[Federal Register Volume 59, Number 42 (Thursday, March 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4891]
[[Page Unknown]]
[Federal Register: March 3, 1994]
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Part III
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 301 and 318
Meat Produced by Advanced Meat/Bone Separation Machinery and Meat
Recovery Systems; Proposed Rule
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301 and 318
[Docket No. 94-003P]
RIN 0583-AB76
Meat Produced by Advanced Meat/Bone Separation Machinery and Meat
Recovery Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat inspection regulations by amending the
definition of meat to include as meat product resulting from advanced
meat/bone separation machinery and recovery systems that do not crush,
grind, or pulverize bones to remove attached skeletal tissue from the
bones of livestock carcasses and parts of carcasses, establishing the
criteria for meat from advanced meat/bone separation machinery and meat
recovery systems to assure consistency with the characteristics and
composition of meat, and establishing requirements for the handling of
meat derived from advanced meat/bone separation machinery and meat
recovery systems, as well as the material from which it is derived.
This action is being taken to update the definition of meat to
acknowledge and include as meat product derived from the advances made
in the modification of traditional mechanical means of separating meat
from the bones of livestock and the development of advanced recovery
systems that do not involve grinding, crushing, or pulverizing bones to
remove the adhering skeletal tissue.
DATES: Comments must be received on or before May 2, 1994.
ADDRESSES: Written comments to: Policy Office, Attn: Diane Moore, FSIS
Hearing Clerk, room 3171, South Building, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250. (See
also ``Comments'' under SUPPLEMENTARY INFORMATION.)
FOR FURTHER INFORMATION CONTACT:
John W. McCutcheon, Deputy Administrator, Regulatory Programs, Food
Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250, (202) 720-2709.
SUPPLEMENTARY INFORMATION:
Executive order 12866
This proposed rule has been reviewed under Executive Order 12866.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) from imposing with respect
to the premises, facilities, and operations of federally inspected
establishments any requirements that are in addition to, or different
than, those imposed under the FMIA. States and local jurisdictions may,
however, impose recordkeeping and other requirements within the scope
of section 202 of the FMIA, if consistent therewith, with respect to
any such federally inspected establishment. States and local
jurisdictions are also preempted under the FMIA from imposing any
marking, labeling, packaging, or ingredient requirements on federally
inspected meat products that are in addition to, or different than,
those imposed under the FMIA. States and local jurisdictions may,
however, exercise concurrent jurisdiction over meat products that are
outside official establishments for the purpose of preventing the
distribution of meat products that are misbranded or adulterated under
the FMIA, or, in the case of imported articles, which are not at such
an establishment, after their entry into the United States. Under the
FMIA, States that maintain meat inspection programs must impose
requirements that are at least equal to those required under the FMIA.
The States may, however, impose more stringent requirements on such
State inspected products and establishments.
No retroactive effect will be given to this rule. The
administrative procedures specified in 9 CFR 306.5 must be exhausted
prior to any judicial challenge to the provisions of this rule, if the
challenge involves any decision of a program official. The
administrative procedures specified in 9 CFR part 335 must be exhausted
prior to any judicial challenge to the application of the provisions of
this rule with respect to labeling decisions.
Effect on Small Entities
The Administrator has determined that this proposed rule would not
have a significant economic impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
This rule does not require either large or small establishments to use
meat/bone separation machinery and meat recovery systems. Although
there are initial costs involved with the purchase of machinery and
establishing quality control programs, there are no apparent direct
competitive advantages that large establishments would have over small
establishments.
Paperwork Requirements
Manufacturers producing ``meat'' resulting from advances in meat/
bone separation machinery that does not grind, crush, or pulverize bone
in order to remove skeletal muscle tissues (i.e., meat) adhering to
livestock bones would be required to develop and maintain a quality
control program that provides the controls and information necessary to
assure that the product will meet the requirements established for such
product as proposed. The paperwork requirements contained in this
proposed rule have been submitted to the Office of Management and
Budget for approval under the Paperwork Reduction Act (44 U.S.C. 3501
et seq.).
Comments
Interested persons are invited to submit comments concerning this
proposal. Written comments should be sent to the Policy Office and
refer to Docket No. 94-003P. All written comments submitted in response
to this proposal will be available for public inspection in the Policy
Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4:00 p.m.,
Monday through Friday.
Background
Introduction
The FMIA (21 U.S.C. 601 et seq.) requires that the Secretary of
Agriculture administer an inspection program that assures consumers
that meat and meat food products distributed in commerce and within
designated States\1\ are wholesome, not adulterated, and are properly
marked, labeled, and packaged. Under the FMIA and regulations
promulgated thereunder, FSIS provides mandatory inspection, except for
certain exceptions, of meat and meat food products prepared for
distribution in interstate and foreign commerce, as well as for
distribution within designated States.
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\1\Designated States are States that have failed to develop or
are not effectively enforcing requirements at establishments, within
their jurisdiction, for the slaughter of livestock and/or the
preparation of products thereof, that are at least equal to those of
subchapters I and IV of the FMIA. Once a State is designated, the
provisions of subchapters I and IV of the FMIA apply to the
operations and transactions of establishments that operate solely
within the State.
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The Federal meat inspection regulations define meat in 9 CFR
301.2(rr) as follows:
The part of the muscle of any cattle, sheep, swine, or goats,
which is skeletal or which is found in the tongue, in the diaphragm,
in the heart, or in the esophagus, with or without the accompanying
and overlying fat, and the portions of bone, skin, sinew, nerve, and
blood vessels which normally accompany the muscle tissue and which
are not separated from it in the process of dressing. It does not
include the muscle found in the lips, snout, or ears. This term, as
applied to products of equines, shall have a meaning comparable to
that provided in this paragraph with respect to cattle, sheep,
swine, and goats.
