Document ID: EPA-HQ-OA-2018-0259-22422
Agency: epa
Document Type: Rule
Title: Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information
Posted Date: 2021-01-06T05:00Z

[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 469-493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29179]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 30

[EPA-HQ-OA-2018-0259; FRL-10019-07-ORD]
RIN 2080-AA14

Strengthening Transparency in Pivotal Science Underlying 
Significant Regulatory Actions and Influential Scientific Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This action establishes how the Environmental Protection 
Agency (EPA) will consider the availability of dose-response data 
underlying pivotal science used in its significant regulatory actions 
and influential scientific information. When promulgating significant 
regulatory actions or developing influential scientific information for 
which the conclusions are driven by the quantitative relationship 
between the amount of dose or exposure to a pollutant, contaminant, or 
substance and an effect, the EPA will give greater consideration to 
studies where the underlying dose-

[[Page 470]]

response data are available in a manner sufficient for independent 
validation. This action also requires the EPA to identify and make 
publicly available the science that serves as the basis for informing a 
significant regulatory action at the proposed or draft stage to the 
extent practicable; reinforces the applicability of peer review 
requirements for pivotal science; and provides criteria for the 
Administrator to exempt certain studies from the requirements of this 
rulemaking.

DATES: This final rule is effective on January 6, 2021.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OA-2018-0259. All documents in the docket are 
listed on the http://www.regulations.gov website. Although listed in 
the index, some information is not publicly available, e.g., 
confidential business information (CBI) information or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the internet 
and will be publicly available only in hard copy form in the EPA Docket 
Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, 
Washington, DC 20004. The Docket Center's hours are 8:30 a.m. to 4:30 
p.m., Monday through Friday (except Federal Holidays). Publicly 
available docket materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Bennett Thompson, Office of Science 
Advisor, Policy and Engagement (8104R), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone 
number: (202) 564-1071; email address: osp_staff@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. Does this action apply to me?
    B. What action is the Agency taking?
    C. What is the Agency's authority for taking this action?
II. Background
    A. Summary of 2018 Proposed Rule
    B. Summary of 2020 Supplemental Notice of Proposed Rulemaking
III. Description of Final Rule and Responses to Significant Comments
    A. Purpose and Effect of the Action
    1. Purpose
    2. Effect of This Rule on the Studies the EPA Uses To Support 
Significant Regulatory Actions and Influential Scientific 
Information
    3. Effect of This Rule on Human Health and Environmental 
Protection
    B. Dose-Response Data
    C. Definitions
    1. Capable of Being Substantially Reproduced, Independent 
Validation, and Reanalyze
    2. Data and Models
    3. Dose-Response Data
    4. Influential Scientific Information
    5. Pivotal Science
    6. Publicly Available
    7. Research Data
    8. Significant Regulatory Actions
    9. Science That Serves as the Basis for Informing a Significant 
Regulatory Action
    D. Applicability of the Rule
    E. Availability of Dose-Response Data
    F. Proposed 40 CFR 30.6
    G. Administrator's Exemption
    H. Peer Review
    I. Changes to 40 CFR 30.4 ``What requirements apply to EPA's use 
of studies in significant regulatory actions?''
    J. Benefits and Costs
    K. Proposed 40 CFR 30.8 ``How is EPA to account for cost under 
this subpart?''
IV. References
V. Statutory and Executive Orders Reviews
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    L. Congressional Review Act (CRA)

I. General Information

A. Does this action apply to me?

    This final rule does not regulate any entity outside the EPA. 
Rather, the requirements modify the EPA's internal procedures regarding 
the transparency of pivotal science underlying significant regulatory 
actions \1\ and influential scientific information. However, the Agency 
recognizes that any entity interested in the EPA's regulations may be 
interested in this final rule. For example, this final rule may be of 
interest to entities that conduct research or another scientific 
activity that is likely to be relevant to the EPA's regulatory activity 
or development of influential scientific information. This rule has no 
retrospective effect on either final significant regulatory actions or 
influential scientific information.
---------------------------------------------------------------------------

    \1\ Consistent with OMB guidance, this rule would not apply to 
the following regulatory actions: Individual party adjudications, 
enforcement activities, site-specific actions, or permit 
proceedings.
---------------------------------------------------------------------------

B. What action is the Agency taking?

    The EPA is issuing this final rule to help strengthen the 
transparency of the dose-response data underlying certain EPA actions 
and to set the overarching structure and principles for transparency of 
pivotal science in significant regulatory actions and influential 
scientific information. This rule has a much narrower scope than the 
2018 proposed rule (Ref. 5) and the 2020 supplemental notice of 
proposed rulemaking (Ref. 7). The rule describes how the EPA will 
determine the consideration to afford pivotal science of the EPA's 
significant regulatory actions and influential scientific information 
for which the conclusions are driven by the quantitative relationship 
between the amount of dose or exposure to a pollutant, contaminant, or 
substance and an effect based on the availability of the underlying 
dose-response data and other applicable factors. This rule builds upon 
prior EPA actions in response to Government-wide data access and 
sharing policies.
    First, the EPA is requiring that, when promulgating significant 
regulatory actions or developing influential scientific information, 
the Agency will determine which studies constitute pivotal science and 
give greater consideration to those studies determined to be pivotal 
science for which the underlying dose-response data are available in a 
manner sufficient for independent validation.
    Second, the EPA is establishing provisions for how the requirements 
of this part will apply. This rule sets the overarching structure and 
principles for transparency of pivotal science in significant 
regulatory actions and influential scientific information. The final 
rule provides that if implementing the rule results in any conflict 
between this rule and the environmental statutes that the EPA 
administers, and their implementing regulations, this rule will yield 
and the statutes and regulations will be controlling.
    Third, this rule requires that the EPA shall clearly identify all 
science that serves as the basis for informing a significant regulatory 
action. The EPA shall make all such science that serves as the basis 
for informing a significant

[[Page 471]]

regulatory action publicly available to the extent practicable using 
standards for protecting identifiable information.
    Fourth, the EPA is establishing requirements for the independent 
peer review of pivotal science.
    Fifth, the EPA is finalizing a provision that provides criteria for 
the Administrator to consider when granting case-by-case exemptions to 
the requirements of this rule.
    The EPA is also defining the following terms for the purposes of 
this rule: ``data,'' ``dose-response data,'' ``independent 
validation,'' ``influential scientific information,'' ``pivotal 
science,'' ``publicly available,'' ``reanalyze,'' ``science that serves 
as the basis for informing a significant regulatory action,'' and 
``significant regulatory actions.''
    Finally, the EPA intends to issue implementation guidelines that 
will help execute this final rule consistently across programs. This 
may include the process for designating key studies as pivotal science, 
documenting the availability of dose-response data, and requesting an 
Administrator's exemption.

C. What is the Agency's authority for taking this action?

    The EPA is authorized to issue this rule under its authority to 
promulgate housekeeping regulations governing its internal affairs 
(hereinafter, ``housekeeping authority''). This final rule describes 
how the EPA will determine the consideration to afford pivotal science 
of the EPA's final significant regulatory actions and influential 
scientific information based on the availability of the underlying 
dose-response data and other applicable factors. This rule exclusively 
pertains to the internal practices of the EPA and does not regulate the 
conduct or determine the rights or obligations of any entity outside 
the Federal Government.
    The Federal Housekeeping Statute (5 U.S.C. 301) provides that 
``[t]he head of an Executive department or military department may 
prescribe regulations for the government of his department, the conduct 
of its employees, the distribution and performance of its business, and 
the custody, use, and preservation of its records, papers, and 
property.'' As the Supreme Court discussed in Chrysler Corp. v. Brown, 
the intended purpose of section 301 was to grant early Executive 
departments the authority ``to govern internal departmental affairs.'' 
\2\ As the Supreme Court further explained, section 301 authorizes 
``what the [Administrative Procedure Act] terms `rules of agency 
organization, procedure or practice' as opposed to substantive rules.'' 
\3\
---------------------------------------------------------------------------

    \2\ Chrysler Corp. v. Brown, 441 U.S. 281, 309 (1979).
    \3\ Id. at 310.
---------------------------------------------------------------------------

    While the EPA is not one of the ``Executive departments'' referred 
to in 5 U.S.C. 101, the EPA gained housekeeping authority equivalent to 
that granted to Executive departments in section 301 through the 
Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970), which 
created the EPA. The Reorganization Plan established the Administrator 
as ``head of the agency,'' transferred functions and authorities of 
various agencies and Executive departments to the EPA, and gave the EPA 
the authority to promulgate regulations to carry out the transferred 
functions.
    Section 2(a)(1)-(8) of the Reorganization Plan transferred to the 
EPA functions previously vested in several agencies and Executive 
departments including the Departments of the Interior and Agriculture. 
Section 2(a)(9) also transferred so much of the functions of the 
transferor officers and agencies ``as is incidental to or necessary for 
the performance by or under the Administrator of the functions 
transferred'' and provided that ``[t]he transfers to the Administrator 
made by this section shall be deemed to include the transfer of [ ] 
authority, provided by law, to prescribe regulations relating primarily 
to the transferred functions.'' The Federal Housekeeping Statute was 
existing law at the time the Reorganization Plan was enacted. Further, 
the Reorganization Plan does not limit the authority to promulgate 
regulations only to the transferred functions, but rather it transfers 
all authority that ``relate[s]'' to the transferred functions. 
Housekeeping authority is ancillary to the transferred functions 
because it allows the EPA to establish standard, internal procedures 
that are necessary to carry out and support those functions. 
Accordingly, the concomitant Federal housekeeping authority to issue 
procedural rules was transferred to the EPA.
    The Office of Legal Counsel has opined that the Reorganization Plan 
``convey[s] to the [EPA] Administrator all of the housekeeping 
authority available to other department heads under section 301'' and 
demonstrates that ``Congress has vested the Administrator with the 
authority to run EPA, to exercise its functions, and to issue 
regulations incidental to the performance of those functions.'' \4\
---------------------------------------------------------------------------

    \4\ Authority of EPA to Hold Employees Liable for Negligent 
Loss, Damage, or Destruction of Government Personal Property, 32 
O.L.C. 79, 2008 WL 4422366 at *4 (May 28, 2008) (``OLC Opinion'').
---------------------------------------------------------------------------

    Courts have recognized the EPA as an agency with Federal 
housekeeping authority. The U.S. Court of Appeals for the Second 
Circuit, in EPA v. General Elec. Co., 197 F.3d 592, 595 (2nd Cir. 
1999), found that ``the Federal Housekeeping Statute, 5 U.S.C. 301, 
authorizes government agencies such as the EPA to adopt regulations 
regarding `the custody, use, and preservation of [agency] records, 
papers, and property.' '' The U.S. Court of Appeals for the Fourth 
Circuit, in Boron Oil Co. v. Downie, 873 F.2d 67, 69 (4th Cir. 1989), 
held that the district court had exceeded its jurisdiction when it had 
compelled testimony contrary to duly promulgated EPA regulations, which 
the EPA argued were authorized by section 301. The Second and Fourth 
Circuits did not directly address whether the EPA was an ``Executive 
department,'' but rather recognized that the EPA has the authority to 
issue regulations governing its internal affairs and assumed that 
authority comes from section 301. Indeed, if the EPA did not possess 
housekeeping authority, the EPA would not be able to efficiently carry 
out its daily functions, which would in turn compromise the EPA's 
ability to exercise its duties as a Federal regulatory agency.
    On April 30, 2018, the EPA published the Strengthening Transparency 
in Regulatory Science Proposed Rulemaking (``2018 proposed rule,'' Ref. 
5). The 2018 proposed rule cites as authority several environmental 
statutes that the EPA administers: The Clean Air Act (CAA); the Clean 
Water Act (CWA); the Safe Drinking Water Act (SDWA); the Resource 
Conservation and Recovery Act (RCRA); the Comprehensive Environmental 
Response, Compensation, and Liability Act (CERCLA); the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Emergency 
Planning and Community Right-To-Know Act (EPCRA); and the Toxic 
Substances Control Act (TSCA). Subsequently, on May 25, 2018, the EPA 
published a document extending the comment period and announced a 
public hearing on the 2018 proposed rule to be held on July 18, 2018 
(Ref. 6). That document identified 5 U.S.C. 301 as a source of 
authority in addition to those statutes cited in the 2018 proposed 
rule.
    On March 18, 2020, in the Federal Register at 85 FR 15396, the EPA

[[Page 472]]

published the Strengthening Transparency in Regulatory Science 
Supplemental Notice of Proposed Rulemaking (``2020 SNPRM,'' Ref. 7), in 
which the EPA clarified some of the citations in the 2018 proposed rule 
(Ref. 5). However, because this is purely a procedural rule, the EPA is 
not relying on any substantive environmental statutes as authority.
    This action is a procedural rule within the scope of the EPA's 
housekeeping authority. As the Supreme Court explained in Chrysler 
Corp., rules of internal agency management are considered procedural 
rules as opposed to substantive rules under the APA.\5\ Even if there 
could be downstream practical effects on the voluntary behavior of 
outside parties and on outside parties' interactions with the EPA, such 
impacts do not render this procedural rule substantive. (See American 
Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1051 (D.C. Cir. 1987)--``[A]gency 
rules that impose `derivative,' `incidental,' or `mechanical' burdens 
upon regulated individuals are considered procedural, rather than 
substantive.''). As the Supreme Court explained in Chrysler Corp., 
``the central distinction among agency regulations found in the APA is 
that between `substantive rules' on the one hand and `interpretive 
rules, general statements of policy, or rules of agency organization, 
procedure, or practice on the other.' '' \6\ The Supreme Court further 
clarified that unlike procedural rules, substantive rules have legal 
force and effect on individual rights and obligations, and noted that 
whether a rule affects individual rights and obligations is an 
``important touchstone'' for distinguishing substantive rules from 
other types of rules.\7\ This final rule does not regulate the rights 
and obligations of any party outside of the EPA let alone have legal 
force and effect on them. Any incidental impacts on voluntary behavior 
outside of the EPA do not render this a substantive rule.
---------------------------------------------------------------------------

    \5\ Chrysler Corp., 441 U.S. 281 at 301-02.
    \6\ Id. at 301 (quoting 5 U.S.C. 553(b), (d)).
    \7\ Id. at 302.
---------------------------------------------------------------------------

    Some public commenters asserted that the EPA lacks the authority 
under the substantive environmental statutes that it administers to 
promulgate this rule. However, the EPA is relying exclusively on its 
housekeeping authority to promulgate this purely procedural rule. In 
this final procedural rule, the EPA does not interpret or apply 
provisions of a particular statute or statutes that it administers. The 
EPA will undertake such efforts in forthcoming actions, which will be 
either statute-specific science transparency regulations or 
programmatic regulations implementing this procedural rule. Some of 
these subsequent actions will be substantive rules issued under the 
associated environmental statutes and will be subject to judicial 
review. In this action, the EPA is finalizing a rule of internal agency 
procedures, including how the Agency will consider the availability of 
dose-response data underlying pivotal science used in its significant 
regulatory actions and influential scientific information for 
independent validation.
    Some public commenters nonetheless took the position that this rule 
is substantive because it will affect the Agency's interactions with 
regulated parties. First, and as discussed above, this final rule does 
not regulate any party outside of the EPA but rather exclusively 
governs the EPA's internal process for determining the consideration to 
afford pivotal science with respect to certain actions. This rule does 
not require any researcher or other outside entity to provide data or 
models to the EPA. Nor does the rule categorically exclude studies--
even studies where the underlying dose-response data are not available 
for independent validation--and therefore any incidental impact on 
researchers who are developing science and deciding whether to make the 
underlying dose-response data available is negligible. Instead, it 
governs internal agency procedures for determining the consideration to 
afford various studies according to factors that include data 
availability. In doing so, the final rule provides greater transparency 
on the consideration the EPA will give pivotal science where the 
underlying dose-response data are or are not available for independent 
validation.
    Certain commenters stated that the final rule is substantive 
because they asserted it imposes burdens on scientists who endeavor to 
have their research considered by the EPA when it makes regulatory 
decisions or develops influential scientific information. The EPA 
notes, however, that procedural rules do not alter the rights or 
interests of parties but they ``may alter the manner in which the 
parties present themselves or their viewpoints to the agency,'' without 
thereby becoming substantive rules (James A. Hurson Assocs. v. 
Glickman, 229 F.3d 277, 280 (D.C. Cir. 2000)). If researchers want to 
increase the likelihood that their studies receive greater 
consideration by the EPA, they may take steps to ensure that the 
underlying dose-response data are available to the greatest extent 
possible. But any such response to this final rule would be purely 
voluntary. It is not required by this rule.
    Some commenters also argued that this rule is not procedural 
because they asserted it conflicts with the substantive environmental 
statutes administered by the EPA. However, this final rule does not 
interpret or apply the provisions of any environmental statutes; such 
efforts will occur in the subsequent actions under the relevant 
statutes described above. As this rule makes clear, if implementing 
this procedural rule would result in conflicts with existing 
environmental statutes, and their implementing regulations, this rule 
will yield to the EPA statutes and regulations.
    This is a rulemaking of agency organization, procedure, or 
practice. This procedural rule would not regulate any person or entity 
outside the EPA and would not affect the rights or obligations of 
outside parties. As a rule of Agency procedure, this rule is exempt 
from the notice-and-comment and delayed effective-date requirements set 
forth in the Administrative Procedure Act. See 5 U.S.C. 553(a)(2), 
(b)(A), (d). Nonetheless, the Agency voluntarily sought public comment 
on the proposed rule because it believed that the information and 
opinions supplied by the public would inform the Agency's views. Vt. 
Yankee Nuclear Power Corp. v. Nat. Res. Def. Council, Inc., 435 U.S. 
519, 524 (1978) (``Agencies are free to grant additional procedural 
rights in the exercise of their discretion.'') In addition, even 
assuming arguendo that the delayed effective-date requirement of the 
Act applied to this action, the EPA has determined that there would be 
good cause, consistent with 5 U.S.C. 553(d)(3), for making this final 
rule effective immediately because immediate implementation of the 
rule, with its goals of ensuring transparency and consistency in how 
the agency considers dose-response data underlying pivotal science to 
be used in significant regulatory decisions and influential scientific 
information, is crucial for ensuring confidence in EPA decision-making. 
Because this is a procedural rule that only applies internally to 
ensure that the EPA consistently considers data availability, the 
rationale for delayed effectiveness to allow reasonable time for non-
EPA regulated entities to adjust their behavior before and prepare for 
the effective date of the new requirements does not apply. See 
Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 
1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th 
Cir. 1977) (quoting legislative history). For these reasons, the Agency

[[Page 473]]

finds that good cause exists under APA section 553(d)(3) to make this 
rule effective immediately upon publication.

