[Federal Register Volume 63, Number 70 (Monday, April 13, 1998)]
[Proposed Rules]
[Pages 17959-17966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9681]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 63, No. 70 / Monday, April 13, 1998 /
Proposed Rules
[[Page 17959]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 318, and 320
[Docket No. 96-027P]
Meat Produced by Advanced Meat/Bone Separation Machinery and
Recovery Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: In 1994, the Food Safety and Inspection Service amended its
regulations to recognize that product resulting from advanced meat/bone
separation machinery and recovery systems comes within the definition
of meat when these recovery systems are operated to ensure that the
characteristics and composition of the resulting product are consistent
with those of meat. The Agency is proposing to clarify the regulations
and to supplement the rules for assuring compliance. In future
rulemakings, the Agency expects to apply the process control-
performance standards approach of this proposal to other types of
operations for manufacturing meat and poultry trimmings.
DATES: Comments must be received June 12, 1998.
ADDRESSES: Submit one original and two copies of written comments to
FSIS Docket Clerk, Docket No. 96-027P, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th
Street, SW, Washington, DC 20250-3700. All comments submitted in
response to this proposal will be available for public inspection in
the Docket Clerk's office between 8:30 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Regulations and Inspection Methods, Food Safety and
Inspection Service, Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service
(FSIS) administers a regulatory program under the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) to protect the health and
welfare of consumers by preventing the distribution of meat and meat
food products that are unwholesome, adulterated, or misbranded. FSIS's
regulations (9 CFR chapter III) distinguish meat (essentially muscle
that is skeletal or found in the tongue, diaphragm, heart, or
esophagus) from other products of livestock carcasses (Sec. 301.2). In
1994, FSIS amended its regulations to recognize that product resulting
from advanced meat/bone separation machinery and recovery systems comes
within the definition of meat when these systems are operated to ensure
that the characteristics and composition of the resulting product are
consistent with those of meat (59 FR 62551, December 6, 1994).
A livestock (cattle, sheep, swine, goat, horse, mule, or other
equine) product is misbranded under any of a number of circumstances,
including if its labeling is false or misleading in any particular; if
it is offered for sale under the name of another food; if it is an
imitation of another food, unless its label bears (in type of uniform
size and prominence) the word ``imitation'' and, immediately
thereafter, the name of the food imitated; or if it purports to be or
is represented as a food for which a definition and standard of
identity or composition is prescribed by regulations, unless it
conforms to the regulations and its label bears the name of the food
specified in the definition and standard (21 U.S.C. 601(n)(1), (n)(2),
(n)(3), and (n)(7)). A livestock product is adulterated if any valuable
constituent has been in whole or in part omitted or abstracted
therefrom; if any substance has been substituted wholly or in part
therefor; if damage or inferiority has been concealed in any manner; or
if any substance has been added thereto or mixed or packed therewith so
as to increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is (economic
adulteration) (21 U.S.C. 601(m)(8)). A product that does not come
within the definition of meat in Sec. 301.2(rr) may not be marketed as
meat, and its use contrary to regulations such as the definition and
standard in Sec. 319.15(a) would result in misbranding and economic
adulteration.
The FMIA prohibits the preparation of meat or meat food products
for commerce except in compliance with the FMIA requirements and the
selling, transporting, offering for sale or transportation, or
receiving for transportation, in commerce, of meat or meat food
products that are capable of use as human food and are adulterated or
misbranded (21 U.S.C. 610(a) and (c)). Intrastate operations and
transactions are effectively subject to the same prohibitions under
State meat inspection programs, which must enforce requirements at
least equal to those imposed under the FMIA, or designation for Federal
inspection, whereby both intrastate and interstate operations in the
State are federally inspected (21 U.S.C. 661(c)(1)).
FSIS now believes that the provisions adopted in 1994 are confusing
and need revision to prevent misbranding and economic adulteration.
Therefore, the Agency is proposing to clarify the scope of ``bone'' as
used in the definition of meat and other aspects of the regulations and
to reorganize and supplement the rules for assuring compliance with the
regulations, taking into account information and developments since the
1994 rulemaking.
Previous Agency Action
The basis for the 1994 rulemaking was advances in recovery
machinery: The development of meat/bone separators that emulated the
physical action of hand-held high-speed knives for the removal of
skeletal muscle tissue from bone had led to recovery systems that
separated meat from bone by shaving, pressing, or scraping the muscle
tissue from the bone surface, with the bones emerging essentially
intact and in natural physical conformation, resulting in product that
is comparable to meat derived by hand deboning (59 FR 62552-53). As
FSIS stated in its final rule:
* * * 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.
* * * The advanced recovery systems produce distinct whole
pieces of skeletal muscle tissue with a well-defined particulate
size similar in consistency to (species)
[[Page 17960]]
trimmings derived by hand-deboning and used to formulate processed
meat products. The color * * * is similar to that of (species)
trimmings. * * * [T]he meat derived * * * 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 would render the
product adulterated or misbranded * * * [59 FR 62553-54.]
After monitoring advances in meat/bone separation machinery for a
decade, FSIS concluded it should amend its regulations so that they
explicitly provided that when skeletal muscle is separated from
livestock bones using advanced recovery systems under appropriate
controls, the resulting product is treated as meat rather than as
mechanically separated livestock product.
