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Just the Facts

One in a Series of Information Sheets from FDA

Safeguarding Animal Health to Protect Consumers

The FDA's Center for Veterinary Medicine (CVM) affects millions of consumers by helping to assure that animal food products are safe. The average American consumes nearly 200 pounds of meat and fish, 67 pounds of poultry, 30 pounds of eggs, and 600 pounds of dairy products each year. Besides protecting the health of consumers, CVM works to safeguard the health and increase productivity of food-producing animals in the United States—97 million cattle, 59 million pigs, 8.8 billion chickens, 272 million turkeys and 7 million sheep.

CVM also evaluates the safety and effectiveness of drugs used to treat more than 100 million companion animals. Nearly 300 drugs currently on the market have been approved by the FDA for America 's dogs, cats and horses. CVM has two top priorities:

BSE is believed to be caused by proteins that harbor an infectious agent. Cattle can contract the disease by eating feed that contains the infectious protein. To prevent this disease from spreading in the United States , the FDA issued a regulation in 1997 that prohibits the inclusion of most mammalian protein in feed for cattle, sheep, goats and other ruminants. To date, FDA and state feed control specialists have conducted over 27,000 inspections of animal feed production and distribution facilities and ruminant feeders. Over 99 percent of these facilities are in compliance with the 1997 regulation.

To lower even further the risk that cattle will be fed prohibited protein, either purposely or inadvertently, the FDA is implementing an interim final rule that will make four specific changes in the 1997 animal feed rule. These changes will include: eliminating the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source, banning the use of "poultry litter" as a feed ingredient for ruminant animals, and banning the use of "plate waste" as a feed ingredient for ruminants. In addition, the rule will require feed makers to use separate, dedicated equipment, facilities or production lines for non-ruminant animal feeds if the facilities handle protein that is prohibited in ruminant feed. This will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed.

The suspected link between antibiotic resistance in humans and the use of antimicrobials in food animals is supported by a growing body of evidence and therefore is an important public health concern. In October 2003, CVM released a new guidance document for sponsors seeking approval for antimicrobial animal drugs. The guidance encourages drug sponsors to use a risk assessment process to demonstrate that an antimicrobial drug used to treat animals will not create a risk of resistant bacteria that could cause human health problems.

Whether reviewing or monitoring animal drugs, conducting research, or developing and disseminating information, CVM's 300 veterinarians, chemists, animal scientists, toxicologists, and microbiologists are committed to the important goal of protecting animal and human health throughout the United States .

For more information, please call CVM at 301-827-3800 or visit the FDA Web site at www.fda.gov/cvm .

How CVM Approves Animal Drugs

CVM approves drugs for food animals for either over-the-counter sale or for use under a veterinarian's prescription. In both cases, the approval is based on scientific determination that no unsafe residues or metabolites will result when the drug is used in the approved manner, and all important safety factors are considered when setting the approved levels of use.

Publication No. FS 01-6
FDA Web site: www.fda.gov
02/04

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