[Federal Register Volume 83, Number 83 (Monday, April 30, 2018)]
[Proposed Rules]
[Pages 18768-18774]
[FR Doc No: 2018-09078]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 30

[EPA-HQ-OA-2018-0259; FRL-9977-40-ORD]
RIN 2080-AA14

Strengthening Transparency in Regulatory Science

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes a regulation intended to strengthen the
transparency of EPA regulatory science. The proposed regulation
provides that when EPA develops regulations, including regulations for
which the public is likely to bear the cost of compliance, with regard
to those scientific studies that are pivotal to the action being taken,
EPA should ensure that the data underlying those are publicly available
in a manner sufficient for independent validation. In this notice, EPA
solicits comment on this proposal and how it can best be promulgated
and implemented in light of existing law and prior Federal policies
that already require increasing public access to data and influential
scientific information used to inform federal regulation.

DATES: Comments must be received on or before May 30, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OA-
2018-0259, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tom Sinks, Office of the Science
Advisor, Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460;<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:
    Submitting CBI. Do not submit information that you consider to be
CBI electronically through https://www.regulations.gov or email. Send
or deliver information identified as CBI to only the following address
using U.S. Postal Service: U.S. Environmental Protection Agency, EPA
Docket Center, EPA-HQ-OA-2018-0259, Mail Code 28221T, 1200 Pennsylvania
Avenue NW, Washington, DC 20460. For other methods of delivery, see
https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Clearly mark the part or all of the information that you claim to
be CBI. For CBI information in a disk or CD-ROM that you mail to EPA,
mark the

outside of the disk or CD-ROM as CBI and then identify electronically
within the disk or CD-ROM the specific information that is claimed as
CBI. In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. If you submit a CD-ROM or disk that does not contain
CBI, mark the outside of the disk or CD-ROM clearly that it does not
contain CBI. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 Code of Federal Regulations
(CFR) part 2.
    Organization of This Document. The following outline is provided to
aid in locating information in this preamble.

I. General Information
    A. Does this action apply to me?
    B. What action is the Agency taking?
    C. What is the Agency's authority for taking this action?
II. Background
III. Request for Comment
IV. Statutory and Executive Orders

I. General Information

A. Does this action apply to me?

    This proposed regulation does not directly regulate any entity
outside the federal government. However, any entity interested in EPA's
regulations may be interested in this proposal. This proposal may be of
particular interest to entities that conduct research and other
scientific activity that is likely to be relevant to EPA's regulatory
activity.

B. What action is the Agency taking?

    This notice solicits information and comment from the public on a
proposed regulation intended to strengthen the transparency of EPA
regulatory science. The proposed regulation provides that, for the
science pivotal to its significant regulatory actions, EPA will ensure
that the data and models underlying the science is publicly available
in a manner sufficient for validation and analysis. In this notice, EPA
solicits comment on this proposal and how it can best be implemented in
light of existing law and prior statements of policy that have called
for increasing public access to data and influential scientific
information used to inform federal regulation. EPA has not previously
implemented these policies and guidance in a robust and consistent
manner. This proposal will help ensure that EPA is pursuing its mission
of protecting public health and the environment in a manner that the
public can trust and understand.

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

    The Agency proposes to take this action under authority of the
statutes it administers, including provisions providing general
authority to promulgate regulations necessary to carry out the Agency's
functions under these statutes and provisions specifically addressing
the Agency's conducting of and reliance on scientific activity to
inform those functions, including Clean Air Act sections 103, 301(a),
42 U.S.C. 7403, 7601(a); Clean Water Act sections 104, 501, 33 U.S.C.
1254, 1361; Safe Drinking Water Act sections 1442, 1450(a)(1), 42
U.S.C. 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act
sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive
Environmental Response, Compensation, and Liability Act (as delegated
to the Administrator via Executive Order 12580) sections 115, 311, 42
U.S.C. 9616, 9660; Emergency Planning and Community Right-To-Know Act
section 328, 42 U.S.C. 11048; Federal Insecticide, Fungicide, and
Rodenticide Act sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and
Toxic Substances Control Act, as amended, section 10, 15 U.S.C. 2609.
This action is also consistent with requirements in the Administrative
Procedure Act to ensure public participation in the rulemaking process.
As noted in Section III below, EPA solicits comment on whether
additional or alternative sources of authority are appropriate bases
for this proposed regulation.