The Federal meat inspection regulations also establish a definition
and standard of identity for a meat food product called ``mechanically
separated (species)'' (MS(S)) in 9 CFR 319.5. ``Species'' refers to the
species of livestock, e.g., beef or pork. At various times, this
product has also been called mechanically deboned meat and mechanically
processed (species) product. This meat food product is defined as ``any
finely comminuted product resulting from the mechanical separation and
removal of most of the bone from attached skeletal muscle of livestock
carcasses and parts of carcasses'' and meeting the other provisions
specified in 9 CFR 319.5. This provision and other provisions in the
Federal meat inspection regulations provide, among other things, for:
(1) A definition and standard that classifies MS(S) as a meat food
product, (2) limitations on the amount of MS(S) that can be used in
permitted products (viz., 20 percent of the livestock and poultry
product portion of the product), (3) prohibitions on the use of MS(S)
in certain products (e.g., baby food), (4) limitations on certain
components of MS(S), e.g., bone particle size, bone content (measured
as calcium content), protein quality, and a maximum fat content and
minimum protein content, (5) requirements for handling and for the
production of MS(S) under an approved quality control program, and (6)
a requirement that MS(S) be separately identified in the ingredients
statement of a meat food product (9 CFR 317.2 (c) and (f), 318.18,
319.5, and 319.6). FSIS's 1982 final rulemaking on MS(S) (47 FR 28214)
indicates that the Agency determined that material differences in the
consistency and the composition of MS(S) place it outside the scope of
product traditionally defined as meat (9 CFR 301.2(rr)), and that its
differences are such that it should be defined as a distinctive
standardized product. As such, it should be identified by a name that
adequately differentiates it from meat, viz., MS(S). When MS(S) is used
in meat food products, it must be separately listed in the ingredients
statement by its standardized name, e.g., ``mechanically separated beef
(or pork).''
FSIS is considering issues in regard to the lack of a regulatory
definition and standard for certain poultry products produced by
mechanical deboning--products which are deemed to be similar to MS(S).
Poultry products produced by mechanical deboning result from the
mechanical separation and removal of most of the bone from attached
skeletal muscle and other tissue of poultry carcasses and parts of
carcasses. Over the years, the meat and poultry industries have
referred to poultry product produced by mechanical deboning as
``mechanically deboned poultry'' and ``comminuted poultry,'' and have
declared the product as poultry or poultry meat (e.g., ``chicken'' and
``turkey meat'') on the labels of products in which they are used as
ingredients.
Several red meat sausage manufacturers have alleged that without a
regulatory definition and standard for poultry products produced by
mechanical deboning, a disparate situation exists between labeling
poultry products produced by mechanical deboning and MS(S) which poses
an unfair advantage for the manufacturers of poultry products.
FSIS has considered the appropriate course for addressing these
issues and has initiated two actions in response to them. FSIS is
contemplating proposing regulations on poultry products produced by
mechanical deboning, and will be soliciting comments and requesting
data on various tentative positions in a notice that appears elsewhere
in this issue of the Federal Register. The second action is the subject
of this proposed rule which focuses on the meat product derived from
the advances in meat/bone separation machinery and recovery systems
that is comparable to ``meat'' as traditionally defined in 9 CFR
301.2(rr).
FSIS now believes that advances in meat/bone separation machinery
and meat recovery systems, which do not grind, crush, or pulverize bone
in order to remove skeletal muscle tissue adhering to bones of
livestock (i.e., bones of cattle, sheep, swine, and goats) result in a
product which, unlike MS(S), is comparable to ``meat'' as traditionally
defined.
Since the 1970's, there has been increasing commercial production
of processed meat products that are formulated with comminuted (i.e.,
ground) meat, e.g., hot dogs, in order to meet the demands of the
market for such products. Most of the technology that has found
commercial use will evolve in the form of improvements to meet the
demands of consumers and industry. The demands of the industry have
centered around the desire to harvest more usable protein, i.e., muscle
tissue, and to find alternatives to recovering more usable protein,
from livestock carcasses to meet consumer demands for the processed
meat products formulated with skeletal muscle tissue obtained by
mechanical removal. Mechanization also diminishes the economic
implications of removing meat by hand caused by repetitive motion
disorders for workers that hand-debone carcasses and parts of carcasses
using knives, and by knife accidents. Industry data\2\ indicate that
over 300,000 cases of cumulative trauma disorder (e.g., Carpal Tunnel
Syndrome) have occurred in the meat industry due to the strain of
repetitive movements to remove meat from bones. The demands of the
consumer and industry have resulted in improvements in meat/bone
separation machinery and meat recovery systems to improve yields and,
simultaneously, to make the process better ergonomically.
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\2\Data received in comments from Longmont Foods and Butterball
Turkey Company on Docket No. 93-008ANPR, ``Labeling of Poultry
Products Produced by Mechanical Deboning and Products in Which Such
Poultry Product is Used,'' (58 FR 33040) June 1993. These data are
available for public inspection in the FSIS Hearing Clerk's office.
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Over the past decade, FSIS has monitored the tremendous strides in
modernizing the meat/bone separation machinery. FSIS believes that
there are meat/bone separators and meat recovery systems that are
fundamentally different than the machines used to manufacture MS(S).
These differences occur in terms of the efficiency and effectiveness of
the process of separating skeletal muscle tissue and bone.
The Removal of Muscle Tissue From Livestock Bones
Since the advent of automatic means of skeletal muscle tissue
removal from bone using high-speed knives, e.g., the Wizard knife,
machines that are classified as meat/bone separators have been
developed that emulate the physical action of the high-speed knives.
