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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations
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regulatory action publicly available to the extent practicable using standards for protecting identifiable information.
Fourth, the EPA is establishing requirements for the independent peer review of pivotal science.
Fifth, the EPA is finalizing a provision that provides criteria for the Administrator to consider when granting case-by-case exemptions to the requirements of this rule.
The EPA is also defining the following terms for the purposes of this rule: data, dose-response data, independent validation, influential scientific information, pivotal science, publicly available, reanalyze, science that serves as the basis for informing a significant regulatory action, and significant regulatory actions.
Finally, the EPA intends to issue implementation guidelines that will help execute this final rule consistently across programs. This may include the process for designating key studies as pivotal science, documenting the availability of dose-response data, and requesting an Administrators exemption.
C. What is the Agencys authority for taking this action?
The EPA is authorized to issue this rule under its authority to promulgate housekeeping regulations governing its internal affairs hereinafter, housekeeping authority. This final rule describes how the EPA will determine the consideration to afford pivotal science of the EPAs final significant regulatory actions and influential scientific information based on the availability of the underlying dose-response data and other applicable factors. This rule exclusively pertains to the internal practices of the EPA and does not regulate the conduct or determine the rights or obligations of any entity outside the Federal Government.
The Federal Housekeeping Statute 5
U.S.C. 301 provides that the head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. As the Supreme Court discussed in Chrysler Corp. v. Brown, the intended purpose of section 301 was to grant early Executive departments the authority to govern internal departmental affairs. 2 As the Supreme 2 Chrysler Corp. v. Brown, 441 U.S. 281, 309
1979.

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Court further explained, section 301
authorizes what the Administrative Procedure Act terms rules of agency organization, procedure or practice as opposed to substantive rules. 3
While the EPA is not one of the Executive departments referred to in 5 U.S.C. 101, the EPA gained housekeeping authority equivalent to that granted to Executive departments in section 301 through the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 July 9, 1970, which created the EPA. The Reorganization Plan established the Administrator as head of the agency, transferred functions and authorities of various agencies and Executive departments to the EPA, and gave the EPA the authority to promulgate regulations to carry out the transferred functions.
Section 2a18 of the Reorganization Plan transferred to the EPA functions previously vested in several agencies and Executive departments including the Departments of the Interior and Agriculture. Section 2a9 also transferred so much of the functions of the transferor officers and agencies as is incidental to or necessary for the performance by or under the Administrator of the functions transferred and provided that the transfers to the Administrator made by this section shall be deemed to include the transfer of authority, provided by law, to prescribe regulations relating primarily to the transferred functions. The Federal Housekeeping Statute was existing law at the time the Reorganization Plan was enacted. Further, the Reorganization Plan does not limit the authority to promulgate regulations only to the transferred functions, but rather it transfers all authority that relates to the transferred functions. Housekeeping authority is ancillary to the transferred functions because it allows the EPA to establish standard, internal procedures that are necessary to carry out and support those functions. Accordingly, the concomitant Federal housekeeping authority to issue procedural rules was transferred to the EPA.
The Office of Legal Counsel has opined that the Reorganization Plan conveys to the EPA Administrator all of the housekeeping authority available to other department heads under section 301 and demonstrates that Congress has vested the Administrator with the authority to run EPA, to exercise its functions, and to 3 Id.

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issue regulations incidental to the performance of those functions. 4
Courts have recognized the EPA as an agency with Federal housekeeping authority. The U.S. Court of Appeals for the Second Circuit, in EPA v. General Elec. Co., 197 F.3d 592, 595 2nd Cir.
1999, found that the Federal Housekeeping Statute, 5 U.S.C. 301, authorizes government agencies such as the EPA to adopt regulations regarding the custody, use, and preservation of agency records, papers, and property. The U.S. Court of Appeals for the Fourth Circuit, in Boron Oil Co.
v. Downie, 873 F.2d 67, 69 4th Cir.
1989, held that the district court had exceeded its jurisdiction when it had compelled testimony contrary to duly promulgated EPA regulations, which the EPA argued were authorized by section 301. The Second and Fourth Circuits did not directly address whether the EPA was an Executive department, but rather recognized that the EPA has the authority to issue regulations governing its internal affairs and assumed that authority comes from section 301. Indeed, if the EPA did not possess housekeeping authority, the EPA would not be able to efficiently carry out its daily functions, which would in turn compromise the EPAs ability to exercise its duties as a Federal regulatory agency.
On April 30, 2018, the EPA published the Strengthening Transparency in Regulatory Science Proposed Rulemaking 2018 proposed rule, Ref.
5. The 2018 proposed rule cites as authority several environmental statutes that the EPA administers: The Clean Air Act CAA; the Clean Water Act CWA;
the Safe Drinking Water Act SDWA;
the Resource Conservation and Recovery Act RCRA; the Comprehensive Environmental Response, Compensation, and Liability Act CERCLA; the Federal Insecticide, Fungicide, and Rodenticide Act FIFRA; the Emergency Planning and Community Right-To-Know Act EPCRA; and the Toxic Substances Control Act TSCA. Subsequently, on May 25, 2018, the EPA published a document extending the comment period and announced a public hearing on the 2018 proposed rule to be held on July 18, 2018 Ref. 6. That document identified 5 U.S.C. 301 as a source of authority in addition to those statutes cited in the 2018 proposed rule.
On March 18, 2020, in the Federal Register at 85 FR 15396, the EPA
4 Authority of EPA to Hold Employees Liable for Negligent Loss, Damage, or Destruction of Government Personal Property, 32 O.L.C. 79, 2008
WL 4422366 at 4 May 28, 2008 OLC Opinion.

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