[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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Rules and Regulations
Federal Register
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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
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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
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
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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