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

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.

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.

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.

U.S. research facilities, including those managed by federal agencies,  use a wide range of animal species in research, testing, teaching, and  experimentation. These activities can occur in laboratories or field  settings and have many purposes, such as developing knowledge about  human disease diagnosis and treatment, testing medicines and other  products for toxicity, training professionals in veterinary methods, and  conserving animal populations. Federal agencies conducted research  using animals at about 120 domestic and international research facilities  in fiscal years 2014 through 2016. For example, the Departments of  Defense, Health and Human Services (HHS), and Veterans Affairs have  used rats, mice, nonhuman primates, and other species in research on  disease prevention and treatment. The U.S. Department of Agriculture  (USDA) has used cattle, poultry, and other agricultural species in  research on animal production and health and on the effects of animal  agriculture on the environment, among other things. The Departments of  Commerce and the Interior and other agencies have also conducted  conservation research on a wide range of species, often in the field.

Research with animals has led to advances in scientific understanding,  but it has also raised concerns about animal welfare. In particular,  concerns about the welfare of animals used in research encompass a  range of factors, such as efforts to minimize pain, the suitability of living  conditions, the negative effects on wild populations when animals are  removed or handled, and the care provided for animals when they are no  longer needed for research. In response to these and other concerns, the  U.S. government has implemented statutes, regulations, and policies that  govern how animals are to be cared for and used for certain purposes,  including research conducted by federal and nonfederal facilities.

In particular, the USDA’s Animal and Plant Health Inspection Service  (APHIS) is responsible for implementing the Animal Welfare Act. APHIS  is to:  implement standards for the humane handling, care, treatment, and  transportation of the species covered by the act,  routinely inspect nonfederal research facilities for compliance with  those standards, and collect information from federal and nonfederal research facilities  about their uses of animals covered by the act.

The HHS’s National Institutes of Health (NIH) is responsible for  establishing guidelines implementing certain provisions of the Health  Research Extension Act of 1985. Specifically, NIH  is responsible for  reviewing federal and nonfederal research facilities’ animal care and use  programs to determine whether they meet relevant standards and are  thereby eligible to receive funding from HHS’s Public Health Service  agencies, including NIH. To complete this review, NIH  collects  information from research facilities about their use of animals. NIH’s  review includes federal agencies that wish to receive Public Health  Service funding.

These and other statutes also address, to varying degrees, actions that  federal and nonfederal research facilities must take to collect and report  information about their animal research activities to APHIS, NIH,  or the  public. For example, the regulations implementing the Animal Welfare Act  require that all research facilities annually report information about their  use of certain animals to APHIS. Likewise, the Health Research  Extension Act requires that facilities that receive Public Health Service  funding report information about their animal use program to NIH. The  public may request information about agencies’ research activities using  procedures established under the Freedom of Information Act (FOIA),  which requires federal agencies to provide the public with access to  government information, with some exceptions, on the basis of the  principles of openness and accountability in government.

You asked us to review several issues related to federal agencies’ use of  animals in research and related activities—specifically, research with their  own staff using their own facilities and equipment. This report examines:  the extent to which APHIS  and NIH provided federal agencies with  guidance for reporting on their animal use programs,  the extent to which APHIS  and NIH share information on animal use  with the public, and stakeholders’ views on federal agencies’ sharing of additional  information.

We focused our review on federal agencies that conduct research with  vertebrate animals. Our review did not examine the research performed  by nonfederal entities using federal funding. We sought to identify  agencies that conduct activities with vertebrate species because the  Animal Welfare Act and the Health Research Extension Act govern  activities with vertebrate species but not activities with invertebrate  species.

Using these criteria, we focused our review on 10 agencies that we  identified as conducting such activities (with their own staff using their  own facilities and equipment) during fiscal years 2014, 2015, or 2016.  The agencies are Commerce, Defense, HHS, Department of Homeland  Security (DHS), Interior, USDA, VA, the Environmental Protection Agency  (EPA), the National Aeronautics and Space Administration (NASA), and  the Smithsonian Institution. We chose to analyze these agencies’  activities and compliance with the reporting requirements over the 3-year  period in order to better identify issues that might not be evident in  examining a single year, and fiscal year 2016 was the most recent year  for which data reported to APHIS  were available.  To identify these 10  agencies, we contacted a total of 14 independent agencies that we  believed were likely to conduct research using vertebrate animal species  based on information from USDA, HHS, and other relevant sources. We  asked the 14 agencies to identify the species of vertebrate animals that  they used in research within the 3-year time frame. Four agencies responded that they did not conduct research with vertebrate animals in  fiscal years 2014 through 2016. Therefore, they did not meet our criteria  for inclusion in our review. See appendix I for detailed information on the  activities of the 10 agencies included in our review.

To examine the extent to which APHIS and NIH provided federal  agencies with guidance for reporting on their animal use programs, we  took the following steps:

APHIS. We reviewed the Animal Welfare Act and its implementing  regulations and interviewed agency officials to identify relevant  reporting requirements and determine whether they were consistent  with APHIS’s reporting instructions. To assess the instructions, we  examined how agencies followed them in practice. In particular, we  obtained from APHIS the data that federal agencies or their facilities  submitted for fiscal years 2014 through 2016 to determine whether  agencies submitted reports as expected.

NIH. We reviewed the Health Research Extension Act and  accompanying NIH policy to identify the information that federal  research facilities must provide to NIH to be eligible for Public Health  Service funding. We also reviewed NIH’s guidance to research  facilities on how to obtain eligibility  for funding. To assess the  guidance, we examined its implementation through NIH  and other  federal agencies’ actions. In particular, we determined whether NIH  had current approvals for all federal research facilities receiving such  funding through interviews with NIH officials and by reviewing NIH  documents. We then reviewed a sample of 16 assurances from  federal facilities chosen by randomly selecting a facility from each  agency or sub-agency that had approved animal care and use  programs. We compared the information in the selected assurance  documents with NIH’s guidance to determine whether the documents  contained key information.

We also took steps to assess the reliability of information that APHIS  provided us about federal agencies and facilities that report to it under the  Animal Welfare Act and information that NIH provided on federal research facilities receiving Public Health Service funding. In particular, we cross- checked animal use information from APHIS with animal use information  we obtained directly from the 10 agencies in our review of their facilities’  research activities. In addition, we checked summary data on animal use  that we obtained from APHIS against the annual reports that federal  agencies sent to APHIS under the Animal Welfare Act to determine  whether the data were consistent. We also reviewed NIH’s website for  information about research facilities with approved assurances, and we  reviewed NIH documentation and queried NIH officials about their  process for ensuring that facilities receiving Public Health Service funding  for animal research have an assurance. Based on these steps, we  determined that the APHIS and NIH  information on federal facilities that  conduct animal research was sufficiently reliable for examining APHIS  and NIH guidance to agencies on reporting about their animal use  programs.

To examine the extent to which APHIS and NIH share information on  animal use with the public, we interviewed agency officials and reviewed  agency websites. In particular, we interviewed APHIS officials to identify  the agency’s current policies and procedures for collecting and posting to  its website the annual reports the agency receives from research  facilities. We reviewed the APHIS website to document the timespan  covered by the data that are posted and the methods by which the data  can be searched by the public. We also reviewed APHIS’s posting of  annual report data against USDA’s data quality requirements, which state  that USDA’s agencies and its offices will strive to ensure that the  information they disseminate for the public is substantively accurate,  reliable, and unbiased and presented in an accurate, clear, complete, and  unbiased manner. We interviewed NIH officials to identify the agency’s  policies and procedures for making public information about research  facilities that seek approval for a Public Health Service animal welfare  assurance, such as the identity of facilities with approved assurances or  descriptions of their animal care programs.

