FDA plans to strengthen existing BSE firewall

Rockville, Md.-The Food and Drug Administration (FDA) unveiled new controls to help prevent BSE from ever taking a foothold in the United States.

Health and Human Services (HHS)Secretary Tommy G. Thompson announced that several new public health measures, implemented by FDA, to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE) and that help prevent the spread of mad cow disease in U.S. cattle.

The 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, FDA says.

The firewalls include:

• Import controls started in 1989

• Surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December.

• FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle.

• No bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA.

• The fifth firewall is effective 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 immediately upon the discovery of a BSE positive cow in Washington state December 23, FDAreports.

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, the agency reports.

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.

Feeding practices

"Today's actions will make strong public health protections against BSE even stronger," Thompson says. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," says FDA Commissioner Mark B. McClellan, MD, Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. 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."

Thompson adds, "Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections."

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, (including dietary supplements) and cosmetics:

• Any material from "downer" cattle. ("Downer" cattle are defined as 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, 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; and

• The product known as mechanically separated beef, a product 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 even further the risk that cattle will be purposefully or inadvertently fed prohibited protein, FDAsays. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980s and 1990s.

This interim final rule will implement four specific changes in FDA's present animal feed rule.

• First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products collected at slaughter to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.

• Second, the rule will also 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 is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other.

Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry 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 some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.

• Fourth, the 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. Currently, some equipment, facilities and production lines process or handle ruminant and non-ruminant feed - a practice, which could lead to cross-contamination.

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. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers, and other firms that handle animal feed and feed ingredient.