Two federal departments are primarily responsible for ensuring the safety  of the U.S. food supply, including the safe use of antibiotics in food  animals—HHS and USDA. HHS and USDA Increased Oversight and Data Collection for Antibiotic Use in Animals, but Gaps Exist, and the Impact of These Actions Is Unknown

Since 2011, HHS has increased veterinary oversight of antibiotics in food  animals and, along with USDA, collected additional data on antibiotic use  and resistance, but gaps exist in oversight and data collection, and the  impact of the agencies’ efforts is unknown. In addition, agencies in HHS and USDA made  several improvements in collecting and reporting data on antibiotic sales,  resistance, and use. HHS and USDA are continuing to  search for evidence of colistin-resistant  bacteria in the United States through the  National Antimicrobial Resistance Monitoring  System, according to the HHS website. Gaps in Oversight of Antibiotics in Food Animals

FDA’s guidance to industry has improved oversight of some antibiotics,  but it does not address long-term and open-ended use of medically  important antibiotics for disease prevention because some antibiotics do  not have defined durations of use on their labels. Gaps in Farm-Specific Data Persist

Gaps in farm-specific data on antibiotic use and resistance in food  animals persist since we last reported on this in 2011. HHS  and USDA officials told us they are continuing to make progress towards  developing a joint data collection plan but that funding has been an  impediment. FDA and APHIS Do Not Have Measures to Assess the Impact of Actions Taken

FSIS has developed a performance measure to assess the impact of its  actions to manage the use of antibiotics in food animals, but FDA and  APHIS have not done so. Selected Countries and the EU Have Taken Various Actions to Manage Use of Antibiotics

To manage the use of antibiotics in food animals and combat the  emergence and spread of antibiotic-resistant bacteria, the Netherlands,  Canada, Denmark and the EU have taken actions to strengthen the  oversight of veterinarians’ and producers’ use of antibiotics and to collect  farm-specific data. For Oversight and Data Collection, the Netherlands Relied on a Public-Private Partnership, and the EU and Other Countries Used Government Policies and Regulations

To strengthen oversight and collect farm-specific data on antibiotic use in  food animals, the Netherlands primarily relied on a public-private  partnership, whereas Canada, Denmark, and the EU relied on  government policies and regulations. According to FSIS Directive 8080.3, the objectives of foodborne illness  investigation include identifying contributing factors to the foodborne  illness, including outbreaks, and recommending actions or new policies to  prevent future occurrences. Without developing a process to  establish appropriate durations of use on labels of all medically important  antibiotics, FDA will not know whether it is ensuring judicious use of  medically important antibiotics in food animals. In addition, although APHIS and FSIS established a memorandum of  understanding in 2014 to assess the root cause of foodborne illness  outbreaks, the memorandum does not include a decision-making  framework for determining when on-farm investigations are needed. In  the first use of the memorandum in a 2015 outbreak, there was no  consensus among stakeholders on when such investigations were  needed. Developing a framework for deciding when on-farm  investigations are warranted during outbreaks, in coordination with CDC  and other stakeholders, would help APHIS and FSIS identify factors that  contribute to or cause foodborne illness outbreaks, including those from  antibiotic-resistant pathogens in animal products. USDA agreed with our recommendations. HHS neither agreed nor disagreed with our  recommendations. Appendix I: Objectives, Scope, and Methodology

This report (1) examines actions the U.S. Department of Health and  Human Services (HHS) and U.S. Department of Agriculture (USDA) have  taken since 2011 to manage the use of antibiotics in food animals and to  assess the impact of their actions, (2) identifies actions that selected  countries and the European Union (EU) have taken to manage the use of  antibiotics in food animals, and (3) examines the extent to which HHS and  USDA have conducted on-farm investigations of outbreaks of foodborne  illness from antibiotic-resistant pathogens in animal products. To examine the extent to which HHS and USDA conducted on-farm  investigations of outbreaks of foodborne illness from antibiotic-resistant  pathogens in animal products, we reviewed HHS’s Centers for Disease  Control and Prevention and USDA’s Animal and Plant Health Service  (APHIS) and Food Safety and Inspection Service (FSIS) documentation,  including directives, relevant to investigations of foodborne illness  outbreaks, as well as the 2014 APHIS-FSIS memorandum of  understanding and corresponding standard operating procedures to  access farms for investigations during such outbreaks.
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 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.

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.