[Federal Register: February 13, 1998 (Volume 63, Number 30)]

[Rules and Regulations]               

[Page 7279-7281]

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Rules and Regulations

                                                Federal Register


This section of the FEDERAL REGISTER contains regulatory documents 

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[[Page 7279]]




9 CFR Parts 317 and 381

[Docket No. 97-035F]

RIN 0583-AC47


Food Labeling: Nutrient Content Claims, Definition of Term; 


AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.


SUMMARY: In response to a petition, the Food Safety and Inspection 

Service (FSIS) is extending until January 1, 2000, the effective date 

of the requirement that individual meat and poultry products labeled as 

``healthy,'' or any other derivative of the term ``health,'' contain no 

more than 360 mg sodium and meal-type products contain no more than 480 

mg sodium. The petitioner raised issues regarding the technological 

feasibility of developing consumer-acceptable products with reduced 

sodium content and lack of scientific data about a link between sodium 

levels and health and safety factors. FSIS determined that the 

petitioner's concerns have merit and, as a result, is extending the 

effective date for the second tier, lower level sodium provisions.

DATES: Effective date: This rule is effective February 13, 1998. 

Written comments on extension of the effective date should be received 

by March 16, 1998. Written comments about instituting additional 

rulemaking should be received by May 19, 1998.

ADDRESSES: Submit one original and two copies of written comments to 

the FSIS Docket Clerk, Docket #97-035F, Room 102, Cotton Annex 

Building, 300 12th Street, SW., Washington, DC 20250-3700. All comments 

submitted on this rule will be available for public inspection in the 

Docket Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday through 


FOR FURTHER INFORMATION CONTACT: Mr. William J. Hudnall, Assistant 

Deputy Administrator, Office of Policy, Program Development and 

Evaluation; telephone (202) 205-0495.



    In the May 10, 1994, Federal Register (59 FR 24220), FSIS published 

a final rule to establish a definition of the term ``healthy,'' or any 

other derivative of the term ``health'' and similar terms, on meat and 

poultry product labeling. The Agency believes it is important to give 

consumers accurate, informative labeling on meat and poultry products 

that conform with such labeling on other foods. The final rule provides 

a definition for the implied nutrient content claim ``healthy'' for 

individual and meal-type products. Under 9 CFR 317.363(b)(3) and 

381.463(b)(3), for a food to qualify to use the term ``healthy,'' or a 

derivative of that term, on its label or in its labeling, the product 

must not contain more than 360 mg of sodium, except it shall not 

contain more than 480 mg of sodium during the first 24 months of 

implementation (through November 10, 1997) per reference amount 

customarily consumed (RACC) and per labeled serving size. Under 9 CFR 

317.363(b)(3)(i) and 381.463(b)(3)(i), a meal-type product, to qualify 

to bear this term, shall not contain more than 480 mg of sodium, except 

that it shall not contain more than 600 mg. of sodium during the first 

24 months of implementation, per labeled serving size.

