On January 26, the Institute for Laboratory Animal Research; the Animal Law and Policy Program; and the Petri-Flom Center for Health Law Policy, Biotechnology and Bioethics of the Harvard Law School convened a workshop on the future directions of federal animal law in the U.S. Prior to the workshop, Professor Margaret Foster Riley presented an overview of U.S. laws and regulations governing the use of laboratory animals.
The workshop’s keynote came from Bernadette Juarez, Deputy Administrator, Animal Care Program in the Animal and Plant Health Inspection Service (APHIS) at the United States Department of Agriculture (USDA). In this role she enforces the Animal Welfare Act (AWA), a federal law regulating the care and use of certain species of laboratory animals. Ms. Juarez described the polarity of stakeholders interested in laboratory animal use. One pole wants to reduce the number of animals used through increased regulation and is highly critical of the animal facility inspection process; they desire increased transparency within APHIS.
The other pole is concerned that increased regulation could lead to the elimination of animals in research completely and that the facility inspection process only focuses on what goes wrong. Juarez noted their being at times guarded with information-sharing. She also noted little common ground between the two poles.
Following Ms. Juarez’s keynote, four panels examined the revision, reach, and resolution of federal law.
The first panel session focused on what parts, if any, of current federal laws could be revised and featured two speakers with divergent perspectives. Richard Born, MD, a neuroscientist studying visual processing in nonhuman primates, briefly outlined the laws and policies governing his work, stating that the ILAR Guide for the Care and Use of Laboratory Animals directs his research from a regulatory standpoint. He thinks the USDA requirement for a literature search for alternatives to potentially painful or distressful procedures could be revised, underscoring that scientific meetings and interactions with colleagues are better methods for discovering alternative approaches.
Delcianna Winders, VP and Deputy General Counsel for Captive Animal Law Enforcement for The PETA Foundation, cited the lack of translation from animal studies to new therapeutics, suggesting that the National Institutes of Health (NIH) support more “human relevant” studies, such as organs-on-a-chip technology. She also recommended that NIH adopt the use of systematic review prior to funds being awarded for animal studies.
Two panel sessions explored extending laboratory animal law to other species or technologies. Steve Niemi, DVM, Director of the Office of Animal Resources at Harvard University, advocated for coverage of purpose-bred rats, mice, and birds – species specifically bred for research purposes – in the AWA. He cautioned that this should only be done in the context of a larger package of changes, including consolidation of regulatory oversight into one set of laws/policies, a focus on performance-based standards, and establishing a scientific advisory council to provide input on changes to the regulatory landscape.
Larry Schook, PhD, Professor of Animal Science and Radiology at the University of Illinois, shared his perspective of working across research areas (biomedical, agricultural, environmental); he described the difficulties he’s encountered with the varied regulatory systems. He believes the current system of “self-policing” under U.S. regulations is working well and results in better science and sound animal welfare.
In the second panel considering the “reach” of federal law, Lisa Moses, VDM, Pain and Palliative Care Veterinarian at Boston’s MSPCA-Angell Animal Medical Center, described the complicated issue of pet animals: they may be falling through a regulatory gap when it comes to their participation in clinical trials aimed at human drug development. Two workshop attendees challenged Dr. Moses’ suggestion that participation of pet animals in clinical trials is unregulated. Dr. Moses suggested that a hybrid animal use committee/human study review panel be developed to protect this vulnerable population of animals.
Finally, Kenneth Oye, PhD, Director, Program on Emerging Technologies, Massachusetts Institute of Technology, discussed the challenges of using gene drives, which employ genetically modified organisms to control populations of wild species or spread of disease. He noted that regulations around gene drives are progressing too slowly to keep up with this rapidly emerging technology; however, he cautioned against a moratorium on the use of gene drives.
The final presentations covered potential legal conflicts related to laboratory animals that may arise in the coming years. Jerrold Tannenbaum, JD, Professor Emeritus at the UC Davis School of Veterinary Medicine, discussed the concept of ethical review of animal research and questioned whether Institutional Animal Care and Use Committees (IACUCs) should do a full ethical review of proposed research (IACUCs typically conduct a limited ethical review). Current animal law statutes do not require full ethical review, Mr. Tannenbaum says, but for a variety of reasons, including waning public support for animal research, now may be the time to reconsider.
Nathan Herschler, JD, Executive Director of the New England Anti-Vivisection Society (NEAVS), delivered the last presentation, which focused on resolving conflicts. He stated that NEAVS seeks to end the use of animals in research, and suggested that those on opposite poles could find common ground, including the reduction of some regulatory burden in exchange for coverage of purpose-bred rats, mice, and birds in the AWA.