The advances in meat/bone separation have led to recovery systems that
separate meat from bone without crushing, grinding, or pulverizing
bones such that the meat is removed by shaving, pressing, or scraping
the muscle tissue from the bone surface similar to the action of the
hand-held high-speed knives. Thus, this meat is obtained in much the
same manner as that which is obtained using traditional hand-deboning
techniques, where the bones emerge separately from the meat in the
process, essentially intact and in natural physical conformation. For
example, the most commonly used bones would include rib bones and loin
bones and would be recognized as such when they emerge from the meat/
bone separation machinery. FSIS believes that the description of the
bones from which muscle tissue has been removed as ``essentially
intact'' is consistent with the description of the bones resulting from
the removal of muscle tissue by hand-deboning using knives, including
high-speed mechanical knives, such as the Wizard knife. FSIS recognizes
that even with the use of hand-operated knives, e.g., in the processing
establishment, at the supermarket meat counter, or by the consumer,
there is the possibility of shaving, pressing, or scraping close to the
bone surface so as to unavoidably remove a minute amount of the bone's
surface when meat is removed. FSIS believes that this is a normal
occurrence because of the difficulty in exercising precision in hand-
deboning operations, and, as such, it is still in conformance with good
manufacturing practices that render products safe and wholesome.
Because the bones emerge from the advanced meat/bone separators in
their natural shape and structure, i.e., with the connective tissue
linkages that normally occur in bones, FSIS maintains that they are in
natural physical conformation. Furthermore, under FSIS's longstanding
boneless meat inspection procedure for meat derived by hand-deboning
techniques, it is expected that the finished comminuted (i.e., ground)
meat product made from the meat removed from livestock bones contains
no bone perceptible to sight or touch. This result would be expected
for meat derived from the advanced meat/bone separation machinery and
recovery systems.
In contrast, the mechanism of traditional mechanical deboning
machines from which MS(S) results, involves mechanically separating and
removing most of the bone from attached skeletal muscle of livestock
through the application of high pressure to crush, grind, and pulverize
bones from which most of the meat has already been removed, and then
using high pressure to force the resulting paste through a sieve to
separate bone particles and fragments that result from crushing and
pulverizing bones during processing. Due to the mechanism of the
machinery used to manufacture MS(S), bone and bone particles, including
bone marrow, are incorporated into the finished product.
The regulation on MS(S) in 9 CFR 319.5 does not specify the type of
equipment used to separate and remove bone because it is intended to
cover the product manufactured by any such machinery that operates on
the differing resistance of hard bone and soft tissue to passage
through small openings, whether it employs sieves, screens, or other
devices and whether or not bones are pre-broken before being fed into
such equipment. However, the regulation on MS(S) is not intended to
apply to whole pieces of muscle tissue which have been removed from
livestock bones by mechanical or other means (47 FR 28223). FSIS has
determined that the consistency of MS(S) and its content of bone,
including bone marrow, and certain minerals, as well as muscle tissue,
are materially different from those of ``meat,'' and that these
differences have potential consequences for finished product quality
and for health and safety which are addressed by the regulations for
MS(S) (9 CFR 318.18, 319.5, and 319.6) and supported by the Agency's
1979 report on the health and safety aspects of mechanically deboned
meat.\3\
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\3\A copy of the report entitled, ``Health and Safety Aspects of
the Use of Mechanically Deboned Meat, Final Report and
Recommendations Select Panel'' and ``Health and Safety Aspects of
the Use of Mechanically Deboned Meat, Volume II. Background
Materials and Details of Data'' is available for public inspection
in the FSIS Hearing Clerk's office.
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Starting Materials
The starting materials from which the meat from advanced meat/bone
separation machinery and meat recovery systems results are intact
livestock bones with adhering skeletal muscle and other soft tissue.
While it has been reported that it is possible to use whole carcasses,
the raw materials for this type of processing generally are parts of
carcasses with skeletal muscle attached. Adhering skeletal muscle
tissue usually varies in amount, depending on the anatomical origin and
size of the bones. Typically, the livestock bones with adhering
skeletal tissue applicable to the advances in meat recovery are those
where the adhering tissue cannot be efficiently or effectively removed
by traditional hand-deboning techniques, and the bones are of
sufficient hardness and of appropriate size compatible with the
operation of the advanced meat/bone separator/meat recovery system. It
is FSIS's understanding that the advanced machinery is capable of
handling medium to smaller size bones, e.g., rib bones, button bones,
loin bones, and feather bones. The fact that no bone crushing,
grinding, or pulverizing occurs limits the types of bones that are
used. The bones must be hard enough to emerge from the process
essentially intact and in natural physical conformation.
In the traditional mechanical deboning process, described in the
1982 final regulations on MS(S) (47 FR 28214), it is possible to use
whole carcasses; however, generally, the raw materials for the
conventional process are parts of carcasses from which most of the
skeletal muscle already has been removed by traditional hand-deboning
methods. With the mechanical deboning technology described in the
regulations on MS(S), these bones are broken up and pushed under high
pressure through equipment with apertures that allow a small amount of
powdered bone to pass through with the soft tissue.
Characteristics and Composition of Meat
FSIS believes that the resulting product derived from advanced
meat/bone separation machinery and meat recovery systems is comparable
to meat derived by hand-deboning techniques, including the use of
mechanical knives and that, as such it warrants classification as
``meat.'' FSIS believes that current relevant Federal meat inspection
regulations on labeling meat should apply, and, as such, the ``meat''
derived from advanced meat/bone separation machinery and recovery
systems may be described by any term that accurately reflects it as
meat. Advanced meat/bone separation machinery and meat recovery systems
apply a process mechanism that shaves, presses or scrapes adhering
tissue from the surface of livestock bones. The machines do not grind,
crush, or pulverize bones to separate muscle tissue, and the bones and
the interconnecting soft tissues that link bones emerge from the
process in a manner consistent with hand-deboning operations that use
knives.