For insight into stakeholders’ views on federal agencies’ sharing  additional information, we surveyed federal departments and agencies that conduct research as well as nonfederal organizations and individuals  we identified as having knowledge and interest in animal research. We  surveyed the 10 federal agencies that we identified as conducting  research with vertebrate animals in fiscal years 2014, 2015, or 2016. All  10 agencies provided at least one response, with some providing  responses from multiple sub-agencies or components. The total number  of federal responses was 20.

We also sent surveys to a nongeneralizable sample of 28 nonfederal  stakeholders identified using a “snowball selection” methodology. We  sought to gather perspectives from a variety of stakeholders, and our  sample included organizations that advocate on behalf of animals;  research and science organizations; individuals from academia; and other  stakeholders we identified as having knowledge of animal research  issues and a national focus or representation. Nineteen of these 28  groups completed the survey. See app. II for a complete list of  respondents.

The survey asked about specific types of information about animal use  and whether stakeholders believed federal agencies should proactively  and routinely share such information with the public on a website or by  other means. In particular, we asked respondents for their views on  whether agencies should routinely make available to the public  information that we determined agencies may possess for internal  decision-making purposes and, under certain circumstances, may provide  to other parties, including NIH or a private organization for accreditation of  a facility’s animal care program. Such information could include data on  all vertebrate animals used, information on the purpose of specific  research activities, and general descriptions of the agency’s animal care  program. The survey also asked whether stakeholders reviewed and  used annual reports that APHIS posts on its website and what changes  stakeholders would like to see, if any, in how APHIS collects and posts  annual report data on its website. See app. III  for a summary of the  stakeholders’ suggested changes. We included these questions to  understand the extent to which stakeholders use available data and  whether they had suggestions for changes in how APHIS currently makes  data routinely available. We did not ask stakeholders a similar question  about NIH because that agency does not proactively provide data to the  public about federal agencies’ use of animals in research.

We conducted this performance audit from April 2017 to May 2018 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

The Department of Agriculture Administers the Animal Welfare Act

USDA’s APHIS  is responsible for implementing the Animal Welfare Act.  The act and its implementing regulations govern, among other things,  how federal and nonfederal research facilities must treat particular  species of warm-blooded animals to ensure their humane treatment when  used in research, teaching, testing, or experimentation. The Animal  Welfare Act’s definition of “animal” excludes birds, rats of the genus  Rattus, and mice of the genus Mus when those animals are bred for use  in research. The act also excludes horses not used for research purposes  and other farm animals used or intended for use as food or fiber or in  certain types of research. The Animal Welfare Act also excludes cold- blooded animals—such as fish, reptiles, or amphibians—and  invertebrates. See table 1 for a summary of the animals covered and  not covered by the Animal Welfare Act. (Animals covered by the Health  Research Extension Act are also included in table 1 and described in the  next section.)

The Animal Welfare Act and its regulations contain specific standards for  research facilities. These include:

Registration. Nonfederal research facilities that conduct activities  regulated by the Animal Welfare Act must register with APHIS. The  act does not require that federal research facilities register with  APHIS. APHIS does, however, assign federal research facilities  certificate numbers that it uses to track whether they have submitted  their required annual report (see below). As of March 2018, APHIS  had assigned such numbers to 157 federal research facilities. Some  of these federal research facilities, such as VA, have elected to report  information to APHIS on an individual basis, while others, such as the  HHS’s Centers for Disease Control and Prevention, submit a single  report covering research facilities in several states.

Annual report. Reporting facilities that used or intended to use live  animals in research, tests, experiments, or for teaching must submit a  retrospective annual report about those animals to APHIS on or  before December 1 of each calendar year.

Standards for humane handling, care, treatment, and  transportation of animals. The Animal Welfare Act directs research  facilities to meet certain standards of care for the animal species that  are covered by the act. The standards of care are tailored to particular  species of animals or groups of species.  Institutional Animal  Care and Use Committees. Research facilities  must appoint a committee to, at least semi-annually, review the  facility’s program for humane care and use of animals, to inspect all  facilities, and to prepare reports of its evaluation. The committee is  responsible for reviewing research proposals to determine whether  the proposed activities are in accordance with the act or there is an  acceptable justification for a departure from the act.

Federal inspections. APHIS officials have the authority to inspect  nonfederal research facilities, records, and animals to enforce the  provisions of the act. The Animal Welfare Act does not expressly  provide APHIS the authority to inspect federal research facilities, and  APHIS will not do so unless invited.

The Animal Welfare Act exempts farm animals, other than horses, from  its coverage when they are used or intended for use as food or fiber or in  agricultural research that is intended to improve animal nutrition,  breeding, management, or production efficiency, or to improve the quality  of food or fiber. According to officials with USDA’s Agricultural Research  Service (ARS), most of the agency’s research activities fall under this  exemption. Nevertheless, in February 2016, APHIS and ARS signed a  memorandum of understanding concerning laboratory animal welfare.  The intent of the memorandum of understanding is to maintain and  enhance agency effectiveness and avoid duplication by allowing APHIS  to use applicable sections of the Animal Welfare Act’s requirements,  regulations, and standards to inspect ARS animal research facilities.  Among the provisions of the memorandum, ARS agreed to register its  animal research facilities with APHIS and submit an annual report to  APHIS. As of March 2018, 35 ARS animal research facilities were  voluntarily registered with APHIS, and ARS facilities submitted their first  annual reports for activities conducted in fiscal year 2016.

NIH Administers the Health Research Extension Act

NIH, within the Department of Health and Human Services, administers  the Health Research Extension Act. The act calls for the Director of NIH  to establish guidelines that govern how certain research institutions that  conduct activities using animals are to consider animal welfare. In  particular, the guidelines govern how those research institutions— including federal facilities—that receive funding from Public Health  Service agencies are to ensure the humane treatment of all vertebrate  animals used in biomedical or behavioral science research. NIH  conducts  site visits at selected institutions to assess compliance with the act.  Whereas the Animal Welfare Act applies to certain warm-blooded  animals, the definition of animals used for the purposes of the Health  Research Extension Act covers all vertebrates, including mice, rats, and  fish species that are commonly used in laboratory research (see table 1).

Under the act, research institutions are required to provide certain  information to NIH in order to be eligible for Public Health Service funding.  In particular, they must provide for NIH approval a document that  describes their animal care and use program and that assures that the  facility meets applicable standards. NIH calls for research institutions to  provide, among other information, a commitment to comply with all  applicable provisions of the Animal Welfare Act and other federal statutes  and regulations relating to animals, a description of the facility, and an  “average daily inventory” of species housed at the facility. In addition,  research institutions approved for Public Health Service funding must  annually report changes in their animal use program to NIH. As of  September 2017, NIH had approved 111 federal facilities across 8  agencies for funding under the 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. However, APHIS’s reporting instructions have not ensured  consistent and complete reporting because they have been unclear about  which animal species, activities, and activity locations are required to be  reported for the purposes of the Animal Welfare Act. Federal facilities that  conduct activities with animals using Public Health Service funding that  we reviewed met NIH  requirements to provide assurance documentation  about their animal use programs and to provide required annual reports  for fiscal years 2014 through 2016.

