Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain GE CF34-1A, CF34-3A, CF34-3A1, CF34-3A2, CF34-3B, and CF34-3B1 model turbofan engines. The NPRM published in the Federal Register on October 15, 2019 (84 FR 55073). The NPRM was prompted by an in-flight failure of a fan blade that led to an in-flight shutdown. The NPRM proposed to require removal and replacement of the affected fan blades. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA considered the comment received. An individual commenter supported the NPRM.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed.

The FAA reviewed GE Service Bulletin (SB) CF34-BJ S/B 72-0306, dated September 27, 2017, and GE SB CF34-AL S/B 72-0314, dated September 27, 2017. GE SB CF34-BJ S/B 72-0306 describes procedures for removal and replacement of affected fan blades installed on CF34-1A, -3A, -3A1, -3A2, and -3B model turbofan engines. GE SB CF34-AL S/B 72-0314 describes procedures for removal and replacement of affected fan blades installed on CF34-3A1 and -3B1 model turbofan engines. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA also reviewed GE SB CF34-AL S/B 72-0148, Revision 05, dated July 23, 2015; and GE SB CF34-BJ S/B 72-0123, Revision 04, dated October 21, 2015. GE SB CF34-AL S/B 72-0148 describes procedures for repair of fan blades installed on GE CF34-3A1 and -3B1 model turbofan engines. GE SB CF34-BJ S/B 72-0123 describes procedures for repair of fan blades installed on GE CF34-1A, -3A, -3A1, -3A2, and -3B model turbofan engines.

The FAA estimates that this AD affects 121 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

I. Introduction

1. By this instant final action, the Commission is amending form FERC-730, originally adopted in Order No. 679. 1 This form must be filed on an annual basis by public utilities that have been granted incentive rate treatment for transmission projects. 2 This instant final action does not amend or modify the text of the Code of Federal Regulations nor does it amend or modify the information collected by the form. This instant final action imposes no new reporting or other obligations on public utilities or on the public. Rather, at the request of the Office of Management and Budget (OMB), this instant final action clarifies the instructions to the form, as explained below.

2. On July 20, 2006, the Commission promulgated Order No. 679, which, pursuant to section 219 of the Federal Power Act (FPA), 3 provides incentives for transmission infrastructure investment. 4 The Commission determined that it needed to collect certain data in order to meet the objectives of section 219, thus, the Commission adopted the reporting requirement FERC-730. 5 The form was included as an appendix to the rule, 6 but the form itself was not codified in the Commission's regulations. 7

3. The Commission is amending form FERC-730 at the request of OMB, 8 to ensure compliance with the Administrative Procedure Act and the Paperwork Reduction Act of 1995 (PRA). 9 Specifically, the Commission is clarifying the filing instructions. The Commission is not, however, changing the data being collected. Public utilities subject to filing form FERC-730 will not be compelled to file new, additional, or different information. 10 The frequency of filing will also remain unchanged.

4. Examples of changes to the instructions include inserting headers, incorporating instructions for eFiling, minor edits to make existing instructions clearer, and adding information about the PRA. These changes have no impact on the obligations of filers, but rather serve to improve the form and ensure compliance with Federal law. The revised form FERC-730 is attached to this Order. It will be posted in the Commission's eLibrary but will not be published in the Federal Register or Code of Federal Regulations.

5. OMB's regulations require approval of certain information collection requirements imposed by agency rules. 11 OMB has previously assigned this information collection OMB Control Number 1902-0239. The clarifications to the instructions in this order will be submitted to OMB to supplement the pending review and request for approval. Respondents subject to the filing requirements of this action will not be penalized for failing to respond to this collection of information unless the collection of information displays a valid OMB control number. Interested persons may obtain information on the reporting requirements by contacting: Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director, Phone: (202) 502-8663, email: ellen.brown@ferc.gov ].

6. This instant final action results in no new, additional, or different public reporting burden. The public reporting burden will be the same as originally determined and discussed in Order No. 679. 12 This instant final action does not require public utilities to file new, additional, or different information, and it does not change the frequency with which they must file.

7. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 13 Issuance of this final action does not represent a major Federal action having a significant adverse effect on the human environment under the Commission's regulations implementing the National Environmental Policy Act of 1969. Part 380 of the Commission's regulations lists exemptions to the requirement to draft an Environmental Analysis or Environmental Impact Statement. Included is an exemption for rules that are clarifying, corrective, or procedural or that do not substantially change the effect of the regulations being amended. 14 This rulemaking is exempt under that provision.

8. The Regulatory Flexibility Act of 1980 (RFA)  15 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. This instant final action clarifies the instructions of form FERC-730, without creating any additional requirements for filers. The Commission certifies that it will not have a significant economic impact upon participants in Commission proceedings. An analysis under the RFA is therefore not required.

9. In addition to publishing the instant final action without the form itself in the Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page ( http://www.ferc.gov ) and in Commission's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE, Room 2A, Washington, DC 20426.

10. From the Commission's Home Page on the internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

11. User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at ferconlinesupport@ferc.gov, or the Public Reference Room at (202) 502- 8371, TTY (202) 502-8659. Email the Public Reference Room at public.referenceroom@ferc.gov.

12. The Commission is issuing this document as an instant final action without a period for public comment. Under 5 U.S.C. 553(b)(3), notice and comment procedures are unnecessary when the agency finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. This instant final action is such a rulemaking, as it merely clarifies the instructions of form FERC-730 to ensure that they are unambiguous and comply with relevant federal law. This instant final action does not require public utilities to file new, additional, or different information, and it does not change the frequency with which they must file. This instant final action does not render a determination concerning the rights or interests of affected parties, and it will not significantly affect public utilities or the general public.

13. This action is effective April 10, 2020. The Commission requires public utilities that have been granted incentive rate treatment for transmission projects to file a Form 730 by April 18th of each year. 16 The changes adopted in this instant final action will be effective for the filings due April 18, 2020.

Background

In response to the rapid evolution of substances structurally related to fentanyl on the illicit drug market, the former Acting Administrator of DEA published a temporary scheduling order placing fentanyl-related substances, as defined in the order, in schedule I of the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 United States Code (U.S.C.) 811(h)(1). 83 FR 5188, February 6, 2018. That order was effective on the date of publication, and was based on findings by the former Acting Administrator that the temporary scheduling of these substances was necessary to avoid an imminent hazard to the public safety. The temporary scheduling order was codified at 21 Code of Federal Regulations (CFR) 1308.11(h)(30). Under 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related substances was set to expire two years from the effective date of the scheduling order, i.e., on February 6, 2020.

On February 6, 2020, the President signed the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act into law as Public Law 116-114. Section 2 of this Act stated, “notwithstanding any other provision of law, [21 CFR 1308.11(h)(30)] shall remain in effect until May 6, 2021.” Public Law 116-114 thereby ensured that there was no lapse in the temporary placement in schedule I of fentanyl-related substances. In other words, by operation of law, the temporary placement in schedule I of fentanyl-related substances that began on February 6, 2018, has continued uninterrupted and will remain in effect until May 6, 2021, unless DEA permanently places such substances in schedule I prior to May 6, 2021.

The February 6, 2018, temporary order placed fentanyl-related substances in 21 CFR 1308.11(h)(30). As discussed above, this order was set to expire on February 6, 2020, but that expiration date was overridden by Congress through enactment of Public Law 116-114. However, the CFR has not yet been updated to reflect the new expiration date. Rather, the reference to fentanyl-related substances in 21 CFR 1308.11(h)(30) was removed from the electronic version of the CFR after February 6, 2020—even though fentanyl-related substances remained in schedule I by virtue of Public Law 116-114. In accordance with the public law, paragraph (h)(30) is hereby being put back into the CFR, along with the new expiration date of May 6, 2021.

For the reasons set out above, 21 CFR part 1308 is corrected by making the following correcting amendment:

On April 1, 2020, the National Labor Relations Board published a final rule making three amendments to its rules and regulations governing the filing and processing of petitions for a Board-conducted representation election and proof of majority support in construction-industry collective-bargaining relationships. The Board made the rule effective on June 1, 2020.

The Board has determined that a delayed effective date is required to allow the Board's employees and stakeholders to focus on continuity of their operations during the national emergency concerning the Coronavirus pandemic during the next several months, rather than on implementing and understanding the Board's new rule. Therefore, the Board hereby delays the effective date of the rule to July 31, 2020.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C.) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking.

For the following reasons, the Board finds that notice and comment would be impracticable, unnecessary, and contrary to the public interest for this document delaying the effective date of its final rule. First, given the ongoing pandemic and national emergency, the Board believes that regulated entities should be focused on mitigating the pandemic's serious ramifications and on understanding their significant responsibilities and obligations under the pandemic relief laws enacted by Congress in the last month. 1 They should not be required to expend human capital resources reviewing the rule to ensure they understand the substantive changes, as the rule contemplates, or to adjust to the rule's new obligations. 85 FR at 18397. Given the immediate need to provide the Board's regulated entities with certainty regarding the delayed timing of their responsibilities and obligations under the new rule, submitting this short delay in the rule's effective date to notice and comment would be impractical and contrary to the public interest, per 5 U.S.C. 553(b)(3)(B).

Second, the Board concludes that proceeding directly to final rule is appropriate because notice and comment is unnecessary under the circumstances. The Board believes that this change is in the nature of a minor, technical correction. The Board issued its rule on April 1, 2020, only 5 days ago; therefore, the change in effective date is almost contemporaneous with the rule itself. It is therefore unlikely any parties will have relied on the rule to their detriment, and the minor amendment to the effective date of the rule merely extends the status quo for an additional 60 days. Moreover, the Board's initial choice of effective date, June 1, 2020, was discretionary; the Board did not propose an effective date in the NPRM, nor did it receive any comments suggesting one. Given this swift correction, the Board concludes that notice and comment is unnecessary to extend the effective date an additional 60 days, or to July 31, 2020.

The Department of Labor published a temporary rule in the Federal Register on April 6, 2020 titled, Paid Leave under the Families First Coronavirus Response Act. 85 FR 19326. The temporary rule contained an incorrect calculation of hours worked in a particular scenario (page 19329), a paragraph within the preamble describing regulatory text that was erroneously included (page 19338), along with incorrect cross references in §§ 826.20 (page 19349, in the third column), 826.22 (page 19350, second column), and 826.100(d) (page 19355, first column) of the regulatory text. Additionally, the Department is inserting omitted titles in § 826.30(d) and (e) (page 19352, first column); inserting a comma in § 826.30(b)(3) to make a citation more accurate (page 19351, second column); correcting the reference to 5102(a)(2) in § 826.30(c)(1)(iii) (page 19351, third column); and making two corrections to the text of § 826.50(d) (page 19353, second column). The Department is capitalizing a defined term for consistency with the remainder of the definition section (page 19348, third column). Finally, the Department is correcting a date in § 826.70(e) and deleting § 826.70(f) (page 19354, first and second columns) to be consistent with the remainder of the regulations. This action makes the necessary corrections in the regulatory text and preamble.

In rule FR Doc. 2020-07237, published on April 6, 2020 (85 FR 19326), make the following corrections:

1. On page 19329, in the first column, correct by revising “7.5 hours” to “6.5 hours.”

2. On page 19338, in the second column, under “III. Discussion” part G is corrected by deleting the final paragraph under the heading “G. Leave to Care for a Child Due to School or Place of Care Closure or Child Care Unavailability—Intersection between the EFMLEA and the FMLA”.

For the reasons set out in the preamble, the Department of Labor corrects 29 CFR part 826 by making the following correcting amendments:

Electronic Availability

This document and additional information concerning OFAC are available on OFAC's website ( www.treasury.gov/ofac ).

On November 4, 2010, OFAC issued the North Korea Sanctions Regulations, 31 CFR part 510 (75 FR 67912, November 4, 2010) (the “Regulations”). Since then, OFAC has amended the Regulations several times. This rule amends the Regulations to incorporate the Treasury-administered provisions of the North Korea Sanctions and Policy Enhancement Act of 2016, Public Law 114-122, 130 Stat. 93 (22 U.S.C. 9201-9255) (NKSPEA), as amended by the Countering America's Adversaries Through Sanctions Act, Public Law 115-44, 131 Stat. 886 (22 U.S.C. 9201 et seq. ) (CAATSA) and the National Defense Authorization Act for Fiscal Year 2020, Public Law 116-92, 133 Stat. 1198 (FY 2020 NDAA).

On February 18, 2016, the President signed NKSPEA into law. Among other things, section 104 of NKSPEA provides that the President, with certain exceptions, shall block and prohibit all transactions in property and interests in property that are in the United States, that come within the United States, or that are or come within control or possession of a U.S. person of: The Government of North Korea, the Workers' Party of Korea, and other persons the President determines knowingly engage in certain North Korea-related activities.

On August 2, 2017, the President signed CAATSA into law. Title III of CAATSA, among other things, amends NKSPEA. Section 311(a) of CAATSA amends section 104(a) of NKSPEA to provide that the President shall, with certain exceptions, block and prohibit all transactions in property and interests in property that are in the United States, that come into the United States, or that are or come into the possession of U.S. persons of any person the President determines knowingly, directly or indirectly, imports, exports, or reexports to or from North Korea any defense article or defense service or engages in certain other North Korea-related activities. Section 104(b) of NKSPEA provides that the President may, with certain exceptions, block any person that knowingly engages in, contributes to, assists, sponsors, or provides financial, material, or technological support for, or goods and services in support of, any sanctioned person.

On December 20, 2019, the President signed the FY 2020 NDAA. Title LXXI of the 2020 NDAA, titled the “Otto Warmbier North Korea Sanctions and Enforcement Act of 2019,” among other things, amends NKSPEA by adding new sections 104(g), 201B, and 201C. NKSPEA section 104(g) requires the President to designate any person that he determines knowingly engages in certain specified North Korea-related activities.

