[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 469-493]
[FR Doc No: 2020-29179]

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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.

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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-

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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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.
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    \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.
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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

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

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.
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    \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.
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    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

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

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

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

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

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

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

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-

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

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

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

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

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

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

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