[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