Meat products derived by advanced meat/bone separation are
characterized by identifiable muscle fiber structure, visible
differentiation of lean and fat, and components normally associated
with and expected in meat obtained by hand-deboning. The advanced
recovery systems produce distinct whole pieces of skeletal muscle
tissue with a well-defined particulate size similar in consistency to
(species) trimmings derived by hand-deboning and used to formulate
processed meat products. The color of the meat derived from these
systems is similar to that of (species) trimmings.\4\ As such, the meat
derived from the advanced recovery systems conforms to the definition
of ``meat'' because it has the functional and chemical characteristics
of meat; there are no powdered bone or constituents of bone, e.g., bone
marrow, that are not in conformance with the definition and expectation
of meat or that which would render the product adulterated or
misbranded under the regulations. It is FSIS's belief that, unlike
MS(S), consumer expectations of ``meat'' are met with regard to the
product obtained from the advances in meat/bone separation machinery
and recovery systems, because the product's characteristics, in terms
of appearance and texture, and its composition are similar to those of
``meat,'' as currently defined in 9 CFR 301.2(rr).
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\4\Data provided to the Agency by Millbank Processing Machinery
Inc., Englewood, Colorado, are available for public inspection in
the FSIS Hearing Clerk's office.
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In contrast, MS(S) differs from hand-deboned meat and the meat
derived from advanced meat/bone separation due to its highly
comminuted, spread-like consistency and its content of varying amounts
of bone, including bone marrow, and certain minerals, as well as muscle
tissue. MS(S) is amorphous and lacks the characteristic components seen
in meat, e.g., muscle fiber, the presence of connective tissue fibers
in the way they occur naturally, and distinct lean and fat components.
These characteristics render the product materially different than
meat.
The Proposal
FSIS is proposing to amend the definition of meat in the Federal
meat inspection regulations (9 CFR 301.2(rr)) to include as meat
product resulting from advanced meat/bone separation machinery and
recovery systems, establish criteria for meat from advanced meat/bone
separation machinery and recovery systems, and establish requirements
for the handling of meat derived from advanced meat/bone separation
machinery and recovery systems, as well as the material from which it
is derived. FSIS is proposing these amendments to the Federal meat
inspection regulations to update the definition of meat to include as
meat product produced from advanced meat/bone separation machinery and
recovery systems. It is FSIS's intent to recognize that (1) substantial
advances have occurred with regard to the machinery for separating
skeletal muscle of livestock carcasses and parts of carcasses from
livestock bones, since the promulgation of rules on the production,
use, and labeling of MS(S) and the products in which it is used as an
ingredient, and that (2) the characteristics and composition of the
meat from these advances are comparable to the product traditionally
defined as ``meat.'' In proposing the amendments, FSIS continues to
fulfill its statutory responsibility to prevent the preparation and
distribution in commerce of meat and meat food products which are
adulterated or misbranded or not properly marked, labeled, or packaged.
1. Definition of Meat
The proposal would amend the definition of ``meat'' set forth in 9
CFR 301.2(rr) of the Federal meat inspection regulations to include as
meat product, meeting certain criteria, that is derived from the
mechanical separation of skeletal muscle tissue from the bones of
livestock by using advanced mechanical meat/bone separation machinery
and meat recovery systems that do not crush, grind, or pulverize bones,
and from which the bones emerge comparable to those resulting from
hand-deboning, i.e., essentially intact and in natural physical
conformation such that they are recognizable as loin bones, rib bones,
etc., when they emerge from the machinery.
As previously stated, FSIS believes that meat derived from advanced
meat/bone separation machinery and recovery systems has the functional
and chemical characteristics of ``meat.'' This product is also
comparable to meat derived by hand-deboning techniques, including
mechanical high-speed knives. FSIS further believes that consumer
expectations of ``meat'' are met with regard to the identity of the
product, because the product's characteristics, in terms of appearance
and texture, and its composition are similar to those of ``meat,'' as
currently defined in 9 CFR 301.2(rr). Therefore, FSIS is proposing to
amend the definition of ``meat'' to include meat derived from advanced
meat/bone separation machinery and recovery systems.
2. Criteria for Meat Derived From Advanced Meat/Bone Separation
Machinery and Recovery Systems
The proposal would establish protein quality and calcium content
criteria for meat derived from advanced meat/bone separation machinery
and meat recovery systems and assure its compliance with such criteria
through a quality control program in order to assure conformance with
consumer expectations of ``meat'' and production of ``meat'' comparable
to that obtained by hand-deboning techniques. A maximum calcium content
(as a measure of bone solids) of not more than 0.15 percent or 150 mg/
100 gm of product (within a tolerance of 0.03 percent or 30 mg) and a
minimum protein quality requirement of a protein digestibility-
corrected amino acid score of not less than 40 expressed as a percent,
or an alternative measure of at least 33 percent essential amino acids
of the total amino acids present, would be established for the product.
FSIS has carefully considered whether there is a need to establish
minimum protein and/or maximum fat content(s) for product derived from
advanced meat/bone separation machinery and recovery systems. FSIS
believes that such action is not necessary because protein and fat are
nutrients whose declaration becomes mandatory on the labeling of most
multi-ingredient meat and poultry products upon the effective date of
the nutrition labeling regulations which is July 6, 1994 (58 FR 632).
These regulations also establish a voluntary nutrition labeling program
for single-ingredient, raw products, and specify that FSIS will
evaluate significant participation of the voluntary program. If
significant participation is not found, FSIS shall initiate rulemaking
to require nutrition labeling on those products under the voluntary
program. Therefore, with certain exceptions, consumers will have
complete information about the two nutrients in muscle meat that are
the sole source of calories and are characteristic of the nutrient
profile of meat. Such information will ensure that consumers are not
misled about the composition of products containing meat obtained using
advanced meat/bone separation machinery.
FSIS recognizes that not all products sold to consumers at the
retail level will carry nutrition labeling. FSIS's final regulation on
nutrition labeling provided for certain exceptions, including products
produced by small businesses and products in individually wrapped
packages of less than \1/2\ ounce net weight, provided that the labels
for these products bear no nutrition claims or nutrition information.
