DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-6

FDA Web site: www.fda.gov

02/04

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:

• Prevent the establishment of

bovine spongiform encephalopathy

(BSE), “mad cow disease.”

• Counter the risk of antibiotic

resistance in humans from food

animals.

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.

Safeguarding

Animal Health to

Protect Consumers

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.