[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Proposed Rules]
[Pages 15396-15406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05012]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 30

[EPA-HQ-OA-2018-0259; FRL-10004-72-ORD]
RIN 2080-AA14


Strengthening Transparency in Regulatory Science

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: This supplemental notice of proposed rulemaking (SNPRM) 
includes clarifications, modifications and additions to certain 
provisions in the Strengthening Transparency in Regulatory Science 
Proposed

[[Page 15397]]

Rulemaking (``2018 proposed rulemaking,'' Ref. 1), published on April 
30, 2018. This SNPRM proposes that the scope of the rulemaking apply to 
influential scientific information as well as significant regulatory 
decisions. This notice proposes definitions and clarifies that the 
proposed rulemaking applies to data and models underlying both pivotal 
science and pivotal regulatory science. In this SNPRM, EPA is also 
proposing a modified approach to the public availability provisions for 
data and models that would underly significant regulatory decisions and 
an alternate approach. Finally, EPA is taking comment on whether to use 
its housekeeping authority independently or in conjunction with 
appropriate environmental statutory provisions as authority for taking 
this action.

DATES: Comments must be received on or before April 17, 2020.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OA-2018-0259, by any of the following methods:
    Federal eRulemaking Portal: https://www.regulations.gov/ (our 
preferred method). Follow the online instructions for submitting 
comments.
    Mail: U.S. Environmental Protection Agency, EPA Docket Center, 
Office of Research and Development Docket, Mail Code 28221T, 1200 
Pennsylvania Avenue NW, Washington, DC 20460.
    Hand Delivery/Courier: EPA Docket Center, WJC West Building, Room 
3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket 
Center's hours of operations are 8:30 a.m.--4:30 p.m., Monday--Friday 
(except Federal Holidays).
    Instructions: All submissions received must include the Docket ID 
No. for this rulemaking. Comments received may be posted without change 
to https://www.regulations.gov/, including any personal information 
provided.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Hawkins, Office of Science 
Advisor, Policy and Engagement (8104R), Environmental Protection 
Agency, 1200 Pennsylvania Ave NW, Washington, DC 20460; telephone 
number: (202) 564-7307; email address: osp_staff@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    This SNPRM does not regulate any entity outside the Federal 
Government. Rather, the proposed requirements would modify the EPA's 
internal procedures regarding the transparency of science underlying 
regulatory decisions. However, the Agency recognizes that any entity 
interested in EPA's regulations may be interested in this proposal. For 
example, this proposal may be of particular interest to entities that 
conduct research or another scientific activity that is likely to be 
relevant to EPA's regulatory activity.

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

    On April 30, 2018, in the Federal Register at 83 FR 18768 EPA 
published the Strengthening Transparency in Regulatory Science Proposed 
Rulemaking (``2018 proposed rulemaking,'' Ref. 1). The 2018 proposed 
rulemaking cites as authority several environmental statutes that EPA 
administers: The Clean Air Act; the Clean Water Act; the Safe Drinking 
Water Act; the Resource Conservation and Recovery Act; the 
Comprehensive Environmental Response, Compensation, and Liability Act; 
the Federal Insecticide, Fungicide, and Rodenticide Act; the Emergency 
Planning and Community Right-To-Know Act and the Toxic Substances 
Control Act. Subsequently, in the Federal Register at 83 FR 24255, May 
25, 2018, EPA published a document extending the comment period and 
announcing a public hearing on the 2018 proposed rulemaking to be held 
on July 18, 2018 (Ref. 2). That document identified 5 U.S.C. 301 as a 
source of authority in addition to those statutes cited in the 2018 
proposed rulemaking. With respect to the authorities cited in the 2018 
proposal, EPA is clarifying that the citation to the Resource 
Conservation and Recovery Act (``RCRA'') section 7009, 42 U.S.C. 6979, 
should be to RCRA section 8001, 42 U.S.C. 6981; the citation to the 
Comprehensive Environmental Response, Compensation, and Liability Act 
(``CERCLA'') section 116, 42 U.S.C. 9616, should be to CERCLA section 
115, 42 U.S.C. 9615; and including the Clean Water Act section 501, 33 
U.S.C. 1361.
    EPA is authorized to promulgate this regulation under its 
housekeeping authority. The Federal Housekeeping Statute 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.'' 5 U.S.C. 301. 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.'' \1\ As the Supreme Court further notes, section 301 
authorizes ``what the [Administrative Procedure Act] terms `rules of 
agency organization, procedure or practice' as opposed to substantive 
rules.'' \2\
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    \1\ Chrysler Corp. v. Brown, 441 U.S. 281, 309 (1979).
    \2\ Id. at 310.
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    EPA is not one of the 15 ``Executive Departments'' listed at 5 
U.S.C. 101. However, EPA gained housekeeping authority through the 
Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970). The 
Reorganization Plan created EPA, established the Administrator as 
``head of the agency'' and transferred functions and authorities of 
various agencies and Executive departments to EPA.
    Section 2(a)(1)-(8) of the Reorganization Plan transferred to EPA 
functions previously vested in several agencies and executive 
departments including the Departments of 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.''
    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.'' \3\
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    \3\ 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 considered EPA to be an agency with section 301 
housekeeping authority. The U.S. Court of Appeals for the Second 
Circuit, in EPA v. General Elec. Co., 197 F.3d 592, 595 (2d 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 Fourth Circuit Court of Appeals, in Boron Oil Co. v. 
Downie, 873 F.2d 67, 69 (4th Cir. 1989), held that the district court 
exceeded its jurisdiction where it compelled testimony contrary to duly 
promulgated EPA regulations which EPA argued were authorized by section 
301.
    EPA's housekeeping authority was established by the Reorganization 
Plan.

[[Page 15398]]