II. Background

    The best available science must serve as the foundation of EPA's
regulatory actions.\1\ Enhancing the transparency and validity of the
scientific information relied upon by EPA strengthens the integrity of
EPA's regulatory actions and its obligation to ensure the Agency is not
arbitrary in its conclusions. By better informing the public, the
Agency in enhancing the public's ability to understand and meaningfully
participate in the regulatory process.\2\ In applying the best
available science to its regulatory decision-making, EPA must comply
with federal transparency and data integrity laws, and must also ensure
that its decision-making is marked by independence, objectivity,
transparency, clarity, and reproducibility. Although these standards
are important in all scientific endeavors, they are of paramount
importance when the government relies on science to inform its
significant regulatory decisions that will affect the public. When EPA
develops significant regulations using public resources, including
regulations for which the public is likely to bear the cost of
compliance, EPA should ensure that the data and models underlying
scientific studies that are pivotal to the regulatory action are
available to the public. This proposed rule is designed to increase
transparency in the preparation, identification, and use of science in
policymaking.
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    \1\ See Exec. Order No. 13563, 76 FR 3821 (Jan. 21, 2011). ``Our
regulatory system must protect public health, welfare, safety, and
our environment while promoting economic growth, innovation,
competitiveness, and job creation. It must be based on the best
available science.''
    \2\ See Memorandum for the Heads of Executive Department and
Agencies on Scientific Integrity (Mar. 9, 2009). ``If scientific and
technological information is developed and used by the Federal
Government, it should ordinarily be made available to the public. To
the extent permitted by law, there should be transparency in the
preparation, identification, and use of scientific and technological
information in policymaking.''
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    This proposed rule is consistent with the principles underlying the
Administrative Procedure Act and programmatic statutes that EPA
administers to disclose to the public the bases for agency rules and to
rationally execute and adequately explain agency actions.\3\ This
proposed rule is also consistent with Executive Orders 13777 \4\ and
13783,\5\ and the focus on transparency in OMB's Guidelines for
Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity
of Information Disseminated by Federal Agencies \6\ (the Guidelines)
and OMB