II. Background

A. Summary of 2018 Proposed Rule

    In the 2018 proposed rule (Ref. 5), the EPA proposed adding 40 CFR 
part 30, which would direct the EPA to ensure that the pivotal 
regulatory science underlying its actions is publicly available in a 
manner sufficient for independent validation. The EPA proposed to take 
this action under the authority of the statutes it administers, 
including provisions providing general authority to promulgate 
regulations necessary to carry out the Agency's functions under these 
statutes and provisions specifically addressing the Agency's conduct of 
and reliance on scientific activity to inform those functions.
    In the 2018 proposed rule, the EPA defined ``dose-response data and 
models,'' ``pivotal regulatory science,'' ``regulatory decisions,'' 
``regulatory science,'' and ``research data'' (proposed 40 CFR 30.2).
    Many of the provisions in proposed 40 CFR part 30 applied to dose-
response models and data, regardless of the source of funding or 
identity of the party who developed the model or generated the data. 
Specifically, the EPA proposed that the Agency would ensure that dose-
response data and models underlying pivotal regulatory science were 
publicly available in a manner sufficient for independent validation, 
including releasing information necessary for the public to 
``understand, assess, and replicate findings'' (proposed 40 CFR 30.5). 
The public release of such information would be consistent with law; 
protect privacy, confidentiality, and confidential business information 
(CBI); and be sensitive to national security interests.
    In addition to proposing requirements for ensuring that dose-
response data and models were publicly available in a manner sufficient 
for independent validation, the EPA proposed additional requirements 
pertaining to the use of dose-response data and models underlying 
pivotal regulatory science. Proposed 40 CFR 30.6 would have required 
the EPA to: Describe and document any assumptions and methods used; 
clearly explain the scientific basis for each model assumption used and 
present analyses showing the sensitivity of the modeled results to 
alternative assumptions; evaluate the appropriateness of using default 
assumptions (e.g., assumptions of a linear, no-threshold dose-response) 
on a case-by-case basis; and when available, give explicit 
consideration to high-quality studies that explore: A broad class of 
parametric dose-response or concentration-response models, a robust set 
of potential confounding variables, nonparametric models that 
incorporate fewer assumptions, the use of various threshold models 
across the dose or exposure range, and models that investigate factors 
that might account for spatial heterogeneity.
    The 2018 proposed rule also included requirements that pertained 
more broadly to the use of studies in Agency actions and pivotal 
regulatory science. Proposed 40 CFR 30.4 would have required the EPA to 
clearly identify all studies relied upon when taking any final Agency 
action and make all such studies available to the public to the extent 
practicable. Proposed 40 CFR 30.7 would have required the EPA to 
conduct independent peer review of all pivotal regulatory science used 
to justify regulatory decisions. As part of the peer review, the EPA 
would have been required to ask peer reviewers to articulate the 
strengths and weaknesses of the Agency's justification for the 
assumptions applied and the implications of those assumptions for the 
results.
    Finally, the 2018 proposed rule would have allowed for the EPA 
Administrator to grant exemptions to the requirements of the rule when 
the Administrator determined that compliance would be impracticable 
because it was not feasible to either (1) ensure that all dose-response 
data and models underlying pivotal regulatory science were publicly 
available in a manner sufficient for independent validation, in a 
fashion consistent with law; protective of privacy, confidentiality, 
and CBI; and sensitive to national security interests; or (2) conduct 
independent peer review on all pivotal regulatory science used to 
justify regulatory decisions for reasons outlined in Section IX of the 
OMB Bulletin for Peer Review (Ref. 8).
    The EPA solicited comment on the 2018 proposed rule generally and 
on specific provisions in the proposal, including the legal authority 
for the proposed rule, the scope of the proposal, public access to 
dose-response data and models, and how the proposed rule should be 
implemented.

B. Summary of 2020 Supplemental Notice of Proposed Rulemaking

    The 2020 SNPRM (Ref. 7) included clarifications, modifications, and 
additions to certain provisions in the 2018 proposed rule. The 2020 
SNPRM also revised the authority cited in proposed 40 CFR part 30; 
revised proposed 40 CFR 30.2, 30.3, 30.5, 30.6, 30.7, and 30.9; and 
deleted proposed 40 CFR 30.10.
    Through the 2020 SNPRM, the EPA modified proposed 40 CFR part 30 to 
expand the scope of the 2018 proposed rule, clarified the intent of the 
2018 proposed rule, and solicited public comment on two proposed 
approaches for how the Agency would consider data and model 
availability when evaluating studies. The 2020 SNPRM modified the scope 
of the 2018 proposed rule in two ways: (1) Expanded ``dose-response 
data and models'' to ``data and models,'' and (2) expanded the 
applicability of the proposed requirements to influential scientific 
information, which was defined in the 2020 SNPRM as the ``scientific 
information the Agency reasonably can determine will have or does have 
a clear and substantial impact on important public policies or private 
sector decisions,'' consistent with the definition of ``influential 
scientific information'' provided in the OMB Final Information Quality 
Bulletin for Peer Review (Ref. 8). As a result of the 2020 SNPRM, the 
provisions in proposed 40 CFR part 30 would have applied to data and 
models, regardless of the source of funding or identity of the party 
who developed the model or generated the data, underlying pivotal 
science or pivotal regulatory science. The EPA modified proposed 40 CFR 
30.2, 30.3, 30.6, and 30.9 to reflect this change in scope of the 
proposed rulemaking.
    With the expanded scope, the EPA proposed that data and models 
underlying pivotal regulatory science and pivotal science be available 
in a manner sufficient for independent validation. To clarify its 
intent, in the 2020 SNPRM the EPA modified and added proposed 
definitions for key terminology, including ``data,'' ``model,'' 
``publicly available,'' and ``independent validation.'' Specifically, 
the EPA clarified that ``independent validation'' of data and models, 
as proposed, meant the ``reanalysis of study data by subject matter 
experts who have not contributed to the development of the study to 
demonstrate that the same analytic results reported in the study are 
capable of being substantially reproduced'' (2020 SNPRM proposed 40 CFR 
30.2). In the 2020 SNPRM, the EPA also proposed definitions for 
``reanalyze'' and ``capable of being substantially reproduced'' to 
further clarify the intent of the rulemaking.
    In proposed 40 CFR 30.5, the EPA solicited public comment on two 
approaches for how the Agency would consider data and model 
availability

[[Page 474]]

when evaluating studies underlying pivotal regulatory science and 
pivotal science. Under the first approach, the Agency would have only 
used pivotal regulatory science or pivotal science where the underlying 
data and models were either publicly available for independent 
validation or, in the case of restricted data and models (e.g., those 
that include CBI, proprietary data, or personally identifiable 
information (PII) that cannot be sufficiently de-identified to protect 
the data subjects), available through restricted access in a manner 
sufficient for independent validation. Under the second approach, the 
EPA would have, other things equal, given greater consideration to 
studies where the underlying data and models were either publicly 
available in a manner sufficient for independent validation or, in the 
case of restricted data and models, available through restricted access 
in a manner sufficient for independent validation. Proposed 40 CFR 30.9 
would have allowed the EPA Administrator to grant an exemption to the 
requirements in proposed 40 CFR part 30 if the Administrator determined 
that compliance was impracticable because technological barriers 
rendered sharing of the data or models infeasible; the development of 
the data or model was completed or updated before the effective date of 
this final rule; or by making the data and models publicly available, 
it would have conflicted with laws governing privacy, confidentiality, 
CBI, or national security interests.
    Finally, the EPA clarified in the 2020 SNPRM that it is authorized 
to promulgate this rulemaking under its housekeeping authority and 
revised the authority cited in proposed 40 CFR part 30 accordingly. The 
Agency solicited public comment on whether to use its housekeeping 
authority independently or in conjunction with the environmental 
statutory provisions cited as authority in the 2018 proposed rule, 
which were further clarified in the 2020 SNPRM.

III. Description of Final Rule and Responses to Significant Comments

A. Purpose and Effect of the Action

    1. Purpose. The EPA is committed to its mission of protecting human 
health and the environment through sound policy decisions that are 
informed by robust scientific and technical research. Because of the 
potential impact of the EPA's significant regulatory actions and 
influential scientific information on American lives and livelihoods, 
the American people deserve environmental decisions and policies that 
are based on the best scientific information. Only through continuous 
improvement to its procedures, especially those focused on 
transparency, can the EPA fully demonstrate that commitment.
    The purpose of this action is to increase transparency by codifying 
internal procedural requirements for how the EPA will consider the 
availability of the underlying dose-response data that it relies upon 
to promulgate significant regulatory actions and develop influential 
scientific information. These requirements build upon open data 
initiatives in the Federal Government and scientific community and 
advance the EPA's mission and commitment to the public by prioritizing 
transparency of the underlying dose-response data in pivotal science 
for the most impactful of EPA's assessments and regulatory actions. 
Where underlying dose-response data in pivotal science are available, 
subject matter experts could independently reanalyze the data to affirm 
original research conclusions, check for errors, test alternative 
assumptions, and better understand and evaluate the implications of the 
uncertainty used in the original analysis. Such independent reanalyses 
will subsequently enable the EPA to make stronger, data-driven 
decisions in future rulemakings or in revisions to existing rules or 
influential scientific information. This could occur through standard 
cyclical reviews (e.g., revisions to national ambient air quality 
standards, risk and technology reviews, national primary drinking water 
regulations), ad hoc revisions, or revisions through the information 
quality guidelines or other petition processes. Implementation of this 
rule will more effectively share pivotal science for external 
consideration and increase the opportunity for independent validation 
of pivotal science by subject matter experts. As data are better 
understood through independent reanalysis, the public will, if they so 
choose, be able to more effectively comment, engage, and hold the EPA 
accountable during the development of future significant regulatory 
actions and influential scientific information.
    The transparency provisions in this final rule are intended to 
build upon existing Federal Government efforts and provide incremental 
progress toward the Agency's goal of greater transparency. The EPA and 
the Federal Government have long encouraged open data initiatives, as 
the principle of transparency in regulatory decision-making and the 
other operations of government agencies is a fundamental behavior of 
good government that is inherently valuable to the public. For example, 
in 2002 the Office of Management and Budget (OMB) released its 
Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal Agencies, 
which includes discussion of the importance of the reproducibility of 
analyses underlying influential information (Ref. 3). The EPA's 2016 
Plan to Increase Access to Results of EPA-Funded Scientific Research 
noted that ``transparency is a core EPA value'' and that increased 
availability of research data would accelerate scientific breakthroughs 
that support the Agency's mission and policymaking efforts (Ref. 9). 
The EPA's Open Government Plan 5.0 (Ref. 10) also details the EPA's 
progress in implementing the tenets of the numerous data transparency 
initiatives in the Federal Government prior to 2018, including the 
Office of Management and Budget (OMB) M-10-06 (Ref. 11), the Office of 
Science and Technology Policy Memorandum of February 22, 2013 (Ref. 
12), and OMB M-13-13 (Ref. 4). In 2019, Congress passed the Foundations 
for Evidence-Based Policymaking Act of 2018 (or OPEN Government Data 
Act, Public Law 115-435) into law, which included requirements for 
Federal agencies to prioritize making their data available to the 
public, and OMB has released additional guidance for implementing the 
act (Refs. 13, 14).
    The scientific community has also embraced greater data 
transparency, as evidenced by data sharing and availability 
requirements for many high-impact journals (Ref. 15) and the emergence 
of organizations, such as the Center for Open Science, and 
international initiatives like Findable, Accessible, Interoperable, and 
Reusable (FAIR) data principles; Facilitate Open Science Training in 
European Research (FOSTER); and Guidelines for Transparency and 
Openness Promotion (TOP) in Journal Policies and Practices that 
incentivize greater transparency in research (Refs. 16, 17).
    The EPA supports these efforts and is pursuing an incremental 
approach to maximizing transparency in the science that it relies upon 
to ensure that implementation is done in a thoughtful and deliberate 
way that focuses on the EPA's most impactful actions, minimizes 
unintended consequences, and informs future transparency requirements. 
As further described in Section II.B of this preamble, the EPA is 
focusing on the underlying dose-response data for this rulemaking 
because of the influence these data have on particularly impactful 
decisions at

[[Page 475]]

the Agency. Risk assessments and regulations that target emissions and 
risk reduction of one or more pollutants, contaminants, or substances 
are integral to the Agency's mission and the underlying dose-response 
data that inform the quantitative value used to evaluate and mitigate 
potential risk are critical to understanding the assessment or 
regulatory action. In addition, the data underlying the dose-response 
assessment are more distinct than the broad range of data informing an 
entire risk assessment. Therefore, the EPA is concentrating its current 
efforts to increase transparency on a well-defined step in the 
quantitative assessment of risk supporting specific Agency actions. 
This final rule provides an important step in furthering the progress 
already being made toward maximizing transparency and will provide 
important insight for developing future statute-specific requirements.
    Most public commenters on the purpose of the 2018 proposed rule and 
the 2020 SNPRM supported the concept of greater transparency, but 
questioned the ``problem'' the EPA was trying to fix. Other commenters 
indicated that it was not clear how greater data availability would fix 
these perceived problems, given what they asserted were limited detail 
in the proposed rule. Some public commenters and members of the EPA's 
Science Advisory Board (SAB) also suggested that issues related to 
transparency are or may be fixed with existing guidance, mechanisms, 
and other requirements. Other commenters questioned the motivation for 
the rulemaking, asserting that the rulemaking was the result of 
political interests, rather than scientific need; that it was biased to 
benefit industry; or that it was a deliberate attempt to suppress human 
health and climate studies. Some commenters contended that there was 
little evidence of a widespread reanalysis issue in science or, in 
particular, studies that would inform environmental policy. Other 
commenters contended that the rulemaking was at odds with the Agency's 
mission and would result in decreased environmental and human health 
protections. Some commenters asserted that the rule would lead to 
increased litigation and limit the public's trust in the EPA. Other 
commenters contended that the rule was inconsistent with practices in 
other Federal agencies and may adversely impact other Federal and state 
agencies that rely on EPA assessments.
    Commenters supporting the rulemaking generally asserted that the 
greater transparency provided in the proposal and SNPRM was necessary 
and important for developing sound and scientifically robust 
regulations. Some commenters stated that transparency is a principle of 
good government. Some commenters noted specific benefits to greater 
transparency, including more effective public scrutiny and scientific 
debate, less political rhetoric, and clearer, more efficient 
regulations. Some commenters provided specific examples of EPA 
regulations or risk assessments that have relied on incorrect data or 
would have been improved with greater transparency. Other commenters 
contended that greater transparency was consistent or complementary 
with research and publishing policies, Federal Government policies, and 
the scientific method, while other commenters asserted that the rule 
would be an important improvement to transparency at the EPA.
    The EPA continues to believe that codifying internal procedures 
aimed at prioritizing transparency in significant regulatory actions 
and influential scientific information into regulation will improve the 
opportunity for the public to access the EPA's scientific analyses and 
resulting regulatory actions in a way that is beneficial to the 
scientific process, the Agency's mission, and the public's health and 
safety. This rule is designed to build upon OMB M-19-15 (Ref. 18), 
which highlights the need to characterize the sensitivity of an 
agency's conclusions to analytic assumptions, as well as other Federal 
guidance documents that require greater data transparency (Ref. 18). 
The EPA's attention to data transparency is also responsive to the 
broader interest in greater data and model transparency observed in the 
numerous transparency initiatives in the scientific community and 
Federal Government, as well as the criticism the EPA has received from 
members of the public, scientific community, and Congress on the 
transparency of the scientific basis for EPA's decisions in previous 
influential scientific information assessments and regulatory actions 
(Refs. 19, 20, 21, 22, 23). The EPA's continued progress toward 
maximizing transparency is vital to building and maintaining trust with 
the public and credibility in the Agency's decisions.
    The EPA disagrees with the contention that this rule is politically 
motivated, as transparency assumes no political ideology, nor is this 
rule likely to result in decreased human health or environmental 
protections, as the benefits of greater data transparency and the 
significance of reanalyzing and validating study results are well-
documented in scientific literature. McNutt (2014) noted, 
``reproducibility, rigor, transparency, and independent verification 
are cornerstones of the scientific method'' (Ref. 24). The National 
Academies of Sciences, Engineering, and Medicine (NAS) workshop on 
Reproducibility and Replicability in Science also noted that 
``certainly, reproducibility and replicability play an important role 
in achieving rigor and transparency'' (Ref. 16).\8\ Munaf[ograve] et 
al. (2017) state, ``the credibility of scientific claims is rooted in 
the evidence supporting them, which includes the methodology applied, 
the data acquired, and the process of methodology implementation, data 
analysis and outcome interpretation. Claims become credible by the 
community reviewing, critiquing, extending and reproducing the 
supporting evidence. However, without transparency, claims only achieve 
credibility based on trust in the confidence or authority of the 
originator. Transparency is superior to trust'' (Ref. 25). The 2019 NAS 
workshop on Reproducibility and Replicability in Science also 
concluded, ``the scientific enterprise depends on the ability of the 
scientific community to scrutinize scientific claims and to gain 
confidence over time in results and inferences that have stood up to 
repeated testing'' (Ref. 16). Importantly, the workshop also concluded 
that researchers, funding institutions, and journals could make 
advancements to improve reproducibility, rigor, and transparency (Ref. 
16).
---------------------------------------------------------------------------

    \8\ The NAS workshop on Reproducibility and Replicability in 
Science defines ``reproducibility'' to mean the extent to which a 
researcher can obtain consistent computational results using the 
same input data, computational steps, methods, code, and conditions 
of analysis. The use of ``reproducibility'' by the NAS is consistent 
with the intent of the use of ``independent validation'' in this 
rule.
---------------------------------------------------------------------------

    The EPA agrees that data transparency is vital for individuals who 
have not contributed to the study to be able to verify the quality and 
strength of published studies and agrees with commenters that the 
opportunity to independently validate the pivotal science that the EPA 
relies upon is important in furthering scientific understanding and the 
Agency's mission. A presenter in a 2016 NAS workshop on Principles and 
Obstacles for Sharing Data from Environmental Health Research stated 
more directly that ``for environmental policy making to be legitimate, 
the scientific reasoning behind a given decision--including the data 
supporting it--must be transparent'' (NAS Workshop Report, Ref. 26). 
When data are widely available, researchers can validate

[[Page 476]]

research results and help identify and correct unintended errors, as 
well as reanalyze the data for new and different purposes, examine 
novel questions, provide new scientific insights, and improve model 
development. In its April 24, 2020, letter to EPA Administrator Wheeler 
---------------------------------------------------------------------------
(Ref. 27), the EPA's SAB noted that it

``recognizes the importance of this rule and its purpose, 
establishing transparency of the influential scientific information 
used for significant regulations and enhancing public access to 
scientific data and analytical methods to help ensure scientific 
integrity, consistency and robust analysis. Strengthening 
transparency by improving access to data can lead to an increase in 
the quantity and the quality of evidence that informs important 
regulatory and policy decisions. The scientific community is moving 
toward adopting the precept of sharing accurate data and information 
to increase credibility, high-quality outcomes and public confidence 
in science. The SAB supports the adoption of this precept.'' \9\
---------------------------------------------------------------------------

    \9\ The SAB also provided several constructive comments and 
recommendations, which have been considered in the development of 
this final rule.

