[Federal Register Volume 71, Number 7 (Wednesday, January 11, 2006)]
[Rules and Regulations]
[Pages 1683-1686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-268]



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 Rules and Regulations
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  Federal Register / Vol. 71, No. 7 / Wednesday, January 11, 2006 / 
Rules and Regulations  

[[Page 1683]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 05-033IF; FDMS Docket Number FSIS-2005-0038]
RIN 0583-AD19


Food Labeling; Nutrient Content Claims, Definition of the Term: 
``Healthy''

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that its regulations will continue to provide that individual meat and 
poultry products bearing the claim ``healthy'' (or any other derivative 
of the term ``health'') must contain no more than 480 milligrams (mg) 
of sodium; and that meal-type products bearing the claim ``healthy'' 
(or any other derivative of the term ``health'') must contain no more 
than 600 mg of sodium. FSIS is deferring indefinitely, until further 
notice, implementation of 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 11, 2006. Comments must be received on 
or before February 10, 2006.

ADDRESSES: FSIS invites interested persons to submit comments on this 
interim final rule. Comments may be submitted by any of the following 
methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. FSIS prefers to receive comments 
through the Federal eRulemaking Portal. Go to http://www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select the 
FDMS Docket Number to submit or view public comments and to view 
supporting and related materials available electronically. After the 
close of the comment period, the docket can be viewed using the 
``Advanced Search'' function in Regulations.gov.
    Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture, 
Food Safety and Inspection Service, 300 12th Street, SW., Room 102 
Cotton Annex, Washington, DC 20250.
    Electronic mail: [email protected].
    All submissions received must include the Agency name and docket 
number 05-033IF.
    All comments submitted in response to this proposal, as well as 
research and background information used by FSIS in developing this 
document, will be posted to the regulations.gov Web site. The 
background information and comments also will be available for public 
inspection in the FSIS Docket Room at the address listed above between 
8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Director, 
Labeling and Consumer Protection Staff, Office of Policy, Program, and 
Employee 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 that established a 
definition for the term ``healthy'' and that permitted the use of the 
term ``healthy'' or any other derivative of the term ``health,'' such 
as ``healthful'' or ``healthier'' on meat and poultry product labeling 
(59 FR 24220). During the first 24 months of the rule's implementation 
date (November 10, 1995, through November 10, 1997), under Sec. Sec.  
317.363(b)(3) and 381.463(b)(3), an individual meat or poultry product 
that used the term ``healthy'' or any other derivative of the term 
``health'' on its labeling, could not contain more than 480 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. Furthermore, according to the final rule, as set forth in 
Sec. Sec.  317.363(b)(3)(i) and 381.463(b)(3)(i), from November 10, 
1995, through November 10, 1997, a meal-type product that used the term 
``healthy'' or any other derivative of the term ``health'' on its 
labeling could not contain more than 600 mg of sodium per labeled 
serving size. These levels are referred to as the ``first-tier sodium 
levels.''
    After the first 24 months of the rule's implementation (i.e., after 
November 10, 1997), an individual meat or poultry product that used the 
term ``healthy'' or any other derivative of the term ``health'' on its 
labeling could 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. Also 
after November 1997, a meal-type product that used the term ``healthy'' 
or any other derivative of the term ``health'' on its labeling could 
not contain more than 480 mg of sodium per labeled serving size. These 
lower, more restrictive sodium levels that were to go into effect after 
November 10, 1997, are referred to as the ``second-tier sodium 
levels.''
    In the same Federal Register publication as FSIS' final rule, the 
Food and Drug Administration (FDA) published a final rule (59 FR 24232) 
that defined the term ``healthy'' under the Federal, Food, Drug and 
Cosmetic Act. FDA's rule required the same sodium levels for use of the 
``healthy'' claim be met as did FSIS' rule, but the timeframes 
established for meeting the required sodium levels in FDA's rule 
differed from those established in FSIS' rule.
    On December 17, 1996, ConAgra, Inc., petitioned FSIS to eliminate 
the sliding