Memorandum 13-13: Open Data Policy--Managing Information as an
Asset.\7\ It builds upon prior EPA actions \8\ in response to
government-wide data access and sharing policies, as well as the
experience of other federal agencies in this space.\9\ In particular,
this proposal applies concepts and lessons learned from its ongoing
implementation of the 2016 Plan to Increase Access to Results of EPA-
Funded Scientific Research to significant regulatory decisions. The
proposed rule takes into consideration the policies or recommendations
of third party organizations who advocated for open science.\10\ These
policies are informed by the policies recently adopted by some major
scientific journals,\11\ spurred in some part by the ``replication
crisis.'' \12\
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    \3\ EPA has the authority to establish policies governing its
reliance on science in the administration of its regulatory
functions. Historically, EPA has not consistently observed the
policies underlying this proposal, and courts have at times upheld
EPA's use non-public data in support of its regulatory actions. See
Coalition of Battery Recyclers Ass'n v. EPA, 604 F.3d 613, 623 (D.C.
Cir. 2010); American Trucking Ass'ns v. EPA, 283 F.3d 355, 372 (D.C.
Cir. 2002). EPA is proposing to exercise its discretionary authority
to establish a policy that would preclude it from using such data in
future regulatory actions.
    \4\ Exec. Order No. 13777, 82 FR 12285 (Mar. 1, 2017).
Regulatory reform efforts shall attempt to identify ``those
regulations that rely in whole or in part on data, information, or
methods that are not publicly available or that are insufficiently
transparent to meet the standard for reproducibility.''
    \5\ Exec. Order No. 13783, 82 FR 16093 (Mar. 31, 2017). ``It is
also the policy of the United States that necessary and appropriate
environmental regulations comply with the law, are of greater
benefit than cost, when permissible, achieve environmental
improvements for the American people, and are developed through
transparent processes that employ the best available peer-reviewed
science and economics.''
    \6\ February 22, 2002 (67 FR 8453) OMB's Guidelines Ensuring and
Maximizing the Quality, Objectivity, Utility, and Integrity of
Information (2002) https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.
    \7\ Memorandum for the Heads of Executive Departments and
Agencies on Open Data Policy--Managing Information as an Asset
(https://project-open-data.cio.gov/policy-memo/). ``Specifically,
this Memorandum requires agencies to collect or create information
in a way that supports downstream information processing and
dissemination activities. This includes using machine-readable and
open formats, data standards, and common core and extensible
metadata for all new information creation and collection efforts. It
also includes agencies ensuring information stewardship through the
use of open licenses and review of information for privacy,
confidentiality, security, or other restrictions to release.''
    \8\ Plan to Increase Access to Results of EPA-Funded Scientific
Research; EPA Open Government Plan 4.0; Open Data Implementation
Plan; EPA's Scientific Integrity Policy; Guidelines for Ensuring and
Maximizing the Quality, Objectivity, Utility, and Integrity of
Information Disseminated by the Environmental Protection Agency.
    \9\ For example, see related policies from the National Science
Foundation, National Institute of Science and Technology, the
National Institutes of Health; and the U.S. Census Bureau, which
provides secure access to data from several agencies in an
environment that protects against unauthorized disclosure (https://www.census.gov/fsrdc).
    \10\ These include policies and recommendations from: The
Administrative Conference of the United States' Science in the
Administrative Process Project; National Academies' reports on
Improving Access to and Confidentiality of Research Data, Expanding
Access to Research Data, and Access to Research Data in the 21st
Century; the Health Effects Institute; Center for Open Science;
members of the Risk Assessment Specialty Section of the Society of
Toxicology, the Dose Response Section of the Society for Risk
Analysis, and the International Society for Regulatory Toxicology
and Pharmacology; and the Bipartisan Policy Center's Science for
Policy Project.
    \11\ For example, see related policies from the Proceedings of
the National Academy of Sciences, PLOS ONE, Science, and Nature.
    \12\ See: https://www.nature.com/articles/s41562-016-0021;
http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124; http://science.sciencemag.org/content/343/6168/229.long; https://www.economist.com/news/leaders/21588069-scientific-research-has-changed-world-now-it-needs-change-itself-how-science-goes-wrong.; http://stm.sciencemag.org/content/8/341/341ps12.full.
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    Today, EPA is proposing to establish a clear policy for the
transparency of the scientific information used for significant
regulations: Specifically, the dose response data and models that
underlie what we are calling ``pivotal regulatory science.'' ``Pivotal
regulatory science'' is the studies, models, and analyses that drive
the magnitude of the benefit-cost calculation, the level of a standard,
or point-of-departure from which a reference value is calculated. In
other words, they are critical to the calculation of a final regulatory
standard or level, or to the quantified costs, benefits, risks and
other impacts on which a final regulation is based.
    With this notice, EPA is soliciting public comment on a proposed
regulation designed to provide a mechanism to increase access to dose
response data and models underlying pivotal regulatory science 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. The proposal takes comment on how to ensure that, over time,
more of the data and models underlying the science that informs
regulatory decisions (over and above the dose response data and models
underlying ``pivotal regulatory science'') is available to the public
for validation \13\ in a manner that honors legal and ethical
obligations to reduce the risks of unauthorized disclosure and re-
identification. As such this proposed regulation is designed to change
agency culture and practices regarding data access so that the
scientific justification for regulatory actions is truly available for
validation and analysis.
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    \13\ EPA has not consistently followed previous EPA policy (e.g,
EPA's Scientific Integrity Guidance, referenced above) that
encouraged the use of non-proprietary data and models.
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    Regulatory determinations based on science should describe and
document any assumptions and methods used, and should address
variability and uncertainty. Where available and appropriate, EPA will
use peer-reviewed information, standardized test methods, consistent
data evaluation procedures, and good laboratory practices to ensure
transparent, understandable, and reproducible scientific assessments.
EPA's regulatory science should be consistent with the Office of
Management and Budget's Final Information Quality Bulletin for Peer
Review.\14\ Robust peer review plays a critical role in independently
validating key findings and ensuring that the quality of published
information meets the standards of the scientific and technical
community.
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    \14\ https://www.whitehouse.gov/wp-content/uploads/2017/11/2005-M-05-03-Issuance-of-OMBs-Final-Information-Quality-Bulletin-for-Peer-Review-December-16-2004.pdf.
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    In addition, this proposed regulation is designed to increase
transparency of the assumptions underlying dose response models. As a
case in point, there is growing empirical evidence of non-linearity in
the concentration-response function for specific pollutants and health
effects. The use of default models, without consideration of
alternatives or model uncertainty, can obscure the scientific
justification for EPA actions. To be even more transparent about these
complex relationships, EPA should give appropriate consideration to
high quality studies that explore: A broad class of parametric
concentration-response models with a robust set of potential
confounding variables; nonparametric models that incorporate fewer
assumptions; various threshold models across the exposure range; and
spatial heterogeneity. EPA should also incorporate the concept of model
uncertainty when needed as a default to optimize low dose risk
estimation based on major competing models, including linear,
threshold, and U-shaped, J-shaped, and bell-shaped models.
    Across EPA programs, much of the science that informs regulatory
actions is developed outside the Agency. It is the charge of regulators
to ensure that key findings are valid and credible, as required by
OMB's Guidelines \15\ (which apply to ``third party'' information--
e.g., non-government scientific research--if the agency use of that
information provides the appearance of representing agency views).
Using scientific information that can be independently validated will
lead to better outcomes, and strengthen public confidence in the health
and environmental protections underpinning EPA's regulatory actions.
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    \15\ February 22, 2002 (67 FR 8453) OMB's Guidelines Ensuring
and Maximizing the Quality, Objectivity, Utility, and Integrity of
Information (2002) https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.
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    EPA believes that concerns about access to confidential or private
information can, in many cases, be addressed through the application of
solutions commonly in use across some parts of the Federal
government.\16\ Nothing in the proposed rule compels

