[Federal Register Volume 83, Number 83 (Monday, April 30, 2018)]
[Proposed Rules]
[Pages 18768-18774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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; (202) 564-0221; 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

[[Page 18769]]

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

[[Page 18770]]

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

[[Page 18771]]

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

[[Page 18772]]

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

[[Page 18773]]

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

[[Page 18774]]

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]
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