As indicated by the case law and the OLC Opinion, it has long been 
recognized that EPA has been granted full section 301 or equivalent 
authority. Therefore, EPA has ample authority to promulgate regulations 
that govern internal agency procedures.
    The 2018 proposed rulemaking, as supplemented by this SNPRM and 
this accompanying preamble, describes how EPA will handle studies when 
data and models underlying science that is pivotal to EPA's significant 
regulatory decisions or influential scientific information are or are 
not publicly available in a manner sufficient for independent 
validation and analysis. The rule would not regulate the conduct or 
determine the rights of any entity outside the federal government.\4\ 
Rather, it exclusively pertains to the internal practices of the EPA.
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    \4\ See also United States v. Manafort, 312 F. Supp. 3d 60, 75 
(D.D.C. 2018) (explaining that the Department of Justice ``was not 
at all ambiguous about what it was doing when it promulgated the 
Special Counsel Regulations [under the authority of 5 U.S.C. 301], 
and it emphasized that it was not creating a substantive rule.'').
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    Finally, EPA in the 2018 proposed rulemaking, as supplemented by 
this SNPRM and this accompanying preamble, does not propose to 
interpret provisions of a particular statute or statutes that it 
administers. Instead, in this action, EPA proposes a rule of agency 
procedure to establish an agency wide approach to handling studies when 
the data and models underlying EPA's significant regulatory decisions 
and influential scientific information are publicly available and when 
those data and models are not publicly available. Therefore, this is a 
proposed internal rule of agency procedure.
    This internal agency procedure is intended to be consistent with 
the statutes that EPA administers and EPA plans to implement this 
procedural rulemaking in accordance with all applicable statutory and 
regulatory requirements. Indeed, as discussed in this SNPRM, EPA is 
also proposing options that would allow EPA to consider studies even if 
the underlying data and models are not publicly available. [See Section 
IV.] The Agency seeks comment on whether this approach may improve 
consistency between this proposed rulemaking and certain provisions of 
those statutes that refer to standards for data availability. 
Nonetheless, in the event the procedures outlined in the proposed 
rulemaking conflict with the statutes that EPA administers, or their 
implementing regulations, the statutes and regulations will control. 
Moreover, EPA is considering how to proceed, apart from this 
supplemental proposal, to establish regulations interpreting provisions 
of, and/or exercising substantive rulemaking authority delegated to it 
by programmatic statutes, to include one or more of those statutes 
cited as authority in the 2018 proposed rulemaking as clarified in this 
SNPRM.
    Although this is a rule of internal agency procedure and EPA does 
not propose to interpret provisions of a particular statute or statutes 
that it administers, EPA is taking comment on whether to use its 
housekeeping authority independently as authority or in conjunction 
with the environmental statutory provisions cited as authority in the 
2018 proposed rulemaking (as clarified in this SNPRM). The Agency 
continues to consider whether it is appropriate to rely on its 
authority in the above-reference environmental statutory provisions 
(potentially in conjunction with its housekeeping authority). The 
Agency will consider comments on this issue submitted in response to 
the 2018 proposal and in response to this SNPRM.

C. What action is the Agency taking?

    EPA is issuing this SNPRM to clarify, modify and supplement certain 
provisions included in the 2018 proposed rulemaking in response to some 
of the public comments received on the 2018 proposed rulemaking (83 FR 
18768), as well as to ensure consistency with the April 2019 release of 
the White House's Office of Management and Budget (OMB) Memorandum to 
the Heads of Executive Departments and Agencies entitled Implementation 
of the Information Quality Act (OMB M-19-15, Ref. 3). This memorandum 
is directly relevant to several of the provisions of the 2018 proposed 
rulemaking because it updates implementation of OMB's 2002 Guidelines 
for Ensuring and Maximizing the Quality, Objectivity, Utility, and 
Integrity of Information Disseminated by Federal Agencies to, among 
other things, reflect recent innovations and policies surrounding 
information access.
    First, EPA is modifying the regulatory text initially proposed in 
the 2018 proposed rulemaking at 40 CFR 30.3, 30.5, 30.6 and 30.9 so 
that these provisions would apply to data and models, not only dose-
response data and dose-response models. In addition, EPA is clarifying 
that the use of the terms ``model assumptions'' and ``models'' in the 
proposed regulatory text at 40 CFR 30.6 apply to the assumptions that 
drive the model's analytic results. EPA has modified the regulatory 
text at 40 CFR 30.6 to reflect this clarification. This approach is 
consistent with OMB M-19-15 (Ref. 3), which highlights the need to 
characterize the sensitivity of an agency's conclusions to analytic 
assumptions.
    Second, EPA is proposing to expand the scope of this rulemaking to 
apply to influential scientific information 5 6 as well as 
significant regulatory actions. EPA is proposing to add definitions for 
``influential scientific information'' and ``pivotal science'' at 40 
CFR 30.2 that will pertain to the science underlying influential 
scientific information, which are not regulatory, and is making 
conforming changes to proposed 40 CFR 30.3, 30.5, 30.6 and 30.7. EPA is 
retaining the definition of ``pivotal regulatory science'' from the 
2018 proposed rulemaking regulatory text.
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    \5\ The term ``influential scientific information'' means 
scientific information the agency reasonably can determine will have 
or does have a clear and substantial impact on important public 
policies or private sector decisions (OMB M-05-03). A ``highly 
influential scientific assessment'' is a subset of influential 
scientific information and refers to ``an evaluation of a body of 
scientific or technical knowledge that typically synthesizes 
multiple factual inputs, data, models, assumptions, and/or applies 
best professional judgment to bridge uncertainties in the available 
information'' and that the dissemination of such assessment could 
have ``a potential impact of more than $500 million in any one year 
on either the public or private sector or that the dissemination is 
novel, controversial, or precedent-setting, or has significant 
interagency interest'' (OMB M-05-03).
    \6\ See EPA's Peer Review Agenda at https://cfpub.epa.gov/si/si_public_pr_agenda.cfm.
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    Third, EPA is modifying, deleting and proposing new regulatory text 
in addition to proposing definitions for ``influential scientific 
information'' and ``pivotal science'' at proposed 40 CFR 30.2. EPA is 
deleting the first paragraph of the 2018 proposed rulemaking regulatory 
text at 40 CFR 30.2. EPA is deleting the definition of ``research 
data'' at 40 CFR 30.2. EPA is proposing definitions for the terms 
``Capable of being substantially reproduced'', ``Data'', ``Independent 
validation'', ``Influential scientific information,'' ``Model'', 
``Pivotal science'', ``Publicly available'' and ``Reanalyze.'' These 
revisions are intended to provide clarity on key terminology used in 
the regulatory text in the 2018 proposed rulemaking as well as in this 
supplemental proposal.
    Fourth, EPA is deleting the 2018 proposed regulatory text at 40 CFR 
30.10. This change is being made to be consistent with the deletion of 
``research data'' in 40 CFR 30.2 because 40 CFR 30.10 would have 
required EPA to implement this rulemaking to be consistent with the 
definition of ``research data.'' With the deletion of

[[Page 15399]]

