Six Things You Should Know About The EPA’s New Science Restriction Draft Policy

, Research Director, Center for Science and Democracy | April 25, 2018, 4:12 pm EST
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Yesterday, the EPA unveiled a long-awaited policy changing how the EPA can use science in its decision making. Ostensibly about “transparency”, the policy will actually restrict the agency’s ability to use the best available science—and thereby weaken protections for public health and the environment. While many of the provisions were known in advance, there are important details worth pointing out now that we know what the policy looks like:

1. It’s clear: This is about attacking soot and smog protections

It has always been evident that current EPA leadership is keen on dismantling the 2015 ozone standard, but the new proposal makes it abundantly clear that the administration is targeting ozone and particulate pollution protections specifically. The language is prescriptive—focused narrowly on the scientific studies that link air pollutants to adverse health effects, like premature death, heart attacks, and respiratory illness. In other words, the administration is restricting use of the very studies that show the need for air pollution protections. (In breaking with scientific community nomenclature, the proposal refers to these studies as “dose response studies”.) This directly undermines the EPA’s ability to set air pollution standards at a level that is protective of public health—as the agency is legally required to do under the Clean Air Act. The proposal even calls out the 2015 ozone rule specifically, raising the idea of having the new policy retroactively applied to the rule. To be clear, the real-world implications of this policy are likely to extend far beyond ozone and particulate matter—everything from chemical safety of consumer products to pesticide use to water quality—but the administration has showed its hand when it comes to motivations behind this policy.

2. The EPA administrator has absolute power

Tucked into the policy proposal is a provision that gives the EPA administrator notable power over how this would be implemented. He or she gets to decide what information counts and what does not. The administrator can “exempt significant regulatory decisions on a case-by-case basis.” This is a loophole big enough that we could drive a tractor-trailer through (perhaps one that doesn’t meet modern emissions standards?). By allowing the EPA administrator to exempt entire decisions, or just singular studies, this allows political appointees to pick and choose what science is “acceptable” when making (what should be) science-based policy decisions. That politicizes the evidence that can be considered or excluded for arbitrary reasons, making it easier for the EPA administrator to insert politics into existing science-based processes at the EPA.

3. A lot of talk, not a lot of evidence

The proposal provides little justification for the move. In addition to being a solution in search of a problem, the proposal includes no analysis of how this will affect the EPA’s mission-related work and no costs or benefits of such a move. In a proposed rule for public comment, the agency is supposed to present its analysis of the effect of the rule. Do they expect some types of public protections to be harder to implement? Do they expect certain standards will change? Why? And what are the gained or lost benefit to the public? What are the costs in time and resources to the agency and the public?

This lack of clarity on the implications of the proposal is especially concerning in light of a past Congressional Budget Office analysis that found that the similar HONEST Act would cost upwards of $250 million to implement. It is clear that the current proposal would create a tremendous time and resource burden on EPA and by scientists outside of the agency, as they would scramble to (needlessly) track down, collect, compile, and post (including any statistical methods needed to conceal private information) all the data, models, code, etc. for each of the hundreds of studies the EPA cites on any given decision. It is easy to see how this will add administrative red tape, not remove it.

As Senator Tom Carper and his colleagues point out, this policy will likely violate several laws, including the recently updated and bipartisan Toxic Substances Control Act, that requires the use of “best available science” in policymaking. The EPA fails to address this concern in the proposed rule.

4. But how though? The policy is lacking on details.

The proposal is vague about how all of this would happen. How would the Administrator decide what studies would be exempt? Where would the data reside? How would the resources to manage all the data be obtained? Ensuring all this extra information is received, stored, and made publicly accessible would be no small undertaking. The proposal references a system used by the National Institutes of Health to collect health data, but there are barriers and questions to how such a system could apply to the EPA. While the administration asserts that this is about transparency, the NIH system isn’t publicly accessible. There are all kinds of concerns related to disclosing personal health and other data. How will privacy be protected, and privacy laws complied with? Or will this policy simply block the agency from using any study that has relied on protected, private data? It isn’t clear that such processes have been seriously considered by the administration, and they’re hoping the public can figure it out for them.

5. Good laboratory practices, bad idea

The policy makes vague reference to “good laboratory practices.” This sounds, well, good. But it is anything but. This particular standard for good laboratory practices has long been used to ensure the industry studies are weighted heavier than independent studies conducted at universities, for example. Because the scientific community has their own ways of ensuring appropriate practices, many academic institutions do not meet the GLP standard. Historically, this has allowed chemicals with adverse health impacts, like BPA, to stay on the market because the EPA could only rely on industry studies that (conveniently) found no health concerns, while academic studies have. Applying these particular standards more broadly than they are currently applied could restrict the number of independent health studies that EPA can consider in its decision making.

