Last year, the Environmental Protection Agency (EPA) proposed Strengthening Transparency in Regulatory Science, a misleading rule that stipulates that when the EPA utilizes a scientific study to support public health protections, the raw data supporting the rule (potentially including personal medical data) must be publicly available and the studies must be able to be validated by a separate EPA review. This wide-ranging proposal would significantly limit the research and data that the EPA can use to make informed policy decisions under major public health and environmental laws, including the Clean Air Act, Safe Drinking Water Act, and Toxic Substances Control Act.
More than 600,000 comments were received on this proposed rule, and consequently it has not yet been finalized. However, the EPA has recently issued a “supplemental proposed rule” to “clarify” issues in their so-called transparency proposal. The supplemental rule has a very short 30-day public comment period even though it significantly expands the scope, and doesn’t address the most problematic aspects of the original proposed rule.
The Union of Concerned Scientists is calling on scientists and technical experts nationwide continue to speak out and submit public comments on the new supplemental proposed rule on transparency, drawing on their expertise and detailing how the supplemental rule, in combination with the original proposed rule, would impact the use of specific research. Be aware that EPA is stating that it will only consider new comments on the content of the Supplemental Proposed Rule, not on the original proposed rule.
To make sure your comment is considered, frame it with regard to the issues raised in the supplemental proposal:
- Whether EPA should use its authority under its housekeeping authority in addition to other environmental statutes
- Expanding the rule to cover not just pivotal regulatory science but also influential scientific information (which means coverage of the studies informing agency rules and the studies informing internal scientific assessments that aren’t part of rulemaking)
- Inclusion of proposed definitions for “influential scientific information,” “pivotal science,” “capable of being substantially reproduced” “data” “independent validation” “model” “publicly available” and “reanalyze”
- Proposal of EPA consideration of studies only if the underlying data is available in a tiered access approach, so that studies relying on data that can’t be made fully public will be excluded altogether. An alternative approach would down-weight studies relying on data that can’t be made fully public. With either approach, this means studies will be evaluated not on their quality but on a non-scientific metric.
- Whether the rule should apply to data generated before the effective date of this rulemaking
- Whether there are aspects about data that should be considered by the administrator as they decide to grant an exemption to the rule
Submitting a comment can be an effective way to participate in the policymaking process, evaluate proposals, and ultimately shape final policies. Agencies look for information relevant to the proposed policy—from local impacts to technical knowledge—and are required to respond to substantive comments about a proposed policy’s impacts, questions, and concerns. (More on the process at Public Comment Project and in this public comment 101 video.)
How to submit:
Go to the public comment page for the proposed policy on Regulations.gov to enter or upload your comment. Make sure all documents contain your name and contact information. Be sure to submit your comment by the expiration date on the webpage and check your email for a receipt confirmation. While a submission can be typed directly into the website, uploading a separate document may be easier for you to edit, save, and submit.
Tips for writing a comment:
Read through the summary, general information and background to be aware of the context on why the agency is taking this action.
Write concisely, but provide all details you think may be relevant.
Effective comments lay out and support facts the agency has ignored or overlooked.
Describe the personal impact of a proposed rule. That could include how it will impact public health, local environments, ability to find study participants, cost of compliance, vulnerable communities, or any other factor.
Address potential negative impacts of the proposed rule, overlooked impacts, and intended or unintended consequences of the proposed rule, and when available attach key studies and research so they are on the record. Note: With respect to the proposed rule on sidelining science at the EPA, you should also share examples of what types of studies the agency could no longer rely on because of excessive data access requirements. Upload those examples and explain the barrier.
It is not sufficient to simply disagree with the agency’s policy judgments; this is a qualitative exercise, not a poll. Explain why you disagree.
If you cite a study or want to draw EPA’s attention to a study, be sure to attach it is a separate pdf when you submit. This could be useful to draw attention to studies that would not be able to make underlying data public for privacy or other reasons.
Remember that the most effective comments are unique and specific. The public comment process allows scientists and the public to help agencies understand the range of consequences of a proposed rule. Arguments made during this process are often used as evidence for any future court challenge.
