[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Proposed Rules]
[Pages 15396-15406]
[FR Doc No: 2020-05012]

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

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.

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

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

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

    \1\ Chrysler Corp. v. Brown, 441 U.S. 281, 309 (1979).
    \2\ Id. at 310.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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'').
---------------------------------------------------------------------------

    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.

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.
---------------------------------------------------------------------------

    \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.'').
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

``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

types of data and models will also drive the requirements and/or
quantitative analysis of EPA final significant regulatory decisions and
influential scientific information.
---------------------------------------------------------------------------

    \7\ See Sec.  30.6.
---------------------------------------------------------------------------

    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

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

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

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

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:

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:

    (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


MEMORANDUM

SUBJECT: Endangered Species Act Section 7(a)(2) and EPA Withdrawal of Certain Federal Criteria Applicable to Certain Waters in California

Purpose of the Memo

Section 7 of the Endangered Species Act (ESA) and federal regulations at 50 CFR Part 402, require federal agencies to consult with the U.S. Fish and Wildlife Service (FWS) and/or the Nation Marine Fisheries Service (NMFS) to insure their activities are not likely to jeopardize the continued existence of federally-listed endangered or threatened species or result in the destruction or adverse modification of designated critical habitat of such species.  Federal agencies subsequently conduct a biological assessment (or biological evaluation) to determine whether any such species or their critical habitat are likely to be adversely affected by the agency action.  Consultation is only required for actions that "may affect" listed species or designated critical habitat.  40 CFR § 402.03. The purpose of this memo is to address ESA considerations associated with the Environmental Protection Agency's (EPA) withdrawal of federal aquatic life water quality criteria for lead and federal human health criteria for chlorodibromomethane and dichlorobromomethane applicable to certain waters in California.

Summary of Federal Action

EPA is amending its federal regulations to withdraw human health (water & organisms) criteria for chlorodibromomethane and dichlorobromomethane for a segment of New Alamo Creek and a segment of Ulatis Creek, California. In addition, EPA is amending its federal regulations to withdraw freshwater acute and chronic aquatic life criteria for lead for the Los Angeles River and its tributaries. By withdrawing these criteria, the federal action will enable California to implement the State-adopted, EPA-approved water quality criteria for the same waterbodies where federally promulgated water quality criteria were previously applicable.  Upon finalizing this federal action, these federally promulgated water quality criteria will no longer be applicable for CWA purposes.  California's water quality criteria, approved by EPA, will be the effective criteria for CWA purposes.

Relevant Background of Federal Action and Anticipated No Effect Determination

Lead

On May 18, 2000, as part of a final rule known as the "California Toxics Rule" (CTR), EPA promulgated federal regulations establishing aquatic life water quality criteria for lead (40 C.F.R. 131.38; 65 FR 31681, May 18, 2000). On July 11, 2016, California completed its adoption process to incorporate water quality objectives for lead for the Los Angeles River and its tributaries. On July 19, 2016, the State submitted the site-specific objectives to EPA Region 9 for CWA 303(c) review and approval. On December 12, 2016, EPA approved the site-specific objectives for lead for the Los Angeles River and its tributaries. The Los Angeles Regional Water Quality Control Board adopted these site-specific objectives under Resolution No. R15-004.  The California State Water Resources Control Board in Resolution No. 2015-0069 subsequently approved the Regional Board action on these site-specific objectives, and EPA subsequently approved the State Board action. EPA approved the State's site-specific objectives for lead.  Although less stringent than the federally promulgated criteria, EPA determined that the State's site-specific objectives were scientifically sound and protective of the designated use(s) for the Los Angeles River and its tributaries and met the requirements of the CWA and EPA's implementing regulations at 40 CFR 131.

Because California now has site-specific objectives for lead for the protection of aquatic life, approved by EPA for CWA purposes, for the Los Angeles River and its tributaries, EPA has determined that the federally promulgated freshwater acute and chronic aquatic life criteria for lead are no longer needed for the Los Angeles River and its tributaries.

