Talking Points on Proposed Rule “Strengthening Transparency in Regulatory Science”

Docket No. EPA-HQ-2018-0259 —

As written, the proposal would allow the EPA Administrator to limit and restrict the scientific research that the U.S. Environmental Protection Agency uses as the basis for public health and environmental protection regulations. On behalf of the health of my patients and my community, I strongly oppose this proposed rule.

The EPA already uses transparent, peer-reviewed science.  The EPA states in the proposal that “the best available science must serve as the foundation of EPA’s regulatory actions.” As a physician trained in evidence-based care, I agree wholeheartedly with that sentence.  Unfortunately, the proposal enables unnecessary restrictions on the use of such science.

The proposal would block the use of seminal health studies.  The EPA’s proposal would allow the blocking of studies that rely on confidential patient information from being used in policymaking. Many studies, including older studies, depend on or have historically used such data that legally cannot be made public. Indeed, patient information is understandably critical to many studies showing health impacts of pollutants. The fact that this information must be kept confidential to protect patients does not make the data any less valid.  Nor can researchers effectively redact identifying data in a way that will protect confidentiality for many of these studies. The risks to privacy from the availability of patient data are recognized in the research and medical profession.

Industries like the tobacco industry and industrial polluters and their allies have been pushing to exclude studies for decades, using the same arguments found in EPA’s proposal, targeting research that shows harm to public health from their products or their emissions.  Two of the early industry targets were landmark air pollution studies completed in the 1990s that found solid evidence that particulate matter air pollution could cause premature death. The two long-term studies—the 1993 Harvard Six Cities Study and the 1995 American Cancer Society (ACS) Study –looked at large populations in multiple locations. The Six Cities study began tracking the health of 8,111 adults in six small cities in the United States in the 1970s. The much larger ACS study began with data from 552,138 people in 151 cities collected as part of the American Cancer Society’s Cancer Prevention Study II in 1982. Both studies controlled for smoking, education and other factors that could cause differences in outcomes. Both studies found the particulate matter in the air was linked to increased risk of premature death.  Their size and careful controls on other known risks gave these research findings substantial weight in EPA’s review of the particulate matter national ambient air quality standard. EPA incorporated these studies into their review of the research, leading to the first national standard for fine particulate matter (PM2.5) in 1997.

This proposal revives prior efforts to undercut the science behind EPA regulations.  The above studies were challenged in the 1990s by members of Congress and their industry supporters seeking access to the confidential patient information, arguing that the raw patient data should be public since the research was federally funded.  In response, instead of blocking the studies, as this proposal would do, EPA took a logical step and referred both studies to an independent third party, the Health Effects Institute, for a deep-dive review.  There, autonomous independent reviewers examined the data and developed a report on the two studies that confirmed their original findings. Since these studies, other research has confirmed the findings.  Similar third-party reviews could readily address concerns about existing or future studies as needed.

In the proposal, EPA references other scientific publications in its attempt to defend the rationale for these changes, citing “related policies by some major scientific journals” including Science and the Proceedings of the National Academy of Sciences. However, the editors in chief of those publications and others refuted that argument in a letter published in April in the journal Science, stating:

“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 relevant studies simply because they do not meet rigorous transparency standards will adversely affect decision-making processes.”

Simply put, the EPA’s proposed rule seeks to solve a problem that does not exist.  EPA’s existing approach toward science, with its detailed review and deliberation of the research, is already transparent and has worked well for decades.

The title paints the effort as “strengthening transparency,” but the result would be just the opposite: the EPA administrator could obscure major, well-vetted research that has found evidence of a wide range of health risks of pollutants, including risks of premature death.

Given the lack of any substantiated need for this change, the history of similar efforts led by polluting industries, the seminal health studies that stand to be excluded, and the absence of scientific review or support, this is a proposal that should worry all evidence-based medical providers.