[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://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://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://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://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]