The proposed rule will undermine EPA's ability to fulfill its mission to protect human health, safety, and the environment by using the best available information and science. First, the proposed rule would exclude from EPA's consideration any reports, studies, analyses, and models that rely on confidential, inaccessible, or unavailable data but that historically have been considered the best available science and therefore used to support regulations and standards designed to protect public health and safety. Second, in so doing, the rule also eliminates EPA's access to fundamental information necessary for identifying and calculating the "health benefits" of rules and standards needed to protect public health. Finally, it threatens to impose significant costs on both the federal government and independent scientists. Worst of all, the proposed rule creates these multiple problems without providing any significant countervailing benefits.

Other major figures in the scientific community reiterated these criticisms of the Proposal. For example, the editors-in-chief of Science, Nature, PLOS, PNAS, and Cell published a joint statement explaining that:

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 rigid transparency standards will adversely affect decision-making processes.1

Similarly, a coalition of sixty-nine public health, medical, academic, and scientific groups commented that:

If EPA excludes studies because the data cannot be made public, people may be exposed to real harm. The result would be decisions affecting millions based on inadequate information that fails to include well-supported studies by expert scientists. These efforts are misguided and will not improve the quality of science used by EPA nor allow the agency to fulfill its mandate of protecting human health and the environment.2 

This proposal has been justified on the false premise that identities of individuals in health research studies can be reliably masked to protect their privacy as required by law. They cannot be. Hence, this proposal would result in many relevant studies being disallowed, including many that provide the basis for current EPA standards that must be reviewed under applicable legislation.

2. If this is such a good idea, why is it proposed just for EPA rather than as legislation or regulation applying to all health-regulating agencies? Imagine that research used for FDA drug approvals had to pass the same requirements. FDA drug approvals would grind to a halt, just as would EPA health-protective regulations.

3. The single most relevant document for the SAB to consider in responding to the EPA charge is the Comments of the International Society for Environmental Epidemiology on EPA's proposed rule on Strengthening Transparency in Regulatory Science. Since the ISEE submitted it previously to EPA, but the SAB members have not seen it, I am attaching it to this submission. SAB members must read this document. The ISEE recommends that EPA withdraw the proposal in part because the "masking" of personal identities cannot be reliably done and still allow reanalysis of the research.