[Federal Register: April 29, 2003 (Volume 68, Number 82)]
[Rules and Regulations]
[Page 22576-22578]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap03-2]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 319 and 381
[Docket No. 01-032DF]
RIN 0583-AC96
Approving Ingredients Used in the Production of Meat and Poultry
Products: Use of Any Safe and Suitable Binder or Antimicrobial Agent in
Meat and Poultry Products With Standards of Identity or Composition
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Direct final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
regulations to permit the use of any safe and suitable binder or
antimicrobial agent in the production of meat and poultry products that
are subject to a standard of identity or composition that provides for
the use of such ingredients. The use of these ingredients must be
consistent with any limitations or conditions of use prescribed in
applicable FSIS or Food and Drug Administration (FDA) regulations. This
direct final rule will provide establishments with greater flexibility
in formulating meat and poultry products.
DATES: This rule will be effective June 30, 2003 unless FSIS receives
written adverse comments that are within the scope of this rulemaking
or written notice of the intent to submit adverse comments that are
within the scope of this rulemaking on or before May 29, 2003.
If we receive such comment, we will publish a timely withdrawal in
the Federal Register informing the public that this rule will not take
effect.
ADDRESSES: Submit adverse comments or notice of intent to submit
adverse comments within the scope of this rulemaking to: FSIS Docket
Clerk, Docket No. 01-032DF, Room 102, Cotton Annex Building, 300 12th
Street, SW., Washington, DC 20250-3700. Any comments received will be
available for public inspection in the FSIS Docket Room from 8:30 a.m.
to 4:30 p.m., Monday through Friday. Copies of this direct final rule
are available on the Internet at http://www.fsis.usda.gov <http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov>.
FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Director,
Labeling and Consumer Protection Staff, Room 602, 1400 Independence
Avenue, SW., Room 602 Cotton Annex, Washington, DC 20250-3700, 202-205-
0279.
SUPPLEMENTARY INFORMATION:
Background
On December 23, 1999, FSIS published in the Federal Register, a
final rule entitled, ``Food Ingredients and Sources of Radiation Listed
or Approved for Use in the Production of Meat and Poultry Products.''
The final rule provided a comprehensive background regarding the status
of food ingredients and sources of radiation currently listed in Titles
9 and 21 of the CFR, and explained the process by which FDA and FSIS
would be working together regarding future requests for approvals of
ingredients to be used in meat and poultry products, which are under
USDA jurisdiction.
After publishing that rule, the two agencies entered into a
memorandum of understanding (MOU) that outlines the responsibilities of
each Agency during the joint review of new ingredients or new uses of
previously approved ingredients. Under the Federal Food, Drug and
Cosmetic Act (FFDCA), FDA has the responsibility for determining the
safety of ingredients. FSIS has authority under the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to
determine whether new ingredients, or new uses of previously approved
ingredients, are suitable for their intended use in meat and poultry
products. The final rule and MOU are available on the internet at:
http://www.fsis.usda.gov/oppde/larc <http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fsis.usda.gov/oppde/larc>.
As used in this rule, the term ``safe and suitable'' has the same
meaning as in FDA regulations (21 CFR 130.3(d)) and as is applied in
the MOU between the two Agencies. A safe and suitable ingredient is one
that: (1) Performs an appropriate technical function in the food in
which it is used; (2) is used at the lowest level necessary to achieve
its intended purpose in that food; and (3) is currently approved or
listed in FDA regulations as a food additive (21 CFR parts 172-180);
GRAS substance (21 CFR parts 182 and 184); Prior-Sanctioned Food
Ingredient (21 CFR part 181); Color Additive (21 CFR part 70); or is a
self-determined GRAS ingredient for which FDA has provided FSIS with a
written no objection opinion regarding the safety of the use of the
substance in meat and poultry products and for which FSIS has
determined the use to be suitable (per an acceptability determination
described in the MOU).
Under current regulations, a person wishing to use an FDA-approved
ingredient that FSIS has determined to be suitable for use in meat and
poultry products, such as an antimicrobial agent or binder, in a
product for which there exists a regulatory standard that does not
provide for the use of the ingredient, must petition FSIS to amend the
standard. Evaluation of the petition for the proposed ingredient use
and the rulemaking to amend the standard may take two years or more.
FSIS receives approximately 2 to 3 petitions annually for uses of
newly approved or new uses of approved antimicrobials or binders. A
recent example of this was the 1999 petition to allow the use of
transglutaminase enzyme and pork collagen for use in limited amounts as
binders in certain standardized meat and poultry products, which led to
an October 31, 2001, final rule (66 FR 54912). Without amending
specific product standards of identity, the use of the approved
ingredient is limited to non-standardized products only.
The Final Rule
FSIS is amending the general requirements of the regulations
governing standards of identity and composition for meat and poultry
products (9 CFR 319.1 and 381.155). A standard of identity prescribes
the manner of preparation and the ingredients of a product that is to
be called by a certain name. A standard of composition prescribes the
quantity of ingredients, such as the minimum meat or poultry content,
of a product. Numerous specific standards of identity and composition
for meat and poultry products are set out in the regulations (9 CFR
319, subparts A-U and 381, subpart P). FSIS is adding to the general
requirements a provision that will permit the use of any binder or
antimicrobial agent if FDA and FSIS
[[Page 22577]]
have found the ingredients to be safe and suitable in the production of
products that are subject to such standards, and if the standards and
other applicable regulations already allow the use of these types of
ingredients in the preparation or processing of the products.
