’ when consumed, 

depending on the way it is cooked or 

used. Whether or not a product with 

added solution is of improved value, 

quality, desirability, or attractiveness is 

dependent on individual preference. 

FSIS stated in the proposed rule that it 

recognized that the term ‘‘enhanced’’ 

could imply a judgment about the value 

of the product; for this reason, the 

Agency did not propose to include the 

term ‘‘enhanced’’ in the common or 

usual name for products containing 

added solutions (76 FR 44858). The 

Agency has concluded the term 

‘‘enhanced’’ is not appropriate in the 

product name (including the descriptive 

designation) for raw meat and poultry 

products containing added solution and 

is stating in the regulatory text that the 

term ‘‘enhanced’’ must not be used in 

the product name of meat and poultry 

products containing added solutions 

that do not meet a standard of identity. 

The term ‘‘enhanced,’’ however, can be 

used elsewhere on the label, e.g., in a 

starburst, or in advertising language. 

The Agency agrees that the word 

‘‘contains’’ does not imply a judgment 

about the product, and, to provide 

additional clarification and flexibility to 

producers, FSIS is clarifying in this final 

rule that the words ‘‘containing’’ or 

‘‘contains’’ may be used in the 

descriptive designation of raw meat and 

poultry products containing added 

solutions, e.g., ‘‘containing 15% Added 

Solution of Water and Salt,’’ or 

‘‘contains 15% Added Solution of Water 

or Teriyaki Sauce.’’ Other terms that 

may be used in the descriptive 

designation include ‘‘basted’’ or 

‘‘marinated,’’ as listed in the foregoing 

sections. 

E. Comments on Sodium and Salt 

Comment: Many commenters 

expressed the opinion that the current 

labeling of products with added 

solutions does not sufficiently alert 

consumers to the fact that the products 

contain added solutions, or the fact that 

salt is almost always included in the 

added solutions. One commenter 

recommended that the labels of 

products with added salt and sodium 

solutions contain a disclosure statement 

such as ‘‘Contains SALT: See sodium 

content on the Nutrition Facts Panel.’’ 

Another commenter recommended that 

a similar statement be displayed on raw, 

partially-heat treated, and fully cooked 

meat and poultry products with added 

solutions. 

However, other commenters indicated 

that the appropriate place for nutrition 

information, and where consumers will 

look for that information, is the 

Nutrition Facts panel. Additionally, 

some commenters stated that the 

proposed amendments would provide 

improved consumer awareness of the 

added ingredients, and that consumers 

would look at the ingredients statement 

for ingredients of concern, such as salt. 

Response: FSIS agrees that the 

Nutrition Facts panel is the appropriate 

place for the sodium content to be 

displayed and is where consumers will 

look for that information. This 

conclusion is supported by the 2010 

Food and Health Survey conducted by 

the International Food Information 

Council (IFIC) Foundation,2 which 

found that 68 percent of consumers use 

the Nutrition Facts panel to obtain 

nutrition information. Additionally, the 

survey reported that, when asked which 

specific elements consumers use on the 

Nutrition Facts panel, 63 percent of 

consumers mentioned the statement of 

sodium content. FSIS also agrees that 

the proposed amendments will alert 

consumers to products containing 

added solutions, and that, being so 

alerted, consumers are likely to look at 

the Nutrition Facts panel and the 

ingredients statement where all 

ingredients must be listed. 

F. Comments on Fully-Cooked or 

Partially Heat-Treated Products 

Containing Added Solutions 

Comment: A few commenters stated 

that FSIS should establish common or 

usual name requirements for nonstandardized fully-cooked or partiallyheat treated products that contain added 

solutions. One of the commenters 

argued that consumers need this 

information to make informed choices, 

because consumers will not be aware 

that a solution was added that could 

make up a significant portion of the 

product weight or contain significant 

amounts of other ingredients. 

Other commenters stated that FSIS 

should not establish a common or usual 

name for non-standardized fully cooked 

or partially-heat treated products that 

contain added solutions. The 

commenters stated that consumers 

understand that fully cooked or partially 

heat-treated products are not singleingredient products, and that the 

required qualifiers, e.g., ‘‘Breaded,’’ 

‘‘Coated,’’ and ‘‘Glazed,’’ alert 

consumers to any added ingredients in 

the products or that the products have 

been further processed in some way. 

One commenter expressed concern that 

it would not be appropriate to require 

that the common or usual name for 

these types of products include a listing 

of ingredients. One commenter 

suggested that FSIS, in the regulatory 

text, specifically exclude these 

products. 

Response: FSIS agrees with the 

commenters that non-standardized 

fully-cooked or partially heat-treated 

products, which are typically breaded, 

coated, and glazed, are obviously not 

single-ingredient products, and that 

consumers understand that these 

products may contain ingredients that 

affect the products’ weight. These 

commenters support the Agency’s 

tentative conclusion, stated in the 

proposed rule (FR 76 44858), that 

consumers are unlikely to be misled 

into thinking that non-standardized 

fully cooked or partially-heated treated 

products that contain added solutions 

are single-ingredient products. 

The regulatory text clearly states that 

the requirements are for raw meat and 

poultry products that contain added 

solutions and that do not meet a 

regulatory standard (9 CFR 317.2(e)(2) 

and 381.117(h)). Therefore, the Agency 

sees no need to add regulatory text to 

exclude fully-cooked or partially-heat 

treated products that contain added 

solutions. 

G. Comments on Retail Labeling of 

Products With Added Solutions 

Comment: A trade association that 

represents food retailers and 

wholesalers commented that the 

proposed rule would impose a burden 

on the supermarket industry. The 

association stated that retailers would 

be affected directly because it is not 

feasible to calculate marinade 

absorption rates at the retail level 

because they do not operate in the same 

manner as a Federal establishment and 

do not have precise marination times, 

temperatures, or solution composition; 

that retail signage would have to be 

altered; and that retailers would have to 

redesign labels at a very significant cost. 

The trade association also stated that the 

$1,557 per label cost estimate was too 

low. 

Response: As discussed in the 

proposed rule (76 FR 44859), the 

misbranding provisions of the Acts 

apply to all meat and poultry products, 

including products that are not subject 

to the inspection provisions of the Acts 

(21 U.S.C. 623(d) and 464(e)). Therefore, 

these regulations apply to raw meat and 

poultry products containing added 

solutions that do not meet a regulatory 

standard of identity and that are sold for 

retail sale, institutional use, or further 


tkelley on DSK3SPTVN1PROD with RULES4
79050 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

3Model to Estimate Costs of Using Labeling as a 

Risk Reduction Strategy for Consumer Products 

Regulated by the Food and Drug Administration, 

FDA, March 2011 (Contract No. GS–10F–0097L, 

Task Order 5). 

processing. Retail stores must comply 

with amendments in this final rule, 

including determining marinade 

absorption rates, redesigning labels, and 

altering retail signage. 

FSIS requested comment on the 

number of retail facilities that produce 

product containing added solution and 

the volume of such product that would 

be subject to the proposed requirements 

(76 FR 44862). The Agency did not 

receive any comments addressing the 

number of facilities or the volume of 

product produced at retail. As discussed 

in the ‘‘Cost and Benefits’’ section 

below, to acquire a better cost estimate, 

the Agency utilized the March 2011 

FDA labeling cost model and contracted 

for an expert elicitation on the market 

shares for raw meat and poultry 

products containing added solutions, 

including products produced at retail, 

and has adjusted the per-label cost 

estimate to $310 per label for a 

coordinated minor change and $4,380 

for an uncoordinated minor change. The 

expert elicitation concluded that very 

few products containing added 

solutions are produced at retail 

establishments (<5%). FSIS believes the 

revised label change cost, provided from 

the March 2011 labeling cost estimate, 

is a superior estimate as it represents the 

most detailed study available on the 

costs associated with labeling of 

consumer products. FSIS included the 

expected costs borne by the retailers in 

the final estimate. 

