[Federal Register: October 31, 2001 (Volume 66, Number 211)]
[Rules and Regulations]               
[Page 54912-54916]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc01-3]                         

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317, 319, and 381

[Docket No. 01-016DF]

 
Use of Transglutaminase Enzyme and Pork Collagen as Binders in 
Certain Meat and Poultry Products

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 
meat inspection regulations to permit the use of pork collagen and 
transglutaminase enzyme (TG enzyme), in limited amounts, as binders in 
certain standardized meat food products. FSIS also is amending its 
poultry products inspection regulations to permit the use of TG enzyme, 
in limited amounts, as a binder in certain standardized poultry 
products. Additionally, FSIS is amending the meat and poultry 
inspection regulations to require that, when TG enzyme is used to 
fabricate or reform cuts of meat or poultry, the resulting product bear 
labeling to indicate that it has been formed from pieces of whole 
muscle meat, or that it has been reformed from a single cut. FSIS is 
proceeding with this direct final rule in response to petitions 
submitted to the Agency by Ajinomoto, U.S.A., Inc. and AMPC, Corp.

DATES: This rule will be effective December 31, 2001 unless FSIS 
receives written adverse comments within the scope of this rulemaking 
or written notice of intent to submit adverse comments within the scope 
of this rulemaking on or before November 30, 2001. If FSIS receives 
adverse comments, a timely withdrawal will be published in the Federal 
Register informing the public that the 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 #01-016DF, Room 102, Cotton Annex, 300 C Street, SW., 
Washington, DC 20250-3700. Reference materials cited in this document 
and 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.

FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Director, 
Labeling and Consumer Protection Staff, Office of Policy, Program 
Development and Evaluation, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250-3700; (202) 205-0279

SUPPLEMENTARY INFORMATION:

Background

Ajinomoto and AMPC Petitions

    On May 5, 1999, Hogan and Hartson, L.L.P. filed a petition with 
FSIS on behalf of its client, Ajinomoto, USA, Inc. (Ajinomoto), 
requesting that the Agency amend its regulations to allow the use of TG 
enzyme, at usage levels of up to 65 ppm of product formulation, to 
improve texture and cooking yields in various standardized meat and 
poultry products. Ajinomoto also requested that FSIS permit TG enzyme 
to be used as a protein cross-linking agent, at usage levels of up to 
65 ppm, to fabricate or reform cuts of meat. When TG enzyme is used to 
fabricate or reform cuts of meat, Ajinomoto requested that the 
resulting product be distinguished from its non-fabricated counterpart 
through terms such as ``formed'' or ``reformed'' as part of the product 
name (e.g. ``formed beef tenderloin''), as opposed to a statement that 
declares the presence of the enzyme as part of the product name (e.g. 
``beef tenderloin formed with water and transglutaminase enzyme'').
    TG enzyme is derived from a non-toxigenic and non-pathogenic strain 
of Streptoverticillium mobaraense and functions by catalyzing the 
formation of a covalent bond between the glutamine and lysine side 
residues of proteins. There are no current allowances in the FSIS 
regulations or those of the Food and Drug Administration (FDA) for the 
use of TG enzyme as a binder or protein cross-linking agent in 
standardized meat or poultry products.
    In a previous petition submitted in June 1997, Ajinomoto requested 
that FSIS permit the use of TG enzyme in both standardized and non-
standardized meat and poultry products. In support of the petition, 
Ajinomoto submitted data to support the generally recognized as safe 
(GRAS) status of TG enzyme for use as a cross-linking agent in meat and 
poultry products at levels of up to 65 ppm. As part of its review of 
the petition, FSIS asked FDA to evaluate the data submitted by 
Ajinomoto on the safety of TG enzyme for this proposed use. In January 
1998, FDA sent a letter to FSIS that said that, although it has not 
made a determination regarding the GRAS status of any use of this 
enzyme, FDA would not challenge, at this time, Ajinomoto's conclusion 
that TG enzyme is safe under the proposed conditions of use.
    Based on the findings of FDA's evaluation, described above, and the 
technical data provided by Ajinomoto, FSIS concluded that TG enzyme was 
suitable for use in non-standardized meat and poultry products, and in 
meat and poultry products that have been formulated to reduce sodium or 
fat content. Thus, the Agency permits the use of TG enzyme, at levels 
of up to 65 ppm, in such products, provided that the products are 
identified by a truthful descriptive designation, such as ``low fat 
pork sausage, water and TG enzyme product.''
    Although FSIS determined that TG enzyme was suitable for use in 
non-standardized meat and poultry products, and in meat and poultry 
products that have been formulated to reduce sodium or fat content, in 
its review of the 1997 petition, the Agency also found that Ajinomoto 
submitted insufficient data on the suitability of the use of TG enzyme 
in standardized meat and poultry products. FSIS informed Ajinomoto that 
in order to permit the use of TG enzyme in standardized products, the 
Agency must pursue rulemaking to amend the regulatory standards of 
identity. FSIS suggested that Ajinomoto submit a petition to request 
that the Agency amend the individual meat and poultry product standards 
to provide for the use of TG enzyme. The Agency also informed Ajinomoto 
that such a petition must include technical data to establish the 
suitability of TG enzyme for use in standardized meat and poultry 
products. In response, Ajinomoto submitted the May 5, 1999, petition, 
to which this rulemaking responds.
    In support of its most recent petition, Ajinomoto submitted 
numerous published studies on the efficacy of TG enzyme in cross-
linking muscle proteins. FSIS determined that the data demonstrate that 
TG enzyme is effective in improving texture by increasing elasticity 
and improving cooking yields in standardized meat sausage products, 
standardized restructured meat products, standardized ``roast beef 
parboiled and steam roasted'' meat products, and standardized poultry 
rolls. The Agency also determined that TG enzyme is effective in 
binding pieces of whole muscle meat to fabricate or reform cuts of 
meat. FSIS concluded that the data demonstrate efficacy at 65 ppm. 
However, FSIS found that the petition contained insufficient data to 
support the use of TG enzyme in

