Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33803 

(1) Send the producer a maturity 

notice letter before MAL maturity. 

(2) Maintain the MAL or LDP 

documents according to FSA 

requirements. 

(3) Transmit the necessary funds to 

repay the MAL to FSA. 

(b) FSA shall process the CCC release 

of paper receipts or EWR’s where such 

a release is appropriate. 

§ 1421.422 Inspections and reviews. 

The books, documents, papers, and 

records of the DMA and parent 

company shall be maintained for six 

years after the applicable crop year and 

shall be made available to CCC for 

inspection and examination at all 

reasonable times. At any time after an 

application is received, CCC shall have 

the right to examine all books, 

documents, papers, and determine 

whether the DMA is operating or has 

operated in accordance with the 

regulations in this part, any articles of 

incorporation, articles of association, 

partnership documents, agreements 

with producers, the representations 

made by the DMA in its application for 

approval, and, where applicable, its 

agreements with CCC. If the DMA is 

determined to be not complying with 

this part or any of its agreements, CCC 

will take appropriate action as provided 

in elsewhere in this subpart or other 

action CCC determines appropriate. 

§ 1421.423 Appeals. 

Parts 11 and 780 of this title apply to 

this subpart. 

Signed in Washington, DC, on May 25, 

2005. 

James R. Little, 

Executive Vice President, Commodity Credit 

Corporation. 

[FR Doc. 05–11505 Filed 6–9–05; 8:45 am] 

BILLING CODE 3410–05–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 94 

[Docket No. 04–091–2] 

Addition of Malaysia To List of 

Regions in Which Highly Pathogenic 

Avian Influenza Subtype H5N1 Is 

Considered To Exist 

AGENCY: Animal and Plant Health 

Inspection Service, USDA.


ACTION: Affirmation of interim rule as 


final rule. 


SUMMARY: We are adopting as a final 

rule, without change, an interim rule 

that amended the regulations 

concerning the importation of animals 

and animal products by adding 

Malaysia to the list of regions in which 

highly pathogenic avian influenza 

(HPAI) subtype H5N1 is considered to 

exist. We took that action to prevent the 

introduction of HPAI subtype H5N1 in 

the United States. 

DATES: The interim rule became 

effective on August 7, 2004. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Julie Garnier, Staff Veterinarian, 

Technical Trade Issues Team, National 

Center for Import and Export, VS, 

APHIS, 4700 River Road Unit 39, 

Riverdale, MD 20737–1231; (301) 734– 

5677. 

SUPPLEMENTARY INFORMATION: 

Background 

Highly pathogenic avian influenza 

(HPAI) is an extremely infectious and 

fatal disease of poultry and a wide 

variety of other birds. HPAI can strike 

poultry quickly without any infection 

warning signs and, once established, the 

disease can spread rapidly from flock to 

flock. In some instances, strains of HPAI 

viruses can be infectious to people. 

Human infections with AI viruses under 

natural conditions have been 

documented in recent years. Particularly 

alarming is the HPAI strain of most of 

these outbreaks, H5N1, which has 

crossed the species barrier and caused 

severe disease, with high mortality, in 

humans. Recent outbreaks of HPAI in 

Southeast Asia have caused significant 

concern among health authorities 

worldwide because of the potential for 

the human and avian flu viruses to swap 

genes, creating a new virus to which 

humans would have little or no 

immunity. 

The Animal and Plant Health 

Inspection Service (APHIS) of the 

United States Department of Agriculture 

(USDA or the Department) regulates the 

importation of animals and animal 

products into the United States to guard 

against the introduction of animal 

diseases. The regulations in 9 CFR parts 

93, 94, and 95 (referred to below as the 

regulations) govern the importation of 

certain animals, birds, poultry, meat, 

other animal products and byproducts, 

hay, and straw into the United States in 

order to prevent the introduction of 

various animal diseases, including HPAI 

subtype H5N1. 

In an interim rule effective August 7, 

2004, and published in the Federal 

Register on February 1, 2005 (70 FR 

5043–5044, Docket No. 04–091–1), we 

amended the regulations in part 94 by 

adding Malaysia to the list of regions in 

§ 94.6(d) where HPAI subtype H5N1 

exists. 

Comments on the interim rule were 

required to be received on or before 

April 4, 2005. We received one 

comment by that date, from a private 

citizen. The commenter supported the 

interim rule. 

Therefore, for the reasons given in the 

interim rule and in this document, we 

are adopting the interim rule as a final 

rule without change. 

This action also affirms the 

information contained in the interim 

rule concerning Executive Order 12866 

and the Regulatory Flexibility Act, 

Executive Order 12988, and the 

Paperwork Reduction Act. 

Further, for this action, the Office of 

Management and Budget has waived its 

review under Executive Order 12866. 

List of Subjects in 9 CFR Part 94 

Animal diseases, Imports, Livestock, 

Meat and meat products, Milk, Poultry 

and poultry products, Reporting and 

recordkeeping requirements. 

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL 

PLAGUE), EXOTIC NEWCASTLE 

DISEASE, AFRICAN SWINE FEVER, 

CLASSICAL SWINE FEVER, AND 

BOVINE SPONGIFORM 

ENCEPHALOPATHY: PROHIBITED 

AND RESTRICTED IMPORTATIONS 

■ Accordingly, we are adopting as a final 

rule, without change, the interim rule 

that amended 9 CFR part 94 and that was 

published at 70 FR 5043–5044 on 

February 1, 2005. 

Done in Washington, DC, this 6th day of 

June 2005. 

Elizabeth E. Gaston, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 05–11504 Filed 6–9–05; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 319 and 381 

[Docket No. 92–024F] 

Rin 0583–AC82 

Food Standards: Requirements for 

Substitute Standardized Meat and 

Poultry Products Named by Use of an 

Expressed Nutrient Content Claim and 

a Standardized Term 

AGENCY: Food Safety and Inspection 


Service, USDA.


ACTION: Final rule.


33804 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

the Federal meat and poultry products 

inspection regulations to establish a 

general definition and standard of 

identity for standardized meat and 

poultry products that have been 

modified to qualify for use of an 

expressed nutrient content claim in 

their product names. These products 

will be identified by an expressed 

nutrient content claim, such as ‘‘fat 

free,’’ ‘‘low fat,’’ and ‘‘light,’’ in 

conjunction with an appropriate 

standardized term, e.g., ‘‘low fat 

bologna.’’ FSIS is taking this action to: 

Assist consumers in maintaining 

healthy dietary practices by providing 

for modified versions of standardized 

meat and poultry products that have 

reductions of certain constituents that 

are of health concern to some 

consumers, such as fat, cholesterol, and 

sodium; increase regulatory flexibility 

and support product innovation, and 

provide consumers with an informative 

nutrition labeling system. 

DATES: This final rule will be effective 

January 1, 2008, the uniform 

compliance date for all meat and 

poultry products subject to labeling 

regulations issued by FSIS between 

January 1, 2005 and December 31, 2006. 

However, establishments may begin to 

produce meat and poultry products in 

compliance with this final rule anytime 

before the effective date. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Robert Post, Director, Labeling and 

Consumer Protection Staff, Office of 

Policy, Program, and Employee 

Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, Washington, DC 20250– 

3700; (202) 205–0279. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 29, 1995, FSIS 

published a proposed rule in the 

Federal Register to amend the Federal 

meat and poultry products inspection 

regulations to establish a general 

definition and standard of identity (the 

‘‘general standard’’) for standardized 

meat and poultry products that have 

been modified to qualify for use of an 

expressed nutrient content claim in 

their product names (60 FR 67474). 

Under the proposed general standard, 

meat and poultry products with a 

regulatory standard of identity or 

composition in 9 CFR Parts 319 and 

381, subpart P, would be permitted to be 

formulated and processed with 

ingredients otherwise not provided for, 

or in amounts greater than, that allowed 

by the standard in order to qualify for 

certain expressed nutrient content 

claims permitted in 9 CFR 317 subpart 

B and 381, subpart Y, such as ‘‘fat free,’’ 

‘‘low fat,’’ and ‘‘light.’’ Instead of being 

identified as ‘‘substitute’’ standardized 

meat and poultry products, as required 

by the current regulations (9 CFR 

317.313(d) and 381.413(d)), 

standardized meat and poultry products 

formulated or processed in accordance 

with the proposed general standard 

could be identified by an expressed 

nutrient content claim in conjunction 

with the standardized term. 

To allow modified versions of 

standardized meat and poultry products 

that have been formulated to reduce 

their fat content to be marketed without 

having to be labeled as ‘‘substitutes,’’ 

FSIS issued Policy Memo 123, 

‘‘Modified Breakfast Sausage, Cooked 

Sausage, and Fermented Sausage 

Products Identified by a Nutrient 

Content Claim and a Standardized or 

Traditional Name,’’ and Policy Memo 

121B ‘‘Labeling of Low Fat Ground Beef 

and Low Fat Hamburger Containing 

Added Ingredients,’’ in January of 1995. 

These policy memoranda stated, among 

other things, that these products are 

permitted to be identified by a nutrient 

content claim that reflects the reduction 

in fat content in the product in 

conjunction with the appropriate 

standardized product name, e.g., ‘‘Fat 

Free Bologna,’’ ‘‘Low Fat Pepperoni,’’ or 

‘‘Low Fat Hamburger, Water, and 

Carrageenan Product.’’ Both Policy 

Memo 121B and Policy Memo 123 were 

issued as interim measures until such 

time that rulemaking could be 

completed. Both of these policy 

memoranda will be rescinded by this 

final rule. 

In this final rule, FSIS is establishing 

a general definition and standard of 

identity for modified versions of meat 

and poultry products that substitute for 

meat and poultry products defined by a 

regulatory standard of identity or 

composition in 9 CFR Part 319 and 381, 

subpart P, i.e., ‘‘substitute standardized 

products.’’ This rule is needed to 

facilitate the development and 

availability of substitute standardized 

meat and poultry products that have 

reductions in constituents that are of 

health concern to some people, e.g., fat, 

cholesterol, and sodium. The rule 

allows FSIS to rely more on labeling 

requirements and less on restrictive 

recipe-type standards to carry out its 

mandate to ensure that the labels of 

meat and poultry products are truthful 

and not misleading to consumers. 

Comments and Agency Response 

FSIS received 56 comments in 

response to the proposed rule from 

members of the meat and poultry 

processing industry, industry trade 

associations, members of the flavoring 

and ingredients industry, members of 

the soybean industry, academia, health 

professionals, governmental entities, 

consumer advocacy groups, and 

individual consultants. In general, the 

comments submitted in response to the 

proposed rule were favorable. Most 

commenters agreed that FSIS should 

establish a regulatory general standard 

for substitute standardized products that 

are lower in fat, cholesterol, or sodium. 

One commenter opposed the rule 

because the commenter believed it did 

not go far enough in providing 

flexibility to industry. This commenter 

stated that, rather than converting FSIS 

Policy Memo 123 into regulation, FSIS 

should create a new standard for 

substitute standardized meat and 

poultry products to allow the use of 

non-traditional ingredients in all 

products, not just versions of products 

that are identified by a nutrient content 

claim and a standardized product name. 

Response: FSIS recognizes the need to 

explore this and other issues concerning 

reform of the meat and poultry product 

standards. However, expanding the use 

of non-traditional ingredients for all 

standardized products is an issue that is 

outside the scope of this rulemaking. 

The Agency is, however, exploring this 

and other related issues in a separate 

rulemaking to modernize meat and 

poultry product standards. This 

rulemaking is discussed in greater detail 

later in this document. 

Policy Memo 123 and Policy Memo 

121B 

Comment: A few commenters felt that 

FSIS Policy Memo 121B and Policy 

Memo 123 should remain in effect once 

this final rule becomes effective so that 

products produced under these policies 

can continue to be manufactured. Other 

commenters stated that the general 

standard defined in the proposed rule 

should apply to food products whose 

standards are documented in the FSIS 

Food Standards and Labeling Policy 

Book (the Policy Book), as well as those 

products whose standards of identity 

and composition are codified in Parts 

319 and 381, subpart P. The 

commenters noted that the wording in 

proposed 9 CFR 319.10(a) and 

381.172(a) does not specifically include 

the standards described in the Policy 

Book, while FSIS Policy Memo 123 

does. They were concerned that once 

the rule is in place, and Policy Memo 

123 is rescinded, certain products, such 

as ‘‘Low Fat Pepperoni,’’ would no 

longer be permitted because pepperoni 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33805 

does not have a standard of identity 

codified in the regulations. 

Response: The policy embodied in the 

proposed general standard will also 

apply to the informal standards for 

products, such as pepperoni, that are 

described in the Policy Book. Thus, 

Policy Memo 121B and Policy Memo 

123 will not remain in effect once the 

proposed rule becomes final. FSIS 

issued both Policy Memo 121B and 

Policy 123 as interim measures to 

accommodate certain lower fat 

substitute meat and poultry products 

until such time that rulemaking was 

completed. This final rule incorporates, 

expands, and codifies the intent of these 

policy memoranda. Thus, rescinding 

Policy Memo 121B and Policy Memo 

123 will not preclude the production of 

products that have been made under 

those policies. The Agency intends to 

clarify this point in a policy bulletin, 

which is a more appropriate document 

for addressing the informal standards 

described in the Policy Book. 

