Washington Update

Senate Draft Appropriations Bills Include Provisions on Animal Research

By: Naomi Charalambakis
Wednesday, August 10, 2022
On July 28, the Senate Appropriations Committee released all 12 of its draft appropriations bills for fiscal year 2023. The bills, which provide funding for various federal agencies, are accompanied by explanatory statements that provide additional instructions on how the Senate would like agencies to enforce various federally funded programs. Several of the bills and explanatory statements included language related to biomedical research with animals.

In its explanatory statement, the Senate Labor, Health and Human Services, Education, and Related Agencies (LHHS) Appropriations Subcommittee—the subcommittee responsible for allocating funding for the National Institutes of Health (NIH)—specified how they would like to see the agency improve animal research transparency as well as consideration and funding for nonanimal models. For example, Senate appropriators call on NIH to develop a mechanism to collect an inventory of vertebrate animals housed at research institutions on an annual basis rather than every four years, the current NIH policy. The Senate language goes one step further to suggest NIH encourage prospective documentation of study design and analysis plans to mitigate incomplete reporting.

Another section of the Senate LHHS explanatory statement encourages NIH to continue efforts to reduce, refine, and replace the use of animals in biomedical research with nonanimal methods such as organ-on-a-chip, cell culture, and computer simulations where appropriate. Acknowledging the recent work of the NIH Advisory Committee to the Director Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research, Senate appropriators encourage NIH to increase funding for human-relevant methods and provide Congress with an update and review of the animal and nonanimal approaches used in research for major disease areas. This language differs from last year’s Senate LHHS explanatory statement, which instructed NIH to establish incentives for researchers to utilize nonanimal models.

Finally, in two separate sections of the LHHS explanatory statement, Senate appropriators affirm the critical role of research with nonhuman primates, noting this research makes irreplaceable contributions to science and public health. This language contrasts with the House LHHS report, which did not acknowledge the importance of research with nonhuman primates. Earlier this year, FASEB spearheaded a community sign-on letter to House and Senate appropriators that emphasized the need to recognize the value of nonhuman primates in sustaining biomedical research progress.

In a separate legislative package, the Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Subcommittee—the subcommittee in charge of administering funds to the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA)—outlined its priorities for improving animal welfare enforcement and enhancing qualification of nonanimal methodologies in its explanatory statement. For example, given the subcommittee’s concern about violations of the Animal Welfare Act, Senate appropriators urge the USDA to continue making progress towards reforming its licensing and enforcement framework. This includes ensuring consistent and unannounced facility inspection and improved documentation of potential regulatory violations. For the FDA, the explanatory statement encourages the agency to continue qualifying nonanimal methods for safety and efficacy testing of potential drugs. Although the Senate’s instructions for the USDA are consistent with the House’s recommendations, appropriators stopped short of instructing FDA to reduce research with nonhuman primates like the House version.

Similar to previous years, the Senate Military Construction, Veterans Affairs, and Related Agencies draft appropriations bill prohibits funding for all studies with canines, felines, and nonhuman primates conducted at the Department of Veterans Affairs (VA) unless the VA secretary provides written approval. Additionally, the VA secretary is instructed to submit a report to the Senate Appropriations Committee describing the nature of VA’s research with canine, felines, and nonhuman primates and justification for funding approval, among other items. Finally, as the VA continues implementing its Five Year Plan to reduce the use of these species, Senate appropriators request the VA secretary provide an update on its progress. The Senate language is less restrictive than the House bill, which also restricted funding for VA studies with canines and felines but did not offer any exceptions such as Secretary written approval.

House and Senate appropriators will now proceed with conference deliberations to issue a compromise bill that can move forward for full approval by both chambers and the president’s final signature.