[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29902]


  Federal Register / Vol. 59, No. 233 / Tuesday, December 6, 1994 /
  
[[Page Unknown]]

[Federal Register: December 6, 1994]


                                                   VOL. 59, NO. 233

                                          Tuesday, December 6, 1994

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 318, and 320

[Docket No. 94-003F]
RIN 0583-AB76

 

Meat Produced by Advanced Meat/Bone Separation Machinery and Meat 
Recovery Systems

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending 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. This final rule 
also establishes the criteria, including that for calcium content, for 
meat from advanced meat/bone separation machinery and meat recovery 
systems to assure consistency with the characteristics and composition 
of meat, and establishes compliance procedures and recordkeeping 
requirements for the calcium content criteria. 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.

EFFECTIVE DATE: January 5, 1995.

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:

Background

Introduction

    The Federal Meat Inspection Act (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 States1 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 in which it is used (9 CFR 317.2(c) 
and (f), 318.18, 319.5, and 319.6). FSIS' 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 considered 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 separation are similar to MS(S) 
in that they are finely comminuted and paste-like in consistency and 
form, and 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 
separation 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. The Agency first conducted a 
rulemaking regarding poultry products produced by mechanical separation 
in 1969. In subsequent years, the amount of such product being 
manufactured and the number and range of poultry products and meat food 
products in which it is used as an ingredient, has increased 
significantly. Moreover, the Agency has gained a great deal of 
knowledge from its rulemakings regarding the livestock product 
resulting from the mechanical separation and removal process, viz., 
MS(S). More recently, in a lawsuit, Bob Evans Farm, Inc. et al., v. 
Mike Espy, Secretary of Agriculture (D.D.C. Civil Action No. 93-0104) 
several red meat sausage manufacturers alleged that, without a 
regulatory definition and standard for poultry products produced by 
mechanical separation, a disparate situation exists between labeling 
mechanically separated poultry and MS(S), the livestock product 
resulting from the mechanical separation and removal process, for which 
a regulatory definition and standard exist. The red meat sausage 
manufacturers have alleged that the disparate labeling situation poses 
an unfair advantage for the manufacturers of mechanically separated 
poultry products.

Actions in Response to Labeling Issues

    FSIS considered the appropriate course for addressing these issues 
and initiated two actions in response to them. FSIS published an 
advance notice of proposed rulemaking in the Federal Register on March 
3, 1994 (59 FR 10230), which solicited comments and requested data on 
various tentative positions on poultry products produced by mechanical 
separation. The second action was a proposed rule (59 FR 10246), also 
published on March 3, 1994, on which this final rule is predicated, 
that focused 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).
    Taking into account the information and experience acquired since 
1969 and current regulatory policies, FSIS reviewed and reevaluated the 
existing poultry regulations, particularly in light of the labeling 
issues. As a result of its review and reevaluation, the Agency now 
believes that the method of deriving boneless poultry products by the 
mechanical separation and removal of most of the bone from the meat and 
other tissues of poultry carcasses and parts of carcasses results in a 
product whose physical form and texture differ materially from those of 
other boneless poultry products produced by traditional deboning 
techniques. Mechanically separated poultry is derived using a machine 
that operates on the differing resistance of bone and tissue to passage 
through small openings, whether it employs sieves, screens, or other 
devices. Such machines mechanically separate and remove most of the 
bone from poultry carcasses and parts of carcasses resulting in a 
finely comminuted, paste-like product. The starting materials, which 
may have undergone an initial bone breaking process, are pushed under 
high pressure through equipment with apertures that allow a small 
amount of powdered bone to pass through with the soft tissue. This is 
different than boneless poultry derived by traditional means, i.e., 
hand-deboning, and such differences have potential consequences for 
consumer expectations. FSIS has statutory responsibilities under the 
Poultry Products Inspection Act (PPIA) and the FMIA to assure that 
consumers receive poultry and meat food products that are not 
adulterated and that bear labeling that is not false or misleading. 
Mechanically separated poultry is produced by essentially the same 
technology and has characteristics (i.e., physical form and texture) 
similar to those of the livestock product, MS(S). Yet, the regulatory 
requirements for labeling these two products currently are inconsistent 
with one another. Therefore, the Agency is proposing that further 
regulatory action is necessary pursuant to its statutory 
responsibilities to protect the public and prevent the preparation and 
distribution in commerce of poultry products and meat food products 
which are misbranded or not properly marked, labeled, or packaged. As 
such, the Agency is proposing in a separate document in this issue of 
the Federal Register to amend the poultry products inspection 
regulations (9 CFR Part 381) to revise and supplement the requirements 
for the manufacture, characteristics, and labeling of poultry products 
produced by mechanical separation and the labeling of products in which 
they are used as ingredients.
    As a result of data and information provided in response to the 
proposed rule on Meat Produced by Advanced Meat/Bone Separation 
Machinery and Meat Recovery Systems and otherwise acquired by FSIS, 
FSIS has determined 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 data2 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 Docket 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 has determined 
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 from bone.

