[Federal Register Volume 64, Number 241 (Thursday, December 16, 1999)]
[Proposed Rules]
[Pages 70200-70201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32440]
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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. 64, No. 241 / Thursday, December 16, 1999 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 318, and 320
[Docket No. 98-027R]
Meat Produced by Advanced Meat/Bone Separation Machinery and
Recovery Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Reopening of comment period.
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SUMMARY: The Food Safety and Inspection Service (FSIS) issued a
proposed rule on April 13, 1998 (63 FR 17959) to clarify the
regulations and to supplement the rules for ensuring compliance with
the regulatory requirements for deriving meat using advances in
mechanical meat/bone separation machinery and recovery (AMR) systems.
The comment period closed on June 12, 1998. After consideration of the
comments and additional information received by FSIS, the Agency is
reopening the comment period for an additional 30 days to give the
public an opportunity to review and comment on the methods and results
used by the Agricultural Research Service to derive new iron values.
The public also is encouraged to review and comment on materials
submitted by a meat industry group regarding economic effects and
worker safety issues relevant to the proposed rule.
DATES: Comments must be received on or before January 18, 2000.
ADDRESSES: Information used by FSIS in developing the proposed excess
iron requirement and other information concerning economic consequences
of the 1998 proposal will be available in the FSIS Docket Room and on
the FSIS web site at http://www.fsis.usda.gov. Submit one original and
two copies of written comments on the new materials to the FSIS Docket
Clerk, Docket 97-027P, Room 102, Cotton Annex, 300 12th Street, SW,
Washington, DC 20250-3700. All comments submitted in response to this
notice will be available for public inspection in the Docket Room
between 8:30 a.m. and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,
Regulations Development and Analysis Division, Office of Policy,
Program Development, and Evaluation, FSIS at (202) 720-5627 or FAX
(202) 690-0486.
SUPPLEMENTARY INFORMATION:
Background
In 1994, FSIS published a final rule (59 FR 62552; December 6,
1994) to amend the Federal meat inspection regulations by amending the
definition of meat to include product resulting from advanced meat/bone
separation machinery and recovery systems, or AMR. Advances made in
recovery technology precipitated the 1994 rulemaking. The final rule
reflected the Agency's position that calcium content limits and the
physical composition of the bones were sufficient to ensure that the
plant's production process was in control, and that the characteristics
and composition of the resulting product were consistent with those of
meat.
In 1996, in response to concerns raised by consumer groups and
members of industry, FSIS issued a notice to solicit data and
information regarding compliance requirements in the final rule. In
1996, the Agency also conducted a survey of the AMR beef product
produced from neckbones from establishments covered by the final rule.
The data and statistical analysis of the data were presented to the
public in a report entitled ``Advanced Meat Recovery System Survey
Project,'' dated February 21, 1997. As a result of a histological
examination of the 1996 neckbone survey samples for hematopoietic cells
(blood cell precursors), the Agency tentatively concluded that a large
proportion of neckbone samples included more than a negligible amount
of bone marrow. Further, the AMR product, with respect to other food
chemistry properties, was not comparable to corresponding hand-deboned
product, even though a high percentage of the AMR product satisfied the
requirement regarding calcium. FSIS concluded that demonstrating
compliance with the required limit on calcium content was not
sufficient to ensure that the resulting product is comparable to meat
derived by hand deboning.
In 1998, FSIS issued a 1998 proposed rule the objectives of which
were: (1) ``To ensure that the characteristics and composition of the
resulting product are consistent with those of meat,'' and (2) ``To
ensure that the regulations provide clear standards * * * 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).''
Accordingly, FSIS proposed that no more than a negligible amount of
bone marrow could be in a product labeled as meat. FSIS also proposed
to change the calcium requirement from 150 mg/100 g for a lot to 130
mg/100 g, and to add a requirement for ``excess'' iron, to ensure that
no more than a negligible amount of bone marrow would be present. In
addition, FSIS advised that it considered the previous criteria to be
not adequate because they called for subjective judgment and focused on
the physical condition of the bones at an intermediate step, rather
than on the product being recovered. The Agency also proposed
noncompliance criteria for spinal cord and central nervous system
tissue.
The 1998 proposed ``excess'' iron standard was developed using data
from the 1996 survey and was based on the observed relation between
iron levels, adjusted by protein content, and a semi-qualitative
measure of the levels of bone marrow cells in the AMR product. However,
FSIS received comments on this proposed criterion that criticized the
FSIS methodology and the measurement procedures that were used in
developing the standard. The measurement procedures used during the
1996 FSIS survey employed a wet ash digestion procedure. In contrast,
Agricultural Research Service (ARS) scientists, using a method that
employs dry ash procedures for digestion, obtained iron results that
were approximately double those obtained by the FSIS methodology.
Further, the results obtained by the dry ash method were more
consistent with levels reported in the former Agriculture Handbook 8
(now called USDA Nutrient Database for Standard Reference, Release 12).
FSIS received the ARS data, including the new values for iron,
after the
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comment period closed. Therefore, FSIS is making the ARS method and
results available for public review, evaluation, and comment. A
comparison of the results of the dry ash and wet ash procedures is
provided in a technical paper available in the FSIS Docket Room and on
the FSIS homepage.
Information on Economic Effects and Worker Safety Submitted by the
Meat Industry
FSIS also invites comment on materials provided by an ad hoc
committee representing the meat industry on the evolution and
application of the meat/bone separation and recovery technology,
potential worker safety effects, and the economic effects of provisions
in the proposed rule.
The industry's information on worker safety estimates that if the
proposed rule were adopted, meat plant employees would choose to revert
to using vibrating hand-held knives, and that about 20 percent of meat
establishment employees would be likely to experience cumulative trauma
disorders.
According to the industry's economic analysis of the likely effects
of the 1998 proposal, the estimated cost impact to the meat industry
would be approximately $210 million for plant retro-fitting and
reconfiguration, capital cost loss, new labor costs, and yield loss.
The cost estimates were based on the assumption that the meat industry
would no longer use the advanced meat/bone separation and recovery
systems. The industry's report on AMR and the product that is produced
emphasizes the efficiency of the technology and its benefits in
improving worker safety and suggests that the concerns raised about the
1994 rule, and addressed in our 1998 proposed amendment to that rule,
give rise to essentially economic issues, not food safety concerns.
FSIS welcomes comment on the industry-supplied materials.
Additional Public Notification
FSIS has considered the potential civil rights impact of the AMR
rules and proposed amendments on minorities, women, and persons with
disabilities. Public involvement in all segments of rulemaking and
policy development is important. Consequently, in an effort to better
ensure that minorities, women, and persons with disabilities are aware
of this rulemaking, and request for further comment, and are informed
about the mechanism for providing comments, FSIS will announce it and
provide copies of this Federal Register publication in the FSIS
Constituent Update.
FSIS provides a weekly Constituent Update, which is communicated
via fax to more than 300 organizations and individuals. In addition,
the update is available on-line through the FSIS web page located at
http://www.fsis.usda.gov. The update is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, recalls, and any other types of
information that could affect or would be of interest to our
constituents/stakeholders. The constituent fax list consists of
industry, trade, and farm groups, consumer interest groups, allied
health professionals, scientific professionals, and other individuals
who have requested to be included. Through these various channels, FSIS
is able to provide information to a much broader, more diverse
audience. For more information and to be added to the constituent FAX
list, FAX your request to the Congressional and Public Affairs Office,
at (202) 720-5704.
Done in Washington, DC, on: December 8, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-32440 Filed 12-15-99; 8:45 am]
BILLING CODE 3410-DM-P