Federal Agencies Generally Report to APHIS on Animal Use, but APHIS Has Not Provided Sufficient Instructions to Ensure Consistent and Complete Reporting

The Animal Welfare Act regulations require federal agencies that use or  intend to use live animals in research to report on their use of these  animals. As directed by APHIS, these agencies, or their individual  research facilities, must submit an annual report to APHIS on or before  December 1 of each calendar year. APHIS instructs research facilities to  submit an annual report that:  includes information about animals covered by the Animal Welfare  Act’s regulations and the number of such animals used as well as  those held for use but not used, and provides assurances that the facility has met applicable standards,  such as standards for the appropriate use of anesthetic, analgesic,  and tranquilizing drugs.

In addition, facilities must report whether the animals fall into one of three  categories related to pain or distress and the efforts the facilities took to  relieve pain or distress. Facilities must also attach a summary of any  activity that did not meet the standards of the act but that were approved  by the facility’s Institutional  Animal Care and Use Committee.

All 10 of the federal agencies we reviewed submitted annual reports to  APHIS showing that their facilities had used animals in research in fiscal  years 2014 through 2016. APHIS has procedures in place to track which  agencies’ facilities have reported and to notify any that have not done so.  For example, APHIS has developed schedules for sending reminders to  facilities that have not yet reported. APHIS expects federal research  facilities that it has assigned certificate numbers but that did not use any  animals in a particular fiscal year to submit a report with that information.

APHIS data show that the 10 federal agencies in our review reported that  their facilities used more than 210,000 animals covered by the Animal  Welfare Act in fiscal years 2014 through 2016. However, in our  comparison of federal agencies’ annual reports to APHIS  with their  responses to our request for information about their activities, we found  instances in which agencies did not report activities covered by the act or  did not report similar activities consistently across facilities. These  conditions resulted, in part, from APHIS not providing sufficient  instructions on the research activities that federal agencies are to include  in their annual reports. Additionally,  we found that facilities reported  species not covered by the act. As a result, the data that research  facilities submit to APHIS in their annual reports may not accurately  reflect the facilities’ uses of animals covered by the act. We identified  three areas in which federal agencies’ annual reports were inconsistent or  incomplete: birds, animal use outside the United States, and field studies.

Animal Welfare Act  The term animal excludes birds bred for use  in research.

APHIS’s 2017 instructions for  completing the annual report  “o NOT  report the use of … birds, reptiles,  fish or other animals w hich are exempt from  the regulation under the .”

In 2002, Congress amended the definition of animal in the Animal Welfare  Act to exclude birds that are bred for use in research. However, APHIS  instructs facilities to not report any birds in their annual reports,  regardless of whether they were bred for research. Five agencies  reported to us that their research facilities used birds in fiscal years 2014  through 2016—including some not bred for research and therefore  potentially covered by the act—but that they followed APHIS’s  instructions to not report them. According to APHIS officials, since  Congress amended the definition of animal in the act, the agency has  been aware of the need to define which birds are covered by the act and  should, among other things, be reported to APHIS by research facilities.  The officials said that until the agency has defined birds covered by the  act, they do not believe that it is appropriate to require research facilities  to report their use of birds.

However, as of February 2018, APHIS had not provided us with a  schedule or plan for defining birds covered by the act or for developing reporting requirements for those birds. As a result, it is unclear when, or  if, APHIS  will require research facilities to report their use and treatment  in research of birds that are covered by the Animal Welfare Act. Until  APHIS develops such requirements, federal (and other) research facilities  will have incomplete information about what information they should  include in annual reports submitted to APHIS, and APHIS will not have  assurance that annual reports from research facilities fully reflect  research activities covered by the act.

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.

The Animal Welfare Act regulations define a reporting facility to include a  department, agency, or instrumentality of the United States. Officials from  USDA’s Office of the General Counsel told us that there is no exclusion in  the act or its regulations for federal research facilities that are located  outside of the United States. However, APHIS  does not instruct federal  research facilities to report activities involving animal use outside the  United States. Of the 10 agencies with federal research facilities that  submitted annual reports to APHIS, we identified three through our initial  contacts and follow-up interviews that conduct activities outside the  United States involving animals that may be covered by the Animal  Welfare Act: the Departments of Commerce and Defense and the  Smithsonian Institution. We found that officials from the three agencies  had a different understanding of their obligation to report those activities  to APHIS.  A senior official from the Department of Commerce’s National  Marine Fisheries Service said that he knew of no reason to not report on  studies conducted outside the United States and that the agency had  reported such activities in fiscal year 2017. On the other hand, officials  from the Department of Defense and the Smithsonian Institution told us  that APHIS officials have instructed them not to report activities  conducted outside of the United States. As a result, the Department of  Defense and the Smithsonian Institution did not report animal use in their  non-domestic facilities in fiscal years 2014 through 2016. With  instructions from APHIS that federal research agencies report all activities  covered by the Animal Welfare Act, regardless of location, APHIS and the  public would have greater assurance that annual reports fully reflect  activities covered by the act and that agencies are reporting such  activities consistently.

The Animal Welfare Act and field studies

Animal Welfare Act regulations  “Field study means a study conducted on  free-living w ild animals in their natural habitat.  How ever, this term excludes any study that  involves an invasive procedure, harms, or  materially alters the behavior of an animal  under study.”

APHIS’s  2017 instructions for completing  APHIS’s  instructions do not sufficiently clarify  the conditions under w hich a field study w ould  be invasive, harmful, or materially alter  behavior and, therefore, be covered under the  act.

APHIS exempts some research involving wild animals from the  requirements of the Animal Welfare Act regulations, including annual  reporting. Specifically, in promulgating the current definition of “field  studies” in regulation, APHIS stated, “if the research project meets the  definition of field studies, the research project would not fall under the   regulation.” To qualify for this exemption, a study  must take place in a free-living, wild animal’s natural habitat and not  involve an invasive procedure, harm, or materially alter the behavior of an  animal under study. APHIS’s instructions for annual reporting note this  exemption. However, they do not sufficiently clarify the conditions under  which a field study would qualify, nor do they point to any source  providing clarifying language. For example, the instructions do not  describe criteria research facilities could use to identify activities that are  invasive, harmful, or materially alter behavior.

We found that agencies have interpreted the field study exemption  differently. For example,

Officials from three agencies within the Department of the Interior told  us that the agencies did field research with many species in fiscal  years 2014 through 2016, but we found the agencies had different  approaches to reporting that research to APHIS. Specifically, the U.S.  Geological Survey and National Park Service reported using dozens  of animal species to APHIS while the Fish and Wildlife Service did not  report any. An official with the Fish and Wildlife Service explained to  us that the agency did not report the animals to APHIS because they  were only held temporarily. Officials from the Fish and Wildlife Service  and U.S. Geological Service told us that APHIS’s guidance on field  studies is confusing and causes discrepancies in reporting.

NASA conducts research involving temporary capture, blood  sampling, and tagging of animals to study any possible effects of  NASA’s launch sites on the surrounding ecosystem, but the agency  does not include these activities in its annual reports to APHIS. The  National Marine Fisheries Service conducts field research also  involving temporary capture, blood sampling, and tagging of marine  mammals for various purposes. Some of the service’s research  facilities have reported these types of activities to APHIS, and  according to a service official, the other facilities plan to do so. An  official from the service also told us that the agency has received  inconsistent guidance from APHIS about what field research to report.

