Three State Bills/Laws That Don’t Go Far Enough To Reduce And Replace Animals Used In Testing (Part 2)
By Sherman McFarland | February 7th, 2024
Hello and welcome to Part II of the earlier blog post about three state bills (California’s AB 357; Massachusetts’ H.850; and Illinois’ SB 1882) that purportedly prohibit testing on animals when valid non-animal alternative testing methods exist. In Part I, we noted that California’s AB 357 and Illinois’ SB 1882 became law. As of the release of this blog post, the last progress made on Massachusetts’ H.850 was a joint state House and Senate hearing scheduled on November 8, 2023. Part I of this blog post noted that the major problem with the Illinois and California laws is that neither establishes state standards for the validation or acceptance of alternative test methods. In addition, neither the Illinois law nor the Massachusetts bill requires companies testing on animals to report the number and species of animals used in tests, the purpose of those tests, and whether any non-animal alternative tests were used. Without a reporting requirement, it will be difficult for the governments of Illinois and Massachusetts to collect information with which to enforce the animal testing bans in SB 1882 and H.850, respectively.
Part II of this blog post explores another major problem with all three pieces of legislation: their effect has been severely weakened by medical research exemptions. A powerful provision in the March 15, 2023 version of the California bill was the exemption for biomedical research, which was limited in scope. At that time, the bill stated that its animal testing prohibition did not apply to any traditional animal test methods performed for the purpose of biomedical research, with “biomedical research” defined as “the investigation of the biological processes and causes of disease or research conducted to increase fundamental scientific knowledge, and to expand the understanding about how processes in living organisms develop and function, but shall not include traditional animal test methods done to assess the safety or efficacy of chemicals, ingredients, drugs, medical devices, vaccines, product formulations, or products” (emphasis added). Therefore, California’s prohibition on animal testing applied to all traditional animal testing of chemicals, ingredients, drugs, medical devices, vaccines, product formulations, and products, because those items weren’t included in the definition of biomedical research.
Unfortunately, the version of the California bill that passed through the state legislature and became law removed this language, and replaced it with an exemption for “medical research.” Under the law, “medical research” is defined, in part, as “research related to the causes, diagnosis, treatment, control, or prevention of physical or mental diseases and impairments of humans and animals or related to the development of biomedical products, devices, or drugs as defined in Section 321(g)(1) of Title 21 of the United States Code.” As a result, California’s law allows manufacturers and contract testing facilities in California to continue using traditional animal tests for research on diseases and impairments of humans and animals, and for the development of biomedical devices, products, and drugs. Therefore, the effect of California’s law on prohibiting animal testing and requiring the use of non-animal alternative test methods has been severely reduced.
The Massachusetts bill suffers from the same problem. It does not apply to any test methods conducted for the purposes of medical research. In the bill, “medical research” is defined as “investigations, experiments, and studies to discover, develop, or verify knowledge relating to the causes, diagnosis, treatment, prevention, or control of physical or mental diseases and impairments of humans and animals or relating to the development of biomedical products, devices, or pharmaceuticals.” Therefore, in Massachusetts, manufacturers and contract testing facilities may continue to use animal testing for researching diseases and impairments of humans and animals, and the development of biomedical products, devices, and pharmaceutical drugs. Manufacturers and contract testing facilities are under no obligation to use non-animal alternatives for any research that falls under the incredibly broad definition of “medical.”
Finally, the Illinois law includes several exemptions, one of which is for medical research, thereby allowing Illinois testing facilities to continue toxicological experimentation on cats and dogs when it is “related to the causes, progression, diagnosis, treatment, control, or prevention of physical or mental diseases and impairments or chronic conditions of humans or animals or related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code. Medical research does not include research related to the development of drugs as defined in Section 321(g)(1) of Title 21 of the United States Code.” Thus, the Illinois law allows testing facilities to continue performing experiments on dogs and cats for research on diseases, impairments, and chronic conditions of humans and animals, and for the development of biomedical products and devices. With the exception of drug research, which does not qualify as medical research under the law, it appears that toxicological experiments on dogs and cats will continue unabated in Illinois.
The medical research exemptions in California’s law, Illinois’ law, and Massachusetts’ bill are so broad that these pieces of legislation have been rendered almost completely ineffective. If states want to effectively prohibit the use of traditional animal test methods when valid alternative non-animal test methods are available, it would behoove them to remove any biomedical or medical research exemptions from their legislation. Medical research exemptions in AB 357, H.850, and SB 1882 enable manufacturers and testing facilities in California, Massachusetts, and Illinois, respectively, to continue testing on animals to research any malady that afflicts humans or animals. The definitions of “medical research” in all three pieces of legislation are so broad that manufacturers and testing facilities could claim that any of their research is related to a disease or impairment afflicting a human or animal, thereby enabling them to perform unnecessary animal research under the law. And this is permissible despite the fact that the goals of each of these bills or laws is to prohibit animal testing when non-animal alternatives are available. Although the biomedical industry may heavily lobby for the inclusion of such exemptions in legislation that bans animal testing when valid non-animal alternatives exist, state legislators must fight for the exclusion of those exemptions if these bills are ever to become what they appear to be. Otherwise, these bills will only ever be symbolic and insubstantial.
The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.
