[Federal Register: January 6, 2003 (Volume 68, Number 3)]
[Rules and Regulations]
[Page 460-463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja03-3]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 02-025IF]
RIN 0583-AC93
Food Labeling; Nutrient Content Claims, Definition of the 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, 2006, the effective date for the requirements: That
individual meat and poultry products bearing the claim ``healthy'' (or
any other derivative of the term ``health'') contain no more than 360
milligrams (mg) of sodium; and that meal-type products bearing the
claim ``healthy'' (or any other derivative of the term ``health'')
contain no more than 480 mg of sodium.
DATES: Effective date: January 6, 2003.
Comment date: Written comments must be received February 5, 2003.
ADDRESSES: Submit written comments to the FSIS Docket Clerk, Docket
02-025IF, 300 12th Street, SW., Room 102 Cotton Annex
Building, Washington, DC 20250-3700. All comments submitted in response
to this interim final rule will be made 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: Robert Post, Ph.D., Director, Labeling
and Consumer Protection Staff, Office of Policy and Program
Development, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 602 Cotton Annex Building, Washington, DC 20250-3700, (202) 205-
0279.
SUPPLEMENTARY INFORMATION:
Background
On May 10, 1994, 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 (59
FR 24220).\1\ Under 9 CFR 317.363(b)(3) and 381.463(b)(3), after
November 10, 1997, an individual meat or poultry product qualifying to
use the term ``healthy'' or any other derivative
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of that term on its label, or in its labeling, must not contain more
than 360 mg of sodium: (a) per reference amount customarily consumed
(RACC); (b) per labeled serving size; and (c) per 50 grams (g) for
products with reference amounts customarily consumed of 30 g or less or
2 tablespoons or less. Further, under 9 CFR 317.363(b)(3)(i) and
381.463(b)(3)(i), after November 10, 1997, a meal-type product
qualifying to use the aforementioned term or any other derivative of
the term on its label or in its labeling must not contain more than 480
mg of sodium per labeled serving size.
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\1\ Final Rule, Nutrition Labeling; Use of ``Healthy'' and
Similar Terms on Meat and Poultry Product Labeling, 59 FR 24220-
24229, May 10, 1994. This document may be viewed in the FSIS Docket
Room Monday through Friday from 8:30 a.m. until 4:30 p.m., or
accessed via the World Wide Web at http://www.fsis.usda.gov/.
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During the initial 24 months of the requirement's implementation
date, which is defined as the time period prior to November 10, 1997,
the maximum sodium level for individual meat and poultry products would
be allowed to reach 480 mg, and the maximum sodium level for meal-type
products would be allowed to reach 600 mg. This time period and its
correlating maximum levels are referred to as the ``first-tier sodium
level.'' After November 10, 1997, the maximum sodium level for
individual meat and poultry products would be decreased to 360 mg, and
the maximum sodium level for meal-type products would be decreased to
480 mg. This time period and its correlating maximum levels are
referred to as the ``second-tier sodium level.''
Within the same Federal Register publication, the Food and Drug
Administration (FDA) published a final rule (59 FR 24232) to define the
term ``healthy'' under section 403(r) of the Federal, Food, Drug and
Cosmetic Act (21 U.S.C. 343(r)).\2\ FDA's rule established the same
sodium levels associated with the use of the ``healthy'' claim that
FSIS' rule established for two separate timeframes. However, the
timeframes in FDA's rule differed from those established by FSIS' rule.
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\2\ Final Rule, Food Labeling: Nutrient Content Claims,
Definition of Term: Healthy, 59 FR 24232-24249, May 10, 1994. This
document may be accessed via the World Wide Web at http://www.access.gpo.gov/
.
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On December 17, 1996, ConAgra, Inc., petitioned FSIS to ``eliminate
the sliding scale sodium requirement for foods labeled `healthy' by
eliminating the entire second-tier levels of 360 mg sodium requirement
for individual foods and 480 mg sodium for meal-type products.''\3\ In
response to the petition, FSIS published an interim final rule on
February 13, 1998 (63 FR 7279), which amended Sec. Sec. 317.363(b)(3)
and 381.463(b)(3) by extending the effective date for the second-tier
sodium levels (360 mg for individual meat and poultry products and 480
mg for meal-type products) associated with the term ``healthy'' until
January 1, 2000.\4\ The Agency extended the effective date for the
following reasons: (1) To allow time for FSIS to reevaluate the
standard, including the data contained in ConAgra's petition and any
additional data that the Agency received; (2) to conduct any necessary
rulemaking; and finally (3) to allow time for industry to respond to
the rule or to any change in the rule that may have resulted from the
Agency's reevaluation.