    On December 7, 1996, FSIS received a petition from ConAgra, Inc., 

requesting that 9 CFR 317.363(b)(3) and 381.463(b)(3) be amended to 

``eliminate the sliding scale sodium requirement for foods labeled 

`healthy' by eliminating the entire second tier levels of 360 mg sodium 

requirements for individual foods and 480 mg sodium for meal-type 

products.'' As an alternative, the petitioner requested that the 

effective date of November 10, 1997, be delayed until food technology 

can develop acceptable products with reduced sodium content, and until 

there is better understanding of the relationship between sodium and 


    The petitioner cited as grounds for its request: (1) a lack of 

scientific basis supporting the Daily Reference Value for sodium (9 CFR 

317.309(c)(9) and 381.409(c)(9)) and the allowable maximum levels of 

sodium in sections 317.363(b)(3) and 381.463(b)(3); (2) a lack of 

consumer acceptance of products containing low sodium levels; (3) a 

lack of acceptable sodium substitutes and the difficulties in 

manufacturing whole lines of products at these low sodium levels; and 

(4) USDA's failure to provide adequate notice and an opportunity for 

public comment on the ``second tier'' sodium levels in the healthy 

definition, to follow congressional intent and the directives of the 

Nutrition Labeling and Education Act of 1990, and to consider all the 

science available, particularly studies which demonstrate possible harm 

to the general population by low sodium diets. FSIS believes that some 

of these assertions have raised questions that warrant further 


    Regarding the efforts of industry to lower the sodium level in 

foods, the petitioner stated that the technology does not yet exist to 

manufacture certain low fat meat and poultry products at the lower, 

second tier ``healthy'' definition levels of sodium and still provide 

foods that will be acceptable to consumers. The petitioner submitted 

the results of a consumer survey that examines consumer acceptance of 

several products with different sodium levels. Although the survey 

found reductions in consumer acceptance at levels of 480 mg sodium 

compared with higher (600 mg) sodium levels, there was a statistically 

significant drop in acceptance at levels of 360 mg sodium per serving.

    The petitioner described several technological concerns with 

lowering sodium levels in foods. These concerns related to the 

functional role of salt, such as the impact on the microbial stability 

of perishable products, changes in product texture and in water-binding 

capabilities, and effects on flavor characteristics of other 

ingredients and on total electrolyte levels that, according to the 

petitioner, play a critical role in product safety.

    The Agency does not find merit in the petitioner's questions 

regarding the lack of scientific basis for the usefulness of lowered 

sodium levels in the diet of the general population. There is 

significant agreement that lower dietary sodium

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levels reduce the risk of hypertension. (Note references at end of 

document.) The overwhelming majority of experts and of authoritative 

bodies still favors making recommendations for the general public to 

moderate sodium intake. This consensus is reflected in the Dietary 

Guidelines for Americans.

    FSIS also finds the petitioner's claim that the Agency failed to 

provide adequate notice and an opportunity for public comment on the 

second tier sodium levels in the ``healthy'' definition to be without 

merit. The sodium requirements for individual USDA-regulated foods and 

meal-type products that were adopted in the ``healthy'' final rule were 

promulgated in response to full notice-and-comment rulemaking 

procedures. In the proposal, the Agency specifically asked for comments 

in evaluating whether the definition of ``healthy'' that was being 

proposed was appropriate. FSIS also acknowledged its proposed 

definition of the term ``healthy'' differed from the definition that 

was proposed by the Food and Drug Administration (FDA) with regard to 

sodium levels, and asked for comments on whether it was necessary that 

the two Agencies provide uniform criteria for use of this term or 

whether different definitions may be appropriate. FSIS fully considered 

all the comments it received, and then issued final sodium level 

regulations in accordance with proper notice-and-comment rulemaking 

provisions of the Administrative Procedure Act.

    However, the Agency finds that the issues relative to technological 

and safety concerns of reduced sodium foods raise important new 

questions that merit further consideration. FSIS recognizes that the 

food industry has made a significant effort over the last few years to 

lower both the fat and sodium levels in meat food and poultry products 

while maintaining taste and texture attributes that are acceptable to 

consumers. The Agency continues to believe, however, that the 

scientific evidence suggests further reductions in fat and sodium 

intakes will result in meaningful public health gains.

    FSIS has defined the term ``healthy'' to help consumers identify 

meat and poultry products that will help them meet guidelines for a 

healthy diet. Consumers appreciate the significance of this term, and 

many make purchasing decisions based on its presence on a food label. 

Therefore, manufacturers have an incentive to produce foods that 

qualify to bear this term. If the petitioner is correct that the 

technology does not yet exist that will permit manufacturers to produce 

certain types of low fat meat and poultry, products that will contain 

the second tier, lower levels of sodium, and still be acceptable to 

consumers, the possibility exists that ``healthy'' may disappear from 

the market for such foods. Therefore, the Agency finds that it needs to 

explore whether it has created an unattainable sodium standard for some 

meat and poultry products. If it is determined that the standard is 

unattainable, further determination must be made about the health 

implications, if any.

