In addition, FDA’s primary responsibilities as a regulatory body focus on  human health and animal drug safety. Many of the studies we reviewed  found that this transference poses significant risks for human health. Many Studies Have Found That Transference of Antibiotic-Resistant Bacteria from Animals to Humans Is a Human Health Risk, but Researchers Disagree About the Extent of Risk

The extent of harm to human health from the transference of antibiotic- resistant bacteria from animals is uncertain. However, a small number of studies  contend that the health risks of the transference are minimal. Federal Agencies Have Increased Surveillance of Antibiotic Resistance from Animals to Assess Human Health Risk; Effectiveness of Risk Reduction Efforts Is Not Yet Known

FDA, CDC, and USDA have increased their surveillance activities related to  antibiotic resistance in animals, humans, and retail meat since beginning  these activities in 1996. FDA has not made drugs that are critically important for human health its  top priority for review. To develop and evaluate strategies to mitigate resistance. The United States and Its Key Trading Partners and Competitors Differ in the Restrictions They Place on the Use of Antibiotics in Animals

The United States and several of its key trading partners, such as Canada  and South Korea, and its competitors, such as the EU, differ in their use of  antibiotics in animals in two important areas:  the specific antibiotics that  can be used for growth promotion and the availability of antibiotics to  producers (by prescription or over the counter). Denmark, an EU member,  already prohibits all over-the-counter sales. However, the presence of antibiotic residues in meat  has had some impact on trade. For example, according to some government and  industry officials, the United States’ use of antibiotics could become a trade  issue with the EU as it phases out its use of all antibiotics for growth  promotion by 2006. Although FDA  has recently begun the reviews using this approach, its initial reviews have  been for drugs other than those that are critically important for human  health. Additionally, 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, we also recommend that the Secretaries of  Agriculture and of Health and Human Services 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. Objectives, Scope, and Methodology

This report examines the (1) scientific evidence regarding the transference  of antibiotic resistance from animals to humans through the consumption  or handling of contaminated meat, and the extent of potential harm to  human health, (2) progress federal agencies have made in assessing and  addressing the human health risk of antibiotic use in animals, (3) types of  data that federal agencies need to support research on the human health  risk of antibiotic use in animals and the extent to which these data are  collected, (4) use of antibiotics in animals in the United States compared  with antibiotic use by its key agricultural trading partners and competitors,  and (5) information that is available on the degree to which antibiotic use  in animals has affected U.S. trade. We interviewed officials from HHS’s Food and Drug  Administration (FDA) and Centers for Disease Control and Prevention  (CDC) and the U.S. Department of Agriculture (USDA) to determine how  these agencies are assessing the human health risk of antibiotic use in  animals. FDA is conducting risk  assessments of some antibiotics important in human medicine.
Why GAO Did This Study

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.

What GAO Found

Scientific evidence has shown that certain bacteria that are resistant to antibiotics are transferred from animals to humans through the consumption or handling of meat that contains antibiotic-resistant bacteria. However, researchers disagree about the extent of harm to human health from this transference. Many studies have found that the use of antibiotics in animals poses significant risks for human health, but a small number of studies contend that the health risks of the transference are minimal. Federal agencies have expanded their efforts to assess the extent of antibiotic resistance, but the effectiveness of their efforts to reduce human health risk is not yet known. FDA, CDC, and USDA have increased their surveillance activities related to antibiotic resistance. In addition, FDA has taken administrative action to prohibit the use of a fluroquinolone in poultry. FDA has identified animal drugs that are critically important for human health and begun reviewing currently approved drugs using a risk assessment framework that it recently issued for determining the human health risks of animal antibiotics. However, because FDA's initial reviews of approved animal drugs using this framework have focused on other drugs and have taken at least 2 years, FDA's reviews of critically important drugs may not be completed for some time. Although federal agencies have made some progress in monitoring antibiotic resistance, they lack important data on antibiotic use in animals to support research on human health risks. These data, such as the type and quantity of antibiotics and purpose for their use by species, are needed to determine the linkages between antibiotic use in animals and emerging resistant bacteria. In addition, these data can help assess human health risks from this use and develop and evaluate strategies for mitigating resistance. The United States and several of its key agricultural trading partners and competitors differ in their use of antibiotics in animals in two important areas: the specific antibiotics allowed for growth promotion and availability of antibiotics to producers (by prescription or over the counter). For example, the United States and Canada allow some antibiotics important in human medicine to be used for growth promotion, but the European Union (EU) and New Zealand do not. Regarding over the counter sales of antibiotics, the United States is generally less restrictive than the EU. Antibiotic use in animals has not yet been a significant factor affecting U.S. international trade in meat and poultry, although the presence of antibiotic residues in meat has had some impact, according to government and industry officials. Instead, countries raise other food safety issues, such as hormone use and animal diseases. However, according to these officials, antibiotic use in animals may emerge as a factor in the future. They particularly noted that the EU could object to U.S. use of antibiotics for growth promotion as its member countries are phasing out that use.