Under the second Trump administration, the Make American Healthy Again program has as one of its central pillars the “sound science” principle, which aims to reform federal health agencies by demanding that regulations only move to a proposal phase if they are grounded in “sound science.” Recently, several states have latched onto the idea and introduced or passed “sound science” legislation that considerably increases the burden of proof that state regulators will have to overcome before passing legislation – notably, environmental or chemical related regulations will be particularly impacted by these bills. But what effects will the “sound science” bills have on companies, environmental initiatives focused on “emerging contaminants” such as PFAS or microplastics, and will the “sound science” movement impact litigation involving chemicals?
Sound Science Bills
Alabama, Tennessee, Utah and Kentucky have thrown their hats into the ring thus far and introduced “sound science” bills applicable to their own states. Beyond simply requiring “sound science” in support of any environmental or chemical-related regulation, the bills prevent state regulatory agencies from introducing regulations that are stricter than federal standards or from introducing limits for chemical not already regulated at the federal level unless the state agency shows a “direct causal link” between the chemical and bodily harm in humans. Alabama, Utah and Kentucky’s bills further require that in the context of environmental pollution regulations, merely showing an increased risk to human health (the gold standard measure to date for enacting environmental regulations) is no longer sufficient – rather, a higher burden of proof is placed on regulators.
The outcry, of course, is that the standards created by these bills may well be impossible for state regulatory agencies to meet. Consider the example of PFAS, a class of chemicals consisting of over 15,000 chemicals. The EPA and numerous states have studied for years the potential risk to human health from the two original PFAS types (PFOA and PFOS) and kidney cancer, for example. Yet, numerous health agencies and medical science recognize other causes of kidney cancer. How, then, is a regulatory agency to show a “direct causal link” to kidney cancer and PFOA and PFOS, if there will always be scientific evidence supporting other causes of kidney cancer, as well? Actual causation (direct causation) is the crux of personal injury litigation in the United States, and is something that is very fact specific and often contested at trial. Opponents to the “sound science” bills as written argue that regulators will in some fashion be forced to have “mini trials” during the administrative process to prove causation to meet the higher burden required of them by the bill language.
There will be rara exceptions. The link between mesothelioma and asbestos is a valid example whereby asbestos is essentially the only known cause of mesothelioma, so direct causation will be able to be proven (yes, there are a couple of other causes accepted by some medical experts, but they are fairly rarely encountered, such that asbestos is widely seen as the usual cause of mesothelioma). But the exceptions will not swallow the rule in this instance, as the vast majority of other illnesses or impacts on human health have several other potential causes that regulators will have to grapple with.
Impact On Companies and Litigation
Companies doing business the states passing “sound science” bills should not be lulled into a false sense that the developments mean that no environmental regulations will be effectuated within the state boundaries. It is important to note that any regulations that the federal government passes typically apply automatically to all states, especially in the environmental context. So, as the EPA, for example, promulgates new regulations (which yes, is happening, as evidenced by the EPA’s current battle to keep its PFAS regulations alive under CERCLA and the Safe Drinking Water Act), companies in “sound science” states will still have to comply. In some ways, the bills formalize a practice that is typically seen within those states anyway – i.e., the four Republican states that have passed or introduced “sound science” bills thus far have historically not been states that introduce or pass regulations that are more aggressive than the EPA when it comes to the environment.
Further, it should be noted that the bills will not deter private civil litigation or litigation brought by NGOs, which has seen a considerable uptick in recent years. While the lawsuits may not have aggressive state regulations to point to for chemical standards for water, air, soil, etc., such standards have never been necessary or arguably even critical to bring civil litigation for environmental pollution or personal injury.
As such, “sound science” does not equate to no risk and no compliance requirements for companies. While states with “sound science” laws may not be as aggressive as other states in environmental regulation, those states are thus far a small minority of states. Time will tell how many other states follow in the MAHA footsteps and introduce similar “sound science” legislation.