    The EPA also agrees with commenters that the scientific community 
and government agencies are making great strides in data transparency; 
however, improvements can still be made over existing policies and 
mechanisms. Many scientific publications, for example, require authors 
to make a data availability or data access statement, which discloses 
where and under what conditions the underlying study data are 
available. Yet the EPA cannot solely rely on data availability 
statements made in published research because initiatives toward 
greater data sharing and transparency amongst scientific journals and 
international organizations are still being implemented, are 
inconsistently enforced, and the true accessibility of data in a public 
repository is still limited (Refs. 28, 29, 30, 31, 32, 33). For 
example, Christensen et al. (2019) evaluated 1,072 peer-reviewed 
articles and ``found that rates of data availability for empirical 
articles published after journals adopted data-sharing policies differ 
widely between journals, from 0 percent to 83 percent, with a mean of 
35 percent'' (Ref. 32). Stodden et al. (2018) noted they were only able 
to retrieve the dataset and code for 44 percent of the 204 
computational studies published in Science in the 16 months after the 
publisher instituted its data availability requirements (Ref. 34). 
Therefore, the rule requirements for the EPA's independent evaluation 
of the availability of data are necessary and critical to prioritizing 
data transparency in the pivotal science underlying its significant 
regulatory actions and influential scientific information.
    Finally, focusing the final rule requirements on the underlying 
dose-response data is intended to address public comments concerning 
clarity of the rule, potential unintended consequences, and the 
potential for far-reaching impacts. The requirements provide a workable 
framework for evaluating pivotal science in the context of the 
availability of its underlying dose-response data, while balancing 
important technical considerations in order to ensure the Agency 
maintains a strong scientific basis for its decision-making. The 
incremental progress made possible by this rule provides an important 
step towards prioritizing transparency in particularly impactful EPA 
rules and assessments and will inform future statute-specific 
rulemakings.
    2. Effect of this rule on the studies the EPA uses to support 
significant regulatory actions and influential scientific information. 
The EPA received significant comment on the effect of the 2018 proposed 
rule and 2020 SNPRM on the studies the Agency would be able to consider 
and use to support significant regulatory actions and influential 
scientific information. Many commenters asserted that the EPA's action, 
if finalized, would limit the scientific studies the EPA could use 
because the EPA would exclude from consideration any studies where the 
underlying data and models could not be made publicly available or 
available in a manner sufficient for independent validation.
    As discussed in Section III.B of this preamble, based on a 
consideration of the public comments on the 2018 proposed rule and the 
2020 SNPRM, the EPA is finalizing internal procedural requirements for 
how the Agency will consider the availability of underlying dose-
response data of pivotal science when promulgating a significant 
regulatory action or developing influential scientific information that 
relies on dose-response data. The EPA is also further clarifying how 
the Agency will determine the consideration to afford to pivotal 
science in either significant regulatory actions or influential 
scientific information.
    Consistent with existing Agency practice (Ref. 35), the EPA will 
review and evaluate all relevant scientific studies when developing 
significant regulatory actions and influential scientific information. 
The EPA will continue to use the following, established factors to 
assess the quality of studies used to develop significant regulatory 
actions and influential scientific information (Refs. 36, 37):
     Soundness--The extent to which the scientific and 
technical procedures, measures, methods or models employed to generate 
the information are reasonable for, and consistent with, the intended 
application.
     Applicability and Utility--The extent to which the 
information is relevant for the Agency's intended use.
     Clarity and Completeness--The degree of clarity and 
completeness with which the data, assumptions, methods, quality 
assurance, sponsoring organizations and analyses employed to generate 
the information are documented.
     Uncertainty and Variability--The extent to which the 
variability and uncertainty (quantitative and qualitative) in the 
information or in the procedures, measures, methods or models are 
evaluated and characterized.
     Evaluation and Review--The extent of independent 
verification, validation and peer review of the information or of the 
procedures, measures, methods or models.
    When evaluating potential links between exposure to a pollutant, 
contaminant, or substance and effects and the nature of the dose-
response relationship, the EPA will follow best practices and rely on 
the highest quality, most relevant studies in determining the potential 
for hazard due to exposure to a pollutant, contaminant, or substance. 
Where there is convincing and well-substantiated evidence (consistent 
with Agency guidelines on hazard identification and dose-response 
assessment) to support a relationship between exposure and effect, the 
EPA will identify a subset of those studies for use in characterizing 
the quantitative relationship between the amount of dose or exposure to 
a pollutant, contaminant, or substance and an effect. This will be 
based on the exposure situation being addressed, the quality of the 
studies, the reporting adequacy, and the relevance of the endpoints. 
From that subset, the specific dose-response studies or analyses that 
drive the requirements, quantitative analyses, or both will be 
identified as pivotal science (see Section III.E of this preamble).
    Once the EPA has identified pivotal science--for either significant 
regulatory actions or influential scientific information--the EPA will 
then evaluate if the underlying dose-response data are available in a 
manner sufficient for independent validation. The EPA will give greater 
consideration to pivotal science for which the underlying dose-response 
data are either publicly available in a manner sufficient for

[[Page 477]]

independent validation or, in the case of PII, CBI, or proprietary 
data, available through restricted access that affords privacy in a 
manner sufficient for independent validation.
    The EPA acknowledges, and agrees with commenters, that there may be 
pivotal science for which the underlying dose-response data are not 
publicly available due to technological feasibility or cannot be made 
available in a secure environment that still allows for independent 
analysis. For example, dose-response data underlying older pivotal 
science may no longer be available or may not exist in a currently 
usable format. In these cases, the EPA may still use the pivotal 
science after either giving it lesser consideration or receiving an 
exemption from the requirements of this rule from the Administrator 
(see Section III.G of this preamble). See Section III.E of this 
preamble for a description of the factors the EPA will consider when 
determining the consideration to afford to pivotal science when the 
underlying dose-response data are not available for independent 
validation.
    The EPA expects to identify pivotal science, and the consideration 
afforded to pivotal science, in proposed significant regulatory actions 
and external review drafts of influential scientific information, which 
will allow the subject matter experts, if they so choose, to 
independently validate the pivotal science and provide comment to the 
EPA. The EPA believes that this approach will allow the public to more 
effectively comment, engage, and hold the EPA accountable during the 
future development of specific significant regulatory actions and 
influential scientific information.
    3. Effect of this rule on human health and environmental 
protection. Many commenters contended that the 2018 proposed rule and 
the 2020 SNPRM would prevent the EPA from meeting its statutory 
obligations and performing its mission of protecting human health and 
the environment. Some commenters asserted that, by excluding studies 
based on data availability, the EPA would develop regulatory decisions 
that are: (1) Not based on high-quality studies or the best available 
science; and (2) potentially biased towards regulated parties. As a 
result, these commenters argued that human health and environmental 
protections would decrease. Several commenters contended that decreased 
human health and environmental protections would disproportionately 
affect communities of color, indigenous communities, and low-income 
communities because these communities are more likely to live or work 
near sources of pollution.
    The EPA considered these comments when finalizing this rule, and 
the EPA does not agree that its approach will lead to systematic bias 
towards certain types of stakeholder goals. As described above, the EPA 
is not categorically excluding any studies from consideration when 
promulgating significant regulatory actions or developing influential 
scientific information. Rather, the Agency will continue to evaluate 
the quality of all relevant studies, consistent with the intended use 
of the information. The EPA will also continue to rely on the highest 
quality, most relevant studies available in determining the potential 
for hazard due to exposure to a pollutant, contaminant, or substance.
    When characterizing the quantitative relationship between the 
amount of dose or exposure to a pollutant, contaminant, or substance 
and an effect, the EPA will identify pivotal science and give greater 
consideration to pivotal science for which the underlying dose-response 
data are available in a manner sufficient for independent validation. 
Including this review of dose-response data availability for pivotal 
science is critical to the EPA's progress toward increased transparency 
and providing increased opportunity for scientific reanalysis and 
review by independent third parties. This approach will result in 
significant regulatory actions and influential scientific information 
that are based on high quality studies that maximize transparency, 
leading to human health and environmental protections consistent with 
the statutes the EPA administers.
    In response to the 2018 proposed rule, the EPA received comments on 
perceived conflicts between the requirements included in the 2018 
proposed rule and statutory requirements that direct EPA to consider 
certain data and information when developing Agency actions. For 
example, some commenters contended that the requirements in the 2018 
proposed rule conflicted with the FIFRA pesticide registration 
requirements and associated implementing regulations, which require 
registrants to submit data and information to the EPA to enable the 
Agency to make its unreasonable adverse effects determinations. These 
commenters argued that, under the 2018 proposed rule, the EPA would not 
be able to consider these data, which are often claimed as CBI, when 
evaluating the pesticide registrations because the data could not be 
made publicly available. In response to this comment and other similar 
comments, the EPA clarified in the 2020 SNPRM the relationship between 
this rulemaking, the environmental statutes and their implementing 
regulations by adding language to proposed 40 CFR 30.3 stating that 
statutory requirements and corresponding implementing regulations would 
control in the event of any conflicts.
    With this final rule, the EPA is maintaining language from the 2020 
SNPRM in 40 CFR 30.3 stating that statutory requirements and 
corresponding implementing regulations will control in the event of any 
conflict, and clarifying in this preamble that the requirements in this 
final rule set the overarching structure and principles for 
transparency in significant regulatory actions and influential 
scientific information. The EPA plans to promulgate either statute-
specific transparency regulations or programmatic actions implementing 
this procedural rule, as appropriate, to clarify how the Agency will 
implement the provisions from this final rule for specific programs 
authorized under the statutes the EPA administers.

B. Dose-Response Data

    The 2018 proposed rule focused on dose-response data and models, 
although not consistently. For example, some parts of the proposed 
regulatory text appear to limit applicability of certain provisions to 
only dose-response models. In others, the proposed requirements would 
apply more broadly. Commenters noted this variability. As a result, in 
the 2020 SNPRM, the EPA proposed a consistent, broader applicability to 
data and models.
    The EPA received significant comment on this proposed expansion of 
the applicability of the rulemaking to data and models. While some 
commenters supported this expansion, other commenters contended that 
the applicability to dose-response data and models was already very 
broad, and that the broader applicability would significantly limit the 
information that the EPA could consider in a broad ranges of 
assessments (e.g., bioaccumulation data, data on environmental 
releases, exposure estimates used by the EPA across the environmental 
statutes that it administers). Some commenters contended that the EPA 
did not provide sufficient rationale to support this expansion.
    Based on the comments on the 2018 proposed rule and the 2020 SNPRM, 
taking into account the number of studies that would be subject to the 
rule, the EPA determined that the Agency

[[Page 478]]

should pursue an incremental approach to maximizing transparency in the 
science that it relies upon by focusing the final rule requirements on 
dose-response data and, in particular, only those studies that are 
integral to characterizing dose-response relationships (e.g., 
identifying candidate PODs). The EPA considered commenters' assertions 
that the scope of the 2018 proposed rule would be so broad as to make 
implementation infeasible. The 2018 proposed definition of ``dose-
response data and models'' would apply to dose-response data [and 
models] ``used to characterize the quantitative relationship between 
the amount of dose or exposure to a pollutant, contaminant, or 
substance and the magnitude of a predicted health or environmental 
impact.'' This relationship of the dose-response data to the magnitude 
of a predicted health or environmental impact would require the 
consideration of an array of studies beyond those that characterize 
dose-response relationships, including, for example, studies that 
inform the dose-response modeling (e.g., benchmark response selection); 
studies that identify data for toxicokinetic adjustments that inform 
calculation of a human-equivalent point of departure (POD); and studies 
that inform the selection of uncertainty factors. The number of studies 
that are used to establish the relationship between dose-response data 
and models and the magnitude of a predicted health or environmental 
impact can potentially be very large. This may make implementing the 
rule, as proposed, more challenging for at least some significant 
regulatory actions and influential scientific information. While 
transparency in EPA decision-making is the purpose of this action, the 
EPA prefers an incremental approach. Rather than having this final rule 
apply to all the studies that support the assessment of the 
relationship of a dose or exposure of a pollutant, contaminant, or 
substance to the magnitude of a predicted health or environmental 
impact, the EPA is balancing transparency and feasibility by focusing 
on those studies that describe the quantitative relationship between 
the dose or exposure of a pollutant, contaminant, or substance and an 
effect. Specifically, the scope of dose-response data in this final 
rule is those studies consisting of the data integral to characterizing 
dose-response relationships. In some instances, this group will consist 
of a handful of studies. In other instances, where there are multiple 
toxicity endpoints, there may be more studies that are crucial to 
characterizing dose-response relationships. In some other cases, there 
may be a large number of studies that are used to characterize a dose-
response relationship (e.g., where the dose-response is based on a 
meta-regression of epidemiology studies). However, not all of these 
studies would be considered pivotal science (see Section III.C.6 of 
this preamble for the definition of ``pivotal science'').
    Based on comments and other considerations, the EPA is 
concentrating its efforts in the final rule to increase transparency on 
dose-response data, as the dose-response data are discrete and the 
dose-response assessment is a well-defined and impactful step in the 
quantitative assessment of risk. This final rule provides an important 
step in furthering progress toward maximizing transparency and will 
provide insight for future statute-specific requirements. Consistent 
with this targeted focus, the EPA is replacing the proposed definition 
of ``dose-response data and models'' at 40 CFR 30.2 with a definition 
of ``dose-response data'' (see Section III.C of this preamble).

