[Federal Register Volume 64, Number 248 (Tuesday, December 28, 1999)]
[Rules and Regulations]
[Pages 72490-72492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33530]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 99-050IF]
RIN 0583-AC65


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: The Food Safety and Inspection Service (FSIS) is extending 
until January 1, 2003, the effective date of the requirements that, to 
bear the claim ``healthy'' or any other derivative of the term 
``health,'' individual meat and poultry products can contain no more 
than 360 milligrams (mg) sodium, and that meal-type products can 
contain no more than 480 mg sodium.

DATES: Effective date: December 28, 1999.
    Comment date: Written comments should be received by January 27, 
2000.

ADDRESSES: Submit one original and two copies of written comments to 
the FSIS Docket Clerk, Docket #99-050IF, Room 102, Cotton Annex 
Building, 300 12th Street, SW, Washington, DC 20250-3700. All comments 
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: William J. Hudnall, Assistant Deputy 
Administrator, Office of Policy, Program Development and Evaluation; 
telephone (202) 205-0495 or FAX (202) 401-1760.

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 final rule provided a definition for the 
implied nutrient content claim ``healthy'' for individual meat and 
poultry products and for meal-type products. The rule defined two 
separate timeframes in which different criteria for sodium content 
would be effective. According to the regulations, the first timeframe 
would last through the first 24 months of implementation (i.e., through 
November 10, 1997), and the second would begin after the first 24 
months of implementation (after November 10, 1997).
    Before November 10, 1997, under Secs. 317.363(b)(3) and 
381.463(b)(3), for an individual meat or poultry product to qualify to 
bear the term ``healthy'' or a derivative of the term ``health'' on the 
labeling, the product could contain no more than 480 mg of sodium 
(first-tier sodium level): (1) Per reference amount customarily 
consumed (RACC) per eating occasion; (2) Per labeled serving size; and 
(3) Per 50 grams (g) for products with small RACC's (i.e., 30 g or less 
or 2 tablespoons or less). With regard to the last provision, for 
dehydrated products that must be reconstituted with water or a diluent 
containing an insignificant amount of all nutrients, the per-50-gram 
criterion refers to the prepared form. After November 10, 1997, to 
qualify to bear this term, the product could contain no more than 360 
mg of sodium (second-tier sodium level) per RACC, per labeled serving 
size, and per 50 g for products with small RACC's. Under 
317.363(b)(3)(i) and 381.463(b)(3)(i), a meal-type product could 
contain no more than 600 mg of sodium per labeled serving size before 
November 10, 1997, and no more than 480 mg of sodium per labeled 
serving size after November 10, 1997.
    Also in the Federal Register of May 10, 1994 (59 FR 24232), the 
Food and Drug Administration (FDA) published a final rule to define the 
term ``healthy'' under section 403(r) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 343(r)). FDA's rule also defined two separate 
timeframes in which different criteria for sodium content associated 
with the use of the ``healthy'' claim would be effective. FDA's rule 
established the same sodium levels that the FSIS rule established for 
two separate timeframes; however, the timeframes in FDA's rule were 
different (i.e., before January 1, 1998, and after January 1, 1998).
    On December 7, 1996, FSIS received a petition from ConAgra, Inc., 
requesting that Secs. 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 a better understanding of the relationship between sodium and 
hypertension.
    In response to the petition, FSIS issued an interim final rule on 
February 13, 1998, (63 FR 7279) to amend Secs. 317.363(b)(3) and 
381.463(b)(3) to extend the effective date for the lower sodium 
standards associated with the term ``healthy'' until January 1, 2000. 
The extension of the effective date was intended: (1) To allow time for 
FSIS to reevaluate the standard, including the data contained in the 
petition and any additional data that the Agency might receive; (2) to 
conduct any necessary rulemaking; and (3) to allow time for industry to 
respond to the rule or to any change in the rule that may result from 
the Agency's reevaluation.
    FDA also received a petition from ConAgra, Inc., requesting that 
the lower sodium standards associated with use of the term ``healthy'' 
be removed from the regulations. In the Federal Register of April 1, 
1997 (62 FR 15390), FDA announced a stay until January 1, 2000, of the 
provisions relating to the lower sodium standards.
    In its February 13, 1998, interim final rule, FSIS asked for data 
concerning 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 asked 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. The Agency also asked for 
comments on other approaches to reduce the amount of sodium in meat and 
poultry products labeled ``healthy.''
    FSIS received 20 responses to the interim final rule. The comments 
responding to the rule presented strong and opposing views on whether 
FSIS should let the second-tier sodium levels take effect. They also 
contained a significant amount of data relating to use of the term 
``healthy.''
    FSIS has reviewed the comments and has also made an independent 
assessment of the number of foods labeled as ``healthy.'' Based on the 
information available, the Agency tentatively concludes that, in some 
cases, the second-tier sodium levels may

