Also, disease-causing bacteria—or pathogens—may develop resistance spontaneously. As a pesticide for disease treatment and prevention, antibiotics are generally sprayed onto plants. However, data are not available on the quantities of specific antibiotics used in agriculture and the purposes for which they are used. However, each year several thousand persons have severe illnesses resulting in hundreds of deaths. In addition to the direct foodborne transfer of antibiotic resistance from these three specific organisms, some research suggests that the use of antibiotics in food animals may reduce the effectiveness of related antibiotics used to treat humans. FDA approves all antibiotics used for food-producing animals; the Environmental Protection Agency (EPA) approves antibiotics used as pesticides on produce and plants. FDA has approved many antibiotics for use on food-producing animals; EPA has approved two antibiotics for use on plants. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) operates a program to ensure that antibiotic residues in food products are within established limits. FSIS’ National Residue Program tests meat and poultry products for antibiotic residues. Debate Is Ongoing Over the Potential Risk to Human Health From the Agricultural Use of Antibiotics

The debate over whether to further regulate or restrict the use of antibiotics in agriculture centers around the risk their use may pose to human health relative to their benefits to agriculture. They also believe that the research does not warrant restricting the use of antibiotics in agriculture. CDC researchers believe that some antibiotics should not be used in animal feed to promote growth. Recommendation to the Secretaries of Agriculture and Health and Human Services

In light of the emergence of antibiotic resistance in humans, questions about the extent that the agricultural use of antibiotics contributes to the human health burden, and the debate over whether further regulation or restriction of use in agriculture is needed, we recommend that the Secretaries of Agriculture and of Health and Human Services develop and implement a plan that contains specific goals, time frames, and resources needed to evaluate the risks and benefits of the existing and future use of antibiotics in agriculture, including identifying and filling critical data gaps and research needs. Noting that preventive action is needed now, the Department stated, “steps need to be taken to decrease the use in agriculture of antibiotics that contribute to the development of resistant strains of human pathogens.” It also pointed out that the public health community is concerned not only with the growth promotion uses of antibiotics in agriculture but also with uses to treat and prevent disease, which “can be significant contributors to the pool of resistant microorganisms that enter the food chain” and often involve “critical drugs of last resort in treating a variety of human infections.” While the Department believes no further research is needed to prove the link for foodborne pathogens, it does believes more research would be beneficial in assessing agricultural practices that can reduce antimicrobial use, identifying the types of use that are high or low risk, and better understanding the potential risks of resistance transfer from animal organisms other than typical foodborne pathogens. Major contributors to the report are listed appendix V.

Objectives, Scope, and Methodology

This report examines (1) how antibiotics are used in agriculture and the implications of that use for human health; (2) federal roles and responsibilities for overseeing the use of antibiotics in agriculture; and (3) issues surrounding the debate over whether to further regulate or restrict the use of antibiotics in agriculture. 2. 3. 4. HHS states that the Food and Drug Administration’s (FDA) proposal: Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals will address all uses of antibiotics in agriculture. 5. 6. 7. 8. 9. 10. 11.
Why GAO Did This Study

Pursuant to a congressional request, GAO provided information on antibiotic resistance issues that may stem from the use of antibiotics in agriculture, focusing on the: (1) use of antibiotics in agriculture and the implications of that use for human health; (2) federal roles and responsibilities for overseeing the use of antibiotics in agriculture; and (3) issues surrounding the debate over whether to further regulate or restrict the use of antibiotics in agriculture.

What GAO Found

GAO noted that: (1) antibiotics are used in agriculture to treat and prevent diseases in animals and in food plants and as a feed additive to improve the growth rate in animals; (2) data are not available on the quantities of specific antibiotics used in agriculture and the purposes for which they are used; (3) research has linked the use of antibiotics in agriculture to the emergence of antibiotic-resistant strains of disease-causing bacteria; (4) although the ill effects of these foodborne pathogens are generally mild to moderate, each year several thousand persons have severe illnesses resulting in hundreds of deaths; (5) in addition to the direct transfer of antibiotic-resistant organisms through animal products, some research suggests that the use of antibiotics in food animals may reduce the effectiveness of related antibiotics when used to treat humans; (6) approving antibiotics and setting allowable levels for antibiotic residues in food products is determined by the Food and Drug Administration (FDA) for animals and the Environmental Protection Agency for food plants; (7) testing for antibiotic levels in foods is performed by the Food Safety and Inspection Service for meat and poultry and by FDA for eggs, milk, and food plants; (8) monitoring the development of resistance to antibiotics in humans is conducted under a program run jointly by the Department of Agriculture (USDA), FDA and the Centers for Disease Control and Prevention; (9) the debate over whether to further regulate or restrict the use of antibiotics in animals and plants centers around the risk their use may pose to human health relative to their benefits to agriculture; (10) this concern has prompted several European countries to ban the use in animal feed of four antibiotics that are considered very important in treating humans; (11) beef, pork, and poultry producers and pharmaceutical manufacturers believe agricultural use is only one potential contributor to antibiotic resistance in humans; they claim that research does not warrant restricting antibiotic use in agriculture; (12) USDA believes that more research is needed before decisions are made regarding the further regulation or restriction of antibiotic use in food animals; (13) the Department of Health and Human Services believes that based on the scientific evidence, steps are needed now, not at some time in the future, to decrease such use; and (14) FDA's recently proposed framework for evaluating the safety of antibiotics for use in food-producing animals does not include specific timeframes for reevaluating approved antibiotics.