The Removal of Muscle Tissue From Livestock Bones

    Machines that are classified as meat/bone separators have been 
developed that emulate the physical action of hand-held high-speed 
knives for the removal of skeletal muscle tissue from bone, e.g., the 
Wizard knife. 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 essentially intact and 
in natural physical conformation separately from the meat. 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 
when meat is removed with the use of hand-operated knives, e.g., those 
used 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. FSIS has determined 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' 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. Because of the mechanism of the 
machinery used to manufacture MS(S), bone and bone particles, including 
bone constituents such as bone marrow and certain minerals, 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 Docket 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 and meat recovery system. 
It is FSIS' 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 has determined 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 high-speed mechanical knives and that, as such it warrants 
classification as ``meat.'' FSIS has also determined that current 
relevant Federal meat inspection regulations on labeling meat should 
apply and, as such, the product 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, including that 
obtained by using mechanical knives. 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 
meat/bone separation and 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. FSIS has determined 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 Docket 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.

Characteristics of Meat/Bone Separation Machinery

    Machinery of the type described as advanced meat/bone separation 
machinery and meat recovery systems has been developing over the past 
15 years. FSIS believes that the use of such machines has been limited 
because of the uncertain regulatory status of the product from these 
machines. It has not been clearly defined through regulatory means that 
the product of these machines would continue to be declared as meat or 
if the product might be reclassified as MS(S) or some other unique 
ingredient that would be identified on the label of products in which 
it is used as an ingredient. In order to clarify this situation, the 
Agency decided to publish a proposal that clearly defines as ``meat,'' 
product resulting from these advanced systems.

The Proposal

    On March 3, 1994, FSIS published in the Federal Register a proposed 
rule (59 FR 10246) to amend the Federal meat inspection regulations by 
amending definition of ``meat'' set forth in 9 CFR 301.2(rr) to include 
as ``meat,'' product resulting from advanced meat/bone separation 
machinery and recovery systems, establishing criteria for meat from 
advanced meat/bone separation machinery and recovery systems, and 
establishing 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. A summary of the proposed 
rule follows.

1. Definition of Meat

    FSIS proposed to 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.

2. Criteria for Meat Derived From Advanced Meat/Bone Separation 
Machinery and Recovery Systems

    FSIS proposed to 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 (PDCAAS) of not less than 40 expressed as a 
percent, or an alternative measure of at least 33 percent essential 
amino acids (EAA) of the total amino acids present, was proposed to be 
established for the product.
    a. Calcium content. FSIS proposed 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 proposed to establish a tolerance, i.e., an 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 
Docket 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 Docket Clerk's office.
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    b. Protein quality. FSIS proposed to require that meat derived from 
advanced meat/bone separation machinery and recovery systems meet a 
minimum protein quality requirement--a PDCAAS 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. The protein digestibility-corrected amino acid score was 
proposed 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 was 
incorporated by reference in the proposed rule. The proposed protein 
digestibility-corrected amino acid score of 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. 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.
    FSIS proposed 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 proposed 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 proposed rule required 
essential amino acid content 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 was incorporated by reference in the proposed rule.
    c. Quality control. FSIS proposed to require that meat derived from 
advanced meat/bone separation machinery and recovery systems be 
produced under an approved quality control program. 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, FSIS 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 focused on methods that would maintain the 
uniformity of starting materials, and control the handling and 
processing of starting materials and resulting product. It was proposed 
that the methods of analysis for calcium and protein quality that were 
permitted and that were 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.
    To ensure that product satisfies the calcium requirement, FSIS 
proposed that a sample of at least 1 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 was required to demonstrate that 
the product is in compliance with requirements for meat derived from 
meat/bone separation and recovery systems.
    FSIS 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.)7
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    \7\Data from an FSIS study are available for public inspection 
in the FSIS Docket Clerk's office.
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    If any single analytical result is more than 0.18 percent, FSIS 
proposed 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 samples8 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 subsequently produced lot 
would continue until five consecutive lots9 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.
---------------------------------------------------------------------------

    \8\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.
    \9\The provision for sampling five consecutive production lots 
is based on statistical sampling principles that ensure that the 
process is in control and that mean or composite calcium results are 
less than or equal to the calcium requirement.
---------------------------------------------------------------------------

    FSIS proposed that, if the statistical evidence indicated that a 
production lot was 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. FSIS indicated that in this situation, it believed that the 
process was out of control, and that there was the likelihood that too 
much calcium had been incorporated in the recovered meat, and, 
therefore, it should be identified as MS(S).
    FSIS proposed that at least 1 pound of product be sampled each week 
during production of a lot for conformance with protein quality 
criteria. It was proposed that once three consecutive results from 
three production lots were 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 could be 
reduced to a monthly basis. It was also proposed that after 6 months, 
sampling of production lots could be reduced to a quarterly 
basis.10 Subsequently, if samples are out of compliance, sampling 
each week would be repeated until the results are in compliance.
---------------------------------------------------------------------------

    \1\0This sampling schedule ensures the statistical 
representation of the production lots is achieved in regard to 
measuring protein quality.
---------------------------------------------------------------------------

    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 proposed that product from 
advanced meat/bone separation machinery and recovery systems that did 
not meet the requirements of the criteria for protein quality 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 proposed 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 proposed 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. 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. It was proposed that 
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 than 72 hours at 40  deg.F (4  deg.C) or less or indefinitely at 0 
 deg.F (-18  deg.C) or less.

