NIH Administers the Health Research Extension Act

NIH, within the Department of Health and Human Services, administers  the Health Research Extension Act. APHIS and NIH Have Instructed Federal Agencies to Provide Data on Animal Use, but APHIS’s Instructions Have Not Ensured Consistent and Complete Reporting

As directed by the regulations implementing the Animal Welfare Act, the  10 agencies we reviewed submitted to APHIS the required annual reports  on their use of animals covered by the act from fiscal years 2014 through  2016. Animal Use outside the United States

The Animal Welfare Act and reporting  facilities
Animal Welfare Act regulations  “The reporting facility shall be that segment of  the research facility, or that department,  agency, or instrumentality of the United  States, that uses or intends to use live  animals in research, tests, experiments, or for  teaching.”
APHIS’s 2017 Instructions for  completing the annual report  The instructions do not instruct federal  research facilities to report activities involving  animal use outside the United States. Federal Research Facilities We Reviewed Met Instructions to Report Information on Their Animal Care and Use Programs to NIH

NIH has provided guidance to federal and nonfederal research facilities  about what they are required to report on their animal use, and federal  facilities we reviewed met those requirements. NIH provided us with its data for tracking which  facilities were receiving Public Health Service funding and which facilities  had approved programs. APHIS and NIH Publicly Share Some Federal Animal Use Information, but APHIS Does Not Describe the Quality of the Information It Shares

APHIS and NIH publicly report some information about federal agencies’  use of research animals. Reports of APHIS inspections. APHIS has not fully implemented this guidance for the animal use data it  shares publicly. NIH posts a list of federal and nonfederal facilities with active assurances  on its website. Stakeholder Groups Have Differing Views on Whether Agencies Should Share Additional Animal Use Information with the Public

Federal agencies may have additional information about their animal use  programs. In contrast, stakeholders from  animal advocacy organizations cited the need for more transparency and  oversight as reasons that federal agencies should make additional  information routinely available to the public, among other reasons. Conclusions

APHIS and NIH routinely collect information about federal agencies’  research with vertebrate animals and provide the public with related  information. By defining  the birds that need to be reported, by instructing federal research facilities  to report research activities outside the United States, and by working  with the research community to develop clear criteria for identifying field  studies, APHIS would have greater assurance that the data it receives  from research facilities fully reflect the activities covered by the Animal  Welfare Act. In particular, APHIS does not explain issues related to the  completeness and accuracy of the data it provides to the public, for  example, issues such as inconsistencies in the types of field studies  reported by federal agencies. Regarding our first recommendation that the Administrator of APHIS  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,  USDA stated that APHIS  will submit a recommendation and timeline by  September 30, 2018, to USDA officials regarding the development of a  definition for birds. However, we  did not include those activities in our review. Agencies are not  required by the Animal Welfare Act to report their use of animals that are  not covered by the act to the U.S. Department of Agriculture’s Animal and  Plant Health Inspection Service (APHIS). Appendix II: List of Federal and Nonfederal Participants in GAO’s Survey

	Federal departments, agencies, and components:

	Animal advocacy organizations:

	Research and science organizations:

	Academic stakeholders (speaking as individuals and not on behalf of their institutions):

	Other stakeholders:

American Association for Laboratory Animal Science  AAALAC  International  (formerly known as the Association for Assessment  and Accreditation of Laboratory Animal Care International)

Appendix III: Analysis of GAO’s Survey about Whether Federal Agencies Should Publicly Provide Information on Their Use of Animals in Research, Testing, and Training

As described in this report, GAO conducted a survey of federal agencies  and stakeholder groups regarding their opinions on whether federal  agencies should proactively and routinely and publicly share information  about their animals on a website or other means. 1, 2, and 3, respectively.)
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.

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

What GAO Recommends

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.