[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


[[Page 461]]


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


[[Page 463]]


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]