Discussion of Comments

    FSIS received 30 comments in response to the proposed rule. Fifteen 
comments were submitted by consumers, 9 by food manufacturers/
distributors, 4 by trade associations, 1 by a member of academia, and 1 
by a machinery manufacturer. The majority of the comments supported the 
proposed rule, provided that some modification or deletion is made with 
regard to the proposed requirements for protein quality, quality 
control, and handling.

Consumers Comments

    All 15 consumers supported the proposed rule and stated that the 
new nutritional labeling on meat and poultry will help satisfy the 
informational needs of consumer's regarding the nutrient contents of 
meat and meat products containing meat as an ingredient, including meat 
produced by advanced meat/bone separation and meat recovery systems.

Food Manufacturers/Distributors Comments

    Three food manufacturers/distributors who submitted comments did 
not provide comments that either support or take issue with any 
particular facet of the proposal; their comments were general in 
nature. They stated that they support harmonization of regulations for 
meat and poultry products and would endorse a regulation that would 
allow meat products with bone solids contents of less than or equal to 
1 percent (measured as calcium) to be categorized as meat (i.e., 
``species''), regardless of the processing procedure, i.e., traditional 
mechanical deboning or advanced meat/bone separation and meat recovery 
systems.
    The other six comments submitted by the food manufacturers/
distributors supported the proposed rule, provided that some 
modifications are made in specific areas, i.e., the definition of meat, 
calcium content criteria, protein quality, quality control, handling 
requirements, and bone breakage tolerance and the new machinery.
    All six food manufacturers/distributors to which the previous 
paragraph refers had some reservations about the definition of the meat 
derived from the advanced machinery and recovery systems and the types 
of machinery capable of producing such meat. Their statements indicated 
that it is not necessary to define meat by making distinctions based 
upon whether specific pieces of machinery do or do not crush, grind or 
pulverize bones; if product complies with finished product calcium 
requirements, the specific of the methods of processing should be 
irrelevant. This was based on a belief that there is equipment that can 
successfully separate ``meat'' where grinding, crushing, or pulverizing 
is part of the process. These same commenters suggested that incidental 
bone breakage occurs during any meat/bone separation operation, 
therefore, it should be clearly identified that incidental bone 
breakage would be acceptable and would be controlled by bone particle 
size limits. It was also suggested by one commenter that the word 
``crushing'' should be substituted with the word ``chopping'' when 
describing meat and machinery systems that do not ``chop,'' grind, or 
pulverize bones because such systems do result in some minor 
``crushing.''
    Of the six food manufacturers/distributors that supported the 
proposal with some condition for modification, three supported the 
calcium criteria in the proposed rule. The other three did not support 
it stating that (1) the Agency should develop a single calcium criteria 
applicable to all ``meat'' species, which should be applied to all 
products independent of the processing method or bone separation 
technique, (2) product should be from skeletal muscle tissue and 
contain no more than 1 percent bone solids or an equivalent calcium 
content of 250 mg/100 gm of product, and (3) any meat with 1 percent 
bone or more than 0.235 percent calcium should be called by its common 
or usual name regardless of species.
    Of the six food manufacturers/distributors who supported the 
proposal with some condition, two supported the protein quality 
criteria in the proposed rule. The other four did not support the 
proposed criteria citing that (1) the nutritive value of meat is well 
recognized, and the amino acid content of meat separated by hand, or by 
machine, will be the same when the same beginning sources are used; (2) 
to segregate ``meat'' from a mechanical source from hand deboned 
``meat'' by requiring an amino acid analysis casts undeserved doubts 
upon the meat from mechanical means, especially if it is asserted to be 
compositionally the same as hand-deboned meat; (3) if this ruling is to 
recognize meat from a mechanical process as ``meat,'' then the protein 
quality requirement for mechanically ``harvested'' meat is unfounded; 
(4) the marketplace will determine the quality of the protein in the 
meat produced by meat/bone separation machinery and meat recovery 
systems; (5) protein quality was not an issue with the Nutrition 
Labeling and Education Act of 1990, so it should not be of concern as a 
processing control for a product that will eventually be nutritionally 
labeled; (6) if the protein quality is of such a concern, it should be 
a mandatory parameter and required to be labeled in the Nutrition Facts 
panel on all products; and (7) products that require such extensive 
testing will take 2 to 3 days turnaround just to ensure the product 
meets compliance.
    Of the six food manufacturers/distributors who supported the 
proposal with some condition for modification, only one supported the 
quality control criteria in the proposed rule. The other five did not 
support the provisions for quality control in the proposed rule and 
their statements included the following: (1) Mandatory quality control 
programs will be an additional burden for the meat processor in 
situations where special controls are not needed; (2) the process of 
separating meat from bones has been historically accepted by the Agency 
and the industry without mandatory programs; (3) the process is 
comparable to removing meat from bones by hand, a situation that does 
not require a mandatory quality control program; (4) if the definition 
of meat includes an evaluation of the physical condition of the bones 
after the meat has been removed plus the bone content of the meat as 
measured by calcium content, the proposal should be referring to a 
partial quality control program to ensure appropriate labeling 
requirements are met; (5) the Department can and should maintain its 
focus on food safety questions and not quality issues, possibly through 
the requirement of some type of Hazard Analysis Critical Control Point 
(HACCP) program; and (6) issues of product quality, as opposed to 
safety, should remain within the discretion of the processing 
establishment.
    Of the six food manufacturers/distributors who supported the 
proposal with a condition for modification, three supported the 
handling requirements criteria in the proposed rule. The other three 
did not support the rule and their statements included the following: 
(1) If the current industry practices are reviewed, the Agency will 
find numerous processors that exceed the proposed 72-hour time limit 
for using starting materials and the meat derived from the advanced 
systems; (2) today, storage of meat from advanced systems at 
temperatures colder than 40 deg. F (4 deg. C) and pre-blending meat 
from advanced systems with curing ingredients allows the time necessary 
for transporting and processing; (3) requiring the proposed time/
temperature criteria will change the nature of meat as traded today by 
restricting supply locations and will alter the economic balance of the 
market--some processors may discontinue use of these materials because 
they cannot receive adequate supplies in 72 hours; and (4) the 
producing plant should be responsible for controlling the environment 
around meat from advanced systems to ensure that microbial spoilage 
does not occur.