the disclosure of any confidential or private information in a manner
that violates applicable legal and ethical protections. Other federal
agencies have developed tools and methods to de-identify private
information for a variety of disciplines.\17\ The National Academies
have noted that simple data masking, coding, and de-identification
techniques have been developed over the last half century and that
``Nothing in the past suggests that increasing access to research data
without damage to privacy and confidentiality rights is beyond
scientific reach.'' \18\ More recently, both the National Academies and
the Bipartisan Commission on Evidence Based Policy \19\ have discussed
the challenges and opportunities for facilitating to secure access to
confidential data for non-government analysts.
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    \16\ See examples from the U.S. Department of Health and Human
Services, National Institute of Standards and Technology, U.S.
Department of Education, and the U.S. Census Bureau.
    \17\ https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html.
    \18\ https://www.nap.edu/catalog/11434/expanding-access-to-research-data-reconciling-risks-and-opportunities.
    \19\ https://www.cep.gov/content/dam/cep/report/cep-final-report.pdf; https://www.nap.edu/catalog/24652/innovations-in-federal-statistics-combining-data-sources-while-protecting-privacy;
https://www.nap.edu/catalog/24893/federal-statistics-multiple-data-sources-and-privacy-protection-next-steps.
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    Considering the breadth of dose response data and models used in
the development of significant EPA regulations, the requirements for
availability may differ. These mechanisms may range from deposition in
public data repositories, consistent with requirements for many
scientific journals,\20\ to, for certain types of information,
controlled access in federal research data centers that facilitate
secondary research use by the public.\21\ EPA should collaborate with
other federal agencies to identify strategies to protect confidential
and private information in any circumstance in which it is making
information publicly available. These strategies should be cost-
effective and may also include: Requiring applications for access;
restricting access to data for the purposes of replication, validation,
and sensitivity evaluation; establishing physical controls on data
storage; online training for researchers; and nondisclosure
agreements.\22\
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    \20\ For example, see policies or recommendations of publishers
Taylor & Francis, Elsevier, PLOS, and Springer Nature.
    \21\ For example: https://osp.od.nih.gov/scientific-sharing/requesting-access-to-controlled-access-data-maintained-in-nih-designated-data-repositories-e-g-dbgap/; https://www.census.gov/fsrdc.
    \22\ These recommendations are consistent with those of Lutter
and Zorn (2016). https://www.mercatus.org/system/files/Mercatus-Lutter-Public-Access-Data-v3.pdf.we re.
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    Implementation of this proposed rule will be consistent with the
definition of ``research data'' in Uniform Administrative Requirements,
Cost Principles, and Audit Requirements for Federal Awards, exemptions
in Public Law 89-487, and other applicable federal laws.
    This proposed regulation is intended to apply prospectively to
final regulations that are determined to be ``significant regulatory
actions'' pursuant to E.O. 12866. The Agency's offices should be guided
by this policy to the maximum extent practicable during ongoing
regulatory action, even where such research has already been generated,
solicited, or obtained.