Nutrient Content Claims That 

Emphasize the Presence of an 

Ingredient 

Comment: Some commenters 

disagreed with the Agency’s proposal to 

permit only expressed nutrient content 

claims that relate to reductions in 

constituents such as fat, cholesterol, or 

sodium, in conjunction with the 

standardized name of the substitute 

product. These commenters felt that 

nutrient content claims, such as ‘‘high 

in’’ and ‘‘good source of,’’ that 

emphasize the presence of an 

ingredient, should also be permitted to 

be used as part of the substitute 

standardized product’s name, provided 

that the product qualifies for these 

claims under 9 CFR part 317 subpart B 

or 9 CFR 381 subpart Y. 

Response: Under the current 

regulations, meat and poultry products 

that satisfy the criteria for use of 

nutrient content claims defined in 9 

CFR part 317 subpart B and 9 CFR 381 

subpart Y are permitted to make claims, 

such as ‘‘high in’’ or ‘‘good source of,’’ 

that emphasize the presence of a 

nutrient. The ability to make these kinds 

of nutrient content claims is not affected 

by this rulemaking. 

In the preamble to the proposed rule, 

FSIS noted that the meat and poultry 

product standards did not appear to 

preclude the making and marketing of 

standardized products that qualify for 

the use of claims such as ‘‘high in’’ and 

‘‘good source of.’’ Therefore, in the 

proposed regulation, the Agency did not 

expressly provide for these types of 

nutrient content claims in the general 

standard. However, in the proposal, 

FSIS did solicit comments on whether 

current regulatory standards prevent the 

distribution of products with nutrient 

content claims other than those that 

reflect a reduction in the level of a 

nutrient. 

None of the comments received 

suggested that the existing meat and 

poultry product standards preclude the 

making and marketing of standardized 

products that qualify for the use of 

claims such as ‘‘high in’’ or ‘‘good 

source of.’’ Furthermore, because of the 

FSIS policy that precludes direct 

nutrient fortification of meat and 

poultry products, standardized meat 

and poultry products are not permitted 

to be modified to qualify to use a 

nutrient content claim by adding 

nutrients to the product. Therefore, FSIS 

has decided not to modify the scope of 

coverage in this final rule to permit 

nutrient content claims other than those 

that reflect a reduction of constituents 

that are of health concern to some 

people, e.g., fat, cholesterol, and 

sodium, to be used as part of the 

product name. Products that qualify for 

‘‘high in’’ and ‘‘good source of’’ nutrient 

content claims may continue to 

highlight these claims as provided in 9 

CFR 317.354 and 9 CFR 381.454. 

Nutrient Fortification 

Comment: Four commenters 

suggested that FSIS reexamine its policy 

precluding direct nutrient fortification 

of meat and poultry products. Two of 

these commenters suggested that FSIS 

allow selective nutrient fortification in 

meat and poultry products to permit 

standardized products to be modified so 

that they qualify to use nutrient content 

claims, such as ‘‘high in Vitamin A,’’ as 

part of the product name. One of these 

commenters requested that FSIS modify 

the language in proposed 9 CFR 

319.10(a) to delete the following 

italicized words ‘‘* * * because of a 

compositional deviation that results 

from reduction of a constituent that is 

described by an expressed nutrient 

content claim * * *’’ 

Another commenter suggested that 

FSIS permit selective protein 

fortification in substitute standardize 

products so that they may use claims 

such as ‘‘High in Protein’’ and ‘‘Good 

Source of Protein’’ as part of the product 

name. This commenter recommended 

that FSIS continue to require substitute 

standardized products to meet the same 

basic minimum meat and poultry 

content requirements contained in the 

existing meat and poultry product 

standards, but that the overall protein 

level in these products should be 

allowed to be fortified using ingredients 

such as soy protein. Another commenter 

that expressed support for permitting 

direct nutrient fortification of meat and 

poultry products felt that, because the 

over-consumption of protein in the 

American diet, that protein fortification 

should not be permitted. 

Two other commenters requested that 

FSIS allow fortification to replace 

vitamins and minerals that may be lost 

due to formulation adjustments to 

produce nutrient-modified foods. These 

commenters also requested that FSIS 

exempt substitute standardized 

products subject to the general standard 

from the minimum meat and poultry 

content requirements imposed by the 

existing meat and poultry product 

standards. Both commenters suggested 

that for these substitute products, FSIS 

should focus on nutritional equivalency 

to the traditional standardized product 

rather than meat content equivalency, 

and permit reductions in the meat and 

poultry content for purposes of reducing 

the product’s fat content. The 

commenters stated that if FSIS were to 

permit such reductions in the meat and 

poultry content, fortification might be 

necessary to replace lost nutrients. 

One commenter suggested that, while 

existing FDA regulations state that the 

FDA does not consider it appropriate to 

fortify meat and poultry products (21 

CFR 104.20(a)), the FDA regulations 

appear to make an exception for 

fortification of foods that replace 

traditional foods when fortification is 

necessary to avoid nutritional 

inferiority. 

Response: The comments requesting 

that FSIS reexamine its policy on 

nutrient fortification raise some 

interesting points, particularly with 

respect to the issues concerning 

nutritional equivalency versus meat 

content equivalency. However, the 

decision to allow fortification of meat 

and poultry products involves several 

complex issues, many of which are 

outside the scope of this rulemaking. 

FSIS’’ fortification policy is derived 

from FDA’s policy statement on nutrient 

fortification codified at 21 CFR part 104, 

subpart B, which states, in part, that the 

FDA ‘‘* * * does not consider it 

appropriate to fortify fresh produce; 

meat, poultry, or fish products * * * 

(21 CFR 104.20(a)). The fundamental 

objective of FDA’s fortification policy is 

‘‘* * * to establish a uniform set of 

principles that will serve as a model for 

the rational addition of nutrients to 

food’(21 CFR 104.20(a)). As stated in its 

policy, FDA determined that, ‘‘*** 

random fortification of foods could 

result in over-or under-fortification in 

consumer diets and create nutrient 

imbalances in the food supply’’ (21 CFR 

104.20(a)). 

33806 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

FSIS has a long history of prohibiting 

direct fortification of meat and poultry 

products, which is supported by the 

codified FDA fortification policy. Thus, 

when determining whether to revise its 

nutrient fortification policy for meat and 

poultry products, FSIS must consider 

the issues in relationship to the codified 

FDA policy statement on fortification. 

Furthermore, in order to maintain 

consistent policies regarding nutrient 

fortification between the two agencies, 

any effort by FSIS to revise its 

prohibition on direct nutrient 

fortification of meat and poultry 

products should include FDA 

participation and involve the scientific 

community (e.g., the National Academy 

of Sciences, Institute of Medicine). FSIS, 

FDA, and the scientific community need 

to first consider the guiding scientific 

principles that form the basis for 

establishing a public health need for 

fortifying meat and poultry with 

nutrients. Only after these principles are 

applied could there be consideration of 

revising the current fortification policy.1 

Obviously, this type of effort is outside 

the intended purpose and scope of this 

rulemaking. It would be more 

appropriate to consider this matter in a 

separate rulemaking where the Agency 

can receive the benefit of an open and 

thorough review of all issues related to 

the fortification of meat and poultry 

products. 

Furthermore, FSIS believes that the 

formulation adjustments needed to 

produce substitute standardized 

products with reductions in 

constituents such as fat, cholesterol, and 

sodium, will not result in a product that 

is nutritionally inferior to the product 

for which it is a substitute. Important 

nutrients, such as iron, zinc, B vitamins, 

and protein, are associated with the lean 

muscle portion of meat and poultry 

tissue, not the fat. Because the 

minimum meat and poultry requirement 

for substitute standardized products is 

not changed by this rule, reductions in 

the fat content should not affect the 

levels of nutrients associated with the 

lean muscle portion of these products. 

Therefore, nutrient fortification is not 

necessary to prevent the products 

subject to the general standard defined 

by this rule from being nutritionally 

inferior to the standardized products for 

which they are a substitute. 

1 See report: Institute of Medicine, National 

Academy of Science, 2003. Dietary Reference 

Intakes, Guiding Principles for Nutrition Labeling 

and Fortification. The National Academies Press, 

Washington, DC. 

Differences in Performance 

Characteristics 

Comment: The proposed regulation 

stated that a substitute standardized 

product with performance 

characteristics, e.g., cooking quality, 

freezing quality, spreadability of 

product, and shelf-life, that materially 

limit the use of the product must 

include a disclaimer on the product’s 

label adjacent to the product name 

informing the consumer of such 

differences. 

Most commenters agreed that 

limitations in a product’s performance 

characteristics should be disclosed on 

the product label, and be conspicuous 

and readable. A number of commenters 

stated that the disclaimer should be 

adjacent to the most prominent claim on 

the label. One commenter, although in 

agreement with the disclaimer 

requirement, felt that disclosure on the 

label, not necessarily adjacent to the 

product name as provided in the 

proposed rule, was sufficient to inform 

the consumer of performance 

differences. This same commenter 

recommended that FSIS harmonize the 

requirement for labeling of performance 

differences with a similar FDA rule, 

which requires a disclaimer adjacent to 

the most prominent claim on the label 

(21 CFR, 101.13(d)). Another commenter 

stated that the disclaimer should be 

adjacent to the most prominent claim 

and should most likely appear on the 

principal display panel. 

Response: In the preamble to the 

proposed rule, FSIS stated that ‘‘if there 

is a difference in performance 

characteristics that materially limits the 

use of the product, the product may still 

be considered a substitute if the label 

includes a disclaimer adjacent to the 

most prominent claim in accordance 

with 9 CFR 317.313(d)(1) and (2) and 9 

CFR 381.413(d)(1) and (2), informing the 

consumer of such difference’’ (60 FR 

67480). However, in the text of the 

proposed rule, FSIS stated that the label 

must include, ‘‘adjacent to the product 

name,’’ a statement in accordance with 

9 CFR 317.313(d)(1) and (2) and 9 CFR 

381.413(d)(1) and (2) informing the 

consumer of differences in performance 

characteristics (60 FR 67486, 67487). 

Thus, the preamble and the text of the 

proposed rule differed in that the 

preamble did not mention that the 

disclaimer must be ‘‘adjacent to the 

product name.’’ The regulations 

referenced by both the preamble and the 

text of the proposed rule, 9 CFR 

317.313(d)(1) and 9 CFR 381.413(d)(1), 

require that differences in performance 

characteristics that materially limit the 

performance of a substitute product be 

disclosed adjacent to the most 

prominent claim on the product label. 

FSIS is resolving the discrepancy 

regarding placement of the disclaimer. 

FSIS agrees with the comment that 

disclosure on the label, not necessarily 

adjacent to the product name, is 

sufficient to inform the consumer of 

performance differences. Therefore, in 

this final rule, FSIS is not requiring that 

the disclaimer be placed adjacent to the 

product name. As in FDA regulations 21 

CFR 130.10 and 101.13(d), a disclaimer 

for differences in performance 

characteristics shall be placed adjacent 

to the most prominent claim on the 

label. To reflect this decision, FSIS is 

removing the phrase ‘‘adjacent to the 

product name’’ from proposed 

§§ 319.10(b)and 381.172(b). 

Comment: Two commenters disagreed 

with the need for the proposed 

disclaimer requirement and suggested 

that disclosure of any limitations in the 

performance characteristics of a 

substitute standardized product be 

voluntary. One of these commenters 

stated that disclaimers on a product’s 

labeling informing consumers of 

performance characteristics that 

materially limit the use of the product 

need not be required by regulations 

because a substitute standardized 

product produced under the general 

standard will succeed or fail in the 

market place based on consumer 

expectations associated with the 

product’s performance. This commenter 

stated that businesses would voluntarily 

place disclaimers on a product’s label in 

the absence of a regulation requiring 

that they do so because it would be good 

business to inform consumers that a 

product they are purchasing can not be 

used in a traditional application. 

The other commenter agreed that, in 

practice, poorly formulated products 

would fail in the marketplace long 

before any regulatory system could 

determine that they did not meet the 

specific performance characteristics 

they would be expected to have. 

However, this commenter 

acknowledged that requiring a 

disclaimer informing consumers of 

limitations in a product’s performance 

characteristics, when they exist, will 

require manufacturers of substitute 

standardized products to monitor 

performance characteristics during 

product development and may help 

ensure that new low- and reduced-fat 

standardized products are formulated 

well from the beginning. The 

commenter went on to state that 

consumers are also more likely to accept 

this category of substitute products if 

they are well formulated from the 

beginning. 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33807 

Response: FSIS disagrees with the 

commenters’ suggestion that disclosure 

of performance characteristics that 

materially limit the use of a substitute 

standardized product compared to the 

use of the traditional standardized 

product should be voluntary. The FMIA 

and the PPIA require that the labeling of 

a meat or poultry product must be 

truthful and not misleading, and that 

such labeling accurately disclose to 

consumers what they are buying when 

they purchase any meat or poultry 

product. Information disclosing 

differences in performance 

characteristics that affect the use of a 

substitute standardized product (e.g., 

cooking quality, freezing quality, 

spreadability of product, and shelf life) 

is a material fact that must be disclosed 

on the labeling of these products. 