H. Use of the Term ‘‘Natural’’ 

Comment: Numerous consumers 

commented that products with added 

solutions should not be labeled as 

‘‘natural.’’ Several commenters wanted 

FSIS to take immediate action or 

quickly move forward on a proposed 

rule. 

Response: Products with added 

solutions may meet the current FSIS 

labeling policy guidance for the term 

‘‘natural’’ if (1) the product does not 

contain any artificial flavor or flavoring, 

coloring ingredient, or chemical 

preservative (as defined in 21 CFR 

101.22), or any other artificial or 

synthetic ingredient; and (2) the product 

and its ingredients are not more than 

minimally processed (the practice of 

marinating or tenderizing products prior 

to consumption is a minimal process). 

The Agency is developing a proposed 

rule to define the ‘‘natural’’ claim in 

response to comments received on the 

2009 advance notice of proposed 

rulemaking, ‘‘Product Labeling: Use of 

the Voluntary Claim ‘‘Natural’’ in the 

Labeling of Meat and Poultry Products’’ 

(74 FR 46951). 

I. Compliance Date and Label Review 

Time 

Comment: One commenter stated that 

the proposed January 1, 2014, 

compliance date was excessive and 

unnecessary. The commenter believed 

that immediate action should be taken, 

and that the effective date of the final 

rule could be 30–60 days after 

publication of the final rule because 

labeling changes can be easily 

implemented by industry at a minimal 

cost. 

Another commenter stated that 

processors need ample time to get 

through their label inventories and 

requested that the status of products incommerce on the effective date of the 

final rule be clarified by the Agency. 

Response: The January 1, 2014, 

uniform compliance date was applicable 

for meat and poultry product labeling 

final rules published between January 1, 

2011 and December 31, 2012. On 

December 31, 2012, FSIS published a 

final rule establishing January 1, 2016, 

as the uniform compliance date for meat 

and poultry product labeling regulations 

issued between January 1, 2013, and 

December 31, 2014 (77 FR 76824). 

Therefore, the effective date of this final 

rule is January 1, 2016. However, as 

discussed above, the Agency is 

providing an applicability date of 

January 1, 2018 for the one-third (1⁄3) 

type size requirement for the descriptive 

designation to provide additional time 

and flexibility for establishments to 

make labeling changes. Based on current 

guidance for the labeling of these 

products, many establishments likely 

use one-fourth (1⁄4) type size for the 

descriptive designations or qualifying 

statements for products with added 

solutions. Establishments may continue 

to do so until January 1, 2018. 

Comment: Several commenters 

expressed concern that the proposed 

amendments would overly burden the 

Agency’s label approval process, 

especially since the proposed labeling 

changes could not be generically 

approved within the parameters of 9 

CFR 317.5 and 381.133. 

Response: On November 7, 2013, FSIS 

published the final rule, ‘‘Prior Label 

Approval System: Generic Label 

Approval’’ (78 FR 66826) that expands 

the circumstances in which FSIS 

generically approves meat and poultry 

labels. The labels of meat and poultry 

products containing added solutions 

can be generically approved, i.e., the 

labels do not have to be submitted to 

FSIS for approval, provided that they 

display all mandatory features in a 

prominent manner in compliance with 

part 317 or part 381, and are not 

otherwise false or misleading in any 

particular (9 CFR 412.2). In addition, in 

May 2012, the Agency launched the 

Label Submission and Approval System 

(LSAS). The LSAS will have a 

significant impact on the speed and 

accuracy of label review. 

J. Comments on Costs and Benefits of 

the Proposal 

Comment: A number of commenters 

suggested that FSIS underestimated the 

costs to the industry of the proposed 

amendments and did not accurately 

identify the proportion of products with 

added solution in the marketplace. 

Response: FSIS used the more up-todate model 3 from the secondary cost 

analysis in the proposed rule to estimate 

the cost of label changes for the 

industry. Although a few commenters 

provided additional cost estimates for 

label plates, FSIS did not receive any 

additional numbers that contradict the 

cost estimates presented in the proposed 

rule. FSIS continues to believe that 

these cost estimates are accurate 

because they represent the most detailed 

study available on the costs associated 

with the labeling of consumer products. 

In the proposed rule, FSIS estimated 

that the proportion of products 

containing added solutions to be about 

39 percent of all raw meat and poultry 

products sold (76 FR 44862). This 

percentage was based on FSIS’s label 

review process estimates and the 

pounds of poultry, beef, and pork 

consumed by households. The sources 

cited for the pounds of poultry, beef, 

and pork consumed by household were 

the U.S. Poultry & Egg Association: 

Poultry Statistics, 2007; the Economic 

Research Service, USDA, U.S. Beef and 

Cattle Industry: Background Statistics 

and Information, 2007; and the National 

Pork Producers Council: Background 

Statistics and Information, 2007. 

However, the source of the information 

for the pounds of poultry, beef, and pork 

consumed by households should have 

been ‘‘Livestock, Dairy, and Poultry 

Outlook,’’ Dec. 17, 2009. The proposed 

rule also stated that the number of 

pounds of poultry consumed by 

households was 49.2 billion (76 FR 

44862), that number, based on the 

corrected source information, should 

have been 42.7 billion pounds. 

For a better estimate of the amount of 

product with added solution purchased, 

FSIS contracted for an expert elicitation 

on the market shares for raw meat and 

poultry products containing added 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79051 

solutions. The results of that elicitation 

showed that the amount of product with 

added solution purchased is 

approximately 60 percent of the total. 

The cost analysis in this final rule uses 

this market share analysis. 

Comment: A number of commenters 

suggested that the costs associated for 

the rule would be borne by the 

consumer in a time of economic 

uncertainty. Conversely, a number of 

commenters also suggested that 

consumers unfairly pay a premium 

price for products with added solutions. 

Some commenters suggested that this 

rule will place products with added 

solutions at a competitive disadvantage 

to products without the solution. 

Response: The overall impact of the 

final rule on costs to the consumer is 

expected to be minimal. The estimated 

additional cost per package is between 

$0.0013 and $0.003. Thus, the increase 

in cost of buying two packages per week 

is between $.13 and $0.36 per year, and 

the consumer will only pay a portion of 

the this cost based on the relative 

elasticity of demand. Given the high 

elasticity of demand for this product 

because of the availability of close 

substitutes, the minimal cost imposed 

may be borne more by the producers 

than the consumers. 

FSIS has no data to determine that 

this rule places products with added 

solutions at a competitive disadvantage 

to products without the solution and 

has no evidence to suggest that the 

market for these products will be 

adversely impacted. 

Comment: One commenter suggested 

that the current labeling practices will 

result in higher health care costs. 

Response: This rule does not provide 

new nutrition information. FSIS did not 

quantify the health care costs and 

benefits of this rule. 

K. Miscellaneous Comments 

Comment: One commenter 

recommended that all of the proposed 

requirements apply to meat and poultry 

products that meet standards of identity. 

Response: As explained in the 

preamble to the proposed rule, under 

this rule, meat and poultry products that 

comply with a standard of identity in 

the regulations will continue to be 

labeled as the named food specified in 

the standard. For example, ‘‘corned 

beef,’’ which includes curing solution, 

is allowed up to a 10 percent gain from 

the fresh weight of the uncured beef in 

accordance with the 9 CFR 319.100 

standard of identity for corned beef. 

Products that comply with this standard 

would be named and labeled as ‘‘corned 

beef.’’ However, if a product similar to 

‘‘corned beef’’ includes a solution 

amount that is greater than the standard 

allows, the product is no longer a 

standardized product, and, under this 

proposed rule, it would need to be 

labeled with a descriptive designation. 

Standard of identity regulations 

provide requirements for added 

solutions for standardized products. 

Therefore, consumers likely understand 

and are aware that products with a 

standard of identity, such as corned beef 

or poultry roast, include solutions. The 

intent of this final rule is to eliminate 

confusion between single-ingredient 

products and those similar types of 

products that contain additional 

ingredients and solutions. Therefore, the 

Agency will not include products with 

a standard of identity in this 

rulemaking. 

