[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