However, labeling will be required on most processed products purchased
by consumers in retail stores so that, together with the voluntary
program for retail store information on single-ingredient, raw
products, consumers will have information on protein and fat for most
products purchased for consumption at home. Furthermore, FSIS believes
that the fat and protein contents of meat derived from advanced meat/
bone separation machinery and recovery systems would be comparable to
the fat and protein contents of meat derived from hand-deboning. Based
on these considerations, FSIS maintains that there is no need to
establish minimum protein and/or maximum fat contents for products
derived from advanced meat/bone separation and recovery systems.
a. Calcium content. FSIS is proposing to include in the amendment
to the definition of ``meat,'' criteria on maximum calcium content (as
a measure of bone solids content) of this meat to assure that the meat
derived from advanced meat/bone separation machinery and recovery
systems is both consistent with consumer expectations of ``meat,''
e.g., beef trimmings, and comparable to ``meat,'' as traditionally
defined, that is used to formulate further processed meat food
products. The criteria is a measure designed to ensure that bones are
not crushed, ground, or pulverized during processing. The maximum
calcium content of 0.15 percent or 150 mg/100 gm of product is
supported by data submitted to FSIS for the product derived from
advanced meat/bone separation machinery.\5\ Furthermore, based upon
analytical repeatability studies conducted by the Agency for calcium,
FSIS proposes to establish a tolerance, i.e., allowance for statistical
variability, of 0.03 percent or 30 mg/100 gm for individual samples.\6\
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\5\A summary report of data provided to FSIS on the calcium
content of meat from advanced meat/bone separation machinery and
recovery systems is available for public inspection in the FSIS
Hearing Clerk's Office.
\6\A copy of an FSIS report containing data on the repeatability
of analyzing calcium content (June 1992) is available for public
inspection in the FSIS Hearing Clerk's Office.
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b. Protein quality. FSIS is proposing to require that meat derived
from advanced meat/bone separation machinery and recovery systems meet
a minimum protein quality requirement--a protein digestibility-
corrected amino acid score of not less than 40 expressed as a percent
and to accept as evidence of compliance with this requirement an
alternative measurement--the content of 7 essential amino acids being
at least 33 percent of the total of 17 amino acids present. Protein
quality is a measure of the content, proportion, and availability of
essential amino acids in food protein and a measure of the ability of
the food protein to support human growth and body protein maintenance.
When the regulations on MS(S) were published in 1982 (47 FR 28214),
one of the methods specified for measuring protein quality was the
Protein Efficiency Ratio (PER) procedure. The PER method measures the
ability of a protein source to support growth in young growing rats,
and is an expensive and time-consuming assay. FSIS adopted a newer
method for measuring protein quality, in order to assure the value of
the protein contributed by meat and poultry to human dietary needs, in
its final regulations on nutrition labeling of meat and poultry
products published in the Federal Register on January 6, 1993 (58 FR
632). The newer procedure, termed the protein digestibility-corrected
amino acid score method, is contained in ``Protein Quality Evaluation,
Report of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation,'' Rome, 1990.\7\ The protein digestibility-corrected amino
acid score method is based on human amino acid requirements and,
therefore, is more appropriate for evaluating the protein quality of
foods for human consumption than the PER which is based on amino acid
requirements of rats. The protein digestibility-corrected amino acid
score method measures the ability of amino acids in food proteins to
meet the dietary protein needs of humans.
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\7\A copy of the document is available for public inspection in
the FSIS Hearing Clerk's Office.
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FSIS is proposing to require that the protein in meat derived from
advanced meat/bone separation and recovery systems have a protein
quality value that is a protein digestibility-corrected amino acid
score of not less than 40 expressed as a percent. The protein
digestibility-corrected amino acid score would be required to be
determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in the
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation'' which is incorporated by
reference in the proposed rule. The proposed protein digestibility-
corrected amino acid score or not less than 40 expressed as a percent
is consistent with nutrition labeling requirements for protein in foods
for children older than one but less than four years of age, as
provided in 21 CFR 101.9(c)(7), which FSIS cross-referenced in its
final nutrition labeling regulations (58 FR 632) in 9 CFR 317.309(b).
FSIS believes this value protects the young consumer from inadequate
nutrition from the use of poor quality protein (i.e., protein that does
not meet the dietary needs for growth) and, in turn, protects people
other than young consumers. FSIS also believes it is appropriate to
assure comparability of the meat derived from advanced meat/bone
separation systems with that derived by hand-deboning to maintain the
quality and integrity of the meat supply.
FSIS is proposing to permit an alternative measurement to the
protein digestibility-corrected amino acid score method, which requires
a digestibility measurement in addition to an amino acid analysis, to
control the cost of monitoring compliance with the protein quality
requirement. FSIS is proposing that, for the purpose of measuring the
protein quality of meat derived from advanced meat/bone separation
machinery and recovery systems, an alternative measurement of protein
quality would be allowed that is comparable to the protein
digestibility-corrected amino acid score. This measure would be based
on a comparison between the ``essential amino acid content of meat''
and ``total amino acids present in meat,'' i.e., an essential amino
acid content of at least 33 percent of the total amino acids present in
the meat. Essential amino acid content includes isoleucine, leucine,
lysine, methionine, phenylalanine, threonine, and valine content, and
the total amino acids present include isoleucine, leucine, lysine,
methionine, phenylalanine, threonine, valine, tyrosine, arginine,
histidine, alanine, aspartic acid, glutamic acid, glycine, proline,
serine, and hydroxyproline content. The essential amino acid content
would be required to be determined by methods given in sections 5.4.1,
7.2.1, and 8.00 in the ``Protein Quality Evaluation, Report of the
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation'' which
is incorporated by reference in the proposed rule.