[[Page 1684]]

scale sodium requirement for foods labeled ``healthy'' by eliminating 
the entire second-tier required levels of 360 mg sodium for individual 
foods and 480 mg sodium for meal-type products. (FSIS Petition 96-08.) 
In response to the petition, FSIS published an interim final rule on 
February 13, 1998, that amended Sec. Sec.  317.363(b)(3) and 
381.463(b)(3) by extending the effective date for the second-tier 
sodium levels until January 1, 2000 (63 FR 7279).
    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 effective date of the provisions 
that established lower sodium standards be met, i.e., the second-tier 
sodium levels, until January 1, 2000 (62 FR 15390).
    In its interim final rule, FSIS asked the public for data and 
comments in regard to the second-tier sodium levels established in the 
``healthy'' definition and other approaches that could be implemented 
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. They also provided a significant amount of data relating to the 
use of the term ``healthy.'' Based on the information available, the 
Agency tentatively concluded that, in some cases, a required reduction 
of sodium to the second-tier levels might be overly restrictive, 
thereby eliminating a term that could assist consumers in making 
healthful food choices and 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. Similarly, FDA published a final rule (64 
FR 12886) that extended its stay, through January 1, 2003, for the 
lower sodium levels for foods that it had established.
    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 levels until adequate medical and 
technological research could be conducted to demonstrate that lowering 
the maximum amount of sodium used to produce meat and poultry products 
would contribute to or enhance a ``healthy'' diet. 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 allowed 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.
    On January 6, 2003, FSIS again published an interim final rule that 
amended Sec. Sec.  317.363(b)(3) and 381.463(b)(3) by extending the 
effective date of the second-tier sodium levels until January 1, 2006 
(68 FR 460). Similarly, on May 8, 2002, FDA further extended its 
partial stay, until January 1, 2006 (67 FR 30795), for the lower sodium 
levels for foods that it had established. The agencies took these 
actions to continue 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 intent 
behind establishing maximum sodium content levels for foods, while 
providing manufacturers with the opportunity to use the term on food 
labeling consistently with dietary guidelines. FSIS did not receive any 
comments in response to its January 6, 2003, interim final rule 
extending the effective date of the lower sodium limits.

2004 ConAgra Foods, Inc., Petition

    On November 30, 2004, ConAgra Foods, Inc., petitioned FSIS 
concerning the second-tier sodium levels in the definition of 
``healthy'' (FSIS Petition 05-07). The company stated that 
implementation of the second-tier sodium levels could cause the 
disappearance of whole categories of ``healthy'' food products from the 
market. The company explained that taste, food safety, and 
manufacturing issues preclude hotdogs, processed meats, and soups from 
being produced to meet consumers' expectations at a sodium level of 360 
mg. According to the petition, at this sodium level, hot dogs fall 
apart, and processed meats have an unacceptable texture and reduced 
microbial protection. In addition, the company stated that market data 
and taste tests show that consumers will not eat these products when 
they contain no more than 360 mg of sodium. The company also stated 
that there are no viable salt substitutes currently on the market.
    According to the company, consumers overall buy relatively few 
``healthy'' products even at the present sodium levels utilized in the 
manufacture of products, and lowering the sodium levels of a product 
line that already has relatively low sodium levels, by 120 mg, will 
have no positive effect on public health. The company opined that the 
first-tier sodium levels in the ``healthy'' definition appear to have 
succeeded in lowering the overall sodium in foods since the rule's 
implementation. However, the company predicted that implementing the 
second-tier sodium levels could have the unintended consequence of 
forcing some products out of the marketplace. This result would leave 
higher sodium substitutes in the marketplace and, therefore, create an 
overall increase in sodium intake.

