A Proposed EPA Regulation Would Endanger the Public’s Health

The U.S. Environmental Protection Agency has one job: to protect public health and safety and the environment we live in, with the best available science. It is a mission that saves lives. But that mission could end if EPA administrator Andrew Wheeler succeeds in restricting the science that the agency can use.

Wheeler is pushing a new proposed rule—cloaked in the rhetoric of “transparency”—that in most cases would effectively bar the EPA from using a study in its policy making if all of that study's data, computer code and models have not been made public. In practice, this eliminates all studies that protect the confidential medical information of participants, even though such research is vital for understanding the public health impacts of pollution. The rule would make laws such as the Clean Air Act harder to fully implement. It sounds like a small change, but it has the potential to do enormous damage.

An attempt to add this rule in 2018 was met with widespread condemnation from public health experts and the science community. A supplemental proposal is a new effort by Wheeler to abandon science-based protections that have worked effectively for decades to deliver cleaner air, cleaner water and healthier communities. So what does the rule do in its “clarified” form?

It applies to all the science used by the agency. Initially the new rule applied to “dose-response” studies used to quantify the effects of a pollutant or chemical on human health. But now the EPA says that all science used by the agency would fall under the same constraint, whether it is a survey, an environmental assessment, a modeling study or anything else that could help inform policy.

The use of gold-standard studies of health impacts based on personal medical data that participants and researchers agreed, legally, to keep private would be restricted. And even without such restrictions, companies could pick and choose what research they show the agency. This could be applied retroactively to studies published years ago, meaning that as regulations are reconsidered and updated, some of the original scientific basis for existing protections may be excluded, inevitably resulting in weaker rules.

It requires endless, pointless reanalysis. EPA scientists already critically review the quality and strength of scientific research, going above and beyond the rounds of peer review that are standard in science. But the proposed rule calls for the agency to engage in reanalysis, effectively forcing it to check the math of every study to make sure it gets the same answer. It also requires an overly broad set of sensitivity studies on all parameters. That work is quite time-consuming and impractical.

It upends the value placed on studies. There are established ways to evaluate scientific research: Is it well designed? Are its assumptions reasonable? Are sample sizes big enough? Are the methods solid? Is the evidence strong enough to point to a conclusion, and if so, how does it compare with findings from other studies in the field? The supplemental proposal imposes an arbitrary bureaucratic standard unrelated to robustness or merit. The weight the evidence received would be based primarily on the public availability of raw data.

It is a political change made to achieve political goals. Far from a move toward transparency, this rule was designed by political staff on the basis of proposals long pushed by lobbyists for the tobacco industry and fossil-fuel extractors. The EPA's own scientific experts were secondary to the process, and its Science Advisory Board was given very little opportunity to review it. Worse, the EPA administrator can pick and choose when the rule does and does not apply—the exact opposite of a transparent or science-based process. The EPA got nearly 600,000 critical comments on the original proposal, including opposition from major scientific societies, public health groups and universities. It largely ignored them.

This proposal puts a set of handcuffs on the agency, with industry-linked political appointees holding the key. It will make it harder for the EPA to protect communities or to hold polluters accountable. It is a declaration by Wheeler and his deputies that they don't care about public health.