C. Definitions

    The 2018 proposed rule included proposed definitions for ``dose-
response data and models,'' ``pivotal regulatory science,'' 
``regulatory decisions,'' ``regulatory science,'' and ``research 
data.'' Some commenters stated that several of the proposed definitions 
were unclear, including some that seemed to overlap (e.g., ``pivotal 
regulatory science'' and ``regulatory science''). Some commenters also 
stated that certain terms used in the proposed regulatory requirements 
were not clear and should be defined.
    In response to these comments on the 2018 proposed rule, the EPA 
proposed in the 2020 SNPRM definitions for ``capable of being 
substantially reproduced,'' ``data,'' ``independent evaluation,'' 
``models,'' ``publicly available,'' and ``reanalyze.'' In the 2020 
SNPRM, the EPA also proposed a definition of ``influential scientific 
information'' to comport with the proposed expansion of the 
applicability of the rulemaking to influential scientific information.
    Based on a consideration of the public comments on both the 2018 
proposed rule and the 2020 SNPRM, the EPA is finalizing the definitions 
at 40 CFR 30.2 as follows.
    1. Capable of being substantially reproduced, independent 
validation, and reanalyze. In the 2018 proposed rule, the EPA used the 
term ``replicate'' in the proposed regulatory text at 40 CFR 30.5 but 
did not define it at 40 CFR 30.2. Proposed 40 CFR 30.5 read, in 
pertinent part, ``[i]nformation is considered `publicly available in a 
manner sufficient for independent validation' when it includes the 
information necessary for the public to understand, assess, and 
replicate findings . . . .'' Some commenters contended that the EPA was 
not clear about what it meant by the term ``replicate'' and interpreted 
the term ``replicate'' in several different ways. For example, some 
commenters asserted that the EPA used the term ``replicate'' but 
actually meant ``reanalyze.'' The EPA finds that these comments have 
merit and is clarifying that the intent of the term in the proposed 
regulatory text at 40 CFR 30.5 was ``reanalyze'' rather than 
``replicate.'' In the 2020 SNPRM, the EPA proposed using the term 
``reanalyze'' instead of ``replicate'' and proposed at 40 CFR 30.2 a 
definition for ``reanalyze.'' Given that proposed 40 CFR 30.5 also 
included the term ``independent validation'' and that this term 
directly relates to ``replicate,'' the EPA also proposed a definition 
at 40 CFR 30.2 for this term. The proposed definition of ``independent 
validation'' included the term ``capable of being substantially 
reproduced.'' The EPA also defined this term because it was an 
important component of the definition of ``independent validation.''
    While commenters generally supported the inclusion of the proposed 
definitions for ``capable of being substantially reproduced,'' 
``independent validation,'' and ``reanalyze,'' some commenters 
addressed aspects of the proposed definitions and suggested 
modifications. One commenter suggested replacing the term 
``validation'' with ``verification'' because they asserted the term 
``validation'' has specific meanings in the context of assay 
development and in the context of model development. The EPA 
understands that the term validation is used differently in some 
scientific disciplines than the EPA has defined it. However, for the 
purposes of this rule, the EPA has defined validation in terms of 
independent reanalysis.
    Another commenter contended that the proposed definition of 
``independent validation'' was inconsistent with the remainder of the 
proposal because it restricts the concept of ``independent validation'' 
to ``subject matter experts who have not contributed to the development 
of the study,'' rather than the public as was the stated intent of the 
rule. Because this rule is about scientific data, the EPA finds it 
unlikely that without the necessary expertise, one could reasonably 
reanalyze the dose-response data underlying pivotal

[[Page 479]]

science. This final rule does not preclude the public from engaging 
subject matter experts to determine whether a study can be 
independently validated. Also, the definition cannot be considered 
solely in isolation. The regulatory text in which the term is used 
informs the extent of the availability of dose-response data underlying 
studies. Specifically, 40 CFR 30.5 requires, in part, that the dose-
response data underlying studies that the EPA will consider as pivotal 
science be available in a manner sufficient for independent validation. 
Scientific information is considered available in a manner sufficient 
for independent validation when it includes the information necessary 
to understand, assess, and reanalyze findings. The efficacy of the 
reanalysis will depend on the expertise of the person conducting the 
reanalysis.
    One commenter noted that the term ``reproduced'' in the proposed 
definition of ``capable of being substantially reproduced'' and the use 
of ``capable of being substantially reproduced'' in the proposed 
definition of ``independent validation,'' were inconsistent with the 
description of reproduce in the 2020 SNPRM preamble and the NAS 
Workshop Report (Ref. 26). The commenter contended that this adds 
confusion. Another commenter asserted that there is insufficient 
guidance or standards for what the term ``substantially'' means or who 
will make the determination (e.g., scientific staff with oversight of 
an EPA scientific advisory panel). Another commenter stated that there 
were inconsistencies with the proposed definitions for the terms 
``capable of being substantially reproduced'' and ``reanalyze.'' 
Commenters asserted that the former proposed definition specifies the 
use of ``identical methods,'' whereas the latter proposed definition 
specifies the use of the ``same or different'' methods.
    The EPA finds that these comments have merit. The EPA is modifying 
the definition of ``independent validation'' in the final rule by 
replacing ``capable of being substantially reproduced'' with 
``produced.'' The EPA will not finalize the proposed 40 CFR 30.2 
definition of ``capable of being substantially reproduced'' because the 
term is not used in the final rule's definition of ``independent 
validation'' or elsewhere in 40 CFR 30. As a result, ``substantially'' 
will not need to be defined or described in the final rule. The EPA is 
also modifying the definition of ``reanalyze'' to specify the use of 
the same methods because as proposed it specified the use of the ``same 
or different'' methods. This change was made so that the definition 
would be consistent with the final rule's definition of ``independent 
validation.''
    2. Data and models. In the 2020 SNPRM, the EPA proposed a 
definition of ``data'' in response to comments on the 2018 proposed 
rule, contending that a definition for this term was needed to clarify 
the applicability of the rulemaking. Commenters requested that the EPA 
clarify which stage of data would need to be available to allow for 
independent validation. The stage of data that the EPA identified in 
the proposed 40 CFR 30.2 definition of ``data'' is based on the 
discussion of the different stages of data in the NAS Workshop Report 
(Ref. 26). The 2020 SNPRM adapted the description of the stage of data 
from the NAS Workshop Report (Ref. 26) that was data at the appropriate 
level of detail to allow for independent validation via reanalysis.
    Several commenters asserted that the proposed definition of 
``data'' was so broad that it could include potentially any 
information. One commenter contended that as published scientific 
results are often the final steps in a process involving several 
processing and analysis steps, the proposed definition of ``data'' 
definition did not identify what intermediate step of data processing 
would be subject to this rule. The commenter noted that determining 
which of the multiple data processing and analysis steps that should be 
used would differ from study to study. Another commenter suggested that 
the EPA should identify the actual final dataset used in statistical 
analysis as the appropriate stage of data to be made available.
    As the EPA described in the 2020 SNPRM, there are different stages 
of data. The EPA presented the different stages described in the NAS 
Workshop Report (Ref. 26), ``There are raw data, which come straight 
from the survey or the experiment. There are cleaned-up data, which 
consist of the raw data modified to remove obvious errors.'' (These are 
the data that are ready to be analyzed to extract relevant 
information.) ``There are processed data, which are data that have been 
computed and analyzed to extract relevant information. There is the 
final clean data set that is provided with a publication.'' Since the 
purpose of 40 CFR 30.5 is to determine the consideration to afford to 
studies based on, among other factors, the availability of the 
underlying dose-response data that would support independent validation 
via reanalysis of the data underlying pivotal science, the appropriate 
stage of data would not be the processed data (data that have been 
computed and analyzed to extract relevant information) or the final 
clean data set that is provided with a publication. At these two stages 
of data, the analysis has already been conducted, and the results have 
already been determined. In order to determine if these results are 
valid, data that had not already been computed and analyzed are needed.
    In this final rule, the EPA is not identifying a specific step in a 
multi-step analysis as the stage of data that would be sufficient for 
independent validation through reanalysis because this would be overly 
prescriptive and not informative. As noted by commenters, the step at 
which the final clean data set will be generated will vary from study 
to study. The level of detail required would be that needed for a 
separate party to reanalyze the study. The appropriate step is where 
the data are ready to be analyzed to extract relevant information.
    One commenter requested that the EPA introduce and define a new 
term, ``validated data,'' which are the data with the proper level of 
quality assurance. While the EPA routinely conducts quality assurance 
to ensure that data are acceptable for use, the EPA does not see the 
need to create a separate definition. The focus of this rulemaking is 
the independent validation of the results of studies underlying pivotal 
science, not the quality assurance of the data itself.
    Some commenters contended that the EPA should define ``data'' as 
the raw data in which obvious errors have not been removed. Other 
commenters stated that raw data in which obvious errors have not been 
removed would result in skewed analyses for third parties not familiar 
with the data collection process. Given concerns about potentially 
skewed analyses, the final definition of ``data'' maintains the stage 
of data in which obvious errors have been removed.
    Some commenters also requested that the EPA define ``model'' to 
clarify the applicability of the rulemaking. In the 2020 SNPRM, the EPA 
proposed a definition of ``model'' at 40 CFR 30.2, but the Agency is 
not finalizing the definition of ``model'' because this regulation 
applies only to dose-response data (see Section III.B of this 
preamble).
    3. Dose-response data. In the 2018 proposed rule, the EPA proposed 
a definition of ``dose-response data and models.'' The EPA did not 
receive significant comment on the definition of ``dose-response data 
and models'' itself. However, as discussed in Section III.B of this 
preamble, this final rule applies to dose-response data, and thus the 
EPA is not finalizing a definition for ``dose-

[[Page 480]]

response data and models.'' Rather, consistent with the applicability 
of this final rule, the EPA is finalizing a definition of ``dose-
response data'' that is specific to the relationship between a dose or 
exposure and an effect.
    4. Influential scientific information. In the 2020 SNPRM, the EPA 
proposed expanding the scope of the 2018 proposed rule to include 
influential scientific information and proposed to define ``influential 
scientific information'' as ``scientific information the Agency 
reasonably can determine will have or does have a clear and substantial 
impact on important public policies or private sector decisions,'' 
consistent with the definition of ``influential scientific 
information'' provided in the OMB Final Information Quality Bulletin 
for Peer Review (Ref. 8).
    The EPA received public comments in support of and against the 
Agency's proposed 40 CFR 30.2 definition of ``influential scientific 
information.'' Some commenters believed that the proposed definition 
was too broad to be useful and, as a result, would apply to all 
scientific documents produced by the EPA. Other commenters believed 
that the proposed definition was too narrow and would not adequately 
capture the types of information that may be considered influential.
    The EPA finds that these comments have merit, in part. The 
definition of ``influential scientific information'' at proposed 40 CFR 
30.2 in the 2020 SNPRM is the same definition as in the OMB Final 
Information Quality Bulletin for Peer Review (Ref. 8). The EPA proposed 
to adopt this definition because it intended the scope to be consistent 
with how that term has been interpreted and applied in the context of 
peer review.\10\ Given that the definition is both established and has 
been routinely applied by the EPA, the EPA disagrees with the 
suggestion that the term is inherently too narrow or too broad. Rather 
than modify the proposed 40 CFR 30.2 definition of ``influential 
scientific information,'' the EPA is modifying 40 CFR 30.3 in the final 
rule to clarify the Agency's intent that the requirements in 40 CFR 
30.3 apply to influential scientific information, unless the 
influential scientific information is exempted from peer review 
requirements as described in Section IX of the OMB Final Information 
Quality Bulletin for Peer Review (Ref. 8). Consistent with this 
approach, the EPA is finalizing the definition of ``influential 
scientific information'' as proposed in the 2020 SNPRM.
---------------------------------------------------------------------------

    \10\ For example, see the Environmental Protection Agency Annual 
Report on Peer Review Fiscal Year 2017 (October 1, 2016-September 
30, 2017) that the Agency submitted to OMB, https://cfpub.epa.gov/si/EPA%20FY%202017%20Annual%20Peer%20Review%20Report.pdf. Each 
annual report identifies influential scientific information and 
highly influential scientific assessments.
---------------------------------------------------------------------------

    5. Pivotal science. In the 2020 SNPRM, the EPA introduced the term 
``pivotal science,'' defined in proposed 40 CFR 30.2 as ``the specific 
scientific studies or analyses that underly [sic] influential 
scientific information.'' This term was proposed as a parallel to 
``pivotal regulatory science,'' defined in 40 CFR 30.2 of the 2018 
proposed rule as ``the specific scientific studies or analyses that 
drive the requirements and/or quantitative analysis of EPA significant 
regulatory decisions.''
    The EPA received comment on the use of ``regulatory'' in ``pivotal 
regulatory science.'' Some commenters contended that there is no such 
thing as science that is regulatory; rather, there is science used to 
support regulation. Some commenters also noted that the terms ``pivotal 
science'' and ``pivotal regulatory science'' have similar scopes.
    The EPA acknowledges that no scientific study is inherently 
regulatory; rather, the EPA uses science to inform its significant 
regulatory actions. In order to increase the clarity of this final 
rule, to take into account the similarities between the two 
definitions, and to more accurately describe the science that the EPA 
uses, the EPA is removing the term ``pivotal regulatory science'' and 
combining the definitions of ``pivotal science'' and ``pivotal 
regulatory science'' under the single term ``pivotal science'' in 40 
CFR 30.2. The EPA is responding to comments on both terms together.
    Some commenters noted that the scope of studies that could be 
considered ``pivotal science'' was unclear but appeared broad. Some 
commenters argued that since properly conducted science reviews the 
entire body of scientific evidence, nearly any study evaluated could be 
considered ``pivotal science.'' The EPA's SAB suggested that the Agency 
clarify whether ``pivotal science'' refers to all the hazard 
characterization and dose-response models that the EPA evaluates and 
captures in its analysis (Ref. 27). Other commenters asserted that if 
the EPA interprets ``pivotal science'' broadly to include all studies 
involved in the development of significant regulatory actions or 
influential scientific information, implementing this rule would be 
infeasible.
    As discussed in Section III.B of this preamble, the EPA finds merit 
in comments that the proposed definition for ``pivotal science'' 
appeared too broad to feasibly implement in this rule. Because of the 
EPA's commitment to basing its decisions on sound science, the EPA may 
review several hundred or thousands of scientific studies in the 
development of significant regulatory actions or influential scientific 
information. As such, the EPA agrees that determining data availability 
for all the studies EPA considers in significant regulatory actions and 
influential scientific information may be infeasible at this time. 
Future statute-specific rulemakings may be more expansive as the EPA 
continues to make incremental progress toward maximizing transparency.
    Further, although this rulemaking does not require reanalysis of a 
study's underlying data, the EPA finds that limiting the scope of 
``pivotal science'' will still provide meaningful and impactful 
opportunity for reanalysis. Lewandowsky et al. (2020) evaluated the 
cost-effectiveness of reanalysis studies under various scenarios and 
concluded that reanalysis studies are most cost-effective when they are 
focused on studies of the greatest interest to the scientific community 
(in this study, the number of citations was a surrogate for interest) 
(Ref. 38). This finding is consistent with results in other studies 
that found and encouraged narrowing the focus of attempted reanalysis 
studies to those studies of greater significance (Refs. 37, 39, 40, 
41).
    In this final rule, rather than considering all studies that 
support the assessment of the relationship of a dose or exposure of a 
pollutant, contaminant, or substance to the magnitude of a predicted 
health or environmental impact as ``pivotal science,'' the EPA is 
balancing transparency and feasibility by focusing on those studies 
that inform the quantitative relationship between the dose or exposure 
of a pollutant, contaminant, or substance and an effect. Thus, 
``pivotal science'' includes only those studies that are integral to 
characterizing dose-response relationships (e.g., identifying candidate 
PODs). These are the studies that drive the requirements or 
quantitative analyses of EPA significant regulatory actions or 
influential scientific information. Although this rule takes an 
incremental approach and therefore does not include studies informing 
the dose-response modeling (e.g., benchmark response selection), 
studies identifying data for toxicokinetic adjustments, or studies 
informing the selection of uncertainty factors do not drive the 
requirements or quantitative analyses of EPA significant regulatory 
actions or influential scientific

[[Page 481]]

information. Future statute-specific rulemakings may interpret 
``pivotal science'' more broadly.
    This clarified definition of ``pivotal science'' in the final rule 
is also responsive to the SAB's comments that pivotal science should be 
more focused (Ref. 27). Consistent with the intent of this rulemaking, 
the EPA intends to clearly identify the studies considered pivotal in 
the documentation at the proposed rule stage for significant regulatory 
actions and when influential scientific information is disseminated for 
peer review.
    Some commenters also expressed confusion regarding how ``pivotal 
science'' relates to ``best available science.'' One commenter 
recommended that if this rulemaking is intended to alter the EPA's 
definition and use of the best available science, the EPA should issue 
further guidance for public comment. To be clear, this rulemaking is 
not intended to modify the Agency's interpretations of ``best available 
science.'' The EPA will continue to consider all peer-reviewed science, 
consistent with existing study quality assessment factors and 
corresponding statutory mandates. The EPA will then identify and 
consider ``pivotal science in accordance with the provisions of this 
rule,'' unless the implementation of the rule conflicts with statutory 
requirements and associated implementing regulations.
    6. Publicly available. In the 2018 proposed rule, the EPA used the 
term ``publicly available,'' but did not propose a definition at 40 CFR 
30.2 or describe it in the preamble to the 2018 proposed rule. Some 
commenters on the 2018 proposed rule asked the EPA to explain what it 
meant by the term. In the 2020 SNPRM, the EPA proposed a definition for 
``publicly available'' at 40 CFR 30.2.
    One commenter stated that the proposed definition was vague because 
it did not make clear whether the study data itself would proactively 
be made available to members of the public by data holders in 
government sources, media sources, or other online sources. The 
definition is not intended to describe the mechanism for making the 
information available (i.e., whether the information is made available 
proactively or is made available upon request). Rather, the definition 
describes whether, given the nature of the information, it can be, must 
be, or is already generally available (i.e., where the information can 
be made lawfully available from government records, is required to be 
made available by government law or regulation, or is information that 
is widely available to the general public).
    Another commenter requested that the EPA consider data and models 
to be publicly available when they are available through restricted 
access when the data includes CBI, proprietary data, or PII that cannot 
be sufficiently de-identified to protect the data subjects. The EPA 
disagrees with the commenter. The plain meaning of ``publicly 
available'' does not include availability through restricted access to 
data that includes CBI or PII because there are laws that preclude the 
disclosure of CBI or PII to those not authorized for its access. Thus, 
the general public cannot access the un-sanitized CBI data or non-
anonymized PII data in a manner that will allow for independent 
validation through reanalysis. If the public cannot access such data, 
it is not publicly available.
    Several commenters contended that the proposed definition of 
``publicly available'' would introduce a bias favoring industry data 
submitted to the EPA. They asserted that industry-generated studies 
submitted to the EPA pursuant to FIFRA would be considered publicly 
available because they could be obtained by the public in response to a 
Freedom of Information Act (FOIA) request. However, this does not mean 
that these are immediately or easily available to the public. Some 
commenters cited the EPA's Freedom of Information Act Annual Report 
Fiscal Year 2019 (2020), which lists a median response time for 
``expedited processing'' of FOIA requests by the EPA as 493 days (Ref. 
42). The EPA finds that such comments have merit and is modifying the 
definition in the final rule to add the following at the end of the 
definition: ````the public must be able to access the information on 
the date of publication of the proposed rule for the significant 
regulatory action or dissemination of the draft influential scientific 
information for public review and comment.''
    7. Research data. Proposed 40 CFR 30.2 in the 2018 proposed rule 
included a definition of ``research data.'' In the 2020 SNPRM, the EPA 
deleted the proposed definition of ``research data.'' While one 
commenter on the 2020 SNPRM noted that the exclusions in the proposed 
definition of ``research data'' of trade secrets and personal and 
medical information were not incorporated into the proposed definition 
of ``data,'' commenters did not request that the EPA maintain a 
definition of ``research data.'' The EPA is not including a definition 
of ``research data'' in this final rule given that it is finalizing the 
definition of ``data.''
    8. Significant regulatory actions. In the 2018 proposed rule, the 
EPA defined the term ``regulatory decisions'' as final regulations 
determined to be significant regulatory actions under Executive Order 
(E.O.) 12866, Regulatory Planning and Review. Some commenters stated 
that the use of regulatory decisions was confusing given that the term 
was only intended to apply to a subset of regulations. The EPA agrees 
with these comments, and to clarify the definition, the Agency is 
changing the term from ``regulatory decisions'' to ``significant 
regulatory actions'' in the final rule.
    9. Science that serves as the basis for informing a significant 
regulatory action. In the 2018 proposed rule, the EPA proposed to 
define the term ``regulatory science.'' A number of commenters 
expressed confusion over both the meaning and scope of this proposed 
term. One commenter noted that other Federal agencies have defined 
``regulatory science.'' For example, the U.S. Food and Drug 
Administration (FDA) has described ``regulatory science'' as ``the 
science of developing new tools, standards, and approaches to assess 
the safety, efficacy, quality, and performance of all FDA-regulated 
products'' (Ref. 43).This commenter suggested that a simplified 
definition would be ``regulatory science consists of the scientific 
segment of the regulatory process.'' The EPA acknowledges that the term 
``regulatory science'' may be confusing because it suggests either that 
the term refers to a scientific discipline of regulatory decision-
making (akin to FDA's description), or that the EPA considers some 
science inherently regulatory. Neither of these interpretations 
reflects the Agency's intent in defining this term. The EPA considers 
the breadth of scientific evidence in its rulemakings; while this 
scientific evidence informs policy decisions, the EPA's consideration 
of the science does not make it ``regulatory science.'' To reflect this 
fact, in the final rule the EPA is changing the proposed term 
``regulatory science'' to ``science that serves as the basis for 
informing a significant regulatory action.''
    In the 2018 proposed rule, the EPA defined regulatory science as 
``scientific information, including assessments, models, criteria 
documents, and regulatory impact analyses, that provide the basis for 
EPA final significant regulatory actions.'' Several commenters claimed 
that this definition was vague and without discernable meaning. The EPA 
disagrees with the assertion that the proposed definition was without 
meaning, but in response to comments