Without such labeling, consumers 

would be misled about significant 

characteristics and uses the product has 

compared to the standardized product 

for which it substitutes. Accordingly, 

this information must be communicated 

to consumers on the product’s label, or 

the label will be misleading and the 

product will be misbranded under the 

FMIA or PPIA. 

Moreover, FSIS agrees with the 

commenter who suggested that 

processors are more likely to monitor 

the performance characteristics of 

substitute standardized products during 

product development when limitations 

in the product’s performance 

characteristics are required to be 

disclosed on the product’s labeling. 

FSIS also agrees that if substitute 

standardized products are well 

formulated from the beginning, it will 

promote consumer acceptance of this 

category of meat and poultry products. 

Comment: One commenter pointed 

out that it may be possible for 

performance characteristics to be 

introduced into a substitute 

standardized product that improve upon 

the performance characteristics of the 

traditional standardized product. The 

commenter suggested that the Agency 

consider substituting the term ‘‘not 

inferior’’ for ‘‘similar’’ in proposed 9 

CFR 319.10(b). 

Response: FSIS did not intend to 

prohibit improvements in the 

performance characteristics of substitute 

products when it proposed that 

substitute standardized products subject 

to the general standard perform 

similarly to the traditional standardized 

products for which they substitute. 

However, FSIS disagrees that it should 

require that substitute standardized 

products have performance 

characteristics that are ‘‘not inferior to’’ 

rather than ‘‘similar to’’ the traditional 

standardized products as suggested by 

the commenter. As proposed, 

§§ 319.10(b) and 381.172(b) permit 

products subject to the general standard 

to have limitations in performance 

characteristics provided that such 

limitations are properly disclosed on the 

product’s labeling. The Agency believes 

that requiring disclosure of any 

performance limitations on the labeling 

of products subject to the general 

standard provides sufficient incentive 

for manufacturers of these products to 

market products that are not inferior to 

the traditional standardized products. 

Furthermore, proposed 9 CFR 319.10(b) 

and 9 CFR 381.172(b) require a 

disclaimer for performance 

characteristics that ‘‘materially limit’’ 

the use of a substitute standardized 

product, not for characteristics that 

improve the performance of the product. 

Thus, the disclaimer requirement 

contained in proposed 9 CFR 319.10(b) 

and 9 CFR 381.172(b) will not 

discourage manufacturers from making 

improvements to the performance 

characteristics of substitute products 

when it is possible to do so. 

Enforcement 

Comment: Two commenters 

questioned FSIS’s ability to enforce and 

ensure uniform compliance with the 

performance characteristics 

requirements proposed in 9 CFR 

319.10(b) and 381.172(b). One 

commenter asked how FSIS intends to 

determine differences in performance 

characteristics. The commenter went on 

to state that the proposed performance 

characteristics requirements seem to be 

‘‘command and control’’ regulations that 

are not related to product safety. The 

other commenter stated that, in practice, 

poorly formulated products would fail 

in the marketplace long before any 

regulatory system could determine that 

they did not meet the specific 

performance characteristics discussed in 

the proposal. 

Response: FSIS expects that substitute 

standardized products that are produced 

under the general standard will conform 

to the performance characteristics 

requirements set forth in proposed 9 

CFR 319.10(b) and 381.172(b). To 

ensure that there is compliance, FSIS 

will examine the performance 

characteristics and product quality of 

substitute products as it would other 

types of products, through scientific 

review and experimental investigations. 

In addition, FSIS will use traditional 

methods available to the Agency, such 

as sample analysis, inspections, surveys, 

and follow-up investigations of 

consumer and trade complaints to 

identify products that do not comply 

with the new regulations in order to 

enforce this regulation as the need 

arises. 

Furthermore, FSIS disagrees with the 

comment that the proposed performance 

characteristics requirements are 

‘‘command and control’’ regulations. 

Under §§ 319.10(b) and 381.172(b), FSIS 

is not establishing specific criteria for 

determining similarities in performance 

characteristics. FSIS believes that 

judgments about similarity are best left 

to product developers, who have the 

incentive to market a product that 

resembles the traditional standardized 

product as closely as possible and to 

disclose product performance 

limitations to ensure that there is 

consumer satisfaction with the 

substitute standardized product. 

Safe and Suitable Ingredients 

Comment: There was general 

agreement among the commenters that 

the ingredients used in a substitute 

standardized product produced under 

the general standard should be those 

ingredients provided by the traditional 

standard, with the exception of ‘‘safe 

and suitable ingredients,’’ as defined in 

(former) 9 CFR 318.7 and 381.147, at the 

minimum level necessary to improve 

texture and prevent syneresis. However, 

several commenters requested 

clarification and expansion of the 

ingredients permitted under this 

provision. 

Three commenters stated that 

allowances for ingredients should be 

broadened to include any safe and 

suitable ingredients to replace 

functional characteristics. These 

commenters all noted that the FSIS 

proposal limits ingredient usage to 

achieve textural improvement and to 

prevent syneresis. They felt that FSIS 

should build additional flexibility into 

the final rule to allow for a wider use 

of safe and suitable ingredients to 

replace functional characteristics that 

may be lost when a formulation is 

adjusted to meet a claim requirement. 

These commenters mentioned that the 

comparable FDA regulation allows the 

use of safe and suitable ingredients 

‘‘* * * to add flavor, extend shelf life, 

improve appearance, or add sweetness’’ 

(21 CFR 130.10(d)). One commenter 

suggested that any ingredient that is 

generally recognized as safe (GRAS) or 

that is an approved additive should be 

permitted to be used as desired by the 

manufacturer. Another commenter 

stated that limiting the use of safe and 

suitable ingredients to the minimum 

level necessary to improve texture and 

to prevent syneresis severely limits the 

ability to produce a consumeracceptable meat or poultry product. One 

33808 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

commenter specifically requested that 

FSIS clarify the acceptability of 

flavorings, especially meat flavorings, as 

safe and suitable ingredients in 

substitute standardized products. 

Response: For purposes of 

clarification, since it published the 

general standard proposal, FSIS issued 

the final rule ‘‘Food Ingredients and 

Sources of Radiation Listed or 

Approved for Use in Meat and Poultry 

Products’’ (64 FR 72168, December 23, 

1999). The rule is intended to improve 

the efficiency of the procedures used by 

FSIS and FDA to review and approve 

the use of food ingredients and sources 

of radiation in the production of meat 

and poultry products. Under the new 

regulations, rather than listing 

substances approved for use in the 

production of meat and poultry 

products in the chart of substances 

contained in former 9 CFR 318.7(c)(4) 

and former 9 CFR 381.147(f)(4), FDA 

now lists food ingredients and sources 

of radiation that are safe for specific use 

in the production of meat and poultry 

products in its regulations in title 21 of 

the CFR. In the final rule, FSIS also 

created a list of food ingredients 

approved for use in the production of 

meat and poultry products by 

combining the listing contained in 

former section 318.7(c)(4) with the 

listing contained in former section 

381.147(f)(4) and moving the combined 

listing to section 424.21(c). The final 

rule became effective on January 24, 

2000. 

FSIS did not include ingredients that 

would affect flavor, shelf life, or 

sweetness because these kinds of 

ingredients do not affect the ability of a 

manufacturer to modify a meat or 

poultry product to reduce fat, 

cholesterol, or sodium, which was the 

focus of this rulemaking. Thus, 

§§ 319.10 and 381.172 provide only for 

increased amounts of safe and suitable 

ingredients that are needed to achieve 

the effect of replacing fat, i.e., binders, 

texturizers, and emulsifiers. 

As for the acceptability of flavorings 

in substitute standardized products, 

manufacturers will not be limited by 

§§ 319.10 or 381.172 in their ability to 

use ingredients that impart flavor. This 

final rule does not limit a 

manufacturer’s ability to use safe and 

suitable meat and poultry flavorings. 

‘‘Fat Replacing’’ Binders 

Comment: In the preamble to the 

proposed rule, FSIS provided a list of 

‘‘fat replacing’’ binders to assist meat 

and poultry processors to understand 

the types of ingredients that are 

permitted to be used to achieve the 

effects of fat in making substitute 

standardized products under the general 

standard. However, the list was not 

intended to be all-inclusive. One 

commenter supported the use of 

ingredients not identified in the 

preamble as part of a fat replacement 

system and requested that FSIS clarify 

whether other fat replacers, such as milk 

protein concentrates, would be 

permitted in substitute standardized 

products, given this substance’s 

similarities to the listed substances. The 

commenter also requested that the 

preamble to the final rule specifically 

note that milk protein concentrates and 

egg whites are acceptable substances in 

fat replacement systems. 

Three commenters agreed that the 

ingredients listed in the preamble are 

appropriate for use in a substitute 

version of a standardized product but 

felt that the list should be broadened to 

include other safe and suitable 

ingredients that have a demonstrated 

ability to function as a fat replacement 

system. One of these commenters 

requested that if the list provided within 

the context of the preamble is not meant 

to be all-inclusive, FSIS should state 

that fact. The commenters also 

encouraged FSIS to include a list of 

criteria for evaluating fat replacing 

binders not on the list to determine 

whether they qualify as acceptable 

binders. 

Response: The list of ‘‘fat-replacing 

binders’’ presented in the preamble to 

the proposed rule represents examples 

of ingredients or additives historically 

classified as binders by food scientists 

and ingredient technologists. This list is 

not intended to be all encompassing, 

and other safe and suitable ingredients 

historically recognized as binders are 

permitted to be used in ‘‘fat 

replacement’’ systems for substitute 

standardized products produced under 

the general standard. 

In general, a safe and suitable 

ingredient qualifies for use as a fat 

replacing binder under this final rule if 

it is only used for its functional 

properties and does not impart other 

characterizing qualities, such as taste 

and nutritional value, to the 

standardized product when used in the 

product formulation. FSIS will evaluate 

whether safe and suitable ingredients 

that were not listed in the preamble to 

the proposal qualify as fat replacing 

ingredients on a case-by-case basis. 

As a point of clarification, milk 

protein concentrates have historically 

been used by meat and poultry product 

manufacturers as binding ingredients in 

meat and poultry products and 

therefore, under the general standard, 

FSIS will permit milk protein 

concentrates to be used as binders in fat 

replacement systems for substitute 

standardized products. 

Regarding the use of egg whites as a 

fat replacing binder, egg whites are 

considered an egg product and as such 

function as an individual food product 

that is consumed for its own taste and 

nutritional value. Thus, FSIS considers 

the use of egg whites in the formulation 

of a meat or poultry product to be 

sufficiently characterizing so as to result 

in a product that is not a substitute 

standardized product, but one that is a 

non-standardized product, e.g., 

identified with a true product name, 

such as ‘‘Low Fat Pork Sausage made 

with Egg Whites.’’ 

Although FSIS is not providing an all 

inclusive list of suitable fat replacing 

binders in this final rule, the Agency 

did provide an extensive listing of 

binders in the preamble to the proposed 

rule to convey the intent of the rule (see 

60 FR 67481). Persons interested in 

determining whether an ingredient is an 

appropriate fat replacing binder may 

refer to this original listing.Furthermore, 

safe and suitable ingredients that meet 

the general criteria outlined above, i.e., 

have historically been classified as 

binders, are only used for their 

functional properties, and do not impart 

other characterizing qualities when used 

in the formulation of substitute 

products, will also qualify as acceptable 

fat replacing binders under this final 

rule. 

Textured Vegetable Protein (TVP) as a 

‘‘Fat Replacer’’ 

Comment: In the preamble to the 

proposed rule, FSIS stated that the 

Agency views TVP as a ‘‘meat or poultry 

replacer,’’ and that the use of TVP as a 

fat replacing ingredient in a substitute 

standardized product subject to the 

general standard would be 

inappropriate. At the time that the 

proposal was published, FSIS had 

determined that the use of TVP in a 

substitute standardized product would 

change the nature of the product to such 

an extent that it would no longer be a 

substitute product within the 

parameters of the proposed rule. This 

view, in part, was based on the belief 

that TVP was used as a ‘‘meat 

replacing’’ ingredient in foods 

considered ‘‘meat replacing products,’’ 

such as ‘‘veggie-burgers,’’ which are 

primarily TVP with water, flavorings, 

and seasonings. 

FSIS received numerous comments 

expressing strong disagreement with 

FSIS’s historic views. Forty-three 

commenters submitted statements in 

support of allowing TVP as a fat 

replacer in substitute standardized meat 

and poultry products subject to the 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33809 

general standard so that these products 

may be identified by a nutrient content 

claim. Many of these commenters 

provided supporting studies on the 

health and nutritional benefits of soy 

protein, along with data on consumer 

awareness and acceptance of products 

containing TVP. Many commenters felt 

that not permitting TVP as a fat 

replacing ingredient would greatly limit 

the ability of the industry to develop 

substitute standardized meat and 

poultry products that are lower in fat. 

These commenters stated that the use of 

TVP as a fat replacer is important in 

expanding the flexibility of the meat 

and poultry industry to create and 

market an increased variety of healthful 

substitute meat and poultry products. 