Mechanically separated livestock product, unlike meat, is made by
mechanically separating and removing most of the bone from attached
skeletal muscle of carcasses and parts of carcasses, using machinery
that operates on the differing resistance of hard bone and soft tissue
to passage through small openings. For 20 years the Department's
position has been that although mechanically separated livestock
product has many of the characteristics of meat and, as regulated, may
be used as a meat ingredient in the formulation of quality meat food
products, it is not meat (as defined in Sec. 301.2(rr)). In particular,
the consistency of mechanically separated livestock product and its
content of bone and certain minerals, as well as muscle tissue, are
materially different from those of meat, and these differences have
potential consequences for finished product quality and for health and
safety (see, e.g., 47 FR 28214, 28223, June 29, 1982). Also, to the
extent that it is made from materials which contain spinal cord and
bone marrow in addition to muscle and fatty tissue, the cholesterol
content of mechanically separated livestock product appears to be
greater than the cholesterol content of meat (47 FR 28238).
Part 319 of the regulations specifies ``Mechanically Separated
(Species)'' (MS(S)) as the name of mechanically separated livestock
product that meets various regulatory requirements and limits the level
at which, and products in which, MS(S) may be used (Secs. 319.5 and
319.6). The Department has prohibited the use of MS(S) in certain meat
food products, based on determinations about the basic characteristics
expected in those products, and in baby, junior, and toddler foods,
based on a determination that available information was insufficient to
conclude that other regulatory restrictions are adequate to prevent the
mottling of infants' teeth as a result of increased fluoride intakes
(Sec. 319.6(d); see, e.g., 47 FR 28240-41).
The MS(S) definition and standard does not specify the type of
equipment used to separate and remove bone because, as intended by the
Department, it covers product manufactured by any machinery that
operates on the differing resistance of hard bone and soft tissue to
passage through small openings, whether the machinery employs sieves,
screens, or other devices and whether or not bones are prebroken before
being fed into the equipment. However, the MS(S) definition and
standard was not intended to apply to whole pieces of muscle removed
from livestock bones by mechanical or other means. (47 FR 28223.)
In 1994, FSIS determined that there were meat/bone separators and
recovery systems that were fundamentally different than the machines
used to manufacture MS(S). The Agency's final rule specifically
contrasted skeletal muscle separated from livestock bones using
advanced recovery systems with the characteristics and composition of
MS(S). FSIS concluded that, unlike with 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'' (59
FR 62554).
The amendments adopted in 1994 did not change the applicability or
requirements of the MS(S) regulations. Instead, they recognized FSIS's
conclusion that product resulting from advanced meat/bone separation
machinery and recovery systems comes within the definition of meat when
the systems are operated to ensure that product characteristics and
composition are consistent with those of meat.
In response to compliance concerns raised after the amendments took
effect (on January 5, 1995), FSIS surveyed federally inspected
establishments known to be using advanced meat/bone separation
machinery and a variety of starting materials (in the fall of 1995),
met with industry members, and issued a directive to inspection program
personnel to increase consistency in the application of regulatory
requirements (FSIS Directive 7160.1, September 13, 1996). FSIS then
published a notice that summarized the survey results, discussed
various issues, and solicited additional data and information from the
public (1996 notice) (61 FR 57791, November 8, 1996). The Agency
received 34 comments (from regulated industry members, various trade
associations, equipment manufacturers, consumer organizations,
consultants, academics, an FSIS inspector, and a U.S.
Senator),1 but no new data. The Agency subsequently took
steps to assure that, as intended, product which contained spinal cord
was not treated as meat (see, e.g., FSIS Directive 7160.2, April 14,
1997).
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\1\ Comments submitted in response to the 1996 notice are
available for public inspection in the FSIS Docket Clerk's office.
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After considering information obtained since 1994 on production
practices and product characteristics, including a 1996 survey of
establishments mechanically separating muscle from beef neck bones and
additional data subsequently submitted to the Agency,2 along
with the views expressed in the comments submitted in response to the
1996 notice, FSIS came to believe that it is necessary to amend the
regulations regarding products resulting from advanced meat/bone
separation machinery. FSIS also initiated a review of available
information on poultry product processing operations that may present
similar issues under the Poultry Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.).3 However, in view of the concerns about
possible incorporation of spinal cord and bone marrow in products
resulting from advanced meat/bone separation machinery, the Agency has
determined that it should not delay action on this matter. FSIS will
consider the poultry product issues during its reevaluation of how FSIS
regulates operations for manufacturing meat and poultry trimmings
(including grinding, low temperature rendering and other preparation
and processing of whole muscle and other starting materials into
comminuted livestock and poultry products). The Agency plans to obtain
additional information on current industry practices and, in future
rulemakings, to apply a consistent
[[Page 17961]]
process control-performance standards approach to those operations as
well.
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\2\ The ``Advanced Meat Recovery System Survey Project Final
Report'' (final report) (prepared February 21, 1997, by Dr. Robert
J. Hasiak and Harry Marks), data submitted since the 1994
rulemaking, and an evaluation of information used in developing two
of the proposed noncomplying product criteria (``Establishment of
calcium and excess iron limits,'' Dr. Daniel L. Engeljohn, FSIS) are
available from the FSIS Docket Clerk.
\3\ See FSIS's September 20, 1996, letter responding to the
National Turkey Federation's request to postpone the effective date
of the Mechanically Separated (Kind of Poultry) final rule and adopt
a regulation to treat product derived using advanced recovery
systems as ``turkey''.
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Proposed Rule
The Agency's objective for this rulemaking is to assure that the
regulations provide clear standards under which industry members assume
their responsibility to avoid misbranding and economic adulteration in
compliance with enforceable regulatory requirements that include
adequate markers for bone-related components at greater than
unavoidable defect levels (levels consistent with defects anticipated
when meat is separated from bone by hand). In 1994, the Agency expected
that the exclusion of meat/bone separation machinery and recovery
systems which ``crush, grind, or pulverize bones'' meant that the
calcium content limit and the requirement that ``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 specified in Sec. 301.2(rr), would be
sufficient to ensure that the production process is in control and the
characteristics and composition of the resulting product are consistent
with those of meat. As discussed below and evidenced by data on product
composition that FSIS has evaluated since issuance of the 1994 final
rule, FSIS's expectations have not been borne out. FSIS believes that
this rulemaking is necessary to accomplish the intended purpose of the
amendments adopted in 1994: ensuring control of the production process
to prevent the recovery of soft as well as hard bone tissues and
providing adequate bases for verifying the exclusion of bone-related
components and, thus, the production of meat.
