Antibiotic Resistance:

Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals

GAO-11-801: Published: Sep 7, 2011. Publicly Released: Sep 14, 2011.

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Antibiotics have saved millions of lives, but antibiotic use in food animals contributes to the emergence of resistant bacteria that may affect humans. The Departments of Health and Human Services (HHS) and Agriculture (USDA) are primarily responsible for ensuring food safety. GAO reviewed the issue in 2004 and recommended improved data collection and risk assessment. GAO was asked to examine the (1) extent to which agencies have collected data on antibiotic use and resistance in animals, (2) actions HHS's Food and Drug Administration (FDA) took to mitigate the risk of antibiotic resistance in humans as a result of use in animals, (3) extent to which agencies have researched alternatives to current use practices and educated producers and veterinarians about appropriate use, and (4) actions the European Union (EU) and an EU member country, Denmark, have taken to regulate use in animals and lessons that have been learned. GAO analyzed documents, interviewed officials from national organizations, and visited producers in five states and Denmark..

HHS and USDA have collected some data on antibiotic use in food animals and on resistant bacteria in animals and retail meat. However, these data lack crucial details necessary to examine trends and understand the relationship between use and resistance. For example, since GAO's 2004 report, FDA began collecting data from drug companies on antibiotics sold for use in food animals, but the data do not show what species antibiotics are used in or the purpose of their use, such as for treating disease or improving animals' growth rates. Also, although USDA agencies continue to collect use data through existing surveys of producers, data from these surveys provide only a snapshot of antibiotic use practices. In addition, agencies' data on resistance are not representative of food animals and retail meat across the nation and, in some cases, because of a change in sampling method, have become less representative since GAO's 2004 report. Without detailed use data and representative resistance data, agencies cannot examine trends and understand the relationship between use and resistance. FDA implemented a process to mitigate the risk of new animal antibiotics leading to resistance in humans, which involves the assessment of factors such as the probability that antibiotic use in food animals would give rise to resistant bacteria in the animals, but it faces challenges mitigating risk from antibiotics approved before FDA issued guidance in 2003. FDA officials told GAO that conducting postapproval risk assessments for each of the antibiotics approved prior to 2003 would be prohibitively resource intensive, and that pursuing this approach could further delay progress. Instead, FDA proposed a voluntary strategy in 2010 that involves FDA working with drug companies to limit approved uses of antibiotics and increasing veterinary supervision of use. However, FDA does not collect the antibiotic use data, including the purpose of use, needed to measure the strategy's effectiveness. HHS and USDA have taken some steps to research alternatives to current antibiotic use practices and educate producers and veterinarians on appropriate use of antibiotics. However, the extent of these efforts is unclear because the agencies have not assessed their effectiveness. Without an assessment of past efforts, the agencies may be limited in their ability to identify gaps where additional research is needed. Except for one $70,400 USDA project, all other federal education programs have ended. Since 1995, the EU, including Denmark, banned the use of antibiotics to promote growth in animals, among other actions. Some of their experiences may offer lessons for the United States. For example, in Denmark, antibiotic use in animals initially decreased following a series of policy changes. The prevalence of resistant bacteria declined in food animals and retail meat in many instances, but a decline in humans has only occasionally been documented. Denmark's data on use and resistance helped officials track the effects of its policies and take action to reverse unwanted trends. The EU faces difficulty collecting data that can be compared across countries, but officials there said such data are needed to fully understand how use in animals may lead to resistance in humans. GAO recommends that HHS and USDA (1) identify and evaluate approaches to collecting detailed data on antibiotic use in animals and use these data to evaluate FDA's voluntary strategy, (2) collect more representative data on resistance, and (3) assess previous efforts on alternatives to identify where more research is needed. HHS and USDA agreed with GAO's recommendations.

Recommendations for Executive Action

  1. Status: Open

    Comments: In September 2015, officials from the Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) stated that it proposed several initiatives to collect detailed data on antimicrobial use and resistance in food animals at the animal and farm level. According to officials, these initiatives include studies repeated over time -longitudinal studies - to investigate the purposes of antimicrobial use. In addition, officials told us they plan to conduct an annual antimicrobial use survey that collects data over time as part of the National Agricultural Statistics Service standard data collection system. Furthermore, APHIS officials requested $10 million to carry out its proposed initiatives, but the agency has not received appropriations to implement them yet. APHIS anticipates funding in fiscal year 2016 and plans to implement these initiatives.

    Recommendation: To track the effectiveness of policies to curb antibiotic resistance, including FDA's voluntary strategy designed to reduce antibiotic use in food animals and to address action items in the surveillance focus area of the 2001 interagency plan, the Secretaries of Agriculture and Health and Human Services should direct agencies to, consistent with their existing authorities, (1) identify potential approaches for collecting detailed data on antibiotic use in food animals, including the species in which antibiotics are used and the purpose for their use, as well as the costs, time frames, and potential trade-offs associated with each approach; (2) collaborate with industry to select the best approach; (3) seek any resources necessary to implement the approach; and (4) use the data to assess the effectiveness of policies to curb antibiotic resistance.

