[Federal Register Volume 61, Number 218 (Friday, November 8, 1996)]
[Proposed Rules]
[Pages 57791-57794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28768]


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DEPARTMENT OF AGRICULTURE
9 CFR Part 318

[Docket No. 96-027N]


Advanced Meat/Bone Separation Machinery and Meat Recovery Systems

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice; request for public comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is soliciting 
data and information, from the public and industry, concerning the 
compliance requirements of its regulation entitled ``Meat Produced by 
Advanced Meat/Bone Separation Machinery and Meat Recovery Systems.'' 
FSIS also requests information and data on other approaches that might 
be utilized to assure that product derived from advanced meat/bone 
recovery systems is ``meat.'' This action responds to concerns raised 
by consumer groups and industry members.

DATES: Comments must be received on or before January 7, 1997.

ADDRESSES: Send an original and two copies of written comments to: FSIS 
Docket Clerk, DOCKET #96-027N, Room 3806, 1400 Independence Avenue, 
SW., Washington, DC 20250-3700. Reference material cited in this notice 
and any comments received will be available for public inspection in 
the FSIS Docket Room from 8:30 a.m. to 1:00 p.m. and from 2:00 p.m. to 
4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product 
Assessment Division, Regulatory Programs, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250-3700, 
(202) 254-2565.

SUPPLEMENTARY INFORMATION:

Background

    On December 6, 1994, FSIS published a final rule titled ``Meat 
Produced by Advanced Meat/Bone Separation and Meat Recovery Systems'' 
that was effective on January 5, 1995. The final rule amended the 
definition of ``meat'' (9 CFR 301.2(rr)) to include as ``meat'' product 
resulting from advanced meat/bone recovery (AMR) systems that do not 
crush, grind, or pulverize bones to remove adhering edible skeletal 
tissue. The final rule provides the criteria under which these systems 
must operate for finished product from the systems to be called 
``meat.''
    The first criterion is a calcium content limit. This criterion was 
established to ensure that the meat derived from AMR systems is both 
consistent with consumer expectations of ``meat'' and comparable to 
meat that is used to formulate further processed meat food products. 
This criterion was included to ensure that bones are not crushed, 
ground, or pulverized during processing, i.e., that the processes are 
operating in control. The regulation requires that product resulting 
from the separating process not exceed a calcium content of 0.15 
percent or 150 mg/100 gm of product with a tolerance of 0.03 percent or 
30 mg.
    The second criterion relates to the mechanism of the machinery 
involved and the appearance of the bones emerging from the AMR systems. 
AMR systems must not crush, grind, or pulverize bones, and the bones 
must emerge from the machinery comparable to those resulting from hand-
deboning (i.e., essentially intact and in natural physical conformation 
so that they are recognizable as, for example, loin bones or rib bones 
when they emerge from the machinery).
    If statistical evidence indicates that a production lot is not in 
compliance with the limit established for calcium content, the lot of 
product must be labeled ``Mechanically Separated (Species) (i.e., Beef 
or Pork)'' (MS(S)) (9 CFR 319.5) and meet all the requirements for 
MS(S).
    MS(S) is a meat food product that is derived by crushing and 
pulverizing bones from livestock with attached edible tissue under high 
pressure and screening out the bone particles which results in a paste-
like material with a limited bone solids content. The machinery used to 
manufacture MS(S) causes bone and bone particles, including bone 
constituents such as bone marrow and certain minerals, to be 
incorporated into the finished product. A fundamental difference 
between the processed utilized for AMR systems and those utilized for 
making MS(S) is that the bones with attached meat that are the starting 
materials for deriving ``meat'' from AMR systems are essentially intact 
and recognizable when they exit the system crushed and pulverized 
during the process of making MS(S).
    After the effective date of the final rule, consumer groups in 
meetings and correspondence alleged that the following occurs in the 
operation of certain AMR systems: (1) Bones are crushed, ground, or 
pulverized which violates the regulations, (2) bones are pre-sized to 
expose marrow which is being ``harvested'' as ``meat,'' (3) bones 
emerge from certain systems in a compressed ``cake,'' and, thus, are 
not essentially intact and recognizable, and (4) bone particles are 
screened out as a separate step after meat is separated from bone and 
before analysis to determine compliance with the calcium limit.
    Responding to the consumer groups' contentions, FSIS surveyed a 
number of federally inspected meat establishments using AMR systems 
during October and November of 1995. Survey questions were distributed 
to inspection personnel at the establishments using the AMR systems. 
The following questions were asked:
    (1) What type of machine is being used; how does it work?
    (2) What are the starting materials; what bones with attached meat 
are used and are the bones split prior to processing, i.e., pre-sized, 
and to what size?
    (3)(a) What is the calcium content of the ``meat'' that is derived 
from the first step of removing lean tissue from the bone, i.e., the 
material that is pressed off the bone prior to desinewing?
    (3)(b) What is the calcium content of the ``meat'' that is derived 
at each of any subsequent deboning or desinewing steps?
    (4) Are the bones recognizable after the lean tissue (``meat'') is 
recovered after the first step or any subsequent steps?
    (5) What other comments can you offer on the AMR systems?
    Inspection personnel reported results from 52 establishments using 
meat/bone separators and recovery systems. Of the 52, four represented 
establishments that