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\3\ FSIS Petition 96-08, ConAgra, Inc.; received
December 17, 1996. This document may be viewed in the FSIS Docket
Room Monday through Friday from 8:30 a.m. until 4:30 p.m., or
accessed via the World Wide Web at http://www.fsis.usda.gov/FOIA/popular.htm
as a related document under the Notice, Directives, and
Federal Register Publications section.
\4\ Interim Final Rule, Food Labeling: Nutrient Content Claims,
Definition of Term; Healthy, 63 FR 7279-7281, February 13, 1998.
This document may be viewed in the FSIS Docket Room Monday through
Friday from 8:30 a.m. until 4:30 p.m., or accessed via the World
Wide Web at http://www.fsis.usda.gov/FOIA/popular.htm under the
Notices, Directives, and Federal Register Publications section.
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FDA also received a petition from ConAgra, Inc., requesting that
the second-tier sodium levels associated with use of the term
``healthy'' be removed from the regulations. In response to this
petition, FDA announced a stay of the provisions relating to the lower
sodium standards until January 1, 2000 (62 FR 15390).\5\
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\5\ Final Rule; partial stay, Food Labeling: Nutrient Content
Claims, Definition of Term: Healthy, 62 FR 15390-15391, April 1,
1997. This document may be accessed via the World Wide Web at http://www.access.gpo.gov/
.
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In its interim final rule, FSIS asked the public for data and
comments in regard to the second-tier sodium levels in the ``healthy''
definition and other approaches to reduce the amount of sodium in meat
and poultry products labeled ``healthy.'' FSIS received 20 responses to
the February 13, 1998, interim final rule, which presented strong and
opposing views on whether the Agency should let the second-tier sodium
levels take effect, and provided a significant amount of data relating
to the use of the term ``healthy.'' Based on the information available,
the Agency concluded that, in some cases, the second-tier sodium levels
may be overly restrictive, thereby eliminating a term that may
potentially assist consumers in maintaining a healthy diet.
Accordingly, FSIS published a subsequent interim final rule on December
28, 1999 (64 FR 72490), further extending the second-tier sodium
levels' effective date until January 1, 2003.\6\ Similarly, FDA
published a final rule (64 FR 12886), which extended the stay on their
provisions in regard to the lower sodium levels through January 1,
2003, as well.\7\
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\6\ Interim Final Rule, Food Labeling; Nutrient Content Claims,
Definition of Term: Healthy, 64 FR 72490-72491, December 28, 1999.
This document may be viewed in the FSIS Docket Room Monday through
Friday from 8:30 a.m. until 4:30 p.m., or accessed via the World
Wide Web at http://www.fsis.usda.gov/FOIA/popular.htm under the
Notices, Directives, and Federal Register Publications section.
\7\ Final Rule; extension of partial stay, Food Labeling;
Nutrient Content Claims, Definition of Term: Healthy; Extension of
Partial Stay, 64 FR 12886, March 16, 1999. This document may be
accessed via the World Wide Web at http://www.access.gpo.gov/.
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FSIS received 8 responses to its December 28, 1999, interim final
rule. Six responses conveyed support for extending the effective date
of the second-tier sodium level until adequate medical and
technological research can be conducted to demonstrate that lowering
the maximum amount of sodium used to produce these types of products
will contribute to or enhance a ``healthy'' diet. The commenters stated
that a ``healthy'' diet can not be solely defined or maintained by
consuming lower amounts of sodium. Instead, a ``healthy'' diet must
rely on maximizing and minimizing a consumer's intake of all nutrients,
including sodium, based on the individuality of the consumer. In
addition, the commenters stated that lowering the sodium level would
affect the products' palatability, which would negatively impact the
demand for such products. Further, consumers would be forced to add
salt to these products to enhance their taste prior to consumption,
which negates the premise of lowering sodium intake as a means of
lowering the health risks associated with consuming high levels of
sodium. One commenter asserted that establishing a maximum level of
sodium contained in meat and poultry products labeled as ``healthy''
does not correlate to the definition of ``healthy'' with respect to
positive health benefits. Another commenter stated that the lowest
achievable sodium level should be used as the maximum limit when
producing individual or meal-type meat and poultry products, and that
FSIS should proceed with the intended effective date for the second-
tier sodium level requirements.
