Safeguards expanded to strengthen firewalls against BSE

On Jan. 26, Health and Human Services Secretary Tommy G. Thompson announced several new public health measures that the Food and Drug Administration will implement to strengthen the firewalls against bovine spongiform encephalopathy.

According to the FDA, the new safeguards are science-based and bolster the already effective firewalls developed by Department of Agriculture and the HHS.

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

The FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminants. Those measures will strengthen the FDA's 1997 animal feed ban, which prohibits the feeding of most mammalian protein to ruminant animals, including cattle.

FDA Commissioner Mark B. McClellan, MD, PhD, said, "FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. ... "

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

• Any material from downer cattle
• Any material from dead cattle (that die on the farm)
• "Specified risk materials" that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health
• The product known as mechanically separated beef, which may contain specified risk materials; however, meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones) may be used

The second interim final rule is designed to further lower the risk that cattle will be purposefully or inadvertently fed prohibited protein. This rule will implement four changes in the FDA's animal feed rule. First, it will eliminate the exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent 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 litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry are raised. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bonemeal. The concern is that when poultry feed is spilled in the chicken house, it will be 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 collected from large restaurant operations and rendered into meat and bonemeal for animal feed.

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

To accompany these new measures, the FDA will also step up its inspections of feed mills and renderers this year. The agency will conduct 2,800 inspections and will continue to work with state agencies to fund 3,100 contract inspections. Through partnerships with states, the FDA will receive data on additional inspections.

FDA has publicly discussed many of those measures with stakeholders, and in November 2002, it published an advance notice of proposed rulemaking concerning possible changes to the animal feed rule. Comprehensive information about the agency's work on BSE and links to related Web sites are available at www.fda.gov.