FDA to Publish BSE Feed Rule Amendments on April 25; Rule to be Final in 12 Months

Richard Sellers

Two and a half years after FDA published a proposed rule suggesting amendments to the 1997 BSE feed rule (21 C.F.R. § 589.2000), the agency will publish a final rule on April 25th with only one major change from the proposed rule. You can view the current 1997 rule by clicking here http://a257.g.akamaitech.net/7/257/2422/10apr20061500/edocket.access.gpo.gov/cfr_2006/aprqtr/21cfr589.2000.htm . The proposed rule will place a serious, economic burden on the independent rendering industry that picks up dead animals on farm. However, the burden to feed manufacturers is little to nothing with this change. Feed mills will have to remain diligent regarding insuring the vehicles bringing incoming ingredients have not hauled prohibited protein or at a minimum the vehicles have been cleaned, flushed or sequenced.

AFIA maintains on its website the 1997 BSE feed rule compliance guide, which can be accessed and printed by clicking here http://www.afia.org/Afia/Files/BAMN-%20BSE-%20DDGS-%20Biosecurity%20Awareness/BSE%20Guidelines.pdf. This guide will also meet the new rule’s requirements for feed mills.

The final rule will prohibit in any animal feed the use of rendered cattle 30 months of age or older from which the brains and spinal cords (B/SC) have not been removed. The agency is creating a new section of the rule 21 C.F.R. § 589.2001 and defining this newly prohibited product as “cattle materials prohibited in animal feed.” This is essentially rendered cattle from which the B/SC have not been removed. If rendered, the product must be colored and labeled with the warning “Do Not Use in Animal Feed.” Rendered fat from these animals can be used in animal feed if the insoluble impurities level are less than 0.15%.

The agency will continue to exempt from this rule blood, gelatin and milk products. It also did not address poultry feeding to ruminants; therefore, it remains allowed.

The rule’s effective date is 12 months (April 27, 2009). During that time, the agency will develop guidance documents and train investigators.

The finalization of this rule has been driven by trade considerations with several Asian countries, most notably Korea. Recent reports on the beef trade agreement with Korea have indicated that US beef from animals under 30 months of age can be shipped to Korea and beef from animals over 30 months old would be permitted after the U.S. strengthened its feed rule.

The final rule addresses a miniscule portion of potential infectivity that may reach animals by inadvertent carryover from other feed operations. The human illness concern was addressed several years ago with the establishment of packing plant rules that require removal of all specified risk materials, including B/SC in cattle over 30 months of age.

AFIA urged FDA and other government agencies to address the impending loss of rendering market, a potentially massive disposal problem from a decreasing dead haul industry and other issues associated with animal disposal. Although FDA notes in the final rule that the costs are major (in excess of $100 million), the agency is not charged with regulating disposal issues. Discussions with USDA officials regarding this issue have been met with a lack of concern.

For a copy of the pre-publication copy of the rule, contact AFIA VP Richard Sellers (rsellers@afia.org).