Changing What Science the EPA Will Consider – Part I

The EPA intends to change which scientific studies it will consider in a thinly-veiled attempt to undermine settled conclusions about the health impacts of air pollution. This is Part 1 of 3. Click here for Part 2 and here for Part 3.

The EPA has historically relied on the best available peer-reviewed science in carrying out its mission. Federal law and good governance require that the EPA consider all available information in its decision-making. Yet, in a recent interview Administrator Pruitt said that he would soon announce a policy that would exclude science – including peer-reviewed science that has served as the foundation of EPA’s critical rulemaking – from being considered by the EPA. Under this policy, the EPA would only be allowed to consider the results of scientific studies if the underlying data are made public in a way that would allow an independent researcher to reproduce the results.

Under the guise of “transparency,” Mr. Pruitt claims to solve a problem that the scientific community already solved decades ago through peer-review – which accomplished the transparency Mr. Pruitt claims to be serving here. The real effect of his solution would be to impair the EPA’s ability to use science in protecting public health.

Administrator Pruitt claims that these newly devised limits on science are necessary to validate its trustworthiness, as if the peer-review process has not been performing that same function for decades. Given that the EPA’s Peer Review Policy sets the expectation that the EPA will use the best available science and will use the peer-review process to ensure its credibility, Pruitt’s action begs the question as to why he is purporting to re-solve a problem that was solved long ago.

Thanks to Steven Milloy, the self-described “junk science” agitator and a member of the Trump Administration’s EPA transition team, we have an unmistakable clue: to target two bedrock studies that definitively prove that particle pollution, or soot, harms people’s health: the Harvard Six Cities study and the American Cancer Society’s Cancer Prevention Study II.

These two ground-breaking studies from the 1990s followed tens of thousands of people over nearly two decades, and linked personal medical histories, occupational histories, and home locations to detailed air quality data to show that people exposed to more particulate matter are more likely to die prematurely. In order to collect all that information, the researchers made confidentiality agreements with the study participants stating that their private information would not be made public. That promise of confidentiality is part of what makes the studies vulnerable to the impending Pruitt policy, which, in turn, will deprive the EPA of the ability to use the studies in future decisions, analyses, and actions.

The studies demonstrated how significant the public health benefits of reducing pollution are. That demonstration is why Mr. Milloy, who in addition to doubting the health effects of fine particles, disputes the science behind secondhand smoke, climate change, DDT, and asbestos, welcomes the new exclusionary policy.

What belies the Pruitt-Milloy rationale for the new policy is the fact that the science underlying these so-called “non-transparent” studies and their conclusions has been thoroughly peer-reviewed, and that the studies and their results have been replicated by scientists around the world. In addition, the nonprofit Health Effects Institute – which has received funding both from the EPA and from the motor vehicle industry – conducted a thorough reanalysis of the two studies that validated their findings. If “transparency” is a principle of sound science, as Mr. Pruitt without explanation implies, then it is through peer-review and the replication of experimental results that it is achieved, not through the release of raw data from peer-reviewed studies already completed. If Mr. Milloy and his ideological allies nevertheless wish to contrive a new meaning for “transparency,” they do have the option of contacting the researchers who own the data and seeking to review it for themselves, provided they agree to keep it confidential.

There are at least three big problems with a policy that excludes these two foundational studies, and the other peer-reviewed studies built on them that would also be restricted by the policy.

First, the policy would hamper EPA’s carrying out of one of its most critical public health duties — conducting the ongoing review of the health-based air quality standards for particulate matter. These standards for particle pollution (along with those for five other air pollutants) form the backbone of the Clean Air Act’s air quality improvement process, and have been the key to transforming America’s air from dirty to clean over the past half century. The law requires that EPA look specifically and exclusively at health science in setting these crucial air quality standards when it is determining what amount of air pollution is safe to breathe. To meet its explicit once-every-five-years obligation under the Clean Air Act, the EPA is required to be working right now on a new health-based air quality standard for particulate matter. (The last one was finalized in December 2012, and the Clean Air Act requires the EPA to update it every five years.)

While this is an ambitious schedule that the EPA does not always meet, the next update is already overdue, and now Administrator Pruitt is proposing to exclude the fundamental science that underpins this public health protection. According to the American Lung Association, more than 43 million people live in areas where there are too many days of high particle pollution. Administrator Pruitt’s action, effectively removing the foundational studies from consideration, will likely threaten their public health protections; distorting through exclusion the scientific record on which the EPA will rely opens the door to relaxing limits on how much particulate matter people can be exposed to.

Second, this policy will limit what information the EPA can consider in other matters. Mr. Pruitt’s statement of intention, taken at face value, suggests that setting air quality standards is not the only EPA public health function that will be imperiled. Manufacturers of pesticides and chemicals, for example, are required to submit information to the EPA on the toxicity of their substances in order to register their substances and get permission to sell them, and this often includes substantial amounts of confidential-business information. Similarly, motor vehicle certifications can include confidential engineering science. The intended policy threatens to hamstring the EPA’s ability to work with those industries to register their products. In addition, the policy could threaten the EPA’s ability to consider science stemming from unique events like natural disasters, if those data are not “reproducible.”

Of course, Pruitt has the option of sparing these applications of confidential or non-reproducible data from the reach of his so-called transparency policy, but only if the agency can meet the burden of explaining why the purported logic of excluding from agency use the soot studies doesn’t apply to these uses.

