Antibiotic Resistance:

More Information Needed to Oversee Use of Medically Important Drugs in Food Animals

GAO-17-192: Published: Mar 2, 2017. Publicly Released: Mar 16, 2017.

Multimedia:

Additional Materials:

Contact:

John Neumann
(202) 512-3841
neumannj@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

Antibiotic-resistant bacteria are one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is strong evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine).

We found gaps in FDA's oversight of antibiotic use in food animals and USDA’s and HHS’s data collection, among other things. For example, they lack farm-specific data, do not have metrics to assess their actions to manage antibiotics use, and have not conducted on-farm investigations during foodborne illness outbreaks.

We made recommendations to address these concerns.

How Antibiotic-Resistant Bacteria Can Develop and Spread

Illustration of how antibiotic-resistant bacteria can develop, spread, and impact humans

Illustration of how antibiotic-resistant bacteria can develop, spread, and impact humans

Multimedia:

Additional Materials:

Contact:

John Neumann
(202) 512-3841
neumannj@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

What GAO Found

Since 2011, when GAO last reported on this issue, the Department of Health and Human Services (HHS) has increased veterinary oversight of antibiotics and, with the Department of Agriculture (USDA), has made several improvements in collecting data on antibiotic use in food animals and resistance in bacteria. For example, HHS's Food and Drug Administration (FDA) issued a regulation and guidance for industry recommending changes to drug labels. However, oversight gaps still exist. For example, changes to drug labels do not address long-term and open-ended use of antibiotics for disease prevention because some antibiotics do not define duration of use on their labels. FDA officials told GAO they are seeking public comments on establishing durations of use on labels, but FDA has not clearly defined objectives for closing this gap, which is inconsistent with federal internal control standards. Without doing so, FDA will not know whether it is ensuring judicious use of antibiotics. Moreover, gaps in farm-specific data on antibiotic use and resistance that GAO found in 2011 remain. GAO continues to believe HHS and USDA need to implement a joint on-farm data collection plan as previously recommended. In addition, FDA and USDA's Animal and Plant Health Inspection Service (APHIS) do not have metrics to assess the impact of actions they have taken, which is inconsistent with leading practices for performance measurement. Without metrics, FDA and APHIS cannot assess the effects of actions taken to manage the use of antibiotics.

Three selected countries and the European Union (EU), which GAO reviewed, have taken various actions to manage use of antibiotics in food animals, including strengthening oversight of veterinarians' and producers' use of antibiotics, collecting farm-specific data, and setting targets to reduce antibiotic use. The Netherlands has primarily relied on a public-private partnership, whereas Canada, Denmark, and the EU have relied on government policies and regulations to strengthen oversight and collect farm-specific data. Since taking these actions, the use or sales of antibiotics in food animals decreased and data collection improved, according to foreign officials and data reports GAO reviewed. Still, some U.S. federal officials and stakeholders believe that similar U.S. actions are not feasible because of production differences and other factors.

HHS and USDA officials said they have not conducted on-farm investigations during foodborne illness outbreaks including those from antibiotic-resistant bacteria in animal products. In 2014, USDA agencies established a memorandum of understanding to assess the root cause of foodborne illness outbreaks. However, in 2015 in the agencies' first use of the memorandum, there was no consensus among stakeholders on whether to conduct foodborne illness investigations on farms and the memorandum does not include a framework to make this determination, similar to a decision matrix used in other investigations. According to a directive issued by USDA's Food Safety and Inspection Service, foodborne illness investigations shall include identifying contributing factors and recommending actions or new policies to prevent future occurrences. Developing a framework, in coordination with HHS's Centers for Disease Control and Prevention (CDC) and other stakeholders, would help USDA identify factors that contribute to or cause foodborne illness outbreaks, including those from antibiotic-resistant bacteria in animal products.

Why GAO Did This Study

According to the World Health Organization, antibiotic resistance is one of the biggest threats to global health. CDC estimates antibiotic-resistant bacteria cause at least 2 million human illnesses in the United States each year, and there is strong evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, and swine). HHS and USDA are primarily responsible for ensuring food safety, including safe use of antibiotics in food animals. In 2011, GAO reported on antibiotic use and recommended addressing gaps in data collection. GAO was asked to update this information. This report (1) examines actions HHS and USDA have taken to manage use of antibiotics in food animals and assess the impact of their actions, (2) identifies actions selected countries and the EU have taken to manage use of antibiotics in food animals, and (3) examines the extent to which HHS and USDA conducted on-farm investigations of foodborne illness outbreaks from antibiotic-resistant bacteria in animal products.