[[Page 72491]]

be overly restrictive, thereby eliminating a term that may potentially 
assist consumers in maintaining a healthy diet. The Agency has been 
unable to complete its reevaluation of the definition of the term 
``healthy'' or to consider fully options that preserve the public 
health intent while permitting manufacturers to use this term on foods 
that are consistent with dietary guidelines.
    FSIS has not completed its reevaluation of sodium levels associated 
with the term ``healthy'' in the time allowed by the February 13, 1998, 
interim final rule because of: (1) Other Agency priorities; and (2) the 
need to investigate independently the validity of the strong opposing 
positions expressed in the comments. Because FSIS needs additional time 
to consider whether to propose a change in the definition, the Agency 
is extending the effective date until January 1, 2003.
    FSIS also recognizes, as mentioned in the petition, that 
manufacturers must begin very soon to revise the formulations and 
labeling, if they have not already done so, for those products that do 
not comply with the requirement that must be met after January 1, 2000, 
to bear the claim ``healthy.'' FSIS needs time to consider the 
supporting and opposing positions and to conduct any necessary 
rulemaking on the issues raised.
    Given these factors, the Agency is persuaded that it is in the 
public interest to extend the effective date of the provisions for the 
lower standards for sodium in the definition of ``healthy.'' This 
action is being taken to: (1) Allow FSIS time to reevaluate the 
information that supports and opposes the petition, (2) conduct any 
necessary rulemaking to revise the sodium limits for the term 
``healthy,'' and (3) provide time for companies to respond to any 
changes that may result from Agency rulemaking.
    In the Federal Register of March 16, 1999, FDA published a final 
rule that extended the stay of the provisions relating to the lower 
sodium levels associated with the term ``healthy'' until January 1, 
2003 (64 FR 12886). FDA's reasons for extending the stay of these 
provisions were largely the same as those that FSIS set out above.
    Interested persons may submit comments regarding the 
appropriateness of the basis for this extension of the effective date 
of the lower sodium standards in the definition of the term 
``healthy.'' FSIS encourages manufacturers who can meet the lower 
sodium levels for particular foods and still produce an acceptable 
product to do so even as the Agency reevaluates the issues discussed.

Executive Order 12988

    This interim final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. States and local jurisdictions are 
preempted by the Federal Meat Inspection Act (FMIA) and the Poultry 
Products Inspection Act (PPIA) from imposing any marking, labeling, 
packaging, or ingredient requirements on federally inspected meat and 
poultry products that are in addition to, or different than, those 
imposed under the FMIA and PPIA. States and local jurisdictions may, 
however, exercise concurrent jurisdiction over meat products that are 
outside official establishments for the purpose of preventing the 
distribution of meat and poultry products that are misbranded or 
adulterated under the FMIA and PPIA, or, in the case of imported 
articles, that are not at such an establishment, after their entry into 
the United States.
    This interim final rule is not intended to have retroactive effect.
    If this interim final rule is adopted, administrative proceedings 
will not be required before parties may file suit in court challenging 
this rule. However, the administrative procedures specified in 9 CFR 
306.5 and 381.35 must be exhausted prior to any judicial challenge of 
the application of the provisions of this interim final rule, if the 
challenge involves any decision of an FSIS employee relating to 
inspection services provided under the FMIA or PPIA.

