Both HHS and USDA officials  have stated that it is likely that the use of antibiotics in animal agriculture  leads to some cases of antibiotic resistance among humans and that  medically important antibiotics should be used judiciously in animals. Agency Data Are Limited and Restrict Efforts to Understand Antibiotic Resistance

The 2001 interagency plan discusses two types of data needed to  understand antibiotic resistance—data on the amount of antibiotics used  in food animals (“use data”) and data on the level of antibiotic resistance  in bacteria found in food animals and retail meat (“resistance data”). Agencies have collected some data to track antibiotic use in animals, but  these data lack crucial details identified by the 2001 interagency plan as  essential for agencies to examine trends and understand the relationship  between use and resistance. However, FDA faces several  challenges in collecting detailed antibiotic sales data from drug sponsors. Instead, FDA has proposed a voluntary strategy to  mitigate this risk but has neither developed a plan nor collected the  “purpose of use” data necessary to measure the effectiveness of its  strategy. In 2003, FDA issued guidance recommending that antibiotic sponsors  include a risk assessment of any new antibiotics for use in food animals. FDA officials told us that conducting individual postapproval  risk assessments for all of the antibiotics approved prior to 2003 would be  prohibitively resource intensive, and that pursuing this approach could  further delay progress on the issue. Agencies Took Steps to Research Alternatives and Educate Users, but Progress Is Unclear

USDA and HHS agencies have taken some steps to research alternatives  to current antibiotic use practices and educate producers and  veterinarians on appropriate use of antibiotics but the extent of these  steps is unclear because neither USDA nor HHS has assessed the  progress toward fulfilling the related action items in the 2001 interagency  plan. Without an assessment of past research  efforts, agencies may be limited in their ability to identify gaps where  additional research is needed. Regulation of Antibiotics in the EU and Denmark May Offer Lessons for the United States

Since 1995, the EU and Denmark have taken a variety of actions to  regulate antibiotic use in food animals and mitigate the risk such use may  pose to humans. Officials also mentioned declines in  resistance among Campylobacter bacteria (which can cause foodborne  illness in humans) from food animals and retail meat. Second, they  mentioned that data on both antibiotic use and antibiotic resistance are  needed in order to fully understand how use in animals is related to  resistance in humans. EU officials said these baseline studies provide information that is  comparable across countries. For  example, although FDA has a new effort to collect data on antibiotics sold  for use in food animals, these data lack crucial details, such as the  species in which the antibiotics are used and the purpose for their use. In addition, two USDA  agencies collect data on antibiotic use from food animal producers, but  data from these surveys provide only a snapshot of antibiotic use  practices and cannot be used to examine trends. For data on antibiotic resistance, HHS and USDA agencies have  leveraged existing programs to collect samples of bacteria, but the  resulting data are not representative of antibiotic resistance in food  animals and retail meat throughout the United States. Recommendations for Executive Action

We are making the following three recommendations:    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, we recommend the Secretaries of  Agriculture and Health and Human Services 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. Appendix I: Objectives, Scope, and Methodology

The objectives of our review were to determine (1) the extent to which  federal agencies have collected data on antibiotic use and resistance in  food animals; (2) the actions the Food and Drug Administration (FDA) has  taken to mitigate the risk of antibiotic resistance in humans as a result of  antibiotic use in food animals; (3) the extent to which federal agencies  have conducted research on alternatives to current antibiotic use  practices and educated producers and veterinarians about appropriate  antibiotic use; and (4) what actions the European Union (EU) and an EU  member country, Denmark, have taken to regulate antibiotic use in food  animals and what lessons, if any, have been learned.
Why GAO Did This Study

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..

What GAO Found

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.

What GAO Recommends

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.