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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 589
          - [Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273)
          - RIN 0910-AF46

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule; confirmation of effective date.

# SUMMARY:

                        The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the final rule that published in the                         **Federal Register**                         of April 25, 2008 (73 FR 22720), entitled “Substances Prohibited From Use in Animal Food or Feed.” The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for renderers to comply with the new requirements. This additional time will also give other affected persons, including cattle producers and packers, more time to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.                     

# DATES:

*Effective Date*: The effective date of the final rule published in the                         **Federal Register**                         of April 25, 2008 (73 FR 22720), is April 27, 2009.                    

*Compliance Date*: The compliance date is October 26, 2009.                    

# FOR FURTHER INFORMATION CONTACT:

                        Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6860, e-mail:                         *burt.pritchett@fda.hhs.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

                    In the                     **Federal Register**                     of April 25, 2008, FDA published a final rule entitled “Substances Prohibited From Use in Animal Food or Feed” (referred to herein as the April 25, 2008, final rule), that would become effective 1 year after the April 27, 2009, date of publication. These measures were established to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). FDA recently became aware that some affected persons are experiencing difficulties modifying their operations to comply with the new requirements contained in the April 25, 2008, final                           ( print page 18627)                        rule and, therefore, may not be in full compliance by the April 27, 2009, effective date. Accordingly, in the                     **Federal Register**                     of April 9, 2009 (74 FR 16160) (referred to herein as the April 9, 2009, proposal), FDA published a proposal that would delay the effective date of the April 25, 2008, final rule for 60 days and provided a period for public comment on this proposal of 7 days.                

## II. Comments

The agency received comments from over 400 organizations and individuals on the April 9, 2009, proposal. Many comments were received from state and national cattle producer organizations, as well as from individual cattle producers. A large number of individual consumers also submitted comments. Comments were also received from renderers, meat processors, dairy organizations, and State agriculture agencies.

Those opposed to a delay of the effective date primarily cited a heightened risk of BSE to U.S. consumers and the U.S. cattle herd from imports of live Canadian cattle, particularly those cattle over 30 months of age. Most of these comments also noted that the current U.S. feed ban implemented in 1997 is comparable to the initial Canadian feed ban, also implemented in 1997, which, according to these comments, has proven to be ineffective at preventing the spread of BSE in Canada. This position was echoed in the many comments received from persons concerned with Creutzfeldt-Jakob Disease.

Those in favor of a delay of the effective date cited the need for more time to identify alternative methods of disposal of cattle material prohibited in animal feed (CMPAF) from slaughter and dead stock cattle in areas of the country where rendering services are curtailed or no longer available because of the rule. Some renderers and dead stock haulers commented that they were choosing to discontinue picking up dead cattle due to difficulties complying with the new rule. Many of the comments suggested that the proposed 60-day delay was not adequate with some comments suggesting delays of 6 months to 1 year. Also, a number of comments asked that the effective date be delayed indefinitely until the carcass disposal problem was more fully resolved. Several comments urged FDA to work with other Government agencies to develop a disposal plan for CMPAF and dead stock cattle before implementing the rule.

## III. Discussion

FDA continues to believe that the new measures contained in the April 25, 2008, final rule are necessary to further strengthen existing safeguards against BSE. The underlying bases for these new measures were fully considered through the notice and comment rulemaking process. (See the October 6, 2005, proposed rule (70 FR 58570) and the April 25, 2008, final rule).

The April 9, 2009, proposal to delay the effective date was issued solely for the purpose of considering whether a delay should be provided to allow time to address concerns that some entities were not adequately prepared to comply with the April 25, 2008, final rule and that adequate alternative carcass disposal methods had not been developed. Therefore, any delay in the implementation of this rule is intended to help address these concerns and is not intended to signal that the agency is reconsidering the final rule. Based on the significant number of comments that oppose delaying the effective date of the April 25, 2008, final rule due to public and animal health concerns, FDA is confirming the original April 27, 2009, effective date of the final rule. However, although the final rule is effective on April 27, 2009, FDA has decided to establish a compliance date of October 26, 2009, for those who need it, to help address the compliance and implementation concerns.