New section 201B of NKSPEA requires the Secretary of the Treasury to impose sanctions with respect to any foreign financial institution (FFI) that the Secretary of the Treasury determines, in consultation with the Secretary of State, knowingly on or after April 18, 2020, provides significant financial services to any person designated for the imposition of sanctions with respect to North Korea under NKSPEA subsections 104(a), 104(b), or 104(g), an applicable Executive order, or an applicable United Nations Security Council resolution. Section 201B provides that the Secretary may impose blocking sanctions on such FFIs, or may prohibit or impose strict conditions on the opening or maintenance of a correspondent account or a payable-through account in the United States.

New section 201C of NKSPEA requires the Secretary of the Treasury, in consultation with the Secretary of State, to prohibit an entity owned or controlled by a U.S. financial institution and established or maintained outside the United States from knowingly engaging in any transaction, directly or indirectly, with the Government of North Korea or any person designated for the imposition of sanctions with respect to North Korea under NKSPEA subsections 104(a), 104(b), or 104(g), an applicable Executive order, or an applicable United Nations Security Council resolution.

With this rule, OFAC is incorporating the blocking and correspondent or payable-through account sanctions contained in sections 104(a), 104(b), 104(g), and 201B of NKSPEA, as amended by CAATSA and the FY 2020 NDAA (NKSPEA, as amended), into the Regulations as new § 510.201(a)(3)(vii) through (x), respectively. OFAC is incorporating the correspondent or payable-through account sanctions of section 201B of NKSPEA, as amended, in § 510.210(c), and adding a new provision at § 510.214 to implement section 201C of NKSPEA, as amended.

OFAC is also incorporating certain statutory exemptions under NKSPEA, as amended, in new paragraph (f) to § 510.213; amending the definition of luxury goods at § 510.317 to create a regulatory exception to exclude items approved for import, export, or reexport to or into North Korea by the United Nations Security Council; making technical and conforming edits to the definitions of “effective date” in § 510.304, “financial, material, or technological support” in § 510.306, and “North Korean person” in § 510.319; amending the interpretive provision at § 510.413 related to significant transactions; updating the authorities section of the Regulations to incorporate the FY 2020 NDAA and to shorten citations to conform with Federal Register guidance; and amending the delegation section at § 510.802 to add the delegation of certain functions with respect to the FY 2020 NDAA.

Because the amendment of the Regulations involves a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 510 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

On July 22, 2019, the Coast Guard was notified of a wire crossing event that will take place on the Ohio River, between Mile Marker (MM) 731.0 & 734.0 from 7 a.m. through 6 p.m. each day from April 14, 2020, through April 23, 2020. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the wire crossing would be a safety concern for anyone within a three mile radius of the construction area. In response, on February 25, 2020, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zones; Coast Guard Sector Ohio Valley Wire Crossing (85 FR 10640). The Coast Guard invited comments on our proposed regulatory action related to this wire crossing. During the comment period that ended March 26, 2020 no comments were received.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is necessary to respond to the potential safety hazards associated with the wire crossing.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Ohio Valley (COTP) has determined that potential hazards associated with the wire crossing occuring on April 14, 2020 through April 23, 2020, will be a safety concern for anyone near the construction zone. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

As noted above, no comments were received on NPRM published February 25, 2020. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone from 7 a.m. to 6 p.m. each day, April 14, 2020 through April 23, 2020. The temporary safety zone would cover all navigable waters on the Ohio River extending from MM 731.0 to MM 734.0. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 7 a.m. to 6 p.m. wire crossing. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, and duration of the temporary safety zone. The temporary safety zone would only be in effect for 11 hours each day over ten days and limit access to a three-mile stretch of the Ohio River. The Coast Guard expects minimum adverse impact to mariners. Also, mariners would be permitted to request authorization from the COTP or a designated representative to transit the temporary safety zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone lasting 11 hours each day over 10 days, which would prohibit entry within a 3-mile stretch of the Ohio River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. We prepare a preliminary REC for these types of field regulations because the DHS Instruction Manual (and U.S. Coast Guard Environmental Planning Implementing Procedures) direct that a REC be prepared for these specified field regulations when certain conditions apply—see L59(a), L60(a), and L60(d).

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard is amending 33 CFR part 165 as follows:

In the direct final rule, EPA stated that if adverse comments were submitted by March 16, 2020, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed rule also published on February 14, 2020 (85 FR 8520). EPA will not institute a second comment period on this action.

On February 21, 2020 at 85 FR 10064 the EPA approved a request from the Indiana Department of Environmental Management (IDEM) to revise the Indiana State Implementation Plan (SIP) to incorporate the following: A new rule concerning nitrogen oxide (NO X ) emissions for the ozone season from Electric Generating Units (EGUs) and large non-EGUs; revisions concerning NO X emission rate limits for specific source categories; the repeal of the NO X Budget Trading Program; and the repeal of the Clean Air Interstate Rule (CAIR) NO X ozone season trading program. The State of Indiana submitted this revision as a modification to the SIP on August 27, 2018. In the direct final rule, EPA stated that if adverse comments were submitted by March 23, 2020, the rule would be withdrawn and not take effect. On March 23, 2020, EPA received adverse comments, and, therefore, is withdrawing the direct final rule. EPA will address the comments in a subsequent final action based upon the proposed action also published on February 21, 2020 (85 FR 10127). EPA will not institute a second comment period on this action.

Throughout this document “we,” “us,” and “our” means the EPA.

On March 12, 2008, the EPA promulgated a new NAAQS for ozone, revising the levels of primary and secondary 8-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436). More recently, on October 1, 2015, the EPA promulgated and revised the NAAQS for ozone, further strengthening the primary and secondary 8-hour standards to 0.070 ppm (80 FR 65292). The October 1, 2015 standards are known as the 2015 ozone NAAQS.

Section 110(a)(1) of the CAA directs each state to make an infrastructure SIP submission to the EPA within 3 years of promulgation of a new or revised NAAQS. Infrastructure requirements for SIPs are provided in section 110(a)(1) and (2) of the CAA. Section 110(a)(2) lists the specific infrastructure elements that a SIP must contain or satisfy. The elements that are the subject of the action are described in detail in our notice of proposed rulemaking (NPRM) published on July 29, 2019 (84 FR 36516).

Comments on our NPRM were due on or before August 28, 2019. The EPA received two substantive comments on the NPRM. The first comment, pertaining to the Colorado portion of the NPRM, was submitted by the Center for Biological Diversity (CBD); the second comment, pertaining to the North Dakota portion of the NPRM, was submitted by the Dakota Resource Council (DRC). The comments are summarized, and the EPA responds to the comments in the following paragraphs.

Comment: Commenter asserts that Colorado's Air Quality Control Commission (AQCC) did not adequately consider its comments before voting to approve Colorado's 2015 ozone infrastructure SIP for submission to the EPA. The commenter states that the AQCC admitted on the record at the public hearing that it had not reviewed its comment, including the supporting exhibits that the commenter had submitted prior to the public hearing and that Colorado's public comment period was not adequate. The commenter maintains that it is arbitrary and contrary to the public comment requirement for a state to grant an opportunity for public comment, but then admit that it did not review the submissions. The commenter acknowledges that the Colorado Air Pollution Control Division (APCD) provided verbal responses to their comments during the hearing, but characterizes these remarks as “off the cuff” statements, which were insufficient because they were not made by the decision-maker itself—the AQCC—and because the comments could only be addressed by performing new air quality modeling. 1

Response: As noted, the Colorado 2015 ozone infrastructure SIP was submitted to the EPA on September 17, 2018, following a public hearing held by the State on August 16, 2018. Subsequently, on September 17, 2019, Colorado supplemented its submission and transmitted CBD's original comment and exhibits to the EPA (available in the docket to this action).

After reviewing the comment, exhibits, and audio file of the AQCC hearing, the EPA concludes that CBD's comment fails to demonstrate that the State's public comment period was not adequate. On the date of the hearing, CBD sent an email to the State, commenting, in relevant part, “Attached are two papers I intend to discuss in my comments today on the proposed good neighbor SIP for the 2015 ozone NAAQS.” The email contained two exhibits: An article titled “Unexpected slowdown of US pollutant emission reduction in the past decade” and an article titled “Agriculture is a major source of NO X pollution in California.” At the hearing, CBD asserted that the AQCC must consider the two reports. The first report, according to CBD, “finds that the reductions of NO X ”—an ozone precursor—“are becoming much slower than what was predicted.” Thus, CBD concludes, the AQCC must “take that into account.” The second report concerns NO X emissions from agricultural fertilizer in California. While CBD acknowledges that the report addresses California, CBD claims the AQCC must determine whether agricultural emissions are adequately accounted for “in all relevant states.”

The commenter had the opportunity, at the public hearing, to explain the significance of the documents it submitted to support its oral comments and, the commenter did so. The audio record of the hearing indicates that a commissioner of the AQCC stated that because the commenter had submitted the documents shortly before the hearing, the AQCC had not had a chance to look at them. Nevertheless, a commissioner of the AQCC invited a response from “staff” to the issues raised by the commenter at the hearing. In response, a representative from the APCD stated, in part, that its interstate transport SIP submission is not designed to address other states' contributions to Colorado's nonattainment areas. A second state representative explained that Colorado's “highest value is at 0.33 [ppb of ozone?], which is less than half of the value that is deemed significant” and there would need to be a “dramatic change” to show that Colorado was significantly contributing to another state. These statements indicate that the State did consider the commenters' concerns at the public hearing, even if the State disagreed with the commenter and the relevance of the submitted documents.

CAA section 110(a) requires that each state provide “reasonable notice and public hearing” in connection with SIP submissions. The EPA's regulations further require, in part, that states provide notice and the opportunity to submit written comments. 40 CFR 51.102. Under the specific circumstances, here, although Colorado's response to the comment was not robust, the commenter has not demonstrated that Colorado's public hearing was not adequate, nor that Colorado had failed to provide an opportunity to submit comments. Despite being provided the opportunity to explain the significance of the submitted documents (either orally or in writing), the commenter's remarks about the significance of the documents were brief and general. 2 The AQCC did not ignore the commenter, but provided the commenter with an opportunity to explain concerns based on the submitted documents, apparently attended to that explanation, and invited (and received) input from APCD staff concerning the material submitted by the commenter. The commenter's suggestion that the remarks by APCD staff were speculative and meaningless and that it was necessary for Colorado to re-run modeling based on the submitted documents is not adequately supported. 3 Under the circumstances, including the commenter's very limited explanation concerning the significance of the documents submitted at the hearing, the input from APCD staff at the hearing, and the apparent nature of the documents (including that they were prepared in other contexts and not directly germane to the SIP submission at issue), Colorado not conducting additional photochemical grid modeling based on a general request to take the reports “into account” was reasonable. Given the lack of specificity in CBD's comments and with respect to the significance of the submitted documents, the agency does not agree that the public comment opportunity provided by Colorado was not adequate. It is a commenter's responsibility to make assertions with reasonable specificity during the public comment period.

Comment: Commenter asserts that the EPA must disapprove the CAA section 110(a)(2)(D)(i)(I) (interstate transport prongs 1 and 2) portion of Colorado's SIP for the 2015 ozone NAAQS because the proposed approval relied on the EPA's source-apportionment modeling for the year 2023 that was released with the EPA's March 2018 Memo. 4 The commenter states that this modeling is not reliable because the “EPA is actively working to undo a number of major rules that underpin the 2023 modeling results.” The commenter specifically cites the EPA's proposed repeal of the “Glider Rule” establishing emission requirements for glider vehicles, glider engines, and glider kits;  5 the Department of Transportation's National Highway Traffic Safety Administration (NHTSA) proposed repeal of the Corporate Average Fuel Economy (CAFE) standards for light-duty vehicles and the EPA's simultaneous proposed repeal of vehicle Greenhouse Gas (GHG) standards;  6 and the proposed withdrawal the Control Techniques Guidelines (CTG) for the oil and gas industry. 7 The commenter also cites the repeal of the Clean Power Plan and its replacement with the “more-polluting” Affordable Clean Energy (ACE) rule. The commenter states that all of these actions “erode the accuracy of EPA's 2023 modeling projections and further demonstrates the arbitrariness of EPA's reliance on that modeling to approve Colorado's Good Neighbor provision.” The commenter asserts that reliance on the modeling is arbitrary with regard to both steps 1 and 2 of the EPA's analysis because it underestimates values at downwind receptors as well as Colorado's contributions to those receptors.

The commenter also states that the EPA's 2023 modeling projections failed to account for non-air quality regulations that had been rolled back, stating without reference “both the coal combustion waste and the steam electric effluent limitation guidance rules” and “state level bailouts for dirty sources of pollution, like in Ohio.” The commenter states that “these rollbacks are designed to make dirty forms of energy more economic so that they are dispatched more, which results in more pollution.”

Response: The EPA disagrees with the commenter that its 2023 modeling projections are unreliable because of potential changes to other regulations. The EPA first notes that the Agency has not finalized proposed regulatory changes to the Glider Rule or the oil and gas CTG. The EPA's normal practice is to only include changes in emissions from final regulatory actions in its modeling because, until such rules are finalized, any potential changes in NO X or VOC emissions are speculative.

The EPA did finalize a portion of the revisions to the CAFE standards for light duty vehicles, specifically the withdrawal of the waiver the agency had previously provided to California for its GHG and Zero Emissions Vehicle programs under section 209 of the CAA. 8 This final action does not have any impact on Colorado's modeled 2023 emissions. The model year 2017-2025 GHG regulations for cars and light trucks were projected to yield small but measurable criteria and toxic emissions reductions from vehicles. Because the vehicles affected by the 2017-2025 GHG standards would still need to meet applicable criteria pollutant emissions standards ( e.g., the Tier 3 emissions standards; 79 FR 23414), the regulatory impact analysis that accompanied the proposed revision to the GHG standards estimated a very limited impact on criteria and toxic pollutant emissions (increases in upstream emissions  9 and decreases in tailpipe emissions). Moreover, the proposed SAFE Vehicles Rule specifically notes that none of the regulatory alternatives considered “would noticeably impact net emissions of smog-forming or other `criteria' or toxic air pollutants.” 83 FR 42996. Although on September 19, 2019, the EPA signed a final rule withdrawing a waiver for the State of California's GHG and zero emissions vehicle programs under CAA section 209, the EPA has not yet acted on the regulatory alternatives identified in the proposed SAFE Vehicles Rule. 10 In general, the mobile source and non-EGU emissions inventories do not reflect changes in emissions resulting from rulemakings finalized in calendar year 2016 or later, nor do they reflect any rules proposed but not yet finalized since 2016, as only finalized rules are reflected in modeling inventories.

