[Federal Register: January 11, 2006 (Volume 71, Number 7)]
[Rules and Regulations]
[Page 1683-1686]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja06-1]
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Rules and Regulations
Federal Register
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[[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.
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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: fsis.regulationscomments@fsis.usda.gov.
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
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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