FSIS continues to believe that meat found to be in compliance by
the proposed amino acid content measurement would have protein of high
quality. This belief is supported by the 1982-83 evaluation of an
Expert Work Group that was organized by the Department's Agricultural
Research Service, in cooperation with the University of Maryland, to
develop recommendations based on available scientific knowledge for
consideration in policy decisions regarding the protein quality of
meat, poultry, and their products.\8\
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\8\``The Protein Nutritional Quality of Meat and Poultry
Products: Scientific Basis for Regulation'' is the final report of
the Expert Working group, with accompanying background papers. C.E.
Bodwell, ed., American Journal of Clinical Nutrition, 40(3): 671-
742, supplement, September 1984. A copy of the report is available
for public inspection in the FSIS Hearing Clerk's office.
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The public should be aware that FSIS continues to have interest in
investigations of protein quality which include among their objectives
the identification of improved methods for determining protein quality.
In evaluating the possible use of alternative approaches to assuring
protein quality, FSIS will consider data and other comments submitted
by the public.
c. Qualify control. FSIS is proposing to require that meat derived
from advanced meat/bone separation machinery and recovery systems be
produced under an approved quality control program. FSIS believes
quality control is necessary to assure that establishments manufacture
meat from advanced meat/bone separation machinery and recovery systems
that complies with the provisions of the proposed amendment of the
definition of meat. Utilization of such a quality control program in
producing this product would be prerequisite for the approval of labels
for products consisting of or containing meat from advanced recovery
systems. In other words, an approved quality control program would be
necessary prior to the production of meat using advanced meat/bone
separation machinery and recovery systems.
The function of a quality control program would be to restrict
potential deviations from the prescribed definition of meat by
controlling the factors that can affect conformance with the
definition. Thus, it is proposed to require that the quality control
program provide the controls and information necessary to assure that
the meat from advanced meat/bone separation and recovery systems will
meet each of the requirements of the regulations and will enable
establishment personnel and FSIS to monitor it for effectiveness. FSIS
is focusing on methods that will maintain the uniformity of starting
materials and control the handling and processing of starting materials
and resulting product. The methods of analysis for calcium and protein
quality that are permitted and are intended to be used should be
identified in the quality control system.
Under the proposal, the owner or operator of an establishment that
intends to manufacture meat from advanced meat/bone separation
machinery and recovery systems would request the Administrator of FSIS
to approve the establishment's quality control program. The procedures
and criteria for receiving such requests and assessing the adequacy of
programs for quality control, as well as for terminating approval,
would be those set forth in 9 CFR 318.4. These provisions provide
guidance on the development and maintenance of appropriate quality
control programs.
FSIS believes that with a quality control approach to preventing
noncompliance from occurring, the need for testing the resulting
product to assure compliance can be reduced and, consequently, the
costs of production kept down. Moreover, the proposed quality control
requirement builds on the control and information programs that
processors use to predict and minimize the likelihood of manufacturing
products that are inconsistent and of varying quality, and do not
comply with regulatory requirements. Proposing to rely on a approved
quality control program, rather than continual testing by processors,
is a means for assuring that operations achieve compliance with the
applicable proposed requirements and, thereby, prevents misbranding and
adulteration of the resulting meat.
The goal of preventing misbranding and adulteration are key issues
with regard to meat products produced by mechanical meat/bone
separation, and can be achieved effectively and efficiently where a
program for quality control incorporates appropriate methods and
monitoring techniques, and adheres to good manufacturing practices.
FSIS believes that product exceeding the calcium limit should not be
classified as meat because if it exceeds the proposed calcium limits,
it would reflect unacceptable incorporation of bone in the product
during processing. To ensure that product satisfies the calcium
requirement, FSIS is proposing that a sample of at least one pound from
each lot of production would be taken and analyzed for calcium. A lot
would consist of the meat derived from advanced meat/bone separation
machinery and recovery systems, designated as such by the operator of
the establishment or his or her agent, from the product produced from a
single species of livestock in no more than one continuous shift of up
to 12 hours. The results from chemical analyses would be compared to
the requirement of 150 mg/100 gm of product within a tolerance of 0.03
percent or 30 mg. If statistical evidence exists that product may not
be in compliance, then further sampling of the product will be required
to demonstrate that the product is in compliance with requirements for
meat derived from meat/bone separation and recovery systems.
It is proposed that statistical evidence of non-compliance exists
when an individual analytical result is more than 0.03 percent (i.e.,
30 mg) above the requirement, i.e., greater than 0.18 percent (i.e.,
180 mg). (This tolerance is derived by equating it to three times the
expected standard deviation (i.e., 0.1 percent) of the analytical
procedure used by FSIS to measure the calcium contents in samples.)\9\
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\9\Data from a FSIS study are available for public inspection in
the FSIS Hearing Clerk's office.
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If any single analytical result is more than 0.18 percent, FSIS
proposes that, before product from a production lot that is still at
the establishment or one subsequently produced can be considered to be
in compliance, at least three samples\10\ from that lot must be taken
and analyzed for calcium, either separately or as a composite (i.e.,
combining the three samples for analysis), at the option of the
establishment. The average of the results or the composite result must
comply with the requirement for calcium (i.e., less than or equal to
0.15 percent). Taking three samples from each lost would continue until
five consecutive lots\11\ have mean or composite results less than or
equal to 0.15 percent. Individual results or an average of results
would be rounded to the nearest 0.01 percent based on the precision of
the methodology for measuring calcium. If the FSIS program official
detects any results out of compliance, the program official may
undertake normal compliance procedures.
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\10\Three samples, either analyzed as individual samples or as a
composite sample (i.e., combining the three samples), are
statistically representative for measuring calcium in a production
lot.
\11\The provision for sampling five consecutive production lots
is based on statistical sampling principles that ensure the process
is in control and that mean or composite calcium results are less
than or equal to the calcium requirement.