Further, the commenter has not demonstrated that the potential changes to nationally applicable rules noted by the commenter might reasonably be expected to impact Colorado's modeled contributions to projected downwind nonattainment and maintenance receptors, to the degree that Colorado sources might contribute significantly to nonattainment or interfere with maintenance at any of these receptors. In the 2011 Cross-State Air Pollution Rule (CSAPR) and the 2016 CSAPR Update, the EPA used a threshold of one percent of the NAAQS (0.7 ppb of ozone) to determine whether a given upwind state was “linked” at step 2 of the four-step framework and would therefore contribute to downwind nonattainment and maintenance sites identified in step 1. If a state's impact did not equal or exceed the one percent threshold, the upwind state was not “linked” to a downwind air quality problem, and on this basis the EPA concluded the state will not significantly contribute to nonattainment or interfere with maintenance of the NAAQS in the downwind states.

As stated in the NPRM, the EPA's updated 2023 modeling, discussed in the March 2018 Memo, indicates that Colorado's largest impacts on any potential downwind nonattainment and maintenance receptor in the United States are 0.33 ppb and 0.27 ppb, respectively. These values are less than half of 0.70 ppb, or the value equivalent to one percent of the 2015 ozone NAAQS. 11 The commenter has not provided any information to demonstrate how ozone precursor emissions from sources located in Colorado might be expected to increase in such a way as to cause Colorado's projected impact to approach a 0.70 ppb contribution at any downwind receptor. Therefore, the EPA disagrees with the commenter that the EPA's 2023 modeling projections cannot be relied upon to conclude that emissions from Colorado will not significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.

The commenter also has not demonstrated that the potential changes to nationally applicable rules noted by the commenter might reasonably be expected to cause our 2023 modeling analysis to underestimate values at downwind receptors, and specifically to underestimate these values in such a way that would cause receptors to which Colorado contributes above 0.70 ppb to be considered nonattainment and/or maintenance in 2023. Table 1 below lists the downwind receptors in the 2023 modeling to which Colorado was projected to contribute above 0.70 ppb. As shown, none of these downwind receptors is projected to come near the nonattainment or maintenance level of 71.0 ppb. For this reason, even if downwind receptor 2023 projections were expected to increase (which we do not anticipate), such increases would be very unlikely to convert these receptors to nonattainment or maintenance for the 2015 ozone NAAQS.

Regarding the commenter's assertion that the EPA's 2023 modeling projections failed to account for non-air quality related “rules” and “bailouts,”  12 the EPA finds that the commenter has failed to provide any data or other information to show how these actions “would have a significant effect” on the EPA's modeling results. 13 Based on this particular comment's lack of both context and information, the EPA finds that the comment does not present evidence that the EPA's 2023 modeling projections are not a sufficient basis for the EPA to conclude that Colorado does not significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in the downwind states.

Comment: Commenter asserts that the EPA's reliance on the 2023 modeling projections from the March 2018 Memo was inappropriate because the Marginal attainment date for the 2015 ozone NAAQS falls before 2023, and “most of the downwind areas are marginal nonattainment areas.” The commenter explains that the EPA's use of the attainment date for Moderate areas is contrary to the good neighbor provision of section 110(a)(2)(D)(i)(I), as well as the CAA requirements for expeditious attainment of the NAAQS. Thus, the commenter concludes that the EPA must use a date in its future year modeling analysis no later than the attainment date for marginal nonattainment areas, which would both increase the number of nonattainment and maintenance receptors and increase Colorado's contribution to those receptors.

Response: The EPA disagrees with the commenter that it is inappropriate to rely on the EPA's modeling from the March 2018 Memo because our 2023 projections are aligned with the Moderate rather than Marginal attainment date for the 2015 ozone NAAQS. The EPA further notes that, even if it were appropriate to evaluate downwind air quality and upwind contributions consistent with the Marginal area attainment date of 2021, Colorado's impacts on these areas in 2021 would be similar to those projected in 2023, as detailed further below. EPA modeling in support of the CSAPR Update Rule for the 2008 ozone NAAQS projected that Colorado's largest impact to any downwind nonattainment or maintenance receptor in 2017 was 0.31 ppb. 14 As noted, in the March 2018 Memo we projected a maximum impact of 0.33 ppb to any downwind nonattainment or maintenance receptor in 2023. Both of these maximum impacts were projected at the same receptor in Tarrant County, Texas. To estimate Colorado's maximum contribution to a potential nonattainment or maintenance receptor in 2021, the EPA used a linear interpolation which calculated the average contribution from Colorado to the Tarrant County receptor using the underlying daily 2023 contribution data for the same days that were used to calculate the average contribution for 2017. Specifically, the 2017 contribution analysis included 5 days and we used the daily contributions from these same 5 days to calculate the Transport Future Year 2023 average contribution. Using this consistent methodology, the contribution from Colorado to the Tarrant County receptor in 2023 is 0.3135 ppb, virtually unchanged from the 0.3137 ppb contribution modeled in 2017. The EPA calculated the linear rate of decline for contribution from Colorado to the Tarrant County receptor to calculate a 2021 contribution of 0.3136 ppb. 15 Based on this analysis, the EPA finds it reasonable to conclude that Colorado impacts to downwind nonattainment and maintenance receptors in any years between 2017 and 2023, including 2021, would also be projected to be well below 0.70 ppb.

The EPA also believes that 2023 is an appropriate year for analysis of good neighbor obligations for the 2015 ozone NAAQS because the 2023 ozone season is the last relevant ozone season during which achieved emissions reductions in linked upwind states could assist downwind states with meeting the August 2, 2024 Moderate area attainment date for the 2015 ozone NAAQS. The EPA recognizes that the attainment date for nonattainment areas classified as Marginal for the 2015 ozone NAAQS is August 2, 2021, which currently applies in several nonattainment areas downwind of Colorado evaluated in the EPA's modeling. 16 The EPA is further cognizant of the D.C. Circuit's September 13, 2019 decision in Wisconsin v. EPA. 938 F.3d 303. In this ruling, the court addressed legal challenges to the CSAPR Update, in which the EPA partially addressed certain upwind states' prongs 1 and 2 obligations for the 2008 ozone NAAQS. While the court generally upheld the rule as to most of the challenges raised in the litigation, the court remanded the CSAPR Update to the extent it failed to require upwind states to eliminate their significant contributions in accordance with the attainment dates found in CAA section 181 by which downwind states must come into compliance with the NAAQS. Id. at 313. However, as explained below, the EPA does not believe that either the statute or applicable case law requires the evaluation of good neighbor obligations in a future year aligned with the attainment date for nonattainment areas classified as Marginal.

The good neighbor provision instructs the EPA and states to apply its requirements “consistent with the provisions of” title I of the CAA. CAA section 110(a)(2)(D)(i); see also North Carolina v. EPA, 531 F.3d 896, 911-12 (D.C. Cir. 2008). This consistency instruction follows the requirement that plans “contain adequate provisions prohibiting” certain emissions in the good neighbor provision. As the D.C. Circuit held in North Carolina, and more recently in Wisconsin, the good neighbor provision must be applied in a manner consistent with the designation and planning requirements in title I that apply in downwind states and, in particular, the timeframe within which downwind states are required to implement specific emissions control measures in nonattainment areas and submit plans demonstrating how those areas will attain, relative to the applicable attainment dates. See North Carolina, 896 F.3d at 912 (holding that the good neighbor provision's reference to title I requires consideration of both procedural and substantive provisions in title I); Wisconsin, 938 F.3d at 313-18.

While the EPA recognizes, as the court held in North Carolina and Wisconsin, that upwind emissions-reduction obligations therefore must generally be aligned with downwind receptors' attainment dates, unique features of the statutory requirements associated with the Marginal area planning requirements and attainment date under CAA section 182 lead the EPA to conclude that it is more reasonable and appropriate to require the alignment of upwind good neighbor obligations with later attainment dates applicable for Moderate or higher classifications. Under the CAA, states with areas designated nonattainment are generally required to submit, as part of their state implementation plan, an “attainment demonstration” that shows, usually through air quality modeling, how an area will attain the NAAQS by the applicable attainment date. See CAA section 172(c)(1). 17 Such plans must also include, among other things, the adoption of all “reasonably available” control measures on existing sources, a demonstration of “reasonable further progress” toward attainment, and contingency measures, which are specific controls that will take effect if the area fails to attain by its attainment date or fails to make reasonable further progress toward attainment. See, e.g., CAA section 172(c)(1); 172(c)(2); 172(c)(9). Ozone nonattainment areas classified as Marginal are excepted from these general requirements under the CAA—unlike other areas designated nonattainment under the Act (including for other NAAQS pollutants), Marginal ozone nonattainment areas are specifically exempt from submitting an attainment demonstration and are not required to implement any specific emissions controls at existing sources in order to meet the planning requirements applicable to such areas. See CAA section 182(a) (“The requirements of this subsection shall apply in lieu of any requirement that the State submit a demonstration that the applicable implementation plan provides for attainment of the ozone standard by the applicable attainment date in any Marginal Area.”)  18 Marginal ozone nonattainment areas are also exempt from demonstrating reasonable further progress towards attainment and submitting contingency measures. See CAA section 182(a) (does not include a reasonable further progress requirement and specifically notes that “Section [172(c)(9)] of this title (relating to contingency measures) shall not apply to Marginal Areas”).

Existing regulations—either local, state, or Federal—are typically a part of the reason why “additional” local controls are not needed to bring Marginal nonattainment areas into attainment. As described in the EPA's record for its final rule defining area classifications for the 2015 ozone NAAQS and establishing associated attainment dates, history has shown that the majority of areas classified as Marginal for prior ozone standards attained the respective standards by the Marginal area attainment date ( i.e., without being re-classified to a Moderate designation). 83 FR 10376. As part of a historical lookback, the EPA calculated that by the relevant attainment date for areas classified as Marginal, 85 percent of such areas attained the 1979 1-hour ozone NAAQS, and 64 percent attained the 2008 ozone NAAQS. See Response to Comments, section A.2.4. 19 Based on these historical data, the EPA expects that many areas classified Marginal for the 2015 ozone NAAQS will also attain by the relevant attainment date as a result of emissions reductions that are already expected to occur through implementation of existing local, state, and Federal emissions reduction programs. To the extent states have concerns about meeting their attainment date for a Marginal area, the CAA under section 181(b)(3) provides authority for them to voluntarily request a higher classification for individual areas, if needed.

Areas that are classified as Moderate typically have more pronounced air quality problems than Marginal areas or have been unable to attain the NAAQS under the minimal requirements that apply to Marginal areas. See CAA sections 181(a)(1) (classifying areas based on the degree of nonattainment relative to the NAAQS) and (b)(2) (providing for reclassification to the next highest designation upon failure to attain the standard by the attainment date). Thus, unlike Marginal areas, the statute explicitly requires a state with an ozone nonattainment area classified as Moderate or higher to develop an attainment plan demonstrating how the state will address the more significant air quality problem, which generally requires the application of various control measures to existing sources of emissions located in the nonattainment area. See generally CAA sections 172(c) and 182(b)-(e).

Given that downwind states are not required to demonstrate attainment by the attainment date or impose additional controls on existing sources in a Marginal nonattainment area, the EPA believes that it would be inconsistent to interpret the good neighbor provision as requiring the EPA to evaluate the necessity for upwind state emissions reductions based on air quality modeled in a future year aligned with the Marginal area attainment date. Rather, the EPA believes it is more appropriate and consistent with the nonattainment planning provisions in title I of the Act to evaluate downwind air quality and upwind state contributions, and, therefore, the necessity for upwind state emissions reductions, in a year aligned with an area classification in connection with which downwind states are also required to demonstrate attainment and implement controls on existing sources — i.e., with the Moderate area attainment date, rather than the Marginal area date. With respect to the 2015 ozone NAAQS, the Moderate area attainment date will be in the summer of 2024, and the last full year of monitored ozone-season data that will inform attainment demonstrations is, therefore, 2023.

The EPA's interpretation of the good neighbor requirements in relation to the Marginal area attainment date is consistent with the Wisconsin opinion. For the reasons explained below, the court's holding does not contradict the EPA's view that 2023 is an appropriate analytic year in evaluating good neighbor SIPs for the 2015 ozone NAAQS. The court in Wisconsin was concerned that allowing upwind emission reductions to be implemented after the applicable attainment date would require downwind states to obtain more emissions reductions than the Act requires of them, to make up for the absence of sufficient emissions reductions from upwind states. See 938 F.3d at 316. As discussed previously, however, this equitable concern only arises for nonattainment areas classified as Moderate or higher for which downwind states are required by the CAA to develop attainment plans securing reductions from existing sources and demonstrating how such areas will attain by the attainment date. See, e.g., CAA section 182(b)(1) & (2) (establishing “reasonable further progress” and “reasonably available control technology” requirements for Moderate nonattainment areas). Ozone nonattainment areas classified as Marginal are not required to meet these same planning requirements, and thus the equitable concerns raised by the Wisconsin court do not arise with respect to downwind areas subject to the Marginal area attainment date.