[[Page 57792]]

used AMR systems to remove the bone from bone-in hams or pork shoulders 
which were never considered to be operations that were covered by the 
final rule. In the remaining 48 establishments, there were a variety of 
bones used as starting materials and some inspection personnel reported 
that pre-sizing occurred for some of these bones and that the bones 
were presized to between 4 and 14 inches. The type of bones and the 
degree to which bones were pre-sized was not reported to affect the 
calcium content of the meat produced or the assessment of bone 
appearance. The calcium content results reported from the 48 
establishments represented results of analysis of samples of finished 
product, i.e., ``meat'' that exited the AMR systems.
    Of the 48 establishments surveyed, inspection personnel in 13 
establishments reported results that were not in compliance with either 
the calcium or bone criteria in the final rule. Of these 13 
establishments, two establishments had product samples that were not in 
compliance with the final rule because their calcium content exceeded 
the limit established. Both of these establishments used an AMR system 
that had a one-step process. Calcium was found to be as high as 220 mg/
100 gm of product. Inspection personnel reported, however, that bones 
exiting these systems were recognizable. The remaining 11 
establishments had results that were not in compliance with the final 
rule because the bones exiting the system were not recognizable. In 
these 11 instances, calcium content did not exceed the established 
limit. One of the 11 establishments was using an AMR system that had a 
one-step process; the others used multi-step processing systems. In 
some of these 11 establishments, inspection personnel reported that 
bones emerged in a ``cake'' and, therefore, were not recognizable. Upon 
review of these findings and in subsequent discussions with inspection 
personnel, it was determined that, in many instances, the bones could 
be recognizable when the ``cake'' was disassembled. This point is 
addressed further in this document.
    Representatives of certain establishments that operate AMR systems 
also met with Agency staff in regard to the advanced meat/bone 
separation regulations. These representatives stated that (1) the 
regulations do not require that samples taken after ``intermediate'' 
separation stages conform to the calcium limit, and that there is 
compliance with the established calcium content limitation of the 
regulations if the finished product that will be called ``meat'' meets 
the regulation's calcium criterion, (2) FSIS was aware that multi-step 
systems were in use before the regulations were published and intended 
that their use be continued, (3) the regulations do not prohibit the 
bones from emerging from the machinery in a ``bone cake'' provided they 
are intact and recognizable when disassembled, and (4) continued use of 
AMR systems should be encouraged since they produce a safe product 
without the cumulative trauma disorders (e.g., carpal tunnel syndrome) 
experienced by establishment personnel whose work entails hand 
deboning.
    The Agency has reviewed the issues raised by the consumer groups 
and the industry. The regulations were designed to allow manufacturers 
the flexibility to develop and use any technology that would remove 
meat from bones of livestock without crushing, grinding, or pulverizing 
the bone, and that would result in product that satisfied the 
established calcium content limit. Thus, an AMR system, regardless of 
whether it involves a one-step or multi-step process, can be used to 
produce product identified as ``meat,'' as long as the operations of 
these systems, and the product exiting the systems, meet the 
regulation's criteria.
    The rule's flexibility is consistent with prior FSIS policies 
reflected in an ``Inspection Procedure'' and then in a Partial Quality 
Control (PQC) program (#812) requirement. As discussed below, the final 
rule involves two criterion that must be met, for the product that 
emerges from the AMR systems to be classified ``meat.''
    First, as discussed earlier, the regulation requires that product 
exiting AMR systems meet a calcium limit of 150 mg/100 gm of product 
within a tolerance of 0.03 percent (30 mg). The compliance procedure 
provided in the regulation focuses on the finished product derived from 
the systems, and requires sampling for calcium of ``meat,'' from 
production lots. In this regard, noncompliance occurs when calcium 
analyses of the samples of meat from finished lots exceed the 
established calcium limit. When calcium results exceed the limit, the 
product must be called MS(S), e.g., mechanically separated beef or 
pork, and comply with the regulations on MS(S).
    Second, the bones emerging from AMR systems must emerge comparable 
to those from hand deboning. Therefore, if pre-sizing of bones results 
in bones that are not recognizable, the product exiting the AMR systems 
could not be identified as ``meat.'' The rule clearly intends that 
establishments ensure that their systems are operating in control and 
in accordance with the regulations. Thus, establishments need to carry 
out procedures to ensure that bones exiting the AMR systems are 
comparable to those resulting from hand-deboning (i.e., essentially 
intact and in natural physical confirmation such that they are 
recognizable, such as loin bones and rib bones, when they emerge from 
the machinery. Establishments must also carry out the calcium content 
analysis procedures required, and, in turn, comply with the 
regulation's requirement in cases where compliance with the calcium 
content limit is not demonstrated. Although establishments are 
responsible for assuring that they comply with the regulations, FSIS 
inspectors will also verify establishment operations, which may include 
periodic examination of bones exiting AMR systems, to ensure that such 
systems operate in accordance with the regulations.
    FSIS believes that the provisions in the AMR regulations must be 
consistently enforced. FSIS enforcement serves to ensure establishment 
compliance with the two criteria that must be met in order for product 
exiting from AMR systems to come within the definition of ``meat.'' 
FSIS has issued instructions to field personnel so that they will have 
a consistent understanding of their role and receive uniform guidance 
in ensuring that establishments comply with the regulations.
    FSIS is reviewing all establishments which operate AMR systems at 
least once per week to ascertain if the establishments are operating in 
compliance with the regulations. Reviews are scheduled through the 
Agency's Performance Based Inspection System and are currently being 
conducted. FSIS Reviews examine available establishment records 
required to be maintained regarding the calcium content limit of 
product classified as ``meat'' and actions taken by the establishment 
if the calcium limit is exceeded. FSIS is also examining representative 
samples of bones before they enter and after they exit the AMR system 
to determine if the bones emerge from the AMR system essentially intact 
and in natural physical conformation.