Trade Association Comments

    Three of the four trade associations commenting on the proposed 
rule supported its provisions, provided that some modifications are 
made in specific areas (i.e., the definition of meat, calcium content 
criteria, protein quality, quality control, and handling requirements). 
The other trade association did not support the proposed rule and 
suggested that parity was the issue in defining meat and that the same 
labeling that is required for MS(S) should apply to MDP.
    All four trade associations had some concerns regarding the 
proposed calcium content criteria and their statements included the 
following: (1) Establishing a uniform standard for calcium content for 
both meat and poultry (i.e., 250 mg/100 gm of product of calcium) would 
create comparability; and (2) a calcium content limit is unnecessary; 
the Department's nutrition labeling requirements will serve to ensure 
that all consumers will receive specific calcium information.
    Three of the four trade associations had some reservations 
regarding the proposed protein quality requirements and their 
statements included the following: (1) A protein digestibility 
corrected amino acid score of not less than 40 expressed as a percent 
or an essential amino acid content of at least 33 percent of the total 
amino acids present in the meat should not be required by this or any 
other regulation because protein quality varies significantly 
throughout the meat and food supply as a whole; (2) protein quality is 
a marketplace issue and need not be regulated by an Agency which is 
focusing on direct food safety concerns; (3) the United States is not a 
protein deficient society which requires every protein source to be of 
highest ``quality''; and (4) there should be no restrictions on protein 
and fat content for product qualified to be labeled as ``meat'' because 
the protein and fat content of finished products will either be 
dictated by existing regulatory finished product standards, or by 
manufacturing specifications, and/or will be fully delineated in 
nutrition labeling on finished food product packages.
    Three of the four trade associations had some reservations 
regarding the proposed requirement for a mandatory quality control 
program to assure compliance with the provisions of the definition of 
meat derived from advanced systems. Their statements included the 
following: (1) This requirement would only serve to impose a special 
requirement upon a newer technology and a discrete sub-category of 
product in an arbitrary manner when other technology does not induce 
the same requirement; and (2) partial quality control programs should 
be a voluntary option.
    Three of the four trade associations had some reservations 
regarding handling requirements and their statements included the 
following: (1) Proper product handling is a legitimate concern for both 
government and industry, but there is no apparent basis for singling 
out the product to be addressed by the regulation for special scrutiny; 
such detailed requirements are not in place for other meat products, 
e.g., ground beef; (2) issues which truly relate to food safety 
concerns will be addressed more frequently in industry HACCP programs 
as the Agency proceeds to clarify its HACCP strategy; and (3) because 
such refrigeration/freezing requirements may be more broadly applied to 
other red meat products, they should be developed separately from the 
current proposal, be broadly based, and preferably handled within a 
company's HACCP framework.

Machinery Manufacturer Comment

    The manufacturer of machinery supported the proposed rule. The 
machinery manufacturer also stated that, with this new technology, meat 
processors will be able to fully utilize edible portions of meat 
carcasses by mechanical means without the incorporation of pulverized 
bone or otherwise introducing significant levels of bone that are of 
potential health consequence into meat systems.