Some commenters specifically 

mentioned that prohibiting TVP would 

limit product development in areas of 

coarse ground cooked and fermented 

sausage. 

Several commenters stated that TVP 

should be permitted as a fat replacer so 

long as its use conforms to the 

requirements of the general standard. 

These commenters stated that TVP 

should be permitted as part of a ‘‘fat 

replacement system’’ in substitute 

standardized meat and poultry products 

so long as: (1) Its use does not 

substantially change the nature of the 

finished product; (2) it is not used to 

replace the meat or poultry content 

required by the traditional standard; and 

(3) it is used only at the minimum level 

necessary in a fat replacement system to 

qualify for use of the nutrient content 

claim. 

A number of commenters stated that 

TVP should be regulated on the basis of 

its functional properties rather than on 

its physical form. Many of these 

commenters pointed out that, while in 

the past TVP was used as a ‘‘filler’’ or 

‘‘substitute’’ for meat components in 

food, advancements in TVP technology 

have made TVP a highly functional 

ingredient that could now be used as 

part of a fat replacement system to 

improve the textural character and 

quality of a substitute standardized meat 

or poultry product. Many commenters 

noted that TVP, when used in 

combination with other water binders, 

provides improved product texture, 

visual appearance, performance, and 

storage characteristics. Data supporting 

this view were presented to the Agency. 

Some commenters felt that TVP 

should be allowed as a fat replacer in all 

meat items where non-textured 

vegetable proteins are allowed. One 

commenter stated that texture is a 

matter of degree, and that forms of 

vegetable proteins range from fine 

powders, to small granules, to small 

flakes, to larger granules and flakes. 

This commenter stated that it is 

arbitrary to require that TVP be 

excluded as a ‘‘fat replacer’’ but not the 

powdered forms. One commenter 

questioned the logic of permitting soy 

flour, soy protein concentrate, and 

isolated soy protein in products because 

they replace fat, but prohibiting the use 

of TVP because it is inappropriately 

thought to replace meat. The commenter 

pointed out that the proposed rule does 

not permit a reduction in the meat or 

poultry content, and therefore, TVP 

could not be used as a meat replacer. 

Another commenter mentioned that 

other binders, such as carrageenan, can 

be texturized, and therefore, TVP is 

being singled out unfairly. 

A number of commenters stated that, 

because the presence of TVP can be 

disclosed in product labeling, 

consumers should be allowed to decide 

for themselves whether to purchase a 

lower fat standardized product that 

contains TVP. Some commenters 

pointed out that the presence of TVP in 

a meat food product could be 

communicated to consumers in the 

same manner as any other ingredient, in 

the ingredient statement. The 

commenters asserted that appropriate 

product labeling required by the general 

standard would ensure that consumers 

would not be misled about the presence 

of TVP in substitute standardized 

products produced. 

Some commenters stated that if TVP 

is permitted as a fat replacer in 

substitute standardized products, the 

substitute product should provide the 

same amount of animal protein as the 

traditional standardized product. One 

commenter stated that this approach 

would provide manufacturers with 

optimum flexibility, yet guarantees that 

the consumer receives a product that is 

at least as valuable as the unmodified 

product. Another commenter mentioned 

that consumers are interested in over-all 

nutrition, not in specific ingredients. 

Some commenters expressed the view 

that TVP should not be considered as a 

‘‘food,’’ because it is not consumed by 

itself as a food. These commenters 

stated that TVP is a functional food 

ingredient that can be used as part of a 

fat replacement system. 

Response: FSIS has been persuaded 

by the comments, information, and 

other data submitted by commenters to 

permit the use of TVP as a part of a fat 

replacing system in substitute 

standardize products produced under 

the general standard. Accordingly, in 

this final rule, proposed §§ 319.10(c) 

and 381.172(c) have been modified to 

provide for the use of TVP, alone or in 

combination with other binders and 

water, as part of a fat replacement 

system. 

The Agency will permit the use of 

TVP as a functional food ingredient that 

is used to replace fat. Like the other fat 

replacing ingredients permitted to be 

used under this final rule, the use of 

TVP as an ingredient in a substitute 

standardized product will be permitted 

only at the lowest level necessary to 

achieve the intended effect of replacing 

fat. When TVP is used to replace fat, the 

ingredients statement on the product 

label must alert the consumer to the fact 

that TVP is not permitted in the 

traditional standardized product or is 

used in excess of amounts permitted in 

the traditional standardized product. 

The labeling requirements will ensure 

that consumers will not be misled when 

TVP is used to replace fat in substitute 

standardized meat and poultry products 

subject to the general standard. 

Under this final rule, TVP may not be 

used to replace the meat or poultry 

content of a product when a product 

standard specifies a minimum meat or 

poultry content requirement. However, 

if the formulation of a substitute 

product produced under the general 

standard contains the same amount of 

meat or poultry prescribed by the 

traditional standard, the fat component 

of the meat or poultry in the substitute 

product may be removed during 

processing and replaced with TVP, or 

any other safe and suitable binder, alone 

or in combination with water as part of 

a fat replacement system. 

For example, the product standard for 

‘‘chili con carne’’ provides that the 

product shall contain not less than 40% 

meat computed on the weight of the 

fresh meat (9 CFR 319.300). The product 

formulation for a substitute version of 

chili con carne produced under the 

general standard must contain 40% 

meat, but the fat content of the meat 

component may be replaced with TVP 

during processing. 

According to information presented to 

the Agency, TVP is particularly useful 

in developing lower fat versions of 

cooked sausages and other comminuted 

meat and poultry products. Although 

the standards for these kinds of 

products generally do not prescribe a 

minimum meat or poultry content, most 

of these standards limit the amount of 

fat that is permitted in the product. For 

example, the standard for cooked 

sausages defined in 9 CFR 319.180 

limits the fat content of these products 

to no more than 30% of the finished 

product, and the standard for ground 

beef defined in 9 CFR 319.15 limits the 

fat content in this product to no more 

than 30%. Thus, under this final rule, 

the amount of TVP permitted in such 

33810 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

products will be limited by both the 

requirement that fat replacing 

ingredients may be used only at the 

lowest level necessary to replace fat and 

by the minimum fat content 

requirement established by the product 

standard. 

For example, a substitute cooked 

sausage produced under the general 

standard is permitted to contain up to 

30% TVP, provided that the sole 

function of the TVP is to replace the fat. 

For purposes of this rule, FSIS does not 

consider replacing the fat component of 

a single ingredient standardized 

product, such as ground beef, as 

reducing the product’s meat content, 

provided that the product complies with 

the manufacturing and labeling 

requirements prescribed in this final 

rule. 

To eliminate the possibility of 

confusion, the phrases ‘‘textured 

vegetable protein shall not replace 

meat’’ and ‘‘textured vegetable protein 

shall not replace poultry,’’ which were 

used as examples in the regulatory text 

of proposed 9 CFR 319.10(c)(2) and 

381.172(c)(2), will be removed in the 

final rule. These phrases are 

unnecessary because the regulation 

already prohibits reductions in the meat 

or poultry content required by a 

regulatory standard regardless of 

whether TVP is used in the product. 

Other Foods as ‘‘Fat Replacers’’ 

Nine commenters indicated that in 

the final rule, FSIS should permit foods, 

such as bread, rice, potatoes, fruits, and 

vegetables to be used in substitute 

standardized meat and poultry products 

to reduce their fat content. Some of 

these commenters stated that these 

ingredients could serve the same role as 

the water and binder systems permitted 

as fat replacers in the proposed rule, but 

that food ingredients are more beneficial 

because they may contain some 

nutritional constituents, such as 

vitamins and minerals, that many 

binders do not. One commenter stated 

that food ingredients, when used at 

proper levels, help to provide 

consumers with substitute standardized 

products that perform similarly to 

traditional standardized products. 

Another commenter stated that the 

nutrition label would enable consumers 

to make informed purchase decisions 

based on the entire nutritional profile of 

the product. This commenter pointed 

out that many consumers would prefer 

the nutritional profile of substitute 

standardized products that use starchy 

vegetables and complex carbohydrates, 

such as rice and potatoes, rather than a 

combination of water and ingredients 

such as highly refined vegetable gums to 

lower the percentage of calories from 

fat. One commenter stated that it makes 

sense to allow other foods as fat 

replacers if the goal is to make more 

healthful products available to 

consumers. Another commenter 

suggested that consumers might be more 

interested in overall nutritional quality, 

taste, convenience, and performance of 

the product than in the specific 

ingredients present in the product. 

Response: FSIS concedes that because 

foods such as bread, rice, potatoes, 

fruits, and vegetables, have little or no 

fat, their use as ingredients in 

standardized meat and poultry product 

could have the effect of reducing the fat 

content of such products. However, 

when foods are used as ingredients in a 

standardized product, the composition 

of the product may be altered to such an 

extent that the resulting product is not 

a substitute version of the traditional 

standardized product but a new and 

different product with a separate 

identity that reflects the combination of 

the individual foods. For example, 

because diced apples and rice are not 

specified as ingredients in the 

standardized product ‘‘Pork Sausage,’’ 

when they are added to ‘‘Pork Sausage,’’ 

the result is a new product, which, 

provided that it does not have a 

standard of identity or composition 

prescribed by 9 CFR part 319 or other 

established common or usual name, is 

required to bear a descriptive name, 

such as ‘‘Pork Sausage with Diced 

Apples and Rice,’’ that clearly identifies 

the product (see 9 CFR 317.2(c)(1) and 

(e) and 9 CFR 381.117(a)). Because the 

product ‘‘Pork Sausage with Diced 

Apples and Rice’’ is a new product and 

not a substitute version of the 

standardized product ‘‘Pork Sausage,’’ it 

is not the type of product that the 

general standard established by this 

final rule is intended to address. 

As a point of clarification, this final 

rule does not prevent non-standardized 

meat and poultry products that use food 

ingredients to reduce their fat content 

from using a traditional nutrient content 

claim permitted under 9 CFR 317 

subpart B and 381 subpart Y, provided 

they meet the requirements of the claim. 

For example, the product ‘‘Pork Sausage 

with Diced Apples and Rice’’ is 

permitted to bear the claim ‘‘low fat’’ on 

its label if it complies with § 317.362, 

and therefore, may be referred to as 

‘‘Low Fat Pork Sausage with Diced 

Apples and Rice.’’ Consumers who 

prefer the nutritional profile of meat and 

poultry products that use other foods, 

rather than binders and water, or other 

functional food additives, to reduce 

their fat content will be able to identify 

these products by their descriptive 

product name and the traditional 

nutrient content claim on the product 

labeling. Furthermore, any benefits in 

the nutritional profile of products that 

use foods as ingredients to reduce their 

fat content will be reflected in the 

nutrition facts panel, as well, if 

appropriate, in other nutrient content 

claims. 

Prohibited Ingredients 

Comment: One commenter expressed 

agreement with the provision in 

proposed 9 CFR 319.10(c)(3) and 

381.172(c)(3) that states that ingredients 

specifically prohibited for use in 

standardized meat and poultry products 

should also be prohibited for use in 

substitute standardized products subject 

to the general standard. However, the 

commenter felt that ingredients 

prohibited from use in all meat and 

poultry products should be based on 

safety considerations rather than quality 

considerations. 

Response: The general standard 

allows for the use of any safe and 

suitable fat replacement ingredient, e.g., 

binders and water. Under the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.), FDA is responsible for 

determining the safety of food 

ingredients for use in food in general. 

Under the authority of the FMIA and 

PPIA, FSIS acquiesces to FDA’s safety 

judgments, but FSIS determines the 

suitability of ingredients determined to 

be safe by FDA for use in meat and 

poultry products. These responsibilities 

are fully described in the final rule 

‘‘Food Ingredient and Sources of 

Radiation Listed or Approved for Use in 

the Production of Meat and Poultry 

Products,’’ which was published in the 

December 23, 1999, Federal Register (64 

FR 72168). 

Thus, although it is the responsibility 

of the FDA to evaluate the safety of a 

substance for use in meat or poultry 

products, under the authority of the 

FMIA and PPIA, FSIS may preclude the 

use of a substance in meat or poultry 

products for reasons other than safety. 

There are instances in which the use of 

a substance, even if safe, may promote 

deception when used in a meat and 

poultry product, and, accordingly, such 

use would be prohibited by FSIS. For 

example, paprika is considered GRAS 

by FDA and is also listed for use as a 

color additive, but the FSIS regulations 

prohibit its use on fresh, uncooked meat 

products because such use adds color 

that may make the meat appear fresher 

than it actually is (9 CFR 424.23(a)(1)). 

Therefore, it is incumbent upon FSIS to 

consider suitability, as well as the 

safety, of ingredients for use in the 

production of meat and poultry 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33811 

products in order to prevent these 

products from being adulterated or 

misbranded. 

Processing Methods/Anatomical 

Location for Meat and Poultry 

Ingredients 

Comment: One commenter stated that 

the provision in proposed §§ 319.10 and 

381.172 that requires that the meat 

portion of a substitute standardized 

product undergo the same basic 

processing procedures as the traditional 

standardized product for which it is a 

substitute has the potential to limit the 

use of new technologies without 

producing any stated goal that would 

justify the limitation. The commenter 

stated, that as long as the substitute 

standardized product has performance 

characteristics that are similar to the 

traditional standardized product, and is 

produced only from authorized 

ingredients, additional restrictions on 

processing procedures are unnecessary 

and undesirable. 