[[Page 54913]]

standardized poultry products other than poultry rolls.
    In support of its request that cuts of meat fabricated or reformed 
using TG enzyme be identified as ``formed'' or ``reformed'' in 
conjunction with the product name, Ajinomoto claimed that TG enzyme 
does not change the essential character of a meat product. According to 
the data presented by Ajinomoto, TG enzyme functions to fuse together 
muscle tissue, and that whole muscle tissues fused together with the TG 
enzyme have the same taste, aroma, nutritional profile, and other 
properties as untreated whole muscle tissue. Thus, Ajinomoto argued, 
the primary difference between a cut of meat formed with TG enzyme and 
an untreated cut will be the shape or size of the final product.
    Because muscle fibers treated with TG enzyme will not be aligned as 
they would be naturally, the Agency does not agree that TG enzyme does 
not affect the essential character of a product. However, the Agency 
does agree that, because the primary difference between a cut of meat 
formed with TG enzyme and an untreated cut is the shape of the product, 
special labeling to alert the consumer to the presence of the TG enzyme 
in the product, such as ``beef tenderloin formed with water and 
transglutaminase enzyme,'' is not necessary. Therefore, in this direct 
final rule, the Agency is requiring that products that are fabricated 
using TG enzyme bear the term ``formed'' or ``reformed'' in conjunction 
with product name. The words ``formed'' and ``reformed'' are 
appropriate terms to identify these products because these terms reveal 
the material fact that multiple pieces of meat have been formed to look 
like a solid piece of meat. Otherwise, consumers could be misled. The 
product must also declare the presence of TG enzyme in the list of 
ingredients on the product's label, as required by 9 CFR 317.2(f)(1) 
and 381.118(a)(1).
    On September 27, 1999, AMPC, Inc., petitioned FSIS to amend its 
regulations to allow the use of pork collagen, a connective tissue 
protein, as a binder in sausage as provided in 9 CFR Part 319, at usage 
levels of up to 3.5% of product formulation. In addition to sausage as 
provided in 9 CFR Part 319, AMPC requested that FSIS allow the use of 
pork collagen as a binder in other standardized meat and poultry 
products, such as cured pork products, luncheon meat, meat food entree 
products, pies, turnovers, meat snacks, hors d'oeuvres, pizza and 
specialty items, meat salads, meat spreads, barbecued meats, poultry 
breakfast sausages, and canned, frozen, or dehydrated meat food 
products. There are no current allowances in the FSIS regulations for 
the use of pork collagen as a binder in standardized meat or poultry 
products.
    Before petitioning FSIS, AMPC submitted a GRAS Notification to FDA 
concerning the use of pork collagen as a binder in meat products. After 
consulting with FSIS, FDA sent a letter to AMPC on July 29, 1999, that 
said that FDA ``has no questions at this time regarding the conclusion 
of AMPC that pork collagen is GRAS for use as a binder and purge 
reducing additive in meat and meat type products at a level of 1-3.5% 
`` (GRAS Notice No. GRN 000021). FDA instructed AMPC to consult with 
FSIS regarding the suitability of the use of pork collagen in meat and 
poultry products, and the acceptability of use within the context of 
the Federal meat and poultry products inspection regulations.
    AMPC has conducted research to support the efficacy of pork 
collagen as a binder in sausages and submitted data with the petition. 
After evaluating the data submitted by AMPC, FSIS determined that the 
data demonstrate that pork collagen is effective at reducing purge and 
improving cooking yields in those meat sausages whose standards permit 
binders, in certain standardized cured pork products, and in non-
standardized meat and poultry products. FSIS also determined that the 
data demonstrate efficacy at 3.5% of the product formulation. Thus, the 
Agency permits the use of pork collagen, at the specified levels, in 
non-standardized meat and poultry products, provided that these 
products are identified by a truthful descriptive designation, such as 
``low fat pork sausage, water and pork collagen.''
    However, to permit the use of pork collagen in standardized meat 
and poultry products, the Agency must conduct rulemaking to amend the 
individual product standards. Therefore, in response to AMPC's 
petition, FSIS is publishing this direct final rule to amend the 
standards of identity for certain meat sausages and certain 
standardized cured pork products. The Agency is not amending other 
product standards in this rulemaking because it found that the petition 
contained insufficient data to support the suitability of pork collagen 
for use in standardized poultry products.

