Animal Use in Federal Research: Agencies Share Information, but Reporting and Data Quality Could Be Strengthened

GAO-18-459 Published: May 31, 2018. Publicly Released: May 31, 2018.
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Fast Facts

Federal agencies must treat research animals humanely in their quest to answer scientific questions. As a check on their practices, the agencies must submit data about their animal use to the Animal and Plant Health Inspection Service (APHIS) and the National Institutes of Health.

Concerned members of the public seek data on animal use to help ensure humane treatment. We found that agencies publicly report some data on animal use but do not report other data unless asked.

We also found that agencies may not accurately report their animal use to APHIS because of inadequate instructions. We recommended that APHIS improve its instructions.

 

Photo of federal animal welfare policy documents, test tubes, gloves, and other lab equipment.

Photo of federal animal welfare policy documents, test tubes, gloves, and other lab equipment.

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Highlights

What GAO Found

The Department of Health and Human Services' (HHS) National Institutes of Health (NIH) and the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) have provided guidance to federal research facilities on what they must report about their animal use programs under the Health Research Extension Act and the Animal Welfare Act, respectively. Federal research facilities we reviewed met NIH's reporting instructions. However, APHIS's instructions have not ensured consistent and complete reporting in three areas: research with birds, activities outside the United States, and field studies outside a typical laboratory. By clarifying its instructions, APHIS could improve the quality of animal use data it receives from agencies.

APHIS and NIH voluntarily share some information about agencies' animal research with the public. In particular, APHIS posts to its website data on agencies' annual use of animals covered by the Animal Welfare Act, and NIH publicly posts a list of research facilities with approved animal use programs. However, APHIS does not describe potential limitations related to the accuracy and completeness of the data it shares as called for by USDA guidance. For example, APHIS does not explain that the data do not include birds used for activities that are covered by the Animal Welfare Act and may include field studies that are not covered by the act. APHIS could increase the data's usefulness to the public by making such disclosures.

Federal agencies may have additional information about their animal use programs, including data on vertebrate species used but not reported to APHIS; the purpose of research activities; and internal inspection reports. However, stakeholders GAO surveyed had different views on agencies' sharing such data with the public. Some stakeholders, particularly animal advocacy organizations, cited the need for more transparency and oversight while others, including federal agencies and research and science organizations, raised concerns about the additional administrative burden on agencies.

Animal Species Covered by the Animal Welfare Act and the Health Research Extension Act

 

Animal Welfare Act

Health Research Extension Acta

Species covered

Dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, horses used for research purposes, and other warm-blooded animals, with certain exceptions

Any live, vertebrate animal

Species not covered

Invertebrates

Birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research

Livestock or poultry used in certain agricultural research

Cold-blooded vertebrates, such as fish and reptiles

Invertebrates

Source: GAO analysis of the Animal Welfare Act and the Office of Laboratory Animal Welfare's Public Health Service Policy on Humane Care and Use of Laboratory Animals. | GAO-18-459.

aThe act covers research funded by the public health service agencies of the U.S. government.

Why GAO Did This Study

Research facilities, including those managed by federal agencies, use a wide range of animals in research and related activities each year. The Animal Welfare Act and the Health Research Extension Act have varying requirements for federal agencies and others to protect the welfare of and report on the use of different research animals to APHIS and NIH.

GAO was asked to review several issues related to animals used in federal research. This report examines (1) the extent to which APHIS and NIH have provided federal facilities with guidance for reporting their animal use programs, (2) the extent to which APHIS and NIH have shared agencies' animal use information with the public, and (3) stakeholder views on federal agencies' sharing additional information. GAO identified federal agencies that used vertebrate animals in research in fiscal years 2014 through 2016, reviewed their reports to APHIS and NIH, and examined publicly available data. GAO also surveyed a nongeneralizable sample of stakeholders from federal agencies and animal advocacy, research and science, and academic organizations.

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Recommendations

GAO recommends that APHIS clarify its reporting instructions and fully describe the potential limitations of the animal use data it makes available to the public. USDA stated that APHIS will take steps to implement GAO's recommendations, with the exception of clarifying reporting instructions for activities outside the United States. GAO continues to believe that APHIS needs to ensure complete reporting of such activities by federal facilities.

Recommendations for Executive Action

Agency Affected Recommendation Status
Animal and Plant Health Inspection Service The Administrator of APHIS should develop a timeline for (1) defining birds that are not bred for research and that are covered by the Animal Welfare Act, and (2) requiring that research facilities report to APHIS their use of birds covered by the act. (Recommendation 1)
Closed – Implemented
In February 2022, APHIS published a timeline for a proposed rule that, according to the agency, would amend the regulations to establish standards governing the humane handling, care, treatment, and transportation of birds, excluding birds bred for use in research, covered under the Animal Welfare Act. The proposed rule includes new definitions of birds, bred for use in research, and poultry; and, states that the "proposed changes to the regulations would also result in the creation of new reportable activities" for research facilities and other entities. A final rule is expected in February 2023.
Animal and Plant Health Inspection Service The Administrator of APHIS should instruct federal agencies to report their use of animals covered by the Animal Welfare Act in federal facilities located outside of the United States. (Recommendation 2)
Open
USDA disagreed with this recommendation for several reasons. These reasons include (1) the lack of an exclusion in the Animal Welfare Act (AWA) or APHIS' regulations under the Act not explicitly or implicitly creating any requirement to collect information; (2) the collection of information about research activities outside of the United States not enabling or informing the agency's daily administration of the AWA and charge to ensure the humane treatment of animals; and (3) the additional regulatory burden on federal research facilities. In March 2022, APHIS officials reiterated these reasons for the agency's continued disagreement with the recommendation. As explained in our report, we continue to believe that the Administrator of APHIS should instruct federal agencies to report their use of animals in activities covered by the Animal Welfare Act in federal facilities located outside of the United States.
Animal and Plant Health Inspection Service In developing the definition of field studies, the Administrator of APHIS should provide research facilities with clear criteria for identifying field studies that are covered by the Animal Welfare Act's regulations and that facilities should report to APHIS as well as field studies that facilities should not report. (Recommendation 3)
Closed – Implemented
In its comments on our draft report, USDA stated that APHIS agreed to issue a guidance document. In September 2020, APHIS sought public comment on a proposed policy document to assist research institutions in determining whether an activity meets the regulatory definition of "field study." In May 2021, APHIS published a "Tech Note"--a document that restates, summarizes and provides interpretative guidance on the law--entitled "Research Involving Free-Living Wild Species in Their Natural Habitat." This Tech Note identifies criteria for identifying field studies covered by the Animal Welfare Act and states the types of field studies that should and should not be reported to APHIS.
Animal and Plant Health Inspection Service The Administrator of APHIS should ensure APHIS fully describes on its website how the agency compiles annual report data from research facilities, what the data represent, and any potential limitations to the data's completeness and accuracy. (Recommendation 4)
Closed – Implemented
In October 2018, APHIS updated its website to include additional information describing how the agency compiles annual report data from research facilities, including steps it takes to validate the completeness and accuracy of data. In addition, APHIS included text on its website stating that research facilities may include additional data in their annual reports that is not required under the Animal Welfare Act. According to APHIS, the agency implemented on-line submission of the annual report, which also clarified the information that is not required to be reported. These clarifications addressed a limitation in the data that we had identified in our report.

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