[[Page 482]]

is altering the final definition to increase clarity. For example, the 
EPA notes that the proposed definition for ``regulatory science'' 
combined both general categories of scientific information, such as 
assessments and models, with specific examples of EPA scientific 
products, such as criteria documents and regulatory impact analyses. 
The EPA acknowledges that this may increase confusion and is therefore 
limiting the final definition to general categories. As such, the EPA 
is altering the definition of ``science that serves as the basis for 
informing a significant regulatory action'' in 40 CFR 30.2 to mean 
``studies, analyses, models, and assessments of a body of evidence that 
provide the basis for EPA significant regulatory actions.'' Examples of 
models include those used in regulatory impact analyses. Examples of 
assessments of a body of evidence include risk assessments, hazard 
identifications, Integrated Risk Information System (IRIS) assessments, 
and criteria documents.
    Other commenters expressed confusion over the scope of what 
constitutes science that serves as the basis for informing a final 
significant regulatory action, as defined in the proposed rule. One 
commenter asserted that the phrase ``provides the basis'' means that 
science that serves as the basis for informing a final significant 
regulatory action could be all the science considered, relied upon, and 
included in the administrative record of a rulemaking by the EPA. The 
EPA agrees with this and clarifies in the final rule that the scope of 
science that serves as the basis for informing a significant regulatory 
action is equivalent to the science included in the public docket as 
part of a rulemaking, but not all of that body of science would 
typically be considered ``pivotal science.''

D. Applicability of the Rule

    In the 2018 proposed rulemaking, the EPA proposed to apply the 
requirements of this rulemaking on significant regulatory decisions. 
The EPA then solicited comment on whether the requirements of this 
rulemaking should apply to (1) other stages of the rulemaking process; 
(2) a narrower scope of coverage; and (3) certain categories of 
regulatory actions, such as individual party adjudications, enforcement 
activities, or permit proceedings or other agency actions. In the 2020 
SNPRM, the EPA proposed to expand the applicability of this rulemaking 
to include influential scientific information.
    The EPA received significant comment on the proposed applicability 
of this rulemaking to significant regulatory decisions and influential 
scientific information. Some commenters supported the proposed 
applicability, while other commenters disagreed with it.
    A few commenters addressed the potential for expansion or narrowing 
of the scope of the rule to include other actions in addition to final 
significant regulatory decisions and influential scientific 
information. Of the few commenters that explicitly addressed potential 
expansion beyond the proposed rulemaking, a majority focused on 
recommendations to include the science underlying Integrated Science 
Assessments (ISAs) and IRIS assessments. A few commenters expressed 
support to expand the proposed rulemaking to include one or more of the 
following: TSCA risk evaluations; CERCLA remedial actions; RCRA 
corrective actions; as well as assessments and actions under the CWA. 
Additional comments recommended expansion of the scope of the proposed 
rulemaking to include enforcement and permitting actions, as well as 
agency guidance documents. Some commenters supported applying the 
requirements of this rulemaking to proposed rules and advance notices 
of proposed rulemakings. Other commenters specifically opposed 
expanding the proposed rulemaking to include the aforementioned 
actions. Additionally, some commenters recommended narrowing the scope 
to only rulemakings subject to the Congressional Review Act or 
economically significant regulatory actions under E.O. 12866 (i.e., 
those rules that ``have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities'').
    Some of the assessments that commenters suggested should be subject 
to the requirements of this rulemaking are categorized as influential 
scientific information. The EPA notes that many assessments categorized 
as influential scientific information support rulemakings and other 
actions under several environmental statutes that the EPA administers. 
For example, the ISA for lead and the IRIS assessment for 
trichloroethylene have been used in a variety of actions (including 
those that are not significant regulatory actions) under TSCA, RCRA, 
and the CAA. IRIS assessments are routinely used under the CAA, RCRA, 
and CERCLA. By finalizing the scope rule to include influential 
scientific information, the Agency is applying the applicability of the 
rule to an important category of scientific assessments that influence 
a wide range of EPA regulatory actions.
    The EPA sees no need to include the proposed rule stage of final 
significant regulatory actions in the regulatory text because as a 
practical matter proposed rules must comply with this final rule before 
being finalized. As a general matter, the EPA does not introduce the 
studies and analyses it relies on for a rulemaking at the final rule 
stage. The scientific basis for a rulemaking is provided for public 
review and comment in the public docket when the proposed rule is 
issued or, if subsequently added to the docket, through a separate 
opportunity for public comment. Advance notices of proposed rulemakings 
are not consistent with the purpose of this rule, given their 
preliminary nature and frequent focus on soliciting comments on a 
regulatory issue or approach.
    Transparency is important in ensuring that the decisions the EPA 
makes are based on sound science. The EPA is finalizing the 
applicability of this rule to significant regulatory actions and 
influential scientific information because of the potential broad 
impact of these actions and assessments on American lives and 
livelihoods. The EPA is not applying this rulemaking to permit 
proceedings, site-specific actions, or enforcement actions because 
these actions are typically focused on individual regulated entities.

E. Availability of Dose-Response Data

    In the 2018 proposed rule, the EPA proposed to require at 40 CFR 
30.5 that ``[w]hen promulgating final significant regulatory decisions, 
the Agency shall ensure that dose-response data and models underlying 
pivotal regulatory science are publicly available in a manner 
sufficient for independent validation.'' The EPA received a large 
number of comments stating that the approach in the 2018 proposed rule 
would likely preclude the use of valid data and models from 
consideration as pivotal science. The comments indicated that the 
proposed requirement to ensure data and models are publicly available 
in a manner sufficient for independent validation would prevent the use 
of data and models that include CBI, proprietary data, and PII that 
cannot be sufficiently de-identified to protect the data subjects, as 
well as many older studies. In response to such comments, in the 2020 
SNPRM, the EPA proposed a modified version of the 2018 proposed 
regulatory text at 40 CFR 30.5. Proposed 40 CFR 30.5 would allow

[[Page 483]]

agency consideration of studies with restricted access to data and 
models that have CBI, proprietary data, or PII that cannot be 
sufficiently de-identified to protect the data subjects. For all other 
studies, data and models should be publicly available if the studies 
were to be used as pivotal regulatory science or pivotal science. In 
the 2020 SNPRM, the EPA also proposed an alternative. Under the 
alternative 40 CFR 30.5 proposal, when promulgating significant 
regulatory decisions or developing influential scientific information, 
the Agency would, other things equal, give greater consideration to 
studies where the underlying data and models are available in a manner 
sufficient for independent validation either because the information is 
publicly available or available through tiered access when the data 
include CBI, proprietary data, or PII and appropriate techniques have 
been used to reduce the risk of re-identification. In the 2020 SNPRM, 
the Agency proposed that in developing the final significant regulatory 
decision or influential scientific information, the EPA would identify 
those studies that were given greater consideration and provide a short 
description of why and how greater consideration was given.
    A few commenters contended that 40 CFR 30.5 as proposed in the 2018 
proposed rule was superior to proposed 40 CFR 30.5 in the 2020 SNPRM 
and the alternative proposed 40 CFR 30.5 in the 2020 SNPRM. The 
commenters asserted that privacy or confidentiality should not have 
priority over transparency. They further asserted that the approaches 
in the 2020 SNPRM would impose substantial limits on the effect of the 
rule since privacy, confidentiality, and restricted access are all 
concepts and practices that inhibit full transparency.
    Some commenters supported the categorical approach taken in 
proposed 40 CFR 30.5 in the 2020 SNPRM in which pivotal science would 
need to be available for independent validation. A few commenters 
suggested that it be expanded to apply to all studies, not only those 
that are pivotal science. Other commenters contended the proposed 2020 
SNPRM approach was flawed because it would exclude from consideration 
valid scientific studies for which the underlying data at the stage 
required by this regulation are unavailable, regardless of whether the 
studies have been peer reviewed or would be considered part of the 
``best available science'' under the environmental statutes that EPA 
administers that require the use of ``best available science.'' These 
commenters stated that such a categorical exclusion is inconsistent 
with current scientific standards and the requirements of the 
environmental statutes that the EPA administers. Other commenters noted 
that there are a variety of reasons, including the age of a study, why 
the underlying data at the stage required by this rulemaking would not 
be available, publicly or otherwise, for independent validation.
    Some commenters supported and other commenters opposed alternate 
proposed 40 CFR 30.5 in which the Agency would, all else being equal, 
give greater consideration to studies where the underlying data and 
models are available in a manner sufficient for independent validation. 
Some commenters stated that this was a reasonable way to consider 
transparency because studies would be assessed on a case-by-case basis 
and valid studies would not be categorically excluded. Other commenters 
did not support alternate proposed 40 CFR 30.5 because they contended 
there is no scientific justification for a rule that directs the EPA to 
selectively give greater consideration to certain studies over others 
based on data availability.
    Upon consideration of the comments, the EPA agrees that it is 
important not to categorically exclude any study because the data 
underlying a study at the stage required by this rulemaking may not be 
available for independent validation. Therefore, the EPA is not 
finalizing the primary proposal in the 2020 SNPRM that would have 
categorically required that for studies to be considered pivotal 
science, the underlying data would need to be available for independent 
validation. However, given that transparency is an important aspect of 
EPA's regulatory actions and assessments, it should be an important 
consideration in how the Agency considers pivotal science. As described 
in 40 CFR 30.5 of the final rule, the EPA will rely on the highest 
quality, most relevant studies available in determining the potential 
for hazard due to exposure to a pollutant, contaminant, or substance. 
Where there is convincing and well substantiated evidence to support a 
relationship between exposure and effect, the EPA will identify those 
studies--based on the exposure situation being addressed, the quality 
of the studies, the reporting adequacy, and the relevance of the 
endpoints--that would inform a dose-response assessment for those 
effect endpoints. From that subset, the specific dose-response studies 
or analyses that drive the requirements or quantitative analyses of an 
EPA significant regulatory action or influential scientific information 
will be identified as pivotal science.
    Further, the EPA is finalizing the approach that gives greater 
consideration to pivotal science whose underlying dose-response data 
are publicly available or available through restricted access. 
Restricted or tiered access in this final rule means that the 
underlying dose-response data are available through a data sharing 
mechanism, such as through an agreement with the originating author or 
institution, access to a refined or redacted dataset that anonymizes 
the more sensitive portions of the analyzable dataset, a restricted 
access data repository or secure data enclave, or some other mechanism 
(e.g., Data Use Agreements) that allows a qualified subject matter 
expert access to enough data to support independent validation while 
still protecting sensitive information.
    Some commenters argued that the EPA did not sufficiently explain 
how it will identify ``pivotal science.'' For example, one commenter 
stated that the EPA did not explained what it means for a study to 
``underly'' [sic] influential scientific information or to ``drive the 
requirements'' of final significant regulatory actions. Some commenters 
on the 2018 proposed rule asked for the EPA to clarify in what stage of 
the review process the Agency would identify pivotal science. In the 
2020 SNPRM, the EPA explained, ``under this [proposed] regulation EPA 
would continue to use standard processes for identifying, evaluating, 
and reviewing available data, models, and studies. When the Agency has 
potentially identified multiple key studies or models of similar 
quality that could drive its subsequent decisions, the Agency will 
investigate the availability of the underlying data.'' In response to 
the 2020 SNPRM, one commenter suggested the EPA provide a transparent 
explanation of how and why studies are determined to be pivotal science 
over others. A commenter also argued that if the EPA interprets 
``pivotal science'' narrowly (i.e., not as all the studies included in 
the weight of evidence), this would introduce risk of selecting 
``pivotal science'' in a biased manner without sufficient 
accountability. Another commenter recommended that the EPA establish 
criteria for designating studies as pivotal science.
    The EPA disagrees with the proposition that designating a set of 
key studies as ``pivotal science'' will necessarily be biased or 
without accountability. The EPA follows an objective, unbiased process 
for identifying and evaluating scientific

[[Page 484]]

studies and already identifies key or pivotal studies in some of its 
actions (e.g., IRIS assessments). The EPA intends to issue 
implementation guidelines and statute-specific rulemakings that will 
further describe these criteria and how the EPA will identify pivotal 
science in its assessments and rulemakings. In general, the EPA will 
rely on the highest quality, most relevant studies available in 
determining the potential for hazard due to exposure to a pollutant, 
contaminant, or substance. Where there is convincing and well 
substantiated evidence to support a relationship between exposure and 
effect, the EPA will identify a subset of those studies based on the 
exposure situation being addressed, the quality of the studies, the 
reporting adequacy, and the relevance of the endpoints that would 
inform a dose-response assessment for those effect endpoints and drive 
the requirements and/or quantitative analyses of an EPA final 
significant regulatory action or influential scientific information 
will be identified as pivotal science.
    Further, the EPA intends to promulgate regulations under the 
environmental statutes that the EPA administers to further clarify how 
the Agency will apply the definition of ``pivotal science'' in specific 
programs authorized under those statutes (e.g., CAA, CWA, SDWA, RCRA, 
FIFRA, TSCA, EPCRA). The specific criteria for determining ``pivotal 
science'' may necessarily be specific to the authorizing statute, as 
well as the significant regulatory action or the influential scientific 
information. The EPA intends to explain in each significant regulatory 
action and for influential scientific information how the pivotal 
studies were identified.
    In response to comments on the meaning of ``drive the requirements 
and/or quantitative analysis,'' these are the studies that are integral 
to quantitatively characterizing dose-response relationships for the 
toxicity endpoints that underlie the requirements or analyses of EPA 
significant regulatory actions or influential scientific information. 
The EPA may further interpret the meaning of ``drive,'' and describe 
the process for designating key studies as pivotal science in 
subsequent implementation guidelines and/or statute-specific 
rulemakings.
    Some commenters stated that the EPA did not explain what was meant 
by ``other things being equal.'' Some of these commenters requested 
clarity on what factors in addition to transparency would be 
considered. Some specific suggestions from commenters include that EPA 
should give consideration to quality studies that evaluate a range of 
models, that are scientifically sound for the intended use, and that 
have study ``characteristics (e.g., sample size, confidence intervals 
of results, or overall methods validity) [that] may compensate for any 
lack of full transparency.'' In consideration of these and other public 
comments, the EPA developed additional factors that clarify specific 
technical factors that it may consider in balancing study quality and 
data availability. Although the EPA is prioritizing transparency in 
pivotal science, the Agency also recognizes that there will be 
instances where the underlying dose-response data of pivotal science is 
unavailable for independent validation. In order to ensure that the 
Agency maintains a strong scientific basis for its decision-making, the 
availability of underlying dose-response data should be considered as 
long as other significant technical considerations can provide some 
level of certainty or confirmation of a study's conclusions, 
importance, and applicability, even in the absence of maximum 
transparency. Though EPA's list of factors herein is not exhaustive or 
exclusive, the EPA has identified several factors in 40 CFR 30.5(d) 
that balance some of the important technical considerations the EPA 
will consider in addition to data availability and that are 
particularly relevant to the stage of the analysis where dose-response 
data are used. These factors are intended to assist the EPA in 
determining the consideration to afford to pivotal science with 
underlying dose-response data that are not available for independent 
validation. The final rule requirements and the consideration of these 
factors apply to any data used in characterizing the relationship 
between the amount of dose or exposure to a pollutant, contaminant, or 
substance and an effect, regardless of the direction of that effect. 
Because study quality factors (including soundness, applicability and 
utility, clarity and completeness, uncertainty and variability, and 
evaluation and review) would have already been evaluated at an earlier 
stage in the assessment process (see 40 CFR 30.5(b)), the EPA envisions 
that at the stage of the evaluation that utilizes the factors described 
in 40 CFR 30.5(d), the studies to be evaluated would generally be of 
the highest quality available.
    Some of the factors in 40 CFR 30.5(d) are intended to be evaluated 
for pivotal science with underlying data that are not available for 
independent validation relative to pivotal science with underlying data 
that are available for independent validation. For example, when 
assessing studies, the EPA may determine that greater consideration 
should be given to a study with underlying data that are unavailable 
for independent validation when that study is of higher quality 
compared to a medium-quality study with underlying data that are 
available for independent validation (factor 1), the conclusions of the 
significant regulatory action or influential scientific information are 
or are not highly sensitive to the exclusion of the study for which the 
underlying data are not available for independent validation (factor 
3), the study with data unavailable for independent validation was 
better fit for the purpose of the EPA assessment (factor 4), or the 
results of the study for which the underlying data are not available 
are supported by other scientific evidence, such as mechanistic data 
(factor 6).
    Importantly, the factors in 40 CFR 30.5(d) do not apply to other 
stages in the assessment process (although they are relevant to 
determining whether to grant an exemption under 40 CFR 30.7, as further 
explained below). For example, the consideration for exposures that 
were conducted at more environmentally relevant exposure concentrations 
(factor 5) does not suggest that epidemiological studies will 
automatically be given greater weight than laboratory studies. The EPA 
will continue to use established guidelines for identifying and 
integrating evidence and will use the factors in 40 CFR 30.5(d) only 
when evaluating the data availability requirements of this rule (or 
when determining whether to grant an exemption under 40 CFR 30.7, as 
further explained below). In addition, not all of these factors will be 
applicable to all studies or assessments. For example, some pollutants, 
chemicals, or substances may have unique scientific considerations 
(factor 7), such as the valence state of a metal compound or endogenous 
contributions to internal concentrations, that may not be relevant for 
other pollutants, chemicals, or substances. Therefore, the weight 
afforded to each factor by the EPA may vary by assessment, and how 
those factors were considered will be documented in the assessment. If 
two studies, one with and one without available data and are relatively 
equal with respect to the study quality factors in 40 CFR 30.5(b), the 
study where the underlying data is available will be given greater 
consideration and the weight of the other study will be based on an 
assessment of the factors in 40

