Federal Register, Volume 66 Issue 211 (Wednesday, October 31, 2001)

[Federal Register Volume 66, Number 211 (Wednesday, October 31, 2001)]
[Rules and Regulations]
[Pages 54912-54916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27264]

=======================================================================
-----------------------------------------------------------------------

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.

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

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://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