Another commenter stated that the 

general standard should permit 

substitute standardized products to 

contain different meat species and 

different kinds of poultry than those 

prescribed by the traditional standard, 

and that it should permit meat or 

poultry from different anatomical 

locations than the locations prescribed 

by the traditional standard, provided 

that the difference in species or 

anatomical location is stated in the 

product name. This commenter felt that 

a literal reading of the proposed 

regulation could be interpreted to mean 

that products such as ‘‘Beef Bacon’’ or 

‘‘Pork Shoulder Bacon’’ would no longer 

be permitted to include the term 

‘‘Bacon’’ in their product names if 

coupled with a nutrient content claim. 

The commenter went on to say that 

these kinds of products should continue 

to be permitted to be marketed under 

the same familiar names that have been 

used in the past, and that use of a 

nutrient content claim next to the 

product name should not change this. 

Response: The intent of the general 

standard for substitute standardized 

products is to enable the meat and 

poultry industries to produce modified 

versions of standardized products that 

have reductions of certain constituents 

that are of health concern to some 

consumers, such as fat, cholesterol, and 

sodium, and to increase flexibility and 

support product innovation. Under this 

rule, deviations from the existing 

standards are not expected to result in 

a product that no longer resembles the 

original standardized product. Thus, the 

use of a different meat species or kind 

of poultry, or the use of meat or poultry 

from different anatomic locations from 

those specified in the standard, that 

results in a product that is so physically 

dissimilar from the traditional 

standardized product that it does not 

meet the definition of ‘‘substitute’’ set 

forth in 9 CFR 317.313(d) and 

381.413(d) would be inconsistent with 

the intent of this rule. For these kinds 

of products to represent themselves as 

substitute standardized products would 

be false and misleading under the FMIA 

and PPIA. 

As an illustration, the regulatory 

standard for ‘‘Bacon’’ under 9 CFR 

319.107 requires that this product be 

prepared from cured, sliced pork bellies. 

Curing and slicing a cut of meat from a 

different livestock species or from a 

different anatomical location, or 

preparing sliced pork bellies using a 

method other than curing, would result 

in a product with physical 

characteristics so different from the 

standardized product ‘‘Bacon’’ that the 

resulting product could not be 

considered a ‘‘substitute’’ for bacon 

under 9 CFR 317.313(d) and 381.413(d). 

Thus, instead of being identified as a 

substitute product, the product would 

be identified by a descriptive term such 

as ‘‘Beef Bacon’’ or ‘‘Pork Shoulder 

Bacon.’’ 

However, FSIS will consider the types 

of changes requested by the 

commenters, such as amending a 

standard to permit the use of alternative 

processing methods, on a case-by-case 

basis. FSIS agrees that certain 

technologies used to prepare 

standardized foods may yield a product 

with the same physical, nutritional, and 

sensory characteristics as the food made 

in accordance with the traditional 

standards. To reflect this fact, instead of 

specifying that substitute standardized 

products must contain all ingredients 

specifically required by a standard of 

identity or composition, and that the 

meat or poultry portion of substitute 

products come from the same 

anatomical location, be of the same kind 

and amount, and undergo the same 

basic processing procedures as the 

standardized product as was proposed, 

FSIS is revising §§ 319.10(c)(4) and 

381.172(c)(4) to require only that 

substitute standardized products 

comply with all other applicable 

standards of identity or composition. 

Regarding the comment expressing 

concern that under the general standard, 

products such as ‘‘Beef Bacon’’ or ‘‘Pork 

Shoulder Bacon’’ would no longer be 

permitted to include ‘‘Bacon’’ in their 

product names if coupled with a 

nutrient content claim, as previously 

mentioned, FSIS intends to apply the 

principles embodied in the general 

standard established by this final rule to 

other products as appropriate. The 

Agency will clarify this fact in a policy 

bulletin after this final rule is published. 

Thus, this final regulation will not 

prohibit the ‘‘bacon-like’’ products 

described in the Policy Book, such as 

‘‘Turkey Bacon-Cured Turkey Breast 

Meat-Chopped and Formed,’’ from being 

modified to qualify to use a nutrient 

content claim as part of the product 

name. The modified version of this 

‘‘bacon-like’’ product would be 

permitted to be identified as ‘‘Low Fat 

Turkey Bacon-Cured Turkey Breast 

Meat-Chopped and Formed.’’ FSIS 

reiterates that the intent of this rule is 

to provide a wider array of nutritionally 

improved substitute products that 

would provide consumers with more 

meat and poultry products from which 

to choose. The intent is not to diminish 

or interfere with markets providing 

innovative as well as traditional kinds 

of products to consumers. 

Minimum Meat and Poultry 

Requirement 

Comment: Several commenters 

submitted statements both for and 

against the proposed requirement that a 

substitute standardized product subject 

to the general standard rule maintain 

the same minimum meat or poultry 

requirement as the standardized product 

for which it is a substitute. Seven 

commenters agreed that substitute 

standardized products should be 

required to maintain the minimum meat 

and poultry requirement established by 

the traditional standard, while ten 

commenters expressed disagreement 

with this requirement. 

Several commenters stated that the 

meat or poultry content of a 

standardized product often contains the 

highest concentration of fat, and, while 

it may be theoretically possible for 

manufacturers to use leaner meat to 

reduce fat, it is not economical. One of 

these commenters stated that fatreduced products that meet the existing 

minimum meat or poultry content 

requirement would be prohibitively 

expensive. Another commenter stated 

that relying exclusively on leaner meat 

to reduce fat might also make products 

tougher in texture and less palatable. 

Another commenter stated that, without 

reducing the ‘‘meat block’’ (meat or 

poultry content), the proposed general 

standard can not deliver on its promise 

to encourage innovation and the 

production of nutritionally improved 

meat and poultry products. 

Some commenters stated that 

minimum meat and poultry content 

requirements for substitute products are 

not necessary so long as the labeling of 

33812 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

the substitute standardized products 

provides sufficient information to 

distinguish these products from the 

traditional standardized products for 

which they substitute. One commenter 

submitted data showing that consumers 

do not mind if part of the meat block in 

a substitute product is replaced with 

another ingredient, so long as the 

labeling of the substitute standardized 

product discloses the presence of the 

replacing ingredient. Another 

commenter stated that trends in 

consumer behavior, which include 

reducing the amount of meat consumed 

in order to reduce fat intake, strongly 

support the argument that consumers 

will not be misled by nutrient-modified 

food products that contain less meat and 

poultry than is required by the 

traditional standardized form of the 

food. One commenter suggested that a 

substitute standardized product with 

reductions in its meat or poultry content 

should state on its label that, ‘‘in order 

to reduce fat, this product contains less 

meat than the traditional standardized 

product.’’ Some commenters stated that 

nutritional equivalency, rather than 

meat-content equivalency, should serve 

as the basis for defining requirements 

for the use of nutrient content claims. 

These commenters felt that FSIS should 

allow for necessary reductions in meat 

or poultry content to meet the 

requirements of the claim, with the 

reduction accomplished in such a 

manner that nutritional equivalency to 

the traditional standardized product is 

maintained. One commenter stated that 

meat replacers may be more desirable 

than some of the fat replacers, which 

hold water but contribute little in taste 

or nutritional value. 

One commenter stated that it is 

widely recognized that the requirements 

for minimum meat content are based on 

the notion that meat and poultry 

represented the most valuable 

constituent of a meat or poultry product. 

This commenter claimed that meat and 

poultry are simply no longer the 

indisputable ‘‘highest value’’ 

components of food products. Another 

commenter mentioned that FDA 

regulations provide for marketing of 

products, such as reduced-fat peanut 

butter, which allows for reduction of the 

peanut content of the product below 

that required for the standardized 

product. 

Those commenters that agreed with 

the requirement that substitute 

standardized products subject to the 

general standard maintain the same 

minimum meat and poultry requirement 

as the standardized product for which 

they are a substitute maintained that 

consumers have come to expect a 

certain amount of meat or poultry in 

products that bear a standardized term, 

and that the meat and poultry content 

of the product is still the most valued 

constituent. 

Response: Because many consumers 

have come to expect a certain amount of 

meat or poultry in products that bear a 

standardized term, deviations in the 

prescribed meat or poultry content will 

not be permitted in this final rule. 

Moreover, while FSIS appreciates these 

comments, the Agency does not view 

this rulemaking as the appropriate 

vehicle for changing the specific meat 

and poultry content requirements of 

meat and poultry product standards. 

These issues will be considered in a 

separate rulemaking that will examine 

FSIS’s overall regulatory approach to 

standardized meat and poultry products 

that was described in the ANPR ‘‘Meat 

and Poultry Standards of Identity and 

Composition’’ published in the 

September 9, 1996, edition of the 

Federal Register (61 FR 47453). 

In response to that ANPR, FSIS and 

FDA are jointly working on a more 

comprehensive approach to 

modernizing food standards whose goal 

is to establish ‘‘general principles’’ that 

interested parties could follow in 

requesting changes to food standards. 

One change that interested parties may 

be able to pursue, if these principles are 

adopted, would be reductions in the 

meat or poultry content requirements of 

standardized products. FSIS and FDA 

expect to soon publish the joint 

proposed rule in the Federal Register. 

Nomenclature-Labeling of Nutrient 

Content Claims 

Comment: Of those who commented, 

all agreed that the name of a substitute 

standardized product subject to the 

general standard should be an expressed 

nutrient content claim in conjunction 

with (i.e., next to) the appropriate 

standardized term, as provided in the 

proposal. However, several commenters 

did not agree with the provision in 

proposed 9 CFR 319.10(d) and 9 CFR 

381.172(d) that states that the nutrient 

content claim and standardized term 

should be presented ‘‘in the same style, 

color, and size of type on the product 

label.’’ 

One commenter stated that it was 

unaware of any evidence that 

consumers are confused or misled by 

the labels currently in the marketplace 

on similar FDA-regulated products, 

which are not subject to a style, color, 

and size of type requirement. The 

commenter stated that the 3:1 type size 

requirement that generally applies to 

names on FSIS-regulated products 

should apply to foods that are marketed 

under the general standard rule. 

Another commenter stated that some 

flexibility should be allowed for the 

type size of the nutrient content claim. 

The commenter stated that some 

product names are fairly lengthy, and 

therefore, FSIS’s Policy Memo 87A , 

Word Size in Labeling of Product Names 

and Fanciful Names, states that the 

Agency will not object to a 1⁄3 type size 

flexibility between the largest letter and 

the smallest letter in a product name. 

The commenter also noted that the 

existing FSIS regulations for nutrient 

content claims allow a 1⁄2 type size 

flexibility to assure that nutrient claims 

are not disproportionately larger than 

the product’s statement of identity. 

Two commenters stated that the FDA 

regulation establishing a general 

standard for FDA-regulated substitute 

standardized products (21 CFR 

130.10(e)) does not contain the same 

restrictions on the style, color, and size 

of type of the nutrient content claim that 

FSIS’s proposed rule does. One of these 

commenters requested that FSIS 

consider modifying the proposed 

nomenclature for products subject to its 

general standard to make it similar in 

format to that prescribed by the FDA 

regulation. A similar comment 

suggested that FSIS delete the last 

clause from the nomenclature section, 

i.e., ‘‘ * * * which shall be in the same 

style, color, and size of type,’’ because 

it is unwarranted and unnecessary to 

inform consumers of the nature of the 

substitute product. 

Response: FSIS agrees with the 

commenters’ arguments and in this final 

rule has deleted the last clause from the 

nomenclature section (‘‘ * * * which 

shall be in the same style, color, and 

size of type’’). FSIS has been persuaded 

by the arguments against requiring the 

nutrient content claim portion of the 

substitute standardized product’s name 

to be presented in the same style, color, 

and size of type, as the standardized 

product term and agrees that this 

requirement is unnecessary for 

consumers to distinguish the substitute 

product from other products that bear 

nutrient content claims but that are not 

substitute products that meet the 

requirements of this final rule. 

Therefore, to harmonize, to the extent 

possible, its labeling requirements with 

the labeling requirements of FDA’s 

corresponding regulations found in 21 

CFR 130.10, FSIS will not require that 

the expressed nutrient content claim 

that is part of the product identity 

appear in ‘‘the same style, color, and 

size of type’’ as the standardized term. 

The product name on the principal 

display panel of the substitute product, 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33813 

as well as its ingredients statement, are 

the pertinent labeling features that 

identify the differences between the 

traditional standardized product and the 

modified version bearing the 

standardized name. 

Ingredient Labeling 

Comment: Twenty commenters 

expressed agreement with the provision 

in proposed 9 CFR 319.10(e) and 

381.172(e) that all safe and suitable 

ingredients not provided for by the 

traditional standard, as well as 

permitted ingredients added at a level in 

excess of those allowed by the 

traditional standard, must be 

appropriately identified as such with an 

asterisk in the ingredients statement. 

Three commenters disagreed. 

