The Food and Drug Administration proposed new rules that would prevent cattle feed from containing materials that could cause BSE.  But the Agency says the rulemaking is not going to take place immediately.  In fact, it is going to be delayed until more information comes to the Agency from the industry and other sources, FDA officials said.  The changes being considered would be made to the ruminant feeding rule (21 CFR 589.2000).

The officials said that FDA is considering proposing a rule that would ban specified risk materials from all animal feed, because risk assessments the Agency carried out indicates that would be the best way to tighten safeguards to prevent BSE, or "mad cow disease.."  FDA says it wants the public to have a chance to comment first on the idea.  An actual proposed rule would not come until later this year, possibly in the fall.

The US Department of Agriculture and FDA also published an Advance Notice of Proposed Rulemaking (ANPRM) that will seek public comments on the following topics.  This is a very general type of rulemaking designed to ask questions and get public reactions to Agency ideas.  The ANPRM includes the following:

* Requiring dedicated equipment or facilities for feed or ingredients to prevent cross contamination.

* Forbidding materials from non-ambulatory cattleand dead stock from use in any type of animal feed, including for cattle, swine, poultry and pet food.

* Outlawing the use of protein from mammals and poultry in ruminant feed.

* Changing a proposed animal behavior plan from voluntary to mandatory.

A number of U.S. trading partners, who have been delaying publishing their own feeding restrictions while they wait for FDA's rulemaking, have been pressuring the Bush White House to get additional rules out as soon as possible.

This Advance Notice focuses on the International Review Panel report commissioned by USDA-APHIS using a panel that reviewed the Canadian BSE situation.  This panel made some specific recommendations, including that Specified Risk Materials (SRMs) should be removed from all feeds, and that protein from animals older than 12 months could not be used in either human, animal or pet food.  But FDA does not want to ban protein from cattle as young as 12 months. 

AAMP has great concerns about the ban of specified risk materials from all cattle feed.  It would hurt the rendering industry severely, as well as the processing industry.  There would be a huge drop in markets for renderers.  This in turn would make it even more difficult for small and very small plants to have their materials picked up by renderers.  While large packers generally have their own rendering operations, the small industry is dependent on independent renderers.  It is not going to pay the independents to send to trucks to very small plants to pick up separated SRM and non-SRM waste materials.  Since there has been no "homegrown" case of BSE found in the United States, eliminating SRMs from all animal feed is unnecessary and a duplicate of current feed restrictions.

FDA also announced an interim final rule in effect July 14 that would outlaw the use of SRMs in dietary supplements and cosmetics.  Most tallow could still be used in cosmetics.  There would also be a proposed rule on recordkeeping requirements, so that manufacturers could prove to the Agency that SRMs would no longer be employed in those products.

The toughening of the feed rule is happening in part to the incident at the end of April when a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.  FDA investigated the incident by inspecting the slaughterhouse, rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal had already been rendered into "meat and bone meal" and was able to track down the implicated material.  Cattle with central nervous system symptoms are of particular interest to FDA and USDA because cattle with bovine spongiform encephalopathy (BSE), also known as "mad cow disease," can exhibit such symptoms.  In this case, there is no way to test for BSE.  Even if the cow had BSE, the animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals, such as cows, goats, sheep and bison, but not to hogs.  It's also not fed to poultry.   FDA established its animal feed rule in 1997 after the BSE epidemic in the UK showed that the disease spreads by feeding infected ruminant protein to cattle.  As a result of this incident back in the spring, FDA indicated that it would be strengthening the animal feed rule, to make the "firewall" even more protective against BSE. 

GAO Accompanying FDA Investigators on BSE Feed Rule Inspections

AAMP has also learned that Congress' watchdog Agency, the General Accounting Office, has asked the FDA to set up at least one inspection in each of its 25 district offices for auditors to accompany the FDA investigators.  This is part of a continuing investigation of FDA's enforcement of the BSE feed rule, and follows up GAO accompanying other investigators earlier this year.  Three senators asked GAO to audit FDA enforcment of the rule.  This is a follow-up to a GAO issued on the rule in January 2002.  GAO will look at whether FDA implemented changes GAO suggested, and how well it is doing in canvassing the feed industry.