III. Request for Comment

    EPA solicits comment on all aspects of the proposed regulation and
the bases articulated for it above. Specifically, EPA believes that it
has identified appropriate sources of statutory authority for this
proposed regulation in Section I(c) above, and solicits public comment
on whether additional or alternative sources of authority are
appropriate bases for this proposed regulation. EPA further believes
that a generally applicable regulatory provision of the type proposed
here is the appropriate vehicle to establish and implement the policies
articulated in Section II above, in the interests of consistency,
predictability, and transparency across the functions that EPA
performs.
    EPA solicits comment on whether alternative or additional
regulatory or other policy vehicles are appropriate to establish and
implement these policies, and whether further regulatory or other
policy vehicles at the programmatic or statutory level would be
appropriate as alternative or additional steps the agency may take to
further the policies articulated in Section II above.
    EPA solicits comment on the effects of this proposed rule on
individual EPA programs, including whether certain activities are
appropriate to be excepted or if other requirements would affect
implementation. EPA also seeks comments on which criteria the Agency
should use to base any exceptions, including whether case-by-case
exceptions may be appropriate.
    Although the proposed regulatory text would impose requirements
specifically on final regulations determined to be ``significant
regulatory actions'' under E.O. 12866, EPA solicits comment on whether
and to what extent these requirements, or other provisions and
policies, should apply to other stages of the rulemaking process,
including proposed rules, as well as to other types of agency actions
and promulgations, such as guidance. EPA also solicits comment on
whether a narrower scope of coverage would be appropriate, such as only
final regulations that are determined to be ``major'' under the
Congressional Review Act, or ``economically significant'' under E.O.
12866. EPA also requests comment on whether certain categories of
regulations should be excluded from coverage, such as those that merely
reaffirm an existing standard, or some other category. For instance, we
request comment on whether the provisions of the proposed rule should
apply to individual party adjudications, enforcement activities, or
permit proceedings when EPA determines that these provisions are
practical and appropriate and that the actions are scientifically or
technically novel or likely to have precedent-setting influence on
future actions. EPA seeks comment on whether the Agency should apply
the provisions of the proposed rule to these actions or to specific
types of actions within these categories. The Agency also seeks comment
on whether other agency actions, beyond significant final regulatory
actions under E.O. 12866, should be included, such as site-specific
permitting actions or non-binding regulatory determinations.
    EPA solicits comment on the definitions of ``pivotal regulatory
science,'' and ``dose response data and models'' and how to implement
such definitions.
    EPA also solicits comment on how to incorporate stronger data and
model access requirements into the terms and conditions of cooperative
agreements and grants. EPA solicits comments on how it can build upon
other federal agencies' policies regarding grantee and cooperator
requirements for data access and data sharing. EPA also solicits
suggestions for a platform that would enable the Agency to implement
the provisions of this proposal related to increasing public access to
EPA-funded data. EPA also seeks comment on methodologies and
technologies designed to provide protected access to identifiable and
sensitive data, such as individual health data, and on commenters
experience with the use of such methodologies and technologies and
their strengths and limitations. Similarly, EPA seeks comment on how to
balance appropriate protection for copyrighted or confidential business
information, including where protected by law, with requirements for
increased transparency of pivotal regulatory science. EPA also requests
comment on whether there are other compelling interests besides
privacy, confidentiality, national and homeland

security that may require special consideration when data is being
released.
    EPA solicits comment on implementation of the proposed regulation,
including which parts of the Agency should be responsible for carrying
out these requirements. EPA seeks comment on the effective date of a
rule as well as on whether the Agency should seek to phase-in the
requirements for certain significant regulatory actions or seek to
prioritize specific actions. For regulatory programs, like the National
Ambient Air Quality Standards program, in which future significant
regulatory actions may be based on the administrative record from
previous reviews--particularly where the governing statute requires
repeated review on a fixed, date-certain cycle--EPA seeks comment on
the manner in which this proposed rule should apply to that previous
record. EPA also solicits comments on whether and how the proposed rule
should apply to dose response data and models underlying pivotal
regulatory science if those data and models were developed prior to the
effective date. In addition, EPA seeks comment on how the prospective
or retrospective application of the provisions for dose response data
and models or pivotal regulatory science could inadvertently introduce
bias regarding the timeliness and quality of the scientific information
available. EPA seeks comment on how to address a circumstance in which
EPA has a statutory requirement to make a determination for which
scientific information publicly available in a manner sufficient for
independent validation does not exist. EPA also seeks comment on any
additional implementation challenges not discussed in this notice that
commenters may be aware of as well as suggestions for addressing them.
    The proposed rule includes a provision allowing the Administrator
to exempt significant regulatory decisions on a case-by-case basis if
he or she determines that compliance is impracticable because it is not
feasible to ensure that all dose response data and models underlying
pivotal regulatory science are publicly available in a fashion that is
consistent with law, protects privacy and confidentiality, and is
sensitive to national and homeland security, or in instances where
OMB's Information Quality Bulletin for Peer Review provides for an
exemption (Section IX). The agency requests comment on whether these
exemptions are appropriate, and on whether there are other situations
in which specific significant regulatory actions, or specific
categories of significant regulatory actions should be exempted.
    EPA also requests comment on whether the disclosure requirements
applicable to dose response data and models in the proposed rule should
be expanded to cover other types of data and information, such as for
example economic and environmental impact data and models that are
designed to predict the costs, benefits, market impacts and/or
environmental effects of specific regulatory interventions on complex
economic or environmental systems.

