May 2, 2008 | On Friday, April 25, 2008, the Food and Drug Administration (FDA) published a final rule that tightens restrictions on certain ruminant materials, disallowing brains and spinal cords from cattle over 30 months of age from all animal feed. The publishing of the rule, first proposed in October 2005, was part of trade negotiations with South Korea to allow imports of U.S. beef. The final rule will go into effect 12 months after its official publication, or April 27, 2009.
According to an initial analysis of the final rule by the National Renderers Association (NRA), the following will be prohibited: “The entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSE positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule.”
The NRA submitted comments opposing the proposed rule back in late 2005, supplying documentation that the rule would be costly to not only renderers but also livestock producers, would be difficult to enforce, and could reduce the availability of deadstock collection leading to environmental consequences (see “Industry Makes its Case for Needless Regulation” in the February 2006 Render). The NRA is presently analyzing the final rule published last week to determine exactly how it will impact the U.S. rendering industry. Once that analysis is complete and vetted with NRA members, association leaders will discuss with FDA’s Center for Veterinary Medicine (CVM) any questions the industry has relative to the intent and application of the feed rule. NRA, as it has since the publication of the original 1997 feed rule, will work closely with CVM and the regulated industry to ensure the most efficient and practical application of the rule. A report on the industry’s analysis of the final rule will be included in the June 2008 issue of Render.
NRA also concluded in its initial analysis that the rule will “require renderers to develop and maintain written procedures for determining the age of and/or removing the brain and spinal cord from, dead cattle, and to make the written procedures available for FDA inspection.” Renderer’s records must also include documentation that establishments supplying cattle materials to the renderers have adequate procedures in place to effectively exclude cattle materials prohibited from animal feed (CMPAF). Records must be kept for one year.
CMPAF material is required to be marked and labeled “Do not feed to animals.” FDA is not prohibiting the use of blood and blood products in animal feed, and the agency intends to develop new regulations on processing and ingredient standards and ingredient definitions for all animal feed, and updated labeling standards for pet food.
The main difference between the proposed rule and the final rule is that the proposed rule would also define as CMPAF the brain and spinal cord of cattle under 30 months of age that were not inspected and passed for human consumption. “Inspected and passed for human consumption” in this rule refers to ante mortem inspection rather than post mortem inspection.
FDA believes it has minimized the burden to the rendering industry by not specifying the procedures to be followed so as to provide the latitude to establish procedures that can most efficiently be incorporated into rendering operations. FDA estimates that the cost per renderer for compliance with the new requirement for establishing and maintaining written procedures will be $340 per renderer. FDA also states in the rule that they will “vigorously enforce this new rule to ensure that CMPAF is not used in animal feed."
Much of the volume of the 40-page publication covers the many comments FDA received on their proposed rule of 2005 and the agency’s response to the comments. They paid considerable attention to NRA comments and its commissioned analysis by Informa Economics. FDA either refuted comments or accepted them and explained how the concerns were addressed in the final rule. Many comments complained that the proposed rule did not “go far enough.” FDA believes they struck a reasonable balance between leaving the 1997 rule in place as is and restricting much more material as some advocated. FDA raised their economic impact from the one they did in 2005, but they did not accept the impact to be as high as NRA’s analysis. Similarly, they acknowledged little environmental impact from disposal problems and predicted lower disposal costs to producers than NRA predicted. FDA also passed responsibility for monitoring animal health and environmental impacts to states and other agencies.
Many uncertainties remain on FDA enforcement, how thorough the written procedures need to be, and what the final impacts and unintended consequences might be. NRA will be discussing strategies and possible next step.