Who should write
Scientists who research public health, toxicology, etc.-- and those who have produced or worked with rigorous research without publishing underlying datasets in full. Individuals who have participated in peer review can also illustrate how that process works to validate studies without looking at raw data. Anyone who can speak to the impact of the restrictions on the EPA’s ability to protect human health and the environment should submit a comment
What to address
The EPA needs to hear from scientists why excluding research based on non-publishable datasets limits the EPA’s access to the best available science, and the harm that these restrictions would create for people. Be as specific as possible, including detail on specific studies that would be excluded, what the burden would be to redact information, or participate in a reanalysis exercise with the EPA on individual studies.
Consider the following as you decide what to address in your comment:
Limiting consideration of science in EPA decisions. The supplemental proposal now states that all research used to support agency rules would be covered by these transparency requirements, not just dose response studies. (That means studies on the fate of contaminants in the environment and impacts of regulations for example.) All raw data (that is the underlying data analyzed in the study including outliers but with errors corrected), models computer code and other information would need to be publicly available. Would the rule make it more difficult for your research to be used in policymaking? If so, how? If available, insert examples of research that would be excluded if available.
Feasibility and Costs of reducing privacy. The EPA hasn’t determined how to make data and information available to the public, nor estimated the cost of doing so for the agency or researchers. They have also not clearly stated how the proposal would relate to research requirements including those from grant conditions or institutional review boards. They have indicated that they may in future use systems for confidential data that are currently in use at CDC, like tiered access to data and models, but they don’t explain how or when. How might this affect the work you do? Do you see conflicting requirements? Would it be more difficult to do you work without being able to guarantee confidentiality? What are the costs you might anticipate?
Impact on research and public health. The supplemental proposed rule states that in considering scientific studies, the agency intends to give the most weight to those studies where the underlying data are fully publicly accessible, and consequently lesser or no weight to studies where the data, models and computer code are not accessible to the public. Does that make sense to you from a scientific perspective? How would that impact your work or the application of your work? Do you think this will impact the evidentiary basis for public health and safety protections implemented by EPA to meet its mission of protecting the public?
Current quality control and peer review methods. The supplemental rule clarifies that by requiring all studies to be reproduced, they mean reanalyzed. That is: they want to recalculate all results with the same data models, methods and code – check your arithmetic if you will. They also propose that sensitivity analyses be done to further explore uncertainty in the results. Does this make sense to you as a scientist or researcher? How does peer review work in your field to ensure that research is of sufficient quality? When you participate in peer review is the raw data normally part of your review? What kinds of safeguards already exist? What genuine improvements could be made in improving transparency?
Impact on people. What communities near you would be affected if the EPA restricts the types of evidence that can be used to make decisions as described in the supplemental proposed rule? How would the communities be affected? Use specific examples. Do you work with communities that have more exposure to pollution? Would they be more or less exposed to pollution if data and evidence are restricted?
Shifting responsibility for evaluating science. Under the supplemental proposal the EPA Administrator has the authority to waive the requirements for the data to be public on a case-by-case, study by study basis. In effect, the Administrator could decide the science that may be considered in crafting regulatory policies. Does this make sense to you as a scientist? Should the EPA administrator be able to decide to exclude specific studies from consideration or exempt specific studies from data disclosure? What would be the effect of shifting the responsibility for evaluating the weight of the evidence from scientists to political appointees?
Getting ready to write
As you prepare for writing your comment, you can check out the following on the “supplemental proposed rule” and its implications:
- The EPA’s Science Restrictions Go from Bad to Worse, Scientific American
- E.P.A. to Limit Science Used to Write Public Health Rules, The New York Times
- Updated Restricted Science Rule Spells Reanalysis Paralysis for the EPA, UCS Blog
- List of scientific organizations and joint letter from scientific journal editors in opposition of original proposed rule
- The Trump EPA Is Restricting EPA Science. It’s Somehow Worse than We Expected.
- EPA Moves to Handcuff Its Scientists
Let us know if you are submitting a comment by either filling out our response form or contacting Danielle Fox at [email protected]. We will follow up with additional hands-on resources or support for your comment writing.