FDA announces expanded safeguards against mad cow disease.

The Food and Drug Administration (FDA) has announced several new measures designed to protect the public against the agent thought to cause mad cow disease, or bovine spongiform encephalopathy (BSE). FDA and the U.S. Department of Agriculture (USDA) already have a number of protective measures in place or currently being implemented:

* import controls that began in 1989;

* surveillance of the U.S. cattle population for the presence of BSE;

* FDA's 1997 animal feed rule, which prohibits most mammalian protein from being fed to ruminant animals, including cattle (this feeding practice was the route of transmission for the BSE epidemic among cattle in the United Kingdom in the 1980s and 1990s);

* recently announced USDA policies designed to ensure that certain bovine tissues known to have a high risk of carrying the BSE agent do not enter the human food supply regulated by USDA; and

* response planning to contain the potential for any damage from a BSE-positive animal, if one is discovered (this contingency response plan, which had been developed over the past several years, was initiated upon the discovery of a BSE-positive cow in Washington State on December 23, 2003).

The new FDA safeguards are as follows:

* The Department of Health and Human Services (HHS) intends to ban a wide range of bovine-derived material from FDA-regulated human food (including dietary supplements) and cosmetics.

* FDA also will prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals.

To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication. The first interim final rule will ban the following materials from FDA-regulated human food and cosmetics:

* any material from "downer" cattle ("downer" cattle are animals that cannot walk);

* any material from "dead" cattle ("dead" cattle are cattle that die before reaching the slaughterhouse);

* specified risk materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord tissues of cattle at least 30 months of age, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and

* the product known as "mechanically separated beef," which may contain SRMs (meat obtained by Advanced Meat Recovery, an automated system for cutting meat from bones, may be used since USDA regulations do not allow the presence of SRMs in this product).

The second interim final rule is designed to lower the risk that cattle will be purposefully or inadvertently fed prohibited protein. This rule will implement four changes to FDA's present animal feed rule. First, it will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.

Second, the rule will ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that poultry feed is spilled in chicken houses and that this feed (which may contain protein prohibited in ruminant feed) is then collected as part of the poultry litter and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from large restaurant operations and rendered into meat and bone meal for animal feed.

Fourth, the rule will require equipment, facilities, or production lines to be dedicated to nonruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some facilities handle both prohibited and non-prohibited materials and make both ruminant and nonruminant feed--a practice that could lead to cross-contamination.

In tandem with these new measures, FDA will in 2004 step up its inspections of feed mills and renderers.

FDA also is continuing its efforts to assist in the development of better BSE science. For example, to enhance the ability to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and of testing other products for contamination with the agent thought to cause BSE.