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FSIS believes that, if the statistical evidence indicates that a
production lot is not in compliance with the calcium requirement, the
lot must be labeled as MS(S) and meet the requirements for MS(S) in 9
CFR 319.5. In this situation, FSIS believes that the process is out of
control, and there is the likelihood that too much calcium has been
incorporated in the recovered meat, and, therefore, it should be
identified as MS(S).
FSIS is proposing that at least one pound of product be sampled
each week during production of a lot for conformance with protein
quality criteria. Once three consecutive results from 3 production lots
are in compliance with the criteria on protein quality (i.e., a protein
digestibility-corrected amino acid score or essential amino acid
content), sampling of production lots can be reduced to a monthly
basis. After 6 months, sampling of production lots can be reduced to a
quarterly basis.\12\
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\12\This sampling schedule ensures the statistical
representation of the production lots is achieved in regard to
measuring protein quality.
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Subsequently, if samples are out of compliance, sampling each week
would be repeated until the results are in compliance.
A major concern of FSIS is the assurance that consumers receive the
quality of meat they expect in terms of the value of protein needed to
sustain good nutrition. Therefore, FSIS is proposing that product from
advanced meat/bone separation machinery and recovery systems that does
not meet the requirements of the criteria for protein quality must be
identified as ``(species) fat'' or ``(species) connective tissue,'' and
labeled in accordance with the applicable provisions in 9 CFR Part 317.
Protein quality values less than the proposed criteria are comparable
to those associated with ``(species) fat'' and ``(species) connective
tissue.''
3. Handling requirements. FSIS is proposing to specify requirements
for the handling of material that is to be processed into meat derived
from advanced meat/bone separation machinery and recovery systems and
for handling such product. FSIS is proposing that the handling of such
material comply with the same provisions as are currently prescribed in
9 CFR 318.18 for handling material for mechanical processing.
FSIS believes that potential bacterial hazards are diminished as
long as handling accords with good manufacturing practices. Because
meat from advanced meat/bone separation machinery and meat recovery
systems consists of particulates of muscle tissue having more surface
area than whole muscle cuts, there is a greater potential for bacterial
hazards. FSIS has, therefore, concluded that processing and storage
requirements are warranted for the raw materials used to make the
product and for the product itself.
FSIS is proposing to adopt the handling requirements prescribed in
9 CFR 318.18. These requirements would provide that material to be
processed into meat derived from advanced meat/bone separation
machinery and meat recovery systems be processed within 1 hour from the
time it is cut or separated from livestock carcasses or parts of
carcasses, except that such product may be held for no more than 72
hours at 40 deg.F (4 deg.C) or less, or held indefinitely at 0 deg.F
(-18 deg. C) or less. Meat from advanced meat/bone separation machinery
and recovery systems must be used as an ingredient in a meat food
product directly after being processed, except that it may be held
prior to such use for no more 72 hours at 40 deg.F (4 deg.C) or less
or indefinitely at 0 deg.F (-18 deg. C) or less.
List of Subjects
9 CFR Part 301
Meat inspection.
9 CFR Part 318
Incorporation by reference, Meat inspection, Quality control,
Reporting and recordkeeping requirements.
Proposed Rule
For the reasons set forth in the preamble, FSIS is proposing to
amend 9 CFR parts 301 and 318 as follows:
PART 301--DEFINITIONS
1. The authority citation for part 301 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
2. Section 301.2 would be amended by revising paragraph (rr) to
read as follows:
Sec. 301.2 Definitions.
* * * * *
(rr) Meat. (1) The part of the muscle of any cattle, sheep, swine,
or goats, which is skeletal or which is found in the tongue, in the
diaphragm, in the heart, or in the esophagus, with or without the
accompanying and overlying fat, and the portions of bone, skin, sinew,
nerve, and blood vessels which normally accompany the muscle tissue and
which are not separated from it in the process of dressing. It does not
include the muscle found in the lips, snout, or ears. This term, as
applied to products of equines, shall have a meaning comparable to that
provided in this paragraph with respect to cattle, sheep, swine, and
goats.
(2) The product derived from the mechanical separation of the
skeletal muscle tissue from the bones of livestock using the advances
in mechanical meat/bone separation machinery and meat recovery systems
that do not crush, grind, or pulverize bones, and from which the bones
emerge comparable to those resulting from hand-deboning (i.e.,
essentially intact and in natural physical conformation such that they
are recognizable, such as loin bones and rib bones, when they emerge
from the machinery) which:
(i) Meets the criteria of no more than 0.15 percent or 150 mg/100
gm of product for calcium (as a measure of bone solids content) within
a tolerance of 0.03 percent or 30 mg and meets the criteria of a
protein digestibility-corrected amino acid score of not less than 40
expressed as a percent or an essential amino acids content of at least
33 percent of the total amino acids present in the meat, as assured by
an approved quality control program described in Sec. 318.24 of this
subchapter;
(ii) Is produced under an approved quality control program set
forth in Sec. 318.24 of this subchapter; and
(iii) Is handled in conformance with Sec. 318.18 of this
subchapter.
* * * * *
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
3. The authority citation for part 318 would continue 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 318.18 would be revised to read as follows:
Sec. 318.18 Handling of certain material for mechanical processing.
Material to be processed into ``Mechanically Separated (Species)''
or meat derived from advanced meat/bone separation machinery and
recovery systems shall be so processed within 1 hour from the time it
is cut or separated from carcasses or parts of carcasses, except that
such product may be held for no more than 72 hours at 40 deg.F. (4
deg.C.) or less, or held indefinitely at 0 deg.F. (-18 deg.C.) or
less. ``Mechanically Separated (Species)'' or meat derived from
advanced meat/bone separation machinery and recovery systems shall,
directly after being processed, be used as an ingredient in a meat food
product, except that it may be held prior to such use for no more than
72 hours at 40 deg.F. (4 deg.C.) or less or indefinitely at 0 deg.F.
