The Food and Drug Administration has banned from use in animal feed the brains and spinal cords of cattle at least 30 months old, and any tallow that is derived from those materials and contains more than 0.15 percent insoluble impurities. The changes were made to reduce the risk that use of the carcasses in feed could spread bovine spongiform encephalopathy.
Any parts of BSE-positive cattle—including those used to create tallow—and mechanically separated beef derived from the banned materials are also forbidden from use in feed. The same goes for whole carcasses of cattle that are at least 30 months old and that contain the brain or spinal cord.
Previous rules forbade feeding such materials only to ruminants.
Some renderers have reacted to the new regulations by halting pickup of cattle carcasses containing the banned materials—despite extra time allotted to comply with the new rules—because of the cost or difficulty in removing them.
To comply with the rules, renderers need to keep records demonstrating that carcass suppliers are separating from other materials the brains and spinal columns of cattle more than 30 months old.
"Although all parties are expected to exercise due diligence in excluding (cattle material prohibited in animal feed), the new rule places the responsibility on the renderer," information from the FDA states. It also states renderers are responsible for conducting any necessary recalls.
David Meeker, PhD, senior vice president of scientific services for the National Renderers Association, said some renderers in areas with large cattle populations have bought saws and vacuums to remove the banned materials and continue rendering carcasses. He noted the FDA is making renderers responsible for verifying no prohibited materials are distributed in their animal feed.
"We sympathize, but we really are bearing the brunt of compliance," Dr. Meeker said.
The FDA implemented the rule April 27, one year after notification about the rule was published. But the agency cited the need for alternate disposal of cattle carcasses in delaying the compliance date until Oct. 26.
"The additional six months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule," the FDA said in a statement April 22. "FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible."
Dr. Cloninger, a district director for the American Association of Bovine Practitioners, said the feed ban has not directly impacted his business in Centre Hall, Pa., but it has increased difficulties for clients. His ambulatory practice is in dairy country, and his clients include Amish and conventional farm owners.
Since renderers stopped picking them up, the cattle carcasses have been out in the open longer, and composting has increased the work for the farmers, Dr. Cloninger said. This is particularly true for Amish farmers, who have upward of a four-hour chore when they lose one of their large animals.
"I wish FDA would have looked at the ramifications of the ruling before implementing it," Dr. Cloninger said. "The risk of BSE is very small, and everything has some risk. We cannot completely eliminate the risk."
Laura Alvey, spokeswoman for the FDA-CVM, said BSE has caused 200 deaths worldwide, including those of three people in the U.S. who were likely exposed to the agent outside the country. She said the FDA has an obligation to use control measures to prevent threats to public and animal health.
"The added measure of excluding high-risk materials from all animal feeds addresses risks associated with accidental feeding of such material to cattle, which could occur through cross-contamination of ruminant feed with nonruminant feed or feed ingredients during manufacture and transport," Alvey said. She said nonruminant feed could also improperly be fed directly to ruminants on farms.
The FDA-CVM proposed the rule in October 2005, and the US Animal Health Association's board of directors addressed the proposal in November 2005 through a resolution that urged the agency to "more thoroughly evaluate the unintended consequences of changes in the Ruminant Feed Rule so that reducing a very small risk from Bovine Spongiform Encephalopathy (BSE) does not lead to a carcass disposal crisis in many areas of the United States."
Dr. Donald E. Hoenig, president of the USAHA, said many people involved in animal agriculture have been concerned about unintended consequences of the rule, and he has wondered about its need.
The rule was proposed during enhanced surveillance for BSE, and the proposal could not have taken into account information gathered from the completed surveillance, Dr. Hoenig said. He noted that no additional cases have been identified in the United States since the enhanced surveillance ended.
The Department of Agriculture discovered in December 2003 that a cow imported from Canada had BSE.
The USDA tested about 790,000 cattle under an enhanced surveillance program from June 2004 to September 2006, during which time two BSE-positive cattle were found in Texas and Alabama. The USDA tests about 40,000 cattle annually for BSE.
Dr. Hoenig said that if fewer cattle carcasses are submitted for necropsy because of costs associated with carcass disposal, the ruling could reduce surveillance for other concerns such as foot-and-mouth disease. But he is more concerned about the potential environmental impacts of carcass disposal.
Dr. Hoenig said authorities will likely find more BSE cases in the United States if they continue looking. But he thinks the feed ban has been effective.
Dr. Harry W. Momont, a professor at the University of Wisconsin-Madison School of Veterinary Medicine, said the Veterinary Medical Teaching Hospital has increased fees to cover disposal costs for carcasses of cattle more than 30 months old, but the hospital is still taking a small loss with each carcass.
FDA information indicates the banned materials can be disposed of by landfill, incineration, composting, alkaline hydrolysis, and burial.
Some landfills are taking the materials, while others are adding charges because they consider the materials to be hazardous, Dr. Meeker said. But the rule could create opportunities in rendering the cattle carcasses for use in products ranging from biofuels to nursery pots, provided such a venture received the needed mass of the nation's cattle carcasses.
The Environmental Protection Agency has published a statement that the cattle material prohibited in animal feed would not be considered hazardous waste. Nonhazardous solid waste is managed by state and local governments.
"In response to the challenges being raised on the disposal of these wastes, the state agricultural agencies should work very closely with the state environmental/solid waste management agencies to ensure the most effective, environmentally safe, and economic disposal of these materials," according to an agency statement.
The FDA proposed in early April delaying implementation of the new rules, but did not adopt the delay. In response to the proposal, Dr. William A. Grant, president of the California VMA, said in a letter sent April 13 that the CVMA did not oppose strengthening safeguards against BSE but did support delaying implementation of the rule.
Dr. Grant said California was unable to comply with the rule because of state prohibitions on use of landfills and composting of mammalian protein, a lack of infrastructure for large-scale use of incineration or alkaline hydrolysis digestion, and potential consequences of illegal burial.
"The CVMA encourages the FDA to follow a slow and deliberate pathway to allow for alternative methods of carcass disposal to be developed along with adequate infrastructure," Dr. Grant said.
Other organizations and individuals wrote to the FDA to oppose any delays in implementation because of risks of BSE to human health.
"(The Food Animal Concerns Trust) urges the FDA to stop any further delay and promptly move forward with these important requirements needed to ensure that BSE does not become a significant health problem in the United States," the organization's letter states.