[CODATA-international] Public Comment Period Open for New EPA Rule on Strengthening Transparency in Regulatory Science

Mercury Fox ceds at email.arizona.edu
Mon May 4 13:58:08 EDT 2020

Hi All-

Last week's spirited discussion surrounding Dr. Berkman's diagram for
science advice methodology has reminded me of a pressing use case that
applies to the data science community: Docket ID No. EPA-HQ-OA-2018-0259
Strengthening Transparency in Regulatory Science.  This rule undermines
science advisory mechanisms by a device that simultaneously narrows the
scope of evidence that can be considered in the EPA rulemaking process
while it creates a loophole for the Administrator to exercise his
housekeeping authority in adopting the rule.

In short, the EPA wants to consider the political implications of science
advice when it makes new rules by re-defining the legitimate bounds of
acceptable data, models, analysis.  As an Obama-era EPA administrator,
Joseph Goffman, put it, "...they don’t just want to roll back a series of
individual rules. They really want to decommission important components of
the regulatory apparatus itself."

Over 10,000 public comments have been registered and the deadline for new
comments extended to May 18, 2020.  The EPA announced that it intends to
finalize the proposed 2018 rule later this year.

Harvard's Kennedy School of Government developed a tip sheet
February that provides a good background on the 2018 proposed rule.  The
EPA issued a press release
few weeks ago that outlines proposed changes in the Supplemental:

   - proposes that the scope of the rulemaking applies to influential
   scientific information <https://cfpub.epa.gov/si/si_public_pr_agenda.cfm>
   as well as significant regulatory decisions;
   - defines and clarifies that the proposed rule applies to data and
   models underlying both pivotal science and pivotal regulatory science;
   - proposes a modified approach to the availability provisions for data
   and models that would underly influential scientific information and
   significant regulatory decisions, as well as an alternate approach; and,
   - clarifies the ability of the Administrator to grant exemptions.

*Science Advice*
Individual experts and expert communities have a role to play in this
decision about decision-making.  Federal agencies must consider and reply
to "substantive public comments" in the course of issuing new regulations
and policies.  Failure to do so exposes them to legal challenges, and the
courts are often obliged to overturn new rules on this basis.  According to
the EPA's Deputy Administrator, the agency received almost 600,000 comments
in response to the rule as it was proposed in the spring of 2018, of which
approximately 9,200 qualified as unique and substantive public comments.

Substantive comments either support or challenge a rule by documenting the
- the accuracy of evidence that underlies the rule;
- the adequacy of the scientific analysis that drives the rule;
- alternatives to the proposed rule; or
- presenting new information that cause changes or revisions in the

*Summary of Specific Rule Changes*
1. EPA is modifying the regulatory text related to federally funded
research, toxic waste disposal, and data sharing so that (rulemaking)
provisions would apply to data and models, not only dose-response data and
dose-response models.
2. EPA is to add definitions for “*influential scientific information*” and
“*pivotal science*” in federally funded research
3. EPA is proposing definitions for the terms “Capable of being
substantially reproduced”, “Data”, “Independent validation”, “Influential
scientific information, ” “Model”, “Pivotal science”, “Publicly available”
and “Reanalyze.”
4. EPA is deleting the 2018 proposed regulatory definition of “research
5. the Agency will only use pivotal regulatory science and/or pivotal
science if the data and models are available in a manner sufficient for
independent validation and *the Agency will give greater consideration to
studies where the underlying data and models are publicly available*
6. EPA is modifying the factors the Administrator would consider in
determining whether to grant an exemption to the public availability
requirements for using data and models
7. EPA is proposing the option of using its housekeeping authority
<https://www.law.cornell.edu/uscode/text/5/301> independently as authority
for taking this action or in conjunction with the environmental statutory
provisions cited as authority in the 2018 proposed rulemaking


*Merc Fox*Director, CODATA Center of Excellence in Data for Society at the
University of Arizona
Data7 + iSchool
Tucson AZ ♦ Washington DC
(520) 261-4997
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