Two commenters stated that because 

a nutrient content claim calls the 

consumer’s attention to the fact that the 

product has been modified from the 

traditional standardized product, there 

is no need for asterisks to be included 

in the labeling information. These 

commenters believed that the product 

name with the appropriate nutrient 

content claim, along with the 

ingredients statement, is all that is 

necessary to adequately inform the 

consumer that the product has been 

modified from the traditional standard. 

One commenter stated that, in addition 

to adding to label clutter, the 

requirement to highlight ingredients 

present in amounts greater than in the 

standardized product could result in the 

‘‘ludicrous’’ situation where a label 

indicates that the substitute product 

contains more meat than the traditional 

standardized product. The commenter 

felt that requiring an asterisks for 

particular ingredients will provide a 

disincentive for meat and poultry 

processors to make products using the 

new technologies in fat replacement 

products because they must market 

products with labels that are cluttered 

with additional statements. 

One commenter expressed support for 

using an asterisk to identify ingredients 

not provided for, or used in excess of 

those levels provided for, by the 

traditional standard in so far as it 

provides parity with FDA’s regulation 

but questioned the real value of this 

labeling feature to the consumer. The 

commenter suggested that this labeling 

requirement be applicable on a shortterm basis, with provisions for its phaseout in no more than three years as 

consumer become more familiarly with 

nutritionally-modified foods. 

Two commenters felt that FSIS should 

require more than just the identification 

of the substitute ingredients in the 

ingredients listing, as proposed by the 

Agency. These commenters suggested 

that FSIS also require that whenever 

ingredients are present in the substitute 

product that are not permitted by the 

traditional product standard, an 

appropriate disclosure (e.g. ‘‘made with 

non-standard ingredients—see back 

panel for ingredient lists’’) appear on 

the principal display panel. One of 

these commenters stated that such a 

disclosure would alert consumers to the 

fact that a substitute product is different 

from the standardized product and 

would direct them to specific 

information about the differences. 

Several commenters requested that 

FSIS clarify whether the ingredient 

‘‘water’’ or the added moisture not 

normally in or in excess of that 

permitted in a standardized product 

should be indicated with an asterisk. 

Response: FSIS disagrees with the 

comment that ingredients not provided 

for by the traditional standard, as well 

as permitted ingredients added at a level 

in excess of those allowed by the 

traditional standard, need not be 

identified as such with an asterisk in the 

ingredients statement. Differences 

between the ingredients in a 

standardized product and a substitute 

standardized product identified in part 

by a nutrient content claim must be 

highlighted so that consumers will be 

able to differentiate between the 

traditional standardized product and the 

substitute version. Highlighting these 

ingredient differences also ensures that 

the labeling of the substitute product 

will not be misleading. Furthermore, as 

a point of clarification, when water or 

added moisture not found in or used in 

excess of that permitted in a traditional 

standardized product is added to a 

substitute standardized product, this 

fact must be highlighted with an asterisk 

as is required for all other safe and 

suitable ingredients not found in, or 

used in excess of, the amount permitted 

by the traditional standard. 

FSIS disagrees with the comment that 

requiring an asterisks to highlight 

specific ingredients present in a 

substitute standardized product will 

provide a disincentive for meat and 

poultry processors to make and 

manufacture standardized products 

with reductions in their fat content. 

Similar labeling has been required on 

FDA-regulated products for several 

years and does not appear to have been 

a disincentive for industry to develop 

these kinds of products. FSIS also 

disagrees that labeling features in 

addition to those provided in the 

proposed rule are necessary to inform 

consumers of ingredient differences 

between a traditional standardized 

product and its nutritionally modified 

substitute. Highlighting ingredient 

differences with an asterisk in the 

ingredients statement, along with the 

product name on the principal display 

panel, are the pertinent labeling features 

that identify the differences between the 

traditional standardized product and the 

substitute version. Furthermore, to some 

consumers, statements such as ‘‘made 

with non-standard ingredients’’ may 

imply that the ingredients used in a 

substitute product are inferior or 

harmful to the ingredients used in the 

traditional standardized product. Such 

statements could be misleading because 

only ingredients that have been found to 

be safe and suitable for use in meat and 

poultry products are permitted to be 

used in formulating substitute 

standardized products. 

Consumers who have purchased 

substitute standardized products 

manufactured pursuant to FDA’s general 

standard codified at 21 CFR 130.10 are 

familiar with the labeling of such 

products through the use of asterisks 

and the statement referenced by the 

asterisks, which appear adjacent to the 

ingredient list. Thus, many consumers 

already look to the ingredient statement 

to determine differences in formulation 

between traditional standardized 

products and nutritionally modified 

versions of these products. Harmonizing 

labeling to the extent possible with that 

of the FDA benefits consumers by 

providing a more consistent food 

labeling system across all foods. 

FSIS finds no merit in the comment 

that asterisks are unnecessary because 

they could lead to the ‘‘ludicrous’’ 

situation where an ingredients 

statement asterisk would indicate that 

more meat or poultry than required by 

the food standard has been used in the 

product. Because food standards for 

meat and poultry products generally 

require minimum amounts of meat and 

poultry and maximum amounts of fat 

and water, it has always been possible 

for manufacturers to include more meat 

or poultry than the minimum 

established by the food standard in the 

product formulation. This rule does not 

change that fact and there is no need to 

require an asterisk to highlight the fact 

that a manufacture chose to include 

more meat or poultry in a substitute 

product than the minimum required by 

the traditional standard. 

Regarding the comment that the 

asterisk provision should be phased out 

at some point in the future, FSIS does 

not agree with this view because the 

ingredient statement is the primary 

feature where the differences between 

the standardized product and the 

substitute version can be made known 

to the consumer in labeling. As 

33814 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

described earlier, during the joint FSIS 

and FDA standards modernization 

activities, if appropriate, the agencies 

may revisit the issue of phasing out the 

asterisk requirement and consider it 

within the context of a more 

comprehensive approach to food 

standards modernization. 

The Final Rule 

In this final rule, FSIS is establishing 

a general definition and standard of 

identity for standardized meat and 

poultry products that have been 

modified to qualify for use of an 

expressed nutrient content claim in 

their product names in conjunction with 

a standardized term. FSIS is adding new 

§§ 319.10 and 381.172 to the meat and 

poultry products regulations in title 9 of 

the CFR. As was proposed, §§ 319.10(a) 

and 381.172(a) describe the type of meat 

and poultry products that are defined by 

the general standard. These are products 

that substitute, in accordance with 9 

CFR 317.313(d) or 381.413(d), for a 

standardized product, but that do not 

comply with the established standard 

because of a compositional deviation 

that results from reductions of a 

constituent that is described by an 

express nutrient content claim, such as 

‘‘low fat’’ or ‘‘fat free.’’ 

As was proposed, §§ 319.10(b) and 

381.172(b) require that a substitute 

standardized product subject to the 

general standard have similar 

performance characteristics to the 

traditional standardized product for 

which it is a substitute. However, if a 

substitute product has performance 

characteristics that materially limit the 

uses of the product compared to the 

uses of the traditional standardized 

product, §§ 319.10(b) and 381.172(b) 

require that a product’s label include a 

disclaimer informing consumers of such 

differences, such as ‘‘not suitable for 

grilling.’’ In response to some of the 

comments and to be consistent with the 

existing definition of substitute 

products found in 9 CFR 317.313 and 

381.413, FSIS is removing the provision 

in proposed §§ 319.10(b) and 381.172(b) 

that would have required the 

performance characteristics disclaimer 

to appear ‘‘adjacent to the product 

name.’’ Deleting this provision is also 

intended to provide consistency with 21 

CFR 130.10 of the FDA regulations, 

which is the codified general standard 

of identity for substitute standardized 

products under FDA jurisdiction. As 

was proposed, §§ 319.10(b) and 

381.172(b) will require that deviations 

in the ingredients in a substitute 

standardized product be the minimum 

necessary to qualify for the nutrient 

content claim. 

Sections 319.10(c) and 381.172(c) 

prescribe the ingredients that must be 

used in, and the ingredients that are 

permitted to be used in, substitute 

standardized products under the general 

standard. As was proposed, 

§§ 319.10(c)(1) and 381.172(c)(1) require 

that the ingredients used in a substitute 

standardized product be those 

ingredients provided for by the 

traditional standard, except that in 

addition, safe and suitable ingredients 

may be used in the substitute product at 

the minimum level necessary to 

improve texture or prevent synereses. 

The final rule replaces references to 

former §§ 318.7 and 381.147 with the 

phrase ‘‘as provided in a regulation 

permitting that use in this subchapter or 

in 9 CFR Chapter III, Subchapter E, or 

in 21 CFR Chapter I, Subchapter A or 

Subchapter B,’’ to reflect the issuance of 

the final rule ‘‘Food Ingredients and 

Sources of Radiation Listed or 

Approved for Use in Meat and Poultry 

Products’’ (64 FR 72168). 

As was proposed, §§ 319.10(c)(2) and 

381.172(c)(2) forbid substitute 

standardized products to replace or 

exchange ingredients required by the 

traditional standard with functionally 

similar ingredients from other sources 

not provided for in the traditional 

standard. In the final rule, FSIS is 

removing the phrases ‘‘textured 

vegetable protein shall not replace 

meat’’ and ‘‘textured vegetable protein 

shall not replace poultry’’ from 

proposed §§ 319.10 (c)(2) and 

381.172(c)(2). These phrases are 

unnecessary and could potentially cause 

confusion since the final rule permits 

TVP to be used in limited amounts as 

a fat replacer, although it may not be 

used to replace meat. Reductions in the 

meat or poultry content required by the 

traditional standard are already 

prohibited by the final rule regardless of 

whether TVP is used in the product. 

As was proposed, §§ 319.10(c)(3) and 

381.172(c)(3) prohibit substitute 

standardized products from containing 

ingredients that are prohibited for use in 

traditional standardized products. 

Proposed §§ 319.10(c)(2) and(3), and 

381.172(c)(2) and (3) use the phrase 

‘‘[a]n ingredient or component of an 

ingredient’’ when describing the 

ingredients permitted and prohibited in 

substitute standardized products. In this 

final rule, FSIS is deleting the words ‘‘or 

component of an ingredient’’ because 

they are unnecessary and may cause 

confusion. 

Proposed, §§ 319.10(c)(4) and 

381.172(c)(4) required substitute 

standardized products to conform to 

certain aspects of the traditional 

standard, such as the meat or poultry 

content specified in the standard, the 

anatomic location and kind of meat or 

poultry specified in the standard, and 

the processing procedures specified in 

the standard. As previously mentioned, 

deviations from these types of 

requirements may result in a product 

that is so physically dissimilar from the 

traditional standardized product that it 

does not come within the established 

definition of a substitute product. 

However, because certain 

technologies used to prepare 

standardized foods may yield a product 

with the same physical, nutritional, and 

sensory characteristics as the food made 

in accordance with the traditional 

standards, FSIS intends to consider 

certain deviations from product 

standards, such as alternative 

processing methods, on a case-by-case 

basis. As stated above, FSIS and FDA 

are jointly working on a more 

comprehensive approach to 

modernizing food standards to establish 

‘‘general principles’’ that interested 

parties would follow in requesting 

changes to or creating new food 

standards. Therefore, FSIS is revising 

proposed §§ 319.10(c)(4) and 

381.172(c)(4) to require that substitute 

standardized products comply with all 

other applicable standards of identity or 

composition unless otherwise specified 

in part 319 or part 381. The Agency is 

making this revision to accommodate 

changes to food standards that may 

result from the joint FSIS/FDA food 

standards modernization approach. 

As was proposed, §§ 319.10(c)(5) and 

381.172(c)(5) permit water and fatreplacing binders to be used to reduce 

the fat content in a substitute 

standardized product subject to the 

general standard. Based on the 

comments and data submitted in 

response to the proposal in support of 

using TVP as a ‘‘fat replacer,’’ FSIS will 

permit the use of TVP as a functional fat 

replacing ingredient in substitute 

standardized products defined by the 

general standard. FSIS is adding new 

language to the final rule that permits 

the use of TVP as part of a fat 

replacement system at the lowest level 

necessary to achieve the technical effect 

of replacing the characteristics of fat in 

the substitute product. This language is 

found in new §§ 319.10(c)(6) and 

381.172(c)(6). Because §§ 319.10(c)(2) 

and 381.172(c)(2) of the final rule forbid 

reductions in the meat or poultry 

content of a substitute product where 

one is established by a standard, under 

the final rule, TVP may only be used to 

replace fat component and not to 

replace the lean meat or poultry content 

of the substitute standardized product. 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33815 

Sections 319.10(d) and 381.172(d) 

prescribe the nomenclature for the 

substitute meat and poultry products 

that comply with the general standard. 

As was proposed, these products may be 

identified by the appropriate expressed 

nutrient content claim and the 

applicable standardized term (e.g., ‘‘Fat 

Free Bologna’’). If a product meets the 

requirements of the general standard, it 

is itself a standardized product, and 

therefore, its name will not be required 

to contain the term ‘‘substitute’’ despite 

the fact that it does not meet all of the 

requirements of the traditional product 

standard. 

