Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals
GAO-04-490
Published: Apr 22, 2004. Publicly Released: May 24, 2004.
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Highlights
Antibiotic resistance is a growing public health concern; antibiotics used in animals raised for human consumption contributes to this problem. Three federal agencies address this issue--the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), and the Department of Agriculture (USDA). GAO examined (1) scientific evidence on the transference of antibiotic resistance from animals to humans and extent of potential harm to human health, (2) agencies' efforts to assess and address these risks, (3) the types of data needed to support research on these risks and extent to which the agencies collect these data, (4) use of antibiotics in animals in the United States compared with its key agricultural trading partners and competitors, and (5) information on how use has affected trade.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | Because of the emerging public health problems associated with antibiotic resistance in humans and the scientific evidence indicating that antibioticresistant bacteria are passed from animals to humans, the Commissioner of FDA should expedite FDA's risk assessments of the antibiotics used in animals that the agency has identified as critically important to human health to determine if action is necessary to restrict or prohibit animal uses in order to safeguard human health. |
FDA responded by email that it was devoting considerable resources to its work on antimicrobial resistance. FDA's work includes tracking resistance patterns through the National Antimicrobial Resistance Monitoring System and participating in the Public Health Action Plan and international Codex activities. FDA has expanded its analysis of previously approved applications for the use of penicillin in animal feeds to include a review of relevant published literature, new information submitted by sponsors of one of the involved products, and the information contained in two Citizen Petitions submitted to FDA in March of 1999 and April of 2005. When FDA completes an analysis of all of the relevant information, FDA will be able to make the necessary determinations related to the pending Citizen's petitions and the previously approved applications." However, FDA did not respond when asked which risk assessments were completed, what determinations were made, what actions were taken, and how many FTE's and other resources were devoted to this. FDA has not implemented this recommendation.
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| Department of Agriculture | Because more data on antibiotic use in animals--such as the total quantity used, by class; the species in which they are used; the purpose of the use, such as disease treatment or growth promotion; and the method used to administer--are needed to further address the risk of antibiotic resistance, the Secretaries of Agriculture and of Health and Human Services should jointly develop and implement a plan for collecting data on antibiotic use in animals that will adequately (1) support research on the relationship between this use and emerging antibiotic-resistant bacteria, (2) help assess the human health risk related to antibiotic use in animals, and (3) help the agencies develop strategies to mitigate antibiotic resistance. |
USDA has continued collecting data on antibiotic use in animals and emergence of resistant disease strains in the USDA/ARS Antimicrobial Resistance Research Unit in Athens, Georgia. This work has progressed steadily but slowly, because of the limited resources, according to the unit's Research Leader. The research has focused on swine and data from two studies under the National Animal Health Monitoring System (NAHMS)that took random samples of swine in 17 states. While USDA has continued its efforts independently, it has not worked jointly with HHS to develop and implement a focused plan, which was the purpose of the recommendation.
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| Department of Health and Human Services | Because more data on antibiotic use in animals--such as the total quantity used, by class; the species in which they are used; the purpose of the use, such as disease treatment or growth promotion; and the method used to administer--are needed to further address the risk of antibiotic resistance, the Secretaries of Agriculture and of Health and Human Services should jointly develop and implement a plan for collecting data on antibiotic use in animals that will adequately (1) support research on the relationship between this use and emerging antibiotic-resistant bacteria, (2) help assess the human health risk related to antibiotic use in animals, and (3) help the agencies develop strategies to mitigate antibiotic resistance. |
HHS has not provided GAO with information that addresses what the department has done in response to this recommendation.
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Agricultural researchAnimalsAntibioticsComparative analysisControlled substancesData collectionDrugsHealth hazardsInfectious diseasesInternational tradeMedical researchRisk assessment