[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.
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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.
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\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
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.
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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.
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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.
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(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