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Wolf in Sheep’s Clothing (or a Scientist’s Lab Coat)

A scientist in a labcoat redacts data in a book
(Illustration by POGO)

The Environmental Protection Agency (EPA) recently issued a new proposed rule entitled “Strengthening Transparency in Regulatory Science.” Sounds like a good idea, right? Well, that is the point—to make it sound good. Not as many people would like it if they called it “Censoring Science in Rulemaking,” which would be much closer to the reality of the new policy’s impact.

Essentially the proposed rule would require that the agency only use science for which the underlying data is fully public. Again, it sounds pretty good at first. But there are very valid reasons researchers don’t publish all the underlying data—personal privacy being the biggest one. Major health studies often collect large amounts of information about the people who agree to participate. No one wants their personal health information published. In fact there are laws strictly prohibiting sharing a person’s medical information, namely the Health Insurance Portability and Accountability Act of 1996.

EPA’s proposed rule claims there are ways to mask data to ensure privacy is protected, but those efforts are not foolproof. Even when personal identifying information is removed from data, it can be possible to identify individuals in the right circumstances from a combination of simple data points. The best way to protect personal privacy is to not publish the detailed data underlying these studies.

If the policy goes into effect, the EPA won’t be able to use those large human health studies even though they have been conducted by reputable researchers and academic institutions, and peer reviewed to ensure validity. Instead, they will be left with industry studies that more often use animal test subjects, which don’t have personal privacy concerns when it comes to detailed data.

In a published letter from the heads of six major scientific journals, editors note that while data sharing contributes to the robustness of scientific results, “in not every case can all data be fully shared.” They raise concerns about limiting scientific evidence, and conclude that “excluding relevant studies simply because they do not meet rigid transparency standards will adversely affect decision-making processes.”

The EPA’s proposed policy also seeks to ensure “reproducible scientific assessments,” which again sounds reasonable but can actually be used to eliminate important findings of dangerous exposures that have occurred. Studies such as those that linked leaded gasoline to brain damage in children or a Harvard study that found a link between fine particulate air pollution and premature deaths examine dangerous real world exposures and cannot be safely repeated. Just because they can’t—or shouldn’t—be repeated doesn’t mean we should ignore the vital insights they provide. The knowledge we have gained from these tragedies can and should be used to help prevent future problems.

So the policy will result in the agency having less science to work with—and will quite likely force the agency to rely on more industry-funded studies. It is important to note that while there are plenty of quality studies funded by industries, there are also serious risks for conflicts of interest with industry studies. New regulations from an agency like EPA can cost companies millions to comply with, so when industry studies conclude that such regulations are unnecessary, it is only reasonable to want confirmation of those findings from independent scientists that don’t have a financial stake in the outcome.

Placing large portions of scientific research off limits for agencies goes against common sense. We should want agencies to be able use any and all information available to produce the best, most up to date rules. If a study is unreliable or flawed in some way, then the agency can decide that based solely on the study’s own merits. And sometimes even flawed or partial studies can offer important insights that the EPA should benefit from.

Consider a scenario where you or a loved one gets a serious diagnosis. You want your doctor to consider every piece of information that could help—international research, results from experimental treatments, studies of related illnesses, and early reports from research currently underway. Do we really want to use a different standard when EPA is seeking to protect the health of whole communities across the entire country?

The proposed rule would not actually require the government to be more transparent but, instead, demands a new level of transparency from academic and industry studies, a level of transparency that has questionable merit. The reality is that agencies are already required to be pretty transparent when it comes to rulemaking, including about the science they use. When rules are proposed EPA has to state which scientific studies they relied on and explain why they chose those studies. The agency already determines to weight studies differently or not use them on their merits as a function of their methodological clarity and data quality. The notice and comment period for a rule allows outside stakeholders to raise concerns or problems with the science used or offer alternative studies. And the agency has to consider and respond to those comments, which commonly occurs in the form of an extensive explanation that accompanies the final rule in the Federal Register.

The EPA is accepting comments on their proposed rule until May 30. Environmental groups are already pushing to have that deadline extended, almost certainly so they can offer a more comprehensive refutation of the proposal. However, the EPA could press forward no matter how compelling and convincing an argument opponents offer in the comment process. If so, the agency will almost certainly face a court battle next and it could be a difficult one.

Back during the George W. Bush Administration, the American Trucking Association filed suit against EPA over air quality standards for particulate matter and ozone. One of things they argued was that EPA denied them essential procedural right by failing to make public underlying data for the key studies used. The U.S. Court of Appeals for the District of Columbia Circuit ruled against that point agreeing with EPA that such a requirement would be “impractical and unnecessary.”

The three judge panel, two appointed by Ronald Reagan and one by Bill Clinton, said in greater detail:

“If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment.... [S]uch data are often the property of scientific investigators and are often not readily available because of ... proprietary interests ... or because of [confidentiality] arrangements [with study participants].”

In the proposed rule the agency notes that “the best available science must serve as the foundation of EPA’s regulatory actions.” It is hard to argue with that as a fundamental principle. But this policy won’t make scientific information better or more available. Instead, the new rule will often mean the best available science is off limits to the agency. This is a “solution” for a problem that doesn’t exist. In fact, it is a problem dressed up like a solution. It would severely limit the information EPA can use, threaten the personal privacy of those participating in human health studies, and make it more difficult to produce large human health studies. And it’s a problem we don’t need to saddle the EPA with.

By: Sean Moulton
Open Government Program Manager, POGO

Photo of Sean Moulton Sean Moulton is the Open Government Program Manager at POGO.

Topics: Government Accountability, Open Government

Related Content: Inherently Governmental Functions, Effective Government

Authors: Sean Moulton

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