Executive Order 12866 and the Regulatory Flexibility Act

    This interim 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 needs additional time to evaluate the impact of further 
reducing limits on sodium contents of foods labeled as ``healthy'' to 
determine if the costs of such an action exceed the benefits. The 
petitioner requesting the extension has presented data to support that 
lowering the sodium content on foods labeled as ``healthy'' could 
result in fewer ``healthy'' foods being consumed or consumers adding 
table salt to improve the products' palatability. In addition, the 
petitioner suggested that lack of available substitutes for sodium 
would impair the industry's ability to continue manufacturing 
``healthy'' foods as currently defined. If these impacts were to occur, 
the rule would not have the intended effect of improving diets. Some 
commenters to the previous FSIS interim final rule agreed with the 
petitioner. In addition to these comments, other commenters provided 
arguments supporting the implementation of the lower sodium limits. 
Based on comments received, FSIS believes that further benefits could 
be achieved by lowering the sodium content of foods labeled as 
``healthy. However, FSIS has also determined that it is in the public 
interest to extend the effective date for the lower sodium standards in 
the definition of ``healthy'' to provide the Agency additional time to 
determine if the more restrictive limits would have a negative effect. 
Unless the effective date is changed, meat and poultry products labeled 
as ``healthy'' would have to meet the more restrictive sodium standards 
on January 1, 2000, which could possibly deprive consumers of these 
products.

Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994), 
``Federal Actions to Address Environmental Justice in Minority and Low-
Income Populations,'' FSIS has considered potential impacts of this 
interim final rule on environmental and health conditions in low-income 
and minority communities.
    The interim final regulations would not require or compel meat and 
poultry product establishments to relocate or alter their operations in 
ways that could adversely affect the public health or environment in 
low-income and minority communities. Further, this interim final rule 
would not exclude any persons or populations from participation in FSIS 
programs, deny any persons or populations the benefits of FSIS 
programs, or subject any persons or populations to discrimination 
because of their race, color, or national origin.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development are important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
interim final rule, FSIS will announce it and provide copies of this 
Federal Register publication in the FSIS Constituent Update. FSIS 
provides a weekly FSIS Constituent Update, which

[[Page 72492]]

is communicated via fax to over 300 organizations and individuals. In 
addition, the update is available on line through the FSIS web page 
located at http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents/stakeholders. The constituent fax list consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
that have requested to be included. Through these various channels, 
FSIS is able to provide information to a much broader, more diverse 
audience. For more information and to be added to the constituent fax 
list, fax your request to the Congressional and Public Affairs Office, 
at (202) 720-5704.

Waiver of Proposed Rulemaking

    In accordance with the Administrative Procedures Act, 5 U.S.C 553, 
it is the practice of the Administrator to offer interested parties the 
opportunity to comment on proposed regulations. However, the extended 
effective date in this interim final rule does not establish any new 
rules. In addition, this interim final rule must be published in the 
Federal Register prior to January 1, 2000, because that is the current 
effective date in the regulations. Therefore, the Administrator has 
determined that publication of a proposed rule is impracticable, 
unnecessary, and contrary to the public interest under 5 U.S.C. 
553(b)(B). For the same reasons, the Administrator waives the 30-day 
delayed effective date under 5 U.S.C. 553(d).

Paperwork Requirements

    There is no paperwork associated with this action.

List of Subjects

9 CFR Part 317

    Food labeling, Meat inspection, Nutrition.

9 CFR Part 381

    Food labeling, Nutrition, 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 follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

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

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


Sec. 317.363  [Amended]

    2. Section 317.363 is amended by removing the phrase ``through 
January 1, 2000'' in paragraph (b)(3) introductory text and (b)(3)(i) 
and replacing it with ``through January 1, 2003''.

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.


Sec. 381.463  [Amended]

    4. Section 381.463 is amended by removing the phrase ``through 
January 1, 2000'' in paragraph (b)(3) introductory text and (b)(3)(i) 
and replacing it with ``through January 1, 2003''.

    Done at Washington, DC, on: December 21, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-33530 Filed 12-27-99; 8:45 am]
BILLING CODE 3410-DM-P