The National Marine Fisheries Service’s facilities that have reported  animal research to APHIS have represented a large portion of the overall  number of animals that federal facilities reported in fiscal years 2014  through 2016. For example, in fiscal year 2016, the agency’s facilities  accounted for nearly 16,000 of about 82,000 animals reported to APHIS  by the 10 federal agencies in our review. Therefore, whether these  activities should or should not be reported will have a large effect on the  total number of animals that federal facilities reported using for research.

APHIS officials told us that they are developing additional clarifying  guidance on field studies and will publish the guidance for public  comment in the third quarter of fiscal year 2018. However, APHIS has not  yet released a draft of this guidance. A draft with criteria for identifying  which field studies are covered by the Animal Welfare Act and therefore  should be reported—for example, because the studies are considered to  be invasive, harmful, or materially alter behavior—would enable APHIS to  ensure that the research community’s views are incorporated. With  clearer instructions that include such criteria, APHIS and the public would  have greater assurance that annual reports fully reflect activities covered  by the act.

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. In order to obtain funding  from the Public Health Service agencies, research facilities must obtain  approval from NIH of their animal welfare assurance statement and must  provide annual reports to NIH.  To obtain an approved assurance, a  research facility must provide NIH with information about its animal care  and use program. NIH provides facilities with a sample assurance  document that describes the required information, including assurances  of compliance with animal welfare standards signed by appropriate  officials, a roster of Institutional  Animal Care and Use Committee  membership, an average daily census of animals, and other information.  NIH’s approval of an animal care program lasts up to 5 years, and  according to NIH officials, the agency typically begins its review of a  renewal after 4 years. To help facilities meet the annual report  requirement, NIH  provides an annual-reporting sample document that  directs research facilities to update the animal care and use committee’s  roster and to note any change in accreditation from the private  accreditation organization AAALAC  International  and describe any  significant changes in their animal care program, such as the species or  number of animals maintained in housing. NIH officials told us the  purpose of the assurances is to ensure that the proper facilities and  procedures are in place to properly care for the animals, and that NIH  does not use them as a public reporting tool.

Health Research Extension Act of 1985    animal  care  committees at each entity w hich conducts  biomedical and behavioral research with  funds provided under this Act (including the  National Institutes of Health and the national  research institutes) to assure compliance w ith  the guidelines established [by the Director of  NIH].

NIH has procedures to ensure that facilities that seek to receive funding  from Public Health Service agencies have animal care programs with  active assurances. NIH provided us with its data for tracking which  facilities were receiving Public Health Service funding and which facilities  had approved programs. As of November 2017, according to NIH data, all  of the federal facilities receiving funding from Public Health Service  agencies for activities involving  animals had an active assurance. Using a  sample of 16 assurances from federal facilities, we found that these  assurances contained information called for by NIH, including signatures  from institutional officials, rosters of Institutional  Animal Care and Use  Committees, and animal inventories. NIH  data show that all assured  facilities submitted annual reports in calendar years 2014, 2015, and  2016.

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. Although the Animal Welfare Act does not  require APHIS to share this information, APHIS posts the following on its  website:

Annual reports from research facilities. Research facilities’ annual  reports include data on the species and numbers of animals held and  used for research, categorized by the steps taken to minimize pain  and distress to the animal. The annual reports also include the  facility’s explanation  of any exceptions to the Animal Welfare Act’s  standards and regulations during the reporting year. As of April 2018,  APHIS’s website included research facilities’ annual reports from  fiscal years 1999 through 2017.

National summaries of the annual reports. APHIS prepares  national summaries using the annual reports submitted by research  facilities. APHIS’s annual national-summary reports include data  provided by research facilities on species and numbers of animals,  categorized by state and by the steps taken to minimize pain and  distress to the animal. As of March 2018, APHIS’s website had  national summary reports for fiscal years 2008 through 2016. The  national summaries do not categorize the data by types of facilities,  such as federal or nonfederal research facilities.

Reports of APHIS inspections. The APHIS  inspection reports— typically of nonfederal facilities—could contain such information as  descriptions of non-compliance, the number of animals involved in  noncompliance, a correction deadline and a description of what  should be done to correct the problem, and the date of the inspection.  As of March 2018, APHIS’s website contained reports of inspections  at three federal facilities, including a zoo and an aquarium. This  number does not include ARS research facilities, which APHIS  inspects as part of its 2016 memorandum of understanding with ARS.  As of March 2018, APHIS’s website contained inspection reports for  19 ARS research facilities.

USDA’s Chief Information Officer has provided guidance directing the  department’s agencies and offices to strive to ensure and maximize,  among other things, the objectivity of information disseminated to the  public. To ensure objectivity, the guidance directs that USDA agencies  and offices ensure that the information they disseminate is presented in  an accurate, clear, complete, and unbiased manner.

APHIS has not fully implemented this guidance for the animal use data it  shares publicly. In particular, APHIS does not explain on its website  potential limitations related to the accuracy and completeness of the  annual reports that it provides to the public or in the national summaries  of the annual reports that APHIS prepares. For example, APHIS does not  explain that research facilities’ annual reports may contain data on  animals used for activities that are not covered by the Animal Welfare Act  regulations, such as excluded field studies. Additionally,  APHIS does not  explain that the annual reports do not include birds not bred for  research—and consequently covered by the Animal Welfare Act— because APHIS has instructed facilities to not report any birds.  Furthermore, APHIS does not explain that it does not validate the  accuracy and completeness of agencies’ reporting. In particular, APHIS  officials told us that they have the opportunity to validate reporting when  they inspect nonfederal facilities, but do not have the authority to inspect  federal research facilities unless invited to do so.

Some stakeholders responded to our survey that they use the data that  APHIS reports on animal use to identify trends and practices within the  research community. By fully implementing USDA guidance by explaining  what the data represent and possible issues with their quality, APHIS  could have more assurance that it is providing these data to users in a  manner that is as accurate, clear, complete and unbiased as possible.  Users could then be better equipped to properly analyze or assess the  quality of the data, interpret the annual reports, and draw conclusions  based on these data.

NIH posts a list of federal and nonfederal facilities with active assurances  on its website. The Health Research Extension Act does not require NIH  to make such information available through a public website, but NIH  policy directs the agency to provide to Public Health Service agencies a  list of facilities with such assurances. The list includes facilities that  receive Public Health Service funding and facilities that have voluntarily  requested NIH’s review and approval of their programs. Our review did  not identify federal facilities that were missing from or incorrectly included  in NIH’s posted list of assured facilities.

NIH does not regularly post other information—such as the facilities’  average daily inventory of animals, the date they obtained an assurance,  or the date they submitted their most recent annual report.—from  research facilities’ assurance documents. Therefore, we did not review in  detail the information that agencies provide to NIH  to determine its  accuracy.

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. However, stakeholders who responded to our survey had  different views about whether federal agencies should proactively and  routinely make more information on animal use available to the public on  their websites or other means than the data that APHIS and NIH currently  provide. Stakeholders other than animal advocacy organizations— including federal agencies, research organizations, academia, and  others—generally expressed the view that federal agencies should not  routinely make additional information available to the public, citing  reasons including the existence of other methods to obtain this  information and administrative burden. 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. (See  app. III  for more information about stakeholders’ responses to our  questions).

More specifically, we asked stakeholders to provide their views on  whether federal agencies should proactively and routinely report certain  types of information to the public. We selected 10 types of information for  stakeholders to consider, including some types of information that federal  agencies may have for internal purposes and, in some instances, may  provide to other agencies or organizations but that neither they nor others  are required to proactively share with the public. The types of  information we asked stakeholders to consider included data on  vertebrate animals that are not covered by the Animal Welfare Act,  internal or external inspection reports, and general descriptions of  agencies’ animal use programs. See table 2 for the complete list of types  of information we asked stakeholders to consider.