Moreover, the Agency now believes that it is inappropriate to focus
on the physical condition of bones, particularly at an intermediate
processing step, rather than on the food product being recovered by the
machinery. In addition, experience evidences that deciding whether ``*
* * bones emerge . . . essentially intact and in natural physical
conformation * * *'' calls for such individualized judgments that
continuing controversy is inevitable. Application of the emerging bones
criterion has involved the Agency and its personnel in questions about
bones compressed or compacted during mechanical meat/bone separation
into bone ``cakes'' or ``plugs''. Efforts by FSIS personnel to
determine by visual examination whether bones--as they emerge or after
disassembly--are essentially intact and in the same natural physical
conformation as when they entered the system such that they are
recognizable as neck bones, rib bones, etc. (Paragraphs I.D., E., and
F. of FSIS Directive 7160.1) have not resulted in consistent judgments,
either during in-plant verifications or in the laboratory.4
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\4\ These efforts have included an attempt by pathologists at
FSIS's Eastern Laboratory to ``score'' beef neck bone samples
collected in the 1996 survey (before bones entered and after they
exited meat/bone separation machinery) using criteria that divided
bones into three categories (basically (1) recognizable and
essentially intact, (2) recognizable with occasional fracturing and/
or abrasion/laceration or surface polishing, but no evidence of
crushing and minimal bone dust on external surfaces, and (3) not
intact with routine fracturing, loss of joint integrity, cartilage,
and marrow color, and evidence of crushing and bone dust
accumulation external surfaces). (See Attachment 2 to the final
report for the criteria.)
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Nor does the Agency have confidence that these judgments are
correlated with the regulatory objective: the operation of recovery
systems to prepare products that come within the definition of meat. In
FSIS's view, manufacturers should control the advanced recovery
production process to prevent the incorporation of soft bone-related
components as well as hard bone (bone solids), and the Agency should
focus on product composition in verifying whether manufacturers are
fulfilling this responsibility.
As is clear from provisions of the proposed rule, however, FSIS
views replacement of the essentially intact-natural physical
conformation criterion as a question of regulatory focus, not as an
abandonment of visual observations. Thus, for example, comparing bones
entering and exiting a recovery system may well be appropriate, or even
sufficient, when deciding whether spinal cord, a bone-related
component, is being incorporated into a product.
During this rulemaking, inspection program personnel will continue
to observe conditions that are relevant in determining whether
``recovery systems * * * crush, grind, or pulverize bones'' and, hence,
are excluded by Sec. 301.2(rr). However, the Agency intends to withdraw
its instruction to inspection program personnel to disassemble bones
that emerge in a compacted mass (FSIS Directive 7160.2, Paragraph
I.D.2.). Especially when performed before another processing step,
5 this procedure does not appear to be a reliable predictor
of whether a system is recovering bone-related components other than
calcified tissue as well as skeletal muscle tissue.
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\5\ A number of establishments utilize a process that includes
a final desinewing procedure to remove sinew, tendons, cartilage,
and/or incidental bone chips.
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Finally, the Agency believes that the structure of the 1994
amendments has contributed to the problem. FSIS's purpose in adding
language to the definition of meat in Sec. 301.2(rr) was to clarify--
not to expand--the scope of the definition by providing the conditions
under which advanced meat/bone separation machinery and recovery
systems must operate to yield meat. The Agency now recognizes that
addressing these conditions in the definition has resulted in
confusion. For example, comments received by the Agency indicate that
some members of the public have misconstrued the calcium content
criterion as defining a characteristic of meat, rather than as setting
a regulatory limit. FSIS is not defining meat in terms of calcium
content. Instead, the Agency is using calcium content as a measure for
determining that a product has more hard bone (calcified tissue) than
is unavoidable as a defect, consistent with current good manufacturing
practices.
In the proposed rule, the definition of meat reflects, with certain
clarifications, the definition of meat before the 1994 rulemaking,
which the 1994 amendments designated as subparagraph (1) of
Sec. 301.2(rr). The regulatory requirements for deriving meat by
mechanically separating skeletal muscle tissue from the bones of
livestock using advances in mechanical meat/bone separation machinery
and recovery systems are in revised Sec. 318.24, instead of
subparagraph (2) of the definition of meat. As amended by the proposed
rule, the definition of meat would specify that ``the portions of bone
* * * that normally accompany the muscle tissue * * *'' are the bones
found in bone-in products (e.g., T-bone and porterhouse steaks) and
that bone includes bone-related components such as bone marrow and
spinal cord, as well as hard bone. The statement on the scope of bone
(proposed to be designated as subparagraph (2)) would appear after the
statement, in the current definition of meat, that meat does not
include muscle found in lips, snouts, and ears (the second sentence of
the definition, proposed to be redesignated as subparagraph (1)).
The proposed revision of Sec. 318.24 sets out the regulatory
requirements that would apply whenever an establishment operator uses
advances in mechanical meat/bone separation machinery to recover meat.
As amended, paragraph (a) of Sec. 318.24 would provide that:
Meat, as defined in Sec. 301.2 of this chapter, may be derived
by mechanically separating
[[Page 17962]]
skeletal muscle tissue from the bones of livestock using advances in
mechanical meat/bone separation machinery and systems that, in
accordance with this section, recover meat without crushing,
grinding, pulverizing, or otherwise incorporating hard bone or bone-
related components.