The distinction between planning obligations for Marginal nonattainment areas and higher classifications was not before the court in Wisconsin. Rather, the court was considering whether the EPA, in implementing its obligation to promulgate Federal implementation plans under CAA section 110(c), was required to fully resolve good neighbor obligations by the 2018 Moderate area attainment date for the 2008 ozone NAAQS. See 938 F.3d at 312-13. Although the court noted that petitioners had not “forfeited” an argument with respect to the Marginal area attainment date, see id. at 314, the court did not address whether its holding with respect to the 2018 Moderate area date would have applied with equal force to the Marginal area attainment date because that date had already passed. Thus, the court did not have the opportunity to consider these differential planning obligations in reaching its decision regarding the EPA's obligations relative to the then-applicable 2018 Moderate area attainment date because such considerations were not applicable to the case before the court. 20 For the reasons discussed here, the equitable concerns supporting the Wisconsin court's holding as to upwind state obligations relative to the Moderate area attainment date also support the EPA's interpretation of the good neighbor provision relative to the Marginal area attainment date. Thus, the EPA concludes that its reliance on an evaluation of air quality in the 2023 analytical year for purposes of assessing good neighbor obligations with respect to the 2015 ozone NAAQS is based on a reasonable interpretation of the CAA and legal precedent.

Comment: Commenter asserts that the EPA must disapprove the SIP under CAA section 110(a)(2)(E) (Adequate resources and authority) because the State of Colorado lacks adequate legal authority to regulate emissions from agriculture sources. The commenter quotes Colorado Revised Statues 25-7-109(8)(a) to state that this provision prohibits Colorado from being able to protect visibility and air quality in Class 1 areas from agricultural sources. Furthermore, the commenter asserts that the EPA must disapprove the SIP under CAA sections 110(a)(2)(D) (interstate transport prong 4) and 110(a)(2)(J) (consultation with government officials, public notification, and PSD and visibility protection) because of visibility impairment caused by agricultural emissions. Finally, the commenter also calls on the EPA to disapprove the SIP under CAA section 110(a)(2)(A) (emissions limits and other control measures) by explaining the State is unable to maintain the NAAQS because Colorado lacks the authority to control emissions from agriculture and pesticides, “even if such sources are not major stationary sources . . . .”

Response: Colorado's infrastructure SIP submission confirms that “[t]here are no state or federal provisions prohibiting the implementation of any provision of the Colorado SIP.” Specifically, Colorado cites to “general authority to adopt the rules and regulations necessary to implement the SIP” as “set out in the Colorado Air Pollution Prevention and Control Act Section 25-7-105 of the Colorado Revised Statutes (C.R.S.),” general authority to administer and enforce the program in 25-7-111, C.R.S, additional authority to regulate air pollution and implement provisions in the SIP in the Colorado Air Pollution Prevention and Control Act, Article 7 of title 25, and authority delegated under Sections 42-4-301 through 42-4-316, C.R.S. (concerning motor vehicle emissions) and 42-4-414, C.R.S. (concerning emissions from diesel-powered vehicles).

The statutory provision cited by commenter does not bar the State from carrying out its existing SIP; indeed, the provision requires regulation of agricultural, horticultural, or floricultural production, certain animal feeding operations, and pesticide application “if they are `major stationary sources', . . . or are required by Part C (prevention of significant deterioration), Part D (nonattainment), or Title V (minimum elements of a permit program) . . . .” Whether Colorado will need additional emission limitations and other control measures for areas designated nonattainment for the 2015 ozone NAAQS will be reviewed and acted upon as part of the State's attainment plan under CAA title I part D through a separate process at a later time.

While the EPA recognizes the commenter's concern about the impact of agricultural and pesticide emissions, in the context of this rulemaking, the EPA does not find the State deficient in its ability to carry out its infrastructure SIP requirements.

CAA section 110(a)(2)(D)(i)(II) (interstate transport prong 4) generally requires a SIP to contain adequate provisions prohibiting emissions within the state from “interfering with measures required to be in the applicable implementation plan for any other State under part C of this subchapter . . . to protect visibility.” Under the 2013 Infrastructure SIP guidance, 21 a state's infrastructure SIP submission may satisfy prong 4 through confirmation that the state has a fully-approved regional haze SIP. The EPA approved Colorado's Regional Haze SIP for the first implementation period for regional haze on December 31, 2012 (77 FR 76871), which the State identified to demonstrate that Colorado does not interfere with visibility in any other state. The EPA subsequently approved an update to Colorado's Regional Haze SIP on July 5, 2018, meaning that the Colorado Regional Haze SIP for the first implementation period remains fully approved (83 FR 31332). Accordingly, this is a sufficient basis on which to approve the State's prong 4 submittal here.

With respect to CAA section 110(a)(2)(J) (consultation with government officials, public notification, and PSD and visibility protection), the EPA also disagrees with the commenter. Section 110(a)(2)(J) visibility requirements do not need to be addressed in this rulemaking because a state's requirements relating to visibility protection are not affected when the EPA establishes or revises a NAAQS. As the EPA noted in the 2013 Infrastructure SIP guidance, when the EPA establishes or revises a NAAQS, the visibility requirements under Part C of title I of the CAA do not change. There are no new visibility protection requirements under Part C as a result of the revised NAAQS. Accordingly, air agencies do not need to address the visibility sub-element of Element J in an infrastructure SIP submission.

The EPA recognizes the concern for meeting visibility requirements. However, Colorado has a fully approved regional haze SIP for the first implementation period, and the EPA and states, including Colorado, along with various stakeholders have been engaged in an ongoing process of developing SIPs for the second implementation period under the regional haze regulations, 40 CFR part 51, subpart P, which are due to the EPA by July 31, 2021.

Comment: Commenter asserts that the EPA must disapprove the SIP under CAA sections 110(a)(2)(E)(i) and 110(a)(2)(L) stating that in the NPRM, the EPA fails to provide analyses that prove Colorado's resources are adequate. Commenter believes Colorado lacks adequate funding because the State “has missed the statutory deadline to make a final decision” on renewal applications for “dozens of Title V facilities” (asserting that “Colorado does not have the resources to hire enough title V permit writers.” Moreover, commenter assumes Colorado lacks adequate resources to enforce its air program because the State “has approximately 9 inspectors to inspect . . . 50,000 plus oil and gas wells.” Commenter believes Colorado's “Taxpayer Bill of Rights” (TABOR) amendment operates as a legal impediment to the State's budget that impacts its ability to implement the SIP.

Response: The EPA disagrees with the commenter's conclusions concerning the adequacy of the Colorado infrastructure SIP with respect to both CAA sections 110(a)(2)(E)(i) and (L). As stated in the NPRM, CAA section 110(a)(2)(E)(i) requires that each SIP provides, in part, “necessary assurances that the State . . . will have adequate personnel, funding, and authority under State . . . law to carry out such implementation plan” and CAA section 110(a)(2)(L) requires that each state have a permit fee program (although the requirement is suspended when the EPA approves the state's title V fee program, which does not need to be approved into the SIP).

With respect to CAA section 110(a)(2)(E)(i), the EPA evaluates the submitting state's infrastructure SIP submission for evidence that the state has adequate resources. Element E does not require an audit of resources or personnel. As stated in the NPRM for this action, Colorado's infrastructure SIP submission for the 2015 ozone NAQQS indicated that “[t]he Divison has staff and annual budget to operate its six programs (Stationary Sources, Mobile Sources, Indoor Environment, Technical Services, Planning and Policy, Administrative Services).” Further, the Division employed 176 people and had a budget of about $18 million for fiscal year 2018. Of the total budget, about 17 percent was derived from Federal grants, 30 percent from mobile source fees, 50 percent from stationary source fees, and 3 percent from other cash sources. These budget and staff levels have been consistent over the past number of years and over these years Colorado has been able to meet its statutory commitments, including submitting the required air quality data, attainment plans, and monitoring networks. 22

Commenter expresses specific concerns that Colorado “has approximately 9 inspectors to inspect its 50,000 plus oil and gas wells,” and concludes from this that the State “lacks the resources to adequately enforce its air program.” In general, the EPA believes that questions about the specific number of inspectors needed in a given state involve the issue of enforcement discretion and are thus within the state's discretion, within reason. The EPA notes that it does not require physical inspection of every stationary source of emissions. The EPA's stationary source compliance monitoring guidance explains that states are encouraged to use a variety of techniques to determine compliance, including, for example, on-site compliance evaluations and off-site record reviews. 23 Furthermore, state choices such as focusing resources on and targeting inspections to larger sources (such as title V major stationary sources) are consistent with the EPA's inspection guidance, which calls for more frequent inspections of larger sources but does not specify an inspection frequency for smaller sources. And though commenter asserts that there are “50,000 plus oil and gas wells” in Colorado, commenter does not differentiate between smaller sources (or even inactive wells) and major stationary sources, which must be permitted in accordance with the CAA. Indeed, a recent report suggests that only 11,000 of those wells are “permitted” wells. 24 Because the report does not specify the type of permit that the State issued ( e.g., whether the permitted source is a major source or a minor source), in evaluation of this comment the EPA has reviewed the Colorado's title V operating permits database  25 and identified only one permit for an oil and gas production facility. 26 Although the State issued numerous permits (but fewer than 60) for compressor stations that may be located at or near a well-site, such sources may not necessitate a site-visit to assess compliance. 27 Accordingly, commenter's assertion does not, at this juncture, contravene Colorado's assurance that the State has adequate resources and personnel to carry out its SIP. Accordingly, the EPA concludes that Colorado's Infrastructure SIP submission provides the necessary assurances that the State has the staffing and resources needed to meet its SIP obligations in accordance with section 110(a)(2)(E) of the CAA.

Commenter's reliance on the alleged title V permit backlog and perceived shortage of inspectors are not determinative. While the agency agrees that permitting delays are problematic, such delays are not necessarily evidence of insufficient state resources that rise to the level of an inability to implement the requirements of a SIP. In addition, approved title V programs are not a component of a state's SIP and such programs, therefore, are not part of the requirements that states must address in the context of an Infrastructure SIP submission.

Commenter also fails to explain why Colorado's submission does not satisfy CAA section 110(a)(2)(L) and, indeed, fails to acknowledge that Colorado has an EPA-approved fee program under title V (see 65 FR 49919). To the extent commenter alleges that Colorado is not adequately administering and enforcing its title V program, the EPA's review and approval of an infrastructure SIP is not the appropriate time to raise those issues. Instead, CAA section 502(i) authorizes the Administrator to consider such allegations.

Lastly, commenter's general concern with respect to Colorado's constitutional amendment does not provide an adequate basis to disapprove Colorado's SIP with respect to CAA sections 110(a)(2)(E)(i) or 110(a)(2)(L). Commenter provides no explanation as to how the TABOR undermines Colorado's assurances that the State will have adequate personnel, funding, and authority to carry out its SIP or invalidates the EPA-approved fee program under title V.

Comment: Commenter asserts that the EPA must disapprove all of the PSD related infrastructure elements ( i.e., 110(a)(2)(C), (D)(i) (prong 3) and (J)) because of the State's “90 day timing rule.” The commenter explains that the rule allows major stationary sources to construct “without a PSD or NSSR [ sic ] permit” in violation of the CAA.

Response: Although commenter does not offer a citation to a “90 day timing rule,” the EPA believes commenter intended to refer to AQCC Regulation No. 3, Part A, Sec. II.D.1.lll (Exemptions from Air Pollutant Emission Notice Requirements: Oil and exploration and production operations). That rule requires owners or operators of oil and gas exploration and production operations to file an Air Pollution Emission Notice (APEN) no later than ninety days following the first day of production “[i]f production will result in reportable emissions.” Commenter presumably believes that because an APEN need not be filed until after production begins, this rule exempts major stationary sources from new source review permitting ( i.e., PSD or NNSR).

The EPA believes commenter may be misunderstanding AQCC regulations and, accordingly, disagrees with commenter's conclusion. AQCC Regulation 3, Part A, Sec. II addresses Colorado's APEN requirements. Under that program, “no person shall allow emission of air pollutants from, or construction, modification or alteration of, any facility, process, or activity which constitutes a stationary source, except residential structures, from which air pollutants are, or are to be, emitted unless and until” an APEN has been filed with the Division. See AQCC Regulation 3, Part A, Sec. II.A. Each APEN must specify the location at which the proposed emission will occur and provide certain details concerning the facility, process, or activity, including an estimate of the quantity and composition of the expected emission, among other information. Id.

If a source is exempted from the filing of an APEN under Part A, such sources may also be exempted from the State's construction permit program under Part B. See AQCC Regulation 3, Part B, Sec. II.D.1.a. However, Colorado's Part B construction permit program is not the State's EPA-approved major source new source review program, which is found in AQCC Regulation 3, Part D. This may be the source of commenter's misunderstanding. AQCC Regulation 3, Part B is clear that “[p]ermit exemptions taken under this section do not affect the applicability of any State or Federal regulations that are otherwise applicable to the source.” See AQCC Regulation 3, Part B, Sec. II.D. Thus, otherwise applicable permitting requirements in Regulation 3, Part D are not affected by the exemptions in Part B.

Furthermore, AQCC Regulation 3, Part A, Sec. II.D.1 also expressly states that any source that is exempt from filing an APEN “must nevertheless comply with all requirements that are otherwise applicable . . . including, but not limited to: Title V, Prevention of Significant Deterioration, nonattainment New Source Review, opacity limitations, odor limitations, particulate matter limitations and volatile organic compounds controls.” Further, AQCC Regulation 3, Part D (Colorado's major stationary source new source review and PSD program) expressly states that “[a]ny new major stationary source or major modification, to which the requirements of this Part D apply, shall not begin actual construction in a nonattainment, attainment, or unclassifiable area unless a permit has been issued containing all applicable state and federal requirements.” AQCC Regulation 3, Part D, Sec. I.A.1. Accordingly, the EPA disagrees with commenter's allegation that the “90-day timing rule” allows major stationary sources to construct without a PSD or NNSR permit in violation of the CAA.

