It's no secret that Scott Pruitt wants to undermine science at the Environmental Protection Agency. His proposal this week, which I like to call the Censoring Science Rule, is just his latest attack on sound science, one that will reward his polluter allies. The proposed rule will push EPA to rely almost entirely on industry-sponsored studies, while making it nearly impossible to use public health studies and real-world field data and information. The inevitable and intended result is to gut our nation's health and environmental protections.
So, Pruitt’s stated goal is to ensure that the science used by the agency is done in a fair and transparent manner. But it includes a series of obscure but insidious directives pushing the agency to tilt science in the direction of industry and away from that by independent academics, public health professionals and government researchers.
A Joint Statement of scientific journal editors published in Science magazine oppose the Proposed Rule for many reasons, summarized as follows: "It does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them... Excluding relevant studies simply because they do not meet rigid transparency standards will adversely affect decision-making processes." (Science May 4, 2018)
Attorneys General of NY, CA, DE, IA, ME, MN, PA, and DC sent a letter to Pruitt asking that, "In light of the far-reaching impact the proposal could have on EPA’s mission to protect public health and the environment, we ask that you withdraw the proposed rule and convene a process to first consult with the National Academy of Sciences and other independent scientists and science organizations before deciding whether any proposed changes to EPA’s current use of scientific evidence are in order." They also raised concern about the ridiculously short timeline for public comments - only 30 days - and the "vagueness of the proposal" which seems not to have been reviewed by either legal or policy experts.
Consider the different way the proposal treats confidential data by businesses and academics. Industry-funded studies could keep their data secret by claiming it’s “confidential business information.” However, it will make it much harder to use data from non-industry studies due to the near-impossible measures that would need to be taken to protect the privacy of research participants as required by HIPAA medical rules. Medical studies, clinical reports, and real-world field studies all include data and information that cannot be made public without violating confidentiality and patient protection rules under HIPAA. Such studies are used by EPA to provide realistic credible information to the public, including consumers, manufacturers and businesses.
The Censoring Science Rule directs EPA to use industry-sponsored studies by requiring it to use studies that follow “standardized test methods” and “good laboratory practices,” which both sound nice but are actually elaborate, pro-industry code. Standardized test methods are industry-sponsored studies designed to gain regulatory approval of the test substance. Industry test studies have been required to follow good laboratory practices since the 1970s after flagrant violations and fraud were identified. A 2014 National Academies of Sciences report pointed out the limitations of these standards, including that they fail to prevent flawed, unreliable or biased-by-design studies (NAS IRIS report, p.62-63). In contrast, academic research is the cutting edge of methods development, and must meet Institutional Review Board approval, which sets high scientific and ethical standards of conduct.
The proposed rule requires EPA to give equal consideration to all sorts of dose-response models, including those that may presume that there are safe levels of a toxic chemical, or even that it may be good for you. This may be appropriate when testing medical drugs but not for toxic pollution. Moreover, there are literally an infinity of possible dose-response models, as the proposed rule points out; for example, linear, threshold and non-threshold, U-shaped, J-shaped, and bell-shaped. EPA has historically taken the very reasonable position that toxic chemicals and pollution are bad for human health, and that an increase in pollution will lead to an increase in adverse effects. This new Censoring Science Rule will toss those default health-protective assumptions out, and instead invite literally an infinite number of model options from which EPA can choose. In the case of Pruitt’s EPA, if industry argues that pollution is good for your health, the agency could accept that rationale. Of course, the model options are reduced by the other parts of the proposed rule, which directs EPA to select the industry-sponsored options (see above, regarding standardized tests and GLP).
In one of his first acts as head of the EPA, Pruitt sided with Dow Chemical against his own agency scientists by rejecting the evidence that the brain-toxic pesticide chlorpyrifos was too dangerous to continue to be used on food crops. This proposed rule puts into writing his justification for putting agrochemical industry interests ahead of children’s health. And it would allow him to run that same playbook time and time again.
There’s only one way that Pruitt’s Censoring Science rule is actually being transparent: It was designed to tilt the agency toward helping polluters, and it does, in fact, do that. So much for protecting the environment.
See blog from NRDC expert Dr. Vijay Limaye to learn more about the impacts of Pruitt's Proposed Rule on air pollution regulations, and the overly burdensome costs and complications of implementing this reckless rule.