Adoption of this provision will clarify the regulation by shifting the
focus from whether recovery systems ``crush, grind, or pulverize
bones'' to the reason why FSIS has disqualified such systems: they
incorporate hard bone and related components into the resulting
product. This clarification will help prevent debates over how
machinery operates (e.g., whether an establishment's use of a
particular equipment model crushes bones) and will establish a standard
that is not dependent on how machinery operates. For example, if a
system were to utilize centrifugal force or suction to recover meat,
the bones might not be crushed, ground, or pulverized and the resulting
product might have a very low calcium content, even though the action
that separates muscle tissue from bones recovers bone-related
components other than calcified tissue, thus, resulting in product that
is not meat.
FSIS is proposing to revise paragraph (b) of Sec. 318.24 because
the Agency no longer can say with confidence that under the compliance
requirements adopted in 1994, product derived using advances in meat/
bone separation machinery and recovery systems--unlike MS(S)--does not
contain powdered bone or constituents of bone such as bone marrow that
are not in conformance with the definition and expectation of meat or
would render the product adulterated or misbranded (59 FR 62554). After
considering additional information on evolving manufacturing practices
and product composition, the Agency has tentatively concluded that
demonstrating compliance with a limit on calcium content does not
suffice to ensure that the resulting product is comparable to meat
derived by hand deboning (59 FR 62553). 6
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\6\ For example, based on the levels of iron in beef neck bone
products sampled in FSIS's 1996 survey and in both beef and pork
products prepared at a number of other official establishments
(i.e., levels that are beyond the range of values reported for
muscle tissues), bone marrow may be present in products that comply
with the calcium content limit. (See, e.g., pages 6, 8, and 9 and
Figure 2 (page 23) of the final report on the 1996 survey.)
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Paragraph (b) of Sec. 318.4 of the FMIA regulations has long
provided that in order for an establishment operator to carry out
effectively the responsibility to comply with the FMIA and the
regulations thereunder, the operator must institute appropriate
measures to assure (among other things) the preparation and labeling of
products strictly in accordance with the requirements of those
regulations. In the case of advanced meat/bone separation machinery and
recovery systems, the Agency now believes that a process control
approach is necessary to achieve compliance. Therefore, FSIS is
proposing to revise paragraph (b) of Sec. 318.24 by replacing the
compliance program parameters prescribed in 1994 (calcium content
verification based on lot-by-lot sample analyses) with a requirement
that, as a prerequisite to labeling or using product derived by
mechanically separating skeletal muscle tissue from livestock bones as
meat, an establishment operator must implement and document procedures
that ensure that the establishment's production process is in control
(proposed introductory text of paragraph (b)).\7\
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\7\ To avoid possible confusion, FSIS notes that adoption of
this proposed requirement would have no effect on the procedures or
other labeling rules in part 317 of the regulations.
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Proposed paragraph (b)(1) of Sec. 318.24 provides that if any of
the noncomplying product provisions of paragraph (c)(1) applies to the
resulting product, the production process is not in control. FSIS is
not proposing to prescribe how establishment operators maintain control
of the production process. The proposed rule would leave each operator
free to determine what mix of procedures is best for the particular
establishment and to change procedures over time. FSIS is proposing,
however, to require that the documentation of an establishment's
procedures include, in addition to a description of the procedures
themselves, information that substantiates their effectiveness in
preventing the incorporation of hard bone and bone-related components,
including bone marrow and spinal cord (proposed paragraph (b)(2)). To
illustrate the types of documentation that FSIS expects establishments
would maintain to comply with this requirement, proposed paragraph
(b)(2) includes two examples: information on the characteristics of the
product that results when equipment is operated pursuant to
manufacturer specifications and records of establishment monitoring and
verification activities.
Establishment procedures and substantiating information, along with
any other data generated using the process control procedures, would be
required to be made available to inspection program personnel (proposed
paragraph (b)(3)). FSIS is proposing to amend Sec. 320.1(b)(10) to
reflect the fact that, if amended as proposed, Sec. 318.24 would
require records that document control of the production process when
advanced meat/bone separation machinery and recovery systems are used
to produce meat. (See also the record maintenance, retention, and
access rules in Secs. 320.2, 320.3, and 320.4.)
The purpose of proposed paragraph (c)(1) of Sec. 318.24 is to
identify circumstances that would preclude treating product resulting
from advanced meat/bone separation machinery and recovery systems as
meat. These provisions do not (individually or collectively, or
directly or by implication) describe expected or accepted
characteristics of meat. Instead, under any of these circumstances,
product recovered using mechanical meat/bone separation machinery is
not meat.
The proposed rule subdivides paragraph (c)(1) into clauses that
identify the three bone-related components addressed therein: (i) bone
solids, (ii) bone marrow, and (iii) spinal cord. The Agency is using
this format to emphasize that the objective is to make determinations
about bone-related components and not, for example, to control the
amounts of the essential nutrients calcium and iron, which are used as
markers for hard bone and bone marrow, respectively. The inclusion of
other markers for bone-related components, such as an alternative
method for finding that bone marrow is present in a measurably lower
amount or a bone marrow indicator that, unlike proposed clause (ii)(B),
does not measure excess iron content, might be appropriate. However,
FSIS's tentative judgment is that the criteria in proposed paragraph
(c)(1) would provide adequate bases for noncomplying product
determinations.
