[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
[[Page 70200]]
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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 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
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 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