Member of Academia Comment

    The comment from academia provided an objection to the proposed 
protein quality criteria for meat derived from advanced meat/bone 
separation machinery and recovery systems. The commenter stated that 
``every available survey indicates that all meat eating groups in the 
U.S. far exceed their protein quality and quantity requirements'' and 
suggested that the protein quality criteria be removed from the rule. 
Furthermore, the commenter provided literature to support this. The 
commenter also stated that they strongly agree with the red meat 
sausage manufacturers that have alleged that a disparate situation 
exists between labeling certain poultry products produced by mechanical 
separation and MS(S) which poses an unfair advantage for the 
manufacturers of poultry products. The commenter believes that 
standards for MS(S) and meat produced by advanced meat/bone separation 
machinery and meat recovery systems should be similar to the present 
ones for mechanically deboned poultry.

Response to Comments

1. The Definition of Meat

    In response to the comments that it is not necessary to define meat 
by making distinctions based upon whether specific pieces of machinery 
do or do not crush, grind, or pulverize bones, FSIS has determined that 
such a distinction is important because the type of machinery affects 
the characteristics (in terms of appearance, texture, and composition) 
and functionality of the material produced. Such distinction is 
critical because machinery that crushes, grinds, and/or pulverizes 
bones from livestock to remove adhering muscle tissue results in a meat 
food product whose paste-like consistency and content of bone, 
including bone marrow and certain minerals, are materially different 
from those of ``meat.'' Furthermore, these differences have potential 
consequences for finished product quality and health and safety. 
Because of the mechanism of this machinery, bone and bone particles, 
including bone marrow, are incorporated into the finished product which 
is not consistent with that of meat as traditionally defined.
    In contrast, FSIS has determined, as discussed in the section of 
this document entitled ``Characteristics and Composition of Meat,'' 
that the product derived from advanced meat/bone separation machinery 
and recovery systems that do not crush, grind, or pulverize bones to 
remove adhering muscle tissue is comparable to meat derived by hand-
deboning techniques, including the use of mechanical knives, because it 
has the functional and chemical characteristics of ``meat.'' As such, 
the product derived from the advanced systems warrants classification 
as ``meat.''
    Some commenters expressed a need for clarifying the acceptability 
of ``incidental'' bone breakage with regard to the use of advanced 
meat/bone separation machinery and meat recovery systems. FSIS believes 
that the description of the bones from which muscle tissue has been 
removed that emerge from the advanced meat/bone separation machinery 
and meat recovery systems, set forth in the proposed regulations, 
sufficiently addresses this issue, and, thus, this description remains 
as proposed. The description in the proposed amendment to the 
definition of meat is consistent with the description of the bones 
resulting from the removal of muscle tissue by hand-deboning using 
knives, including high-speed hand-held mechanical knives. This 
description indicates that these 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), thus, 
recognizing that some removal of a minute amount of the bone surface 
might unavoidably occur during this process.
    FSIS recognizes that even with the use of hand-operated knives, 
e.g., at the supermarket meat counter to cut up large cuts of beef, 
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 has determined 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. The 
minor abrasion of bone edges or surfaces in removing meat from bone 
using hand-deboning techniques, including mechanical knives, and the 
advanced meat/bone separation machinery is not the same as bone 
crushing, grinding, or pulverizing which would result in bone and 
constituents in bone being incorporated in the finished product in a 
manner inconsistent with meat as traditionally defined.
    In response to the suggested replacement of the word ``crush'' with 
the word ``chop'' in the proposed amendment of the definition of meat, 
i.e., product derived from advanced meat/bone separators that ``do not 
crush, grind, or pulverize bones'' to remove adhering muscle tissue, 
FSIS has concluded that ``crush'' is a more appropriate word. Crushing 
involves altering or destroying structure and, thus, is the action 
which must be avoided in order for bones to emerge essentially intact 
and in natural physical conformation from the advanced machinery. 
Therefore, the amendment to the definition of meat to include as 
``meat,'' product derived from advanced meat/bone separation machinery 
and recovery systems remains as proposed.