This final rule removes the provisions 

in proposed §§ 319.10(d) and 381.172(d) 

that would have required that the 

expressed nutrient content claim part of 

the substitute standardized product’s 

name appear in the ‘‘same style, color 

and size type’’ as the standardized term. 

This change is in response to public 

comments and to harmonize, to the 

extent possible, with similar FDA 

regulations. 

As was proposed, §§ 319.10(e) and 

381.172(e) require each of the 

ingredients used in the substitute 

product to be declared on the product 

label as required by the applicable FSIS 

regulations. 9 CFR parts 317 and 381, 

subpart N, require that all ingredients be 

listed by common or usual name in 

descending order of predominance by 

weight. As was proposed, §§ 319.10(e) 

and 381.172(e) also require that all safe 

and suitable ingredients not provided 

for by the traditional standard, as well 

as those used in excess of those 

permitted by the traditional standard, be 

identified as such with and asterisks in 

the ingredients statement. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been determined to be 

significant and therefore has been 

reviewed by OMB under EO 12866. 

I. Need for the Rule 

FSIS is issuing this rule to facilitate 

the development and availability of 

substitute standardized products that 

have reductions in certain constituents 

that are of health concern to some 

consumers, such as fat, cholesterol, and 

sodium. This rule allows FSIS to rely 

more on labeling requirements and less 

on restrictive recipe-like standards in 

endeavoring to ensure that the labels of 

meat and poultry products are truthful 

and not misleading as well as to 

improve the public health. The names of 

products covered by the General 

Standard will be composed of an 

express nutrient content claim that 

reflects the modifications made in 

formulating and processing the product 

(so that it qualifies to bear the claim) 

and an established standardized term. 

FDA has already promulgated a 

corresponding General Standard for the 

products that it regulates (21 CFR 

130.10). By harmonizing an FSIS 

labeling requirement with that of FDA, 

this final rule represents a significant 

step towards providing consumers with 

an informative and consistent food 

standard and labeling system. This final 

rule also promotes product innovation 

by encouraging the production of meat 

and poultry products that are low in 

constituents that are of health concern 

to some people. 

II. Description of Affected Industry 

FSIS regulations contain 

approximately 80 standards of identity 

or composition for meat and poultry 

products. Most of these standards are for 

processed products, including sliced, 

injected, smoked, fermented, heattreated, and raw products. According to 

the Agency’s Performance Based 

Inspection System Database, in the 

second quarter of 2003, there were 

approximately 6,600 Federal and State 

Establishments 2 that potentially will be 

affected by the final rule if they develop 

and make available substitute products 

for standardized products. Some of 

these establishments, however, are 

already producing sausage and other 

comminuted meat and poultry products 

under FSIS Policy Memo 121B and 

Policy Memo 123 which provide for the 

type of substitute products defined 

under this final rule. Thus, this rule is 

likely to have little or no impact on the 

processing establishments that are 

producing products in accordance with 

the policy memos. 

Ingredient manufacturers who 

produce binders and textured (source) 

protein products (e.g., textured soy or 

wheat protein) will be affected by the 

final rule because the rule will permit 

the increased use of these ingredients as 

fat replacing ingredients in some 

modified standardized products. 

III. Costs 

The decision to produce products 

subject to the General Standard 

established by this rule is voluntary. 

Therefore, only those manufacturers 

that choose to produce and market these 

products will incur the direct costs 

imposed by this rule. These costs 

include research and development, 

production and marketing, and labeling 

production. However, because the rule 

is voluntary, companies that choose to 

2 These establishments processed, froze, stored, or 

otherwise held meat and poultry products. 

produce products covered by the 

General Standard will do so only if they 

determine that the benefits of producing 

and selling these products outweigh the 

costs of complying with the final rule. 

Furthermore, companies that are already 

producing and marketing products 

under Policy Memo 121B and Policy 

Memo 123 (i.e., comminuted meat and 

poultry products) are likely to incur 

minimal or no costs as a result of this 

final rule. 

Under most circumstances, 

companies are likely to charge a 

premium for substitute standardized 

product produced in compliance with 

this final rule because many consumers 

will be willing to pay a premium for 

products with improved nutritional 

profiles. They view these products as 

‘‘value added’’ products.3 Therefore, 

based on the experience of food 

companies that are operating under 

FDA’s 21 CFR 130.10 regulations, e.g., 

the manufacturers of fat-free ice cream 

and reduced fat cream cheese, any costs 

associated with producing and 

marketing substitute products most 

likely will be passed on to the consumer 

in the form of higher retail prices. 

However, once this rule becomes 

effective, some companies that are not 

producing substitute meat and poultry 

products under Policy Memo 121B or 

Policy Memo 123 may begin to 

manufacture and market substitute 

standardized products in accordance 

with the General Standard because of 

the market value of using traditional 

product names. Their decision to do so 

could have the effect of increasing the 

supply of these types of products in the 

short run, which could translate into 

lower prices for consumers. 

IV. Benefits 

This rule will assist consumers in 

making dietary choices by providing for 

modified versions of standardized meat 

and poultry products that have 

reductions of certain constituents that 

are of health concern to some 

consumers, such as fat, cholesterol, and 

sodium. Therefore, there will be a 

greater opportunity for consumers to 

maintain or to initiate healthy dietary 

practices. In the United States, diets 

high in fat, cholesterol, and sodium are 

associated with chronic diseases such as 

coronary heart disease, cancer, stroke, 

and diabetes. In 2002, according to the 

Centers for Disease Control National 

Center for Chronic Disease Prevention 

and Health Promotion, 7 out of every 10 

U.S. deaths and more than 60% of 

medical care expenditures are attributed 

to chronic diseases. In addition, the 

3 Consumer purchasing trends. 

ER10JN05.003</GPH>

33816 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

prolonged illness and disability decrease the quality of life for millions 

associated with many chronic diseases of consumers. 

ESTIMATED DIRECT AND INDIRECT COSTS OF CARDIOVASCULAR DISEASES, STROKE, DIABETES, AND CANCER IN THE 

UNITED STATES—2002 

[In Billion of Dollars] 

Costs Cardiovascular 

diseases Stroke Diabetes Cancer 

Direct ................................................................................................................ $168.7 $30.8 $92.0 $61.0 

Indirect ............................................................................................................. 111.1 18.6 40.0 111.0 

Total .......................................................................................................... 279.8 49.4 132.0 172.0 

According to the 2002 Heart and 

Stroke Statistical Update published by 

the American Heart Association and the 

American Stroke Association, the total 

cost of cardiovascular diseases and 

strokes in the United States was 

estimated at $279.8 billion and $49.4 

billion, respectively, as reflected in the 

above table and figure 1 below. Direct 

costs ($168.7 billion and $30.8 billion, 

respectively) consist of the cost of 

physicians and other health 

professionals, hospital and nursing 

home services, medication, home health 

care, and other medical durables. 

Indirect costs ($111.1 billion and 18.6 

billion, respectively) consist of lost 

productivity resulting from morbidity 

and mortality. 

The total cost in 2002 associated with 

diabetes was $132 billion of which $92 

billion were direct costs and $40 billion 

were indirect costs.4 The estimated total 

costs for all cancers in 2002 were $172 

billion ($61 billion in direct costs and 

$110 billion in indirect costs) 5. 

Most chronic diseases are 

preventable, or their onset can be 

delayed, through increased physical 

activity and healthy eating. There is 

research to support that practicing good 

nutrition lowers the risk of chronic 

diseases for many consumers.6 The total 

estimated cost of chronic diseases to the 

consumer is $633.2 billion. The extent 

to which these costs might be reduced 

by an improved diet cannot be 

calculated precisely, but some 

researchers estimate that a balanced and 

healthful diet might forestall at least 20 

percent of the annual deaths from heart 

disease, stroke, cancer, and diabetes.7 

It is reasonably expected that the final 

rule could contribute to the reduction of 

these costs, but this contribution, too, 

cannot be calculated precisely. In the 

‘‘Economic Benefits of Nutrition 

Labeling: A Case Study for Fresh Meat 

and Poultry Products,’’ the Agency 

estimated the potential benefits of 

reducing the incidence of coronary heart 

disease and three types of cancers at 

$61.8 million, (7 percent discount rate); 

and $125 million (3 percent discount 

rate).8 

The results of the 2002 ‘‘Trends’’ 

survey’’ conducted by the Food 

4 ‘‘The Economic Costs of Diabetes in the U .S. 

2002’’, American Diabetes Association. 

5 Heart Disease and Stroke Statistics—2003 

Update, American Heart Association. 

6 CDC National Center for Chronic Disease 

Prevention and Health Promotion, ‘‘Physical 

Activity and Good Nutrition: Essential Elements to 

Prevent Chronic Diseases and Obesity.’’ 

7 ‘‘The American Diet: A Costly Health Problem, 

Food Review.’’ 

8 The Agency estimated the potential benefit of an 

FSIS rule (2001). Nutrition Labeling of ground or 

chopped meat and poultry products and singleingredient products. Federal Register, 66, 4969– 

4999. 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33817 

Marketing Institute (Trends in the 

United States, Consumer Attitudes and 

the Supermarket) stated that 80 percent 

of consumers surveyed indicated that 

they had sought out and purchased 

products based on ‘‘low-fat’’ claims; 60 

percent had purchased products 

because of ‘‘low cholesterol’’ claims; 59 

percent purchased products because of 

‘‘natural’’ claims; and 52 percent 

purchased products because of ‘‘low 

salt’’ claims. If this trend continues, and 

the final rule is promulgated, it is more 

than likely that the final rule will assist 

in the reduced incidence of chronic 

diseases by expanding the availability of 

meat and poultry products with lower 

levels of constituents such as fat, 

cholesterol, and sodium. 

In conclusion, this final rule will 

assist consumers who want to reduce 

their dietary intake of fat, cholesterol, 

and sodium by encouraging the 

production of modified versions of 

traditional meat and poultry products 

that are formulated with fat, cholesterol, 

and sodium-replacing ingredient 

systems that reduce these constituents. 

The final rule will provide parity with 

FDA’s regulations and will promote a 

unified approach to food standards and 

labeling. Most importantly, the final 

rule supports national efforts to reduce 

the expenditures for health care and the 

cost of morbidity and lost productivity 

by permitting the introduction of 

modified, substitute foods. 

In terms of administrative benefits, 

the General Standard established by this 

final rule will permit industry to 

introduce modified, substitute versions 

of traditional standardized meat and 

poultry products without having to 

petition FSIS to establish new standards 

for products on a case-by-case basis. 

This will generate efficiency within the 

food standards system by saving time 

and resources that would have been 

expended by both the industry and FSIS 

to establish new or modified product 

standards. It will also permit companies 

to introduce standardized meat and 

poultry products with improved 

nutritional profiles into the marketplace 

in a timely manner, making such 

products more readily available to 

consumers. 

V. Regulatory Flexibility Analysis 

The FSIS Administrator has made a 

final determination that this rule will 

not have a significant economic impact 

on a substantial number of small 

entities, as defined by the Regulatory 

Flexibility Act (5 U.S.C. 601). 

This final rule will not impose any 

new requirements on small entities. The 

decision to produce versions of 

standardized products that have been 

modified to qualify for use of an 

expressed nutrient content claim in 

conjunction with a traditional product 

name is voluntary. Therefore, the 

requirements of this final rule will only 

apply to those small manufacturers who 

choose to produce these types of 

products. Those small entities that 

choose to produce these products will 

be required to design new labels or to 

revise current labels to comply with this 

new rule, and thereby incur some costs. 

However, small entities who will be 

marketing these substitute products will 

most likely have anticipated that the 

revenues generated from the sale of 

these products will outweigh the costs 

of complying with the new regulation. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This final rule: (1) 

Preempts State and local laws and 

regulations that are inconsistent with 

this rule; (2) has no retroactive effect; 

and (3) does not require administrative 

proceedings before parties may file suit 

in court challenging this rule. However, 

the administrative procedures specified 

in 9 CFR 306.5, 381.35, and 590.320 

through 590.370 must be exhausted 

before any judicial challenge of the 

application of the provisions of this 

rule, if the challenge involves any 

decision of an FSIS employee relating to 

inspection services provided under the 

FMIA or PPIA. 

Paperwork Reduction Act 

In accordance with section 3507(j) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), FSIS will 

submit the information collection and 

recordkeeping requirements in this final 

rule to the Office of Management and 

Budget (OMB) for approval. 

Title: Food Standards: Requirements 

for Substitute Standardized Meat and 

Poultry Products Named by Use of an 

Expressed Nutrient Content Claim and a 

Standardized Term. 

Type of collection: New. 

Abstract: Under this final rule, FSIS is 

requiring that establishments that 

produce meat and poultry products in 

accordance with the definition and 

general standard of identity for 

substitute standardized products design 

new product labels and submit sketches 

of the new labeling to FSIS for approval. 

To receive approval of the labels, 

establishments must complete FSIS 

form 7234–1. FSIS employees review 

FSIS form 7234–1 to ensure that 

information on the labels complies with 

the regulations. 

Estimate of burden: FSIS estimates 

that it will take 60 minutes to design 

and develop modified product labels in 

accordance with the final regulations 

and 15 minutes to prepare FSIS form 

7234–1 and submit it, along with the 

label, to FSIS. 