FSIS has determined that conducting rulemaking to amend individual
food standards of identity to permit the addition of new ingredients on
a case by case basis is not an efficient use of Agency resources and
results in unnecessary delays for the use of safe and suitable binders
and antimicrobial agents by meat and poultry establishments. Therefore,
the objectives to be accomplished by this direct final rule is to
provide for efficient use of Agency resources and to provide
establishments greater flexibility in the formulation of meat and
poultry products with a standard of identity and composition in 9 CFR
parts 319 and 381 which already permit the use of ingredients of these
types.
With the implementation of this direct final rule, establishments
that prepare or process meat or poultry food products for which a
standard of identity or composition provides for the use of binders or
antimicrobial agents will be able to choose from a larger number of
antimicrobial agents or binders than at present when formulating their
products. Even though the standardized products will be permitted to
contain these new antimicrobial agents or binders, the products will
continue to be identified by the same standardized product names. The
establishments thus would benefit from continued consumer acceptance of
their products.
Executive Order 12988
This direct final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This direct final rule: (1) Preempts all
state and local laws and regulations that are inconsistent with this
rule; (2) has no retroactive effect; (3) does not require
administrative proceedings before parties may file suit in court
challenging this rule.
Executive Order 12866 and Regulatory Flexibility Act
This direct final rule has been reviewed under Executive Order
12866. It has been determined to be not significant for purposes of
E.O. 12866 and therefore, has not been reviewed by the Office of
Management and Budget (OMB).
Effect on Small Entities
Costs associated with this direct final rule will be voluntary.
Establishments can be expected to assume such costs only if it would be
profitable for them to do so. The direct final rule will not mandate
any changes in the way meat food or poultry products are produced or
labeled. The rule will increase the availability to establishments of
antimicrobial agents and binders that may be added to standardized meat
food and poultry products without prolonged regulation development
processes to amend food standards. Establishments that choose to
prepare or process products that contain antimicrobial agents or
binders will continue to incur the normal costs of production,
labeling, and marketing.
This direct final rule will not impose any new requirement on small
entities but will provide them with greater flexibility in the use in
their products of antimicrobial agents and binders. The decision to use
a new antimicrobial agent or binder in the production of standardized
meat and poultry products is strictly voluntary. The rule could benefit
as many as 1,150 federally inspected establishments. Most of these
establishments--almost 900--are small operations, each employing fewer
than 500 persons. If States operating meat or poultry inspection
programs for products in intrastate commerce that are ``equal to'' the
Federal program for products in interstate commerce issue similar
regulatory amendments, an additional 1,100 establishments could
benefit. Nearly all the State-inspected establishments are small
business entities.
Paperwork Requirements
Abstract: Establishments choosing to take advantage of the
flexibility of this rule by changing their product formulations to
include different antimicrobial agents or binders would have to change
their labels. In most cases, the label changes will be subject to the
provisions for generically approved labeling in 9 CFR 317.5 and 381.133
because the changes will apply to products with standards of identity.
That means that the label changes would not entail prior review and
approval by FSIS before the new labels could be used. In most cases,
the changes involved will be limited to changes in the statement of
ingredients. A small percentage of the establishments affected by this
rule may find that they need to revise and revalidate their HACCP
plans.
Estimate of Burden: FSIS estimates that it will take at most one
hour to develop a modified label. As many as 300 federally inspected
establishments, principally establishments that manufacture products
that are heat-treated, not-fully-cooked, and not shelf-stable would be
more likely to consider changes, such as the addition or substitution
of an antimicrobial agent, that might entail a reassessment of their
HACCP plans. For example, an establishment wishing to add an
antimicrobial to its product formulation, or substitute another
approved antimicrobial for one that the establishment is already using,
may have determined that such a change in product formulation would
improve product safety. If so, FSIS estimates that it may take up to
two hours for an establishment to reassess its HACCP plan as a result
of a formulation change.
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
direct final rule, 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 <http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 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 <http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 319
Food Standards, Meat Inspection.
[[Page 22578]]
9 CFR Part 381
Food Standards, Poultry Inspection.
0
For the reasons set out in the preamble, FSIS is amending 9 CFR part
319 and part 381 as follows:
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
Subpart A--General
0
1. The authority for Part 319 continues to read as follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
0
2. Section 319.1 is amended by designating the existing text as
paragraph (a) and by adding a new paragraph (b) as follows:
Sec. 319.1 Labeling and preparation of standardized products.
(a) * * *
(b) Any binder or antimicrobial agent that has been found to be
safe and suitable by the Food and Drug Administration and the Food
Safety and Inspection Service may be used in the production of meat
products with standards of identity in this part, where the product
standards and applicable Federal regulations already permit the use of
these types of ingredients.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
Subpart P--Definitions and Standards of Identity or Composition
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.
0
4. Section 381.155 is amended by adding a new paragraph (b) to read as
follows:
Sec. 381.155 General.
* * * * *
(b) Any binder or antimicrobial agent that has been found to be
safe and suitable by the Food and Drug Administration and the Food
Safety and Inspection Service may be used in the production of poultry
products with standards of identity in this part, where the product
standards and applicable Federal regulations already permit the use of
these types of ingredients.
Done at Washington, DC on: April 21, 2003.
Garry L. McKee,
Administrator.
[FR Doc. 03-10392 Filed 4-28-03; 8:45 am]
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