[[Page 485]]

CFR 30.5(d). In this way, the EPA will balance the importance of 
transparency with the need to maintain a strong scientific basis for 
its assessments.
    This final rule requires the consideration of the factors in 40 CFR 
30.5(d) when assessing pivotal studies for which the dose-response data 
are not available for independent validation. The EPA may adapt these 
factors in upcoming statute-specific rulemakings, as appropriate, for 
significant regulatory actions under the different environmental 
statutes that the EPA administers. How scientific information is to be 
considered varies among the different environmental statutes and 
sometimes within an individual statute. Interpretation of the 
assessment factors will be tailored to the specific circumstances and 
the specific environmental statutes.
    Some commenters asserted that the 2018 proposed rule and the 2020 
SNPRM failed to explain how historical data, which may have been 
collected under different policies and procedures, will be treated. 
These commenters noted that underlying dose-response data may have been 
lost for older studies due to record retention schedules. Some 
commenters also contended that a significant amount of work would be 
required to locate, curate, and retrospectively make datasets available 
for public access.
    The EPA intends to determine the extent of the consideration that 
should be given to pivotal studies lacking available data on a case-by-
case basis. The EPA will consider the circumstances specific to each 
such study when it applies the factors listed in 40 CFR 30.5(d) to that 
study. The age of the data is not a consideration under 40 CFR 30.5(d), 
but could be the basis for a 40 CFR 30.7 exemption request.
    Some commenters stated that the EPA should not have the rulemaking 
apply retrospectively to studies given the potential difficulty 
accessing, reviewing, and making data available that were not 
originally intended to be disseminated, as would be required by this 
rulemaking. These commenters requested that the EPA apply the 
rulemaking provisions only to data and models underlying studies 
generated after the promulgation of this rule.
    This final rule applies prospectively to significant regulatory 
actions and influential scientific information and has no retrospective 
effect on existing (i.e., completed) significant regulatory actions or 
influential scientific information. For future, significant regulatory 
actions and influential scientific information, the final rule applies 
equally to all dose-response data underlying studies used as pivotal 
science, regardless of when the study or the data was created. 
Scientific transparency is important regardless of the age of the study 
or the dose-response data.
    Some commenters contended that a substantial amount of work would 
be required in order to make data underlying studies available for 
independent validation, but that the EPA has not identified a 
responsible party for this work, nor has it made clear the timelines, 
electronic data sharing mechanisms, or how public reporting of such 
availability would be achieved, archived, and maintained over time. The 
EPA would like to emphasize that this final rule does not impose 
requirements on any entity outside of the EPA. This is a rule of 
internal procedures and does not direct or require any outside entity 
or the EPA to establish data sharing mechanisms. Further, the final 
rule does not require the EPA to collect, store, or publicly 
disseminate dose-response data underlying pivotal science.
    Some commenters asserted that reproducing findings across similar 
studies is more informative than reanalyzing the data from a single 
study. Such commenters noted that confidence in the study findings is 
best gained when different groups are studying the same thing or are 
conducting similar studies. They asserted that the study results could 
then be averaged, compared, and further analyzed. One commenter noted 
that the ability to reanalyze the data from a study with very poor 
scientific quality does not strengthen the quality of the study. 
Commenters contended that reproducing studies (i.e., producing 
something that is very similar to that research, but it is in a 
different medium or context) is generally viewed as a more informative 
and resource efficient approach to validation of research than 
reanalyzing the data of a particular study. Some commenters contended 
that reanalysis of the data and models underlying studies is not how to 
determine the quality of a study; rather, there are other key aspects 
of studies that are integral to assessing the quality of a study.
    Other commenters supported the proposed requirement for independent 
validation by reanalysis of data and models underlying studies because 
they believe this is key to determining whether the science is accurate 
and of high quality. Some commenters contended that by reanalyzing the 
underlying data and models, independent researchers can evaluate the 
myriad of choices and assumptions the original researchers have made 
regarding the data and statistical models and the potential 
introduction of any sources of bias.
    While the availability of dose-response data underlying a study in 
a manner sufficient for independent validation is an important 
component of determining the level of consideration to afford a study, 
the EPA agrees that availability by itself is not sufficient to 
determine study quality. As explained in 40 CFR 30.5(b), the EPA will 
use existing factors (including soundness, applicability and utility, 
clarity and completeness, uncertainty and variability, and evaluation 
and review) to evaluate study quality. Subsequently, after identifying 
the highest quality, most relevant studies that would inform a dose-
response assessment and identifying the availability of pivotal 
science, the EPA would consider the additional applicable factors in 40 
CFR 30.5(d) when determining the level of consideration to give pivotal 
science where the underlying dose-response data are not available for 
independent validation. Further, although the EPA agrees with 
commenters that meaningful insights can be obtained through similar 
studies in different media or context, the EPA continues to find that 
independent validation of the study findings and conclusions driving 
the EPA's dose-response assessments would provide important 
information. As detailed in Section III.A.1 of this preamble, there is 
scientific support for the usefulness of reanalyzing data, and the EPA 
finds this to be especially true for data that drive the quantitative 
requirements or analyses of EPA significant regulatory actions or 
influential scientific information. Implementation of this rule will 
increase transparency and, thus, the opportunity for independent 
subject matter experts to validate pivotal science, and as the dose-
response data are better understood the public will, if they so choose, 
be able to more effectively comment, engage, and hold the EPA 
accountable during the development of future significant regulatory 
actions and influential scientific information.

F. Proposed 40 CFR 30.6

    In the 2018 proposed rule, the EPA proposed requirements at 40 CFR 
30.6 specific to dose-response data and models. These proposed 
requirements directed the EPA to describe and document the assumptions 
and methods it used; to evaluate the appropriateness of using default 
assumptions, including assumptions of a linear, no threshold dose-
response; to explain the scientific

[[Page 486]]

basis for each model assumption used; and to show the sensitivity of 
the modeled results to alternative assumptions. These proposed 
requirements also directed the EPA to give explicit consideration to 
high quality studies that explore a broad class of parametric dose-
response models, non-parametric models that incorporate fewer 
assumptions, various threshold models, and models that investigate 
factors that might account for spatial heterogeneity.
    The EPA received significant comment on the 2018 proposed rule 
regarding the proposed 40 CFR 30.6 requirement that the EPA evaluate 
the appropriateness of using default assumptions, ``including 
assumptions of a linear, no threshold dose-response.'' The vast 
majority of commenters asserted that the EPA should not focus the 
requirement to evaluate the appropriateness of using default 
assumptions specifically on linear, no threshold dose-response. In the 
2020 SNPRM, in response to these comments, the EPA proposed a variation 
of the regulatory text which did not include the phrase ``including 
assumptions of a linear, no threshold dose-response,'' because this 
could imply that the regulation is specific to those particular 
assumptions.
    The EPA also received significant comment on the 2018 proposed rule 
about the proposed 40 CFR 30.6 requirement to clearly explain the 
scientific basis for each model assumption used and to present analyses 
showing the sensitivity of the modeled results to alternative 
assumptions. Most commenters contended that such a requirement would be 
overly burdensome and unnecessary. They recommended that the EPA should 
present sensitivity analyses only on the most significant assumptions.
    Considering these comments, in the 2020 SNPRM, the EPA clarified 
that the use of the terms ``model assumptions,'' ``assumptions'' and 
``models'' in the proposed regulatory text at 40 CFR 30.6 apply to the 
critical assumptions that drive the model's analytic results, not to 
each assumption used in the model. The EPA's proposed revision of the 
40 CFR 30.6 regulatory text reflected this clarification.
    After considering comments on both the 2018 proposed rule and the 
2020 SNPRM, the EPA has determined that this rule should apply to dose-
response data rather than dose-response data and models. Given the 
specificity of 40 CFR 30.6 to dose-response data and models, and in 
particular dose-response models, the EPA is not finalizing 40 CFR 30.6. 
The EPA is adapting one provision of 40 CFR 30.6 as a factor in 40 CFR 
30.5 in determining the consideration to afford pivotal science for 
which the dose-response data are not available for independent 
validation. Specifically, the EPA is finalizing as a factor in 40 CFR 
30.5 the consideration that the EPA would give to high quality studies 
that explore a broad class of parametric dose-response models, non-
parametric models that incorporate fewer assumptions, various threshold 
models, and models that investigate factors that might account for 
spatial heterogeneity.
    Further, because the EPA is not finalizing any part of the 
provision that is specific to assumptions and methods associated with 
dose-response models, comments on the proposed requirements related to 
these issues are moot. However, while the EPA is not finalizing the 
provisions in 40 CFR 30.6 that include the term uncertainty, the EPA is 
responding to these comments because the term uncertainty is used in 40 
CFR 30.5. The EPA is also responding to comments on the proposed 40 CFR 
30.6 provision incorporated as part of 40 CFR 30.5.
    Some commenters contended that the EPA's use of the term 
``uncertainty'' at 40 CFR 30.6 is vague. A few other commenters 
contended that the EPA should include specific requirements in 40 CFR 
30.6 as to the scope of an analysis of uncertainty. The EPA disagrees 
with the suggestion that the term ``uncertainty'' is vague or that 
there is significant ambiguity about what should be in the scope of a 
characterization of uncertainty. The characterization of uncertainty is 
a key factor in the assessments that the EPA conducts. It is a 
component of various EPA guidelines (e.g., Framework for Human Health 
Risk Assessment to Inform Decision Making, Ref. 36) that the EPA relies 
upon in conducting its assessments. The scope of the uncertainty 
analyses that the EPA conducts necessarily varies across assessments 
and actions. The intent of this regulation is not to force uncertainty 
analyses into a one-size-fits-all approach, as that is not practical, 
good policy, or good science. Thus, a regulation of internal 
procedures, such as this one, does not require a regulatory definition 
for a term that is already a key component of current EPA practices and 
guidelines and EPA's assessment process.
    Several commenters contended that the proposed 40 CFR 30.6 
requirement that the EPA give explicit consideration to high quality 
studies that explore a broad range of parametric dose-response or 
concentration-response models and to non-parametric models that 
incorporate fewer assumptions could force the EPA into situations in 
which it applies dose-response model(s) that are not appropriate for 
the data being assessed. The EPA notes that the final regulatory text 
in 40 CFR 30.5 does not require that a specific type of dose-response 
model be applied to a particular situation. Rather, in determining the 
consideration to afford pivotal science for which the dose-response 
data are not available for independent validation, the EPA will 
evaluate, as appropriate, the extent to which the study considered a 
broad range of parametric dose-response or concentration-response 
models, a robust set of potential confounding variables, nonparametric 
models that incorporate fewer assumptions, various threshold models 
across the dose or exposure range, and models that investigate factors 
that might account for spatial heterogeneity.

G. Administrator's Exemption

    In the 2018 proposed rule, the EPA proposed that the Administrator 
could grant case-by-case exemptions to the requirements in proposed 40 
CFR part 30 when compliance with those requirements is impracticable 
(proposed 40 CFR 30.9). In the 2020 SNPRM, the EPA modified proposed 40 
CFR 30.9 to be consistent with other changes proposed in the 2020 
SNPRM, such that the Administrator could grant case-by-case exemptions 
to the requirements in proposed 40 CFR part 30 under specific 
conditions for which compliance with the requirements in proposed 40 
CFR part 30 is impracticable.
    Some commenters supported the Administrator's exemption provision 
in proposed 40 CFR 30.9 while others opposed it. Commenters expressing 
support for the exemption provision noted that exemptions may be needed 
to account for lawful and reasonable restrictions on underlying data 
and models. Commenters expressing opposition to the exemption provision 
raised concerns about the Administrator granting exemptions from the 
requirements in proposed 40 CFR part 30. These commenters contended 
that the Administrator may lack the scientific expertise to make the 
appropriate exemption decisions and that the Administrator, as a 
political appointee, could be biased. Some public commenters 
recommended that the exemption process require formal consultation with 
EPA career scientists, the EPA's SAB, or another Agency advisory 
committee.
    The EPA also received comment on the following proposed conditions

[[Page 487]]

under which the Administrator could grant an exception in the 2020 
SNPRM: Technological barriers render sharing of the data or models 
infeasible; the development of the data or model was completed or 
updated before the effective date of the final rule; or making the data 
and models available would conflict with laws governing privacy, 
confidentiality, CBI, or national security. Some commenters supported 
the condition that would allow the Administrator to grant an exemption 
based on the age of a study, noting that older studies may not have 
been conducted with the intention of providing access to underlying 
data and models for independent validation, particularly at the stage 
of data and models proposed in the 2020 SNPRM. Other commenters opposed 
this condition, contending that exempting studies based on the age of 
the study is unnecessary and undermines the goal of increasing 
transparency in the development of regulatory decisions. Some 
commenters noted it may be prohibitively expensive for researchers to 
make their data and models available.
    The EPA finds that these comments have merit, in part. The Agency 
agrees with retaining the Administrator's exemption provision because 
there are conditions under which compliance with the requirements in 40 
CFR part 30 might be impracticable. For example, the underlying dose-
response data for some studies, particularly older studies, may not be 
readily publicly available because of the technological barriers to 
data sharing (e.g., differences in data storage devices or data 
retention practices) that existed when they were developed. As a 
result, the EPA is finalizing the Administrator's exemption provision 
as proposed in the 2020 SNPRM, with additional conditions described 
here. Due to other changes described in this preamble, the 
Administrator's exemption provision, which was previously in 40 CFR 
30.9 in the 2018 proposed rule and the 2020 SNPRM, is now 40 CFR 30.7 
in the final rule.
    The EPA does not agree with the comments regarding the role of the 
Administrator in determining whether to grant an exemption and finds 
that the Administrator is the appropriate decision maker in this 
context. To ensure that the Administrator's decision is appropriately 
transparent, in the final rule the EPA has included a provision in 40 
CFR 30.7 that requires the Agency to document the rationale for any 
exemptions granted by the Administrator in the significant regulatory 
action or influential scientific information. This documentation would 
typically be provided as part of the proposed rulemaking, given that it 
would be part of the decision concerning what is the pivotal science 
for the rule. Regardless of what is provided in the proposed rule stage 
of the rulemaking, the final rulemaking will provide clear 
documentation.
    Some commenters and the EPA's SAB (Ref. 27) also requested that the 
EPA include criteria that the Administrator will consider when 
determining whether to grant exemptions from the requirements in 40 CFR 
part 30. The EPA finds that these comments have merit and is including 
additional criteria in 30 CFR 30.7 that may be used by the 
Administrator when he or she is determining whether greater 
consideration should be afforded to pivotal science for which the 
underlying dose-response data are not available in a manner sufficient 
for independent validation. As a result, the Administrator may also 
determine that greater consideration is warranted when a third party 
has independently validated the underlying dose-response data through 
reanalysis or when the EPA's evaluation of the factors in 40 CFR 
30.5(d) indicate that full consideration of the pivotal science is 
justified.
    To assist the Administrator in determining whether to grant an 
exemption, the EPA program or Region responsible for the significant 
regulatory action or influential scientific information and public 
commenters can provide input when the Administrator is considering an 
exemption. The EPA will document the rationale for the Administrator's 
exemption in the significant regulatory action or influential 
scientific information. The EPA is confident that the above criteria 
provide sufficient clarity and boundaries for the Administrator to 
consider when granting an exemption under 40 CFR 30.7.

