Vol. 30.2

Special Edition: Laboratory Animal Law
Volume 30 | Issue 2 | 2024

Laboratory animal law focuses specifically on the laws and regulations around the use of animals in research and testing. The practice of using non-human animals dates as far back as antiquity. But it is not until the early 1900s that the organized and systematic use of animals for research and testing became widespread.

Now more than ever, this area of law needs strong advocates to ensure the best outcome for science and animals. However, some of the best lawyers are hesitant to enter this area of law because it involves not only mastering law but also developing a level of comfort with science, the scientific method, the scientific process, and ethics that are applicable to this field.

As a means of enhancing accessibility, the Animal Law Review and Johns Hopkins Bloomberg School of Public Health’s Toxicology Policy Team have partnered to create a special issue thatfocuses exclusively on the topic of laboratory animal law. This issue is not meant to serve as an introduction to laboratory animal law, but as a next step for those who have mastered the basics and who are looking to expand their knowledge about animals in research and testing.

We hope these articles contribute to the understanding of the laws, trends, and gaps in this area of law and that it will inspire others to embark on a career advocating for laws and policies that support the best science and the best outcome for non-human animals.

Special Issue Editors,
Paul A. Locke & Rebecca Critser

Julia Williams, FDA Modernization Act 2.0: The Beginning of the End for Animal testing in Drug Development

Historical drug testing protocols utilized animal testing to determine whether drugs were safe and effective for use in humans. However, recognizing that testing drugs on other species is potentially dangerous for humans, troubled by failures, unnecessarily expensive, and time consuming, the FDA Modernization Act 2.0, passed in December 2022, removed animal testing as a requirement for new drug applications. While this was an important step forward, a notable failure of that Act is that it did not go far enough to end animal testing. Accordingly, this Article proposes an FDA Modernization Act 3.0.

The FDA Modernization Act 3.0 would ensure the highest level of hu- man safety by making drug development human centered. This would be accomplished by embracing cutting-edge technologies, including cell-based assays, human organ chips, and computer modeling. As proposed, the FDA Modernization Act 3.0 would favor human-centered drug testing by prohibit- ing animal testing where appropriate alternatives exist and adding a report- ing requirement to document researchers’ efforts to utilize human-centered testing in lieu of animal testing

Paul Locke, Richelle Romanchik, Breanne Kincaid, and Emily Golden, The 3Rs and Non-Human Animals in Biomedical Research: The Next 65 Years

It has been 65 years since the publication of Russell and Burch’s “The Principles of Humane Experimental Technique,” which established the ‘3Rs’—refinement, reduction, and replacement—as the key principles applicable to decision making about, and the use of, non-human animals in laboratory settings. The 3Rs are universally accepted by responsible scientists throughout the world and form the basis for many national legal and regulatory systems governing animal use in laboratories. This Article will discuss broadly how the 3Rs have evolved over the past seven decades since the publication of Russell and Burch’s seminal work, and examine the 3Rs in light of the needs of the biomedical research challenges today and into the future. The Article also evaluates recent critiques of the 3Rs and assesses whether such critiques are warranted considering current research practices and societal concerns. To make the 3Rs maximally useful for the 21st century and beyond, additional principles should be added that take into consideration (1) the need to strengthen reproducibility and predictivity of animal-based research; (2) the recognition that animals are sentient beings whose basic needs must be met; and (3) the importance of a harm-benefit evaluation that addresses the benefits, risks, and harms to humans as well as animals. The 3Rs must evolve in these ways so that science can continue to develop, and laboratory animal use can be reduced or replaced.

Maliat Chowdhury, Saving Species or Sacrificing Science?: Navigating the Legal Labyrinth of Research and Conservation Through the Case of the Long-Tailed Macaque

