[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Rules and Regulations]
[Pages 7279-7281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3718]



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  Federal Register / Vol. 63, No. 30 / Friday, February 13, 1998 / 
Rules and Regulations  

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DEPARTMENT OF AGRICULTURE

9 CFR Parts 317 and 381

[Docket No. 97-035F]
RIN 0583-AC47


Food Labeling: Nutrient Content Claims, Definition of Term; 
Healthy

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

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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 
Friday.

FOR FURTHER INFORMATION CONTACT: Mr. William J. Hudnall, Assistant 
Deputy Administrator, Office of Policy, Program Development and 
Evaluation; telephone (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    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 
hypertension.
    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 
consideration.
    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

[[Page 7280]]

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 
levels.
    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.

References

    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:

PART 317--LABELING, MARKING DEVICES AND CONTAINERS

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

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

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, 
2000.''

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

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

    Authority: 7 U.S.C. 138f, 450:21 U.S.C. 451-470; 7 CFR 2.18, 
2.53.

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, 
2000.''

    Done at Washington, DC, on: February 4, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-3718 Filed 2-12-98; 8:45 am]
BILLING CODE 3410-DM-P