(-18 deg.C.) or less.
5. Part 318 would be amended by adding a new Sec. 318.24 to read as
follows:
Sec. 318.24 Compliance procedures for meat derived from advanced meat/
bone separation machinery and recovery systems.
(a) The product resulting from the separating process shall not
have a calcium content exceeding 0.15 percent or 150 mg/100 gm of
product within a tolerance of 0.03 percent or 30 mg, and it shall have
a protein digestibility-corrected amino acid score of not less than 40
expressed as a percent (except as modified in paragraph (b) of this
section).
(b) An essential amino acid content of at least 33 percent of the
total amino acids present in the meat derived from advanced meat/bone
separation machinery and recovery systems shall be accepted as evidence
of compliance with the protein quality requirement set forth in
paragraph (a) of this section. For purposes of this paragraph,
essential amino acid content includes isoleucine, leucine, lysine,
methionine, phenylalanine, threonine, and valine content, and the total
amino acids present include isoleucine, leucine, lysine, methionine,
phenylalanine, threonine, valine, tyrosine, arginine, histidine,
alanine, aspartic acid, glutamic acid, glycine, proline, serine, and
hydroxyproline content.
(c) A prerequisite for label approval for meat derived from
advanced meat/bone separation machinery and recovery systems is that it
shall have been produced by an establishment under an approved plant
quality control program. The Administrator shall receive, evaluate, and
approve requests for plant quality control in accordance with
Sec. 318.4(d) (1) and (2) and (e). Such a plant quality control system
shall provide the controls and information necessary to assure that the
product will meet the requirements described in Sec. 301.2(rr)(2) of
this subchapter and will enable establishment personnel and program
employees to monitor the system for effectiveness. The system shall
include a written description of the methods used by the establishment
to maintain uniformity of the raw ingredients used in manufacturing the
product and to control the handling and processing of the raw
ingredients and the finished product, and shall contain provisions for
chemical analyses of the product and other procedures to determine and
assure compliance with the definition of the product. For purposes of
this paragraph, a lot shall consist of the meat derived from advanced
meat/bone separation machinery and recovery systems, designated as such
by the operator of the establishment or his or her agent, from the
product produced from a single species of livestock in no more than one
continuous shift of up to 12 hours. All units of any lot must be
available for inspection by program employees. The plant quality
control program shall be subject to periodic review, and the approval
of such program may be terminated in accordance with Sec. 318.4(g).
(1) To verify the calcium content in meat derived from advanced
meat/bone separation machinery and recovery systems, an analysis of a
sample of at least one pound from each lot shall be performed by the
operator of the establishment or his or her agent. Individual results
from the chemical analyses shall be compared to the calcium limit,
prescribed in paragraph (a) of this section, in order to demonstrate
compliance. If compliance is not demonstrated, that is, if any single
analytical result is more than 0.18%,\1\\2\ before product from a
production lot that is still at the establishment or one that is
subsequently produced can be considered to be in compliance, at least
three samples from that production lot shall be taken and analyzed for
calcium, either separately, or, at the option of the establishment, as
a composite (i.e., combining the three samples for analysis). The
average of the results or the composite result must be less than or
equal to 0.15%. Taking three samples from each subsequently produced
lot and analyzing them in order to demonstrate compliance shall
continue until five consecutive lots have mean or composite results
less than or equal to 0.15%. If the statistical evidence indicates that
a production lot is not in compliance with the calcium limit, as
prescribed in Sec. 301.2(rr)(2) of this subchapter, the lot must be
labeled as MS(S) and meet all of the requirements for MS(S) in
Sec. 319.5 of this subchapter.
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\1\The value 0.18% was derived by multiplying by 3 the expected
analytical standard deviation obtained by FSIS laboratories on the
approved chemical procedure for measuring calcium which uses
Ethylenediaminetetraacetic acid (EDTA) as provided in the ``Official
Methods of Analysis of the AOAC International'' (formerly the
Association of Official Analytical Chemists), 15th Ed. (1990).
\2\Individual or an average of results shall be rounded to the
nearest 0.01% calcium.
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(2) To verify the protein digestibility-corrected amino acid score
or the essential amino acid content in meat derived from advanced meat/
bone separation machinery and recovery systems, an analysis of a sample
of at least one pound shall be performed by the operator of the
establishment or his or her agency each week during production of a lot
to assure that product will meet the requirements of Sec. 301.2(rr)(2)
of this subchapter. Once three consecutive results from three
production lots are in compliance with the criteria on protein quality
(i.e., a protein digestibility-corrected amino acid score of not less
than 40 expressed as a percent, as reflected in paragraph (a) of this
section or an essential amino acid content of at least 33 percent of
the total amino acids present, as reflected in paragraph (b) of this
section), sampling of production lots can be reduced to a monthly
basis. After 6 months, sampling of production lots can be reduced to a
quarterly basis. Subsequently, if samples are out of compliance,
sampling each week would be repeated until three consecutive results
from three production lots are in compliance. The protein
digestibility-corrected amino acid score and the essential amino acid
content shall be determined by methods given in sections 5.4.1, 7.2.1,
and 8.00 in ``Protein Quality Evaluation, Report of the Joint FAO/WHO
Expert Consultation on Protein Quality Evaluation,'' Rome, 1990. The
``Report of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation'' as published by the Food and Agriculture Organization of
the United Nations/World Health Organization is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Division of Nutrition, Center
for Food Safety and Applied Nutrition (HFF-260), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204. It is also
available for inspection at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC. Product resulting
from the separating process which fails to meet the protein quality
requirement in Sec. 301.2(rr)(2) of this subchapter, shall be labeled
as ``(Species) fat'' or ``(Species) connective tissue.''
Done at Washington, DC on: February 25, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-4891 Filed 3-2-94; 8:45 am]
BILLING CODE 3410-DM-M