IV. Statutory and Executive Orders Reviews

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.
    EPA believes the benefits of this proposed rule justify the costs.
The benefits of EPA ensuring that dose response data and models
underlying pivotal regulatory science are publicly available in a
manner sufficient for independent validation are that it will improve
the data and scientific quality of the Agency's actions and facilitate
expanded data sharing and exploration of key data sets; this is
consistent with the conclusions of the National Academies \23\ This
action should be implemented in a cost-effective way and is consistent
with recent activities of the scientific community and other federal
agencies, which will help to lower costs of implementation. The
proposed rule directs EPA to make all reasonable efforts to explore
methodologies, technologies, and institutional arrangements for making
dose response models and data underlying pivotal regulatory science
used in significant regulatory decisions available to the public in a
manner sufficient for independent validation, consistent with law and
protection of privacy, confidentiality, and national and homeland
security. However, it does not compel the Agency to make that
information available where it concludes after all such reasonable
efforts that doing so in way that complies with the law and appropriate
protections is not possible.
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    \23\ https://www.nap.edu/catalog/11434/expanding-access-to-research-data-reconciling-risks-and-opportunities.
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    By limiting the proposed rule to pivotal regulatory science for
final significant regulatory actions pursuant to E.O. 12866, the
proposed rule ensures that this standard for transparency affects a
smaller subset of regulations which are economically significant,
create inconsistency for other federal agencies, alter budgetary
impacts, or raise novel legal or policy issues. One recent analysis
found that: ``Improvements in reproducibility can be thought of as
increasing the net benefits of regulation because they would avoid
situations in which costs or benefits are wrongly estimated to occur or
in which regulatory costs are imposed without corresponding benefits. .
. .'' They concluded that ``an increase in existing net benefits from
greater reproducibility, which, if it occurred, would cover the costs
of obtaining the data and making the data available.'' \24\
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    \24\ https://www.mercatus.org/system/files/Mercatus-Lutter-Public-Access-Data-v3.pdf.
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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.

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: April 24, 2018.
E. Scott Pruitt,
Administrator.

    For the reasons set forth in the preamble, EPA proposes to add 40
CFR part 30 as follows:

PART 30--TRANSPARENCY IN REGULATORY DECISIONMAKING

0
1. Add part 30 to read as follows:

PART 30--TRANSPARENCY IN REGULATORY DECISIONMAKING

Sec.
30.1 What is the purpose of this subpart?
30.2 What definitions apply to this subpart?
30.3 How do the provisions of this subpart apply?
30.4 What requirements apply to EPA's use of studies in taking final
action?
30.5 What requirements apply to EPA's use of dose response data and
models underlying pivotal regulatory science?
30.6 What additional requirements pertain to the use of dose
response data and models underlying pivotal regulatory science?
30.7 What role does independent peer review play in this section?
30.8 How is EPA to account for cost under this subpart?
30.9 May the EPA Administrator grant exemptions to this subpart?
30.10 What other requirements apply under this subpart?

    Authority:  Clean Air Act sections 103, 301(a), 42 U.S.C. 7403,
7601(a); Clean Water Act sections 104, 501, 33 U.S.C. 1254, 1361;
Safe Drinking Water Act sections 1442, 1450(a)(1), 42 U.S.C. 300j-1,
300j-9(a)(1); Resource Conservation and Recovery Act sections
2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive
Environmental Response, Compensation, and Liability Act (as
delegated to the Administrator via Executive Order 12580) sections
115, 311, 42 U.S.C. 9616, 9660; Emergency Planning and Community
Right-To-Know Act section 328, 42 U.S.C. 11048; Federal Insecticide,
Fungicide, and Rodenticide Act sections 25(a)(1), 136r(a), 7 U.S.C.
136r(a), 136w; and Toxic Substances Control Act, as amended, section
10, 15 U.S.C. 2609.