FDA Rule

    On September 29, 2005, FDA amended its regulations concerning the 
maximum sodium levels permitted for foods that bear the implied 
nutrient content claim ``healthy.'' The Agency retained the less 
restrictive, first-tier sodium level requirements for all food 
categories, including individual foods (480 mg) and meals and main 
dishes (600 mg), and dropped the second-tier (more restrictive) sodium 
level requirements for all food categories. Based on comments received 
about technological barriers to reducing sodium in processed foods and 
poor sales of products that meet the second-tier sodium level, FDA 
determined that requiring the more restrictive sodium levels would 
likely inhibit the development of new ``healthy'' food products and 
risk substantially eliminating existing ``healthy'' products from the 
marketplace. After reviewing the comments and evaluating the data from 
various sources, FDA became convinced that retaining the first-tier 
sodium level requirements for all food products bearing the term 
``healthy'' would encourage the manufacture of a greater number of 
products that were consistent with dietary guidelines for a variety of 
nutrients (70 FR 56828).

Control of Listeria Moncytogenes in Ready-to-Eat Products

    On June 6, 2003, FSIS published an interim final rule that amended 
its regulations to require that official establishments that produce 
post-lethality exposed ready-to-eat (RTE) meat and poultry products 
meet the specific requirements of one of three alternatives for 
addressing L. monocytogenes (68 FR 34208). In Alternative 1, an 
establishment controls L. monocytogenes by using a post-lethality 
treatment of the product AND an antimicrobial agent or process that 
suppresses or limits the growth of L. monocytogenes. In Alternative 2, 
an

[[Page 1685]]

establishment may choose to address L. monocytogenes by using a post-
lethality treatment OR an antimicrobial agent or process that 
suppresses or limits the growth of the pathogen. In Alternative 3, an 
establishment may control L. monocytogenes in the post-lethality 
processing environment through sanitation procedures only.
    Many of the antimicrobial agents used to control L. monocytogenes 
under Alternatives 1 and 2 are sodium containing agents such as sodium 
lactate, sodium diacetate, and sodium citrate. These agents usually 
affect sodium levels in foods. In the 2004 ConAgra Foods, Inc. 
petition, ConAgra explained that companies have consistently used 
sodium lactate or sodium lactate and diacetate blends to control L. 
monocytogenes in processed meats. The petition explains that these 
ingredients can be incorporated in product formulation to completely 
suppress the growth of L. monocytogenes. According to the company, 
potassium lactate may also be used to inhibit L. monocytogenes. This 
antimicrobial compromises the flavor of products, however, while the 
sodium containing antimicrobials minimize any adverse effects on 
products' tastes or other organoleptic properties.

Conclusion

    In light of the interim final rule concerning L. monocytogenes 
controls and ConAgra Foods' 2004 petition to FSIS, FSIS has determined 
that it needs additional time to evaluate what levels of sodium in meat 
and poultry products are appropriately associated with the use of the 
term ``healthy'' on these products'' labeling and to fully consider all 
options that preserve the public health intent of establishing sodium 
content limitations while providing manufacturers with the opportunity 
to use the term in food labeling consistently with dietary guidelines. 
Moreover, FSIS needs, when appropriate, to have its labeling 
regulations be consistent with those promulgated by FDA. As is 
explained above, FDA amended its regulations to drop the second-tier 
sodium level requirements for all categories of ``healthy'' foods. At 
this time, FSIS has concluded that 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 codified effective date 
of January 1, 2006. Therefore, FSIS is amending the regulations to 
provide that the first-tier, less restrictive, sodium levels are 
effective indefinitely, until further notice.

