[Federal Register: December 16, 1999 (Volume 64, Number 241)]

[Proposed Rules]               

[Page 70200-70201]

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



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.


[[Page 70200]]




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.


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.



    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 


    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 


    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 


    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,


[FR Doc. 99-32440 Filed 12-15-99; 8:45 am]