H. Peer Review

    In the 2018 proposed rule and the 2020 SNPRM, the EPA proposed to 
require independent peer review on pivotal regulatory science and 
pivotal science. The EPA also proposed to require that the Agency ask 
peer reviewers to opine on the strengths and weaknesses of the EPA's 
justifications for the assumptions used in models.
    Some commenters on the 2018 proposed rule and 2020 SNPRM 
specifically asked why the EPA would need to peer review health and 
scientific studies and scientific literature that had already undergone 
independent peer review. They stated that the EPA failed to explain why 
existing peer review requirements and mechanisms are insufficient. Such 
commenters also noted that in addition to being duplicative and 
unnecessary, the proposed requirement would cause unnecessary delays in 
the EPA actions and would result in increased costs for the Agency. One 
commenter noted that the EPA already has policies in place for peer 
review and referred to the EPA's Peer Review Handbook (Ref. 44). 
Another commenter stated that, while it is certainly best practice to 
consider only science that has been independently peer reviewed when 
making regulatory decisions, that does not necessitate independent peer 
review by the EPA. The commenter noted that most scientific bodies and 
publications--including Nature, Science, the Bipartisan Policy Center, 
and Proceedings of the National Academy of Sciences--employ some of the 
most robust peer review practices and that they already apply to the 
types of studies which the proposed rule would require the EPA to peer 
review anew. Some commenters also stated that the proposed peer review 
requirements specific to assumptions used in models suggest that the 40 
CFR 30.7 regulatory text would require that the EPA conduct peer review 
of the proposed Agency action itself, rather than of the science 
underlying that action. One of the commenters contended that it is 
entirely unclear how peer review could be applied to EPA's reasoning 
itself, rather than the pivotal science supporting the regulatory 
decision.
    The EPA finds that these comments have merit, in part. However, in 
this rule, the EPA is not changing the pre-existing requirements of the 
OMB Final Information Quality Bulletin for Peer Review (Ref 8). The 
preamble of the Bulletin states that ``the intensity of peer review is 
highly variable across journals'' and ``prior peer review and 
publication is not by itself sufficient grounds for determining that no 
further review is necessary'' (Ref. 8). Peer review does not typically 
include reanalysis of the underlying data (i.e., the proper stage of 
data where the data that are ready to be analyzed to extract relevant 
information) and, thus, peer review is not considered a replacement for 
the data availability requirements of this rule.
    The EPA is, therefore, finalizing the language at 40 CFR 30.6 
(formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to 
clarify that the Agency will evaluate whether or not to initiate peer 
review, consistent with the OMB Final Information Quality Bulletin for 
Peer Review (Ref. 8) and the EPA's Peer Review Handbook (Ref. 44), of

[[Page 488]]

individual studies identified as pivotal science if the studies have 
already undergone journal peer review. If the Agency conducts peer 
review on pivotal science, the EPA shall ask peer reviewers to 
articulate the strengths and weaknesses of the justification for the 
assumptions applied in analyzing dose-response data and the 
implications of those assumptions for the results.

I. Changes to 40 CFR 30.4 ``What requirements apply to EPA's use of 
studies in significant regulatory actions? ''

    In the 2018 proposed rule, the EPA proposed to require at 40 CFR 
30.4 that ``EPA shall clearly identify all studies (or other regulatory 
science) relied upon when it takes any final action. The EPA should 
make all such studies available to the public to the extent 
practicable.'' Some commenters expressed concern that proposed 40 CFR 
30.4 would permit the Agency to exclude valid studies from 
consideration on the basis of the availability of underlying data or 
models. Another commenter noted that this section would apply to any 
final agency action, rather than regulatory decisions. In response to 
these comments, the EPA notes that this section does not require the 
EPA to exclude studies from consideration when developing final 
significant regulatory actions either on the basis of the availability 
of underlying data or models, or depending on the practicability of 
making these studies available to the public.
    The EPA agrees with the commenter that the scope of 40 CFR 30.4 
should be limited to significant regulatory actions, which are defined 
in 40 CFR 30.2 as ``final regulations determined to be `significant 
regulatory actions' by the Office of Management and Budget pursuant to 
Executive Order 12866.'' The EPA is finalizing additional changes to 
the title and body of 40 CFR 30.4 by using terms defined in 40 CFR 
30.2. In the title of 40 CFR 30.4, the EPA is replacing ``taking final 
action'' with ``significant regulatory actions'' to improve clarity and 
specificity, since the latter term is defined. In the body of 40 CFR 
30.4, the EPA is replacing ``all studies (or other regulatory science) 
relied upon when it takes any final agency action'' with ``science that 
serves as the basis for informing a significant regulatory action'' to 
improve specificity, since the latter language is defined; replacing 
``should'' with ``shall;'' ``studies'' with ``science that serves as 
the basis for informing a significant regulatory action'' to improve 
specificity, since the latter term is defined; and ``available to the 
public'' with ``publicly available'' to improve specificity, since the 
latter term is defined. Together, these changes are meant to clarify 
that the requirements of 40 CFR 30.4 are consistent with the EPA's 
existing practice of making science that serves as the basis for 
informing a significant regulatory action available in the public 
docket as part of the rulemaking.

J. Benefits and Costs

    In the 2018 proposed rule, as part of its E.O. 12866 and E.O. 13563 
reviews, the EPA stated that the benefits of the proposal justify the 
costs. The EPA's rationale was that the rule would facilitate expanded 
data sharing and exploration of key data sets, improve the ability to 
independently validate analyses underlying significant regulatory 
actions, and would be implemented in a cost-effective way. The 2020 
SNPRM did not provide additional characterizations of benefits and 
costs. A number of commenters noted that the EPA did not provide an 
economic assessment to support the Agency's benefit-cost claims. 
Commenters also noted that the EPA did not characterize costs to the 
Agency, including administrative costs to ascertain the public 
availability of underlying data, costs for additional analyses 
required, and costs to ensure that PII and CBI are not disclosed. Other 
commenters noted that the EPA had not adequately explained the benefits 
of this rule, including enabling increased secondary analyses by third 
party researchers.
    The EPA agrees that neither the 2018 proposed rule nor the 2020 
SNPRM included a characterization of costs to the Agency. The EPA 
emphasizes that this is a rule of internal procedure promulgated under 
the EPA's housekeeping authority. However, the EPA has identified some 
incremental costs that the Agency may incur as a result of this final 
rule. As stated in Section III.A.2 of this preamble, the EPA will 
continue its current practice of conducting extensive review of 
scientific studies during the development of significant regulatory 
actions and influential scientific information. The additional 
procedures required by this rule apply only to pivotal science, which 
is a subset of the total number of studies that the EPA would evaluate. 
Given the costs of the current robust process for identifying and 
reviewing scientific studies and documentation that are existing Agency 
practice, as well as that the determination of dose-response data 
availability is limited to pivotal science underlying significant 
regulatory actions and influential scientific information, the EPA 
anticipates that the incremental costs of this rule will be small. The 
Agency may also incur other administrative costs to perform analyses 
and evaluations to support activities such as exemption decisions made 
by the Administrator, and documenting these or other decisions made 
pursuant to the requirements of the final rule. Again, the Agency 
anticipates that the incremental costs for these activities will be 
small relative to current administrative costs for developing 
significant regulatory actions or influential scientific information. 
Finally, this final rule does not require the EPA to disclose or host 
data, but to determine if dose-response data are available and to give 
greater consideration to those studies for which such data are 
available. Hence, this rule does not impose costs on the EPA or any 
other party to make data available, including costs to ensure that PII 
and CBI are not disclosed. The Agency may opt, at its discretion, to 
incur the costs associated with making data available when it is in the 
public interest to do so, but that will be decided on a case-by-case 
basis and is not a requirement of the final rule.
    The EPA also agrees that the benefits of the rule were not fully 
characterized in the 2018 proposed rule or the 2020 SNPRM. The EPA 
emphasizes, however, that this is a rule of internal procedure 
promulgated under the EPA's housekeeping authority. As discussed in 
Section III.A.1 of this preamble, the main benefits of this rule spring 
from greater transparency in significant regulatory actions and 
influential scientific information. By placing greater emphasis on the 
availability of dose-response data underlying pivotal science, the rule 
will allow for greater scientific scrutiny as EPA decision makers are 
developing significant regulatory actions and influential scientific 
information and increases the likelihood that any errors will be 
identified and corrected. Greater transparency is also inherently 
valuable as a principle of good government and provides benefits to the 
public at large, including reducing the risk of errors in EPA analyses 
and in the science such analyses rely upon. The ability for independent 
subject matter experts to validate pivotal science will facilitate more 
effective comment and engagement with the public during development of 
future significant regulatory actions and influential scientific 
information.
    Some commenters further argued that the EPA failed to account for 
costs external to the EPA as consequence of

[[Page 489]]

this rule, including costs to third party researchers and their 
institutions to make their raw data available and protect PII/CBI 
through data-masking, de-identification, or deposition in public data 
repositories. The EPA disagrees with the argument that this rule would 
impose costs on third-party researchers. This is a rule of internal 
procedure that does not impose requirements on any party other than the 
EPA. This rule imposes no costs on researchers or their institutions, 
and the EPA will consider and evaluate all relevant and appropriate 
science in its significant regulatory actions and influential 
scientific information. The EPA recognizes that researchers and other 
third parties may voluntarily consider the EPA's position on data 
availability, as described in this rule, as they make their own 
decisions about how to conduct research and the extent to which they 
make data and models available. Researchers may choose to make more 
data and models available, but the EPA recognizes that these parties 
will weigh their own benefits and costs and make choices that they deem 
appropriate.
    Some commenters argued the 2018 proposed rule and the 2020 SNPRM 
would impose costs on third parties because it would prohibit the EPA 
from using necessary science where the underlying data and models are 
not publicly available, which would prevent the EPA from meeting its 
statutory obligations and performing its mission of protecting human 
health and the environment. Some commenters also contended that the 
proposed rule requirements would impose costs to the public by delaying 
EPA regulatory actions that protect human health and the environment.
    As described earlier, the EPA acknowledges and agrees with 
commenters that there may be pivotal science where the underlying data 
are not publicly available or available through restricted access. The 
final rule is limited to dose-response data and, as no studies are 
categorically excluded from consideration, the EPA will continue to 
rely on the full body of the highest quality, most relevant studies 
available in determining the potential for hazard due to exposure to a 
pollutant, contaminant, or substance. Consistent with the requirements 
of this rule, the EPA will identify a subset of those studies based on 
the exposure situation being addressed, the quality of the studies, the 
reporting adequacy, and the relevance of the endpoints that would 
inform a dose-response assessment, and will give greater consideration 
to pivotal science for which the underlying dose-response data are 
available. The EPA disagrees with commenters that the requirements of 
this rule will result in any meaningful delay in promulgating 
regulations. While this final rule requires the Agency to evaluate the 
availability of dose-response data for pivotal science, the incremental 
burden to the Agency to carry out these requirements is expected to be 
small given (1) the extensive scientific review the EPA already 
conducts regularly and (2) that the requirement is limited to pivotal 
science (i.e., typically a small, though highly important, subset of 
the studies the EPA would review). Further, with this final rule, the 
EPA is maintaining language in 40 CFR 30.3 stating that the statutes 
that the EPA administers, or their implementing regulations, will 
control in the event of any conflicts with the requirements of this 
rule. The Agency will continue to comply with and abide by the 
requirements in those statutes and implementing regulations, including 
regulatory deadlines.

K. Proposed 40 CFR 30.8 ``How is EPA to account for cost under this 
subpart?''

    In 2018, the EPA proposed in 40 CFR 30.8 that ``EPA shall implement 
the provisions of this subpart in a manner that minimizes costs.'' A 
number of commenters argued that this statement was vague and that the 
2018 proposed rule neither explained what costs this rule would incur, 
nor how they would be minimized. One commenter further raised concern 
that, in order to minimize costs, proposed 40 CFR 30.8 may require the 
EPA to exclude valid data from consideration rather than take 
potentially expensive steps to protect CBI, proprietary data, and PII. 
Still other commenters interpreted proposed 40 CFR 30.8 as requiring 
the EPA to base its final significant regulatory actions and 
influential scientific information on cost. Commenters expressed 
concern that this would be at the exclusion of considerations such as 
the best available science and public health. A commenter further 
argued that the EPA does not have the statutory authority to base its 
assessment of science on cost without consideration of public health 
and environmental costs and benefits and privacy-related costs and 
benefits, and that doing so would be irrational and arbitrary.
    As explained in Section III.J of this preamble, this rule of 
internal procedure is anticipated to incur small incremental costs 
related to the additional review of data availability, as compared to 
the Agency's existing costs for extensive review and documentation as 
part of the development of significant regulatory actions and 
influential scientific information. In consideration of the public 
comments, however, the EPA is not finalizing proposed 40 CFR 30.8 ``How 
is EPA to account for cost under this subpart?'' This rule is not 
intended to require the EPA to exclude valid data from consideration on 
the basis of cost, nor interpret the EPA's statutory authority to 
consider costs in significant regulatory actions or influential 
scientific information. Given the EPA's existing commitment to fulfill 
its duties in a cost-effective manner, the EPA has determined not to 
finalize proposed 40 CFR 30.8.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this notice. The docket includes these documents and 
other information considered by EPA, including documents referenced 
within the documents that are included in the docket, even if the 
referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. E.O. 13777, Enforcing the Regulatory Reform Agenda, 82 FR 12285 
(March 1, 2017), available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.
2. E.O. 13783, Promoting Energy Independence and Economic Growth, 82 
FR 16093 (March 31, 2017), available at https://www.federalregister.gov/documents/2017/03/31/2017-06576/promoting-energy-independence-and-economic-growth.
3. Office of Mgmt. & Budget, Exec. Office of the President, 
Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal 
Agencies, 67 FR 8451 (February 22, 2002), available at https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.
4. Office of Mgmt. & Budget, Exec. Office of the President, Open 
Data Policy--Managing Information as an Asset, OMB M-13-13 (May 9, 
2013), available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2013/m-13-13.pdf.
5. U.S. EPA. Strengthening Transparency in Regulatory Science; 
Proposed Rule, 83 FR 18768 (April 30, 2018) (FRL-9977-40), available 
at https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science.
6. U.S. EPA. Strengthening Transparency in Regulatory Science; 
Proposed Rule, 83 FR 24255 (May 25, 2018) (FRL-9978-31),

[[Page 490]]

