10/22/2018 - EPA Mission Tracker

Changing What Science the EPA Will Consider – Part 3

by EELP Staff

We have written previously about the EPA’s effort to close its eyes to established science as a means of undermining public health protections. Part 1 explains what this anti-science effort is and why it matters, and Part 2 outlines the flaws in the specific proposal that the EPA offered.

As part of the public comment process, a group of 97 medical and public health experts affiliated with Harvard University submitted a detailed comment outlining the proposal’s misunderstanding of how science works. These signatories ranged from the leading epidemiologists who conducted some of the studies under attack to department chiefs at world-class hospitals who rely on advances in science to treat patients on a daily basis.

The comment explains how the EPA’s proposal would actually frustrate its stated goal of relying on the “best available science.” The EPA attempts to equate the public release of raw data – including confidential personal medical histories – with the quality of a scientific study, but as the experts state, “there are a variety of other best practices that already exist to test and ensure the rigor, quality, and validity of research.” (p. 3). As we wrote before, this includes the peer-review process that scientists have long relied on to ensure that scientific studies are sound.

Instead of improving the quality of the science that the EPA considers in its decisions, these scientists and caregivers believe that the proposal will actually “undermine EPA’s ability to make reasonable decisions.” (p. 4). That is because it will, as they say, “effectively prohibit [the] EPA from considering studies that by design are based on data that cannot be made publicly available.” (emphasis in original, p. 4).

Further, the comment identifies two categories of “critically-important, health-based studies for which it will be impractical or illegal to make the underlying data publicly available.” (emphasis added, p. 6). The first are studies relying on confidential human health data. As the comment notes, many types of health studies rely on human participants, and the privacy rules under the Health Insurance Portability and Accountability Act of 1996 (better known as HIPAA) imposes strict confidentiality requirements, while federal funding for research often includes confidentiality requirements as well. The EPA’s proposal simply asserts that private data will be withheld or de-identified, but true de-identification can be elusive. As the comment notes, one study found that researchers were able to re-identify about one-quarter of purportedly anonymized data.1 Moreover, it can be the case that even anonymous data is covered by legally binding confidentiality agreements.

Second, the proposal could prevent the EPA from relying on studies from many years ago for which the data are no longer available or accessible, jeopardizing long-established landmark studies and potentially any subsequent research building upon those studies. For example, a bedrock study of lead in children’s teeth formed the basis for a series of EPA regulatory actions to limit lead exposure from air pollution, water systems, and paint, each of which built upon the prior actions. That study was conducted more than forty years ago and many of the scientists are no longer alive, making it unclear whether the data are available, but reproducing the study would be difficult because children no longer suffer from the lead exposure – because of the EPA’s actions, in other words. Yet the EPA is required to review some of its actions on a regular basis, including rules limiting lead air pollution and lead water pipes. The EPA anti-science proposal would break this successful cycle by undermining decades of science and public health protection.

Further, the comment points out that some studies rely on unusual events that mean the data cannot be reproduced, such as studies of survivors of nuclear attacks on Hiroshima and Nagasaki that are used to regulate radioactive particles in drinking water. (p. 13). The proposal would seemingly eliminate such studies because they cannot be repeated.

This fits the pattern of the EPA’s results-based science and regulation: starting with an answer and then searching for the rationale and analysis to support it. (We have written about that separately). In this instance, the EPA’s proposal seeks to undermine foundational public health studies that enable the EPA to regulate deadly air pollutants, and in doing so tilt the scales on its own economic analysis to ignore health benefits of regulation. But as the Harvard experts point out, the means it chooses betray a fundamental misunderstanding of science.

Read the comment in its entirety.

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