HHS Expands "Mad Cow" Safeguards To Strengthen Existing Firewalls Against BSE Transmission

The Department of Health and Human Services (HHS) Secretary Tommy G. Thompson announced new measures to strengthen the multiple existing firewalls protecting Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease). The measures are also designed to help prevent the spread of BSE in U.S. cattle.

Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.

The five existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. Firewalls consist of actions such as import controls, surveillance of the U.S. cattle population, prohibiting the feeding of most mammalian protein to ruminant animals, including cattle and other measures.

FDA will issue two rules that will take effect immediately. First, the FDA will ban use of the following materials from FDA-regulated human food, (including dietary supplements) 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 on the farm (i.e. before reaching the slaughter plant);
• Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE of cattle 30 months or older, and other portions of cows that may be thought to be harboring BSE regardless of their age or health; and
• The product known as mechanically separated beef, a product which may contain SRMs.

The second rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. The rule includes banning mammalian blood and blood products from feed and banning the use of "poultry litter" as a feed ingredient for ruminant animals.

Additionlly, the FDA will ban the use of "plate waste" as a feed ingredient for ruminants.

Another rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed.

To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers.

To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost.

FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm) concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related websites are available at www.fda.gov.