FSIS is proposing, in Sec. 318.24(c)(1)(i), to change the criterion
for bone solids from a calcium content limit of no more than 0.15
percent or 150 mg per 100 grams of product, within a tolerance of 0.03
percent or 30 mg per 100 grams of product (i.e., if any analytical
result is more than 0.18 percent or 180 mg per 100 grams of product),
to a proscription of more than 130.0 mg of calcium per 100 grams. This
aspect of the proposal reflects the Agency's tentative judgment that
the existing calcium content limit should be reduced because it is
higher than the level that is unavoidable under current good
manufacturing practices. The Agency also believes that the calcium
content limit should be stated as an absolute maximum (i.e., with no
tolerance) because accounting for analytical (and any other)
variability is a production process control question for industry to
address.
[[Page 17963]]
In developing the proposed calcium cut-off, FSIS evaluated data
obtained in the 1996 survey of product recovered from beef neck bones
and reviewed other information that has become available since
1994.8 The Agency found it particularly noteworthy that
despite the abrasion of bones and the increase in exposed surfaces that
results when neck bones are split prior to meat/bone separation, 90
percent of the samples analyzed in the 1996 survey would have been in
compliance under this limit. Nevertheless, FSIS is very interested in
receiving additional information on the composition of products
recovered from materials other than neck bones before it finally
determines whether, and if so, by how much, to reduce the existing
calcium content limit. The Agency is especially interested in receiving
information on production practices for mechanically separating pork
meat from pork bones and, in particular, whether available data support
establishing a different, species-specific limit for the calcium
content of the resulting product.
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\8\ See, for example, the industry data submitted to FSIS by the
American Meat Institute (``AMR Research Update,'' July 16, 1997) and
the Cargill Animal Nutrition & Meat Sector (``Advanced Meat
(Poultry) Recovery System,'' August 25, 1997, cover letter to Daniel
L. Engeljohn, FSIS).
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FSIS is proposing, in Sec. 318.24(c)(1)(ii) and (c)(1)(iii), to
replace the emerging bones criterion (``the bones emerge comparable to
those resulting from hand-deboning (i.e., essentially intact and in
natural physical conformation such that they are recognizable * * *)'')
with noncompliance criteria for bone marrow and spinal cord. Under
proposed clause (ii), either of two conditions would constitute failure
to comply: the presence of bone marrow in bones entering the recovery
system and its absence or presence in a measurably lower amount in
bones exiting the recovery system, or an excess iron content in the
resulting product, as determined by a specified formula (proposed
clauses (ii)(A) and (ii)(B), respectively).
Assessing products for bone marrow content has been controversial,
in large part because the composition of marrow and muscle tissues
overlap (i.e., they both contain such substances as fat, protein, and
cholesterol). This has engendered debates about whether a ``unique''
constituent of marrow can be identified and and its presence reliably
measured. What is not in dispute is the Agency's longstanding position
that marrow is part of bone, not muscle, and that bone marrow is a
feature of MS(S), not meat. This proposal makes that position clearer
(proposed subparagraph (2) of the Sec. 301.2(rr) definition of meat).
It also shifts the regulatory focus from precisely characterizing a
product or product component to determining product noncompliance
(proposed Sec. 318.24(c)(1)).
Under a noncompliance approach, the issue becomes the
identification of a criterion that can be associated with the presence
of bone marrow above an unavoidable defect level. Excess iron is such a
criterion,9 and the Agency has developed a formula for
determining excess iron content. Using data collected in FSIS's 1996
survey and other data (from both the literature and industry members)
on the relative amounts of iron and protein in muscle trimmed by hand
and in product resulting from the use of advanced mechanical meat/bone
separation machinery to recover meat from beef neck bones, as sampled
in the 1996 survey, the Agency derived general values to represent the
ratio of iron content to protein content in beef and in pork. The beef
value, 0.067, is based on samples collected in the 1996 survey. The
pork value, 0.034, is based on USDA Handbook 8 and other reported data
indicating that the ratio of iron content to protein content in pork is
half that of the ratio in beef. FSIS then used these values to
calculate a figure that represents excess iron: more than 1.80 mg of
iron per 100 grams of product.
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\9\ Research and other reports supporting the position that
product resulting from advanced meat/bone separation machinery has a
higher iron content than meat prepared by hand trimming include
FSIS's 1996 survey and a special committee report prepared in
response to consumer concerns by the American Meat Science
Association (``Advanced meat recovery systems: A scientific review
of the status, with conclusions,'' AMSA, 444 North Michigan Avenue,
Chicago Illinois 60611; May 19, 1997).
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Under proposed clause (ii)(B), unless an establishment's operator
has verified and documented an alternative value for the ratio of iron
content to protein content (as explained below), a difference of more
than 1.80 between a product's iron content and its protein content
multiplied by 0.067 or 0.034 constitutes noncompliance. (In other
words, when [iron content--(protein content x 0.067)] > 1.80 mg per 100
grams of beef product or when [iron content--(protein content x 0.034)]
> 1.80 mg per 100 grams of pork product, there is noncompliance.)
Almost 40 percent of the samples in the 1996 survey of product
recovered from beef neck bones would not have been in compliance under
the standard proposed for beef products. Given the significant amounts
of marrow in beef neck bones and the exposure of additional surface
area when neck bones are split prior to meat/bone separation, this
finding indicates that unless operators control the production process,
primarily by controlling the pressure applied by advanced recovery
systems, they can recover bone marrow. A histological examination of
the 1996 survey samples of products that were the result of hand
trimming and those that were the result of mechanical separation from
neck bones, for hematopoietic cells (blood cell precursors), supports
the Agency's tentative conclusion that a large proportion of the latter
included bone marrow (see pages 4, 6, and 10 of the final
report).10
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\10\ FSIS scientists conducted this examination because
hematopoietic cells have been identified as an indicator of bone
marrow. The results confirm the potential usefulness of
hematopoietic cells in identifying the presence of bone marrow, and
the Agency is now considering volumetric hematopoietic cellular
residue and other possible measures of bone marrow content.