Sec.  30.1  What is the purpose of this subpart?

    This subpart directs EPA to ensure that the regulatory science
underlying its actions is publicly available in a manner sufficient for
independent validation.

Sec.  30.2  What definitions apply to this subpart?

    As used in this subpart, all terms not defined herein shall have
the meaning given them in the Act or in subpart A; and the following
terms shall have the specific meanings given them.
    Dose response data and models means the data and models used to
characterize the quantitative relationship between the amount of dose
or exposure to a pollutant, contaminant, or substance and the magnitude
of a predicted health or environmental impact. Such functions typically
underlie pivotal regulatory science that drives the size of benefit-
cost calculations, the level of a standard, and/or the points of
departure from which reference values (reference doses or reference
concentrations) are calculated.
    Pivotal regulatory science means the specific scientific studies or
analyses that drive the requirements and/or quantitative analysis of
EPA final significant regulatory decisions.
    Regulatory decisions mean final regulations determined to be
``significant regulatory actions'' by the Office of Management and
Budget pursuant to Executive Order 12866.
    Regulatory science means scientific information, including
assessments, models, criteria documents, and regulatory impact
analyses, that provide the basis for EPA final significant regulatory
decisions.
    Research data means ``research data'' as that term is defined in
Uniform Administrative Requirements, Cost Principles, and Audit
Requirements for Federal Awards.

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

    The provisions of this subpart apply to dose response data and
models underlying pivotal regulatory science that are used to justify
significant regulatory decisions regardless of the source of funding or
identity of the party conducting the regulatory science. The provisions
of this section do not apply to physical objects (like laboratory
samples), drafts, and preliminary analyses. Except where explicitly
stated otherwise, the provisions of this subpart do not apply to any
other type of agency action, including individual party adjudications,
enforcement activities, or permit proceedings.

Sec.  30.4  What requirements apply to EPA's use of studies in taking
final action?

    EPA shall clearly identify all studies (or other regulatory
science) relied upon when it takes any final agency action. EPA should
make all such studies available to the public to the extent
practicable.

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

    When promulgating significant regulatory actions, the Agency shall
ensure that dose response data and models underlying pivotal regulatory
science 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 fashion that is consistent with law,
protects privacy, confidentiality, confidential business information,
and is sensitive to national and homeland security. Information 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. 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.
    The provisions of this section apply to dose response data and
models underlying pivotal regulatory science regardless of who funded
or conducted the underlying data, models, or other regulatory science.
The agency shall make all reasonable efforts to explore methodologies,
technologies, and institutional arrangements for making such data
available before it concludes that doing so in a manner consistent with
law and protection of privacy, confidentiality, national and homeland
security is not possible. Where data is controlled by third parties,
EPA shall work with those parties to endeavor to make the data
available in a manner that complies with this section.

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

    EPA shall describe and document any assumptions and methods used,
and should describe variability and uncertainty. EPA shall evaluate the
appropriateness of using default assumptions, including assumptions of
a linear, no-threshold dose response, on a case-by-case basis. EPA
shall clearly explain the scientific basis for each model assumption
used and present analyses showing the sensitivity of the modeled
results to alternative assumptions. When available, EPA shall give
explicit consideration to high quality studies that explore: A broad
class of parametric dose-response or concentration-response models; a
robust set of potential confounding variables; nonparametric models
that incorporate fewer assumptions; various threshold models across the
dose or exposure range; and models that investigate factors that might
account for spatial heterogeneity.

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

    EPA shall conduct independent peer review on all pivotal regulatory
science used to justify regulatory decisions, consistent with the
requirements of the OMB Final Information Quality Bulletin for Peer
Review (70 FR 2664) 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.

Sec.  30.8  How is EPA to account for cost under this subpart?

    EPA shall implement the provisions of this subpart in a manner that
minimizes costs.

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

    Yes. The Administrator may grant an exemption to this subpart on a
case-by-case basis if he or she determines that compliance is
impracticable because:
    (a) It is not feasible to ensure that all dose response data and
models underlying pivotal regulatory science is publicly available in a
manner sufficient for independent validation, in a fashion that is
consistent with law, protects privacy, confidentiality, confidential
business information, and is sensitive to national and homeland
security; or
    (b) It is not feasible to conduct independent peer review on all
pivotal regulatory science used to justify regulatory decisions for
reasons outlined in OMB Final Information Quality Bulletin for Peer
Review (70 FR 2664), Section IX.

