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The FY 2021 funding bills adopted at the end of last year included several instances of language on animal research. These measures will be in place for the fiscal year ending September 30, 2021. Language on National Institutes of Health (NIH) research was included in the legislative report filed with the funding bill and addressed research with nonhuman primates (NHPs); retirement of NIH-owned chimpanzees; post-research adoption of animals; and the validation and use of non-animal alternatives. Animal research in the Medical and Prosthetic Research Program was addressed in both the Veterans Affairs (VA) funding bill and the accompanying legislative report.

NIH

NIH is funded through the Labor, Health and Human Services and Education Appropriations bill. The explanatory statement accompanying the final bill included compromise versions of report language the House and Senate Appropriations Committees wrote addressing these topics:

Research with nonhuman primates:

The final report language affirmed that Congress “recognizes the use of nonhuman primates in biomedical research for developing vaccines and treatments for public health threats” and told NIH to have the National Academies of Sciences, Engineering, and Medicine (NASEM) conduct a study of current and future needs for NHPs in its intramural research program. This replaced language in the House report asserting that adequate replacements for NHP research are already available.

Final report language: Primate Research.- The [conference] agreement recognizes the use of nonhuman primates in biomedical research for developing vaccines and treatments for public health threats. It also acknowledges the obligation in Federal law to minimize animal research and consider the use of alternatives wherever possible. The agreement directs NIH to commission an independent study by the National Academies of Sciences, Engineering, and Medicine (NASEM) to explore the current and future use of nonhuman primates in intramural NIH research. This study should include, but not be limited to: an assessment of the extent to which primates will continue to be necessary for intramural NIH biomedical research and, if so, in what areas; an analysis of primate availability and transportation options to fulfill current and future research needs; and a review of existing and anticipated future alternatives to the use of primates and how these could reduce NIH's reliance on nonhuman primates to fulfill the agency's mission currently and in the future.

Chimpanzee Maintenance, Care, and Transportation:

The final report language called upon NIH to prioritize the welfare of aged and infirm chimpanzees in deciding whether they should be “retired in place” or sent to the Chimp Haven national sanctuary. The language reflected NIH’s November 5, 2020 statement on transportation restrictions for NIH-owned chimpanzees that are “significantly compromised” and replaced House report language calling upon NIH to send all chimpanzees to Chimp Haven to “live the remainder of their lives in [a] sanctuary, even if for a short period.” The final language also calls upon NIH to keep Congress informed about deaths that occur not only among animals retired in place at the National Primate Research Centers, but also at Chimp Haven.

Final Language: Chimpanzee Maintenance, Care, and Transportation.-The [conference] agreement directs NIH to provide a written report to the Committees every 180 days, beginning no later than December 31, 2020, that shall include (1) the number of chimpanzees transported to the national sanctuary over the last quarter; (2) a census of all government-owned and supported chimpanzees remaining, if any, at the Alamogordo Primate Facility (APF), the Keeling Center for Comparative Medicine and Research (KCCMR), or the Southwest National Primate Research Center (SNPRC); and (3) a list of any chimpanzee deaths that have occurred at any time after January 1, 2020, at APF, KCCMR, SNPRC, and the national sanctuary system.

Post-Research Adoption of Animals in Research:

The final report language calls upon NIH to develop a policy to have grantee institutions implement programs for the post-research adoption of animals. (Many institutions already have such programs.) NIH’s policy should include consideration of potential costs and regulatory burden associated with such programs since PHS funds may not be used for these purposes. The original House-passed language called upon NIH to require grantees to implement post research adoption policies without consideration of the potential cost or burden.

Final Language: Post-Research Adoption of Animals in Research – The [conference] agreement directs NIH to provide a written update on the development of a policy requiring grantees receiving extramural grants for research using animals to implement post-research adoption policies, including an analysis of the associated costs and potential regulatory burdens, to the Committee within 180 days of the enactment of this Act.

Humane Research Alternatives:

The final report language combined two topics addressed in the House report. The House called upon the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to help the Environmental Protection Agency (EPA) achieve its goal of replacing animal tests by 2035. The House also called upon NIH to encourage both intramural and extramural researchers to transition “away from methods that rely on animals” because—according to the report—“humane, cost-effective, and scientifically suitable non-animal methods are available but underutilized.” The final language neither prescribes what ICCVAM should do nor asserts that existing alternatives are adequate to replace research with animals.

Final Language: Humane Research Alternatives – The [conference] agreement directs NIH to provide a report to the Committees no later than 180 days after the enactment of this Act on: 1) progress the Interagency Coordinating Committee on the Validation of Alternative Methods has made on finding alternatives to non-animal research methods; and 2) the incentives, if any, NIH offers to encourage grantees to consider these alternatives. This directive also replaces the directive included under the heading “Office of the Director” entitled “Animal Use in Research” in the House Report 116-450.

VA Medical and Prosthetic Research

Language regarding VA animal research was included in both the Military Construction-VA (Mil-Con-VA) Appropriations bill and in explanatory report filed with the legislation. The House version of the Mil-Con VA bill would have prohibited any VA dog research that fell under USDA pain categories D or E. This would have prohibited any research involving surgeries. The Senate bill did not have this prohibition but it expanded upon approval requirements approved in last year’s legislation. Those requirements applied only to canine research, but the Senate expanded them also to cats and NHPs. The final version of the bill now requires the VA Secretary to personally approve any research involving dogs, cats or NHPs. The Secretary must also report in detail on the research and affirm that it addresses a combat-related condition and cannot be performed in any other species.

In addition to these provisions that have been written into the law for FY 2021, the legislative filed with the bill included language requiring the VA to give Congress its responses to the recommendations of the 2020 NASEM study on Necessity, Use and Care of Laboratory Dogs at the U.S. Department of Veterans Affairs.