available at https://www.federalregister.gov/documents/2018/05/25/2018-11316/strengthening-transparency-in-regulatory-science-extension-of-comment-period-and-notice-of-public.
7. U.S. EPA. Strengthening Transparency in Regulatory Science; 
Supplemental Notice of Proposed Rulemaking, 85 FR 15396 (March 18, 
2020) (FRL-10004-72-ORD), available at https://www.federalregister.gov/documents/2020/03/18/2020-05012/strengthening-transparency-in-regulatory-science.
8. Office of Mgmt. & Budget, Exec. Office of the President, Final 
Information Quality Bulletin for Peer Review, 70 FR 2664 (January 
14, 2005), available at https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review.
9. U.S. EPA. (2016). Plan to Increase Access to Results of EPA-
Funded Scientific Research. (EPA/601-R-16-005). Washington, DC: U.S. 
Environmental Protection Agency. Available at https://www.epa.gov/sites/production/files/2016-12/documents/epascientificresearchtransperancyplan.pdf.
10. U.S. EPA. (2018). Open Government Plan 5.0. Washington, DC: U.S. 
Environmental Protection Agency. Available at https://www.epa.gov/sites/production/files/2018-10/documents/epaopengovplanversion5_0final.pdf.
11. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
10-06, Open Government Directive (December 8, 2009), available at 
https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2010/m10-06.pdf.
12. Office of Science and Technology Policy. (2013). Memorandum for 
the Heads of Executive Departments and Agencies: Increasing Access 
to the Results of Federally Funded Scientific Research. Available at 
https://www.epa.gov/sites/production/files/2015-01/documents/ostp_memo_increasing_public_access.pdf.
13. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
19-23, Phase 1 Implementation of the Foundations for Evidence-Based 
Policymaking Act of 2018--Learning Agendas, Personnel, and Planning 
Guidance (July 10, 2019), available at https://www.whitehouse.gov/wp-content/uploads/2019/07/M-19-23.pdf.
14. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
20-12, Phase 4 Implementation of the Foundations for Evidence-Based 
Policymaking Act of 2018--Program Evaluation Standards and Practices 
(March 10, 2020), available at https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-12.pdf.
15. McNutt, M. (2016). Taking up TOP. Science 352, 1147. Available 
at https://doi.org/10.1126/science.aag2359.
16. NAS (National Academies of Sciences, Engineering, and Medicine). 
(2019). Reproducibility and replicability in science. Washington, 
DC: The National Academies Press. Available at https://www.nationalacademies.org/our-work/reproducibility-and-replicability-in-science.
17. Nosek, B.A. et al. (2015). Promoting an open research culture. 
Science 348, 1422-1425. Available at https://doi.org/10.1126/science.aab2374.
18. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
19-15, Improving Implementation of the Information Quality Act 
(April 24, 2019), available at https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-15.pdf.
19. Calabrese, E.J. (2019). EPA transparency proposal: Testimony of 
Edward J. Calabrese, Ph.D., October 3, 2018. J Cell Commun Signal. 
13(1): 145-147. https://doi.org/10.1007%2Fs12079-018-0497-8.
20. Perrone, J. (2014). Secrets are no fun. The Hill. Available at 
https://thehill.com/blogs/congress-blog/energy-environment/224583-secrets-are-no-fun.
21. U.S. Congress. (2010). Current Science on Public Exposures to 
Toxic Chemicals: Hearing before the Subcommittee on Superfund, 
Toxics and Environmental Health of the Committee on Environment and 
Public Works, 111th Congress. Available at https://www.govinfo.gov/content/pkg/CHRG-111shrg21160/html/CHRG-111shrg21160.htm.
22. U.S. Congress. (2010). Letter to EPA Administrator Jackson. 
Available at https://assets.documentcloud.org/documents/1202768/letter-from-congress-to-lisa-jackson-on-arsenic.pdf.
23. U.S. Congress. (2011). EPA's IRIS Program: Evaluating the 
Science and Process Behind Chemical Risk Assessment: Hearing before 
the Subcomm. on Oversight & Investigations of the H. Comm. on 
Science, Space, & Technology, 112th Cong. Available at https://www.govinfo.gov/content/pkg/CHRG-112hhrg67255/html/CHRG-112hhrg67255.htm.
24. McNutt, M. (2014). Journals unite for reproducibility. Science 
346(6210): 679. Available at https://doi.org/10.1126/science.aaa1724.
25. Munaf[ograve], M.R. et al. (2017). A manifesto for reproducible 
science. Nature Human Behaviour 1(0021). Available at https://doi.org/10.1038/s41562-016-0021.
26. NAS (National Academies of Sciences, Engineering, and Medicine). 
(2016). Principles and obstacles for sharing data from environmental 
health research: Workshop summary. Washington, DC: The National 
Academies Press. Available at https://doi.org/10.17226/21703.
27. U.S. EPA's Science Advisory Board. (2020). Science Advisory 
Board Consideration of the Scientific and Technical Basis of EPA's 
Proposed Rule Titled ``Strengthening Transparency in Regulatory 
Science.'' EPA-SAB-20-005. Available at https://yosemite.epa.gov/
sab/sabproduct.nsf/LookupWebProjectsCurrentBOARD/
2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf.
28. Alsheikh-Ali, A.A., Qureshi, W., Al-Mallah, M.H., and Ioannidis, 
J.P. (2011). Public availability of published research data in high-
impact journals. PloS ONE 6, e24357. Available at https://doi.org/10.1371/journal.pone.0024357.
29. Iqbal, S.A., Wallach, J.D., Khoury, M.J., Schully, S.D., and 
Ioannidis, J.P. (2016). Reproducible research practices and 
transparency across the biomedical literature. PLoS Biol. 14, 
e1002333. Available at https://doi.org/10.1371/journal.pbio.1002333.
30. Peterson, E.D. and Rockhold, F.W. (2018). Finding means to 
fulfill the societal and academic imperative for open data access 
and sharing. JAMA Cardiology. Available at https://doi.org/10.1001/jamacardio.2018.0129.
31. Wicherts, J.M., Borsboom, D., Kats, J. and Molenaar, D. (2006). 
The poor availability of psychological research data for reanalysis. 
Am. Psychol. 61, 726-728. Available at https://doi.org/10.1037/0003-066x.61.7.726.
32. Christensen, G., Dafoe, A., Miguel, E., Moore, D.A., and Rose, 
A.K. (2019). A study of the impact of data sharing on article 
citations using journal policies as a natural experiment. PLoS ONE 
14(12): e0225883. Available at https://doi.org/10.1371/journal.pone.0225883.
33. Vasilevsky, N.A. et al. (2017). Reproducible and reusable 
research: Are journal data sharing policies meeting the mark? PeerJ 
5:e3208. Available at https://doi.org/10.7717/peerj.3208.
34. Stodden V., Seiler J., and Ma Z. (2018). An empirical analysis 
of journal policy effectiveness for computational reproducibility. 
PNAS 115(11): 2584-2589. Available at https://doi.org/10.1073/pnas.1708290115.
35. U.S. EPA. (2002). Guidelines for Ensuring and Maximizing the 
Quality, Objectivity, Utility, and Integrity of Information 
Disseminated by the Environmental Protection Agency. (EPA/260R-02-
008). Washington, DC: U.S. Environmental Protection Agency. 
Available at https://www.epa.gov/sites/production/files/2020-02/documents/epa-info-quality-guidelines_pdf_version.pdf.
36. U.S. EPA. (2014). Framework for Human Health Risk Assessment to 
Inform Decision Making. (EPA/100/R-14/001). Washington, DC: U.S. 
Environmental Protection Agency, Office of the Science Advisor, Risk 
Assessment Forum. Available at https://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf.
37. U.S. EPA. (2003). A Summary of General Assessment Factors for 
Evaluating the Quality of Scientific and Technical Information. (EPA 
100/B-03/001). Washington, DC: U.S. Environmental Protection Agency. 
Available at https://www.epa.gov/sites/production/files/2015-01/documents/assess2.pdf.
38. Lewandowsky, S. and Oberauer, K. (2020). Low replicability can 
support robust and efficient science. Nat Commun 11, 358. https://doi.org/10.1038/s41467-019-14203-0.
39. Mueller-Langer, F., Fecher, B., Harhoff, D., and Wagner, G.G. 
(2019). Replication studies in economics--How many and which papers 
are chosen for replication, and why? Research Policy 48: 62-83. 
Available at https://doi.org/10.1016/j.respol.2018.07.019.

[[Page 491]]

40. Field, S.M. et al. (2019). When and Why to Replicate: As Easy as 
1, 2, 3? Collabra: Psychology, 5(1): 46. Available at https://doi.org/10.1525/collabra.218.
41. Hardwicke, T., Tessler, M., Peloquin, B., and Frank, M. (2018). 
A Bayesian decision-making framework for replication. Behavioral and 
Brain Sciences, 41, E132. Available at https://doi.org/10.1017/s0140525x18000675.
42. U.S. EPA. (2020). Freedom of Information Act Annual Report 
Fiscal Year 2019. Washington, DC: U.S. Environmental Protection 
Agency. Available at https://www.epa.gov/foia/epa-foia-annual-report-2019.
43. FDA (Food and Drug Administration). (2011). Advancing Regulatory 
Science at FDA. Available at https://www.fda.gov/science-research/advancing-regulatory-science/strategic-plan-regulatory-science.
44. U.S. EPA. (2015). Peer Review Handbook, 4th Edition. (EPA/100/B-
15/001). Washington, DC: U.S. Environmental Protection Agency. 
Available at https://www.epa.gov/sites/production/files/2020-08/documents/epa_peer_review_handbook_4th_edition.pdf.

V. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review. Any changes 
made in response to OMB recommendations have been documented in the 
docket. The EPA does not anticipate that this rulemaking will have an 
economic impact on regulated entities.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is not subject to Executive Order 13771 because this 
final rule is a rulemaking of agency organization, procedure, or 
practice.

C. Paperwork Reduction Act (PRA)

    This action does not contain any information collection activities 
and therefore does not impose an information collection burden under 
the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. This 
action will not impose any requirements on small entities. This action 
does not regulate any entity outside the Federal Government.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the states, on the relationship between 
the National Government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this action.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive order. This action is not subject to 
Executive Order 13045 because it does not concern an environmental 
health risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' within the 
meaning of Executive Order 13211. It is not likely to have a 
significant adverse effect on the supply, distribution or use of 
energy, and it has not otherwise been designated as a significant 
energy action by the Administrator of the Office of Information and 
Regulatory Affairs (OIRA).

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order 
12898 (59 FR 7629, February 16, 1994) because it does not establish an 
environmental health or safety standard.

L. Congressional Review Act (CRA)

    This rule is exempt from the CRA because it is a rule of agency 
organization, procedure or practice that does not substantially affect 
the rights or obligations of non-agency parties.

List of Subjects in 40 CFR Part 30

    Environmental protection, Administrative practice and procedure, 
Reporting and recordkeeping requirements.

Andrew Wheeler,
Administrator.

0
For the reasons set forth in the preamble, the EPA is adding 40 CFR 
part 30 to read as follows:

PART 30--TRANSPARENCY IN SIGNIFICANT REGULATORY ACTIONS AND 
INFLUENTIAL SCIENTIFIC INFORMATION

Sec.
30.1 What is the purpose of this part?
30.2 What definitions apply to this part?
30.3 How do the provisions of this part apply?
30.4 What requirements apply to the EPA's use of studies in 
significant regulatory actions?
30.5 What requirements apply to the EPA's use of dose-response data 
underlying pivotal science?
30.6 What role does independent peer review have in this part?
30.7 May the EPA Administrator grant exemptions to this part?

    Authority: 5 U.S.C. App.; Pub. L. 98-80, 84 Stat. 2086.

Sec.  30.1  What is the purpose of this part?

    This part directs the EPA to give greater consideration to pivotal 
science when the underlying dose-response data are available in a 
manner sufficient for independent validation.

Sec.  30.2  What definitions apply to this part?

    For the purposes of this part:
    Data means the set of recorded factual material commonly accepted 
in the scientific community as necessary to validate research findings 
in which obvious errors, such as keystroke or coding errors, have been 
removed and that is capable of being analyzed by either the original 
researcher or an independent party.

[[Page 492]]

    Dose-response data means the data used to characterize the 
quantitative relationship between the amount of dose or exposure to a 
pollutant, contaminant, or substance and an effect.
    Independent validation means the reanalysis of study dose-response 
data by subject matter experts who have not contributed to the 
development of the study to evaluate whether results similar to those 
reported in the study are produced.
    Influential scientific information means scientific information the 
Agency reasonably can determine will have or does have a clear and 
substantial impact on important public policies or private sector 
decisions.
    Pivotal science means the specific dose-response studies or 
analyses that drive the requirements or quantitative analyses of EPA 
significant regulatory actions or influential scientific information.
    Publicly available means lawfully available to the general public 
from Federal, state, or local government records; the internet; widely 
distributed media; or disclosures to the general public that are 
required to be made by Federal, state, or local law. The public must be 
able to access the information on the date of publication of the 
proposed rule (or, as appropriate, a supplemental notice of proposed 
rulemaking, or notice of availability) for the significant regulatory 
action or on the date of dissemination of the draft influential 
scientific information for public review and comment.
    Reanalyze means to analyze exactly the same dose-response data to 
determine whether a similar result emerges from the analysis by using 
the same methods, statistical software, models, or statistical 
methodologies that were used to analyze the dose-response data, as well 
as to assess potential analytical errors and variability in the 
underlying assumptions of the original analysis.
    Science that serves as the basis for informing a significant 
regulatory action means studies, analyses, models, and assessments of a 
body of evidence that provide the basis for EPA significant regulatory 
actions.
    Significant regulatory actions means final regulations determined 
to be ``significant regulatory actions'' by the Office of Management 
and Budget pursuant to Executive Order 12866.

Sec.  30.3  How do the provisions of this part apply?

    (a) The provisions of this part apply to science that serves as the 
basis for informing a significant regulatory action or influential 
scientific information, as well as to dose-response data underlying 
pivotal science, regardless of the source of funding or identity of the 
party conducting the science. The provisions of this part apply to 
significant regulatory actions for which a proposed rule was published 
in the Federal Register after January 6, 2021 and influential 
scientific information submitted for peer review after January 6, 2021.
    (b) The provisions of this part do not apply to physical objects 
(like laboratory samples), drafts, and preliminary analyses, and 
influential scientific information or pivotal science that meet one or 
more of the exemptions identified in Section IX of the OMB Final 
Information Quality Bulletin for Peer Review. In the event the 
procedures outlined in this part conflict with statutes the EPA 
administers, or their implementing regulations, the statutes and 
regulations will control. Except where explicitly stated otherwise, the 
provisions of this part do not apply to any other type of Agency 
action, including individual party adjudications, enforcement 
activities, site-specific actions, or permit proceedings.

Sec.  30.4  What requirements apply to the EPA's use of studies in 
significant regulatory actions?

    The EPA shall clearly identify the science that serves as the basis 
for informing a significant regulatory action. The EPA shall make all 
such science that serves as the basis for informing a significant 
regulatory action publicly available to the extent permitted by law.

Sec.  30.5  What requirements apply to the EPA's use of dose-response 
data underlying pivotal science?

    (a) When promulgating a significant regulatory action or developing 
influential scientific information that relies on dose-response data, 
the Agency shall follow best practices to evaluate potential links 
between exposure to a pollutant, contaminant, or substance and the 
effect and the nature of the dose-response relationship.
    (b) The EPA will use the following factors to assess the quality of 
studies identified in the systematic review: soundness, applicability 
and utility, clarity and completeness, uncertainty and variability, and 
evaluation and review. The EPA will rely on the highest quality, most 
relevant studies in determining the potential for hazard due to 
exposure to a pollutant, contaminant, or substance. Where there is 
convincing and well-substantiated evidence of a relationship between 
exposure and effect, the EPA will identify those studies based on the 
exposure situation being addressed, the quality of the studies, the 
reporting adequacy, and the relevance of the endpoints that would 
inform a dose-response assessment for those effect endpoints. From the 
subset in the preceding sentence, the specific dose-response studies or 
analyses that drive the requirements, quantitative analyses, or both of 
an EPA significant regulatory action or influential scientific 
information will be identified as pivotal science.
    (c) The EPA shall give greater consideration to pivotal science 
where the underlying dose-response data are publicly available in a 
manner sufficient for independent validation. The Agency shall also 
give greater consideration to pivotal science based on dose-response 
data that include confidential business information, proprietary 
information or personally identifiable information if these data are 
available through restricted access in a manner sufficient for 
independent validation. For pivotal science where there is no access to 
dose-response data, or access is limited, the Agency may still consider 
these studies but will give them lesser consideration unless the 
Administrator grants an exemption under Sec.  30.7. The Agency will 
identify the pivotal science that was given lesser consideration and 
provide a short description of why lesser consideration was given.
    (d) In determining the degree of consideration to afford pivotal 
science for which the dose-response data are not available for 
independent validation, the EPA shall consider the following factors 
and any other relevant factors, as applicable:
    (1) The quality of the study relative to other studies for which 
the dose-response data are available;
    (2) The extent to which there are other studies for which the dose-
response data are available;
    (3) The sensitivity of the conclusions in the significant 
regulatory action or influential scientific information based on the 
use of the study;
    (4) The extent to which the study is fit for the purpose or 
intended use relative to other pivotal science for which the dose-
response data are available;
    (5) The use of exposures or doses in a range and duration that is 
relevant for the intended use and that minimizes the need for 
extrapolations;
    (6) The extent to which the study is supported by other scientific 
evidence;
    (7) The extent to which the study accounted for unique scientific 
considerations;

[[Page 493]]

    (8) The extent to which the study minimizes the use of defaults and 
assumptions, uses appropriate and strong statistical methods, and 
includes a robust representation of uncertainty and confidence 
intervals; and
    (9) The study's consideration of a broad range of parametric dose-
response or concentration-response models, a robust set of potential 
confounding variables, nonparametric models that incorporate fewer 
assumptions, various threshold models across the dose or exposure 
range, and models that investigate factors that might account for 
spatial heterogeneity.
    (e) The EPA shall also describe critical assumptions and methods 
used in its dose-response assessment and shall characterize the 
variability and uncertainty of the assessment. The EPA shall evaluate 
the appropriateness of using default assumptions on a case-by-case 
basis. The EPA shall clearly explain the scientific basis for critical 
assumptions used in the dose-response assessment that the EPA relied on 
for the significant regulatory action or influential scientific 
information.
    (f) Where the Agency is making dose-response data publicly 
available, it shall do so in a fashion that is consistent with law, 
protects privacy, confidentiality, confidential business information, 
and is sensitive to national security. Dose-response data is considered 
``publicly available in a manner sufficient for independent 
validation'' when it includes the information necessary for the public 
to understand, assess, and reanalyze findings and may include, for 
example:
    (1) Data (data would be made available subject to access and use 
restrictions);
    (2) Associated protocols necessary to understand, assess, and 
extend conclusions;
    (3) Computer codes and models involved in the creation and analysis 
of such information;
    (4) Recorded factual materials; and
    (5) Detailed descriptions of how to access and use such 
information.
    (g) The provisions of this section apply to dose-response data 
underlying studies that are pivotal science, regardless of who funded 
or conducted the studies. The Agency shall make all reasonable efforts 
to explore methodologies, technologies, and institutional arrangements 
for making such data available before it concludes that doing so in a 
manner consistent with law and protection of privacy, confidentiality, 
national security is not possible.

Sec.  30.6  What role does independent peer review have in this part?

    The EPA shall conduct independent peer review consistent with the 
requirements of the OMB Final Information Quality Bulletin for Peer 
Review and the exemptions described therein. The EPA will evaluate 
whether or not to conduct additional peer review of individual studies 
identified as pivotal science if the studies have already undergone 
journal peer review. Because transparency in pivotal science includes 
addressing issues associated with assumptions used in analyzing dose-
response data, the EPA shall ask peer reviewers to articulate the 
strengths and weaknesses of the justification for the assumptions 
applied and the implications of those assumptions for the results.

Sec.  30.7  May the EPA Administrator grant exemptions to this part?

    (a) The Administrator may grant an exemption to this part for a 
study on a case-by-case basis if he or she determines that greater 
consideration is warranted because:
    (1) Technological or other barriers render sharing of the dose-
response data infeasible;
    (2) The development of the dose-response data was completed or 
updated before January 6, 2021;
    (3) Making the dose-response data available would conflict with 
laws and regulations governing privacy, confidentiality, confidential 
business information, or national security;
    (4) A third-party has conducted independent validation of the 
study's underlying dose-response data through reanalysis; or
    (5) The factors used in determining the consideration to afford to 
the pivotal science indicate full consideration is justified.
    (b) When making a decision to grant an exemption, the Administrator 
may consider input from EPA staff and public commenters. The EPA shall 
document the rationale for exemptions granted by the Administrator in 
the significant regulatory action or influential scientific 
information.

[FR Doc. 2020-29179 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P