Comment: The DRC submitted a comment letter and supporting documentation to the EPA on August 28, 2019, in which the DRC raises concerns that North Dakota's SIP does not adequately regulate VOC emissions for upstream oil and gas industry operations, and therefore the State risks future ozone nonattainment status. Specifically, the DRC contends that the North Dakota infrastructure SIP submittal is deficient because oil and gas activities “are not covered by North Dakota's minor source permitting program.” The DRC asserts that while oil and gas production facilities are required to file registration notices, these sources are otherwise exempt from permitting. The DRC explains that upstream oil and gas facilities have a significant emissions impact (pointing to the EPA's 2014 National Emissions Inventory) and will continue to grow over the coming years. The DRC believes North Dakota has failed to aggregate emissions from production facilities because of a lack of personnel and funding (contrary to CAA section 110(a)(2)(E)). Accordingly, the DRC declares that the EPA has a mandatory duty to reject North Dakota's SIP and issue a SIP call for a revised plan for its deficiencies under section 110(a)(2)(C).

Response: The EPA recognizes that the DRC is concerned that North Dakota's minor NSR program exempts upstream oil and gas facilities from more rigorous permitting and believes North Dakota's SIP should include mandatory emission limits, monitoring, and recordkeeping for such sources. However, the EPA disagrees with the DRC's conclusion that the North Dakota infrastructure SIP submission for the 2015 ozone NAAQS is thereby deficient.

Section 110(a) of the CAA requires states to make SIP submissions to establish they already have, or are adding, the SIP infrastructure to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as the EPA may prescribe. Specifically, section 110(a)(1) provides the procedural and timing requirements for such SIPs (commonly referred to as infrastructure SIPs), and section 110(a)(2) lists specific elements that a state's infrastructure SIP must meet for a newly established or revised NAAQS. These requirements include basic SIP elements, such as requirements for monitoring, basic program requirements, and legal authority, that are designed to assure attainment and maintenance of the NAAQS. Consequently, the EPA considers action on infrastructure SIP submissions required by sections 110(a)(1) and (2) to be an exercise to assure that a state's SIP meets the basic structural requirements for the new or revised NAAQS.

For example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in section 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address construction and modification of major sources and all regulated NSR pollutants, including greenhouse gases, in accordance with the requirements of the EPA's PSD regulation at 40 CFR 51.166.

Similarly, section 110(a)(2)(C), includes, among other things, the requirement that states have a program to regulate construction of minor new sources, but the EPA's regulations provide states with more discretion than the EPA's PSD regulations as to which sources must be covered by such a program. Thus, to satisfy the sub-element for preconstruction regulation of the modification and construction of minor stationary sources and the minor modification of major stationary sources, an infrastructure SIP submission should identify the existing EPA-approved SIP provisions and/or include new provisions that govern the minor source pre-construction program that regulates emissions of the relevant NAAQS pollutant(s). The EPA's rules addressing SIP requirements for such programs are at 40 CFR 51.160 through 51.614. The EPA's focus in the infrastructure SIP context is on evaluation of whether the state has an EPA-approved minor NSR program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, therefore, the EPA does not think it is necessary to re-review each and every provision of a state's existing minor source program ( i.e., already in the existing SIP) for compliance with the requirements of the CAA and the EPA's regulations that pertain to such programs. 28 We have previously found that North Dakota's program meets all minor new source review permitting requirements set forth at 40 CFR 51.160 through 51.164, including the requirement that a SIP-approved minor source program specifically identify the types and sizes of facilities that will be subject to review (see 40 CFR 51.160(e)).

With respect to the North Dakota infrastructure SIP submission presently before us, the EPA reviewed the submission itself, and evaluated the text of its provisions for compliance with the relevant elements of section 110(a)(2). In the NPRM, the EPA explicitly evaluated the State's infrastructure SIP submission on a requirement-by-requirement basis and explained its views on the adequacy of the State's submission for purposes of meeting the applicable infrastructure SIP requirements. Specifically, we found that North Dakota has EPA-approved minor NSR and major NSR permitting programs, which regulate ozone precursors for the purposes of the 2015 ozone NAAQS. Accordingly, North Dakota's infrastructure SIP submission satisfies the general requirement in section 110(a)(2)(C) to include a program in the SIP that regulates the modification and construction of stationary sources as necessary to assure the maintenance and attainment of the NAAQS. See 2013 Infrastructure SIP guidance at page 24.

Nevertheless, the EPA appreciates and takes seriously the DRC's concern and assertions that North Dakota's minor NSR permitting program may not adequately capture upstream oil and gas emissions, and that the aggregate emissions from the oil and gas industry may interfere with attainment and maintenance of the 2015 ozone NAAQS now or in the future. However, these concerns are best addressed outside the context of an infrastructure SIP action. The EPA has previously explained, as part of infrastructure SIP approvals, that EPA does not need to reconsider whether it should have approved or disapproved a state's existing minor NSR program. 29 The statutory requirements of CAA section 110(a)(2)(C) provide for considerable flexibility in designing minor NSR programs. Furthermore, states have some discretion with respect to sources that are subject to minor NSR permitting requirements, and the EPA has previously approved the States' exercise of that discretion with regard to their minor NSR programs. 30 A detailed re-review of how the State has chosen to exercise this discretion is not needed in the context of an infrastructure SIP review to ensure that the minor NSR portion of a SIP meets basic structural requirements.

Because this action involves a review of the infrastructure SIP and North Dakota already has an approved minor source NSR program that covers the necessary pollutants, we have not conducted a detailed examination of the DRC's assertions concerning the perceived inadequate regulation of upstream oil and gas production facilities in the State's minor NSR program. The EPA understands that North Dakota's previously-approved regulations exempt certain oil and gas production facilities from needing a permit to construct (provided there is no Federal requirement for a permit or approval for construction or operation), but such sources are subject to registration and reporting requirements under North Dakota Administrative Code (NDAC) Chapter 33.1-15-20. That regulation requires registration forms to “contain sufficient information to allow the department to determine if the oil or gas well and associated production facility is in compliance with all applicable sections of this chapter,” and mandates compliance with major source permitting under PSD for any oil or gas well production facility that is a major stationary source (or that has undertaken a major modification). Chapter 33.1-15-20-04 also contains requirements for the control of production facility emissions and specifically notes that “any volatile organic compound gas or vapor may be subject to controls as specified in chapter 33.1-15-07.” Accordingly, upstream oil and gas production facilities are not wholly exempt from regulation in the State's SIP.

If the DRC believes these previously-approved provisions are substantively inadequate considering the nature of oil and gas operations in North Dakota, the DRC can petition the EPA to evaluate the merits of these assertions, separate from this action. We note that multiple statutory tools and avenues exist that the EPA can use to rectify potential deficiencies with a SIP and a state's implementation thereof, and the existence of these tools is consistent with the EPA's interpretation of section 110(a)(2) with respect to the EPA's role in reviewing infrastructure SIP submissions. For example, the CAA provides the EPA the authority to issue a SIP call, 42 U.S.C. 7410(k)(5); make a finding of failure to implement, id. sections 7410(m), 7509(a)(4); and take measures to address specific permits pursuant to the EPA's case-by-case permitting oversight. See, e.g., id. section 7661d(b). The appropriateness of employing these authorities depends on the nature and extent of the particular problems at issue; however, the public is encouraged to use such avenues and tools to provide the EPA with notice of any alleged problem or deficiency.

In the meantime, the EPA is finalizing its approval of the North Dakota infrastructure SIP submission that is currently before the EPA with respect to the general requirement in section 110(a)(2)(C). If the EPA was to later determine that the scope of the minor source permitting program administered by the State is not sufficient to protect the NAAQS, we could at that time take appropriate action to ensure those problems and deficiencies are rectified using whatever statutory tools are appropriate. The EPA is committed to working with states and the public to correct SIP deficiencies.

Finally, addressing the commenter's assertion that North Dakota has a deficiency pertaining to section 110(a)(2)(E), i.e., a lack of personnel and funding, given that the DRC has not provided any information to support this claim or to counter our prior analysis of the State's submittal with respect to section 110(a)(2)(E), we are approving this action in accordance with our analysis from the NPRM.

Comment: The DRC asserts that the North Dakota submittal has problematic ozone monitoring data, which “masks rising ozone pollution in North Dakota.” The DRC also explains that they expect “that when the 2016 data falls away and is replaced by the 2019 data from this year, that North Dakota's 3-year average ozone emissions in western North Dakota will increase significantly.” Accordingly, the DRC concludes that the EPA must “object to North Dakota's plan now, because this SIP is intended to carry North Dakota well into the future . . . .”

Response: The EPA disagrees with the DRC that North Dakota's submittal is erroneous, and we disagree that the monitoring data  31 provided by the State disguises ozone data. The State's submission includes a time-series bar graph (without discrete values noted) showing nine distinct monitoring sites' ozone design values in increments of 5 parts per billion (ppb), beginning in 2003 and ending in 2017. The EPA notes that this State-provided graph  32 depicts ozone design value data for monitoring sites, not annual fourth-highest daily maximum 8-hour average ozone concentration monitoring data. A design value is a statistical representation of the air quality status of a given location relative to the level of the NAAQS. The DRC has calculated its own data table in page three of their comment; the values that DRC has calculated correspond to the EPA's own truncated  33 data for annual fourth-highest daily maximum 8-hour average ozone concentration monitoring data. Although a design value for an ozone air quality monitoring site is related to the annual fourth-highest daily maximum 8-hour average ozone concentration (the design value being the rolling three-year average of that data), the values are not equivalent. The EPA has provided a table of design values that supports the graph provided by the State. See Table 2. Furthermore, the EPA has provided a graph (current to year 2018) of the ozone design value long-term trends for North Dakota; both Oliver County and Williams County are labeled as to their design value trends. See Graph 1. We also note that design values are typically used to designate and classify nonattainment areas, as well as to assess progress towards meeting the NAAQS. It should be noted that North Dakota has not violated the 2008 or 2015 ozone NAAQS, nor is North Dakota classified as nonattainment for the 2008 or 2015 ozone NAAQS; moreover, the trend lines in Graph 1 indicate generally that the design values for ozone monitoring sites in North Dakota show a somewhat downward to level trend, excluding Oliver and Williams counties which show a slight upward trend.

While the EPA acknowledges that ozone monitoring data may change over time, such factors are not relevant to the EPA's review of the State's infrastructure SIP submission.

The EPA is approving multiple elements and disapproving a single element of the following infrastructure SIP submissions with respect to infrastructure requirements for the 2015 ozone NAAQS for Colorado and North Dakota.

With respect to Colorado, the EPA is approving Colorado's September 17, 2018 infrastructure SIP submission as meeting all of the CAA section 110(a)(2) infrastructure elements for the 2015 ozone NAAQS.

With respect to North Dakota, the EPA is approving North Dakota's November 6, 2018 SIP submission  36 for the following CAA section 110(a)(2) infrastructure elements for the 2015 ozone NAAQS: (A), (B), (C), (D)(i)(I) Prong 1 Interstate transport—significant contribution, (D)(i)(I) Prong 2 Interstate transport—interference with maintenance, (D)(i)(II) Prong 3 Interstate transport—prevention of significant deterioration, (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M).

For the reasons stated in the NPRM, the EPA is partially disapproving North Dakota's SIP submittal as to 110(a)(2)(D)(i)(II) prong 4 Interstate transport—visibility. 84 FR 36527. As noted in the NPRM, the EPA is not required to take further action with regard to the prong 4 disapproval. The EPA has an obligation to disapprove prong 4 requirements as a result of disapproving portions of a state's regional haze SIP submission. However, as discussed in the NPRM, FIP requirements promulgated by the EPA are already in effect that correct all regional haze SIP deficiencies for the first planning period for North Dakota. All of North Dakota's obligations under 40 CFR 51.308 and 51.309, including those relevant to participation in a regional haze planning process and achieving the State's apportionment of emission reduction obligations as to Class I areas in other states, are being addressed either through FIPs or SIPs for the first planning period. This ensures that emissions from sources within North Dakota are not interfering with measures required to be included in other air agencies' plans to protect visibility. Under the EPA's 2013 iSIP guidance, this is sufficient to satisfy prong 4 requirements for the first planning period. See 2013 Guidance at 33. Thus, there are no additional practical consequences from this disapproval for the State, the sources within its jurisdiction, or the EPA. See id. at 34-35. The EPA finds its prong 4 obligations for North Dakota for the 2015 ozone NAAQS are satisfied.

Finally, we are approving a portion of North Dakota's May 2, 2019 submission of Chapter 33.1-15-15, the air pollution control rules of the State of North Dakota, which updates the date of IBR of Federal rules. The EPA is solely approving the revision applicable to the IBR date for 40 CFR 52.21(l)(1).

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of North Dakota Administrative Code Chapter 33.1-15-15 described in Section III of this preamble. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 Office (please contact the persons identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the State implementation plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 37

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 9, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our December 3, 2019 proposal (84 FR 66103). In that document we proposed to approve revisions to the Oklahoma SIP submitted on May 16, 1994; July 26, 2010; January 8, 2018; May 16, 2018; and December 19, 2018, and as clarified by letter dated May 16, 2018. The revisions include the incorporation by reference dates for federal requirements and updates to the NSR Prevention of Significant Deterioration (PSD) and Nonattainment NSR permitting programs to maintain consistency with federal requirements. Our proposal included an analysis of these provisions and made a preliminary determination that the revisions were developed in accordance with the CAA and EPA's regulations, policy, and guidance for SIP development and NSR permitting.

We received one relevant comment on our proposed approval; the comment and our response are presented below.

Comment: The commenter stated that the EPA needs to be clearer when it is approving regulations into the SIP, especially when acting on multiple SIP submittals at once. As an example, the commenter noted that the EPA appears to be trying to approve the January 8, 2018, and December 19, 2018 versions of Oklahoma Administrative Code (OAC) 252:100, Subchapter 2 and Appendix Q, both of which incorporate by reference federal rules as of a date certain. The commenter maintained that the EPA cannot approve both versions simultaneously, because the SIP can only incorporate by reference one version of the federal rules at a time. The commenter asserted that the EPA must find all instances of overlapping rules in all the SIP submissions and only approve one. Once the EPA decides which of the overlapping rules should be approved ( i.e., which submission is more recent), the commenter stated that the EPA must then disapprove the older versions of the rule as moot. The commenter concluded that the EPA approval of multiple overlapping SIPs would simply confuse the public.