Comment: FSIS received numerous 

comments on an array of issues 

including: Country of origin labeling for 

all meat, poultry, fruits, and vegetables; 

the labeling of genetically modified 

foods; organic claims; concerns over 

raising conditions of animals and the 

use of hormone implants; pesticides and 

herbicides; mandatory nutrition labeling 

for liquor products; mandatory 

declaration of potassium and 

phosphorus in the Nutrition Facts 

panel; healthy eating; and nutrition 

education. 

Response: These comments are 

outside the scope of this rulemaking. 

Compliance With This Final Rule 

To facilitate Agency verification of 

compliance with regulatory labeling 

requirements, FSIS requires that 

establishments make labeling records 

available to any authorized USDA 

official upon request (9 CFR 320.4). 

Inspection program personnel will 

perform labeling verification activities 

to ensure that establishments are 

complying with the requirements of this 

final rule. FSIS also performs 

verification and post-market 

surveillance activities in-commerce to 

ensure that meat and poultry product 

labels comply with all applicable 

regulations. The Agency will provide 

guidance on its Web site to assist 

establishments in meeting the 

requirements in this final rule. Figures 

1 and 2 (below) are examples of labels 

of pork product containing added 

solutions and Figure 3 (below) is an 

example of poultry product containing 

added solution, all three examples meet 

the labeling requirements of this final 

rule. 

BILLING CODE 3410–DM–P 


tkelley on DSK3SPTVN1PROD with RULES4
79052 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 


tkelley on DSK3SPTVN1PROD with RULES4ER31DE14.000</GPH>

Figure 1. Label example - The product name includes a descriptive designation at one-third 

(113t the size ofthe largest letter (9 CFR 317.2(e)(2)(iv)), a multi-ingredient component 

(Teriyaki Sauce), all ingredients in the product are declared in a separate ingredients statement (9 

CFR 317.2( e )(2)(iii)). 

Pork Tenderloin - 15% Added solution of 

Nutrition Facts 

Panel 

Water and Teriyaki Sauce 

Safe Handling 

Instructions 

4 Label shown using the one-third (1/3) font size requirement applicable January 1, 2018. 
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79053 


tkelley on DSK3SPTVN1PROD with RULES4ER31DE14.001</GPH>

Figure 2. Label example - The product name includes a descriptive designation at one-third 

(113i the size ofthe largest letter (9 CFR 317.2(e)(2)(iv)), includes the word "contains" (9 CFR 

317 .2( e )(2)(i) ), the individual ingredients in the solution listed in descending order of 

predominance by weight (9 CFR 317 .2( e )(2)(ii), followed by a vignette of the product. 

Nutrition Facts 

Panel Safe Handling 

Instructions 

INSPECTED 

AND PASSED BY 

DEPARTMENT OF 

AGRICULTURE 

5 Label shown using the one-third {1/3) font size requirement applicable effective January 1, 2018. 
79054 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 


tkelley on DSK3SPTVN1PROD with RULES4ER31DE14.002</GPH>

Figure 3. Label example- The product name includes a descriptive designation at one-third 

(113/ the size ofthe largest letter (9 CFR 381.117(h)(4)), includes the term "flavored with," the 

individual ingredients in the solution listed in descending order of predominance by weight (9 

CFR 381.117 (h)(2)). 

Chicken Breast Flavored with 15% Added 

Solution of Water, Salt, Spices, and Sodium Phosphate 

Nutrition Facts 

Panel 

Safe Handling 

Instructions 

6 Label shown using the one-third (1/3) font size requirement applicable effective January 1, 2018. 
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79055 

7FDA March 2011 labeling cost model: A copy of 

the document is available in the FSIS Docket Room, 

Patriots Plaza 3, 355 E. Street SW., Room 8–164, 

Washington, DC 20250–3700. 

8Label Contaminant Statement Package Test: 

Study Results, Prepared for: Tyson Foods, Inc. by 

Lunt Associates. Question 10. May 2011. 

9 ‘‘Enhanced’’ Chicken, Consumer Research, 

November 2004, SAI Project 04177, Sorensen 

Associates, Minneapolis, Minnesota (888–616– 

0123), Portland, Oregon (800–542–4321). 

10The research in the Sorensen Study was 

conducted in six primary sampling units; Atlanta, 

Chicago, San Francisco, Kansas City, Dallas and 

Seattle. 

11Label Contaminant Statement Package Test: 

Study Results, Prepared for: Tyson Foods, Inc. by 

Lunt Associates. May 2011. 

12Expert Elicitation on the Market Shares for Raw 

Meat and Poultry Products Containing Added 

Solutions and Mechanically Tenderized Raw Meat 

and Poultry Products. Final Report. Research 

Triangle Institute. February 2012. Available at: 

http://www.fsis.usda.gov/wps/wcm/connect/

3a97f0b5-b523-4225-8387-c56a1eeee189/Market_

Shares_MTB_0212.pdf?MOD=AJPERES. 

13FSIS data estimated the 2010 total volume by 

multiplying slaughter volumes by average carcass 

weights. 

BILLING CODE 3410–DM–C 

Executive Orders 12866 and 13563 and 

the Regulatory Flexibility Act 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order (E.O.) 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This final 

rule has been reviewed under E.O. 

12866. The Office of Management and 

Budget (OMB) has determined that it is 

a significant regulatory action under 

section 3(f) of E.O. 12866 and, therefore, 

it has been reviewed by OMB. 

The final rule will apply to all incommerce raw meat and poultry 

products containing added solution that 

do not meet a standard of identity. The 

labeling requirements would apply to 

such products that are produced at 

federal establishments, retail facilities, 

such as grocery stores, and products 

produced in countries deemed 

equivalent under 9 CFR 327.2 and 

381.196. 

FSIS updated the Regulatory Impact 

Analysis to take into account recently 

updated source data and modified 

timelines for implementation of the 

final rule. The changes to the costs and 

benefits sections incorporate the 

following factors: 

• Information Resources, Inc., (IRI) 

scanner data was used to calculate the 

number of raw meat and poultry 

products in the retail market and the 

number of private and branded 

products. IRI gathers data by scanners in 

supermarkets, drugstores, and mass 

merchandisers and maintains a panel of 

consumer households that record 

purchases at outlets by scanning UPC 

codes on the products purchased. 

• FSIS used the FDA March 2011 

labeling cost model 7 from the secondary 

cost analysis in the proposed rule to 

estimate the cost of label changes for the 

industry. FSIS believes the FDA March 

2011 labeling cost model represents the 

most detailed study available on the 

costs associated with labeling of 

consumer products and reflects more 

recent data than the primary analysis 

used in the proposed rule, and therefore 

is used in the final rule. 

• In response to the change in 

compliance period when calculating the 

relabeling cost, FSIS adjusted the 

percentage of coordinated and 

uncoordinated label changes. 

