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

Federal RegisterDec 6, 1994

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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.

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\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.

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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.

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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.

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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