Response: We agree with the commenter that action on multiple SIP submittals in a single rulemaking can present unique challenges; however, we present the following discussion in order to clarify our action and ensure the commenter, as well as the public, that we are approving only one version of each State regulation addressed by this action, as identified in the amendatory language included below. The Technical Support Document (TSD) associated with this rulemaking identifies each time the State regulatory section has been revised and submitted by Oklahoma as a proposed SIP revision. For each submission, our TSD provides a line-by-line evaluation of whether the submitted revision is approvable under federal requirements. Where a section has been revised multiple times, our TSD will show these multiple submissions side-by-side with a corresponding evaluation as to the approvability of the revisions. The amendatory language included in this final rule revises the Oklahoma SIP at 40 CFR 52.1920 based on the analysis presented in our TSD and the December 3, 2019 proposal. For example, the table at 40 CFR 52.1920(c) titled “EPA Approved Oklahoma Regulations” identifies each component of the Oklahoma SIP by the state citation, name of the section, state effective date, date and citation of EPA's final approval, and any comments pertinent to that section. Finally, the commenter is incorrect in stating that the EPA must disapprove older versions of the submitted rules as moot. As demonstrated in the TSD, the sequential Oklahoma regulations build on the earlier revisions. To disapprove older submittals as moot would be contrary to the State's intended rulemaking. No changes have been made as a result of this comment.

We are approving the following as revisions to the Oklahoma SIP:

• Removal of Regulation 3.8, adopted on March 30, 1994, submitted May 16, 1994;

• New OAC 252:100-8-36.1, Public Participation, adopted on April 28, 2006, effective on June 15, 2006, submitted July 16, 2010;

• Submitted on January 8, 2018:

○ Revisions to OAC 252:100-1-3, Definitions, adopted on June 13, 2017 and effective September 15, 2017;

○ Revisions to OAC 252:100-2-3 and Appendix Q for Incorporation by Reference, adopted on June 13, 2017 and effective September 15, 2017;

○ Revisions to OAC 252:100-8-31, Definitions, adopted on June 13, 2017 and effective September 15, 2017;

○ Revisions to OAC 252:100-8-33, Exemptions, adopted on June 13, 2017 and effective September 15, 2017;

○ Revisions to OAC 252:100-8-35, Air quality impact evaluation, adopted on June 13, 2017 and effective September 15, 2017; and

○ Revisions to OAC 252:100-8-51.1, Emissions reductions and offsets, adopted on June 13, 2017 and effective September 15, 2017.

• Submitted on May 16, 2018:

○ Revisions to OAC 252:4-1-2, Definitions, adopted on June 9, 2016, effective September 15, 2016;

○ Revisions to OAC 252:4-1-3, Organization, adopted on April 25, 2013, effective July 1, 2013, and revisions adopted on June 9, 2016, effective September 15, 2016;

○ Revisions to OAC 252:4-1-5, Availability of a record, adopted on May 6, 2005, effective June 15, 2005, and revisions adopted on April 25, 2013, effective July 1, 2013;

○ Revisions to OAC 252:4-1-6, Administrative fees, adopted on May 6, 2005, effective June 15, 2005;

○ Revisions to OAC 252:4-3-1, Meetings, adopted on March 27, 2007, effective June 15, 2007;

○ Revisions to OAC 252:4-7-5, Fees and fee refunds, adopted on June 13, 2017, effective September 15, 2017;

○ Revisions to OAC 252:4-7-13, Notices, adopted on March 25, 2003, effective June 1, 2003, except for OAC 252:4-7-13(g)(4); and revisions adopted June 13, 2017, effective September 15, 2017;

○ Revisions to OAC 252:4-7-15, Permit issuance or denial, adopted on May 28, 2002, effective June 1, 2002, and revisions adopted April 25, 2013, effective July 1, 2013;

○ Revisions to OAC 252:4-7-18, Pre-issuance permit review and correction, adopted April 25, 2013, effective July 1, 2013;

○ New OAC 252:4-7-20, Agency review of final permit decision, adopted April 25, 2013, effective July 1, 2013;

○ Revisions to OAC 252:4-7-32, Air quality applications—Tier I, adopted March 25, 2003, effective June 1, 2003;

○ Revisions to OAC 252:4-7-33, Air quality applications—Tier II, adopted March 25, 2003, effective June 1, 2003, except for OAC 252:4-7-33(c)(4);

○ Revisions to OAC 252:4-9-32, Individual proceedings filed by others, as adopted on May 1, 2009, effective July 1, 2009 and revisions adopted April 25, 2013, effective July 1, 2013;

○ Revisions to OAC 252:4-9-51, In general, adopted on March 24, 2004, effective June 1, 2004;

○ Revisions to OAC 252:4-9-52, Individual proceedings, adopted on March 24, 2004, effective June 1, 2004;

○ New OAC 252:4-17, Electronic Reporting, sections OAC 252:4-17-1—OAC 252:4-17-7, adopted April 27, 2007, effective June 15, 2017;

○ Revisions to OAC 252:4-17-2, Definitions, adopted June 9, 2016, effective September 15, 2016;

○ Revisions to OAC 252:4-17-4, Electronic signature agreement, adopted June 9, 2016, effective September 15, 2016;

○ Letter to Ms. Anne Idsal, Regional Administrator, EPA Region 6, dated May 16, 2018 regarding “Clarification of PSD Public Participation Procedures under 2017 Revisions to the Oklahoma State Implementation Plan (SIP)”;

○ Definitions of “Process Meeting” and “Response to Comments” at 27A Oklahoma Statutes (O.S.) 2-14-103 added July 1, 1994, and last modified and effective November 1, 2015;

○ The provisions for notification to an affected state at 27A O.S. 2-5-112(E) added May 15, 1992, and last modified and effective June 3, 2004;

○ 27A O.S. 2-14-301, 2-14-302, and 2-14-303 added and in effect July 1, 1996;

○ 27A O.S. 2-14-304 added July 1, 1996, and last modified and effective May 9, 2002;

○ Definition of “Record” at 51 O.S. 24A.3, added November 1, 1985, and last modified and effective November 1, 2014;

○ The requirement to maintain, and the description of the contents of the rulemaking record at 75 O.S. 302(B) promulgated in 1963 and last modified and effective November 1, 1998;

○ The process for adoption, amendment or revocation of a rule at 75 O.S. 303 promulgated in 1963 and last modified and affective November 1, 2013; and

○ Definition of “Meeting” at 25 O.S. 304(2) added October 1, 1977, and last modified and effective in 2010.

• Submitted December 19, 2018:

○ Revisions to OAC 252:100-2-3 and Appendix Q adopted on June 18, 2018 and effective September 15, 2018; and

○ Revisions to OAC 252:100-8-35, Air quality impact evaluation, adopted on June 18, 2018 and effective September 15, 2018.

The EPA finds that the provisions in OAC 252:4-1-1, 4-1-2, 4-1-3, 4-1-4, 4-1-5, 4-1-6, 4-1-7, 4-1-8, and 4-1-9, and OAC 252:100-5-1, 5-1.1 and 5-2.2 are applicable to the entirety of the Oklahoma SIP and the amendatory language table at 40 CFR 52.1920(c) is modified to reflect this finding. Additionally, the EPA is removing the disapprovals listed in 40 CFR 52.1922(b)(2), (b)(3), (b)(4), and (c), because the state has submitted appropriate revisions to the SIP to correct the disapprovals.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference the revisions to the Oklahoma regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 9, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 52 as follows:

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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0266 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before June 9, 2020. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0266, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-93), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 8F8697) by AgBiTech Pty Ltd., 8 Rocla Ct., Glenvale, Queensland 4350, Australia (c/o V.A. Forster Consulting, Inc., P.O. Box 4097, Wilmington, DE 19807). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the insecticide Autographa californica multiple nucleopolyhedrovirus strain R3 in or on all food commodities. That notice referenced a summary of the petition prepared by the petitioner AgBiTech Pty Ltd. and available in the docket via http://www.regulations.gov. No relevant comments were received.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on Autographa californica multiple nucleopolyhedrovirus strain R3 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Autographa californica Multiple Nucleopolyhedrovirus strain R3” (“Safety Determination Document”). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

The available data demonstrated that, with regard to humans, Autographa californica multiple nucleopolyhedrovirus strain R3 is not toxic, pathogenic, or infective via any reasonably foreseeable route of exposure and when used in accordance with label directions and good agricultural practices. Baculoviruses, such as Autographa californica multiple nucleopolyhedrovirus strain R3, are ubiquitous in the environment and have been extensively studied with no adverse effects in mammals observed or known. Although there may be dietary and non-occupational exposure to residues when Autographa californica multiple nucleopolyhedrovirus strain R3 is used on food commodities, there is not a concern due to the lack of potential for adverse effects when used in accordance with label directions and good agricultural practices. EPA also determined that retention of the Food Quality Protection Act safety factor was not necessary as part of the qualitative assessment conducted for Autographa californica multiple nucleopolyhedrovirus strain R3.

Based upon its evaluation in the Safety Determination Document, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Autographa californica multiple nucleopolyhedrovirus strain R3 when used in accordance with label directions and good agricultural practices. Therefore, an exemption from the requirement of a tolerance is established for residues of Autographa californica multiple nucleopolyhedrovirus strain R3 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method for enforcement purposes is not required because EPA has determined that reasonably foreseeable exposure to residues of Autographa californica multiple nucleopolyhedrovirus strain R3 from use of the pesticide will be safe, due to lack of toxicity, pathogenicity, and infectivity. Under those circumstances, it is unnecessary to have an analytical method to monitor for residues.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

A. What were the comments and responses to EPA's proposal?

During the initial public comment period that ended on November 23, 2018, EPA received comments from three sources regarding EPA's proposal to (1) authorize State-initiated changes to Texas' hazardous waste regulations in accordance with 40 CFR part 271 and (2) codify in 40 CFR part 272, the prior approval of Texas' hazardous waste management program and incorporate by reference authorized provisions of the State's statutes and regulations. For the public comment period ending August 9, 2019, EPA received one comment from one of the initial commenters which reiterated concerns about the Texas authorized program. The full set of comments can be found in the docket for this action.

In accordance with 40 CFR parts 271 and 272, EPA provides the following responses to comments regarding the authorization and codification of Texas' hazardous waste program under RCRA subtitle C:

One commenter made a reference to a previous Texas authorization Federal Register notice published on September 3, 2014 (79 FR 52220; EPA-R06-RCRA-2013-0624-0003) in which the commenter raised an issue about Texas' land disposal restrictions (LDR) requirements. In an initial comment received on November 19, 2018 for the October 24, 2018 Proposed Rule, the commenter asserted that EPA does not address public comments that oppose a State's authorization and requested a “complete top-to-bottom review” of Texas' RCRA program, starting with the Texas land disposal restrictions and the hazardous fluorescent lamp programs to ensure that the State's program is no less stringent than the Federal law and regulations. This same commenter reiterated the same concerns in a comment submitted during the extended public comment period that ended on August 9, 2019. EPA responds to this comment as follows:

The commenter's assertion that EPA does not address public comments that oppose a State's authorization is incorrect. The EPA does address adverse comments that pertain to specific final rules for which a State is seeking authorization. In the case of the September 3, 2014 Federal Register notice, the Texas authorization did not pertain to the LDR program and therefore the comment about LDR was not relevant to the action addressed in that authorization notice. See www.regulations.gov for the response to the comment posted on September 15, 2014. With respect to the hazardous waste lamp rule, as introduced into the Federal regulations on July 6, 1999 (64 FR 36466), EPA reviewed Texas regulations for those provisions and determined that they were equivalent to the Federal requirements and authorized the State for the lamp requirements (70 FR 34371, June 14, 2005). EPA can only address the comments and take action on the specific set of rules which are identified in the current rulemaking. Prior rulemakings should be challenged at the time they are proposed and finalized. If they are not challenged in a timely manner, the concept of final agency action under the Administrative Procedure Act (See 5 U.S.C. Sec.704) would be undermined. In order to adequately address the concerns of this anonymous commenter, EPA recommends that the commenter contact EPA directly and send written documentation, outlining the specific reasons for their assessment and conclusions about the Texas authorized hazardous waste program. The information sent to EPA should provide supporting documentation and rationale for their evaluation of the Texas program or the commenter may contact the Region to discuss their concerns.

A second set of comments were submitted by the Sierra Club which raised a number of issues related to: (1) EPA's proposed authorization of State-initiated changes to Title 30, Texas Administrative Code, sections 335.155(1) and 335.261(b)(15), analogous to 40 CFR 264.77(a) and 273.8(a)(2), respectively; (2) authorized Texas provisions and amendments to previously authorized provisions in the Texas regulations; and (3) limited explanation and information about accessing the agency's documents underlying the proposed action.

In the first issue, the Sierra Club objected to EPA authorizing the State-initiated changes that EPA has deemed minor without the State submitting a formal application for EPA authorization or providing the citation of authority which explains the basis for the absence of a formal application. The Sierra Club further asserted that the formal application would have provided the associated public participation processes. EPA's response to this comment is discussed in Section B below.