2. Calcium Content Criteria

    The proposal to amend the definition of meat to include product 
derived from advanced meat/bone separation machinery and recovery 
systems included criteria on maximum calcium content, as a measure of 
bone solids. 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) was proposed. This equates to a 
bone solids content of 0.6 percent.
    FSIS has determined that a maximum calcium content restriction for 
meat derived from advanced meat/bone separation and recovery systems is 
warranted. Because bones are composed primarily of calcium, calcium 
content is an indicator that the advanced meat/bone separation 
operation is in control and that the bones with adhering tissue are not 
ground, crushed, or pulverized during the process of removing the 
tissue from the bones. As such, by restricting the calcium content of 
the product resulting from the advanced meat/bone separation and 
recovery systems, in combination with the requirement that bones emerge 
from the advanced meat/bone separation systems essentially intact, 
there is an assurance that the product derived from the advanced 
systems is comparable to ``meat'' derived by traditional means, 
including that resulting from the use of mechanical knives. Moreover, 
calcium content criteria provides assurance that the meat derived from 
the advanced systems is consistent with consumer expectations of 
``meat,'' e.g., beef trimmings, as traditionally defined, that is used 
to formulate further processed meat food products.
    FSIS has also concluded that the proposed maximum calcium content 
for meat derived from advanced meat/bone separation and recovery 
systems is supported by data that reflect its comparability with meat 
produced by hand-deboning techniques and other mechanical means of 
removing meat from bone that do not involve crushing, grinding, or 
pulverizing bone. The maximum calcium content reflects what is 
achievable when good manufacturing practices (GMP's) are followed. 
Additionally, the criteria reflect the expected statistical variability 
attributed to analytical methodology for determining calcium. These 
data were available for public inspection during the comment period. 
The criteria on which these data are based will assure that the meat 
derived from the advanced 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.
    In response to the suggestions that the criteria be changed to a 
calcium content of 235 mg/100 gm or a calcium content of 250 mg/100 gm 
(i.e., 1 percent bone solids content), these comments were not 
supported by data. These values were considered reasonable by the 
commenters because they relate to the current allowance for the maximum 
bone solids content permitted in boneless poultry. However, FSIS 
believes that because there are inherent physical and compositional 
differences between the bones from poultry and bones from livestock 
species, one calcium criteria cannot be applied to both types of 
animals. The calcium criteria FSIS is adopting here and for 
mechanically separated poultry reflect these differences and what FSIS 
considers achievable when the respective technologies are applied in 
accordance with GMP's. Therefore, FSIS is maintaining the calcium 
criteria of 150 mg/100 mg of product (within a tolerance of 30 mg), as 
proposed.

3. Protein Quality

    FSIS agrees with the commenters' views regarding the lack of need 
for a mandated protein quality requirement for the meat derived from 
the advanced meat/bone separation machinery.
    In the proposed rule, FSIS proposed that meat derived from advanced 
meat/bone separation systems and recovery systems meet a minimum 
protein quality requirement, i.e., a protein digestibility corrected 
amino acid score of not less than 40 expressed as a percent or the 
alternative measurement of essential amino acids being at least 33 
percent of the total 17 amino acids present. FSIS has concluded that 
the lack of the need for a protein quality requirement is founded on 
scientific literature provided and cited by comments from academia and 
statements made by other commenters regarding the status of the quality 
of protein in diets of individuals in the U.S. with which FSIS agrees. 
According to scientific literature,11 there has not been an 
indication of health problems identified with protein quality--
consumption of enough high-quality protein by humans in the U.S. is not 
a problem. In the preamble of the final nutrition labeling regulations, 
both FSIS and the Food and Drug Administration (FDA) stated that 
current evidence suggests that the diet typically consumed in the U.S. 
provides for an adequate protein intake of sufficiently high quality to 
meet the nutritional needs of adults and children 4 or more years of 
age (58 FR 632 and 2079). Furthermore, because there are no outstanding 
health implications requiring the establishment of protein quality 
criteria for food products, in general, it would be unnecessary to 
require such criteria for a specific product, viz., red meat. 
Therefore, FSIS is removing its proposed provision for a protein 
quality requirement which would include the requirement for identifying 
product as ``(Species) fat'' and ``(Species) connective tissue.''
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    \1\1Public comment, including attached research article, 
submitted by R.A. Field, University of Wyoming, is available for 
review in the FSIS Docket Clerk's office.
---------------------------------------------------------------------------