Need for the Rule 

Under FSIS’s current regulatory 

approach, some raw products are not 

conspicuously identifying that they 

contain added solution. A survey 8

submitted during the comment period 

found that only 40 percent of all 

consumers are aware that the products 

they purchase may contain added 

solutions, and therefore, FSIS assumes 

that current regulations are insufficient 

to fully inform consumers about the 

nature of the product they purchase. It 

is important for consumers to have 

readily available information on meat 

and poultry products with added 

solutions as 87 percent of chicken 

purchasers care if their chicken contains 

additives (Sorensen, November 2004).9

Fifty-four percent of the respondents in 

this study indicated they felt deceived 

at the disclosure that some chicken 

products include additives and 10 

percent indicated they felt angry. This 

research has some limitations such as 

no reported peer review and some 

methodological weakness. The research 

did not provide information on response 

rate or sample selection which could 

contribute to survey bias. On the other 

hand, this study is strengthened by the 

diversity of the six primary sampling 

units 10 and a significant sample size; 

moreover, its results are similar to those 

of other consumer studies.11

FSIS, in response to stakeholder 

petitions and after evaluating its 

experience in reviewing labels, 

determined that some added-solution 

product labels that follow current 

labeling guidance and comply with 

current regulations are misleading 

because they do not clearly and 

conspicuously show that the product 

contains an added solution, and that, 

without updated labeling regulations 

that require the conspicuous qualifying 

statement, consumers likely cannot 

distinguish between raw singleingredient products versus similar raw 

products containing added solution. A 

market failure exists when raw products 

with added solutions are misbranded 

and information is not readily available 

for the consumer. This market failure 

results from inadequate information in 

misbranded products and information 

asymmetry between producers and 

retail consumers and leads to 

suboptimal equilibrium quantities for 

both products containing solutions and 

products not containing solutions 

because consumers cannot readily 

identify the differences between the two 

groups. For example, the name for a 

single-ingredient chicken breast and a 

chicken breast with added solution is 

‘‘chicken breast,’’ even though one is 

100 percent chicken breast and one may 

be 60 percent chicken breast and 40 

percent solution. The new regulation 

presented in the final rule addresses the 

market failure by requiring that all 

labels for these types of products 

provide clear and conspicuous labeling. 

Baseline 

FSIS contracted for an expert 

elicitation on the market shares for raw 

meat and poultry products containing 

added solutions (February 2012 

report).12 The February 2012 report, 

using FSIS data on the number of 

establishments that produce each type 

of product by species and establishment 

size and the 2010 total volume,13

provided estimates of numbers of 

establishments that produce products 

with added solutions only (i.e., without 

mechanical tenderization) and 

establishments that produce 

mechanically tenderized products with 

added solutions and estimates of the 

total volume of these products. 


tkelley on DSK3SPTVN1PROD with RULES4
79056 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

14Expert Elicitation on the Market Shares for Raw 

Meat and Poultry Products Containing Added 

Solutions and Mechanically Tenderized Raw Meat 

and Poultry Products. Final Report. Table 3–11 and 

3–16. Available at: http://www.fsis.usda.gov/wps/

wcm/connect/3a97f0b5-b523–4225–8387- 

c56a1eeee189/Market_Shares_MTB_

0212.pdf?MOD=AJPERES. 

15The expert elicitation report referred to 

products ‘‘containing added solutions’’ as 

‘‘enhanced.’’ 

16Model to Estimate Costs of Using Labeling as 

a Risk Reduction Strategy for Consumer Products 

Regulated by the Food and Drug Administration, 

FDA, March 2011 (Contract No. GS–10F–0097L, 

Task Order 5). 

TABLE 1—ESTIMATED NUMBER OF ESTABLISHMENTS THAT PRODUCE EACH TYPE OF PRODUCT BY SPECIES AND

ESTABLISHMENT SIZE 14

Species Product Very small Small Large Total 

Beef ............................... Containing added solutions only 15 ..................... 181 218 21 420 

Mechanically tenderized with added solutions .... 251 218 21 490 

Pork ............................... Containing added solutions only ......................... 285 439 34 758 

Mechanically tenderized with added solutions .... 256 293 27 576 

Lamb and Goat .............. Containing added solutions only ......................... 24 29 0 53 

Mechanically tenderized with added solutions .... 35 34 0 69 

Chicken .......................... Containing added solutions only ......................... 282 371 131 784 

Mechanically tenderized with added solutions .... 267 346 116 729 

Turkey ............................ Containing added solutions only ......................... 80 123 21 224 

Mechanically tenderized with added solutions .... 75 127 21 223 

Note: Establishments may produce multiple types of products and species and, therefore, may be represented in more than one row of the 

table. 

The February 2012 report also 

provided updated estimates for the 

proportion of products containing 

added solutions. The preliminary 

regulatory impact analysis estimated 

that the proportion of products 

containing added solutions was 39 

percent (76 FR 44855–44865). Based on 

the findings of the February 2012 report, 

FSIS estimates that approximately 60 

percent of all raw meat and poultry 

products sold contain added solutions. 

The proportions and volumes for 

specific product classes are found in 

Table 2. 

TABLE 2—PROPORTION OF RAW PRODUCTS CONTAINING ADDED SOLUTIONS IN MILLIONS OF POUNDS BY SPECIES

Product category 

Volume 

produced 

(2010) 1

Proportion of 

product 

containing 

added 

solutions 

(%) 2

Estimated 

amount of raw 

product 

containing 

added 

solutions 

(volume * 

proportion) 

Beef .............................................................................................................................................. 24,300 21 5,127 

Pork .............................................................................................................................................. 21,400 57 12,134 

Lamb and Goat ............................................................................................................................ 185 30 55 

Chicken ........................................................................................................................................ 49,400 78 38,532 

Turkey .......................................................................................................................................... 7,000 74 5,194 

Total ...................................................................................................................................... 102,285 60 61,042 

1 Numbers derived from FSIS data, as reported in the Expert Elicitation on the Market Shares for Raw Meat and Poultry Products Containing 

Added Solutions and Mechanically Tenderized Raw Meat and Poultry Products. Final Report. Research Triangle Institute. February 2012. Section 3.2.1 Available at http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_

0212.pdf?MOD=AJPERES. 2 Id., Table 3.6. Derived by summing median estimates for ‘‘enhanced only’’ and ‘‘mechanically tenderized and enhanced.’’ 

* Totals in Estimated Amount do not necessarily add up due to rounding in Proportion of Product Containing Added Solutions. 

Currently, although labeling 

regulations and guidance state that the 

labeling of products must include a 

qualifying statement that reflects the 

fact that the product contains added 

solution, the statement may not be 

readily apparent to consumers. This is 

because the statement is not 

conspicuous. For example, through 

label review, FSIS has found product 

labels contain product names in bold 

fonts with strong contrasting 

backgrounds, with the qualifying 

statement on added solution printed in 

narrow or slanted fonts at the smallest 

height permitted, and on background of 

poor color contrast. While such labeling 

may be consistent with existing Agency 

regulations and guidance, it does not 

clearly identify to consumers that the 

product contains added solutions. This 

rule addresses these issues. 

The final rule will apply to all incommerce raw meat and poultry 

products containing added solution that 

do not meet a standard of identity. 

These products will require a new label 

in order to comply with the final rule. 

A March 2011 FDA report 16 defines 

all labeling changes as minor, major, or 

extensive. A minor change is one in 

which only one color is affected, and 

the label does not need to be redesigned. 

Examples of this type of change include 

changing an ingredient list or adding a 

toll-free number. A major change 

requires multiple color changes and 

label redesign. An example of a major 

change is adding a facts panel or 

modifying the front of a package. An 

extensive change is a major format 

change requiring a change to the 

product packaging to accommodate 

labeling information. An example of an 

extensive change is adding a peel-back 

label or otherwise increasing the 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79057 

17FDA March 2011 labeling cost model: A copy 

of the document is available in the FSIS Docket 

Room, Patriots Plaza 3, 355 E. Street SW., Room 8– 

164, Washington, DC 20250–3700. 

18Source: FSIS Labeling and Program Delivery 

Staff. 

19Enhanced’’ Chicken, Consumer Research, 

November 2004, SAI Project 04177, Sorensen 

Associates, Minneapolis, Minnesota (888–616– 

0123), Portland, Oregon (800–542–4321). 

package surface area. FSIS estimates the 

cost of label modification to 

accommodate the requirements of this 

final rule to fall into the minor category. 

The March 2011 FDA Report divides 

the minor category into minor 

coordinated and minor uncoordinated 

changes based on the assumption that 

all products are typically relabeled at 

least as often as every 3 to 4 years. The 

cost estimate is $310 per label (with a 

range of $170 to $440) for minor 

coordinated changes and $4,380 per 

label (with a range of $2,417 to $7,330) 

for minor uncoordinated changes.17 The 

model, defined in the report, assigns 

additional costs, e.g. labor, to any 

change that does not fall into this 3 to 

4 year period and is designated to be an 

uncoordinated change that requires 

additional cost attributes. 