For stakeholder groups that generally expressed the view that federal  agencies should not make additional information available to the public on  a proactive and routine basis, one of the most frequently cited reasons  included that the public could obtain this information through other  publicly available means. For example, several stakeholders said that agencies’ reports of noncompliance to APHIS or NIH  and data on  resource expenditures are already available via the FOIA. One federal  stakeholder said that it provides the public with information about the  nature and extent of field research when it is required by the Marine  Mammal Protection Act of 1972 or the Endangered Species Act of  1973 to obtain permits; the permitting processes include public notice  and comment. In addition, some stakeholders said that certain types of  information, such as the identity of the species used and the purpose and  expected benefit of specific research projects are already published in  peer-reviewed journals that are accessible to the public.

Several stakeholders also responded that providing additional information  would impose an administrative burden on agencies. For example,  several stakeholders said any potential public benefit from the additional  information shared with the public would not justify the effort to collect and  share the information, and one stakeholder said that providing certain  types of information would reduce the time they have to do actual  research. In addition, one stakeholder said that a requirement to make  additional information available to the public would be in direct conflict  with a 2016 law that directed NIH, the Food and Drug Administration, and  USDA to look for ways to reduce administrative burdens associated with  animal welfare regulations.

Other less frequently cited reasons that stakeholders gave for not  believing that agencies should proactively and routinely share additional  information with the public included:

Certain information, such as expenditures on animal use, could be  difficult to collect from disparate sources. For example, one federal  agency said that much of its animal use funding is allocated in  different areas of research and that it would need guidance to collect  data on expenditures separately from each area.

Disseminating information could jeopardize the security of facilities or  personnel or disclose proprietary data. For example, one stakeholder  said agency reports contain key details about federal research  facilities that opposition groups could use to target personnel in those  facilities.

Disseminating information could confuse the public unless appropriate  context is provided. One stakeholder said that the passive  dissemination of data on animal research on a website, without  appropriate context, would potentially increase public confusion and  add misplaced scrutiny on animal use in federal research facilities.

For those stakeholder groups that generally expressed the view that  federal agencies should make additional information available to the  public on a proactive and routine basis, the most frequently cited reasons  were the importance of transparency to allow the public to assess and  understand animal use in federal research facilities and the need for  oversight and accountability of federal agencies’ use of animals. For  example, some stakeholders responded that sharing additional  information with the public would aid their efforts to monitor the reduction,  refinement, and replacement of animals used in federal research. One  stakeholder also mentioned that sharing additional information could be  easily done on a website and would give the public a more complete  picture of the use of animals by federal research facilities. Several  stakeholders also expressed the need for greater oversight and  accountability of federal agencies’ use of animals. For example, two  stakeholders said that making additional information available about the  degree to which animals experience pain or distress would help them  assess whether federal programs’ animal use is in compliance with  specific provisions related to pain and distress in the Animal Welfare Act.  Stakeholder groups less frequently cited other reasons for favoring  routine reporting, such as:

FOIA requests can take several months and sometimes years for  agencies to fulfil.

Certain information, such as the number of all vertebrate animals  used by each agency—including those not reported under the Animal  Welfare Act—should be easy to disseminate because federal  agencies already collect or compile it for internal purposes.

Additional  reporting would align the federal government with other  countries’ practices. For example, according to one stakeholder, the  European Union categorizes and publicly releases animal use  numbers that are more detailed than those reported in the United  States.

APHIS and NIH routinely collect information about federal agencies’  research with vertebrate animals and provide the public with related  information. Having access to this information can help the public observe  trends in animal use in research and learn about facilities’ compliance  with standards of humane care.

Federal agencies met NIH’s requirements for reporting on their animal  use, but the data federal agencies provided to APHIS were not always  consistent or complete. This situation resulted in part from APHIS’s not  providing sufficient instructions to federal research facilities for reporting  on their use of animals covered by the Animal Welfare Act. In particular,  APHIS instructs facilities to not report any birds in their annual reports,  regardless of whether the birds are covered by the act. Although aware of  this limitation, APHIS has not provided a schedule or plan for defining  birds covered by the act or for developing reporting requirements for  those birds. In addition, APHIS’s instructions have not sufficiently clarified  two areas of confusion and differing understanding among federal  agencies: first, activities that involve animal use outside the United States  and, second, the specific conditions under which field studies are or are  not covered by the act. APHIS plans to develop clarifying guidance on  field studies and will publish the guidance for public comment. 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.

APHIS has also not fully implemented the USDA’s information  dissemination policy that calls for the department’s agencies to ensure  information is presented in an accurate, clear, complete, and unbiased  manner. 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. By fully explaining these issues, the agency  would improve users’ ability to accurately interpret and analyze the data.

We are making the following four recommendations to APHIS:  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)

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)

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)

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)

We provided a draft of this report to Commerce, Defense, HHS, DHS,  Interior, USDA, VA, EPA, NASA, and the Smithsonian Institution. USDA  and VA provided written comments on the draft, which are presented in  appendixes IV and V, respectively. In its written comments, USDA said  that APHIS provided planned corrective actions and timeframes for  implementing three of our four recommendations; APHIS disagreed with  one recommendation. In its written comments, VA said that the report’s  conclusions were consistent with our findings.

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. USDA’s comments did not specifically respond to our  recommendation that APHIS also develop a timeline for requiring that  research facilities report their use of birds covered by the act; we continue  to believe that APHIS  should develop such a timeline.

USDA’s written comments stated that APHIS disagreed with our second  recommendation that 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. USDA provided  several reasons for the disagreement:

USDA stated that the absence of an exclusion to the requirements of the Animal Welfare Act or its regulations for federal research located outside of the United States does not create a requirement to collect information about such facilities’ use of animals. However, the Animal Welfare Act regulations define a reporting facility to include a department, agency, or instrumentality of the United States. In addition, officials from USDA’s Office of the General Counsel told us that there is no exclusion in the act or its regulations for federal research facilities that are located outside the United States. We have no reason to believe that such facilities should be excluded from the requirements of the Animal Welfare Act or its implementing regulations. We also note that in February 2018, APHIS officials told us that if federal agencies’ activities involving animals outside of the United States are in fact covered by the Animal Welfare Act based on the specific facts and circumstances of their activities, they should report those activities to APHIS.

USDA’s comments stated that the collection of information related to  research activities outside of the United States does not enable or  inform its daily administration of the Animal Welfare Act and its charge  to ensure the humane treatment of animals. Rather, USDA stated that  our recommendation would impose an additional regulatory burden on  federal research facilities. As stated above, we have no reason to  believe that such facilities should be excluded from the requirements  of the Animal Welfare Act or its implementing regulations. Without  such an exclusion, the regulatory burden already exists; our  recommendation would simply have APHIS instruct federal agencies  to meet that regulatory requirement.

Finally, USDA commented that our recommendation would place  APHIS in the position of collecting different information from “reporting  facilities,” as defined in the regulations, which in turn, would impact  any summary presentation of information involving the use of animals.  We understand that, if our recommendation were implemented,  APHIS may receive “different” information from federal and nonfederal  facilities; that is, federal research facilities might report activities  outside of the United States while nonfederal facilities would not.  However, as stated above, we have no reason to believe that such  facilities should be excluded from the requirements of the Animal  Welfare Act or its implementing regulations. Without such an  exclusion, activities covered by the Animal Welfare Act in federal  facilities located outside of the United States must already be  reported. We also note that, as we state in our fourth  recommendation, APHIS  should inform the public about the nature of  its data. That information could include describing any differences in  reporting by federal and nonfederal research facilities.

