Three State Bills/Laws That Don’t Go Far Enough To Reduce And Replace Animals Used In Testing (Part 1)

By Sherman McFarland | October 26, 2023

Some states have attempted through legislation to prohibit or reduce the number of animals used for research when non-animal testing alternatives are available. Have these attempts been effective? This blog post is the first of two parts. In this Part 1, we introduce three state bills and analyze their efficacy with respect to validation and acceptance of alternative test methods. Although these bills have the ostensible goal of preventing the unnecessary suffering and death of animals, we will explore whether these bills could adequately achieve that goal.  

California’s Assembly Bill (AB) 357, which was enacted into law on October 8, 2023, prohibits manufacturers and contract testing facilities from using traditional animal test methods for which an appropriate alternative test method or strategy exists, or a waiver has been granted by the agency responsible for regulating the specific product or activity for which the test is being conducted.  

Massachusetts’ Bill H.850 states that, “When testing a product, product formulation, chemical, or ingredient in the Commonwealth, no manufacturer or contract testing facility shall use a traditional animal test method for which a valid alternative test method exists.” 

In Illinois, SB 1882 prohibits a testing facility from conducting a canine or feline toxicological experiment in the state, except for testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any product intended for beneficial use in dogs or cats. 

Under California’s AB 357, an alternative test method is a method that, among other things, does not use animals, and such a method must be identified and accepted for use by a federal agency, or program within an agency responsible for regulating the specific product or activity for which the test is being conducted. Illinois’ SB 1882 requires the reliability and relevance of an alternative test method (defined as a test method that does not use animals, or in some cases reduces or refines the use of animals) to be established by “validation bodies” such as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) or Organization for Economic Cooperation and Development (OECD). 

This is one of the problems with AB 357 and SB 1882: neither establishes state standards for the validation or acceptance of alternative test methods. Instead of requiring testing facilities and manufacturers to use alternative test methods that the state has validated and accepted for use, the bills seem to trust that testing facilities and manufacturers will use alternative test methods validated or accepted for use by a federal agency, program within an agency, or other validating body instead of using a traditional animal test. The problem is that there is no guarantee that manufacturers or testing facilities will use an alternative test method that has been validated or accepted for use by a federal agency, program within an agency, or validation body instead of a traditional animal test. Counteracting this concern is a provision in AB 357, which requires manufacturers and contract testing facilities to annually report the number and species of animals used in tests, the purpose of the animal tests, and the number and types of alternative test methods used.  

Presumably, the California Department of Public Health, which is tasked with reviewing the annual reports submitted by contract testing facilities and manufacturers starting on January 1, 2027, could ensure compliance with the law by checking whether an alternative test method used by a facility has been accepted for use by a federal agency, or whether said facility used an animal test method when a federally accepted non-animal alternative existed. In addition, AB 357 requires the California Department of Public Health to make the information shared in the annual reports submitted by contract testing facilities and manufacturers publicly available on the Department’s website. Therefore, this reporting requirement could serve as an effective monitoring and enforcement mechanism, as well as a way to discourage testing facilities and manufacturers from simply ignoring the alternative test methods that federal agencies have accepted for use. At the same time, it is unclear whether the California Department of Public Health has the resources or political will to ensure that contract testing facilities and manufacturers are using federally accepted non-animal test methods instead of traditional animal test methods. Can the Department establish an inspection program and set up a regulatory infrastructure to make this bill work effectively? It is a fair question to ask because, again, California does not establish state standards for the validation or acceptance of alternative test methods through AB 357, but requires manufacturers and contract testing facilities to use alternative methods accepted for use by a federal agency or program. If the California Department of Public Health doesn’t have the time or money to read every annual report submitted by contract testing facilities and manufacturers to verify that they are using federally accepted non-animal test methods, those businesses could flout the law by continuing to use animal test methods without punishment.  

Interestingly, Massachusetts’ H.850 enables the Commissioner of the Massachusetts Department of Public Health to “establish standards for alternative test methods to ensure safety and comparable validity of results to traditional animal test methods.” Unlike California’s AB 357, which seems to trust that manufacturers and contract testing facilities will use federally accepted alternative test methods instead of traditional animal methods, H.850 creates state validation standards. Therefore, Massachusetts would have the authority to validate non-animal test methods, and contract testing facilities and manufacturers would have to use those state-validated non-animal test methods. The concern, however, is that there is no reporting requirement for H.850 as there is for AB 357. Therefore, similar to AB 357, it is possible that contract testing facilities and manufacturers in Massachusetts could continue to use animal test methods even when validated non-animal alternatives exist. H.850 states that the Commissioner of the Massachusetts Department of Public Health shall promulgate regulations to implement and enforce the requirement that contract testing facilities and manufacturers must use validated non-animal test methods, so it is possible that a reporting requirement would be part of these regulations. The bill was referred to the Committee on Environment and Natural Resources in February 2023, but no further action has been taken.  

Finally, Illinois’ SB 1882 has the flaws of AB 357 and H.850. Not only is there no reporting requirement (just like H.850), but there is also no state validation or acceptance standard (just like AB 357). Rather than requiring testing facilities to use alternative test methods validated or accepted by the state, SB 1882 seems to trust that testing facilities will use an alternative test method validated by a “validating body” before said facilities perform a toxicological experiment on a dog or cat. This self-policing provision, combined with the lack of a reporting requirement, means that SB 1882 has no enforcement mechanism, and will seemingly enable testing facilities to continue to test on dogs and cats without consequence. This bill became an Illinois law on June 30, 2023. 

It is important to note that AB 357 and SB 1882 include provisions that authorize the Attorneys General of California and Illinois, respectively, and the district attorneys in both of those states, to enforce the animal test method bans in these laws by bringing civil actions for injunctive relief against testing facilities or manufacturers in violation of these laws. However, if neither AB 357 nor SB 1882 contain a reporting requirement for manufacturers or testing facilities that can be administered by a state agency with the resources necessary to do so (e.g. time and money in the agency’s budget), it will be difficult for the Attorneys General, or district attorneys in California or Illinois, to successfully identify a manufacturer or testing facility in violation of their respective animal test method bans, and pursue an injunctive action against it. For clarity, Illinois’ SB 1882 only applies to testing facilities, while California’s AB 357 applies to manufacturers and contract testing facilities.

To effectively ban traditional animal test methods when non-animal methods are available, state governments should designate an agency, or agencies, whose tasks include: (1) validating and accepting alternative test methods for use, and (2) creating a list of those methods and making it publicly available on an agency’s website. If a state government takes these steps, manufacturers and testing facilities will know what validated and accepted alternatives are available that must be used, and they will know where to look for updates when new alternative test methods are validated and accepted for use. Simply put, these measures would allow testing facilities and manufacturers to easily comply with an animal test method ban. The state would also be able to consult the list on its website for easy reference when it needs to enforce the law against a non-compliant testing facility or manufacturer. To better enforce prohibitions on animal test methods when non-animal alternatives are available, states should also require manufacturers and testing facilities to submit monthly reports that identify and describe (1) all tests performed during the month, (2) whether those tests used animals, (3) the number of animals and species used during the tests, and (4) whether any alternative test methods were used. Of course, the state should make these monthly reports publicly available, and ensure that the agency or agencies tasked with reviewing these reports have the resources to do so. Stay tuned for Part 2 of this blog post, where we will examine the medical research exemptions present in all three of the bills/laws analyzed above. 

Reference:
AB 357 (California): https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB357 

H.850 (Massachusetts): https://malegislature.gov/Bills/193/H850 

SB 1882 (Illinois): https://www.ilga.gov/legislation/103/SB/10300SB1882.htm 

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.