[Federal Register: April 13, 1998 (Volume 63, Number 70)]

[Proposed Rules]               

[Page 17959-17966]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13ap98-13]



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Proposed Rules

                                                Federal Register

________________________________________________________________________



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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[[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),<SUP>1</SUP> 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,<SUP>2</SUP> 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.).<SUP>3</SUP> 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.<SUP>4</SUP>

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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, 

<SUP>5</SUP> 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). <SUP>6</SUP>

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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.<SUP>8</SUP> 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,<SUP>9</SUP> 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.

---------------------------------------------------------------------------



    \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).

---------------------------------------------------------------------------



    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).<SUP>10</SUP>

---------------------------------------------------------------------------



    \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.

---------------------------------------------------------------------------



    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.<SUP>11</SUP>

---------------------------------------------------------------------------



    \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).

---------------------------------------------------------------------------



    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.<SUP>12</SUP> 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.

---------------------------------------------------------------------------



    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