Issues and Advocacy

Post-approval Government Regulation

The government’s oversight of antibiotics does not stop once the drug is put on the market. In fact, after the Food and Drug Administration (FDA) approves animal antibiotics for use, both the Centers for Disease Control and Prevention (CDC) and Department of Agriculture (USDA) are as involved as the FDA in ensuring that public health is protected.

CDC

As the main agency in charge of public health, the Centers for Disease Control and Prevention maintains primary jurisdiction over antibiotic resistance. The CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) is the principal foodborne disease component of CDC’s Emerging Infections Program (EIP). FoodNet consists of active surveillance for foodborne diseases. FoodNet also oversees studies designed to help public health officials better understand the epidemiology of foodborne diseases in the United States.

USDA

The U.S. has seen dramatic declines in meat-caused foodborne illness as a result of the Hazard Analysis and Critical Control Points (HACCP) procedures overseen by USDA’s Food Safety and Inspection Service. These procedures identify physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. Once these hazards are identified, actions are taken to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production and preparation processes including slaughter, packaging, and distribution.

One element of the HAACP program is to ensure that pathogens are not in the animal when it is slaughtered, and that the pathogens are not detected in the meat after the time of slaughter. Antibiotics that keep animals healthy  help to reduce the number of pathogens in the animal during this process.

FDA has set what is known in the industry as “withdrawal periods,” or periods of time prior to slaughter when the medicine cannot be used. Withdrawal times ensure that medicine residues do not end up in the food. The withdrawal period specifies the number of days that must pass after the last antibiotic treatment before the animal can enter the food supply, and are printed on the product label at the time of sale to a producer or veterinarian.

To that end, FSIS inspectors enforce the withdrawal period. There are more than 1,100 federal veterinarians conducting inspections each day. Each year, the FSIS veterinarians examine more than six billion poultry carcasses and 125 million livestock carcasses.

Intergovernmental Collaboration: NARMS

The National Antimicrobial Resistance Monitoring System (NARMS) is a joint FDA, CDC and USDA effort to detect, control and manage antibiotic resistance.

Through NARMS, the FDA coordinates the programs and monitors retail meats for resistant bacteria, the CDC collects samples from public health laboratories to monitor the emergence of antibiotic resistant foodborne pathogens in humans, and the USDA Agricultural Research Service (ARS) collects samples from slaughter and processing facilities to monitor for antibiotic resistance trends in farm animals.

Animal health companies supports surveillance and monitoring, which are important and necessary for monitoring the health and well-being of both animals and humans. So far, NARMS has produced 15 years of data representing more than 50,000 animals and 11,000 human Salmonella isolates. The human isolates have been tested against most drug classes used in animal agriculture (), and have shown stable or declining patterns of resistance through 2004. Most of the multiple-drug resistance types, such as Salmonella Typhimurium DT104, have shown stable or declining prevalence in both food animals and humans since 1996.

SENTRY
The SENTRY Antimicrobial Surveillance Program is the most comprehensive  surveillance program of antibiotic resistant bacteria in humans  in the world. SENTRY data document the resistant organisms of greatest risk for poor therapy outcomes in patients, and that have little link to animal antibiotics. These data are reflected in a separate measurement showing that the use of animal antibiotics may account for only a very small portion of the total human burden of antibiotic resistance in humans — less than 5 percent based on an opinion of the human health community (Bywater R. and Casewell M., Journal of Antimicrobial Chemotherapy 2000; 6:643-645).