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 needs time to complete its evaluation of the effects of 
further reducing the levels of the sodium content of meat and poultry 
products labeled as ``healthy'' to determine whether the costs of such 
an action exceed its benefits. There are data that support the belief 
that if the sodium content of foods labeled as ``healthy'' is required 
to be lowered it could result in fewer ``healthy'' foods being consumed 
or in consumers adding table salt to improve the palatability of the 
``healthy'' products. In addition, data suggest that lack of available 
substitutes for sodium would impair the industry's ability to continue 
manufacturing ``healthy'' foods as currently defined, especially with 
the increased usage of antimicrobial agents that contain sodium to 
control L. monocytogenes in RTE meat and poultry products as a result 
of FSIS' June 6, 2003, interim final rule. Moreover, FSIS is taking 
this action so that its labeling regulations remain consistent with 
those promulgated by FDA. As is explained above, FDA amended its 
regulations to drop the second-tier sodium level requirements for all 
categories of ``healthy'' foods.

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 should be 
published in the Federal Register as soon as possible following January 
1, 2006, because that is the current effective date for the second-tier 
sodium levels in the ``healthy'' definition regulations. Therefore, the 
Administrator has determined that publication of a proposed rule is 
impracticable and contrary to the public interest under 5 U.S.C. 
553(b)(B). For the same reasons, the Administrator is waiving 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 ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this final rule, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Interim_&_Final_Rules_Index/index.asp. The Regulations.gov Web site is the central online 
rulemaking portal of the United States government. It is being offered 
as a public service to increase participation in the Federal 
government's regulatory activities. FSIS participates in 
Regulations.gov and will accept comments on documents published on the 
site. The site allows visitors to search by keyword or

[[Page 1686]]

Department or Agency for rulemakings that allow for public comment. 
Each entry provides a quick link to a comment form so that visitors can 
type in their comments and submit them to FSIS. The Web site is located 
at http://www.regulations.gov/.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up 
for subscription options across eight categories. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their account.

List of Subjects

9 CFR Part 317

    Food labeling, Meat inspection, Nutrition.

9 CFR Part 381

    Food labeling, Nutrition, Poultry and poultry products.


0
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

0
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]

0
2. Section 317.363 is amended by:
0
A. Removing the phrases ``shall not contain more than 360 mg of sodium, 
except that it'' and ``effective through January 1, 2006,'' in 
paragraph (b)(3) introductory text;
0
B. Removing the phrases ``shall not contain more than 480 mg of sodium, 
except that it'' and ``effective through January 1, 2006,'' in 
paragraph (b)(3)(i); and
0
C. Adding a footnote 1 after ``serving size'' in paragraph (b)(3)(i) to 
read ``This regulation previously provided that, after January 1, 2006, 
individual meat products bearing the claim ``healthy'' (or any 
derivative of the term ``health'') must contain no more than 360 mg of 
sodium and that meal-type products bearing the claim ``healthy'' (or 
any other derivative of the term ``health'') must contain no more than 
600 mg of sodium. Implementation of these sodium level requirements for 
products bearing the claim ``healthy'' (or any derivative of the term 
``health'') has been deferred indefinitely due to technological 
barriers and consumer preferences.''

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
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]

0
4. Section 381.463 is amended by:
0
A. Removing the phrases ``shall not contain more than 360 mg of sodium, 
except that it'' and ``effective through January 1, 2006,'' in 
paragraph (b)(3) introductory text;
0
B. Removing the phrases ``shall not contain more than 480 mg of sodium, 
except that it'' and ``effective through January 1, 2006,'' in 
paragraph (b)(3)(i); and
0
C. Adding a footnote 1 after ``serving size'' in paragraph (b)(3)(i) to 
read ``This regulation previously provided that, after January 1, 2006, 
individual poultry products bearing the claim ``healthy'' (or any 
derivative of the term ``health'') must contain no more than 360 mg of 
sodium and that meal-type products bearing the claim ``healthy'' (or 
any other derivative of the term ``health'') must contain no more than 
600 mg of sodium. Implementation of these sodium level requirements for 
products bearing the claim ``healthy'' (or any derivative of the term 
``health'') has been deferred indefinitely due to technological 
barriers and consumer preferences.''

    Done at Washington, DC, on: January 9, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. 06-268 Filed 1-10-06; 8:45 am]
BILLING CODE 3410-DM-P