``research data'' from proposed 40 CFR 30.2, proposed 40 CFR 30.10 is 
no longer needed.
    Fifth, EPA is proposing a modified version of the regulatory text 
at 40 CFR 30.5 from that proposed in the 2018 proposed rulemaking. 
Under this new approach to proposed 40 CFR 30.5, when promulgating 
significant regulatory decisions or finalizing influential scientific 
information, the Agency will only use pivotal regulatory science and/or 
pivotal science if the data and models are available in a manner 
sufficient for independent validation. This includes studies with data 
and models that are publicly available as well as studies with 
restricted data and models (i.e., those that include confidential 
business information (CBI), proprietary data, or Personally 
Identifiable Information (PII) that cannot be sufficiently de-
identified to protect the data subjects) if there is tiered access to 
these data and models in a manner sufficient for independent 
validation. Tiered access includes the appropriate techniques used to 
reduce the risk of re-identification and, therefore, mitigate certain 
disclosure privacy risks associated with providing such access.
    As an alternative, EPA is proposing that under proposed 40 CFR 
30.5, when promulgating significant regulatory decisions or finalizing 
influential scientific information, other things being equal, the 
Agency will give greater consideration to studies where the underlying 
data and models are available in a manner sufficient for independent 
validation either because they are publicly available or because they 
are available through tiered access when the data includes CBI, 
proprietary data, or PII that cannot be sufficiently de-identified to 
protect the data subjects. The Agency will identify those studies that 
are given greater consideration and will provide a short description of 
why greater consideration was given. As discussed later in the 
preamble, such approaches to increasing access to data and models can 
often allow stakeholders to reanalyze the data and models and explore 
the sensitivity of the conclusions to alternative assumptions while 
accessing only the data and aspects of the models that they need. This 
proposal would apply to reviews of data, models, and studies at the 
time a rule is developed or influential scientific information is 
finalized, regardless of when the data and models were generated. See 
Section IV of this preamble for a description of these proposals.
    Sixth, EPA is modifying 40 CFR 30.9 to describe the factors the 
Administrator would consider in determining whether to grant an 
exemption to the proposed public availability requirements for using 
data and models in significant regulatory decisions and influential 
scientific information.
    Seventh, the EPA is proposing the option of using its housekeeping 
authority independently as authority for taking this action or in 
conjunction with the environmental statutory provisions cited as 
authority in the 2018 proposed rulemaking (as clarified in this 
supplemental proposal). The Agency continues to consider whether it is 
appropriate to rely on its authority in the above-referenced 
environmental statutory provisions (potentially in conjunction with its 
housekeeping authority). The Agency will consider comments on this 
issue submitted in response to the 2018 proposal and in response to 
this SNPRM. Section 301 authority as transferred to EPA in 
Reorganization Plan No. 3 of 1970 provides appropriate authority for 
EPA to promulgate regulations that govern internal agency procedures. 
This action establishes internal agency procedures governing how EPA 
employees will handle studies when the data and models underlying 
science that is pivotal to EPA's significant regulatory decisions and/
or influential scientific information are or are not publicly 
available.
    The 2018 proposed rulemaking solicited comment on all aspects of 
the proposed rulemaking. This SNPRM solicits comment only on the 
changes and additions to the proposed regulatory text discussed in this 
supplemental document. Comments submitted in response to this 
supplemental document that address aspects of the 2018 proposed 
rulemaking that are not addressed, altered, or replaced by this SNPRM 
will be deemed outside the scope of this supplemental action.

D. Why is the Agency taking this action?

    EPA received extensive comment on the 2018 proposed rulemaking 
regarding the clarity of certain aspects of the proposed rulemaking and 
the challenges in making all dose-response data and models publicly 
available. The intent of this supplemental proposal SNPRM is to address 
certain concerns raised about the clarity of the 2018 proposed 
rulemaking; to clarify consistency with OMB M-19-15, OMB M-05-03 (Final 
Information Quality Bulletin for Peer-Review, Ref. 4), and Executive 
Order 13891 (Ref. 5); to propose an alternate 40 CFR 30.5 provision for 
availability of data and models underlying pivotal regulatory science 
and pivotal science, and to propose relying on 5 U.S.C. 301 
independently or in conjunction with the environmental statutory 
provisions cited as authority in the 2018 proposed rulemaking (as 
clarified in this SNPRM). The Agency continues to consider whether it 
is appropriate to rely on its authority in the above-reference 
environmental statutory provisions (potentially in conjunction with its 
housekeeping authority). The Agency will consider comments on this 
issue submitted in response to the 2018 proposal rulemaking and in 
response to this SNPRM.

II. Applicability to Data and Models

    As identified by some public commenters, the 2018 proposed 
rulemaking did not put its discussion of increasing access to the data 
and models underlying pivotal regulatory science into the context of 
the broader approach that EPA uses to evaluate the entire body of 
scientific literature--that is, before it identifies candidates for 
``pivotal regulatory science.'' Under this 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. If, for example, 
multiple high-quality studies exist but only two studies have data and 
models that are available for independent validation and reanalysis, 
EPA would only include those two studies as pivotal regulatory science 
and/or pivotal science in accordance with the 2018 proposed rulemaking. 
However, under the alternative approach in this supplemental proposal, 
EPA would consider using all available high-quality studies but give 
greater consideration to those two studies with data available for 
independent validation.
    As highlighted in some public comments, the terms ``dose-response 
data and models,'' ``dose-response models,'' ``models'' and ``model 
assumptions'' are not used consistently throughout the regulatory text 
of the 2018 proposed rulemaking. For example, some parts of the 
regulatory text appear to limit applicability of certain provisions to 
only dose-response models.\7\ In others, the requirements would apply 
more broadly. EPA is now proposing a broader applicability. 
Transparency of EPA's science should not be limited to dose-response 
data and dose-response models, because other

[[Page 15400]]

types of data and models will also drive the requirements and/or 
quantitative analysis of EPA final significant regulatory decisions and 
influential scientific information.
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    \7\ See Sec.  30.6.
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    EPA is modifying the proposed regulatory text at 40 CFR 30.3, 30.5, 
30.6 and 30.9 by deleting the term ``dose-response,'' except in one 
instance. In proposed 40 CFR 30.6, EPA is not deleting ``dose 
response'' from the sentence specific to parametric dose-response 
models. EPA is also removing ``including assumptions of a linear, no-
threshold dose response'' from 40 CFR 30.6, because this could imply 
that the regulation is specific to those particular assumptions. This 
is not the intent of proposed 40 CFR 30.6.
    Consistent with this broader approach to transparency, the proposed 
requirements of this rule would apply broadly to data and models 
underlying pivotal regulatory science and pivotal science which support 
significant regulatory decisions and influential scientific 
information, respectively, rather than simply to dose-response data and 
models. Some, but not the only, examples of information that would be 
considered to be data and models, in addition to dose-response data and 
dose-response models, include environmental fate studies, 
bioaccumulation data, water-solubility studies, environmental fate 
models, engineering models, data on environmental releases, exposure 
estimates, quantitative structure activity relationship data, and 
environmental studies. The proposed definitions of ``data'' and 
``models'' are discussed more fully in Section III.B of this preamble.
    In addition, EPA is clarifying that the use of the terms ``model 
assumptions'' and ``models'' in the proposed regulatory text at 40 CFR 
30.6 apply to the assumptions that drive the model's analytic results, 
not to each model assumption used in the model. EPA has modified the 
regulatory text at 40 CFR 30.6 to reflect this clarification.
    EPA requests comment on the applicability of proposed 40 CFR 30.3, 
30.5, 30.6 and 30.9 to data and models.