    FSIS is considering whether to institute rulemaking to resolve the 

issues raised by the petitioner and to reevaluate the sodium provisions 

of its nutrient content claims regulations pertaining to the use of the 

term ``healthy.'' In this document, the Agency is asking for data 

regarding the technological feasibility of reducing the sodium content 

of individual foods to 360 mg per RACC and of meal-type dishes to 480 

mg sodium per labeled serving and for additional information or views 

on consumer acceptance of meat and poultry foods with such sodium 


    With regard to technological feasibility, the Agency is asking for 

information about the availability or lack of availability of 

acceptable sodium substitutes, the difficulties in manufacturing 

different lines of meat and poultry products with lowered sodium 

levels, and the impact of these sodium levels on the shelf-life 

stability and the safety of the food. Are there certain types of meat 

and poultry products for which it is not possible to reach the second 

tier levels of sodium? If so, what are these foods? Should FSIS make 

special exemptions for them, or should FSIS exclude them from bearing 

the term ``healthy?'' The Agency also is asking for comments on other 

approaches to reduce the amount of sodium in meat and poultry products 

labeled ``healthy.'' It is important that consumers seeking to eat a 

health-promoting diet have food choices available that enable them to 

reduce the amount of sodium in their diet.

    The Agency believes it is in the public interest to extend the 

effective date for the lower standards for sodium in the definition of 

``healthy'' in 9 CFR 317.363(b)(3) and 381.463(b)(3) while the Agency 

attempts to resolve the issues raised by the petition. Therefore, FSIS 

is announcing an extension in the effective date of the second tier, 

lower sodium level provisions until January 1, 2000.

    FDA also was persuaded by the petitioner that it is in the public 

interest to stay its effective date for the lower standards for sodium 

in its definition of ``healthy.'' Therefore in the April 1, 1997, 

Federal Register (62 FR 15390), FDA issued a stay in the effective date 

until January 1, 2000, for the second tier sodium levels to allow 

itself time to reevaluate the standard, the data contained in the 

petition, and any additional data that it may receive; to conduct any 

subsequent notice-and-comment rulemaking that it finds is necessary; 

and to allow ample time for implementation of the rule or of any 

changes in the rule that may result from the Agency's reevaluation.

    If it appears from the comments that agreement exists that there 

are technological hurdles that cannot be overcome at this time for all, 

or certain types of, meat and poultry products, the Agency is 

interested in exploring options for maximizing the public health gains 

that would come from reducing dietary sodium levels. Therefore, FSIS 

has identified two options that it could consider.

    As an option, FSIS could propose to amend the definition of 

``healthy'' in 9 CFR 317.363(b)(3) and 381.463(b)(3), as requested in 

the petition, and could make the current sodium levels for individual 

foods and meal-type products the qualifying levels. FSIS may propose 

this option if the evidence submitted in response to this rule 

demonstrates that it is technologically impossible to find salt 

substitutes for use in any type of meat and poultry product that would 

satisfy the requirements for texture, safety, and consumer acceptance. 

There must be evidence that failure of some foods to meet the 

definition for ``healthy'' would significantly reduce consumers' 

choices in meeting guidelines for a healthy diet.

    As a second option, the Agency could reconsider the sodium levels 

that it has established as the second tier of the ``healthy'' 

definition. For example, a possibility might be that individual meat 

food and poultry products would have to contain 360 mg sodium or less 

per RACC or at least 25 percent less sodium per RACC than the norm, as 

long as the final sodium level does not exceed 480 mg per RACC. For 

meal-type products, the Agency might consider the use of a percent 

reduction from the disclosure level.

    If the definition is set at a reasonable achievable level of a 25 

percent reduction from the disclosure level, more meat and poultry 

products are likely to be available. Further, market competition may 

encourage some manufacturers to exceed this minimal reduction. On the 

other hand, a primary consideration is whether a 25 percent reduction 

from the disclosure level or market basket norm is of adequate

[[Page 7281]]

dietary significance to warrant the use of the term ``healthy.''

    Based on the above information, the Agency requests comments on 

whether it should institute rulemaking to reevaluate the sodium 

provisions of the nutrient claims regulations pertaining to the use of 

the term ``healthy'' and on the other issues raised in the petition.

    FSIS is dispensing with the requirements of notice and opportunity 

for comment for this final rule because the Agency finds these 

procedures to be impracticable. In light of the information provided by 

the petition, FSIS must have additional time to reevaluate the standard 

for ``healthy'' with regard to sodium levels and to explore whether it 

has created an unattainable sodium standard and other technological 

issues. The Agency is finalizing this rule immediately because the 

original effective date for the second tier sodium level requirements 

has expired. However, FSIS is providing the public with an opportunity 

to comment on its decision to finalize immediately.