Third, the policy is an attack on a tool – cost-benefit analysis – used by the entire government in setting priorities, providing information to decision makers, and developing regulations. If successful, the attack will only make it harder to justify taking action to protect public health, even when action is necessary. While the Clean Air Act and other environmental statutes do not mandate that the EPA conduct a cost-benefit analysis, a longstanding Executive Order does mandate that all executive agencies undertake such an analysis as part of the regulatory process. Scholars have long debated how informative a tool cost-benefit analysis is; it provides a quantitative measure of a policy’s effects, but many benefits are hard to capture using dollars as the measure. In particular, economists have struggled to assign value to health benefits, meaning that cost-benefit analysis can often be skewed towards showing more easy-to-measure costs with relative precision, while understating the monetary value of the full range of benefits.

In contrast, for example, the science is strong that mercury is harmful for a child’s brain development, but because there are no ways to conduct experiments to find out just how bad it is without doing real harm to the human subjects, neither economists nor the EPA can assign a dollar figure to the benefits of sparing children that harm. When EPA issues air pollution rules the agency routinely provides the public with detailed analysis that quantifies how much the rules would reduce asthma attacks, heart attacks, or missed days of school and work. For all practical purposes, though, the economic science does not exist to enable the agency to assign a dollar value to these benefits.

Because so much policy analysis and public information rely on cost-benefit analysis, most agencies and administrations have endeavored to find ways to overcome these limitations – as opposed to compounding them, which is what the Pruitt policy promises to do.

In the vein of seeking to make cost-benefit analyses useful, the two studies that Pruitt’s policy is threatening are particularly influential because scientists have used them to identify immense public health benefits from reducing air pollution. These studies prove that particulate matter pollution causes premature mortality and they tell us how likely it is. With that information, combined with an estimate of the societal cost of a premature death, the EPA can quantify the health benefits from its air pollution rules. Thanks to these studies, the benefits from avoided mortality due to reductions in particulate matter make up the vast majority of the quantified benefits of EPA air pollution rules. This is not because particulate matter is worse than toxic pollutants like mercury or benzene. Rather, because these particular studies were the fruit of scientists’ ability to assemble a vast amount of human health data in a non-intrusive way that posed no risk to the subjects involved, the studies provided science that is not only solid, but also readily amenable to yielding dollar-quantifying analysis.

Because the two studies do enable the EPA to represent the health benefits of reducing pollution in terms of a dollar value, they also enable the agency to provide meaningful cost-benefit information that roughly captures the scale of the benefits. Excluding these studies would prevent the cost-benefit analysis from quantifying the relevant health benefits for any rule that reduces particulate matter pollution – such as the Clean Power Plan or rules governing fuel economy of cars. This has the effect – as Mr. Milloy pointed out and as Mr. Pruitt presumably recognizes – to tip the scales of cost-benefit analysis even further in the direction of understating benefits in dollar-value terms. It’s like making a pro/con list but writing the pros in invisible ink.

At the expense of misleading both the public and decision makers in government and business, opponents of environmental regulation can show high costs and ignore lifesaving benefits because, again, the dollar-value of benefits will be largely missing from the equation. Meanwhile, if and when the EPA is petitioned under statutes like the Clean Air Act to regulate dangerous pollutants, a cost-benefit calculus that has been all but designed to understate benefits will allow the agency both to reject the petition, almost regardless of the health threat involved, and to defend its inaction in court when challenged.

Critics of the particulate matter studies will say that the study authors should just make the data public, but it is not that simple. As described above, in order to identify how much particulate matter contributed to a person’s death, one has to know a lot of private information about where that person lived and worked and how healthy they were otherwise. In order to get that information, the researchers entered into legally-binding confidentiality agreements with the subjects. The EPA does not own these data and had no role in their collection. Conservative critics claim that it is easy to redact personal information, but public health professionals have shown that it is difficult or even impossible to redact information in a way that protects privacy and still leaves the data useful. Again, though, the focus on the availability of the data, or lack thereof, misses the point. Because of the peer-review process and subsequent replication and reconstruction of the studies, the EPA already has a firm scientific basis for using the studies to protect public health. Making the raw data available simply offers no incremental improvement to the robustness of the studies; denying the EPA the ability to use the studies in the first place only cripples the standard-setting and policy-making process.

The impending exclusion of these and potentially other studies comes at a time when Administrator Pruitt has made changes to the makeup of his science advisory panels. The Clean Air Act, for example, requires that he receive advice about setting air quality standards from one of these panels. As he is poised to do here in misappropriating “transparency,” he has already misappropriated “independence,” inverting its common-sense meaning by contriving the removal from science advisory boards of truly independent scientists and effecting their replacement with industry-affiliated scientists. At the same time, in the last six months, the only public notice the Clean Air Science Advisory Committee has given has been to seek new members; otherwise, it has paused its work. The public might be forgiven for concluding that increasingly Pruitt is shielding himself and the agency from sources of science and scientific advice that might otherwise counsel more, rather than less, vigorous efforts to reduce pollution.

In addition to undermining EPA’s mission, Mr. Pruitt’s statements and pending action also raise a set of challenges to his fellow agency and cabinet department heads. A great many agencies rely on physical science, public health science, and engineering studies as well as cost-benefit analysis to do their work in safeguarding the public or otherwise advancing the public interest. Do they agree with Mr. Pruitt and the impending exclusion of the category of studies covered by his new policy?

If so, are they planning to follow suit, and what would be the policy and legal consequences be if they did?

Return to “Can EPA Maintain Its Mission?”


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