III. Definitions

A. ``Reanalyze'' and ``Independent Validation''

    To improve the clarity of the proposed requirements, EPA is 
proposing definitions for certain terms.
    In the 2018 proposed rulemaking, EPA used the terms ``replicate'' 
and ``reproducible'' and related terms. ``Replicate'' is used in the 
proposed regulatory text at 40 CFR 30.5. That section reads, 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 . . .'' ``Replication'' and ``reproducibility'' are 
both used in the 2018 proposed rulemaking preamble though neither is 
defined. Neither ``reproducibility'' nor its cognates are used in the 
regulatory text. ``Replicate'' was used but not defined in the 
regulatory text and its meaning was not discussed in the preamble.
    Commenters contended that EPA was not clear about what it meant by 
the term ``replicate'' and that EPA appears to have conflated the term 
with ``reproducible.'' Commenters interpreted the term ``replicate'' in 
several different ways. For example, some commenters contended that EPA 
used the term ``replicate'' but actually meant ``reanalyze.'' EPA finds 
that these comments have merit and has determined that the intent of 
the term ``replicate'' should be clarified by establishing a regulatory 
definition.
    EPA has considered the definitions in the National Academy of 
Sciences (NAS) ``Principles and Obstacles for Sharing Data from 
Environmental Health Research.'' (Ref. 6, NAS Workshop Report), 
Pellizzari, et al. ``Reproducibility: A Primer on Semantics and 
Implications for Research'' (Ref. 7), and Goodman, et al. ``What does 
research reproducibility mean?'' (Ref. 8). As demonstrated by these 
documents, there are varying definitions and understandings of these 
terms in the scientific community. Several commenters pointed to the 
use of the terms in the NAS Workshop Report (Ref. 6). The definitions 
in the NAS Workshop Report (Ref. 6) define ``reanalysis,'' 
``replication,'' and ``reproduce'' as follows:

    A reanalysis is when you conduct a further analysis of data. A 
person doing a reanalysis of data may use the same programs and 
statistical methodologies that were originally used to analyze the 
data or may use alternative methodologies, but the point is to 
analyze exactly the same data to see if the same result emerges from 
the analysis.
    Replication means that you actually repeat a scientific 
experiment or a trial to obtain a consistent result. The second 
experiment uses exactly the same protocols and statistical programs 
but with different data from a different population. The goal is to 
see if the same results hold with data from a different population.
    When you reproduce, you are producing something that is very 
similar to that research, but it is in a different medium or 
context. In other words, a researcher who is reproducing an 
experiment addresses the same research question but from a different 
angle than the original researcher did.

    EPA's use of ``replicate'' in the proposed regulatory text at 40 
CFR 30.5 in the 2018 proposed rulemaking is generally consistent with 
the NAS Workshop Report (Ref. 6) definition of ``reanalysis.'' However, 
as illustrated by Refs. 4-6, and in the public comments EPA received on 
the 2018 proposed rulemaking, these terms are not consistently used or 
defined in the scientific literature. EPA now proposes to use the term 
``reanalyze'' instead of ``replicate'' in 40 CFR 30.5 and is clarifying 
the intent of the proposed regulation by proposing a definition of 
``reanalyze'' at proposed 40 CFR 30.2 as ``to analyze exactly the same 
data to see if the same result emerges from the analysis by using the 
same or different programs and statistical methodologies that were 
originally used to analyze the data.'' In addition to identifying 
potential analytical errors in the original work, reanalyzing the data 
would allow assessment of the robustness of the original analysis and 
conclusions by, for instance, showing the variability that can occur 
when a previously omitted variable is added to the statistical model, 
different functional form assumptions are made (e.g., a linear marginal 
effect of treatment), or different assumptions are made when estimating 
standard errors and drawing statistical inferences (e.g., allowing for 
spatial correlation in error terms).
    In the 2018 proposed rulemaking, EPA did not define ``independent 
validation.'' The definition of ``independent validation'' depends on 
how the term ``reanalyze'' is defined. Independent validation for a 
scientific study that is being repeated by conducting a second 
scientific study would be different than independent validation where 
the data underlying a study is being reanalyzed to determine if the 
same results can be obtained. Thus, consistent with the proposed 
definition of ``reanalyze'' at proposed 40 CFR 30.2, EPA is proposing 
to define ``independent validation'' as the reanalysis of study data by 
subject matter experts who have not contributed to the development of 
the original study to demonstrate that the same analytic results are 
capable of being substantially reproduced. ``Capable of being 
substantially reproduced'' means that independent analysis of the 
original or supporting data using identical methods would generate 
similar analytic results, subject to an acceptable degree of 
imprecision or error.
    EPA's interpretation of ``capable of being substantially 
reproduced'' as

[[Page 15401]]

included in the proposed definition above builds on the description in 
the ``Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal 
Agencies'' (Ref. 9). These guidelines, which were issued by the Office 
of Management and Budget, are intended to help agencies ensure and 
maximize the quality, utility, objectivity and integrity of the 
information that they disseminate.
    EPA is requesting comment on the proposed definitions of 
``reanalyze'' and ``independent validation'' at proposed 40 CFR 30.2.