4. Quality Control--Compliance Procedures

    FSIS agrees with the commenters' views regarding the lack of need 
for a requirement for a mandatory approved quality control program. 
After reviewing the comments and re-examining the Agency's current 
regulatory agenda, FSIS has concluded that because there are efforts 
underway within the Agency to study and address ways of reducing the 
potential for situations that would render any meat or poultry product 
adulterated, unwholesome, and/or misbranded it is premature to address 
the need for a mandatory quality control program for meat derived by 
this one distinct type of system.
    However, although FSIS has concluded that a mandatory quality 
control program is not needed, recordkeeping, a certain provision that 
would be part of any mandatory quality control program, as set forth in 
9 CFR 318.4, is still needed to prevent noncompliance with the 
definition of meat and to minimize the likelihood of manufacturing 
products that do not comply with regulatory requirements. FSIS has 
concluded that a records maintenance program for assuring product 
complies with the calcium content criteria is still needed and that the 
records must reflect data compiled in a prescribed way, i.e., the 
compliance procedure set forth in its proposed regulation. In regard to 
this matter, the proposed regulation stated that a prerequisite for 
label approval for meat derived from advanced meat/bone separation 
machinery and recovery systems was that it should be produced by an 
establishment under an approved quality control program, which had to 
be approved in accordance with 9 CFR 318.4 (d)(1), (d)(2), and (e). The 
proposed regulation also indicated that the quality control system 
should provide the controls and information necessary to ensure it 
meets the requirements for the product and enables establishment 
personnel and program employees to monitor the system for 
effectiveness. Furthermore, as part of the approval process, 9 CFR 
318.4(d) requires a letter to be submitted by the establishment which 
indicates that all data and information generated by the program will 
be maintained to enable the Department to monitor compliance and it 
also requires that the length of time the records will be maintained be 
stated. Thus, recordkeeping was clearly part of a quality control 
program.
    The records of data from testing must be available to the inspector 
or any other duly authorized representative of the Agency. The 
availability of these types of records for review was part of FSIS' 
proposed regulations for a required quality control program. The 
quality control program was required to provide the information 
necessary to enable program personnel to monitor the system for 
effectiveness, and it set up the method for determining calcium content 
compliance, which is being adopted as part of this final rule.
    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 
monitoring and testing program 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 it would reflect unacceptable incorporation 
of bone in the product during processing. To ensure that product 
satisfies the calcium requirement, FSIS is maintaining the position 
that a compliance program, as described below and set forth in its 
proposal, be used by manufacturers of meat from advanced systems.
    In order to obtain the data to ensure compliance with the calcium 
requirement, a sample of at least 1 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 would ensue to demonstrate that 
the product is in compliance with requirements for meat derived from 
meat/bone separation and recovery systems.
    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.)12
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    \1\2Data from a FSIS study are available in the FSIS Docket 
Clerk's Office.
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    If any single analytical result is more than 0.18 percent, before 
product from a production lot that is still at the establishment or one 
subsequently produced would be considered to be in compliance, at least 
three samples13 from that lot would 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 lot would continue until five consecutive lots14 
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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    \1\3Three 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.
    \1\4Sampling 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.
---------------------------------------------------------------------------

    FSIS believes that, if the statistical evidence indicates that 
product derived from advanced meat/bone separation systems 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, 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).

5. Handling Requirements

    FSIS believes that handling requirements are necessary to produce 
safe and wholesome product, and that potential bacterial hazards are 
diminished as long as handling accords with good manufacturing 
practices. Proper raw material and finished product handling is a 
concern for both the Agency and the meat industry. FSIS believes that 
it is the manufacturer's responsibility, in concert with FSIS', to 
assure that wholesome materials are used in the manufacture of its 
product within sound timeframes, and the safety of such product is not 
negatively affected. However, meat derived by advanced meat/bone 
separation machinery and recovery systems and the raw materials from 
which it is manufactured is not unique; all meat products that result 
from processes that involve cutting muscle tissue present opportunities 
for microbiological growth. Therefore, FSIS agrees with the commenters 
that there is a need to address the issue of handling requirements for 
all meat products, including meat derived from meat/bone separation 
techniques. FSIS is currently developing a separate rulemaking that 
will deal with this issue more fully and will include handling 
requirements for ground meat and meat trimmings, and the materials from 
which they are manufactured. These products are ones in which the meat 
derived from advanced meat/bone separation machinery and recovery 
systems is used. Therefore, FSIS will not include handling requirements 
for meat produced from advanced meat/bone separation systems in this 
rulemaking.

Executive Order 1286615
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    \1\5A separate cost/benefit analysis has been prepared and is 
available from the FSIS Docket Clerk.
---------------------------------------------------------------------------

    This final rule has been determined to be significant and has been 
reviewed by the Office of Management and Budget under Executive Order 
12866.
    This rule formalizes the use of relatively new, advanced meat/bone 
separation machinery that increases the yield of meat trimmings from 
certain bones from livestock carcasses and probably also reduces the 
amount or type of hand-separation labor. The rule allows, but does not 
require, the use of the machinery. Thus, the decision to invest in this 
machinery rests with official meat establishments.
    The product of the advanced meat/bone separation process is 
distinguished from the product identified as MS(S) because the advanced 
process does not crush or grind the bones, and meat output has 
characteristics comparable to those of hand-deboned meat. Qualifying 
product will be defined as ``meat'' and needs no other special 
designation or standard of identity. The product can be used in 
hamburger (beef), sausage, ground pork, and other products normally 
utilizing meat trimmings.
    The advanced meat/bone separation machinery is currently in use in 
approximately 50 to 60 official establishments, all thought to be large 
firms. Product from such machinery is produced by several manufacturers 
using differing mechanisms, i.e., pressing, shaving, and scraping. An 
advanced meat/bone separation machine can process up to 400 beef 
carcasses an hour, yielding 3,500 to 4,000 pounds of product per hour. 
This calculates to 35 to 40 percent of meat from each carcass, about 1 
to 1\1/2\ pounds more per beef carcass than that produced under a hand-
deboning operation.