Current Regulatory Requirements

    In order to permit the use of a food ingredient in the production 
of meat or poultry products, FDA, in consultation with FSIS, assesses 
the safety of the ingredient's proposed use, while FSIS evaluates its 
efficacy and suitability for use in meat and poultry products. At the 
time that AMPC and Ajinomoto submitted their petitions, substances 
permitted for use in the production of meat products were listed in the 
chart of approved substances contained in former 9 CFR 318.7(c)(4), and 
substances permitted to be used in the production of poultry products 
were listed in the chart of approved substances contained in former 9 
CFR 381.147(f)(4). Therefore, in its petition, Ajinomoto requested that 
FSIS amend the chart of substances in former Secs. 318.7(c)(4) and 
381.147(f)(4) to include the acceptable use of TG enzyme as a binder 
and cross-linking agent for sausage and other standardized meat and 
poultry products. Likewise, in its petition, AMPC requested that FSIS 
amend the chart of substances in former Secs. 318.7(c)(4) and 
381.147(f)(4) to include the acceptable use of pork collagen as a 
binder for sausage and other standardized meat and poultry products.
    On December 23, 1999, FSIS published a final rule, ``Food 
Ingredients and Sources of Radiation Listed or Approved for Use in Meat 
and Poultry Products,'' designed to improve the efficiency of the 
procedures used by FSIS and FDA to review and approve the use of food 
ingredients and sources of radiation in the production of meat and 
poultry products (64 FR 72168). Under the new regulations, rather than 
listing substances approved for use in the production of meat and 
poultry products in the chart of substances contained in former 9 CFR 
318.7(c)(4) and former 9 CFR 381.147(f)(4), FDA now lists food 
ingredients and sources of radiation that are safe for specific use in 
the production of meat and poultry products in its regulations in title 
21 of the CFR. 9 CFR parts 310, 318, 319, and 381 of the FSIS 
regulations were amended to include appropriate cross-references to 
title 21 listings of substances and sources of radiation approved for 
use in meat and poultry products. In the final rule, FSIS also created 
one list of food ingredients approved for use in the production of meat 
and poultry products by combining the listing contained in former 
section 318.7(c)(4) with the listing contained in former section 
381.147(f)(4) and moving the combined listing to section 424.21(c). The 
final rule became effective on January 24, 2000.
    Because FDA now lists food ingredients and sources of radiation 
approved for use in the production of