B. Data and Models

    Given the use of the term ``data and models'' in proposed 40 CFR 
30.3, 30.5, 30.6 and 30.9 as described in Section II of this preamble, 
EPA is proposing to define ``data'' and ``models'' at proposed 40 CFR 
30.2. EPA proposes to broaden the scope of the proposal by deleting the 
modifying term ``dose-response,'' as indicated above, so as to extend 
the reference to data and models underlying pivotal regulatory science 
and pivotal science used to support significant regulatory decisions 
and influential scientific information, respectively, not simply dose-
response data and dose-response models. Examples of information that 
would be considered to be data and models for purposes of the proposed 
rulemaking include environmental fate studies, bioaccumulation data, 
water-solubility studies, environmental fate models, engineering 
models, data on environmental releases, exposure estimates, 
quantitative structure activity relationship data, and environmental 
studies. This list is not exhaustive but is intended to provide 
examples of the range of information that would be considered to be 
within the scope of data and models.
    1. Data and research data. Data has been defined to mean, in part, 
the recorded factual material commonly accepted in the scientific 
community as necessary to validate research findings (Ref. 10). As 
noted by public commenters and in the NAS Workshop Report (Ref. 6), 
there are different stages of these data. ``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. And 
there are the metadata that describe the data'' (Ref. 6). These 
different data sets or stages of data may be used for different 
purposes and in different contexts.
    The Agency received comment asking EPA to clarify what stage of 
data would need to be publicly available to allow for independent 
validation. Thus, EPA is incorporating the concept of stage of data 
with the basic concept of research data as ``recorded factual material 
commonly accepted in the scientific community as necessary to validate 
research findings'' from its definition at 2 CFR 200.315. For purposes 
of independent validation through reanalysis, the stage of data would 
be the cleaned-up or analyzable data set in which obvious errors have 
been removed. Obvious errors do not include data that could be 
characterized as outliers. These data are the cleaned-up or analyzable 
data set (Ref. 6). Therefore, EPA is proposing to define ``data'' as 
the set of recorded factual material commonly accepted in the 
scientific community as necessary to validate research findings in 
which obvious errors, such as keystroke or coding errors, have been 
removed and that is capable of being analyzed by either the original 
researcher or an independent party. EPA requests comment on this 
proposed definition and whether the definition of ``data'' should apply 
to another stage of data described in Ref. 6. The focus on this later 
stage of data is consistent with the Federal Government's approach to 
data access, and specifically to EPA's ``2016 Plan to Increase Access 
to Results of EPA-Funded Scientific Research'' (Ref. 11). Finally, EPA 
requests comment on whether there is another definition of ``data'' 
that should be considered.
    EPA is deleting the 2018 proposed 40 CFR 30.2 definition of 
``research data,'' because this definition excludes ``trade secrets, 
commercial information, materials necessary to be held confidential by 
a researcher until they are published, or similar information which is 
protected under law'' and ``[p]ersonnel and medical information and 
similar information the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy, such as information that 
could be used to identify a particular person in a research study.'' 
These types of data are intended to be subject to this rulemaking. To 
conform with this change, EPA is deleting the 2018 proposed 40 CFR 
30.10 regulatory text because it would require EPA implementation of 
this rulemaking to be consistent with the definition of ``research 
data.''
    2. Model. EPA is proposing to define ``model'' as it is defined in 
EPA's Guidance on the Development, Evaluation, and Application of 
Environmental Models (Ref. 12). EPA's guidance document was produced to 
aid in strengthening the Agency's development, evaluation and use of 
models. In this guidance document, a model is described as ``a 
simplification of reality that is constructed to gain insights into 
select attributes of a physical, biological, economic, or social 
system. A formal representation is characterized as the behavior of 
system processes, often in mathematical or statistical terms. The basis 
can also be physical or conceptual.'' This definition is based in part 
on the National Research Council's (NRC) 2007 report Models in 
Environmental Regulatory Decision Making (Ref. 13). As noted by the 
NRC, models can be of many different forms. They can be computational, 
physical, empirical, conceptual or a combination of one or more types. 
EPA is requesting comment on the proposed definition of ``model'' at 
proposed 40 CFR 30.2.

C. Publicly Available

    In the 2018 proposed rulemaking, EPA used the term ``publicly 
available'' but did not define it at 40 CFR 30.2 or in the preamble to 
the 2018 proposed rulemaking. Given its use at 40 CFR 30.1, 30.5 and 
30.9, EPA is proposing to define it. Publicly available information is 
often defined to mean information that is made available to the general 
public (e.g., see 40 CFR 2.201, 17 CFR 160.3, 16 CFR 313.3). EPA is 
proposing to define it similarly to how it is defined at 16 CFR 313.3. 
Although the overall purpose of the regulations at 16 CFR 313 is 
different than the purpose of this rulemaking, the meaning of 
information that is available to the general public should not vary. 
This would encompass information legally available from government 
sources, the media and the internet. EPA is requesting comment on the 
proposed definition of ``publicly available'' at proposed 40 CFR 30.2.

IV. Availability of Data and Models

    In the 2018 proposed rulemaking, EPA proposed to require at 40 CFR 
30.5 that ``[w]hen promulgating 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.'' EPA received a large number of 
comments stating that the approach in the 2018 proposed rulemaking 
would likely preclude the use of valid data and models from

[[Page 15402]]

consideration as pivotal regulatory science, because the proposed 
requirement to make data and models publicly available in a manner 
sufficient for independent validation would prevent the use of data and 
models that include CBI data, proprietary data, PII data that cannot be 
sufficiently de-identified to protect the data subjects, as well as 
many older studies. While having these data and models publicly 
available provides the greatest transparency, these commenters 
expressed concern that this approach could limit the use of certain 
data and models in EPA's significant regulatory decisions. Based on a 
consideration of these comments, EPA is proposing a modified version of 
the 2018 proposed rulemaking regulatory text at 40 CFR 30.5. Proposed 
40 CFR 30.5 would allow Agency consideration of studies where there is 
tiered 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 are to be used as pivotal regulatory science 
or pivotal science.
    As discussed in OMB M-19-15 (Ref. 3), risk reduction techniques 
include creating multiple versions of a single dataset with varying 
levels of specificity and protection. The benefit of tiered access is 
that data users who wish to conduct activities with a statistical 
purpose without first obtaining special authorization have access to 
the versions of the data in the least restricted tiers, allowing them 
to conduct research while protecting confidentiality.
    EPA is also proposing an alternative approach to today's proposed 
40 CFR 30.5. Under alternative proposed 40 CFR 30.5, when promulgating 
significant regulatory decisions or finalizing influential scientific 
information, the Agency will, 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 developing the significant regulatory decision or 
influential scientific information, the EPA will identify those studies 
that are given greater consideration and provide a short description of 
why greater consideration was given. However, the Agency may still 
consider studies where there is no access or limited access to 
underlying data and models.
    EPA is also clarifying that the Agency does not intend to make all 
data and models underlying pivotal regulatory science and pivotal 
science publicly available. There may be instances where EPA does not 
own the data and models, lacks access to part or all of the data and 
models or does not have the authority to provide access to part or all 
of the data and models. Rather, EPA is describing how it will handle 
studies based on whether the underlying data and models are publicly 
available.
    Both today's proposal and alternate proposal are consistent with 
EPA's statements in the April 2018 proposed rulemaking that ``access to 
dose response data and models underlying pivotal regulatory science'' 
should be done ``in a manner consistent with statutory requirements for 
protection of privacy and confidentiality of research participants, 
protection of proprietary data and confidential business information, 
and other compelling interests'' (Ref. 1). Both approaches are also 
based on EPA's recognition that there are statutory restrictions to 
public availability for some data and models that could make 
independent validation difficult. Further, both of these approaches are 
consistent with the OMB's M-19-15 (Ref. 3). OMB's implementation 
updates direct federal agencies to ``explore methods that provide wider 
access to datasets while reducing the risk of disclosure of [PII]. . 
.[T]iered access offers promising ways to make data widely available 
while protecting privacy'' (Implementation Update 3.5, Ref. 3). In 
addition, ``Agencies should prioritize increased access to the data and 
analytic frameworks (e.g., models) used to generate influential 
information'' while being ``consistent with statutory, regulatory, and 
policy requirements for protections of privacy and confidentiality, 
proprietary data, and confidential business information'' 
(Implementation Update 3.4, Ref. 3). This proposal is also consistent 
with OMB Memorandum 13-13: Open Data Policy--Managing Information as an 
Asset (Ref. 14).
    Under a tiered approach to accessing data and models that include 
CBI, proprietary data, or PII that cannot be sufficiently de-identified 
to protect the data subjects, access is more restricted for more 
sensitive data and models. Thus, the amount of information available 
for analysis is dictated by the tier. The greatest amount of 
information is made available at the most restricted access tier. 
Access to data involving PII would be consistent with the requirements 
of the Common Rule, the Health Insurance Portability and Accountability 
Act (HIPPA), the 21st Century Cures Act, the Privacy Act, and other 
relevant laws and regulations, and EPA privacy policies. Reanalyzing 
findings of studies based on data and models that include PII (e.g., 
residence) or CBI may not be possible given the degree of perturbation 
caused by de-identification that would be needed for the information to 
be made publicly available. Restricted access for researchers through 
secure data enclaves for PII or through non-disclosure agreements for 
CBI may result in access to sufficient information about the data and 
models to allow for independent validation. This ability to reanalyze 
findings may be much more limited for less restricted tiers. Thus, 
reanalysis of findings for some data and models may be limited to 
authorized researchers and not possible for the general public.
    A model of tiered access for data involving PII is the Research 
Data Center (RDC), National Center for Health Statistics (NCHS), 
Centers for Disease Control (CDC). The NCHS operates the RDC to allow 
researchers access to restricted-use data. The RDC provides access to 
the restricted-use data while protecting the confidentiality of survey 
respondents, study subjects, or institutions. For access to the 
restricted-use data, researchers must submit a research proposal 
outlining the need for restricted-use data. The submitted research 
proposal is intended to provide a framework for NCHS to identify 
potential disclosure risks and how the data will be used (Ref. 15). EPA 
is currently conducting a pilot study using the RDC's secure data 
enclave to host EPA datasets in a restricted use environment.
    Development of standard data repositories is still ongoing. For 
example, the White House Office of Science and Technology Policy 
recently solicited public comments on a draft set of characteristics of 
data repositories used to locate, manage, share, and use data resulting 
from federally-funded research (85 FR 3085). The effort is intended to 
help federal agencies provide more consistent information on desirable 
characteristics of data repositories ``for data subject to agency 
Public Access Plans and data management and sharing policies, whether 
those repositories are operated by government or nongovernmental 
entities.'' Information received during this public comment period 
will, among other things, help inform improved guidance and best 
practices related to preserving and providing access to data.
    Access to CBI data would continue to be provided consistent with 
the