Costs of Final Rule

    It is estimated that the annual cost for operating one machine for 
beef is $170,000, which includes depreciation, repair, maintenance, 
labor, and compliance costs. The cost per head or per unit of output 
depends upon capacity utilization, labor costs, and other factors. The 
cost of such machinery is $60,000 to $80,000 per unit, and requires one 
person to operate each unit. The cost of compliance with the calcium 
content, as a measure of bone solids, is assumed to be about $5,000 per 
machine annually. This includes costs for testing for calcium content 
and required recordkeeping to support the validity of the calcium 
content.
    Use of the machinery requires replacement of a $600 belt each 24 to 
40 hours of operation. In addition, manufacturers indicate that an 
establishment producing 100 head of cattle per hour (400 head per hour 
for pork) is the minimum size necessary to justify use of such 
machinery.
    To the extent that advanced meat/bone separation machinery is 
already in use, a portion of the costs have already been incurred by 
those establishments currently using such machinery. If such 
establishments choose to continue using the advanced meat/bone 
separation machinery, their only additional cost would be related to 
compliance with the calcium content requirement. Because this is a 
permissive rule, other establishments would incur the new costs 
associated with the use of such machinery if increased net returns are 
anticipated.

Benefits of the Final Rule

    The net benefits to the economy in the first year of implementation 
would be over $30 million, based on use of economic model for the U.S. 
livestock sector. It is estimated that annual net benefits would 
increase over time as the industry increases its use of this method 
which yields an additional 1 to 1\1/2\ pounds of output per carcass.
    While establishments that already use advanced technology or those 
that adopt the new technology immediately may enjoy high returns, the 
primary long-run benefits of adoption of advanced technology accrue to 
consumers of meat and stem from a net increase in meat supply through 
increased yield from each animal processed. Under pure competition, 
depending upon price elasticity of demand and supply, packer cost 
savings will be passed forward to consumers or backward to producers in 
the marketing chain.
    FSIS believes that adoption of advanced meat/bone separation 
machinery may reduce the incidence of cumulative trauma disorder among 
meatcutters by eliminating some tasks which contribute to the disorder. 
Thus, this final rule may result in a reduction in costs associated 
with any reduced incidence of cumulative trauma disorder among workers. 
The U.S. Department of Labor reported an incidence rate for repeated 
trauma of 1,493.7 per 10,000 workers in the meatpacking industry in 
1991, the highest rate of any listed private industry segment.

Executive Order 12778

    This final 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 final rule will 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 
advanced meat/bone separation machinery and meat recovery systems. 
Although there are initial costs involved with the purchase of 
machinery, 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 are required to maintain records of a compliance 
program for calcium content that provides the information necessary to 
assure that the product will meet the requirements as established by 
this final rule for such product. The paperwork requirements contained 
in this final rule have been approved by the Office of Management and 
Budget under control number 0583-0095.

List of Subjects

9 CFR Part 301

    Meat inspection.

9 CFR Part 318

    Recordkeeping requirements. Meat inspection.

9 CFR Part 320

    Meat inspection, Reporting and recordkeeping requirements.

Final Rule

    For the reasons set forth in the preamble, FSIS is amending 9 CFR 
parts 301, 318, and 320 of the Federal meat inspection regulations as 
follows:

PART 301--DEFINITIONS

    1. The authority citation for part 301 continues to read as 
follows:

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.17, 2.55.

    2. Section 301.2 is 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 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.
* * * * *

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS: REINSPECTION AND 
PREPARATION OF PRODUCTS

    3. The authority citation for part 318 continues to read as 
follows:

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.17, 2.55.

    4. Part 318 is 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, as prescribed in 
Sec. 301.2(rr)(2) of this subchapter.
    (b) To verify the calcium content in meat derived from advanced 
meat/bone separation machinery and recovery systems, a compliance 
program consisting of the following parameters shall be followed by 
manufacturers of meat defined in Sec. 301.2(rr)(2) of this subchapter.
    (1) An analysis of a sample of at least 1 pound from each lot shall 
be performed by the operator of the establishment or his or her agent. 
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. 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 percent,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 percent. 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 percent. 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 percent 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 percent calcium.
---------------------------------------------------------------------------

    (2) The management of the establishment must maintain records to 
support the validity of the calcium content (as a measure of bone 
solids) to assure the process is in control. Such records shall be made 
available to the inspector or any other duly authorized representative 
of the Agency upon request. (Recordkeeping requirements were approved 
by the Office of Management and Budget under control number 0583-0095.)

PART 320--RECORDS, REGISTRATION, AND REPORTS

    5. The authority citation for part 320 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    6. Section 320.1 is amended by adding a new paragraph (b)(10) to 
read as follows:


Sec. 320.1  Records required to be kept.

* * * * *
    (b) * * *
    (10) Records of calcium content in meat derived from advanced meat/
bone separation machinery and meat recovery systems as required by 
Sec. 318.24 of this subchapter.

    Done at Washington, DC, on: November 30, 1994.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 94-29902 Filed 12-2-94; 8:45 am]
BILLING CODE 3410-DM-P