For the reasons given above, 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.

In response to our third recommendation that the Administrator of APHIS  take certain steps to clarify the definition of field studies that are covered  by the Animal Welfare Act, USDA stated that APHIS  agreed to issue a  guidance document by December 31, 2018. We appreciate APHIS’s  commitment to issuing new guidance on field studies, but note that  USDA’s written comments did not directly respond to the language in our  draft recommendation that called for the agency to provide research  facilities with clear examples of field studies that are covered by the  Animal Welfare Act regulations. We also note that the Forest Service  stated in technical comments that the extensive number and variation in  wildlife species preclude providing specific examples of activities that  meet a prescribed definition of a field study. The Forest Service  suggested that we modify our recommendation to call for APHIS to  provide criteria for how research facilities should determine which studies  qualify as an exempted field study. We agreed with that suggestion and  modified our recommendation to call on APHIS to provide research  facilities with criteria to help research facilities determine which studies  are covered by the Animal Welfare Act.

APHIS agreed with our fourth recommendation that the Administrator of  APHIS direct the agency to fully describe animal use data on its website.  USDA’s comments stated that, beginning with the fiscal year 2017  summary activities, APHIS will describe how it compiles annual report  data from research facilities, what the data represent, and any potential  limitations to the data’s completeness and accuracy. USDA stated that  APHIS will update the website with this information by September 30,  2018.

In its written comments, VA stated that our overall descriptions of its  animal research program were accurate. The agency also stated that it  looks forward to a time when the use of animals in research is no longer  needed, but until that time, the agency will use all necessary research  strategies to reduce and prevent the suffering of veterans.

APHIS, HHS, and DHS also provided technical comments, which we  incorporated as appropriate.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Agriculture, the Secretary of Commerce, the  Secretary of Defense, the Secretary of Health and Human Services, the  Secretary of Homeland Security, the Secretary of the Interior, the  Secretary of Veterans Affairs, the Administrator of the Environmental  Protection Agency, the Administrator of the National Aeronautics and  Space Administration, the Secretary of the Smithsonian Institution, and  other interested parties. In addition, the report will be available at no  charge on the GAO website at http://www.gao.gov.

If you or your staff members have any questions about this report, please  contact us at (202) 512-3841 or morriss@gao.gov or  neumannj@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this report.  GAO staff who made key contributions to this report are listed in appendix  VI.

Appendix I: Animal Species Used in Research by Federal Agencies in Fiscal Years 2014 through 2016

Federal agencies conduct research with animals for a variety of purposes,  including to benefit human or animal populations. We identified 10  agencies that conducted research using vertebrate animals in fiscal years  2014, 2015, or 2016 with their own staff using their own facilities and  equipment. Federal agencies also fund activities that use animals,  meaning that the research is done by a nonfederal entity. However, we  did not include those activities in our review.

In the process of identifying federal agencies that conducted research  with animals, we also identified the wide range of vertebrate animal  species that these agencies used from fiscal years 2014 through 2016. In  response to our survey of agencies, we learned that some agencies  conducted research with a dozen or more species of animal while others  conducted activities with hundreds of species. For example, NASA  reported to GAO that it used 16 species while the National Museum of  Natural History—one of the four animal research facilities within the  Smithsonian Institution that responded to our survey—reported it  conducted research on about 1,400. Table 3 shows groups of vertebrate  species the 10 agencies reported to GAO that they used in research in  fiscal years 2014 through 2016.

Some of the species groups shown in table 3 are not covered by the  Animal Welfare Act (i.e., amphibians, fish, and reptiles), while some  animal species within a group may not be covered by the act. For  example, farm animals are not covered by the Animal Welfare Act if  researchers use them for agricultural purposes, such as improving animal  nutrition, breeding management, or production efficiency, or for improving  the quality of food or fiber, but are covered if researchers use them for  human health purposes. Mice and rats are not covered by the Animal  Welfare Act if they are of the genus Mus or Rattus and bred for use in  research. Similarly, the act does not cover birds bred for use in research.  Furthermore, agencies may have used animal species in a field study that  is not covered by Animal Welfare Act regulations. 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). Nevertheless, the agencies are  required by other policies and statutes to ensure that they treat those  animals humanely.

Appendix II: List of Federal and Nonfederal Participants in GAO’s Survey

Federal departments, agencies, and components:

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

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. The graphics in this  appendix illustrate the responses to our survey by stakeholder group. The  stakeholder groups included 20 federal departments, agencies, and sub- agencies that conduct animal research on vertebrate species; eight  animal advocacy organizations that advocate on behalf of animals; six  research and science organizations; and five other stakeholders including  individuals in academia and other knowledgeable entities. Stakeholders  from federal agencies, research organizations, and academia and other  entities except animal advocacy organizations generally expressed the  view that federal agencies should not make additional information made  routinely available to the public. (See figs. 1, 2, and 3, respectively.) In  contrast, animal advocacy organizations generally expressed the view  that federal agencies should make additional information routinely  available to the public. (See fig. 4.) Figure 5 provides examples of  stakeholders’ statements explaining their views on whether federal  agencies should or should not provide additional information to the public.

GAO also asked stakeholder groups in the survey about their opinion  regarding whether the Animal and Plant Health Inspection Service  (APHIS) should modify how it collects and posts annual report data under  the Animal Welfare Act. Seventeen of 39 stakeholders responded that  they would like to see changes to the way APHIS collects and posts  annual report data. Specifically, all stakeholders from animal advocacy  organizations and individuals in academia would like to see changes to  how APHIS collects and posts annual report data while some  stakeholders from federal agencies and research and science  organizations also noted that they would like to see changes. Table 4  provides examples of stakeholders’ views and suggestions regarding  such changes.

Appendix IV: Comments from the Department of Agriculture

Appendix V: Comments from the Department of Veterans Affairs

Appendix VI: GAO Contacts and Staff Acknowledgments

In addition to the individuals named above, Mary Denigan-Macauley  (Acting Director), Joseph Cook (Assistant Director), Ross Campbell  (Analyst-in-Charge), Kevin Bray, Tara Congdon, Hayden Huang, Marc  Meyer, Amber Sinclair, and Rajneesh Verma made key contributions to  this report.

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.


Energy Infrastructure Permitting: Factors Affecting Timeliness and Efficiency

Congress recognizes the harmful effects of permitting delays on infrastructure projects and has passed legislation to streamline project reviews and hold agencies accountable. For example, in 2015 Congress passed the Fixing America's Surface Transportation Act, which included provisions streamlining the permitting process. Federal agencies, including the Department of the Interior and FERC, play a critical role by reviewing energy infrastructure projects to ensure they comply with federal statutes and regulations.

This testimony discusses factors GAO found that can affect energy infrastructure permitting timeliness and efficiency. To do this work, GAO drew on reports issued from July 2012 to December 2017. GAO reviewed relevant federal laws, regulations, and policies; reviewed and analyzed federal data; and interviewed tribal, federal, state and industry officials, among others.

GAO's prior work has found that the timeliness and efficiency of permit reviews may be affected by a range of factors. For the purposes of this testimony, GAO categorized these factors into five categories.