[[Page 15403]]

environmental statutes EPA implements and the regulations at 40 CFR 
part 2, subpart B, which govern CBI. These regulations establish basic 
rules governing business confidentiality claims, how EPA handles 
business information that is or may be entitled to confidential 
treatment, and how EPA determines whether information is entitled to 
confidential treatment for reasons of business confidentiality. Various 
statutes under which EPA operates contain special provisions concerning 
the entitlement to confidential treatment of information gathered under 
such statutes. The regulations at 40 CFR part 2 subpart B prescribe 
rules for treating certain categories of business information obtained 
under the various statutory provisions.
    In accordance with these statutes, both the proposed and 
alternative 40 CFR 30.5 provide that access to underlying data and 
models that include CBI, proprietary information, or PII, for the 
subset of studies that could be considered pivotal science, may be 
limited to authorized officials and researchers and not provided to the 
general public.
    Proposed 40 CFR 30.5 would maintain the temporal approach to data 
and models taken in the regulatory text of 40 CFR 30.5 of the 2018 
proposed rulemaking, and thus would apply to data and models evaluated 
at the time a significant regulatory action or influential scientific 
information is developed, regardless of when the data and models were 
generated. EPA is requesting comment on whether this should apply only 
to data and models that are generated (i.e., when the development of 
the data set or model has been completed or updated) after the 
effective date of this rulemaking. If the proposed or alternative 
approach were finalized, EPA would consider the availability of 
underlying data and models only for studies that are potentially 
pivotal to EPA's significant regulatory decisions or influential 
scientific information that are developed in the future.
    Although the ability to independently validate pivotal regulatory 
science or pivotal science is a key component of this rulemaking, EPA 
would like to clarify that neither the proposed nor the alternative 40 
CFR 30.5 would require that EPA, a member of the public or other entity 
must independently validate a study before it can be considered to be 
pivotal regulatory science or pivotal science. EPA would also like to 
clarify that independent validation is not required under proposed 40 
CFR 30.7 which describes the role of independent peer review.
    EPA is requesting comment on the regulatory text being proposed 
today for 40 CFR 30.5. For alternate proposed 40 CFR 30.5, EPA is also 
requesting comment on how much consideration should be given to studies 
when there is limited or no access to the underlying data and models. 
In addition, EPA is requesting comment on how to ensure that, over 
time, more of the data and models underlying the science that informs 
significant regulatory decisions and influential scientific information 
are available to the public for independent validation in a manner that 
honors legal and ethical obligations to reduce the risks of 
unauthorized disclosure and re-identification. Finally, EPA is 
interested in comments about how to provide sufficient incentives and 
support to researchers to increase access to the data that may be used 
as pivotal regulatory science or pivotal science. Such comments will be 
used to develop implementation guidance.

V. Exemption by the Administrator

    The 2018 proposed rulemaking includes a provision at 40 CFR 30.9 
allowing the Administrator to grant exemptions from the rule on a case-
by-case basis if he or she determines that compliance is impracticable 
because it is not feasible to ensure that data and models underlying 
pivotal regulatory science are publicly available in a manner that is 
consistent with law and protects privacy and confidentiality. EPA is 
clarifying that the exemption may be given if compliance is 
impracticable because technological barriers render sharing of the data 
or models infeasible.
    EPA is also modifying the scope of the data and models that can be 
considered when determining whether to grant an exemption. The 
underlying data, models and computer code for some studies, 
particularly older studies, may not be readily publicly available 
because of the technological barriers to data and model sharing (e.g., 
differences in data storage devices or data retention practices) that 
existed when they were developed. Thus, in 40 CFR 30.9(a), EPA is 
proposing to use the age of data and models as a factor in the 
determination that compliance with the rule is impracticable. This 
modification of scope is intended to acknowledge the evolution of best 
practices for information sharing given innovations in information 
generation, access, management and use (See Ref. 3). EPA is proposing 
that a study or studies would be eligible for consideration under 40 
CFR 30.9(a), regardless of whether they contain CBI, proprietary 
information, or PII, if the underlying data or models were collected, 
completed or updated before the effective date of this rule. EPA 
requests comment on this consideration of the age of data and models in 
determining the feasibility of making underlying data and models 
publicly available. EPA also requests comment on whether there are 
aspects other than the year the data or model was collected, completed 
or updated that EPA should consider in determining whether to grant an 
exemption in order to evaluate the technological barriers to sharing.
    The 2018 proposed rulemaking also included a provision at 40 CFR 
30.9 allowing the Administrator to grant exemptions from the rule on a 
case-by-case basis if he or she determines that compliance is 
impracticable because it is not feasible to conduct independent peer 
review on all pivotal regulatory science. EPA is deleting that 
provision of the proposed exemption because EPA does not believe that 
peer review of pivotal regulatory science or pivotal science would be 
infeasible. Thus, EPA no longer believes the provision is necessary.