The second issue raised by the Sierra Club involved the documentation EPA provided in the proposed rule relative to the codification and incorporation by reference of the Texas authorized program. The Sierra Club acknowledged that in the proposed rule, EPA notified the public that there are some provisions of the Texas hazardous waste management program that are not part of the Federally authorized State program; such as State analogs to Federal provisions for which the State is not authorized, unauthorized amendments to previously authorized State provisions, new unauthorized State requirements and Federal rules for which Texas is authorized but which have since been vacated. See, 83 FR 53597, October 24, 2018. In addition, the Sierra Club emphasized that “[S]imply noting that there are such unauthorized provisions in the Texas program and that they are not Federally enforceable falls short of EPA's legal obligations under RCRA.” and “if the Texas hazardous waste program contains any provision that is less stringent than the Federal requirements, it is unlawful and EPA must disapprove it until those provisions are corrected or eliminated.” EPA responds to this comment as follows:

As discussed in Section II.C of the proposed rule, the purpose of the codification of the Texas statutes and regulations under 40 CFR part 272 is to clarify which of the Texas provisions are included in the authorized and Federally enforceable program and for the public to be able to discern the status of Federally approved requirements of the Texas hazardous waste management program. The codification process that EPA follows requires the Agency to review the State's entire regulations in order to document the provisions that EPA has already authorized, and to identify all provisions and language in the State's regulations that EPA has not authorized. Such unauthorized State provisions may include (1) analogs to Federal provisions adopted by the State; (2) State-only provisions with no Federal analogs; (3) amendments to previously authorized provisions; or (4) Federal provisions adopted by the State but which have since been vacated by a Court at the Federal level. The process allows EPA to identify regulatory and statutory deficiencies in the State's authorized program and to require the State to make corrections and amendments to the State regulations and statutes to be at least equivalent and consistent and not less stringent than the Federal program. The State is then required to submit a program revision application to EPA for review and approval. While the State is addressing those issues, EPA proceeds with the codification of the State's authorized program and makes it clear to the public in the codification Federal Register document which State provisions are not part of the authorized program.

In the case of the Comparable Fuels Exclusions (63 FR 33782, 6/19/98) and the Hazardous Waste Gasification Exclusion (73 FR 57 1/2/08) for which Texas was previously authorized, but which have since been vacated by the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Cir. No. 98-1379 and 08-1144, respectively; June 27, 2014), the EPA is clarifying in this final rule, that the Texas provisions are no longer part of the State's authorized program. The effect of the vacaturs on all States, including Texas, is that the previously authorized comparable fuels and gasification rules from the State program are no longer to be considered part of the Federally authorized program. Thus, EPA may bring enforcement actions under RCRA Section 3008 at facilities that do not comply with the RCRA hazardous waste regulations.

EPA has been working with the State of Texas to make the necessary corrections to its regulations and to submit an application to EPA for review. In the Binder entitled “EPA-Approved Texas Statutory and Regulatory Requirements Applicable to the Hazardous Waste Management Program,” dated December 2015 (the Binder) that is incorporated by reference, EPA crosses out all provisions and language that EPA has determined are not part of the State's authorized requirements. The “Addendum to the EPA Approved Texas Regulatory Requirements Applicable to the Hazardous Waste Management Program” (the Addendum) includes the actual State regulatory text authorized by the EPA for the citations listed at 272.2201(c)(4).

Finally, the commenters indicated that EPA did not make available in the e-docket at www.regulations.gov all supporting documents for EPA's proposed authorization and codification of the Texas hazardous waste management program. With the publication of the August 9, 2019 Federal Register notice that extended the public comment period for 30 days, EPA provided all supporting documents at www.regulations.gov. Copies of both the Binder and the Addendum were also made available to the public in the e-docket at www.regulations.gov.

The Sierra Club objected to EPA authorizing the State-initiated changes that EPA has deemed minor without the State submitting a formal application for EPA authorization or providing the citation of authority which explains the basis for the absence of a formal application. The Sierra Club further asserted that the formal application would have provided the associated public participation processes. EPA responds to this comment as follows:

According to 40 CFR 271.21 Procedures for revision of State Programs —40 CFR 271.21(a) provides, “Either EPA or the approved State may initiate program revision.” Further, 40 CFR 271.21(b)(1) states “The State shall submit a modified program description, . . . , or such other documents as EPA determines to be necessary under the circumstances.” Under the circumstances of these revisions EPA has determined that the only documents deemed necessary are the Texas RCRA statutes and regulations. We determined this because State-initiated changes addressed in the proposed rule were corrections to technical errors in the State's regulations that did not impact substance of the State's authorized hazardous waste management program. Specifically, Texas amended 335.155(1) [analog to 40 CFR 264.77(a)] to correct an error in the internal reference by replacing “264.56(j)” with “264.56(i). Texas also amended 335.261(b)(15) [analog to 40 CFR 264.77(a) and 273.8(a)(2)] to provide correct references to 40 CFR 273.8(a)(2) and 261.5. EPA deemed these corrections to be of a such a non-substantive/minor nature that submission of additional material was not necessary. The State's laws and regulations, as amended by these provisions, provide authority which remains equivalent to, and no less stringent than the corresponding Federal laws and regulations.

Based on EPA's responses to the comments received regarding the proposed authorization of the State-initiated changes, the EPA now makes a final decision that Texas' hazardous waste program revisions satisfy the requirements necessary to qualify for final authorization in accordance with 40 CFR 271.21(a). EPA will continue to implement and enforce Hazardous and Solid Waste Amendments of 1984 (HSWA) provisions for which the State is not authorized. EPA also retains its authority under RCRA sections 3007, 3008, 3013 and 7003 which include, among others, authority to: (1) Take enforcement actions regardless of whether the State has taken its own action, (2) enforce RCRA requirements and suspend or revoke permits; and (3) perform inspections, and require monitoring, tests, analyses or reports.

In this final action, the EPA is incorporating by reference the Texas authorized hazardous waste program in subpart SS of 40 CFR part 272. Section 272.2201(c)(1) incorporates by reference Texas' authorized hazardous waste statutes and regulations. Section 272.2201 also references material which is not being incorporated by reference, but which the EPA considered in determining the adequacy of Texas' program. Section 272.2201(c)(2) references sections of the Texas statutes which provide the legal basis for the State's implementation of the hazardous waste management program. In addition, §§ 272.2201(c)(6), (7), and (8) reference the Memorandum of Agreement, the Attorney General's Statements, and the Program Description, respectively. These documents are evaluated as part of the approval process of the hazardous waste management program in accordance with subtitle C of RCRA but are not part of the material to be incorporated by reference.

State provisions that are “broader in scope” than the Federal program are not incorporated by reference in 40 CFR part 272. For reference and clarity, the EPA lists in 40 CFR 272.2201(c)(3) the Texas statutory and regulatory provisions that are “broader in scope” than the Federal program, and which are not part of the authorized program being incorporated by reference. While “broader in scope” provisions are not part of the authorized program and cannot be enforced by the EPA, the State may enforce such provisions under State law. At 40 CFR 272.2201(c)(4) and (5), EPA lists amendments to Texas regulations and Federal rules which are not part of the Texas authorized program.

The October 24, 2018 proposed rule provides details about the effect of Texas's codification on enforcement (See, Section III.D, 83 FR 53597) and on Federal requirements promulgated under the Hazardous and Solid Waste Amendments of 1984 (HSWA) (See Section III.F, 83 FR 53598).

In the Federal Register document published on October 24, 2018 (83 FR 53595), the EPA also proposed to codify the EPA's authorization of Texas' base hazardous waste management program and the State's revisions to that program. In this action, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Texas authorized hazardous waste statutes and regulations described in the amendments to 40 CFR 272.2201 set forth below. The EPA has made, and will continue to make, these materials generally available electronically through http://www.regulations.gov and in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

In this final rule, the EPA is making corrections and clarifying the language in 40 CFR 272.2201(c)(5) and the associated Table. The Table includes an incorrect entry for Withdrawal of the Emission Comparable Fuel Exclusion under RCRA (Checklist 224—amendments to 40 CFR 261.4(a)(16) and 261.38) (75 FR 33712, June 15, 2010). Texas adopted and was authorized for the Comparable Fuel exclusion as introduced by the Hazardous Waste Combustors Revised Standards final (63 FR 33782, June 19, 1998 (Revision Checklist 168); however, the State did not adopt, and was not authorized for the amendment to the Comparable Fuel exclusion published on June 15, 2010. Thus, EPA is correcting the § 272.2201(c)(5) Table to remove the third entry regarding the June 15, 2010 final rule (Revision Checklist 224). The EPA is also adding language to § 272.2201(c)(5) to clarify that EPA may bring enforcement action under RCRA section 3008 at facilities that do not comply with the terms of the court vacaturs. The EPA is also correcting a typographical error in the entry for Checklist 224 in the § 272.2201(c)(4)(iv) Table by replacing the Federal Register reference “73 FR 33712” with “75 FR 33712.”

This final action authorizes and codifies State requirements for the purpose of RCRA section 3006 and imposes no additional requirements beyond those imposed by State law. For further information on how this authorization and codification comply with applicable executive orders and statutory provisions, please see the proposed rule published in the Federal Register (83 FR 53595, October 24, 2018).

The Congressional Review Act, 5 U.S.C. 801—808, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective April 10, 2020.

For the reasons set forth in the preamble, under the authority at 42 U.S.C. 6912(a), 6926, and 6974(b), the EPA is granting final authorization under 40 CFR part 271 to the State of Texas for State-initiated revisions to its hazardous waste program under the Resource Conservation and Recovery Act and is amending 40 CFR part 272 as follows:

I. Background A. The Current COVID-19 Pandemic

COVID-19 is a communicable disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that was first identified as the cause of an outbreak of respiratory illness that began in Wuhan, Hubei Province, People's Republic of China. The virus is thought to be transmitted primarily by person-to-person contact through respiratory droplets produced when an infected person coughs, sneezes, or talks. Some recent studies have suggested that COVID-19 may be spread by people who are not showing symptoms. It also may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes. Older adults and people of all ages with underlying medical conditions, particularly if not well controlled, are at higher risk for more serious COVID-19 illness. 1

On January 30, 2020, the Director-General of the World Health Organization (WHO) declared that the outbreak of COVID-19 is a Public Health Emergency of International Concern under the International Health Regulations. 2 The following day, the Secretary of Health and Human Services (HHS) declared COVID-19 a public health emergency under Section 319 of the Public Health Service (PHS) Act. 3 On March 11, 2020, the WHO declared COVID-19 a pandemic. On March 13, 2020, the President issued a Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak under sections 201 and 301 of the National Emergencies Act, 50 U.S.C. 1601 et seq., and consistent with section 1135 of the Social Security Act, 42 U.S.C. 1320b-5. 4 On March 13, 2020, the President declared a nationwide emergency under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, authorizing FEMA to provide assistance for emergency protective measures to respond to the COVID-19 pandemic. 5

As of April 7, 2020, there were over 333,000 cases of COVID-19 in the United States, resulting in over 9,500 deaths due to the disease, with new cases being reported daily. Worldwide, there have been over 1.28 million confirmed cases, resulting in over 72,600 deaths. 6 At this time, there is no vaccine that can prevent infection with COVID-19, nor is there currently any FDA-approved post-exposure prophylaxis for people who may have been exposed to COVID-19. Treatment is currently limited to supportive (or palliative) care for patients who need it. Clinical management for hospitalized patients with COVID-19 is focused on supportive care for complications, including supplemental oxygen and advanced organ support for respiratory failure, septic shock, and multi-organ failure. 7

Within the United States, widespread transmission of COVID-19 has occurred. Widespread transmission of COVID-19 has resulted and will continue to result in large numbers of people needing medical care at the same time. Public health and healthcare systems may become overloaded, with elevated rates of hospitalizations and deaths, as well as elevated demand for PPE, including the PPE covered by this rule.

FEMA is issuing this temporary rule as part of its response to the COVID-19 pandemic. The rule is issued pursuant to the following authorities, among others:

• The Defense Production Act of 1950, as amended (“DPA” or “the Act”), and specifically sections 101 and 704 of the Act, 50 U.S.C. 4511, 4554;

• Executive Order 13909, 85 FR 16227 (Mar. 23, 2020);

• Executive Order 13910, 85 FR 17001 (Mar. 26, 2020);

• Executive Order 13911, 85 FR 18403 (Apr. 1, 2020);

• DHS Delegation Number 09052 Rev. 00.1, “Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency” (Apr. 1, 2020); and

• The Presidential Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use (April 3, 2020). 8

FEMA describes each authority in turn. The President has broadly delegated authority to make determinations and take action with respect to health and medical resources for COVID-19 response under Section 101 of the DPA to the Secretary of Homeland Security in Executive Order 13911. This authority has in turn been delegated to the FEMA Administrator in DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020).

First, under subsection 101(a) of the Act, 50 U.S.C. 4511(a), the President may (1) require that performance under contracts or orders (other than contracts of employment) which he deems necessary or appropriate to promote the national defense shall take priority over performance under any other contract or order, and, for the purpose of assuring such priority, require acceptance and performance of such contracts or orders in preference to other contracts or orders by any person he finds to be capable of their performance. The President may also (2) allocate materials, services, and facilities in such manner, upon such conditions, and to such extent as he shall deem necessary or appropriate to promote the national defense. FEMA refers to these authorities as relating to “priority ratings” and “allocation,” respectively.

Under subsection 101(b) of the Act, 50 U.S.C. 4511(b), the President may not use the aforementioned authorities to control the general distribution of any material in the civilian market unless the President finds (1) that such material is a scarce and critical material essential to the national defense, and (2) that the requirements of the national defense for such material cannot otherwise be met without creating a significant dislocation of the normal distribution of such material in the civilian market to such a degree as to create appreciable hardship.

Under subsection 101(d) of the Act, 50 U.S.C. 4511(d), the head of each Federal agency to which the President delegates authority under section 101 of the Act (1) shall issue, and annually review and update whenever appropriate, final rules, in accordance with 5 U.S.C. 553, that establish standards and procedures by which the priorities and allocations authority under section 101 is used to promote the national defense, under both emergency and nonemergency conditions; and (2) as appropriate and to the extent practicable, consult with the heads of other Federal agencies to develop a consistent and unified Federal priorities and allocations system. 9

Second, on March 18, 2020, the President signed Executive Order 13909, which delegated to the Secretary of HHS authority under the DPA for the prioritization and allocation of health and medical resources to respond to the spread of COVID-19. The President determined that to ensure that our healthcare system is able to surge capacity and capability to respond to the spread of COVID-19, it is critical that all health and medical resources needed to respond to the spread of COVID-19 are properly distributed to the Nation's healthcare system and others that need them most at this time. The President found that health and medical resources needed to respond to the spread of COVID-19, including personal protective equipment and ventilators, meet the criteria specified in section 101(b) of the Act (50 U.S.C. 4511(b)). 10

Third, on March 23, 2020, the President signed Executive Order 13910, in which the President delegated to the Secretary of HHS the authority under section 102 of the Act to prevent hoarding and price gouging with respect to health and medical resources necessary to respond to the spread of COVID-19. On March 25, 2020, the Secretary of Health and Human Services designated under section 102 of the Act 15 categories of health and medical resources as scarce materials or materials the supply of which would be threatened by accumulation in excess of the reasonable demands of business, personal, or home consumption, or for the purpose of resale at prices in excess of prevailing market prices (“scarce or threatened materials”). See 85 FR 17592 (Mar. 30, 2020). These designated items include certain PPE materials that are the subject of this rulemaking.