Request for Data and Information

    FSIS welcomes views and information on approaches, other than those 
set forth in the current rule that might be utilized to ensure that 
product derived from AMR systems is ``meat.'' FSIS also invites 
comments and data pertaining to several issues raised by interested 
parties.

[[Page 57793]]

    The compliance requirement for calcium content limitation in the 
regulations applies only to the finished product (i.e., meat) exiting 
the AMR systems. The regulation does not require the calcium content 
limitation of the rule to be met regarding material from an interim 
phase of the continuous operation of the AMR systems (i.e., 
``intermediate'' material). To implement a requirement that calcium 
analysis be made on ``intermediate'' material obtained after the first 
separation step of an AMR system which comes before subsequent 
desinewing or separation steps (as requested by consumer groups), and 
that for product to be identified as ``meat'' such analysis must 
indicate that product from the intermediate step met the calcium 
content limitation, FSIS would need to amend the regulations. Any such 
modification must be based on substantive data which supports the need 
for such a requirement. FSIS invites data and comments pertaining to 
this issue.
    The Agency believes that establishments operating AMR systems 
recognize the need to have controls for their AMR systems which ensure 
that the condition of the bones exiting the systems conform to the 
regulations. However, there are no recordkeeping requirements imposed 
by the regulations. Records of the condition of bones before and after 
they exit the AMR system's machinery could facilitate FSIS' 
determination of whether bones exiting the systems are intact and 
recognizable. FSIS invites comments regarding the need to modify the 
compliance procedures to include recordkeeping requirements to show 
that bones that emerge from the systems are being monitored by the 
establishment.
    FSIS is also interested in receiving data to assess certain issues 
raised by interested parties. FSIS is interested in data and comments 
on the following questions: (1) What practices are being conducted in 
regard to presizing and do these have any effect on bone recognition? 
Should presizing criteria be established that would establish the 
minimum dimensions a bone must be to be allowed to be used in the AMR 
systems? (2) If the calcium content of the material being separated in 
AMR systems is higher at an interim stage of the process than that 
established for the finished product (i.e., 150 mg/100 gm of product, 
within a tolerance of 30 mg), does this mean bones have been crushed, 
ground, or pulverized and is there data to support such a conclusion? 
(3) If the ``meat'' derived from the AMR system conforms to the 
definition of meat, i.e., it does not exceed the calcium limit and the 
bones are essentially intact and recognizable, are there other helpful 
compliance measures that should be examined, and, if so, why? (4) 
Should the current criteria requiring that bones emerge essentially 
intact and in natural physical conformation be further qualified to 
indicate that only minor abrasions of bone edges or removal of minute 
amounts of bone would be permitted in order to meet this criteria? What 
standards should be established as indicators that these standards have 
been met? The answers to these questions require data that are 
representative of the various AMR systems used. These data are 
currently unavailable to the Agency. FSIS is seeking comments from all 
interested parties on the issues raised in this notice and specifically 
encourages the submission of views and data by equipment manufacturers.
    FSIS has also received letters from various consumer groups which 
assert that bones are being pre-sized, then crushed, ground, and 
pulverized in AMR systems to ``harvest'' marrow. The assertions focus 
on marrow allegedly ``harvested'' from beef neck bones due to the 
