The Food and Drug Administration (FDA) has primary responsibility in the federal government for food safety in the United States. FDA is charged with the enforcement of the Federal Food, Drug and Cosmetic Act (FFDCA), and food safety related aspects of the Public Health Service Act (PHSA). Under these acts, a part of the FDA responsibility is to ensure that human foods and animal feeds are safe and, among other things, do not contain illegal residues of drugs, pesticides, environmental contaminants or microorganisms such as fungi or bacteria, including mycotoxins and bacterial toxins, that may be harmful to public health.

While FDA's food safety mandate is clear, according to the General Accounting Office, in 1989 USDA (FSIS, AMS and FGIS) accounted for about 72 percent and FDA about 19 percent of the federal funding for food safety. The FDA mandate under the PHSA and the FFDCA includes widespead responsibilities to help ensure preharvest food safety. For example, one mission of FDA's Center for Veterinary Medicine (CVM) is to protect the public health through pre-approval evaluations and acceptance of sponsor-submitted safety and effectiveness studies for regulation of animal drugs, medicated feeds and food (feed) additives. CVM regulates veterinary devices such as drug residue and bacteria screening tests to ensure that the labeling is not false or misleading and that directions for use are adequate. CVM also regulates the levels of chemical, mycotoxin and bacterial contaminants in animal feeds to ensure that food for man and animals is safe and free of illegal drugs, industrial chemical and pesticide residues, and harmful bacteria. When an animal drug is intended for use in food-producing animals, the safety of food products derived from the treated animals must be established before approval for marketing is granted. The pre-market approval process ensures that foods derived from properly treated animals will not contain potentially harmful drug residues. The preslaughter withdrawal period and milk discard times are based upon the time necessary for drug residues in the animal to deplete to levels that have been shown to be safe. These levels are called tolerances or safe concentrations and are made public in 21 CFR Part 556 and official FDA letters.

The FFDCA defines food as "articles used for food or drink for man or other animals ... and articles used for components of any such article." Food-producing animals, even though not in their final, edible form, have been held to be food under the statute. More generally, courts have long held that unprocessed or unfinished articles are or can be food. Thus, FDA regards live animals raised for food as unprocessed "food" under the FFDCA. Also, under the FFDCA, food is considered adulterated if it is the product of a diseased animal or of an animal which has died otherwise than by slaughter.

FDA works very closely with USDA/FSIS, outside the slaughterhouse, in both preharvest and postharvest initiatives to control illegal tissue residues of veterinary drugs. Preharvest initiatives have included verifying animal identification, determining the premises of origin of animals, testing feed for contaminants and supporting quality control and educational initiatives. Experience in FDA gained from on-farm investigations of FSIS reports of illegal drug residues in animals at slaughter helped to form the basis for our policy guidance on the producer's responsibility to ensure proper drug use.

Persons involved in raising, handling, transporting, holding and marketing food-producing animals must ensure that animal drugs are used properly to prevent potentially harmful drug residues in edible animal products. Control systems should include a method to identify and track animals administered drugs, maintenance of medication and treatment records, proper storage, labeling and accounting of drug products and medicated feeds, and the education of all employees involved in treating animals on proper drug use, including observance of drug preslaughter withdrawal and milk discard times. We regard the Compliance Policy Guide on proper drug use (CPG 7125.37) as an outcome of highly successful communication and cooperation between the regulated industry and FDA. Also, we are pleased with the harmony of principles that exists between this CPG and the Quality Assurance programs of the many food-producing animal organizations.

In May, 1995, Judge Walter Rice in the U.S. District Court for the Southern District of Ohio, Western Division, wrote a 26-page decision on exactly this issue. The Court concludes that the Act and the legislative history of the Act, permit FDA to interpret "food" to include live animals raised for food and intended to be offered for slaughter.

Judge Rice notes that the Food and Drugs Act of 1906 defined "food" as including "all articles used for food, drink, confectionary or condiment by man or other animals, whether simple, mixed or compounded." And he notes that Congress has beeen specifically aware of the FDA understanding and practice concerning live animals for almost 25 years, yet has in no way acted to limit the FDA jurisdiction or prevent its exercise of authority. He further states that it is the intent of Congress to permit FDA to reach the persons who are originally responsible for the adulteration of food.

For anyone who wants a copy of Judge Rice's decision, give me your business card at the end of this session. It has been published and can be found at 888 of Federal Supplement #1416. Lawyers will be able to find it by the citation but more importantly the publication of the decision in the Federal Supplement will result in wide dissemination of the opinion.