This rule will affect foreign 

establishments that manufacture and 

export raw meat or poultry products 

containing added solutions to the 

United States, the same as it affects U.S. 

establishments. The labeling costs for 

the affected foreign establishments are 

captured in the total costs outlined later 

in this analysis. However, these 

products are not typically imported; 

based on label review data,18 the 

amount of raw meat and poultry 

products containing added solutions 

imported into the United States is 

estimated to be less than 1 percent of 

the products imported into the United 

States. For the purposes of this analysis, 

FSIS assumes that the majority (>99.0 

percent) of the affected products are 

domestically produced. 

Regulatory Alternatives 

We have identified three regulatory 

options for this rule. 

1. Require or propose the use of 

‘‘enhanced’’ in the containing statement; 

2. The final rule, except no requirement on 

background color for the qualifying 

statement; 

3. Amend FSIS regulations to establish a 

common or usual name for raw meat and 

poultry products that contain added 

solutions; and 

4. The final rule. 

1. Require the Use of ‘‘Enhanced’’ in the 

Containing Statement 

Under this alternative, FSIS would 

require the word ‘‘enhanced’’ in the 

qualifying statement, or propose the use 

of the term ‘‘enhanced’’ in the 

containing statement, e.g., ‘‘enhanced 

with a 15% solution . . .’’ 

FSIS did not select this alternative to 

require the word ‘‘enhanced’’ in the 

qualifying statement because the word 

implies that the product is improved by 

the addition of the solution. The intent 

of this rule is to increase transparency 

to consumers, not to suggest that the 

product is either better or worse than a 

raw product without the added solution. 

The cost for this alternative is the same 

or slightly less than the preferred 

alternative; however benefits for 

consumers may be reduced as a result 

of decreased transparency of products 

with and without added solutions. 

In addition, consumer research 

(Sorensen, November 2004)19 showed 

that the containing statement, 

‘‘enhanced with up to 15% solution of 

water, salt, and sodium phosphates’’ 

was preferred by fewer study 

participants (about 10% fewer) than the 

use of the description ‘‘contains up to 

15% water, salt, and sodium 

phosphates.’’ 

2. Final Rule, Except No Requirement 

on Background Color for the Qualifying 

Statement 

Under this alternative, the color and 

style of the product’s qualifying 

statement is not required on a singlecolor contrasting background. FSIS 

would still require the qualifying 

statement to include an accurate 

description of the raw meat or poultry 

component, the percentage of added 

solution, and the common or usual 

names of the ingredients in the solution, 

with all of the print in a single font size. 

FSIS did not select this alternative 

because the benefits would likely be 

reduced. A benefit of this rule is to help 

consumers determine whether products 

containing added solutions are suitable 

for their personal preference and dietary 

needs. Removing the requirement for 

background color choice would 

decrease transparency, as a result of the 

reduction in contrast, to consumers. 

The cost for this alternative is slightly 

less than the preferred alternative 

because some existing labels already 

meet these requirements. FSIS does not 

have supporting data to estimate the 

precise number of labels in compliance 

with this alternative, but we expect the 

number is minimal. FSIS expects 

reduced benefits from this alternative as 

consumers are less likely to distinguish 

products with and without added 

solutions, resulting in less informed 

decisions. Consumers would not fully 

benefit from improved consumer 

awareness and understanding that raw 

meat or poultry products may contain 

added solutions. 

3. Amend FSIS Regulations To Establish 

a Common or Usual Name for Raw Meat 

and Poultry Products That Contain 

Added Solutions 

Under this alternative, the common or 

usual name for a raw meat or poultry 

product that contains an added solution 

would need to include the percentage of 

added solution, and list the individual 

ingredients or multi-ingredient 

components of the solution in 

descending order of predominance by 

weight. Also, FSIS considered finalizing 

the proposed provisions that would 

require that the print for all words in the 

common or usual name appear in a 

single font size, color, and style of print. 

As discussed above, after considering 

the comments, FSIS concluded that the 

proposed requirements were more 

onerous and stricter than necessary. 

Therefore, FSIS did not select this 

alternative and made changes to the 

proposed rule to provide more 

flexibility and more consistency with 

other labeling regulations. 

4. The Final Rule 

Under this alternative, FSIS would 

require that the qualifying statement 

includes an accurate description of the 

raw meat or poultry component, the 

percentage of added solution, and the 

common or usual names of the 

ingredients in the solution, with all of 

the print in a single font size, color, and 

style on a single-color contrasting 

background. 

FSIS selected this alternative because 

it is preferred to the other alternatives 

and is likely to improve consumer 

awareness and understanding that the 

raw meat or poultry product contains an 

added solution. The percentage of the 

solution and the ingredients of the 

solution included in a qualifying 

statement is information consumers 

need to make informed purchasing 

decisions. 

Expected Cost of the Final Rule 

The final rule will result in one-time 

costs to establishments and retail 

facilities that produce and package raw 

meat and poultry products containing 

added solutions. Producers may bear 

most of the cost burden, not the 

consumers, given the high elasticity of 

demand for this product because of the 

availability of close substitutes. All of 

the costs pertain to the label 

modification procedures for the affected 

products. The estimated cost of 

modifying labels is determined by the 

number of label plates or digitized label 


tkelley on DSK3SPTVN1PROD with RULES4
79058 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

20Expert Elicitation on the Market Shares for Raw 

Meat and Poultry Products Containing Added 

Solutions and Mechanically Tenderized Raw Meat 

and Poultry Products. Final Report. Tables 3–15 

and 3–16. Available at: http://www.fsis.usda.gov/

wps/wcm/connect/3a97f0b5-b523–4225–8387- 

c56a1eeee189/Market_Shares_MTB_

0212.pdf?MOD=AJPERES. 

21 Information Resources, Inc, (IRI) scanner data 

was used to calculate the number of raw meat and 

poultry products in the retail market. IRI gathers 

data by scanners in supermarkets, drugstores, and 

mass merchandisers and maintains a panel of 

consumer households that record purchases at 

outlets by scanning UPC codes on the products 

purchased. 

22Model to Estimate Costs of Using Labeling as 

a Risk Reduction Strategy for Consumer Products 

Regulated by the Food and Drug Administration, 

FDA, March 2011 (Contract No. GS–10F–0097L, 

Task Order 5). 

23 77 FR 76824. 

templates required to be modified and 

the average cost of modifying labels. 

This methodology provides an 

estimated cost for all labels of products 

with added solution in-commerce, 

including those for retailers and foreign 

entities that sell meat and poultry in the 

United States. 

Market Share 

FSIS has updated the estimates for the 

proportion of products containing 

added solutions to reflect the data 

received in the February 2012 report. 

Based on the findings of the report, FSIS 

estimates that approximately 61.0 

billion pounds or 60 percent of the 

102.3 billion pounds of meat and 

poultry products produced by federally 

inspected establishments in the U.S. 

contain added solutions (Table 2). The 

February 2012 report applies the 

estimate to the estimated pounds of 

enhanced-only products and 

mechanically tenderized and enhanced 

products by species, packaging, and 

labeling type. Based on this data, FSIS 

is able to estimate (Table 3) the 

breakdown by percentage of labels for 

products containing added solutions in 

the marketplace.20

TABLE 3—PERCENT OF ENHANCED-ONLY AND MECHANICALLY TENDERIZED AND ENHANCED PRODUCTS BY SPECIES, 

PACKAGING, AND LABELING TYPE

Packaging or labeling type Beef 

(percent) 

Pork* 

(percent) 

Lamb and 

goat* 

(percent) 

Chicken 

(percent) 

Turkey 

(percent) 

All*1

(percent) 

Brand Name Label for Retail Sales ......... 21 35 34 36 38 35 

Private Label for Retail Sales .................. 22 31 27 22 22 24 

Foodservice .............................................. 51 30 38 37 35 37 

Retail ........................................................ 6 5 2 5 5 5 

1 Unweighted average. 

* Totals do not necessarily add up due to rounding. 

