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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 40. Field, S.M. et al. 2019. When and Why to Replicate: As Easy as 1, 2, 3? Collabra:
Psychology, 51: 46. Available at https
doi.org/10.1525/collabra.218.
41. Hardwicke, T., Tessler, M., Peloquin, B., and Frank, M. 2018. A Bayesian decision-making framework for replication. Behavioral and Brain Sciences, 41, E132. Available at https
doi.org/10.1017/s0140525x18000675.
42. U.S. EPA. 2020. Freedom of Information Act Annual Report Fiscal Year 2019.
Washington, DC: U.S. Environmental Protection Agency. Available at https
www.epa.gov/foia/epa-foia-annualreport-2019.
43. FDA Food and Drug Administration.
2011. Advancing Regulatory Science at FDA. Available at https www.fda.gov/
science-research/advancing-regulatoryscience/strategic-plan-regulatoryscience.
44. U.S. EPA. 2015. Peer Review Handbook, 4th Edition. EPA/100/B15/001.
Washington, DC: U.S. Environmental Protection Agency. Available at https
www.epa.gov/sites/production/files/
2020-08/documents/epa_peer_review_
handbook_4th_edition.pdf.

V. Statutory and Executive Orders Reviews Additional information about these statutes and Executive orders can be found at https www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget OMB for review. Any changes made in response to OMB recommendations have been documented in the docket. The EPA
does not anticipate that this rulemaking will have an economic impact on regulated entities.
B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs This action is not subject to Executive Order 13771 because this final rule is a rulemaking of agency organization, procedure, or practice.

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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
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entities. This action does not regulate any entity outside the Federal Government.
E. Unfunded Mandates Reform Act UMRA
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 15311538, 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 2202 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 within the meaning of Executive Order 13211. It is not likely to have a significant adverse effect on the supply, distribution or use of energy, and it has not otherwise been designated as a significant energy action by the Administrator of the Office of Information and Regulatory Affairs OIRA.
J. National Technology Transfer and Advancement Act NTTAA
This rulemaking does not involve technical standards.

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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.
L. Congressional Review Act CRA
This rule is exempt from the CRA
because it is a rule of agency organization, procedure or practice that does not substantially affect the rights or obligations of non-agency parties.
List of Subjects in 40 CFR Part 30
Environmental protection, Administrative practice and procedure, Reporting and recordkeeping requirements.
Andrew Wheeler, Administrator.

For the reasons set forth in the preamble, the EPA is adding 40 CFR
part 30 to read as follows:

PART 30TRANSPARENCY IN
SIGNIFICANT REGULATORY ACTIONS
AND INFLUENTIAL SCIENTIFIC
INFORMATION
Sec.
30.1
30.2
30.3

What is the purpose of this part?
What definitions apply to this part?
How do the provisions of this part apply?
30.4 What requirements apply to the EPAs use of studies in significant regulatory actions?
30.5 What requirements apply to the EPAs use of dose-response data underlying pivotal science?
30.6 What role does independent peer review have in this part?
30.7 May the EPA Administrator grant exemptions to this part?
Authority: 5 U.S.C. App.; Pub. L. 9880, 84
Stat. 2086.
30.1

What is the purpose of this part?

This part directs the EPA to give greater consideration to pivotal science when the underlying dose-response data are available in a manner sufficient for independent validation.
30.2

What definitions apply to this part?

For the purposes of this part:
Data means the set of recorded factual material commonly accepted in the scientific community as necessary to validate research findings in which obvious errors, such as keystroke or coding errors, have been removed and that is capable of being analyzed by either the original researcher or an independent party.

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