Finally, on the issue of whether or not live animals are food, there is the view of the consumer. From this sector of society, FDA hears the message: "They are not your animals. They are, in fact, my food."

The consumer view is recognized by the leadership of all the major food animal producer organizations and related agribusiness and professional organizations. The evidence of this recognition is in the quality assurance programs and in their education of producers on avoiding illegal residues. These programs have been very successful and I believe have greatly reduced the need for enforcement actions under the Act. The FDA would like these programs to become even more successful. In this respect, FDA endorses the National Show Ring Code of Ethics and its application to show ring animals across the nation and in countries which export animals, meat and meat products to the U.S.

For several years, FDA has been concerned about the use of clenbuterol, a drug not approved for veterinary use in the U.S., to increase muscle in meat-producing animals, particularly show animals. FDA is concerned about this practice because of possible adverse health effects in people who might consume food from treated animals. FDA's concern is based on the fact that clenbuterol is a beta-agonist drug. Beta-agonist drugs affect lung and heart function, and illegal use can present a hazard to consumer health.

It was clenbuterol that drew FDA to the show ring animal. We wanted to avoid, in the U.S., human health effects such as those reported from Spain and France. It was the apparent contempt on the part of a few individuals to the idea of caring for show animals as food that strengthened our resolve to be more helpful to officials of fairs and expositions. Specifically, in six months in 1994, FDA validated an analytical tissue method on clenbuterol.

FDA, several state agencies and private organizations such as state fairs have received information concerning the use of clenbuterol in show animals such as cattle, pigs and sheep. The drug has been used to increase muscle and decrease fat deposition. Some exhibitors believe this effect will help their animals win.

Clenbuterol is approved in Canada, many European and South American countries, Australia and New Zealand for use in nonfood-producing animals. A few countries have approved it for therapeutic uses in food-producing animals. The levels needed to achieve therapeutic effect are much less than those required to increase muscle mass.

FDA's main concern about the use of clenbuterol is the possible adverse effect of its residues on public health. In 1990, there were reports from Spain of illness in 135 individuals (including some who were hospitalized) who consumed beef liver from treated animals. These illnesses were traced to illegal residues of clenbuterol in the liver which these individuals consumed. These individuals exhibited symptoms such as increased heart rates, muscle tremors, headache, dizziness, nausea, fever and chills. In 1991, there was a similar outbreak of food poisoning reported from France involving 22 people who consumed beef liver with clenbuterol residues.

While the residue-produced clenbuterol toxic effects have been described as mild, FDA considers all unintended effects to be unacceptable.

Also, it is possible that individuals being treated with adrenergic agents, or otherwise sensitive to these drugs, may be far more severely affected by toxic levels of clenbuterol than are normal, healthy individuals.

FDA is also concerned about illegal use of clenbuterol leading to occupational-related illness or death. It is possible that clenbuterol's effect on the cardiovascular system may be more hazardous via occupational inhalation exposure than via ingestion in food. However, the agency has not been able to confirm reports of such reaction.

In 1994, traces of clenbuterol residues were found in animals at stock shows held in Ohio and Oklahoma. At the Oklahoma State Fair in Tulsa, a clenbuterol test of champion animals disqualified six animals including steers, sheep and a hog. At the National Western Stock Show held in Denver in 1995, the Grand Champion and Reserve steers were later disqualified because of findings of clenbuterol residues. The exhibitors of those animals agreed to be disqualified and to accept full responsibility for the presence of clenbuterol in their animals.

Since the Denver show, tissue from slaughter class show animals has been negative for clenbuterol residue.

The criminal investigations into the smuggling and illegal use of clenbuterol are incomplete. Two indictments (Thomas & Murray) have been issued and two others, Dr. VanDamme and Dr. Anderson, have each been sentenced to 15 months incarceration, $250,000 fine and one year probation. The analytical method has been shared with the states.

In closing, I want to reinforce the need for all of us federal and state public health officials, exhibitors, fair officials and buyers of show animals to be aware of the need to protect the food supply from the use of harmful substances. For meat-producing show animals, this amounts to three key measures:

1. using approved drugs or chemicals only according to label directions;

2. identifying and tracking animals to which drugs or other chemicals were administered in order to preclude sale of meat containing illegal residues;

3. maintaining a system of medication/treatment records that at a minimum identifies the animal treated, date(s) of treatment, drug(s) administered, amount administered and the withdrawal period prior to slaughter.