6. The EPA claims support for its proposal; it doesn’t hold up.

Notably, the EPA’s own officials don’t agree that this is a good idea. In emails released to the Union of Concerned Scientists last week through an open records request, assistant administrator and former chemical industry rep Nancy Beck, flagged prior EPA positions on this issue established from court cases:

While the EPA therefore strives to ensure that data underlying research it relies upon are accessible to the extent possible, it does not believe that it is appropriate to refuse to consider published studies in the absence of underlying data … If the EPA … could not rely on published studies without conducting independent analyses of the raw data underlying them, then much relevant scientific information would become unavailable for use in setting standards to protect public health and the environment.

Externally, people don’t agree with this proposal either. The EPA policy proposal cites Science magazine and reports by the Bipartisan Policy Center and Administrative Conference of the United States as aligning with their efforts, but that’s not what they said.

Yesterday Editor-in-chief of the Science family of journals Jeremy Berg pushed back on the claim:

It does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them; rather, it is paramount that the full suite of relevant science vetted through peer review, which includes ever more rigorous features, inform the landscape of decision making. Excluding studies that do not meet rigid transparency standards will adversely affect decision-making processes.

Today, Rob Meyer of the Atlantic today talked with Wendy Wagner, University of Texas School of Law professor and author of both the BPC and ACUS reports. She too challenged the claims the reporters support the EPA’s proposal.

They don’t adopt any of our recommendations, and they go in a direction that’s completely opposite, completely different. They don’t adopt any of the recommendations of any of the sources they cite. I’m not sure why they cited them.

A new source, but still dishonest

Some parts of the legislation on which the EPA proposal is based were so indefensible that the agency didn’t even bother to propose it. Large portions of the HONEST Act suggest that studies should only be considered in rulemaking if they are reproducible—as if we should expose kids repeatedly to lead or mercury to make sure that the initial studies hold up. We will need to ensure that a final rule does not further limit the science that EPA can use through bogus reproducible arguments.

In the end, this policy will have broad implications for the EPA’s ability to fulfill its mission of protecting public health and the environment. By restricting the science that EPA can use to make decisions, we are forcing them to protect us with their hands tied and blinders on. This doesn’t serve transparency. It doesn’t serve efficiency. And it certainly doesn’t serve the public interest.

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  • Bill Sekerak

    So refusing to rely on studies that are not repoducable and when blindly accepted as valid may , and often do,have enormous negative financial effects is unreasonable?
    Restricting EPA paid researchers from sitting on committees that these government employees have a personal stake , financially or otherwise, in their acceptance of studies they’ve authored or participating in is not a mistake it’s the logical thing to do. In fact no one whose judgment may be affected by personal gain of any sort ,other than seeking the truth, should not be allowed on committees whose recommendations often cause the public to suffer financial loss.
    For far too long the EPA has run roughshod over the American public without any concern whatsoever for the damage they’ve been inflicting on them. No thought is given to the cost of what regulations they’ve enacted. The EPA consists of UNELECTED individuals whose decisions have a greater impact on the public than the individuals elected to office. How many people have been needlessly killed in automobile accidents because the EPA has enacted laws that require,in actual effect, that automobiles become smaller,lighter and thus more susceptible of being unable to protect the passengers from death due to accidents ? The answer is far too many. Yes, I’ve heard the BullShit that studies show that that assertion is false. How many studies have shown that size and weight of a vehicle aren’t factors in mortality due to auto crashes? How many have been reproduced? How many have been performed by objective, independent researchers who have no skin in the game?
    This article is little more than Fascist propaganda.

  • Gaythia

    Since this is being posted to social media, I believe great care needs to be taken as to how to present counter arguments to the proposed rules proposed by Pruitt to bar what he wants to refer to as “secret science” in ways that the public can see as maintaining high scientific standards. After all, Pruitt’s apparent strategy here hinges on how sensible his calls for greater transparency seem to be.

    In particular, I believe that item #5 above, especially the headline, is very poorly phrased. Scientists do have standards for “Good laboratory practices” that can still attempt to maintain patient confidentiality. A quick glance at the headline here seems to link “good laboratory practices” with “bad idea”. This, in my opinion, plays right into the “Merchants of Doubt” strategy.

    This is definitely not the message we want to convey.