GAO reviewed documents and interviewed officials and stakeholders. GAO selected three countries and the EU for review because they have taken actions to mitigate antibiotic resistance.

What GAO Recommends

GAO is making six recommendations, including that HHS address oversight gaps, HHS and USDA develop metrics for assessing progress in achieving goals, and USDA develop a framework with HHS to decide when to conduct on-farm investigations. USDA agreed and HHS neither agreed nor disagreed with GAO's recommendations.

For more information, contact John Neumann at (202) 512-3841 or neumannj@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA published a notice in the Federal Register In September 2016 requesting information from the public about how to establish appropriately targeted durations of use for therapeutic products affected by Guidance for Industry #213 with no defined duration of use. According to HHS, FDA evaluated the comments received and plans to develop a strategy to address this issue.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

    Agency Affected: Department of Health and Human Services

  2. Status: Open

    Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA recognizes that a limited number of medically important antimicrobial products, available in dosage forms other than feed or water (e.g., injectable), continue to be marketed as OTC products and the agency intends to work with the sponsors to put these products under veterinary oversight..

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

    Agency Affected: Department of Health and Human Services

  3. Status: Open

    Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS noted that FDA has taken steps to develop performance measures and targets. According to HHS, FDA issued a final rule in May 2016 revising annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, and turkeys). Additionally, in August 2017, FDA published a paper proposing the use of a biomass denominator to adjust annual data on the volume of antimicrobials sold or distributed for use in food-producing animals in the United States. According to HHS, this adjusted estimate will provide insight into broad shifts in the volume of antimicrobials sold for use in food-producing animals. FDA is also funding two grants for antimicrobial use data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (i.e., cattle, swine, chickens, and turkeys), which is a critical element in measuring overall impact of the agency's judicious use strategy. FDA expects these data collection efforts to provide important information on methodologies to help optimize long-term strategies to collect and report such antimicrobial use data. In addition, FDA has been working in close collaboration with USDA, including providing input on recent surveys administered by USDA to collect information on antimicrobial use on farms.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

    Agency Affected: Department of Health and Human Services

  4. Status: Open

    Comments: USDA agreed with this recommendation. In August 2018, the Animal and Plant Health Inspection Service stated that it has developed and plans to finalize performance measures and targets for collecting farm-specific data on antibiotic use in farm animals and antibiotic resistant bacteria. We will follow-up with the agency on the status of finalizing these measures.

    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic use in food animals.

    Agency Affected: Department of Agriculture

  5. Status: Open

    Comments: USDA agreed with this recommendation. In August 2018, the Animal and Plant Health Inspection Service stated that it has developed and plans to finalize performance measures and targets for laboratory monitoring for antibiotic resistance of pathogens. We will follow-up with the agency on the status of finalizing these measures.

    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic-resistant bacteria in food animals.

    Agency Affected: Department of Agriculture

  6. Status: Open

    Comments: USDA agreed with this recommendation. In August 2018, USDA's Animal and Plant Health Inspection Service (APHIS) stated that it is working closely with USDA's Food Safety and Inspection Service (FSIS) and HHS' Centers for Disease Control and Prevention to develop a framework for deciding when on-farm antimicrobial resistance investigative activities are warranted. According to APHIS, to assure that the framework will be effectively implemented, the federal partners have requested input from state animal health officials and industry representatives because input from these cooperators is critical to develop a meaningful and usable decision-making framework. However, this has slowed the project schedule because of the additional time needed to share ideas and concerns. APHIS and FSIS have planned a workshop to be held in the Washington, D.C. area in September 2018, to obtain input from state animal health officials and industry representatives (swine, poultry, and cattle). The expected completion date for the requested framework is June 30, 2019.

    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

    Agency Affected: Department of Agriculture

 

Explore the full database of GAO's Open Recommendations »

Jul 17, 2018

Jul 2, 2018

Jun 5, 2018

Apr 18, 2018

Apr 16, 2018

Apr 10, 2018

Mar 5, 2018

Nov 30, 2017

Nov 27, 2017

Nov 21, 2017

Looking for more? Browse all our products here