Coordination and Communication. GAO found that better coordination between agencies and applicants is a factor that could result in more efficient permitting. Coordination practices that agencies can use to streamline the permitting process include the following:

Designating a Lead Coordinating Agency . GAO found having a lead agency to coordinate the efforts of federal, state, and local stakeholders is beneficial to permitting processes. For example, in a February 2013 report on natural gas pipeline permitting, industry representatives and public interest groups told GAO that the interstate process was more efficient than the intrastate process because in the interstate process the Federal Energy Regulatory Commission (FERC) was lead agency for the environmental review.

Establishing Coordinating Agreements among Agencies . In the February 2013 report, GAO reported that FERC and nine other agencies signed an interagency agreement for early coordination of required environmental and historic preservation reviews to encourage the timely development of pipeline projects.

Human Capital. Agency and industry representatives cited human capital factors as affecting the length of permitting reviews. Such factors include having a sufficient number of experts to review applications. GAO reported in November 2016 on long-standing workforce challenges at the Department of the Interior's Bureau of Indian Affairs (BIA), such as inadequate staff resources and staff at some offices without the skills to effectively conduct such reviews. GAO recommended that Interior incorporate effective workforce planning standards by assessing critical skills and competencies needed to fulfill its responsibilities related to energy development. Interior agreed with this recommendation, and BIA stated that its goal is to develop such standards by the end of fiscal year 2018.

Collecting and Analyzing Accurate Milestone Information. GAO's work has shown that a factor that hinders efficiency and timeliness is that agencies often do not track when permitting milestones are achieved, such as the date a project application is submitted or receives final agency approval. Having quality information on permitting milestones can help agencies better analyze process deficiencies and implement improvements.

Incomplete Applications. Agency officials and agency documents cited incomplete applications as affecting the duration of reviews. For example, in a 2014 budget document, BLM reported that—due to personnel turnover in the oil and gas industry—operators were submitting inconsistent and incomplete applications for drilling permits, delaying permit approvals.

Significant Policy Changes. Policy changes unrelated to permitting can affect permitting time frames. For example, after the 2010 Deepwater Horizon incident and oil spill, Interior issued new safety requirements for offshore drilling. GAO found that review times for offshore oil and gas drilling permits increased after these safety requirements were implemented.

GAO has made numerous recommendations about ways to improve energy infrastructure permitting processes. Federal agencies have implemented a number of GAO's recommendations and taken steps to implement more efficient permitting, but several of GAO's recommendations remain open, presenting opportunities to continue to improve permitting processes.

I am pleased to be here today to discuss our work on the role of federal  agencies in the permitting processes for energy infrastructure projects.

Federal agencies, including the Department of the Interior and the  Federal Energy Regulatory Commission (FERC), play a critical role in  ensuring that energy infrastructure projects developed in the United  States comply with a wide range of federal statutes and regulations.  Perhaps the most notable is the National Environmental Policy Act  (NEPA), which requires federal agencies to evaluate the potential  environmental effects of actions they propose to carry out, fund, or  approve, such as by permit.

Over the years, we have issued numerous reports describing the role of  federal agencies in permitting various types of energy infrastructure,  including onshore and offshore oil and gas projects, natural gas pipelines,  and liquefied natural gas (LNG) export facilities. Two common themes  emerge from these reports. First, permitting processes are varied and  complex, often requiring an applicant to comply with a range of federal,  state, and local laws and regulations. Second, permitting processes can  involve several federal and state agencies, as well as other stakeholders,  many of whom have approval responsibilities. For example, to construct  an LNG export facility, an applicant must coordinate with federal agencies  such as FERC—the lead agency responsible for the environmental and  safety review—as well as the U.S. Coast Guard—which assesses  waterway suitability; the applicant may also need permits from, among  others, the U.S. Army Corps of Engineers for dredging activities and the  U.S. Environmental Protection Agency for permits under the Clean Air  Act. In addition to federal permits and consultations, applicants may also  be required to obtain other permits under state and local law. Because of  the wide variety of projects, locations, and state and local laws, permitting  requirements vary by project. Public interest groups and the public also  contribute to the process.

We have found that inefficiencies in the permitting process can have real  world effects. For example, in a June 2015 report on Indian energy  development, we reported that a review by the Bureau of Indian Affairs  (BIA) could be a lengthy process and increase development costs and  project development times, resulting in missed development opportunities  and lost revenue and jeopardizing the viability of projects. As we  reported then, the Acting Chairman for the Southern Ute Indian Tribe  reported in 2014 that BIA’s review of some of its energy-related  documents took as long as 8 years, and during that time the tribe  estimated it lost $95 million in revenues.

Congress has recognized the harmful effects of permitting delays and  passed legislation to streamline permitting and to hold agencies  accountable, including Fixing America’s Surface Transportation Act.  When Congress passed this act in 2015, it included provisions for  streamlining the infrastructure permitting process and codified into law the  use of a permitting dashboard to track project timelines.

This testimony discusses factors that can affect permitting timeliness and  efficiency. This statement draws on findings from our reports issued from  July 2012 to December 2017. In conducting that work, we reviewed  relevant federal laws, regulations, and policies; reviewed and analyzed  federal data; and interviewed tribal, federal, state and industry officials,  among others. More detailed information on our scope and methodology  can be found in each of the cited reports.

We conducted the work on which this testimony is based in accordance  with generally accepted government auditing standards. Those standards  require that we plan and perform the audit to obtain sufficient, appropriate  evidence to provide a reasonable basis for our findings and conclusions  based on our audit objectives. We believe that the evidence obtained  provides a reasonable basis for our findings and conclusions.

Factors Affecting Federal Infrastructure Permitting

In our prior work, we identified a range of factors that can affect permitting  timeliness and efficiency. For the purposes of this statement, we have  categorized the factors into five broad categories: 1) coordination and  communication, 2) human capital, 3) collecting and analyzing accurate  milestone information, 4) incomplete applications, and 5) significant policy  changes.

Effective coordination and communication between agencies and  applicants is a critical factor in an efficient and timely permitting process.  Standards for internal control in the federal government call for  management to externally communicate the necessary quality information  to achieve the entity’s objectives, including by communicating with and  obtaining quality information from external parties. We found that better  coordination between agencies and applicants could result in more  efficient permitting. For example, in our February 2013 review of natural  gas pipeline permitting, we reported that virtually all applications for  pipeline projects require some level of coordination with one or more  federal agencies, as well as others, to satisfy requirements for  environmental review. For example, BIA is responsible for, among other  things, approving rights of way across lands held in trust for an Indian or  Indian tribe and must consult and coordinate with any affected tribe.

We have reported on coordination practices that agencies use to  streamline the permitting process, including the following.

We have found that having a lead agency coordinate efforts of federal,  state, and local stakeholders is beneficial to permitting processes. For  example, in our February 2013 review on natural gas pipeline permitting,  industry representatives and public interest groups told us that the  interstate process was more efficient than the intrastate process because  in the interstate process FERC was designated the lead agency for the  environmental review. Other agencies may also designate lead entities  for coordination. For example, in a November 2016 report, we described  how BIA had taken steps to form an Indian Energy Service Center that  was intended to, among other things, help expedite the permitting  process associated with Indian energy development. We recommended  that BIA involve other key regulatory agencies in the service center so  that it could more effectively act as a lead agency.

Establishing coordinating agreements among agencies can streamline  the permitting process and reduce time required by routine processes.  For example, in our February 2013 review of natural gas pipeline  permitting, we reported that FERC and nine other agencies signed an  interagency agreement for early coordination of required environmental  and historic preservation reviews to encourage the timely development of  pipeline projects.