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FSIS notes that the iron content of samples collected in the 1996
survey was determined using a hydrochloric acid wet ash method. This
method is known to recover less iron than two other reliable methods
for determining iron content: the sulfuric acid wet ash method and the
dry ash method. The Agency is interested in receiving comments on its
tentative conclusion that despite differences in the amounts recovered,
clause (ii)(B) of Sec. 318.24 need not address iron methodology.
FSIS recognizes that values based on the specific carcass part used
in an advanced recovery system would more accurately represent the iron
to protein ratio of meat from that part. Therefore, the proviso in
proposed clause (ii)(B) states that when the operator of an
establishment has verified and documented the ratio of iron content to
protein content in the skeletal muscle tissue attached to bones prior
to their entering the recovery system, based on analyses of hand-
trimmed samples, that value is to be substituted for the multiplier
0.067 or 0.034 (as applicable) with respect to product that the
establishment mechanically separates from those bones (e.g., product
derived by mechanically separating skeletal muscle tissue from neck
bones). Addressing the use of alternative values clearly sets out when
a noncompliance determination is to be based on an establishment's own
value. This provision would assure that FSIS acknowledges the product-
specific values that an establishment has elected to use in ensuring
its production process is in control.
FSIS wishes to emphasize that the proposed rule does not prescribe
how
[[Page 17964]]
establishment operators ensure that they are achieving process control.
If adopted, operators could utilize whatever techniques work best for
them. Among other things, they might wish to pursue use of pH
(potential of hydrogen, a measure of the acidity or alkalinity of a
solution), hematopoietic cell concentration, or other variables that
have been investigated as indices of bone marrow.11
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\11\ See, e.g., K. Pickering, et al., Investigation of Methods
to Detect Mechanically Recovered Meat in Meat Products--IV:
Immunology, Meat Science, 40:327-36 (1995); R.A. Field and P. Arasu,
A simple method for estimating amount of red marrow present in
mechanically deboned meat, J. Food Sci., 46:1622 (1981).
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The provisions of the proposed rule do not address cholesterol
content, which is found in widely varying amounts in livestock carcass
tissues. However, if manufacturers improve the effectiveness of
processing controls in preventing the recovery of bone marrow, along
with skeletal muscle tissue, FSIS would expect to see some reduction in
the cholesterol content of the resulting product, given the higher
cholesterol content of bone marrow as compared with muscle tissues and
the evidence in the 1996 survey that bone marrow has been incorporated
in product derived by mechanically separating muscle from beef neck
bones.
Under proposed clause (iii), either of two conditions would
constitute failure to comply: the presence of spinal cord in bones
entering the recovery system and its absence or presence at a lower
level in bones exiting the recovery system or the identification of
central nervous system tissue in the product. Because the Agency does
not view any level of spinal cord as consistent with defects
anticipated when muscle is trimmed from bones by hand, the criterion in
the first portion of this provision is presence at a lower level.
During the 1996 survey, the Agency began adapting existing
technology for identifying central nervous system tissue based on
histological examination of prepared samples to determine whether
characteristic features of central nervous system tissue were present
(see pages 4, 6, and 10 of the final report). Work on this methodology,
which FSIS has shared with industry members, has proceeded to the point
where the Agency is confident that the information that the method
yields is useful in evaluating the products of advanced mechanical
meat/bone separation machinery, but it has not yet been published in a
peer reviewed journal. (FSIS generally uses published methods to
determine whether there has been a violation of law.)
Adoption of the proposed rule also would clarify what now appears
to be a requirement to market product not in compliance with the
calcium content limit as MS(S) (last sentence of current
Sec. 318.24(b)(1)). Under proposed paragraph (c)(2) of Sec. 318.24, if
product that may not be labeled or used as meat meets the requirements
of Sec. 319.5(a) (the MS(S) definition and standard), it may bear the
name ``Mechanically Separated (Species)''.
In view of comments received in response to the 1996 notice, the
Agency wishes to note two additional points about the role of this
rulemaking, as opposed to other FSIS initiatives. First, undertaking
this rulemaking is consistent with the philosophy underlying the
modernization of FSIS's regulatory system and not, as some have
asserted, contrary to the Agency's efforts to focus on food safety
concerns. FSIS's decisions about how best to utilize Agency resources
in no way abrogate industry members' responsibility to comply with
statutory requirements and prohibitions, including those mandated to
protect the public against products that are misbranded or economically
adulterated. Moreover, the amendments in this proposed rule are
designed to further the Agency's objective of shifting from a command-
and-control approach that prescribes how industry members conduct their
operations to a standard-setting approach under which industry members
are responsible for achieving compliance and FSIS focuses on verifying
the effectiveness of an establishment's processes and process controls.
Second, the amendments that FSIS is proposing to increase the
assurance that products marketed as meat do not include spinal cord are
not intended as a response to concerns that some have expressed about
spongiform encephalopathies. Available data indicate that the United
States is bovine spongiform encephalopathy (BSE) free. The Agency will
continue its extensive monitoring and participation in USDA and
interagency efforts to investigate the public health questions raised
by evidence of the transmissibility of BSE. If, as a result, FSIS
determines that further regulatory action is needed to protect the
public health, it will address the incorporation of central nervous
system tissue and other carcass components of potential concern, if
any, in the range of animal food products in which they may be found.