Costs for Label Modification 

IRI scanner data indicate that there 

are 13,697 21 raw meat and poultry 

labels in retail, 16.39 percent (or 2,245) 

of which are private label, with the 

remainder (or 11,452) branded. 

Although IRI’s geographic coverage— 

which includes the largest urban areas 

in the U.S. and a few whole states—may 

yield a reasonable estimate of the 

universe of branded retail labels, a 

substantial number of chains that are 

large enough to have their own private 

labels but that only serve small or 

medium-sized cities may be missed. For 

this reason, the IRI results will be used 

as a lower bound on the number of retail 

labels affected by this rule. To estimate 

an upper bound, we make use of the 

estimates in Table 3, to calculate that 

37.5 percent (24%/[35% + 24% + 5%]) 

of retail labels may be private label. In 

this case, there are an estimated 6,871 

private retail labels and 18,323 (11,452 

+ 6,871) total retail labels. Because the 

IRI scanner data do not capture food 

service labels, these estimates must be 

adjusted upward; based on the contents 

of Table 3, about 37 percent of all meat 

and poultry products are for food 

service. From this, FSIS estimates about 

37 percent of meat and poultry labels 

are for food service and the remaining 

63 percent of label are for retail, 

yielding estimates of 21,741 (13,697/

63%]) to 29,084 (18323*/63%) raw meat 

and poultry product labels in the 

marketplace. The market share of raw 

meat and poultry products that contain 

added solutions is estimated to be 60 

percent. Therefore, FSIS estimates 

approximately 13,045 (21,741 * 60%) to 

17,450 (29,084 * 60%) unique labels for 

meat and poultry raw products 

containing added solution in-commerce. 

This cost analysis uses the label 

design modification costs for a minor 

coordinated label change and a minor 

uncoordinated label change as defined 

in the March 2011 FDA Report.22 The 

use of the label design modification 

costs for minor coordinated and 

uncoordinated label changes are further 

supported by the 2-year compliance 

increments defined in the FSIS 

regulation titled ‘‘Uniform Compliance 

Date for Food Labeling Regulations.’’ 23

That regulation helps affected 

establishments minimize the economic 

impact of labeling changes because 

affected establishments possibly could 

incorporate multiple label redesigns 

required by multiple Federal rules into 

one modification during the 2-year 

increments. Moreover, the ‘‘Uniform 

Compliance Date for Food Labeling 

Regulations’’ allows establishments time 

to use existing labels and would, 

therefore, result in minimal loss of 

inventory of labels, if any. In other 

words, the ‘‘Uniform Compliance Date 

for Food Labeling Regulations’’ 

increases the number of establishments 

that can incorporate new requirements 

as a coordinated change, which reduces 

the cost of complying with the final 

regulation. (For example, FSIS is 

simultaneously developing a final rule 

that would require additional labeling 

for beef products that are mechanically 

tenderized. The cost associated with the 

labels for mechanically tenderized beef 

products containing added solutions are 

lessened if both rules’ changes are 

required as of the same Uniform 

Compliance Date.) 

The labeling cost model states that the 

allocation of label changes between 

coordinated and uncoordinated depends 

on the compliance period allowed by 

the regulation under consideration. For 

some products affected by this rule, the 

only necessary label change is an 

increase in the formatting of the 

descriptive designation so that the size 

of the smallest letter is at least onethird, rather than just one-fourth, the 

size of the largest letter; the cost impact 

for such products would be 

appropriately analyzed using the 

model’s results for a 36-month 

compliance period (100% of branded 

and 57% of private label changes able 

to be coordinated). On the other hand, 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79059 

24All costs are shown in 2010 Dollars. 25 2010 National Meat Case Study Executive 

Summary. Accessed here: http://

www.beefretail.org/CMDocs/BeefRetail/research/

2010NationalMeatCaseStudy.pdf. 

many products—including the ones 

currently labeled with term 

‘‘enhanced’’—will be subject to a 12- 

month compliance period (for which the 

model shows 11% of branded and 5% 

of private label changes can be 

coordinated). In the absence of data on 

the portion of products that will need to 

have label changes in 12 months and the 

portion that will need to have label 

changes in 36 months, we present 

results using only the 12-month 

estimates, acknowledging that this 

approach leads to an overstatement of 

the actual rule-induced costs. 

The mid-point label design 

modification costs for a minor 

coordinated label change is an estimated 

$310 per label (with a range of $170 to 

$440) and $4,380 per label (with a range 

of $2,417 and $7,330) for a minor 

uncoordinated change.24 Using these 

costs for the number of minor 

coordinated and uncoordinated changes 

in branded and private modified labels 

from Table 4, FSIS estimates that the 

one-time total cost of modifying labels 

for all federally inspected processors is 

between $52 and $84 million as lower 

and upper bound estimates. Over a ten 

year period, the lower and upper bound 

annualized cost for the industry is $5.9 

and $9.6 million at a 3 percent discount 

rate (DR) over ten years and $6.9 and 

$11 million at a 7 percent DR over ten 

years. 

The relabeling cost estimate is an 

overestimate for several reasons beyond 

those already discussed. The model 

used to calculate the cost for updating 

food labels encompasses all food labels 

products, including FDA food labels. 

Information from FSIS’s Labeling and 

Program Delivery Staff’s (LPDS) 

determined label changes for FSIS 

products occur more frequently than the 

model indicates, resulting in an 

overestimate of costly uncoordinated 

changes. Additionally, the relabeling 

estimate includes all unique labels with 

added solutions while many products 

with added solutions are already in 

compliance with regulations provided 

in this rule. For these reasons, FSIS 

considers the relabeling cost estimate an 

overestimate. 

TABLE 4—RELABELING COST FOR MEAT AND POULTRY PRODUCTS WITH ADDED SOLUTIONS, 12 MONTH COMPLIANCE

PERIOD

Lower bound 

Branded Private Cost 

10,907 2,138 Lower Mid Upper 

Coor Chg .............................................................................. 1,200 11% 107 5% $222,129 $405,059 $574,922

Uncoor Chg .......................................................................... 9,707 89% 2,031 95% 28,371,037 51,412,967 71,154,236 

Total Lower Bound Cost ............................................... ........................ ........................ 28,593,166 51,818,026 71,729,158 

Annualized Cost (3% DR, 10 Year) ..................................... ........................ ........................ 3,254,360 5,897,722 8,163,928 

Annualized Cost (7% DR, 10 Year) ..................................... ........................ ........................ 3,804,695 6,895,066 9,544,503 

Upper bound 

Branded Private Cost 

7,670 3,464 Lower Mid Upper 

Coor Chg .............................................................................. 1,944 11% 173 5% 359,879 656,250 931,452 

Uncoor Chg .......................................................................... 15,727 89% 3,291 95% 45,964,902 83,295,933 139,397,075 

Total Upper Bound Cost ............................................... ........................ ........................ 46,324,781 83,952,183 140,328,526 

Annualized Cost (3% DR, 10 Year) ..................................... ........................ ........................ 5,272,502 9,555,104 15,971,635 

Annualized Cost (7% DR, 10 Year) ..................................... ........................ ........................ 6,164,118 11,170,937 18,672,547 

Minor Coordinated ............................................................... ........................ ........................ 170 310 440 

Minor Uncoordinated ............................................................ ........................ ........................ 2,417 4,380 7,330 

The cost of modifying the labels is 

small relative to the total volume of 

meat and poultry products. On a per 

pound basis, the upper bound one-time 

cost for this rule is $.0014/per pound 

($83 million/61.0 billion pounds). 

Further, the 2010 National Meat Case 

Study 25 found that the average number 

of pounds per package in the market 

place is 2 pounds. In the study, chicken 

and pork packages tended to be slightly 

heavier at 2.5 and 2.1 pounds 

respectively. Therefore, by applying a 

range of 1.5 to 2.5 pounds per package 

to the low and high range mid-point 

cost estimates, the estimated additional 

cost per package is between $.0013 and 

$.003. This cost is only incurred once 

and would be even smaller if 

annualized (per package) over future 

years. 