Executive Order 12866 and the Regulatory Flexibility Act

    This final rule has been determined to be non-significant and was 

not reviewed by OMB under Executive Order 12866.

    The Administrator has made an initial determination that this 

interim final 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 interim final rule will impose no 

new requirements on small entities.

    FSIS believes that net social benefits are associated with the 

adoption of this rule because the value of incremental benefits is 

likely to exceed the incremental costs. The incremental benefits 

include the potential reductions in the cases of hypertension 

associated with reduced consumption of sodium. The reductions in 

hypertension cases would tend to reduce the number of visits to doctors 

and hospitals associated with these heart diseases. It also would 

reduce cases of mortality associated with these diseases. The 

reductions in the costs associated with these mortality and morbidity 

cases constitute an incremental benefit to society. Society also is 

likely to benefit from increased productivity brought about by improved 

health and welfare of the workers consuming low sodium diets.

    If the reduction in sodium levels reduces the preservation 

characteristics of the products, the industry might incur additional 

costs to preserve the products by other means such as by innovating new 

chemical preservatives. This incremental cost, however, could be offset 

by the reduced costs of sodium in the products. Hence, the costs 

associated with this rule are not likely to increase.

    Unfortunately, we do not have data on the costs and benefits 

referred to above. Conceptually, however, it appears that the benefits 

are likely to exceed considerably the costs and result in a net benefit 

to society.

Executive Order 12988

    This interim final rule has been reviewed under Executive Order 

12988, Civil Justice Reform. This rule (1) preempts all 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.

Paperwork Requirements

    Paperwork requirements for this rule have been approved under OMB 

Control Number 0583-0092.


    1. Department of Health and Human Services, Public Health 

Service, ``The Surgeon General's Report on Nutrition and Health,'' 

U.S. Government Printing Office, Washington, DC, pp. 139-143, 157-

161, and 167-174, 1988.

    2. Food and Nutrition Bureau (FNB)/National Academy of 

Sciences), ``Diet and Health,'' National Academy Press, Washington, 

DC, pp 353-356, 549-553, and 556-561, 1989.

    3. Joint National Committee on Detection, Evaluation, and 

Treatment of High Blood Pressure, ``The Fifth Report of the Joint 

National Committee on Detection, Evaluation, and Treatment of High 

Blood Pressure,'' Archives of Internal Medicine, 153: 154-183, 1993.

    4. Nutrition Committee, American Heart Association, ``Dietary 

Guidelines for Healthy American Adults--A Statement for Health 

Professionals from the Nutrition Committee, American Heart 

Association.'' Circulation, 94:1795-1800, 1996.

    5. LSRO, ``Evaluation of Publicly Available Scientific Evidence 

Regarding Certain Nutrient-Disease Relations for Sodium and 

Hypertension,'' Bethesda, MD, December 1991.

    6. FNB, National Research Council, ``Recommended Dietary 

Allowances,'' 10th ed., National Academy Press, Washington, DC, pp 

247-261, 1989.

List of Subjects

9 CFR Part 317

    Food labeling, Meat inspection.

9 CFR Part 381

    Food labeling, Poultry and poultry products.

    For the reasons discussed in the preamble, FSIS is amending parts 

317 and 381 of the Federal meat and poultry products inspection 

regulations as set forth below:


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


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

Subpart B--Nutrition Labeling

Sec. 317.363  [Amended]

    2. Section 317.363 is amended by removing the phrase ``during the 

first 24 months of implementation'' in paragraph (b)(3) introductory 

text and (b)(3)(i) and replacing it with ``effective through January 1, 



    3. The authority citation for part 381 continues to read as 


    Authority: 7 U.S.C. 138f, 450:21 U.S.C. 451-470; 7 CFR 2.18, 


Subpart Y--Nutrition Labeling

Sec. 381.463  [Amended]

    4. Section 381.463 is amended by removing the phrase ``during the 

first 24 months of implementation'' in paragraph (b)(3) introductory 

text and (b)(3)(i) and replacing it with ``effective through January 1, 


    Done at Washington, DC, on: February 4, 1998.

Thomas J. Billy,


[FR Doc. 98-3718 Filed 2-12-98; 8:45 am]