EPA concludes that there will be no effect on federally-listed threatened and endangered species and designated critical habitat from its withdrawal of the previously applicable, federally promulgated aquatic life criteria for lead because EPA has completed consultation with FWS on its approval of California's newly adopted aquatic life water quality objectives for lead for the Los Angeles River and its tributaries ("state lead objectives") by the finalization of this federal rulemaking.  EPA initiated consultation with FWS concerning EPA's approval of the state lead objectives on December 12, 2016.  On December 12, 2016, EPA submitted a Biological Evaluation for FWS's review that determined that EPA's approval of the state lead objectives was not likely to adversely affect federally-listed species or adversely modify designated critical habitat. On January 9, 2018,, EPA officially concluded consultation with FWS concurrence that EPA's approval of the state lead objectives was not likely to adversely affect federally-listed species or adversely modify designated habitat.  Furthermore, the consultation on EPA's approval of the state lead objectives was premised on these objectives henceforth being the CWA-applicable water quality objectives.  In addition to EPA's approval, a subsequent step is necessary to make the state lead objectives CWA-applicable.  The additional step is the withdrawal of EPA's federally promulgated criteria for lead for the Los Angeles River and its tributaries ("federal lead criteria").  EPA's withdrawal of the federal lead criteria will have no effect on listed species or designated critical habitat because any effects of the withdrawal were considered during the informal consultation on approval of the state lead objectives. The Section 7 consultation on EPA's approval of the state lead objectives concluded on January 9, 2018 and therefore, any impacts to listed species or designated critical habitat are already included in the environmental baseline. See 50 CFR 402.02. Withdrawal of the federal lead criteria therefore adds no impacts to the environmental baseline and thus, has no effect on listed species or designated critical habitat.

Relevant Background of Federal Action and No Discretion Determination

Chlorodibromomethane and dichlorobromomethane

On May 18, 2000, as part of the CTR, EPA promulgated federal regulations establishing human health water quality criteria for chlorodibromomethane and dichlorobromomethane (40 C.F.R. 131.38; 65 FR 31681, May 18, 2000). On November 3, 2011, California completed its adoption process to incorporate human health water quality criteria for chlorodibromomethane and dichlorobromomethane, for a segment of New Alamo Creek and a segment of Ulatis Creek. On December 13, 2011, the State submitted the site-specific objectives to EPA Region 9 for review and approval. On April 9, 2013, EPA approved site-specific objectives for that segment of New Alamo Creek and that segment of Ulatis Creek. The Central Valley Regional Water Quality Control Board  adopted the objectives in Resolution No. R5-2010-0047, and the State Water Resources Control Board approved the objectives in Resolution 2011-0036, which was submitted to EPA by the State. EPA approved the State's site-specific objectives. Although less stringent than the federally promulgated criteria, EPA determined that the State's site-specific objectives were scientifically sound and protective of the designated use(s) for the segment of New Alamo Creek and the segment of Ulatis Creek.

Because California now has site-specific human health (for water and organisms) criteria approved by EPA for CWA purposes for chlorodibromomethane and dichlorobromomethane for a segment of New Alamo Creek and a segment of Ulatis Creek, EPA determined that the federally promulgated human health (water and organisms) criteria are no longer needed for that segment of New Alamo Creek and that segment of Ulatis Creek.

EPA has concluded that it has no discretion to consult on its withdrawal of the previously applicable human health (water & organisms) criteria for chlorodibromomethane and dichlorobromomethane because the action pertains to criteria supporting designated uses other than aquatic life (e.g., fish consumption, full-body contact, partial-body contact). The rationale for this decision is articulated in the 2009 Memorandum from Benjamin Grumbles, Office of Water Assistant Administrator, which stated that:

      For ESA section 7(a)(2) to apply, EPA must be taking an action in which it has sufficient discretionary involvement or control to protect listed species. State WQS actions where EPA has concluded that it lacks such discretion include... approval of water quality criterion to protect human health... Human heath water quality criteria are designed to protect humans, not plants and animals. EPA's discretion to act on a State submission is limited to determining whether the criteria ensure protection of designated uses upon which the criteria are based (i.e. use by humans). Therefore, EPA has no discretion to revise an otherwise approvable human health criterion to benefit listed species.

Although the rationale articulated in the 2009 Memorandum is provided within the context of EPA approval of state WQS actions, the Memorandum's rationale is relevant and applicable to withdrawals of federally promulgated water quality criteria that effectuate the approval of state WQS actions. Therefore, consultation under Section 7 is not required for EPA's withdrawal of chlorodibromomethane and dichlorobromomethane human health water quality criteria for a segment of New Alamo Creek and a segment of Ulatis Creek.