[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

[[Page 70201]]

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]
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