VI. References

    The following is a listing of the documents that are specifically 
referenced in this notice. The docket includes these documents and 
other information considered by EPA, including documents referenced 
within the documents that are included in the docket, even if the 
referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.
    1. EPA. Strengthening Transparency in Regulatory Science; 
Proposed Rule. Federal Register (83 FR18768, April 30, 2018) (FRL-
9977-40).
    2. EPA. Strengthening Transparency in Regulatory Science; 
Extension of Comment Period and Notice of Public Hearing Federal 
Register (83 FR. 24255, May 25, 2018).
    3. OMB (Office of Management and Budget). (2019). Improving 
Implementation of the Information Quality Act. Memorandum for the 
Heads of Executive Departments and Agencies. OMB Issuance M-19-15. 
Washington, DC: Executive Office of the President. https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-15.pdf.
    4. OMB (Office of Management and Budget). (2004). Memorandum for 
the Heads of Executive Departments and Agencies on Final Information 
Quality Bulletin for Peer-Review. https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-03.pdf.
    5. OMB (Office of Management and Budget). (2019). Executive 
Order 13891 of

[[Page 15404]]

October 9, 2019. Promoting the Rule of Law Through Improved Agency 
Guidance Documents. 84 FR 199. https://www.govinfo.gov/content/pkg/FR-2019-10-15/pdf/2019-22623.pdf.
    6. NAS (National Academies of Sciences, Engineering, and 
Medicine). (2016). Principles and obstacles for sharing data from 
environmental health research: Workshop summary. Washington, DC: The 
National Academies Press. https://doi.org/10.17226/21703.
    7. Pellizzari, YE; Lohr, K, Blatecky, A.; Creel, D. (2017). 
Reproducibility: A Primer on Semantics and Implications for 
Research. Research Triangle Park, NC: RTI Press.
    8. Goodman, SN; Fanelli, D; Ioannidis, JPA. (2016). What does 
research reproducibility mean? Sci Translational Medicine 8: 
341ps12. https://doi.org/10.1126/scitranslmed.aaf5027.
    9. OMB (Office of Management and Budget). (2002). Guidelines for 
Ensuring and Maximizing the Quality, Objectivity, Utility, and 
Integrity of Information Disseminated by Federal Agencies; Final 
guidelines. 67 FR 8452-8460. https://www.govinfo.gov/content/pkg/FR-2002-02-22/pdf/R2-59.pdf.
    10. OMB (Office of Management and Budget). (2013). Uniform 
Administrative Requirements, Cost Principles, and Audit Requirements 
for Federal Awards; Final Rule. 78 FR 78589-78691. https://www.govinfo.gov/content/pkg/FR-2013-12-26/pdf/2013-30465.pdf.
    11.U.S. EPA (U.S. Environmental Protection Agency).(2016). Plan 
to Increase Access to Results of EPA-Funded Scientific Research. 
(EPA/601-R-16-005). Washington, DC: U.S. Environmental Protection 
Agency. https://www.epa.gov/sites/production/files/2016-12/documents/epascientificresearchtransperancyplan.pdf.
    12. U.S. EPA (U.S. Environmental Protection Agency). (2009). 
Guidance on the Development, Evaluations, and Application of 
Environmental Models. (EPA/100/K-09/003). Washington, DC: US. 
Environmental Protection Agency. https://www.epa.gov/sites/production/files/2015-04/documents/cred_guidance_0309.pdf.
    13. NRC (National Research Council). (2007). Models in 
Environmental Regulatory Decision Making. Washington, DC: The 
National Academies Press. https://doi.org/10.17226/11972.
    14. OMB (Office of Management and Budget). (2013). Memorandum 
for the Heads of Executive Departments and Agencies on Open Data 
Policy-Managing Information as an Asset (https://projectopen-data.cio.gov/policy-memo/).
    15. CDC (Centers for Disease Control). Research Data Center. 
https://www.cdc.gov/rdc/index.htm.

VII. Statutory and Executive Order Reviews

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

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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review. Any changes 
made in response to OMB recommendations have been documented in the 
docket.

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

    This action is not expected to be an Executive Order 13771 
regulatory action because it relates to ``agency organization, 
management or personnel.''

C. Paperwork Reduction Act (PRA)

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

D. Regulatory Flexibility Act (RFA)

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

E. Unfunded Mandates Reform Act (UMRA)

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

F. Executive Order 13132: Federalism

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

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

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

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

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

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

    This action is not a ``significant energy action'' because it is 
not likely to have a significant adverse effect on the supply, 
distribution or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

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

List of Subjects in 40 CFR Part 30

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

    Dated: March 3, 2020.
Andrew R. Wheeler,
Administrator.

    Therefore, 40 CFR part 30, as proposed to be added at 83 FR 18768 
(April 30, 2018), is proposed to be amended as follows:

PART 30--TRANSPARENCY IN REGULATORY DECISIONMAKING

0
1. The authority citation for part 30 is revised to read as follows:

    Authority:  5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98-80, 84 Stat. 
2086.

0
2. Revise Sec.  30.2 by adding the definitions for ``Capable of being 
substantially reproduced'', ``Data'', ``Independent validation'', 
``Influential scientific information'' ``Model'', ``Pivotal science'', 
``Publicly available'' and ``Reanalyze'' in alphabetical order to read 
as follows:

[[Page 15405]]

Sec.  30.2   What definitions apply to this part?

    Capable of being substantially reproduced means that independent 
analysis of the original or supporting data using identical methods 
would generate similar analytic results, subject to an acceptable 
degree of imprecision or error.
    Data means the set of recorded factual material commonly accepted 
in the scientific community as necessary to validate research findings 
in which obvious errors, such as keystroke or coding errors, have been 
removed and that is capable of being analyzed by either the original 
researcher or an independent party.
* * * * *
    Independent validation means 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.
    Influential scientific information means scientific information the 
agency reasonably can determine will have or does have a clear and 
substantial impact on important public policies or private sector 
decisions.
    Model means a simplification of reality that is constructed to gain 
insights into select attributes of a physical, biological, economic, or 
social system. A formal representation of the behavior of system 
processes, often in mathematical or statistical terms. The basis can 
also be physical or conceptual.
* * * * *
    Pivotal science means the specific scientific studies or analyses 
that underly influential scientific information.
    Publicly available means lawfully available to the general public 
from federal, state, or local government records; the internet; widely 
distributed media; or disclosures to the general public that are 
required to be made by federal, state, or local law.
    Reanalyze means to analyze exactly the same data to see if the same 
result emerges from the analysis by using the same or different 
statistical software, models, and statistical methodologies that were 
originally used to analyze the data, as well as to assess potential 
analytical errors and variability in the underlying assumptions of the 
original analysis.
* * * * *
0
3. Revise Sec.  30.3 to read as follows:


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

    The provisions of this part apply to data and models, underlying 
pivotal science supporting influential scientific information and/or 
underlying pivotal regulatory science used to justify significant 
regulatory decisions regardless of the source of funding or identity of 
the party conducting the science. The provisions of this section do not 
apply to physical objects (like laboratory samples), drafts, and 
preliminary analyses. In the event the procedures outlined in this part 
conflict with statutes that EPA administers, or their implementing 
regulations, the statutes and regulations will control. Except where 
explicitly stated otherwise, the provisions of this part do not apply 
to any other type of agency action, including individual party 
adjudications, enforcement activities, or permit proceedings.