As of this date, FSIS and FDA are continuing their efforts: (1) To
reevaluate appropriate sodium levels associated with the use of the
term ``healthy''; and (2) to fully consider all options that preserve
the public health
[[Page 462]]
intent while providing manufacturers with the opportunity to use the
term on food labeling consistently with dietary guidelines. Therefore,
as the agencies consider whether alternative levels may be more
appropriate, it would be contrary to the public interest to require
manufacturers to comply with the second-tier sodium levels within the
``healthy'' definition by the current effective date of January 1,
2003. Moreover, FSIS is taking this action so that its labeling
regulations remain consistent with those promulgated by FDA. In the
Federal Register dated May 8, 2002, FDA further extended the partial
stay on their provisions to coincide with the aforementioned effective
date of January 1, 2006 (67 FR 30795).\8\ Accordingly, further
extending the second-tier sodium level requirements' effective date for
meat and poultry products is warranted.
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\8\ Final Rule; extension of partial stay, Food Labeling;
Nutrient Content Claims, Definition of Sodium Levels for the Term
``Healthy;'' Extension of Partial Stay, 67 FR 30795, May 8, 2002.
This document may be accessed via the World Wide Web at http://www.access.gpo.gov/
.
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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 the PPIA. States and local jurisdictions
may, however, exercise concurrent jurisdiction over meat and poultry
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 the Office of Management and Budget 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 is initiating this action so that its labeling regulations
remain consistent with those promulgated by FDA. Moreover, FSIS needs
time to conclude its reevaluation of the impact imposed by 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 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. However, information collected
by the Agency continues to support our belief that it is feasible to
produce individual meat and poultry products with a sodium level of 360
mg or less at this time.
FSIS will use the time allotted by the extension to initiate the
appropriate rulemaking, and respond to its comments. Industry's
constituents will be afforded ample time to reformulate their products
(a critical consideration since product reformulation may not be a
simple task for products such as hot dogs) and modify labeling.
Five commenters to the December 28, 1999, FSIS interim final rule
agreed with the petitioner that lowering the sodium level would affect
the products' palatability. One commenter posited that establishing a
maximum level of sodium contained in meat and poultry products labeled
as ``healthy'' does not correlate to the definition of ``healthy'' with
respect to positive health benefits. Another commenter supported the
implementation of the second-tier sodium level with the intended
effective date. The last commenter stated that the health risk focus
should not be directed towards sodium, and the effective date should be
extended to allow FSIS ``time to conduct a review of the science on
this issue to establish the basis for removing altogether any sodium-
related disqualification for the term `healthy'.''
FSIS continues to believe that further health benefits could be
achieved by lowering the sodium content of foods labeled as
``healthy''. However, the Agency needs time: (1) To conclude its
reevaluation process in conjunction with FDA; and (2) to initiate the
appropriate rulemaking. Therefore, as the agencies consider whether
alternative levels may be more appropriate it would be contrary to the
public interest to require manufacturers to comply with the lower
sodium levels in the ``healthy'' definition by the current effective
date of January 1, 2003.
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, 2003, 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.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that minorities, women, and persons with disabilities are aware of this
notice; FSIS will announce it and make copies of this Federal Register
publication available through the FSIS Constituent Update. FSIS
provides a weekly Constituent Update, which is communicated via
Listserv, a free e-mail subscription service. 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 Listserv
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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 the Listserv
and web page, FSIS is able to provide information to a much broader,
more diverse audience.
For more information contact the Congressional and Public Affairs
Office, at (202) 720-9113. To be added to the free e-mail subscription
service (Listserv) go to the ``Constituent Update'' page on the FSIS
Web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the
``Subscribe to the Constituent Update Listserv'' link, then fill out
and submit the form.
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, 2003'' in paragraph (b)(3) introductory text and (b)(3)(i)
and replacing it with ``through January 1, 2006''.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority 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, 2003'' in paragraph (b)(3) introductory text and (b)(3)(i)
and replacing it with ``through January 1, 2006''.
Done at Washington, DC, on: December 30, 2002.
Dr. Garry L. McKee,
Administrator.
[FR Doc. 02-33150 Filed 12-31-02; 3:25 pm]