Fourth, on March 27, 2020, the President signed Executive Order 13911, which (among other things) delegated to the Secretary of Homeland Security the President's authority under section 101 of the Act with respect to health and medical resources needed to respond to the spread of COVID-19 within the United States. The Executive Order provides that the Secretary of Homeland Security may use the authority under section 101 of the Act to determine, in consultation with the heads of other executive departments and agencies as appropriate, the proper nationwide priorities and allocation of health and medical resources, including by controlling the distribution of such materials (including applicable services) in the civilian market, for responding to the spread of COVID-19 within the United States. 11 The Secretary of Homeland Security has delegated his authorities under Executive Order 13911 to FEMA. See DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020).

Finally, on April 3, 2020, the President signed a Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use. The Memorandum reaffirmed the delegations and findings contained in Executive Orders 13909, 13910, and 13911, including that health and medical resources needed to respond to the spread of COVID-19, including personal protective equipment (PPE) and ventilators, meet the criteria specified in section 101(b) of the Act, i.e., that (1) such material is a scarce and critical material essential to the national defense, and (2) that the requirements of the national defense for such material cannot otherwise be met without creating a significant dislocation of the normal distribution of such material in the civilian market to such a degree as to create appreciable hardship. The President further stated that to ensure that these scarce or threatened PPE materials remain in the United States for use in responding to the spread of COVID-19, it is the policy of the United States to prevent domestic brokers, distributors, and other intermediaries from diverting such material overseas.

In furtherance of such policy, the President directed that the Secretary of Homeland Security, through the FEMA Administrator, and in consultation with the Secretary of HHS, shall use any and all authority available under section 101 of the Act to allocate to domestic use, as appropriate, the following scarce or threatened materials designated by the Secretary of HHS under Section 102 of the DPA:

• N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

• Other Filtering Facepiece Respirators ( e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user's airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;

• Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;

• PPE surgical masks, including masks that cover the user's nose and mouth and provide a physical barrier to fluids and particulate materials; and

• PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.

Pursuant to this Memorandum, and with the authority delegated to the Secretary of Homeland Security in E.O. 13911 and re-delegated to the FEMA Administrator in DHS Delegation 09052 Rev. 00.1, FEMA now issues this allocation order as a temporary rule.

Following consultation with the Secretary of HHS; pursuant to the President's direction; and as an exercise of the Administrator's priority order, allocation, and regulatory authorities under the Act, the Administrator has determined that the scarce or threatened materials identified in the April 3, 2020 Presidential Memorandum (“covered materials”) shall be allocated for domestic use, and may not be exported from the United States without explicit approval by FEMA. See new 44 CFR 328.102(a).

The rule is necessary and appropriate to promote the national defense with respect to the covered materials because the domestic need for them exceeds the supply. Under this temporary rule, before any shipments of such covered materials may leave the United States, CBP will detain the shipment temporarily, during which time FEMA will determine whether to return for domestic use, issue a rated order for, or allow the export of part or all of the shipment under section 101(a) of the Act, 50 U.S.C. 4511(a). FEMA will make such a determination within a reasonable time of being notified of an intended shipment and will make all decisions consistent with promoting the national defense. See new 44 CFR 328.102(b). FEMA will work to review and make determinations quickly and will endeavor to minimize disruptions to the supply chain.

In determining whether it is necessary or appropriate to promote the national defense to purchase covered materials, or allocate materials for domestic use, FEMA may consult other agencies and will consider the totality of the circumstances, including the following factors: (1) The need to ensure that scarce or threatened items are appropriately allocated for domestic use; (2) minimization of disruption to the supply chain, both domestically and abroad; (3) the circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns; (4) the quantity and quality of the materials; (5) humanitarian considerations; and (6) international relations and diplomatic considerations.

This rule contains an exemption that the Administrator has determined to be necessary or appropriate to promote the national defense. See new 44 CFR 328.102(c). Specifically, the Administrator has determined that FEMA will not purchase covered materials from shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer's domestic production of covered materials, on a per item basis, was distributed in the United States in the preceding 12 months. The Administrator decided that this exemption is necessary or appropriate to promote the national defense because it would limit the impact of this order on pre-existing commercial relationships, in recognition of the importance of these commercial relationships to the international supply chain, and for humanitarian reasons, in consideration of the global nature of the COVID-19 pandemic. If FEMA determines that a shipment of covered materials falls within this exemption, such materials may be transferred out of the United States without further review by FEMA, provided that the Administrator may waive this exemption and fully review shipments of covered materials subject to this exemption for further action by FEMA, if the Administrator determines that doing so is necessary or appropriate to promote the national defense. FEMA may develop additional guidance regarding which exports are covered by this exemption, and encourages manufacturers to contact FEMA with specific information regarding their status under this exemption.

The Administrator may establish, in his discretion, additional exemptions that he determines are necessary or appropriate to promote the national defense and will announce any such exemptions by notice in the Federal Register .

FEMA will implement this rule with the cooperation and assistance of other U.S. Government agencies, including CBP, and will work with manufacturers, brokers, distributors, exporters, and shippers to ensure that the applicable requirements are carried out. Any covered materials intended for export may be detained by CBP while FEMA conducts its review of the shipment. FEMA will review the shipment and provide notification as soon as possible regarding the disposition of the covered materials under this order, provided that any goods that have been detained by CBP and are subsequently made subject to a DPA-rated order will be consigned to FEMA pending further distribution or agency direction. FEMA may provide additional guidance regarding the application of any exemptions to this temporary rule, as appropriate.

FEMA may conduct such investigations and issue such requests for information as may be necessary for the enforcement of the Act, including this rule. See new 44 CFR 328.104(a); see also section 705 of the Act, 50 U.S.C. 4555; Executive Order 13911, 85 FR 18403 (Apr. 1, 2020). FEMA may seek an injunction or other order whenever, in the Administrator's judgment, a person has engaged or is about to engage in any acts or practices which constitute or will constitute a violation of the Act or any rule or order issued thereunder. See new 44 CFR 328.104(b); see also section 706 of the Act, 50 U.S.C. 4556. In addition to an injunction, failure to comply fully with this rule is a crime punishable by a fine of not more than $10,000 or imprisonment for not more than one year, or both. See new 44 CFR 328.104(c); see also section 103 of the Act, 50 U.S.C. 4513. In addition, pursuant to 18 U.S.C. 554, whoever fraudulently or knowingly exports or sends from the United States, or attempts to export or send from the United States, any merchandise, article, or object contrary to any U.S. law or regulation, or receives, conceals, buys, sells, or in any manner facilitates the transportation, concealment, or sale of such merchandise, article, or object, prior to exportation, knowing the same to be intended for exportation contrary to any U.S. law or regulation, faces up to 10 years' imprisonment, a fine, or both, if convicted.

At any point in time, and to the extent consistent with United States policy, the FEMA Administrator may determine additional materials to be subject to this allocation order. Upon a determination under section 101(b) of the DPA that an additional material is a scarce and critical material essential for national defense, and that being allocated to domestic use under this allocation order is the only way to meet national defense requirements without significant disruption to the domestic markets, the Administrator will include these additional materials in this allocation order, and will provide notification of this decision through publication in the Federal Register.

Agency rulemaking is generally governed by the agency rulemaking provisions of the Administrative Procedure Act (APA). See 5 U.S.C. 553. Such provisions generally require that, unless the rule falls within one of a number of enumerated exceptions, or unless another statute exempts the rulemaking from the requirements of the APA, FEMA must publish a notice of proposed rulemaking in the Federal Register that provides interested persons an opportunity to submit written data, views, or arguments, prior to finalization of regulatory requirements. Section 553(b)(B) authorizes a department or agency to dispense with the prior notice and opportunity for public comment requirement when the agency, for “good cause,” finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest.

This rule is exempt from the APA under section 709(a) of the Act, 50 U.S.C. 4559(a). Instead, this rule is issued subject to the provisions of section 709(b). Pursuant to section 709(b)(2) of the Act, the Administrator has concluded, based on the facts related to the COVID-19 pandemic, which already have been summarized in this document, that, with respect to this temporary rule, urgent and compelling circumstances make compliance with the notice and comment requirements of section 709(b)(1) of the Act, 50 U.S.C. 4559(b)(1), impracticable. If final regulations become necessary, an opportunity for public comment will be provided for not less than 30 days before such regulations become final, pursuant to section 709(b)(2)(C) of the Act, 50 U.S.C. 4559(b)(2)(C).

Furthermore, the same facts that warrant waiver under section 709(b)(2) of the Act would constitute good cause for FEMA to determine, under the APA, that notice and public comment thereon are impractical, unnecessary, or contrary to the public interest, and that the temporary rule should become effective upon display at the Federal Register .

As the President has noted, although the Federal Government, along with State and local governments, have taken preventative and proactive measures to slow the spread of the virus SARS-CoV-2, and the disease it causes, COVID-19, and to treat those affected. The spread of COVID-19 within the Nation's communities threatens to strain the Nation's healthcare systems. It is imperative that health and medical resources needed to respond to the spread of COVID-19, including the PPE affected by this rule, are allocated for domestic use as appropriate. This temporary rule is needed to appropriately allocate scarce or threatened items for domestic use.

The measures described in this rule are being issued on a temporary basis. This temporary rule will cease to be in effect on August 10, 2020.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a regulation (1) having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The Office of Management and Budget has designated this temporary rule as an economically significant regulatory action. Given that the temporary rule is a significant regulatory action, FEMA proceeds under the emergency provision of Executive Order 12866, section 6(a)(3)(D) based on the need for immediate action, as described above.

The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule that the agency issues under 5 U.S.C. 553 after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the Federal Register . 5 U.S.C. 603, 604.

This is neither a proposed rule, nor a final rule that the agency has issued under 5 U.S.C. 553 of this title after being required by that section or any other law to publish a general notice of proposed rulemaking. This is a temporary rule issued without a prior proposed rule, under the separate authority of the Defense Production Act of 1950. Accordingly, a regulatory flexibility analysis is not required.

Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act), 2 U.S.C. 1532, requires that covered agencies prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $172 million. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires covered agencies to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. DHS has determined that this rule is not expected to result in expenditures by State, local, and tribal governments, or by the private sector, of $172 million or more in any one year. This rule imposes no requirements on State, local, and tribal governments and, therefore, cannot require them to expend any funds, let alone $172 million. To the extent that this rule affects the private sector, it only prohibits conduct, namely certain exports. It does not require any private sector expenditures within the meaning of the Unfunded Mandates Act. Further, the rule is excluded from the Unfunded Mandates Act under 2 U.S.C. 1503(4) and (5).

Under the National Environmental Policy Act of 1969 (NEPA), as amended, 42 U.S.C. 4321 et seq., an agency must prepare an environmental assessment or environmental impact statement for any rulemaking that significantly affects the quality of the human environment. FEMA has determined that this rulemaking does not significantly affect the quality of the human environment and consequently has not prepared an environmental assessment or environmental impact statement.

Rulemaking is a major Federal action subject to NEPA. Categorical exclusion A3 included in the list of exclusion categories at Department of Homeland Security Instruction Manual 023-01-001-01, Revision 01, Implementation of the National Environmental Policy Act, Appendix A, issued November 6, 2014, covers the promulgation of rules, issuance of rulings or interpretations, and the development and publication of policies, orders, directives, notices, procedures, manuals, and advisory circulars if they meet certain criteria provided in A3(a-f). This interim final rule meets Categorical Exclusion A3(a), “Those of a strictly administrative or procedural nature”.

This rule has been reviewed under Executive Order 13132, Federalism, 64 FR 43255 (August 4, 1999). That Executive Order imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. DHS has determined that this temporary rule will not have a substantial direct effect 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. Furthermore, there are no provisions in this rule that impose direct compliance costs on State and local governments. Accordingly, DHS believes that the rule does not warrant additional analysis under Executive Order 13132.

Under the Congressional Review of Agency Rulemaking Act (CRA), 5 U.S.C. 801-808, before a rule can take effect, the Federal agency promulgating the rule must: Submit to Congress and to the Government Accountability Office (GAO) a copy of the rule; a concise general statement relating to the rule, including whether it is a major rule; the proposed effective date of the rule; a copy of any cost-benefit analysis; descriptions of the agency's actions under the Regulatory Flexibility Act and the Unfunded Mandates Reform Act; and any other information or statements required by relevant executive orders.

FEMA has sent this rule to the Congress and to GAO pursuant to the CRA. The Office of Information and Regulatory affairs has determined that this rule is a “major rule” within the meaning of the CRA. As this rule is being promulgated under the good cause exception to notice and comment under the Administrative Procedure Act, there is not a required delay in the effective date. See 5 U.S.C. 808.

Accordingly, for the reasons set forth in the preamble, and effective from April 7, 2020 until August 10, 2020, chapter I of title 44 of the Code of Federal Regulations is amended by adding part 328 to read as follows:

Background

A final rule published April 2, 2020 (85 FR 18459), for the take of marine mammals incidental to the University of California Santa Cruz's Partnership for Interdisciplinary Studies of Coastal Oceans (UCSC/PISCO) rocky intertidal monitoring surveys along the Oregon and California coasts. This document corrects the incorrect final effective date of the regulations contained in the preamble DATES section.

As published on page 18459 of the preamble of the final rule the DATES section was incorrect. This correction does not change NMFS' analysis or conclusions in the final rule.