    Agency Affected: Department of Agriculture

  2. Status: Closed - Not Implemented

    Comments: The Department of Agriculture's Agricultural Research Service (ARS) conducted efforts to assess gaps in research on alternatives to antibiotic use in food animals. For example, to assess gaps in research, the agency participated in a May 2012 Antibiotic Resistance Workshop. ARS also meets regularly with other agencies as part of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR), which aims to identify gaps in antibiotic research. In the most recent 2014 TATFAR progress report, the group summarized the progress and the outcomes of the implementation of 17 recommendations. The next meeting is scheduled for October 2015. In March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria, superseding the 2010 interagency plan. ARS officials stated that the agency is working on implementing steps to address gaps in research on antibiotic alternatives as outlined in the White House's National Action Plan. The plan identifies various future milestones with timeframes from one to five years to identify and close these gaps so actions may not occur in the near future.

    Recommendation: To better focus future federal research efforts on alternatives to current antibiotic use practices, the Secretaries of Agriculture and Health and Human Services should direct agencies to (1) assess previous research efforts on alternatives and identify gaps where additional research is needed, in collaboration with the animal production industry, and (2) specify steps in the draft 2010 interagency plan that agencies will take to fill those gaps.

    Agency Affected: Department of Agriculture

  3. Status: Open

    Comments: In September 2015, officials from the Food and Drug Administration (FDA) told us that in the past two years there have been several efforts related to surveillance. These efforts include enhancements to FDA's Annual Summary Report, publication of a proposed rule that provides FDA with species-specific information on antimicrobial sales and distribution, and continued collaborative efforts to collect on-farm data regarding drug use and resistance. These are important steps and once the rule is finalized and the agency begins to collect the data, it will be in a better position to assess the effectiveness of policies to curb antibiotic resistance.FDA will continue implementing these steps in fiscal year 2016.

    Recommendation: To track the effectiveness of policies to curb antibiotic resistance, including FDA's voluntary strategy designed to reduce antibiotic use in food animals and to address action items in the surveillance focus area of the 2001 interagency plan, the Secretaries of Agriculture and Health and Human Services should direct agencies to, consistent with their existing authorities, (1) identify potential approaches for collecting detailed data on antibiotic use in food animals, including the species in which antibiotics are used and the purpose for their use, as well as the costs, time frames, and potential trade-offs associated with each approach; (2) collaborate with industry to select the best approach; (3) seek any resources necessary to implement the approach; and (4) use the data to assess the effectiveness of policies to curb antibiotic resistance.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: The Department of Agriculture's Food Safety and Inspection Service (FSIS) worked with the Department of Health and Human Services' Food and Drug Administration (FDA) to make several improvements to NARMS. Specifically, according to FDA and FSIS officials, in March 2013, FDA and FSIS implemented a randomized, nationally representative sampling scheme to gather food animal samples for NARMS from slaughter plants, based on slaughter volume. In addition, FDA officials said that in January 2013 FDA expanded the geographic representativeness of their retail meat testing to include three new states: Washington, Louisiana, and Missouri.

    Recommendation: To enhance surveillance of antibiotic-resistant bacteria in food animals, we recommend that the Secretaries of Agriculture and Health and Human Services direct agencies to, consistent with their existing authorities, modify the National Antimicrobial Resistance Monitoring System (NARMS) sampling to make the data more representative of antibiotic resistance in food animals and retail meat throughout the United States.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: The Department of Agriculture's Food Safety and Inspection Service (FSIS) worked with the Food and Drug Administration (FDA) to make several improvements to NARMS. Specifically, according to FDA and FSIS officials, in March 2013, FDA and FSIS implemented a randomized, nationally representative sampling scheme to gather food animal samples for NARMS from slaughter plants, based on slaughter volume. In addition, FDA officials said that in January 2013, FDA expanded the geographic representativeness of their retail meat testing to include three new states: Washington, Louisiana, and Missouri.

    Recommendation: To enhance surveillance of antibiotic-resistant bacteria in food animals, we recommend that the Secretaries of Agriculture and Health and Human Services direct agencies to, consistent with their existing authorities, modify the National Antimicrobial Resistance Monitoring System (NARMS) sampling to make the data more representative of antibiotic resistance in food animals and retail meat throughout the United States.

    Agency Affected: Department of Agriculture

  6. Status: Closed - Not Implemented

    Comments: According to FDA officials in 2013, efforts to research antibiotic alternatives include participation in meetings related to encouraging new technologies related to new drug products. FDA officials also stated that FDA's Center for Veterinary Medicine has an Innovative Technologies Initiative that is conducting outreach with industry to identify ways to better accommodate nontraditional products, such as those that replace antibiotics in FDA's product approval process. In March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria, superseding the 2010 interagency plan. In September 2015, FDA officials stated that the agency is working on implementing steps to address gaps in research on antibiotic alternatives as outlined in the White House's National Action Plan. The plan identifies various future milestones with timeframes from one to five years to identify and close these gaps so actions may not occur in the near future.

    Recommendation: To better focus future federal research efforts on alternatives to current antibiotic use practices, the Secretaries of Agriculture and Health and Human Services should direct agencies to (1) assess previous research efforts on alternatives and identify gaps where additional research is needed, in collaboration with the animal production industry, and (2) specify steps in the draft 2010 interagency plan that agencies will take to fill those gaps.

    Agency Affected: Department of Health and Human Services

 

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