FDA Announces Confirmation of the Effective Date of the BSE Final Rule

The United States Food and Drug Administration today announced that the final rule entitled ‘‘Substances Prohibited From Use in Animal Food or Feed,’’ will become effective on April 27, 2009.  However, to allow renderers additional time to comply with the new requirements, the Agency has established a compliance date of October 26, 2009.  The additional 6 months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.  FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible.

In the April 9, 2009, Federal Register FDA proposed to delay the effective date of the final rule for 60 days and provided a period of 7 days for public comment.  The agency received over 400 comments from state and national cattle producer organizations, individual cattle producers, renderers, meat processors, dairy organizations, State agriculture agencies, and consumers.

Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.

In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.

FDA will conduct outreach to affected stakeholders to help them comply with the rule.   The Agency will hold a 50-state call to discuss the disposal issues in various states or regions and will engage others affected by the rule to assist as much as possible with meeting challenging carcass disposal issues by the October 26, 2009 compliance date.  FDA also plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry.

Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, burt.pritchett@fda.hhs.gov.

For additional information, please see http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf and http://www.fda.gov/cvm/bsetoc.html.