operation of two pieces of press-type meat/bone separation equipment. 
The document provided to FSIS to support these assertions was a 
University of Nebraska doctoral dissertation on ``mechanically 
recovered neck bone lean (MRNL).'' This dissertation, as well as peer-
reviewed journal articles based on the research reported in the 
dissertation, have been reviewed by FSIS. The research focused on 
examining the characteristics of MRNL derived from beef neck bones 
processed using two types of meat/bone separators. The objective of the 
research was to investigate the functional characteristics of the 
material derived from the neck bones in order to provide information 
about how the material can be used to formulate other products. The 
objective of the research was not, however, to test how AMR systems 
operate or to make determinations in regard to what the composition is 
of the finished product derived from AMR systems. Therefore, FSIS does 
not believe that the research can be used to support a conclusion that 
bones are being presized then crushed, ground, and pulverized in AMR 
systems to ``harvest'' marrow. FSIS did consider the issues of bone 
residue and marrow during development of the AMR regulations. In both 
the proposal and final rule, FSIS stated that the contribution of bone 
content to meat resulting from AMR systems is minimal. It would be no 
greater than that which may occur if bone surfaces are abraised, 
pressed, or scraped to expose bone content as part of hand-deboning 
operations. Further, FSIS concluded the potential contribution of bone 
marrow, a portion of a bone's content, to meat from AMR systems poses 
no health or safety hazards nor would it be at a level which would make 
its inclusion an adulteration or misbranding issue.
    The internal part of livestock bones is composed of the same 
constituents as ``meat,'' and consists of adipose (fat) tissue, 
connective tissue, and marrow. Bone marrow is a fraction of the 
internal bone content and also is part of the animal's vascular system. 
When an animal is slaughtered, most of the red (blood) marrow is lost. 
The remaining red marrow is mostly red blood cells. Red (blood) marrow 
is found in higher amounts in certain bones, e.g. the long bones of 
animals (i.e., the femur, shank, and patella, etc.). Long bones remain 
with primal and sub-primal cuts and eventually are cut into retail 
portions of ``meat'' or are used to make soups, stocks, and broth. 
Bones used in the AMR systems are typically the flat bones (e.g., 
vertebrae, sternum, ribs, and pelvis) with adhering tissue and contain 
relatively little marrow.
    There are no standardized methods to determine marrow content 
because it is composed of the same constituents as ``meat'' and, 
therefore, it is difficult to analytically distinguish it.
    There are some experimental approaches that attempt to quantify 
marrow based on a constituent of marrow, e.g., cholesterol, amino acid, 
fatty acid, nucleic acid, mineral, and vitamin content, or pH. However, 
there are many factors that relate to natural variations in marrow and 
meat composition that disqualify these methods from being relied upon 
as standardized methods. Therefore, the suggestion by various consumer 
groups that cholesterol and iron are unique markers for marrow is 
generally unsupported by the scientific literature. Similar to that 
expected in hand-deboning operations, it is conceivable that when a 
pre-sized bone is pressed, compressed, or scraped in an AMR system, it 
may express some bone content through cracks or openings at the ends of 
the bone that may be incorporated in product. This material would 
consist of the fluid portion of the bone content (e.g., red (blood) 
marrow and some fat). However, it is not necessarily marrow that is 
expressed into the meat from AMR systems, it could just as likely be 
blood and fat which are part of ``meat'' as defined in the regulations. 
This would account for