[[Page 54914]]

meat and poultry products in its regulations, FSIS has stated that it 
will limit substance-specific rulemakings to those necessary to 
establish specific prohibitions or limitations on the use of food 
ingredients in the production of meat or poultry products. Such 
rulemakings are necessary when a standard of identity or composition 
prohibits or limits the use of an ingredient. In these instances, the 
standard of identity must be amended to include the permitted use of 
the ingredient. FSIS does not intend to add any new substances to the 
chart contained in 9 CFR 424.21(c).
    As previously mentioned, FSIS currently permits TG enzyme and pork 
collagen to be used in non-standardized meat and poultry products, such 
as meat links or patties, and modified versions of traditional 
products, such as ``low fat pork sausage, water, and pork collagen 
product,'' and ``reduced fat breakfast sausage with transglutaminase 
enzyme,'' provided that these products are identified by a truthful 
descriptive designation (9 CFR 317.2(c)(1), 317.2(e) and 381.117(a)). 
However, according to the petitioners, these descriptive designations 
may confuse some consumers or may cause some consumers to believe that 
the product identified by the descriptive designation is inferior to 
the traditional standardized version. Thus, the petitioners requested 
that, when TG enzyme or pork collagen is used as a binder in certain 
standardized products, these products be permitted to be identified by 
a standardized term, such as ``hotdogs'' or ``breakfast sausage.''