[Option 1]

0
4. Revise Sec.  30.5 to read as follows:


Sec.  30.5  What requirements apply to EPA's use of data and models 
underlying pivotal regulatory science and pivotal science?

    When promulgating significant regulatory decisions or finalizing 
influential scientific information, the Agency will only use pivotal 
regulatory science and/or pivotal science that includes studies with 
restricted data and models (i.e., those that include confidential 
business information (CBI), proprietary data, or Personally 
Identifiable Information (PII) that cannot be sufficiently de-
identified to protect the data subjects) if there is tiered access to 
these data and models in a manner sufficient for independent 
validation, and studies that do not include restricted data and models 
if the data and models are publicly available in a manner sufficient 
for independent validation. Where the Agency is making data or models 
publicly available, it shall do so in a manner that is consistent with 
law, protects privacy, confidentiality, confidential business 
information, and is sensitive to national and homeland security. 
Information is considered ``available in a manner sufficient for 
independent validation'' when it includes the information necessary to 
understand, assess, and reanalyze findings. This may include, for 
example:
    (a) Data (where necessary, data would be made available subject to 
access and use restrictions);
    (b) Associated protocols necessary to understand, assess, and 
extend conclusions;
    (c) Computer codes and models involved in the creation and analysis 
of such information;
    (d) Recorded factual materials; and
    (e) Detailed descriptions of how to access and use such 
information.
    (f) The provisions of this section apply to data and models 
underlying pivotal regulatory science or pivotal science regardless of 
who funded or conducted the underlying data, models, or other 
regulatory science or pivotal science. The agency shall make reasonable 
efforts to explore methodologies, technologies, and institutional 
arrangements for making such data and models available before it 
concludes that doing so in a manner consistent with law and protection 
of privacy, confidentiality, national and homeland security is not 
possible. Where data and models are controlled by third parties, EPA 
may work with those parties to endeavor to make the data and models 
available in a manner that complies with this section.

[Option 2]

0
5. Revise Sec.  30.5 to read as follows:


Sec.  30.5  What requirements apply to EPA's use of data and models 
underlying pivotal regulatory science and pivotal science?

    (a) When promulgating significant regulatory decisions or 
finalizing influential scientific information, the Agency will, other 
things equal, give greater consideration to studies where the 
underlying data and models are publicly available in a manner 
sufficient for independent validation. The Agency will also give 
greater consideration to studies based on data and models that include 
confidential business information, proprietary information or 
personally identifiable information if these data and models were 
available through restricted access, such as through a secure data 
enclave, in a manner sufficient for independent validation. Where there 
is no access to data and models, or access is limited, the Agency may 
still consider these studies, depending on the other attributes of the 
studies. Furthermore, the Agency will identify those studies that are 
given greater consideration and provide a short description of why 
greater consideration was given. Where the Agency is making data or 
models publicly available, it shall do so in a manner that is 
consistent with law, protects privacy, confidentiality, confidential 
business information, and is sensitive to national and homeland 
security. Information is considered ``available in a manner sufficient 
for independent validation'' when it includes the information necessary 
to understand, assess, and reanalyze findings. This may include, for 
example:

[[Page 15406]]

    (1) Data (where necessary, data would be made available subject to 
access and use restrictions);
    (2) Associated protocols necessary to understand, assess, and 
extend conclusions;
    (3) Computer codes and models involved in the creation and analysis 
of such information;
    (4) Recorded factual materials; and
    (5) Detailed descriptions of how to access and use such 
information.
    (b) The provisions of this section apply to data and models 
underlying pivotal regulatory science or pivotal science regardless of 
who funded or conducted the underlying data, models, or other 
regulatory science or pivotal science. The agency shall make reasonable 
efforts to explore methodologies, technologies, and institutional 
arrangements for making such data and models available before it 
concludes that doing so in a manner consistent with law and protection 
of privacy, confidentiality, national and homeland security is not 
possible. Where data and models are controlled by third parties, EPA 
may work with those parties to endeavor to make the data and models 
available in a manner that complies with this section.
0
6. Revise Sec.  30.6 to read as follows:


Sec.  30.6  What additional requirements pertain to the use of data and 
models underlying pivotal science or pivotal regulatory science?

    EPA shall describe and document any assumptions and methods used 
and shall describe variability and uncertainty. EPA shall evaluate the 
appropriateness of using default assumptions on a case-by-case basis. 
EPA shall clearly explain the scientific basis for critical assumptions 
used in the analysis that drove the analytical results and subsequent 
decisions and shall present analyses showing the sensitivity of the 
modeled results to alternative assumptions. When available, EPA shall 
give explicit consideration to high quality studies, including but not 
limited to those 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; various threshold models across the dose or exposure 
range; and models that investigate factors that might account for 
spatial heterogeneity.
0
7. Revise Sec.  30.7 to read as follows:


Sec.  30.7  What role does independent peer review have in this 
section?

    EPA shall conduct independent peer review on all pivotal regulatory 
science used to justify significant regulatory decisions and on all 
pivotal science underlying influential scientific information, 
consistent with the requirements of the OMB Final Information Quality 
Bulletin for Peer Review and the exemptions described therein. Because 
transparency in regulatory science includes addressing issues 
associated with assumptions used in models, EPA shall ask peer 
reviewers to articulate the strengths and weaknesses of EPA's 
justification for the assumptions applied and the implications of those 
assumptions for the results.
0
8. Revise Sec.  30.9 to read as follows:


Sec.  30.9  May the EPA Administrator grant exemptions to this part?

    The Administrator may grant an exemption to this part on a case-by 
case basis if he or she determines that compliance is impracticable 
because technological barriers render sharing of the data or models 
infeasible, the development of the data or model was completed or 
updated before [EFFECTIVE DATE OF FINAL RULE] or making the data and 
models publicly available would conflict with laws governing privacy, 
confidentiality, confidential business information, or national and 
homeland security.

[FR Doc. 2020-05012 Filed 3-17-20; 8:45 am]
 BILLING CODE 6560-50-P