Sec.  30.10  What other requirements apply under this subpart?

    EPA shall implement the provisions of this section consistent with
the definition of ``research data'' in Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for Federal
Awards, exemptions in Public Law 89-487, and other applicable federal
laws. Where appropriate, data sharing agreements and state-of-the-art
data-masking techniques may be employed to facilitate access to
information.

[FR Doc. 2018-09078 Filed 4-27-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46224-46226]
[DOCID:fr11au06-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0530; FRL-8076-7]

Pyridalyl; Receipt of Application for Emergency Exemption,
Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received a specific exemption request from the Georgia
Department of Agriculture to use the pesticide pyridalyl (CAS No.
179101-81-6) to treat up to 32,000 acres of Brassica leafy vegetables
and turnip greens to control diamondback moth larvae. The Applicant
proposes the use of a new chemical which has not been registered by the
EPA. EPA is soliciting public comment before making the

decision whether or not to grant the exemption.

DATES: Comments must be received on or before August 28, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0530, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0530. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

What Action is the Agency Taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the Administrator determines that emergency
conditions exist which require the exemption. The Georgia Department of
Agriculture has requested the Administrator to issue a specific
exemption for the use of pyridalyl on

Brassica leafy vegetables and turnip greens to control diamondback moth
larvae. Information in accordance with 40 CFR part 166 was submitted as
part of this request.
    As part of this request, the Applicant asserts that, the available
alternative controls are no longer providing adequate control, and
asserts that resistance to some of them may be developing. The
Applicant claims that another control chemical is needed to use in
rotation with registered materials, to maintain season long control of
the diamondback moth in these crops, and that without adequate control,
significant economic losses will be suffered.
    The Applicant proposes to make no more than 4 applications of
pyridalyl, at a rate of up to 0.2 lbs. active ingredient (a.i.) per
acre (no more than 0.8 lbs. a.i. total), on up to 32,000 acres, to
Brassica leafy vegetables (including but not limited to cabbage,
collard greens, mustard greens, kale) and turnip greens, in Georgia,
for use year round, resulting in use of up to a total of 25,600 lbs.
a.i. total.
    This notice does not constitute a decision by EPA on the
application itself. The regulations governing section 18 of FIFRA
require publication of a notice of receipt of an application for a
specific exemption proposing use of a new chemical (i.e., an active
ingredient) which has not been registered by the EPA. The notice
provides an opportunity for public comment on the application.
    The Agency, will review and consider all comments received during
the comment period in determining whether to issue the specific
exemption requested by the Georgia Department of Agriculture.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 2, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-13036 Filed 8-10-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50341-50342]
[FR Doc No: 2021-19358]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1121-132]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for Temporary Variance of Flow
Requirements.
    b. Project No: 1121-132.
    c. Date Filed: August 25, 2021.
    d. Applicant: Pacific Gas and Electric Company (licensee).
    e. Name of Project: Battle Creek Hydroelectric Project.
    f. Location: The project is located on Battle Creek and its
tributaries in Shasta and Tehama counties, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Ms. Megan Young, License Coordinator, Pacific
Gas and Electric Company, Mail Code: N11D, P.O. Box 770000, San
Francisco, CA 94177, Phone:<PHONE_NUMBER>.
    i. FERC Contact: John Aedo,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: September 21, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.

Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-1121-132. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests a temporary
variance of the minimum flow requirements at three project locations,
including North Fork Battle Creek below North Battle Creek Dam, North
Fork Battle Creek below Macumber Reservoir, and Battle Creek below
Coleman Powerhouse. Specifically, the licensee requests Commission
approval to reduce flows below North Battle Creek Reservoir and
Macumber Reservoir from a 0.3 cubic feet per second (cfs) instantaneous
requirement to a 24-hour average flow. Similarly, the licensee proposes
to reduce flows in Battle Creek from a 150 cfs instantaneous minimum
flow to a 24-hour average flow. The licensee states that the flow
modification would conserve limited water resources during the current
drought conditions and to maintain reservoir elevation and water
quality in project reservoirs. The licensee requests the variance
through October 31, 2021.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: September 1, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-19358 Filed 9-7-21; 8:45 am]
BILLING CODE 6717-01-P