The Final Rule

    FSIS is amending its meat inspection regulations and poultry 
products inspection regulations to permit the use of TG enzyme as a 
binder at up to 65 ppm of product formulation in sausages as provided 
in 9 CFR part 319, in fabricated steaks under 9 CFR 319.15(d), in 
``roast beef parboiled and steam roasted'' under 9 CFR 319.81, and in 
poultry rolls under 9 CFR 319.81. FSIS is also amending its meat 
inspection regulations to permit the use of pork collagen as a binder 
at up to 3.5% of product formulation in sausages whose standards 
currently permit binders as provided in 9 CFR part 319 and cured pork 
products as provided in 9 CFR 319.104. Under Sec. 319.104, binders are 
only permitted in certain cured pork products, such as ``Ham Water 
Added,'' ``Ham and Water Product-X% of Weight is Added Ingredients,'' 
and ``Ham with Natural Juices.'' Under this direct final rule, the use 
of pork collagen is also limited to those particular cured pork 
products.
    Because it no longer adds new substances to the list of approved 
substances codified at 9 CFR 424.21(c), the Agency is amending the 
standards of identity for sausage at 9 CFR 319.140, fabricated steaks 
at 9 CFR 319.15(d), ``roast beef parboiled and steam roasted'' at 9 CFR 
319.81, certain cured pork products at 9 CFR 319.104, and poultry rolls 
at 9 CFR 381.159 to permit the use of either TG enzyme, pork collagen, 
or both of these substances at the specified levels. The Agency is 
revising the standards of identity for the sausages that currently 
permit the use of binders, such as ``breakfast sausage'' (9 CFR 
319.143), ``frankfurter,'' ``frank,'' ``furter,'' ``hotdog,'' 
``weiner,'' ``vienna,'' ``bologna,'' ``garlic bologna,'' 
``knockwurst,'' and similar products (9 CFR 319.180), and 
``cheesefurters'' and similar products (9 CFR 319.181), to cross 
reference 319.140 for the purpose of determining which binders are 
permitted for use in these products and at what levels. The standards 
of identity for ``braunschweiger'' (9 CFR 319.182(a)) and ``liver 
sausage'' or ``liverwurst'' (9 CFR 319.182(b)) permit the addition of 
binders and contain a cross reference to Sec. 319.140 for purposes of 
determining the permissible use of these substances in these products. 
Therefore, there is no need to change these product standards.
    The Agency is also amending 9 CFR 317.8(b) of the meat inspection 
regulations to require that, when transglutaminase enzyme is used to 
fabricate or reform a cut of meat, the resulting product's labeling 
include a statement to indicate that the product has been ``formed'' or 
``reformed'' as part of the product name. The Agency has determined 
that such labeling is necessary because TG enzyme alters the essential 
character of a product by making multiple cuts of meat or pieces of 
muscle tissue appear to be one intact cut or piece of meat, which could 
mislead consumers about the nature of this type of product. The Agency 
has determined that the terms ``formed'' and ``reformed'' are 
appropriate descriptive terms. Although it must be revealed in the 
ingredients statement, the presence of TG enzyme need not be disclosed 
as part of the product name. The labeling of these products must still 
comply with the requirement that a product that has been prepared by 
salting, smoking, drying, cooking, chopping, or otherwise must be so 
described on the label, unless the name of the product implies, or the 
manner of packaging shows that the product was subject to such 
preparation (9 CFR 317.2(e)).
    The following examples are intended to provide further 
clarification on the application of the labeling requirements for 
products that have been fabricated or reformed using TG enzyme. When 
the surface of two whole beef tenderloins are fused together to create 
a product with a uniform thickness or portion size, an appropriate name 
for the product would be ``Formed Beef Tenderloin.'' However, if TG 
enzyme is used to fuse non-intact pieces of beef tenderloin to form a 
roll that resembles a tenderloin, an appropriate name would be 
``Reformed Beef Tenderloin Pieces.'' When a beefsteak is formed by 
treating chopped pieces of meat trim with TG enzyme to fuse the pieces 
together, an appropriate name for this product would be ``Formed 
Beefsteak, Chopped and Shaped.'' When seam fat is removed from a cut of 
meat and the cut is then reassembled using TG enzyme, an appropriate 
name for the product would be ``reformed'' in conjunction with the name 
of the product, for example, ``Reformed Ribeye Steak.''
    The petition did not request that FSIS adopt these labeling 
requirements for fabricated or reformed poultry products. However, 
because FSIS has determined that TG enzyme is suitable for use in non-
standardized poultry products and modified versions of traditional 
poultry products, and because it is interested in harmonizing the meat 
and poultry inspection regulations, the Agency is amending 9 CFR 
381.129 to require that the labels of poultry products fabricated or 
reformed using TG enzyme state that the product has been ``formed'' or 
``reformed'' as part of the product name.
    Establishments that choose to use TG enzyme or pork collagen in 
their products will be required to list these substances, in descending 
order of predominance, in the product's ingredients statement (9 CFR 
317.2(f)(1) and 381.118(a)(1)). This will require modification of the 
product's label and the printing of new product labels.
    Because the use of these substances at the level that are being 
provided for by FSIS is not controversial, and because these substances 
are permitted in non-standardized products, FSIS expects no adverse 
comment to result from the changes that it is making in this direct 
final rule. Therefore, unless the Agency receives written adverse 
comments within the scope of this rulemaking, or a written notice of 
intent to submit adverse comments within the scope of this rulemaking, 
within 30 days, this action will become final 60 days after publication 
in the Federal Register. If written adverse comments within the scope 
of the rulemaking are received,

[[Page 54915]]

the final rulemaking notice will be withdrawn, and the Agency will 
publish a proposed rulemaking notice that includes a comment period.

Executive Order 12866 and Regulatory Flexibility Act

    This 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

    This direct final rule will permit the use of TG enzyme and pork 
collagen in certain standardized meat food products. It also prescribes 
labeling requirements for meat and poultry products fabricated or 
reformed using TG enzyme.
    The use of these ingredients is voluntary and therefore, the impact 
of this direct final rule on small establishments is likely to be 
minimal. FSIS does not believe that any costs associated with changes 
to labels will be significant. The decision by individual 
establishments to use these ingredients will be based on their 
conclusions that the benefits of providing new product to meet 
consumers' needs outweigh the implementation costs.

Executive Order 12988

    This direct final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. This final rule: (1) Preempts State and 
local laws and regulations that are inconsistent with this rule; (2) 
has no retroactive effect; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule. However, the administrative procedures specified in 9 CFR 306.5, 
381.35, and 590.320 through 590.370, respectively, must be exhausted 
before any judicial challenge of the application of the provisions of 
this direct final rule, if the challenge involves any decision of an 
FSIS employee relating to inspection services provided under the FMIA 
or PPIA.