[[Page 57794]]

the minor color differences of neck bone meat from AMR systems and 
hand-deboned neck meat. However, because the connective tissue 
structure of the internal portion of bone maintains the integrity of 
most of the bone's semi-solid and solid content, and this remains 
intact in AMR systems, most of the bone's content is not expressed when 
AMR systems are utilized. In contrast to this, a more physically 
rigorous process, e.g., the mechanical separation process yielding 
MS(S) that crushes, grinds, and pulverizes bones would, of course, 
destroy the internal bone structure and evenly distribute all the 
contents of the bone in an amorphous tissue mass.
    Although FSIS does not currently know of any standardized methods 
to determine the presence of bone marrow in meat products, FSIS would 
like data that can help establish what constituents are unique to 
marrow that can be relied upon to indicate the presence of bone marrow 
in meat products. If such a standardized method could be established, 
FSIS would like comments on whether a compliance criterion regarding 
marrow should be established in regard to product derived from AMR 
systems. In this regard FSIS would like comments on the following 
questions. (1) Should an acceptable level of marrow be established for 
meat and product derived from AMR systems? If such a level was 
established, should the presizing operations of AMR systems be examined 
to determine if they contribute to the marrow content of product 
derived from AMR systems? (2) If the product derived from the AMR 
systems is determined to have an amount of marrow higher than that 
found in hand deboned meat, should such products be designated as MS(S) 
rather than meat? (3) Is it possible to establish criteria on the 
amount of marrow in product from AMR systems based on the degree to 
which bones emerging from the AMR systems are hollow?

FSIS Studies

    In addition to requesting comments and data from the public, FSIS 
itself will also collect information on how AMR systems are currently 
performing.
    The Agency is interested in collecting information regarding the 
recovery of tissue from bones by use of AMR systems, especially the 
recovery of tissue from split neck bones of beef. Compliance procedures 
for the AMR systems were designed to assure that bone, as measured by 
calcium content, was not intentionally incorporated into product. FSIS 
was aware that desinewing equipment was being used in conjunction with 
the AMR systems to remove hard particle tissues (e.g., bone fragments, 
ligaments, tendons, cartilage) inherent to boning operations. FSIS 
believed that AMR systems which were not being operated in compliance 
(i.e., which crushed, ground or pulverized bones) would be identified 
through the calcium check of the finished product. This conclusion was 
based on the view that desinewing equipment would not remove a 
significant amount of the powdered bone which would result from 
crushing, grinding, or pulverizing, and consequently the finished 
product would exceed the calcium limit. In an effort to assure that the 
desinewing equipment is not being used to remove excess powdered bone 
resulting from bone breakage, FSIS is taking steps to better identify 
what the desinewing equipment is removing. A sampling plan is being 
devised which will statistically establish the expected calcium content 
of a product derived from a properly operating AMR system, prior to and 
after desinewing.
    In another study, FSIS will be identifying the expected range of 
calcium, cholesterol and iron contents, the pH level, and the texture 
and appearance of various products which qualify as ``meat.'' The 
Agency intends to involve the Agricultural Research Service (ARS) in 
this activity. Representatives from ARS were involved in the initial 
steps leading up to the development of the regulation. This study will 
assist FSIS in learning more about the issues concerning marrow in AMR 
products that have been raised.

    Done at Washington, DC, on November 4, 1996.
Thomas J. Billy,
Administrator.
[FR Doc. 96-28768 Filed 11-5-96; 8:45 am]
BILLING CODE 3410-DM-P