In its rulemaking, FDA acknowledged that alternative disposal methods for CMPAF and dead stock cattle would be needed for a substantial volume of material that would be diverted from animal feed use by the new requirements. Accordingly, the rule provided a 12-month delayed effective date to allow sufficient time to arrange for alternative disposal. Where services to remove brain and spinal cord will not be available, such arrangements might include composting dead stock cattle, or disposing of dead stock cattle in landfills. To some extent, we believe the rendering, livestock, meat, and animal feed industries have addressed many of the compliance and carcass disposal challenges and are prepared to meet the April 27, 2009, effective date of the final rule.

                    By affirming the April 27, 2009, effective date, renderers can begin putting the new BSE safeguards into place by removing the prohibited cattle materials from the animal feed chain. However, it is apparent from the comments that a significant number of other stakeholders will not be ready to deal effectively with the new regulation when it goes into effect on April 27, 2009. In particular, smaller entities such as dead stock haulers, small meat processors, and some livestock producers have only recently become aware that their current disposal arrangements will no longer be available, or will be available at increased cost, as a result of the April 25, 2008, final rule. In addition, comments from certain State agencies have indicated that adequate alternative measures have not yet been developed for disposing of animal carcasses, particularly in areas where rendering is limited or may no longer be available. Generally, the disposal of animal carcasses is regulated at the State and local level. For example, State law may dictate whether dead animals can be buried or composted, or whether an incinerator needs to be approved before one is built. Furthermore, some landfill operators have indicated that they do not intend to accept dead animals or CMPAF because they consider it to be hazardous material. FDA has consulted with the Environmental Protection Agency (EPA) on this issue and EPA has recently published a statement on its Web site stating that, under the Resource Conservation and Recovery Act (RCRA), EPA considers CMPAF to be solid waste, not hazardous waste (                    *http://www.epa.gov/​epawaste/​nonhaz/​municipal/​landfill/​cattle.htm*). (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the                     **Federal Register**                    .)                

Based on a consideration of all comments received in response to the April 9, 2009, proposal, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and delay compliance until October 26, 2009. Confirming the April 27, 2009, effective date conveys the agency's clear intent to move forward with the implementation of the new measures. As stated previously, some affected parties are prepared to begin implementation. Providing for a 6-month delay for compliance acknowledges the significant number of affected stakeholders who will require more time to comply with the new regulation or adjust to the loss of rendering service. For renderers, who are directly impacted by this regulation, this means modifying their operations to effectively separate and dispose of CMPAF. For cattle producers, who are also impacted by this regulation, this may mean finding alternative means of disposing of dead stock cattle if rendering services are no longer available to them.
      ( print page 18628)    
FDA acknowledges that carcass disposal problems exist in certain states or regions and that developing and implementing adequate solutions to these problems is challenging. Furthermore, FDA recognizes that in certain circumstances it may be particularly challenging to address such disposal problems by the October 26, 2009, compliance date. FDA intends to finalize the Draft Small Entities Compliance Guide for Renderers that was issued on November 26, 2008. In addition, FDA intends to engage in further outreach to the rendering industry, pertinent State agencies, and others affected by the rule. FDA is committed to working with all affected parties to the extent possible to assist efforts in mitigating the impacts associated with implementation of the rule.

## IV. Conclusion

                    At this time, the agency is confirming the April 27, 2009, effective date of the final rule published in the                     **Federal Register**                     of April 25, 2008, entitled “Substances Prohibited From Use in Animal Food or Feed.” The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for affected persons to comply with the new requirements.                

Dated: April 21, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

[FR Doc. E9-9466 Filed 4-22-09; 11:15 am]

BILLING CODE 4160-01-S