FSIS Budgetary Impact of the Final 

Rule 

This final rule will result in no impact 

on the Agency’s operational costs 

because the Agency will not need to add 

any staff or incur any non-labor 

expenditures. 

Expected Benefits of the Final Rule 

FSIS anticipates benefits for the 

consumer such as improved consumer 

awareness and understanding that raw 

meat or poultry products may contain 

added solutions. This may increase 

consumer welfare. 

The rule will likely improve public 

awareness of product identities by 

providing truthful and accurate labeling 

of meat and poultry products to clearly 

differentiate products containing added 

solutions from single-ingredient 

products. As noted in the need for rule 

sections, nearly 60 percent of consumers 

are unaware that meat and poultry 

products contain added solutions. 

Therefore, 60 percent of consumers 

purchasing a chicken containing 15 

percent added solution are unaware 

they are purchasing a product that is 85 

percent chicken and 15 percent added 

solution. Providing truthful and 


tkelley on DSK3SPTVN1PROD with RULES4
79060 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

26U.S. Department of Agriculture, Agricultural 

Research Service. 2013. USDA National Nutrient 

Database for Standard Reference, Release 26. 

Nutrient Data Laboratory Home Page, available at: 

http://ndb.nal.usda.gov/ndb/. 

27 Institute of Medicine (IOM) of the National 

Academies. ‘‘Sodium Intake in Populations: 

Assessment of Evidence (2013), Chapter 4: Sodium 

Intake and Health Outcomes,’’ Washington, DC: 

National Academies Press; 2013. pp.57. 

28N. Graudal, G. Jurgens, B. Baslund, M.H. 

Alderman. Compared With Usual Sodium Intake, 

Low- and Excessive-Sodium Diets Are Associated 

With Increased Mortality: A Meta-Analysis. 

American Journal of Hypertension, 2014; DOI: 

10.1093/ajh/hpu028. 

29 Dall, T.M., V.L. Fulgoni III, Y. Zhang, K.J. 

Reimers, P.T. Packard, and J.D. Astwood. 2009. 

Potential health benefits and medical cost savings 

from calorie, sodium, and saturated fat reductions 

in the American diet. American Journal of Health 

Promotion. 23 (6), 12–22. 

30Estimate is derived using U.S. Census Bureau, 

2013 population estimates and studies that indicate 

that about 31% of American adults have high blood 

pressure (CDC. Vital signs: awareness and 

treatment of uncontrolled hypertension among 

adults—United States, 2003–2010. MMWR. 

2012;61(35):703–9) and an additional one in three 

have prehypertension (Go AS, Mozaffarian D, Roger 

VL, et al. Heart disease and stroke statistics—2013 

update: a report from the American Heart 

Association. Circulation. 2013;127:e6–245). 

31Label Contaminant Statement Package Test: 

Study Results, Prepared for: Tyson Foods, Inc. by 

Lunt Associates. Question 10. May 2011. 

32FDA. ‘‘Consumer Behavior Research 2008 

Health and Diet Survey’’ Topline Frequencies. 

Question C3. Available at: http://www.fda.gov/

Food/FoodScienceResearch/

ConsumerBehaviorResearch/ucm193895.htm. 

33NHANES. 2013 ‘‘Questionnaires, Datasets, and 

Related Documentation’’ Center for Disease Control 

and Prevention. Accessed on 6/16/2014. Available 

at: http://www.cdc.gov/nchs/nhanes/nhanes_

questionnaires.htm. 

34Expert Elicitation on the Market Shares for Raw 

Meat and Poultry Products Containing Added 

Solutions and Mechanically Tenderized Raw Meat 

and Poultry Products. Final Report. Table 3–11. 

Available at: http://www.fsis.usda.gov/wps/wcm/

connect/3a97f0b5-b523-4225-8387-c56a1eeee189/

Market_Shares_MTB_0212.pdf?MOD=AJPERES. 

accurate information on the label allows 

consumers to compare value among 

such products and make a more 

informed purchasing decision. 

Consumers can better determine 

whether products containing added 

solutions are suitable for their personal 

preferences and dietary needs through 

the added solutions qualifying 

statement. Consumers’ choices of meat 

and poultry products with added 

solutions with a high sodium content 

could have unintended health 

consequences if labels of these products 

were inadequate in revealing the 

information of added ingredients to the 

consumers. For example, a raw chicken 

breast containing added solutions 

averages an additional 333 mg of 

sodium than chicken without added 

solutions, (122mg–455mg).26 High 

intakes of sodium are directly associated 

with elevated blood pressure leading to 

risks of cardiovascular disease (CVD) 

and stroke.27 While some research 28

suggests a U-shape relationship between 

sodium and health with favorable 

sodium intake between 2,645 and 4,945 

mgs, a Nutrition Impact Model 

developed by Tim Dall estimates 1.5 

million fewer cases of hypertension 

with a potential annual savings of $2.3 

billion if adults with uncontrollable 

hypertension reduced their daily 

sodium intake by 400 mg.29

Additionally, it is estimated that there 

are about 3 million pre-hypertensive 

and hypertensive persons in the US 

population.30 A consumer research 

study indicates that 39% of consumers 

read but do not understand current 

labels,31 and an FDA consumer study 

estimates that 49% of consumers would 

read and be able to understand new 

labels.32 Considering that difference and 

the estimates of pre-hypertensive and 

hypertensive adults in the U.S. 

population, about 1 million individuals 

may be able to better understand and 

apply the new label information and, 

thereby, be better able to stay within 

their dietary salt intake requirements. 

More complete label information 

should increase consumer welfare. 

Based on 2009–2010 National Health 

and Nutrition Examination Survey data, 

NHANES, 46 percent of consumers 

rarely or never read food labels when 

buying raw meat, poultry or fish 

products.33 Of the consumers who 

rarely or never using food labels, 21 

percent specified they are not checking 

food labels because they did not know 

what to look for. Results from the 2008 

Health and Diet Survey indicated 29 

percent of respondents who never read 

food labels are not using labels because 

it is hard to understand. The new 

requirements in this rule may make it 

easier for consumers to understand the 

label and identify what to look for. 

Providing more complete label 

information, currently unavailable in 

the marketplace, will reduce transaction 

costs for consumers trying to satisfy 

individual dietary or other preferences. 

Consumers with complete information 

will be better able to discriminate 

between products with added solutions 

and those without and select the 

products they prefer, resulting in an 

increase in consumer welfare. 

Regulatory Flexibility Analysis 

The FSIS Administrator certifies that, 

for the purposes of the Regulatory 

Flexibility Act (5 U.S.C. 601–602), the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities in the United 

States. 

There are about 6,099 federally 

inspected establishments, of which 

2,616 are small (with 10 or more but less 

than 500 employees), and 3,103 are very 

small (with fewer than 10 employees) 

based on the classifications outlined in 

the Pathogen Reduction; Hazard 

Analysis Critical Control Point (HACCP) 

final rule (61 FR 38819). Hence, more 

than 90 percent of the federal 

establishments 34 that produce meat and 

poultry products with added solutions 

which could possibly be affected by this 

rule are small or very small according to 

the FSIS HACCP definition. 

In the cost analysis above, FSIS 

estimated that the total upper and lower 

bound one-time cost for the industry is 

about $52 to $84 million. This results in 

an average one-time cost per 

establishment of about $8496 ($52 

million/6,099 establishments) to $13765 

($84 million/6,099) or $967 to $1567 

annualized (3 percent, 10 years). The 

small and very small establishments 

produce less output and fewer unique 

labels, and therefore their average onetime cost per establishment will be 

lower. Thus, FSIS believes that the cost 

to small and very small establishments 

of providing modified labels for the 

meat and poultry products with added 

solutions will be negligible. 

Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, ‘‘Consultation 

and Coordination with Indian Tribal 

Governments.’’ FSIS has concluded, on 

the basis of its evaluation, that this final 

rule will not have substantial and direct 

effects on Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power or 

responsibilities between the Federal 

Government and Indian Tribes. 