Future Agency Action
As noted above, the Agency is reevaluating how it regulates other
types of operations that are used to manufacture meat and poultry
trimmings from various starting materials and expects that, in future
rulemakings, it will apply a process control-performance standards
approach to those operations as well. The areas that FSIS expects to
address include the development of criteria for the use of meat or
poultry ingredients in formulating livestock products and poultry
products (as beef, chicken meat, turkey, etc.) and criteria for
distinguishing between these ingredients and ``byproducts'' (including,
e.g., technology dependent requirements and nutrition-related
standards).
This effort is part of a comprehensive review of current regulatory
requirements and their implementation by FSIS personnel. To achieve the
objectives of a modernized regulatory system, FSIS plans to move from a
command-and-control approach toward an approach that establishes the
standards that industry must meet and provides appropriate flexibility
in how they are to be achieved or satisfied.
FSIS also plans to consolidate the FMIA regulations (9 CFR chapter
III, subchapter A) and the PPIA regulations (9 CFR chapter III,
subchapter C). The Agency believes that this will provide a vehicle for
reconsidering the current differences between these sets of
regulations. Unless there is a basis, in the statutes or the regulated
practices or products, for different requirements, FSIS intends to
implement regulatory requirements that do not distinguish between
livestock and poultry product establishments or their products.
Executive Order 12866 and Effect on Small Entities
FSIS has determined that this proposed rule is not a significant
regulatory action under the criteria set forth in E.O. 12866 because it
will not have an annual effect on the economy of $100 million or more
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or tribal governments or
communities; create a serious inconsistency or otherwise interfere with
an action taken or planned by another agency; materially alter the
budgetary impact of entitlements, grants, user fees, or loan programs
or other rights and obligations of recipients thereof; or raise novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in E.O. 12866. The proposed
rule would clarify the regulations and supplement the rules for
assuring compliance. Adoption of the
[[Page 17965]]
proposed amendments to the definition of meat in Sec. 301.2(rr) would
not change the scope of the products that are covered by the definition
(in terms of their characteristics or composition). However, FSIS
believes that replacing the emerging bones criterion with noncompliance
criteria for bone-related components will increase the assurance that,
as stated in the 1994 final rule, product marketed as meat ``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 * * *'' (59 FR 62554).
To prevent noncompliance based on bone marrow content, operations
utilizing starting materials that include marrow must control the
production process, primarily by controlling the pressure applied by
advanced recovery systems. Based on the 1996 survey results, the Agency
anticipates that some operations would achieve compliance by reducing
current pressure levels, which would result in a small reduction in
yield. However, as noted above, the Agency's position that marrow is
part of bone and that bone, including bone marrow, is a feature of
MS(S), not meat, is a longstanding one.
Controlling the pressure applied also would minimize the effect, if
any, of the proposed change in the noncompliance criterion for bone
solids. The proposal to reduce the level of calcium (used as a measure
of bone solids) reflects the Agency's belief that the existing calcium
content limit does not ensure that manufacturers limit bone solids to
an unavoidable defect level, as evidenced by the levels currently
achieved. If FSIS adopts a rule that lowers the amount of calcium that
constitutes noncompliance, its decision will be reflective of
information on what operators using good manufacturing practices and
controlling their production processes already can and do achieve.
Adoption of a requirement to implement and document procedures that
ensure the production process is in control is likely to result in some
increase in operators' current expenditures.12 However, the
Agency has long required, in Sec. 318.4(b), that to carry out
effectively the responsibility to comply with the FMIA and the
regulations thereunder, an establishment's operator must institute
appropriate measures to assure the preparation and labeling of products
strictly in accordance with regulatory requirements. FSIS now believes
that a process control approach is necessary to achieve compliance.
Moreover, the proposed rule would replace a prescriptive compliance
program for verifying calcium content (including lot-by-lot sample
analyses) with a performance standard (preventing the incorporation of
hard bone and bone-related components).
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\12\ A copy of the Agency's 1994 economic impact analysis, which
assumed the annual cost of calcium content monitoring to be $5,000
per meat/bone separation machine, is available from the FSIS Docket
Clerk.
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In addition to the limited nature of the amendments and the
marginal increase in anticipated costs, the Agency expects that it will
continue to be large firms that are interested in utilizing advanced
meat/bone separation machinery. Therefore, FSIS also certifies that if
adopted, this proposed rule will not have a significant economic impact
on a substantial number of small entities. Accordingly, as provided in
section 605 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
sections 603 and 604 do not apply.
Executive Order 12898
FSIS has considered potential impacts of this proposed rule on
environmental and health conditions in minority and low-income
communities pursuant to E.O. 12898 (Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations). Adoption of the proposed rule would not require federally
inspected establishments to relocate or alter their operations in ways
that could adversely affect the public health or environment in these
communities. Nor would it exclude any persons or populations from
participation in FSIS programs, deny any persons or populations the
benefits of FSIS programs, or subject any persons or populations to
discrimination because of their race, color, or national origin.
Executive Order 12988
FSIS has reviewed this proposal as provided in E.O. 12988 (Civil
Justice Reform). Section 408 of the FMIA (21 U.S.C. 678) preempts
various actions by States, territories, and the District of Columbia.
They cannot impose requirements with respect to the premises,
facilities, or operations of federally inspected establishments that
are in addition to or different than those made under the FMIA, except
that they may impose recordkeeping and other access and examination
requirements if consistent with section 202 of the FMIA (21 U.S.C.
642). They also cannot impose marking, labeling, packaging, or
ingredient requirements in addition to, or different than, those made
under the FMIA with respect to articles prepared at such
establishments. They may, however, consistent with the FMIA's
requirements, exercise concurrent jurisdiction over articles that the
FMIA requires to be inspected, for the purpose of preventing the
distribution of adulterated or misbranded food which is outside of
federally inspected establishments or, in the case of imported
articles, which are not at federally inspected establishments or after
their entry into the United States.
