Comments on Strengthening Transparency in Regulatory Science

How to comment: 

Comments on this rule change are CLOSED


Comment Text  (for copy/paste into comment field)

I am responding to EPA’s proposal to restrict the use of legitimate, peer-reviewed scientific research in fulfilling its regulatory mission of protecting the health of humans, animals, and the environment. EPA’s proposal is a solution in search of a problem because there are already procedures and processes in place, both in the EPA and the broader scientific community, that address the stated concerns.

A key point in the proposed regulation is that data from studies used in regulatory decision making be made available to third parties for conducting their own analyses. This justification fails to recognize that EPA has successfully addressed this issue in the past. For example, when a series of important studies done in the 1990s by the Harvard School of Public Health and the American Cancer Society on effects of fine particle air pollution on human health were questioned by opponents of air pollution regulations, a re-analysis of the data in 2000 by the reputable Health Effects Institute was undertaken. The independent re-analysis confirmed the findings of the original studies. This demonstrates that experts independent of the regulators and the regulated can already satisfy one of EPA’s primary arguments for the need of the proposed regulation.

Commensurate with having  procedures in place to confirm data from studies used in regulatory decision making is the manner in which such studies are examined initially by the scientific community. As part of the process for the evaluation and publication of scientific research, all of these studies invariably undergo rigorous peer review by independent experts. Peer review is the world-wide gold standard for evaluating scientific research. No study is published in any reputable journal without undergoing peer review. Thus, any pivotal study used for regulatory decision making has already undergone such review. Moreover, in the event that EPA determines that further review is necessary, its own expert panels, such as the Scientific Advisory Board (SAB), exist to serve such a purpose. Unfortunately, and this is truly alarming, EPA’s intentional crippling of its own SAB, involving the replacement of qualified independent experts by industry employees with obvious conflicts of interest, damages the credibility of the SAB to do its job in an impartial manner. The end result is that the ability of EPA to perform its regulatory mission is significantly diminished.

Thirdly, the proposed regulation would require repeating studies before the studies and their findings can be used in regulatory decisions. The proposal fails to recognize that replication is a basic component of scientific research and, as such, replication is an ongoing endeavor. In general, however, most replication efforts aim to confirm and extend the results of a prior study by introducing new manipulations, experimental conditions, data types, etc., with the aim of extending the initial study. This systematic replication is a fundamental aspect of scientific research. Systematic replication by different researchers using different techniques collecting different data sets, yet addressing a similar fundamental health question, provides the strongest possible replication method.

It must be noted that some studies indeed cannot be replicated in the manner suggested in the proposed regulation. For example, epidemiological studies examining the effects of human exposure to toxic substances. On moral, ethical, and legal grounds, it is impossible to intentionally expose humans to known or suspected harmful substances. However, it would be absurd for EPA to argue that these types of epidemiological studies should not be considered when developing policies that affect the health of millions of Americans.

Finally, the proposed rule does not include any assessment of its impact on public health and the environment. Where is the EPA’s “risk assessment” that shows that the proposed changes will have a positive impact on, and not unintended consequences of doing harm to, the groups it is purportedly intended to protect? There are important questions that must be answered before EPA proceeds.

In proposing these dramatic and highly consequential changes to its policy making process, EPA has not provided support for the necessity of these changes. Moreover, there is little evidence to suggest that the proposed changes would not adversely affect the quality of the resulting policies. Sound scientific information is crucial to creating regulations and policies that protect the health and well-being of us all.