For decades, long-tailed macaques have served an instrumental role in advancing biomedical research. However, due to the recent primate shortage in U.S. laboratories, these macaques have become coveted targets for poachers. In 2022, the International Union for Conservation of Nature (IUCN) elevated the long-tailed macaque’s threat level from “Vulnerable” to “Endangered,” citing research-related capture as a critical factor contributing to their decline. Under this new status, long-tailed macaques are at risk of being categorized under Appendix I of CITES, a designation that will subject them to stricter trade regulations. Alarmed by the potential obstacles this reclassification may pose to scientific research, the National Association for Biomedical Research (NABR) petitioned against the IUCN’s assessment of the long-tailed macaque status. Joining the ranks of horseshoe crabs and chimpanzees, the long-tailed macaque finds itself embroiled in an ethical dilemma only science can resolve. While sympathetic to the NABR’s concerns, this Article argues the true threat to scientific progress lies in the IUCN reverting the long-tailed macaque’s conservation status to Vulnerable. Presently listed under Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), States are obligated to regulate the long-tail macaque’s trade within their jurisdictions. However, local laws often fall short in protecting these animals, particularly as human-macaque conflicts breed resentment toward the species. Capitalizing on the long-tailed macaques’ domestic vulnerability and premium international price tag, poachers have resorted to using falsified CITES permits to capture and sell wild macaques to research laboratories. In light of their rapid decline, this Article advocates for heightened protection under CITES for long-tailed macaques to incentivize stronger domestic and international regulations. Furthermore, by aligning the biomedical industry’s objectives with those of conservationists, this Article proposes legal strategies grounded in domestic and international law that the research sector can utilize to advance scienti!c progress while saving a species vital to its success. 

Sophia Pastorini, Neither Covered nor Excluded: Impacts of Speciesism on Aquatic Animal Experimentation under The Animal Welfare Act

Despite significant scientific evidence affirming their capacity for pain and pleasure, aquatic animals in laboratory settings receive limited federal protection. The Animal Welfare Act leaves aquatic animals entirely adrift; they are neither included in the list of protected animals nor explicitly excluded. They inhabit a realm so marginalized that they are not even mentioned in the Act. The urgency of safeguarding aquatic animal welfare is a matter of moral imperative, scientific integrity, and justice. By employing a multifaceted approach that combines ethical considerations and legal frameworks, this Article seeks to catalyze change in the treatment of aquatic animals in research settings. It underscores the importance of aligning our regulatory and ethical frameworks with evolving scientific insights and moral imperatives, ultimately paving the way for more compassionate and just treatment of all sentient beings—whether terrestrial or aquatic—while challenging the underlying speciesism that has long persisted in our society.

Lenore M. Montanaro, Esq., Alchemizing the Bar: An Examination of Global Ethical Considerations for Using Alternatives to Animals in Research, Testing, and Education

Countries regulate scientific research in various ways. Such structures are the result of input from scientists, attorneys, physicians, advocates, and others. These schemes may also derive from outcomes of the research itself. Some countries do not incorporate or require the ethical use of an animal—or an alternative to the use of an animal—to be considered. Others do incorporate, and even require, the ethical use of animals in research. In alignment with The Three Rs—replacement, reduction, and refinement of animals used in science—technological capabilities now allow scientists to increasingly use alternatives, such as microphysiological systems, rather than animal models. This Article (1) discusses ethical codes and systems for using animals in research, testing, and education, (2) surveys whether any countries incorpo- rate ethical considerations of the use of animals in science, and (3) describes potential ways to advance the law in alignment with The Three Rs. As such, advocates become alchemists who do more than continue to ‘raise the bar’ for animals in science; rather, they alchemize the bar, so that transformational and systemic outcomes for people and animals are realized.

This Article posits that changes in U.S. laws and policies regarding animal experimentation depend on the recognition of animal sentience. Sentience—distinct from cognition and self-awareness—is the ability of an animal to experience pain, pleasure, and other emotions. First, this Article reviews the reasons animals are still used in biomedical research and the relevant characteristics of U.S. law. This is followed by a discussion of sentience and the concepts of cognition and self-awareness, and a discourse on societal interests. The Article concludes with an analysis of six bioethical principles considered central to the future of animal experimentation. Overall, conferring sentience would lead to the legal recognition of the moral status of animals. However, such change could only happen with true partnership between veterinarians, scientists, ethicists, lawyers, animal behaviorists, as well as representatives of the public.

Rebecca Critser, De-Myth-ifying Laboratory Animal Law: The Truth behind Four Commonly Minsunderstoon Facts in Laboratory Animal Welfare Law 

The subspeciality of laboratory animal law presents unique difficulties because it requires familiarity with two highly specialized fields: law and science. Consequently, it is not surprising that some aspects of laboratory animal law have been misunderstood. This Article highlights four such misunderstandings surrounding laboratory animal law and provides an explanation of the truth behind each myth. The myths discussed include: (1) the AWA is the only federal law applicable to laboratory animals; (2) states are preempted from regulating the laboratory animal space; (3) birds, rats, and mice are not covered under federal law; and (4) the 3Rs are explicitly required by U.S. federal law.