Paperwork Requirements

    Abstract: FSIS has submitted an emergency information collection 
request for the paperwork and record keeping requirements in this 
direct final rule in accordance with the Paperwork Reduction Act. 
Establishments that choose to use any of the substances permitted by 
this final rule will have to make changes to their product labels.
    Estimate of Burden: Establishments must develop product labels in 
accordance with the regulations. To receive approval of the labels, 
establishments must complete FSIS Form 7234-1. FSIS program employees 
review FSIS Form 7234-1 to ensure that the information on the labels 
complies with the regulations. FSIS estimates that it will take 60 
minutes to design and develop modified product labels in accordance 
with this direct final rule and 15 minutes to prepare FSIS Form 7234-1 
and submit it, along with the sketch label, to FSIS.
    Establishments will only need to make the label change once.
    Respondents: Meat and poultry product establishments.
    Estimated Number of Respondents: 992
    Estimated number of Responses per Respondents: FSIS estimates that 
each establishment will modify one product label.
    Estimated Total Annual Burden on Respondents: 1,240 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, Room 109 Cotton Annex., Washington, DC 20250-3700.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper functions of the Agency, 
including whether the information will have practical utility; (b) the 
accuracy of the Agency's estimate of the burden of the proposed 
collection of information, including the validity of the method and 
assumptions used; (c) ways to enhance the quality, utility, and clarity 
of the information to be collected; (d) ways to minimize the burden of 
the collection of information on those who are to respond, including 
through use of appropriate automated, electronic, mechanical, or other 
technological collection techniques, or other forms of information 
technology. Comments may be sent to Lee Puricelli, see the address 
above, and to the Desk Officer for Agriculture, Office of Information 
and Regulatory Affairs, Office of Management and Budget (OMB) 
Washington, DC 20253.

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 and are informed about the mechanism for providing 
their comments, FSIS will announce it and provide copies of this 
Federal Register publication in the FSIS Constituent Update. FSIS 
provides a weekly FSIS Constituent Update, which is communicated via 
fax to over 300 organizations and individuals. 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 fax list 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 these various channels, FSIS is able to provide 
information to a much broader, more diverse audience. For more 
information and to be added to the constituent fax list, fax your 
request to the Congressional and Public Affairs Office, at (202) 720-
5704.

List of Subjects

9 CFR Part 317

    Food labeling, Meat Inspection.

9 CFR Part 319

    Food grades and standards, Food labeling, Meat inspection.

9 CFR Part 381

    Food labeling, Poultry and poultry products.

    For the reasons discussed in the preamble, FSIS amends 9 CFR 
Chapter III as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

    1. The authority citation for part 317 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
    2. Section 317.8 is amended by adding a new paragraph (b)(39) to 
read as follows:


Sec. 317.8  False or misleading labeling or practices generally; 
specific prohibitions and requirements for labels and containers.

* * * * *
    (b) * * *
    (39) When transglutaminase enzyme is used to bind pieces of meat to 
form a cut of meat, or to reform a piece of meat from a multiple cuts, 
there shall appear on the label, as part of the product name, a 
statement that indicates that the product has been ``formed'' or 
``reformed,'' in addition to other preparation steps, e.g., ``Formed 
Beef Tenderloin'' or ``Reformed and Shaped Beef Tenderloin.''
* * * * *

[[Page 54916]]

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

    3. The authority citation 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.

    4. Section 319.15 is amended by revising paragraph (d) to read as 
follows:


Sec. 319.15  Miscellaneous beef products.

* * * * *
    (d) Fabricated steak. Fabricated beef steaks, veal steaks, beef and 
veal steaks, or veal and beef steaks, and similar products, such as 
those labeled ``Beef Steak, Chopped, Shaped, Frozen,'' ``Minute Steak, 
Formed, Wafer Sliced, Frozen,'' ``Veal Steaks, Beef Added, Chopped--
Molded--Cubed--Frozen, Hydrolyzed Plant Protein, and Flavoring'' shall 
be prepared by comminuting and forming the product from fresh and/or 
frozen meat, with or without added fat, of the species indicated on the 
label. Such products shall not contain more than 30 percent fat and 
shall not contain added water or extenders. Transglutaminase enzyme at 
levels of up to 65 ppm may be used as a binder. Beef cheek meat 
(trimmed beef cheeks) may be used in the preparation of fabricated beef 
steaks only in accordance with the conditions prescribed in paragraph 
(a) of this section.
* * * * *
    5. Section 319.81 is amended by adding the following new sentence 
after the phrase ``shall not exceed 70 percent of the fresh beef 
weight'':
    ``Transglutaminase enzyme at levels of up to 65 ppm may be used as 
a binder in such product.''
    6. Section 319.104 is amended by revising paragraph (d) to read as 
follows:


Sec. 319.104  Cured pork products.