Nonetheless, FSIS will include Tribes 

and intertribal organizations, involved 

in or interested in the meat and poultry 

sectors, in the Agency’s outreach efforts 

associated with implementation and 

administration of this final rule. 

Executive Order 12988 Civil Justice 

Reform 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. Under this rule: (1) All State 

and local laws and regulations that are 

inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) no 

retroactive proceedings will be required 

before parties may file suit in court 

challenging this rule. 


tkelley on DSK3SPTVN1PROD with RULES4
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 79061 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or record keeping 

requirements included in this final rule 

have been submitted for approval to the 

Office of Management and Budget 

(OMB). This information collection 

request is at OMB awaiting approval. 

FSIS will collect no information 

associated with this rule until the 

information collection is approved by 

OMB. 

Copies of this information collection 

assessment can be obtained from Gina 

Kouba, Paperwork Reduction Act 

Coordinator, Food Safety and Inspection 

Service, USDA, 1400 Independence 

Avenue SW., Room 6083, South 

Building, Washington, DC 20250–3700; 

(202) 690–6510. 

E-Government Act 

FSIS and USDA are committed to 

achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et 

seq.) by, among other things, promoting 

the use of the Internet and other 

information technologies and providing 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

Additional Public Notification 

FSIS will announce this rule online 

through the FSIS Web page located at 

http://www.fsis.usda.gov/wps/portal/

fsis/topics/regulations/federal-register/

interim-and-final-rules. 

FSIS will also make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, and other types of 

information that could affect or would 

be of interest to constituents and 

stakeholders. The Update is 

communicated via Listserv, a free 

electronic mail subscription service for 

industry, trade groups, consumer 

interest groups, health professionals, 

and other individuals who have asked 

to be included. The Update is also 

available on the FSIS Web page. In 

addition, FSIS offers an electronic mail 

subscription service which provides 

automatic and customized access to 

selected food safety news and 

information. This service is available at 

http://www.fsis.usda.gov/wps/portal/

fsis/programs-and-services/emailsubscription-service. Options range from 

recalls to export information to 

regulations, directives and notices. 

Customers can add or delete 

subscriptions themselves, and have the 

option to password protect their 

accounts. 

USDA Nondiscrimination Statement 

No agency, officer, or employee of the 

USDA shall, on the grounds of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, 

disability, age, marital status, family/

parental status, income derived from a 

public assistance program, or political 

beliefs, exclude from participation in, 

deny the benefits of, or subject to 

discrimination any person in the United 

States under any program or activity 

conducted by the USDA. 

To file a complaint of discrimination, 

complete the USDA Program 

Discrimination Complaint Form, which 

may be accessed online at http://

www.ocio.usda.gov/sites/default/files/

docs/2012/Complain_combined_6_8_

12.pdf, or write a letter signed by you 

or your authorized representative. 

Send your completed complaint form 

or letter to USDA by mail, fax, or email: 

Mail: U.S. Department of Agriculture, 

Director, Office of Adjudication, 1400 

Independence Avenue SW., 

Washington, DC 20250–9410. 

Fax: (202) 690–7442. 

Email: program.intake@usda.gov. 

Persons with disabilities who require 

alternative means for communication 

(Braille, large print, audiotape, etc.) 

should contact USDA’s TARGET Center 

at (202) 720–2600 (voice and TDD). 

List of Subjects 

9 CFR Part 317 

Food labeling, Food packaging, Meat 

inspection, Nutrition, Reporting and 

recordkeeping requirements. 

9 CFR Part 381 

Food labeling. 

For the reasons discussed in the 

preamble, FSIS is amending 9 CFR 

chapter III as follows: 

PART 317—LABELING, MARKING 

DEVICES, AND CONTAINERS 

■ 1. The authority citation for part 317 

continues to read as follows: 

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

2.53. 

■ 2. Amend § 317.2 by redesignating 

paragraph (e) as paragraph (e)(1) and 

adding paragraph (e)(2) to read as 

follows: 

§ 317.2 Labels: definition; required 

features. 

* * * * * 

(e) * * * 

(2) The product name for a raw meat 

product that contains added solution 

and does not meet a standard of identity 

in 9 CFR part 319 must contain a 

descriptive designation that includes: 

(i) The percentage of added solution 

(total weight of the solution ingredients 

divided by the weight of the raw meat 

without solution or any other added 

ingredients multiplied by 100). The 

percentage of added solution must 

appear as a number (such as, 15, 20, 30) 

and the percent symbol (%). The 

percentage of added solution may be 

declared by the words ‘‘containing’’ or 

‘‘contains’’ (such as, ‘‘contains 15% 

added solution of water and salt,’’ or 

‘‘containing 15% added solution of 

water and teriyaki sauce’’). 

(ii) The common or usual name of all 

individual ingredients or multiingredient components in the solution 

listed in descending order of 

predominance by weight. 

(iii) When the descriptive designation 

includes all ingredients in the solution, 

a separate ingredients statement is not 

required on the label. When the 

descriptive designation includes multiingredient components and the 

ingredients of the component are not 

declared in the descriptive designation, 

all ingredients in the product must be 

declared in a separate ingredients 

statement on the label as required in 

§ 317.2(c)(2) and (f). 

(iv) The product name and the 

descriptive designation must be printed 

in a single easy-to-read type style and 

color and must appear on a single-color 

contrasting background. The print may 

appear in upper and lower case letters, 

with the lower case letters not smaller 

than one-third (1⁄3) the size of the largest 

letter. 

(v) The word ‘‘enhanced’’ cannot be 

used in the product name. 

* * * * * 

PART 381—POULTRY PRODUCTS 

INSPECTION REGULATIONS 

■ 3. The authority citation for part 381 

continues to read as follows: 

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

451–470; 7 CFR 2.7, 2.18, 2.53. 

■ 4. Amend § 381.117 by adding 

paragraph (h) to read as follows: 

§ 381.117 Name of product and other 

labeling. 

* * * * * 

(h) The product name for a raw 

poultry product that contains added 

solution and does not meet a standard 

of identity in this part must contain a 

descriptive designation that includes: 

(1) The percentage of added solution 

(total weight of the solution ingredients 

divided by the weight of the raw poultry 

without solution or any other added 


tkelley on DSK3SPTVN1PROD with RULES4
79062 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Rules and Regulations 

ingredients multiplied by 100). The 

percentage of added solution must 

appear as a number (such as, 15, 20, 30) 

and the percent symbol (%). The 

percentage of added solution may be 

declared by the words ‘‘containing’’ or 

‘‘contains’’ (such as, ‘‘contains 15% 

added solution of water and salt,’’ or 

‘‘containing 15% added solution of 

water and teriyaki sauce’’). 

(2) The common or usual name of all 

individual ingredients or multiingredient components in the solution 

listed in descending order of 

predominance by weight. 

(3) When the descriptive designation 

includes all ingredients in the solution, 

a separate ingredients statement is not 

required on the label. When the 

descriptive designation includes multiingredient components and the 

ingredients of the component are not 

declared in the product name, all 

ingredients in the product must be 

declared in a separate ingredients 

statement on the label as required in 

§ 381.118. 

(4) The product name and the 

descriptive designation must be printed 

in a single easy-to-read type style and 

color and must appear on a single-color 

contrasting background. The print may 

appear in upper and lower case letters, 

with the lower case letters not smaller 

than one-third (1⁄3) the size of the largest 

letter. 

(5) The word ‘‘enhanced’’ cannot be 

used in the product name. 

§ 381.169 [Removed and Reserved] 

■ 5. Remove and reserve § 381.169. 

Done at Washington, DC, on December 23, 

2014. 

Alfred Almanza, 

Acting Administrator. 

[FR Doc. 2014–30472 Filed 12–30–14; 8:45 am] 

BILLING CODE 3410–DM–P 


tkelley on DSK3SPTVN1PROD with RULES4