EPA intends to limit which scientific studies it will consider, which could undermine settled conclusions about the health impacts of air pollution. This is Part 3 of 4. Part 1 explains the origins of this effort and why it matters, Part 2 outlines the shortcomings in EPA’s proposed rule, and Part 4 analyzes the final rule and its downfall.
As part of the public comment process on EPA’s proposed rule, Strengthening Transparency in Regulatory Science, 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 scientific research to treat patients on a daily basis.
The comment explains how EPA’s proposal would frustrate its stated goal of relying on the “best available science.” EPA equates 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). 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 EPA considers in its decisions, these scientists and caregivers argue that the proposal will “undermine EPA’s ability to make reasonable decisions,” because it will “effectively prohibit [the] EPA from considering studies that by design are based on data that cannot be made publicly available.” (p. 4).
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. 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. Federal funding for research often includes confidentiality requirements as well. 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, even anonymous data can be covered by legally binding confidentiality agreements.
The second category of potentially excluded studies are those 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. 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. Reproducing the study would be difficult as well because children no longer suffer from the same amounts of lead exposure – because of EPA’s actions. Yet EPA is required to review some of its regulatory programs on a regular basis, including rules limiting lead air pollution and lead water pipes. EPA’s proposal would break this successful review cycle by removing from consideration in its decision-making many studies that support these important safeguards.
Finally, 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 from consideration because they cannot be repeated.
This proposal fits the pattern of EPA’s results-based science and regulation: starting with a desired outcome, and then searching for the rationale and analysis to support it. In this instance, EPA’s proposal seeks to undermine foundational public health studies that enable EPA to regulate deadly air pollutants, and in doing so, to tilt the scales on its own economic analysis to ignore health benefits of regulation. But as the Harvard experts point out, EPA’s chosen method demonstrates a fundamental misunderstanding of science.
Read the comment in its entirety.
For more information on other changes to science at EPA, please see our other Mission Tracker posts, including:
- Removing Scientists from Advisory Panels, which explains changes to expert committees that advise EPA on the science underpinning its considerations and actions;
- Results-Oriented Regulatory Science about Administrator Pruitt’s approach to regulation and enforcement; and
- Our post and podcast on EPA’s modifications to the national air quality standards five-year review process
This post was edited for clarity on Jan. 16, 2020.