Respondents: Establishments that 

produce substitute standardized meat or 

poultry products in accordance with 

this final rule. 

Estimated Number of Respondents: 

100. 

Estimated Number of Responses per 

Respondent: 5. 

Estimated Total Annual Burden on 

Respondents: 625 hours. 

Copies of this information collection 

assessment can be obtained from John 

O’Connell, Paperwork Reduction Act 

Coordinator, Food Safety and Inspection 

Service, USDA, 112 Annex, 300 12th 

Street, SW., Washington, DC 20250. 

Comments are invited on (a) Whether 

the collection of information is 

necessary for the proper performance of 

the functions of the Agency, including 

whether the information will have 

practical utility; (b) the accuracy of the 

Agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; (c) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, ways to 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques, or other forms of 

information technology. Comments may 

be sent to both John O’Connell, 

Paperwork Reduction Act Coordinator, 

at the address provided above, and the 

Desk Officer for Agriculture, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Washington, DC 20253. To be most 

effective, comments should be sent to 

OMB within 30 days of publication. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this final rule, 

FSIS will announce it on-line through 

the FSIS Web page located at http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2005_Interim_&_Final_Rules_Index/ 

index.asp. The Regulations.gov Web site 

is the central online rulemaking portal 

of the United States government. It is 

being offered as a public service to 

increase participation in the Federal 

government’s regulatory activities. FSIS 

participates in Regulations.gov and will 

33818 Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 

accept comments on documents 

published on the site. The site allows 

visitors to search by keyword or 

Department or Agency for rulemakings 

that allow for public comment. Each 

entry provides a quick link to a 

comment form so that visitors can type 

in their comments and submit them to 

FSIS. The Web site is located at 

http://www.regulations.gov/. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an email 

subscription service which provides an 

automatic and customized notification 

when popular pages are updated, 

including Federal Register publications 

and related documents. This service is 

available at http://www.fsis.usda.gov/ 

news_and_events/email_subscription/ 

and allows FSIS customers to sign up 

for subscription options across eight 

categories. 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 account. 

List of Subjects 

9 CFR Part 319 

Food grades and standards, Meat 

inspection. 

9 CFR Part 381 

Food grades and standards, Meat 

inspection, Poultry and poultry 

products. 

■ For the reasons stated in the preamble, 

FSIS amends 9 CFR parts 319 and 381 as 

follows: 

PART 319—DEFINITIONS AND 

STANDARDS OF IDENTITY OR 

COMPOSITION 

■ 1. The authority citation for part 319 

continues to read as follows: 

Authority: 7 U.S.C. 450, 1901–1906; 21 

U.S.C. 601–695; 7 CFR 2.18, 2.53. 

■ 2. Part 319, subpart A is amended by 

adding a new § 319.10 to read as follows: 

§ 319.10 Requirements for substitute 

standardized meat food products named by 

use of an expressed nutrient content claim 

and a standardized term. 

(a) Description. The meat food 

products prescribed by this general 

definition and standard of identity are 

those products that substitute, in 

accordance with § 317.313(d), for a 

standardized product defined in this 

part and use the name of that 

standardized product in their statements 

of identity, but that do not comply with 

the established standard because of a 

compositional deviation that results 

from reduction of a constituent that is 

described by an expressed nutrient 

content claim that has been defined by 

regulation in part 317, subpart B, of this 

subchapter. The expressed nutrient 

content claim shall comply with the 

requirements of § 317.313 of this 

subchapter and with the requirements of 

part 317, subpart B, of this subchapter 

which define the particular nutrient 

content claim that is used. The meat 

food product shall comply with the 

relevant standard in this part in all other 

respects, except as provided in 

paragraphs (b) and (c) of this section. 

(b) Performance characteristics. The 

performance characteristics, such as 

physical properties, functional 

properties, and shelf-life, of the meat 

food product shall be similar to those of 

the standardized meat food product 

produced under this part. If there is a 

significant difference in a performance 

characteristic that materially limits the 

use of the product compared to the use 

of the standardized product defined in 

this part, the label shall include a 

statement in accordance with 

§ 317.313(d)(1) and (2) of this 

subchapter that informs the consumer of 

such differences (e.g., if appropriate, 

‘‘not recommended for frozen storage’’ 

or ‘‘not suitable for roller grilling’’). 

Deviations from the ingredient 

provisions of the standard must be the 

minimum necessary to qualify for the 

nutrient content claim, while 

maintaining similar performance 

characteristics. 

(c) Ingredients used in substitute 

products. (1) Ingredients used in the 

product shall be those ingredients 

provided for in the standard as defined 

in this part, except that safe and suitable 

ingredients permitted for use in meat 

food products as provided in a 

regulation permitting that use in this 

subchapter or in 9 CFR Chapter III, 

Subchapter E, or in 21 CFR Chapter I, 

Subchapter A or Subchapter B, may be 

used at the minimum level necessary to 

improve texture and prevent syneresis, 

so that the substitute product is not 

inferior in performance characteristics 

from the standardized product defined 

in this part for which it is a substitute. 

(2) An ingredient that is specifically 

required by the standard prescribed in 

this part shall not be replaced or 

exchanged with a similar ingredient 

from another source, for example, turnip 

chunks shall not replace potatoes in 

corned beef hash. 

(3) An ingredient that is specifically 

prohibited from use in any meat food 

product by this part shall not be added 

to the substitute meat food product 

under this section. 

(4) Unless otherwise specified in this 

part, a substitute meat food product 

must meet all other requirements of the 

applicable standards of identity or 

composition. 

(5) Water and fat-replacers (e.g., 

binders), in combination, may be added 

to replace fat in accordance with 

paragraph (c) of this section. 

(6) Textured vegetable protein may be 

used by itself or in combination with 

other binders and water as a fat replacer 

in accordance with paragraph (c) of this 

section. 

(d) Nomenclature. The name of a 

substitute meat food product that 

complies with all parts of this section is 

the appropriate expressed nutrient 

content claim and the applicable 

standardized term. 

(e) Label declaration. (1) Each of the 

ingredients used in the substitute meat 

food product shall be declared on the 

label as required by this section and part 

317 of this subchapter. 

(2) Ingredients not provided for, and 

ingredients used in excess of those 

levels provided for, by the standard as 

defined in this part, shall be identified 

as such with an asterisk in the 

ingredients statement. The statement 

‘‘*Ingredients not in regular llll’’ 

(the blank shall be filled in with the 

name of the traditional standardized 

product) or ‘‘**Ingredients in excess of 

amounts permitted in regular llll’’ 

(the blank shall be filled in with the 

name of the traditional standardized 

product), or both, as appropriate, shall 

immediately follow the ingredients 

statement in the same type and size. 

PART 381—POULTRY PRODUCTS 

INSPECTION REGULATIONS 

■ 3. The authority citation for part 381 

would continue to read as follows: 

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

451–470, 7 CFR 2.18, 2.53. 

■ 4. Part 381, subpart P is amended by 

adding a new § 381.172 to read as 

follows: 

Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations 33819 

§ 381.172 Requirements for substitute 

standardized poultry products named by 

use of an expressed nutrient content claim 

and a standardized term. 

(a) Description. The poultry products 

prescribed by this general definition and 

standard of identity are those products 

that substitute, in accordance with 

§ 381.413(d), for a standardized product 

defined in this subpart and use the 

name of that standardized product in 

their statements of identity, but that do 

not comply with the established 

standard because of a compositional 

deviation that results from reduction of 

a constituent that is described by an 

expressed nutrient content claim that 

has been defined by regulation in this 

subpart. The expressed nutrient content 

claim shall comply with the 

requirements of § 381.413 and with the 

requirements in subpart Y of this part 

which define the particular nutrient 

content claim that is used. The poultry 

product shall comply with the relevant 

standard in this part in all other 

respects, except as provided in 

paragraphs (b) and (c) of this section. 

(b) Performance characteristics. The 

performance characteristics, such as 

physical properties, functional 

properties, and shelf-life, of the poultry 

product shall be similar to those of the 

standardized poultry product produced 

under subpart P of this part. If there is 

a significant difference in a performance 

characteristic that materially limits the 

use of the product compared to the use 

of the standardized product defined in 

subpart P of this part, the label shall 

include a statement in accordance with 

§ 381.413(d)(1) and (2) of this part, that 

informs the consumer of such 

differences (e.g., if appropriate, ‘‘not 

recommended for frozen storage’’ or 

‘‘not suitable for roller grilling’’). 

Deviations from the ingredient 

provisions of the standard must be the 

minimum necessary to qualify for the 

nutrient content claim, while 

maintaining similar performance 

characteristics. 

(c) Ingredients used in substitute 

products. (1) Ingredients used in the 

product shall be those ingredients 

provided for in the standard as defined 

in subpart P of this part, except that safe 

and suitable ingredients permitted for 

use in poultry products as provided in 

a regulation permitting that use in this 

subchapter or in 9 CFR Chapter III, 

Subchapter E, or in 21 CFR Chapter I, 

Subchapter A or Subchapter B, may be 

used at the minimum level necessary to 

improve texture and prevent syneresis, 

so that the substitute product is not 

inferior in performance characteristics 

from the standardized product defined 

in subpart P of this part for which it is 

a substitute. 

(2) An ingredient that is specifically 

required by the standard prescribed in 

subpart P of this part shall not be 

replaced or exchanged with a similar 

ingredient from another source, for 

example, extruded turnips shall not 

replace noodles in poultry with noodles. 

(3) An ingredient that is specifically 

prohibited from use in any poultry 

product by subpart P of this part shall 

not be added to the substitute poultry 

product under this section. 

(4) Unless otherwise specified in this 

part, a substitute poultry product must 

meet all other requirements of the 

applicable standards of identity or 

composition. 

(5) Water and fat-replacers (e.g., 

binders), in combination, may be added 

to replace fat in accordance with 

paragraph (c) of this section. 

(6) Textured vegetable protein may be 

used by itself or in combination with 

other binders and water as a fat replacer 

in accordance with paragraph (c) of this 

section. 

(d) Nomenclature. The name of a 

substitute poultry product that complies 

with this section is the appropriate 

expressed nutrient content claim and 

the applicable standardized term. 

(e) Label declaration. (1) Each of the 

ingredients used in the substitute 

poultry product shall be declared on the 

label as required by this section and 

subpart N of this part. 

(2) Ingredients not provided for, and 

ingredients used in excess of those 

levels provided for, by the standard as 

defined in subpart P of this part, shall 

be identified as such with an asterisk in 

the ingredients statement. The statement 

‘‘*Ingredients not in regular llll’’ 

(the blank shall be filled in with the 

name of the traditional standardized 

product) or ‘‘**Ingredients in excess of 

amounts permitted in regular llll’’ 

(the blank shall be filled in with the 

name of the traditional standardized 

product), or both, as appropriate, shall 

immediately follow the ingredients 

statement in the same type and size. 

Done in Washington, DC, on June 6, 2005. 

Barbara J. Masters, 

Acting Administrator. 

[FR Doc. 05–11493 Filed 6–9–05; 8:45 am] 

BILLING CODE 3410–DM–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Parts 170 and 171 

RIN 3150–AH61 

Revision of Fee Schedules; Fee 

Recovery for FY 2005 

AGENCY: Nuclear Regulatory 

Commission.


ACTION: Final rule; correction.


SUMMARY: This document corrects a 

final rule appearing in the Federal 

Register on May 26, 2005 (70 FR 30526) 

concerning the licensing, inspection, 

and annual fees charged to NRC 

applicants and licensees in compliance 

with the Omnibus Budget 

Reconciliation Act of 1990, as amended. 

This action is necessary to correct 

typographical and printing errors. 

EFFECTIVE DATE: July 25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Tammy Croote, telephone 301–415– 

6041; Office of the Chief Financial 

Officer, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001. 

SUPPLEMENTARY INFORMATION: 

1. On page 30531, in the first column, 

under Response, in the fourteenth line, 

the word ‘‘commenters?’’ is corrected to 

read ‘‘commenters.’’ 

2. On page 30535, in the second 

column, under 4. Charging Fees for 

Unlicensed Sites in Decommissioning, 

in the eleventh line, the word 

‘‘licensees?’’ is corrected to read 

‘‘licensees.’’ 

3. On page 30537, in TABLE III.— 

REBASELINED ANNUAL FEES FOR FY 

2005, the first number under the FY 

2005 Annual Fee column ‘‘$3,115,000’’ 

is corrected to read ‘‘$3,155,000.’’ 

4. On page 30540, in the second 

column, in the fourth line of the 

continued paragraph under Table VIII, 

the number ‘‘$2,966,000’’ is corrected to 

read ‘‘$2,996,000.’’ Also, in the tenth 

line in the same paragraph, the number 

‘‘$3,115,000’’ is corrected to read 

‘‘$3,155,000.’’ 

PART 170—[AMENDED] 

§ 170.31 [Corrected] 

■ 5. On page 30547, in § 170.31, in the 

table entitled SCHEDULE OF 

MATERIALS FEES, the Category of 

materials licenses and type of fees 

column entry for 14.B. ‘‘(insert date 1 

year from effective date of final rule)’’ is 

corrected to read ‘‘July 25, 2006.’’