The proposal specifies how, if adopted, the amendments would change
current regulations. In other respects, regulatory requirements and
procedures (including the rules for directing that the use of labeling
be withheld under section 7(e) of the FMIA (21 U.S.C. 607(e)) are
unchanged. If adopted, the amendments would not apply retroactively.
Paperwork Reduction Act
FSIS has reviewed the collections of information affected by this
proposed rule under the Paperwork Reduction Act (44 U.S.C. chapter 35).
The proposed revision of paragraph (b) of Sec. 318.24 would replace the
calcium content sampling and records requirements, previously approved
by the Office of Management and Budget (OMB) under control number 0583-
0095, with a requirement to implement and document procedures that
ensure the production process is in control. If FSIS adopts this
portion of the proposed rule, it will request that OMB replace the
15,600 burden hours for Sec. 318.24(b) calcium content sampling and
recordkeeping with 13,815 burden hours for documenting process control.
List of Subjects
9 CFR Part 301
Meat and meat products.
9 CFR Part 318
Meat and meat products, Meat inspection, Records.
9 CFR Part 320
Meat inspection, Records.
For the reasons set forth above, the Food Safety and Inspection
Service is proposing to amend 9 CFR chapter III as follows:
PART 301--TERMINOLOGY
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
2.7, 2.18, and 2.53.
In Sec. 301.2, paragraph (rr) is revised to read as follows:
[[Page 17966]]
Sec. 301.2 Definitions.
* * * * *
(rr) Meat. The part of the muscle of any cattle, sheep, swine, or
goats that is skeletal or that is found in the tongue, diaphragm,
heart, or esophagus, with or without the accompanying and overlying
fat, and the portions of bone (in bone-in product such as T-bone or
porterhouse steak), skin, sinew, nerve, and blood vessels that normally
accompany the muscle tissue and that are not separated from it in the
process of dressing. As applied to products of equines, this term has a
comparable meaning.
(1) Meat does not include the muscle found in the lips, snout, or
ears.
(2) Bone includes hard bone and related components such as bone
marrow and spinal cord.
* * * * *
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
3.-4. The authority citation for part 318 is revised to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.7, 2.18, and 2.53.
5. Section 318.24 is revised to read as follows:
Sec. 318.24 Product prepared using advanced meat/bone separation
machinery; process control.
(a) General. Meat, as defined in Sec. 301.2 of this chapter, may be
derived by mechanically separating skeletal muscle tissue from the
bones of livestock using advances in mechanical meat/bone separation
machinery and systems that, in accordance with this section, recover
meat without crushing, grinding, pulverizing, or otherwise
incorporating hard bone or bone-related components.
(b) Process control. As a prerequisite to labeling or using product
derived by mechanically separating skeletal muscle tissue from
livestock bones as meat, the operator of an establishment must
implement and document procedures that ensure the establishment's
production process is in control.
(1) The production process is not in control if any provision of
paragraph (c)(1) of this section applies to the resulting product.
(2) The documentation must include a description of the procedures
that the establishment has implemented and information that
substantiates the effectiveness of these procedures to prevent the
incorporation of hard bone and bone-related components, including bone
marrow and spinal cord, into the resulting product (e.g., information
on the characteristics of resulting product when equipment is operated
pursuant to manufacturer specifications; records of establishment
monitoring and verification activities).
(3) The establishment must make available to inspection program
personnel the documentation described in paragraph (b)(2) of this
section and any other data generated using these procedures.
(c) Noncomplying product. (1) Notwithstanding any other provision
of this section, product that is recovered using mechanical meat/bone
separation machinery is not meat under any one or more of the following
circumstances.
(i) Bone solids. The product's calcium content is more than 130.0
mg per 100 grams.
(ii) Bone marrow. (A) The product includes more than a negligible
amount of bone marrow, as determined by the presence of bone marrow in
bones entering the recovery system and its absence or presence in a
measurably lower amount (e.g., by weight) in bones exiting the recovery
system.
(B) The difference between the product's iron content and the
product's protein content multiplied by 0.067 for a beef product or by
0.034 for a pork product is more than 1.80 mg per 100 grams (i.e.,
[iron content--(protein content x 0.067)] >1.80 mg per 100 grams of
beef product or [iron content--(protein content x 0.034)] >1.80 mg per
100 grams of pork product) (as a measure of excess iron from bone
marrow): Provided, That when the operator of an establishment has
verified and documented the ratio of iron content to protein content in
the skeletal muscle tissue attached to bones prior to their entering
the recovery system, based on analyses of hand-trimmed samples, that
value is to be substituted for the multiplier 0.067 or 0.034 (as
applicable) with respect to product that the establishment mechanically
separates from those bones.
(iii) Spinal cord. The product includes spinal cord, as determined
by the presence of spinal cord in bones entering the recovery system
and its absence or presence at a lower level in bones exiting the
recovery system or by the identification of central nervous system
tissue in the product.
(2) If product that may not be labeled or used as meat in
accordance with this section meets the requirements of Sec. 319.5(a) of
this chapter, it may bear the name ``Mechanically Separated
(Species)''.
PART 320--RECORDS, REGISTRATION, AND REPORTS
6. The authority citation for part 320 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, and 2.53.
Sec. 320.1 [Amended]
7. Paragraph (b)(10) of Sec. 320.1 is amended by removing ``of
calcium content in meat derived from'' and adding, in its place,
``documenting control of the production process using''.
Done at Washington, DC, on April 3, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-9681 Filed 4-10-98; 8:45 am]
BILLING CODE 3410-DM-P