Using Mechanisms to Expedite Routine or Less Risky Reviews

Agencies can also use mechanisms to streamline reviews of projects that  are routine or less environmentally risky. For example, under NEPA, agencies may categorically exclude actions that an agency has found—in  NEPA procedures adopted by the agency—do not individually or  cumulatively have a significant effect on the human environment and for  which, therefore, neither an environmental assessment nor an  environmental impact statement is required. Also under NEPA,  agencies may rely on “tiering,” in which broader, earlier NEPA reviews  are incorporated into subsequent site-specific analyses. Tiering is used to  avoid duplication of analysis as a proposed activity moves through the  NEPA process, from a broad assessment to a site-specific analysis.  Such a mechanism can reduce the number of required agency reviews  and shorten the permitting process.

Agency and industry representatives cited human capital factors as  affecting the length of permitting reviews. Such factors include having a  sufficient number of experts to review applications. Some examples  include:  In June 2015 and in November 2016, we reported concerns  associated with BIA’s long-standing workforce challenges, such as  inadequate staff resources and staff at some offices without the  skills needed to effectively review energy-related documents. In  November 2016 we recommended that Interior direct BIA to  incorporate effective workforce planning standards by assessing  critical skills and competencies needed to fulfill BIA’s  responsibilities related to energy development.

For a September 2014 report, representatives of companies  applying for permits to construct LNG export facilities told us that  staff shortages at the Pipeline and Hazardous Safety Materials  Administration delayed spill modeling necessary for LNG facility  reviews.

In an August 2013 review of Interior’s Bureau of Land  Management (BLM) and oil and gas development, industry  representatives told us that BLM offices process applications for  permit to drill at different rates, and inadequate BLM staffing in  offices with large application workloads are one of the reasons for  these different rates.

Agencies have taken some actions to mitigate human capital issues. For  example, we reported in August 2013 that BLM had created special  response teams of 10 to 12 oil and gas staff from across BLM field offices  to help process applications for permits to drill in locations that were  experiencing dramatic increases in submitted applications. In July 2012,  we recommended that Interior instruct two of its bureaus to develop  human capital plans to help manage and prepare for human capital  issues, such as gaps in critical skills and competencies.

Our work has shown that a factor that hinders efficiency and timeliness is  that agencies often do not track when permitting milestones are achieved,  such as the date a project application is submitted or receives final  agency approval to determine if they are achieving planned or expected  results. In addition, our work has shown that agencies often do not collect  accurate information, which prevents them from analyzing their processes  in order to improve and streamline them. The following are examples of  reports in which we discussed the importance of collecting accurate  milestone information:  In December 2017, we found that the National Marine Fisheries  Service and the U.S. Fish and Wildlife Service were not recording  accurate permit milestone dates, so it was not possible to  determine whether agencies met statutory review time frames.  We recommended that these agencies clarify how and when staff  should record review dates so that the agencies could assess the  timeliness of reviews.

We found in June 2015 that BIA did not have a documented  process or the data needed to track its review and response  times; to improve the efficiency and transparency of BIA’s review  process, we recommended that the agency develop a process to  track its review and response times and improve efforts to collect  accurate review and response time information.

We found in an August 2013 report that BLM did not have  complete data on applications for permits to drill, and without  accurate data on the time it took to process applications, BLM did  not have the information it needed to improve its operations. We  recommended that BLM ensure that all key dates associated with  the processing of applications for permits to drill are completely  and accurately entered into its system to improve the efficiency of  the review process.

Standards for internal control in the federal government call for  management to design control activities to achieve objectives and  respond to risks, including by comparing actual performance with planned  or expected results and analyzing significant differences. Without tracking  performance over time, agencies cannot do so. The standards also call  for agency management to use quality information to achieve agency  objectives; such information is appropriate, current, complete, accurate,  accessible, and provided on a timely basis. As we have found, having  quality information on permitting milestones can help agencies identify the  duration of the permitting process, analyze process deficiencies, and  implement improvements.

According to agency officials we spoke with and agency documents we  reviewed, incomplete applications are a factor that can affect the duration  of reviews. For example, in a 2014 BLM budget document, BLM reported  that—due to personnel turnover in the oil and gas industry—operators  were submitting inconsistent and incomplete applications for permits to  drill, which was delaying the approval of permits. In a February 2013  report, officials we spoke with from Army Corps of Engineers district  offices said that incomplete applications may delay their review because  applicants are given time to revise their application information.  Deficiencies within agency IT systems may also result in incomplete  applications. As we noted in a July 2012 report, Interior officials told us  that their review of oil and gas exploration and development plans was  hindered by limitations in its IT system that allowed operators to submit  inaccurate or incomplete plans, after which plans were returned to  operators for revision or completion.

Agencies can reduce the possibility of incomplete applications by  encouraging early coordination between the prospective applicant and the  permitting agency. According to agency and industry officials we spoke  with, early coordination can make the permitting process more efficient.  One example of early coordination is FERC’s pre-filing process, in which  an applicant may communicate with FERC staff to ensure an application  is complete before formally submitting it to the commission.

Changes in U.S. policy unrelated to permitting are a factor that can also  affect the duration of federal permitting reviews. For example, in  September 2014, we reported that the Department of Energy did not  approve liquefied natural gas exports to countries without free-trade  agreements with the United States for a period of 16 months.  We found  that the Department stopped approving applications while it conducted a  study of the effect of liquefied natural gas exports on the U.S. economy  and the national interest. Exporting liquefied natural gas was an economic  reversal from the previous decade in which the United States was  expected to become an importer of liquefied natural gas.

Policy changes can result from unforeseen events. After the Deepwater  Horizon incident and oil spill in 2010, Interior strengthened many of its  safety requirements and policies to prevent another offshore incident. For  example, Interior put new safety requirements in place related to well  control, well casing and cementing, and blowout preventers, among other  things. In a July 2012 report, we found that after the new safety  requirements went into effect, review times for offshore oil and gas drilling  permits increased, as did the number of times that Interior returned a  permit to an operator.

In conclusion, our past reports have identified varied factors that affect  the timeliness and efficiencies of federal energy infrastructure permitting  reviews. Federal agencies have implemented a number of our  recommendations and taken steps to implement more efficient permitting,  but several of our recommendations remain open, presenting  opportunities to continue to improve permitting processes.

Chairmen Palmer and Gianforte, Ranking Members Raskin and Plaskett,  and Members of the Subcommittees, this concludes my prepared  statement. I would be pleased to answer any questions that you may  have at this time.

If you or your staff members have any questions concerning this  testimony, please contact Frank Rusco, Director, Natural Resources and  Environment, who may be reached at (202) 512-3841 or  RuscoF@gao.gov. Contact points for our Office of Congressional  Relations and Public Affairs may be found on the last page of this  statement. Key contributors to this testimony include Christine Kehr  (Assistant Director), Dave Messman (Analyst-in-Charge), Patrick Bernard,  Marissa Dondoe, Quindi Franco, William Gerard, Rich Johnson, Gwen  Kirby, Rebecca Makar, Tahra Nichols, Holly Sasso, and Kiki  Theodoropoulos.

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Federal agencies play a critical role in ensuring that energy infrastructure projects comply with federal statutes and regulations. We testified about the role of federal agencies in reviewing and permitting various types of energy infrastructure, such as offshore oil and gas projects.

We found that a number of factors affect the timeliness and efficiency of these reviews—such as coordination between federal agencies, the number of experts that agencies have to review applications, whether agencies are tracking and collecting milestone information, the completeness of applications, and changes in federal policy that affect reviews.