* * * * *
    (d) The binders provided for use in cured pork products in a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or 
in 21 CFR Chapter I, Subchapter A or Subchapter B, may be used singly 
in those cured pork products labeled as ``Ham Water Added,'' ``Ham and 
Water Product-X% of Weight is Added Ingredients,'' and ``Ham with 
Natural Juices.'' In addition to the binders referred to in the 
preceding sentence, the following substances are permitted for use as 
binders and may be used singly in those cured pork products labeled as 
``Ham Water Added,'' ``Ham and Water Product-X% of Weight is Added 
Ingredients,'' and ``Ham with Natural Juices'': pork collagen at up to 
3.5% of the product formulation. Unless their use is provided for in a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or 
in 21 CFR Chapter I, Subchapter A or Subchapter B, or in this 
paragraph, these binders are not permitted to be used in combination 
with another such binder listed for use in cured pork products. When 
any such substance is added to these products, the substance shall be 
declared in the ingredients statement by its common or usual name in 
order of predominance.
* * * * *
    7. Section 319.140 is amended by adding the following new sentence 
after the phrase ``may contain binders and extenders as provided in a 
regulation permitting that use in this subchapter or in 9 CFR Chapter 
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter 
B'':
    ``In addition to the binders and extenders referred to in the 
preceding sentence, the following two substances may also be used as 
binders in those sausages in which the use of such class of substances 
is permitted: pork collagen at up to 3.5% of the product formulation 
and transglutaminase enzyme at up to 65 ppm of the product 
formulation.''
    8. Section 319.143 is amended by removing the phrase 
``Sec. 318.7(c)(4) of this subchapter'', and adding ``Sec. 319.140 of 
this part'' in its place.
    9. Section 319.180 is amended by revising paragraph (e) to read as 
follows


Sec. 319.180  Frankfurter, frank, furter, hotdog, weiner, vienna, 
bologna, garlic bologna, knockwurst, and similar products.

* * * * *
    (e) Binders and extenders as provided in Sec. 319.140 of this part 
may be used in cooked sausage that otherwise comply with paragraph (a) 
or (b) of this section. When any such substance is added to these 
products, the substance shall be declared in the ingredients statement 
by its common or usual name in order of predominance.
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    10. The authority citation 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.

    11. Section 381.129 is amended by adding a new paragraph (e) to 
read as follows:


Sec. 381.129  False or misleading labeling or containers.

* * * * *
    (e) When transglutaminase enzyme is used to bind pieces of poultry 
to form a cut of poultry, or to reform a piece of poultry from a 
multiple cuts of poultry, there shall appear on the label, as part of 
the product name, a statement that indicates that the product has been 
``formed'' or ``reformed,'' in addition to other preparation steps, 
e.g., ``Formed Turkey Thigh Roast'' or ``Reformed and Shaped Chicken 
Breast.''
    12. Section 381.159 is amended by revising paragraph (a) to read as 
follows:


Sec. 381.159  Poultry rolls.

    (a) Binders or extenders may be added in accordance with a 
regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or 
in 21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the 
binders referred to in the preceding sentence, the following substances 
are permitted for use as binders in poultry rolls: transglutaminase 
enzyme at up to 65 ppm. When binding agents are added in excess of 3 
percent for cooked rolls and 2 percent for raw rolls, the common name 
of the agent or the term ``Binders Added'' shall be included in the 
name of the product; e.g., ``Turkey Roll-Gelatin Added.''
* * * * *

    Done at Washington, DC, on: October 25, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-27264 Filed 10-30-01; 8:45 am]
BILLING CODE 3410-DM-P