On August 12, 2021, the NRC published a notice in the Federal Register informing the public that it will consider in the rulemaking process the issues raised in a petition for rulemaking regarding reporting requirements for nonemergency events at nuclear power plants (86 FR 44290). The NRC is in the early stages of developing a regulatory basis document that will discuss the regulatory issues, alternatives to resolve those issues, and the NRC staff's recommended alternative. The NRC will consider the information shared at the meeting in the development of the regulatory basis document.

The public meeting will be on November 4, 2021, from 2:00 p.m. to 5:00 p.m. (ET). Interested stakeholders may attend via telephone or online seminar. The purpose of the meeting is to provide background information on this rulemaking activity and obtain stakeholder input to enhance the NRC's understanding of the associated issues. Further, the staff will describe the various opportunities for the public to participate in the rulemaking process. The NRC will not provide formal written responses to the oral comments made at this meeting.

Information for the teleconference and online seminar is available in the meeting notice, which can be accessed through the NRC's public website at: https://www.nrc.gov/pmns/mtg or in ADAMS under accession number ML21288A427. The meeting notice includes questions for discussion to support development of the regulatory basis.

Title III of the Energy Policy and Conservation Act of 1975, as amended (“EPCA” or, in context, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. Part B of Title III (42 U.S.C. 6291-6309) provides for the Energy Conservation Program for Consumer Products Other Than Automobiles. The National Energy Conservation Policy Act (NECPA), Public Law 95-619, amended EPCA to add Part C of Title III, which established an energy conservation program for certain industrial equipment. (42 U.S.C. 6311-6317)  1 Included among the various equipment types addressed by EPCA  2 are electric motors and small electric motors.

As relevant here, DOE's energy conservation program under EPCA consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products and covered equipment must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA; and (2) making representations about the efficiency of those products. Similarly, DOE must use these test procedures to determine whether the products comply with any relevant standards promulgated under EPCA. 3 Further, 42 U.S.C. 6299-6305, 6316, and 6317 authorize DOE to enforce compliance with the energy conservation standards related to a variety of consumer products and commercial equipment, including electric motors and small electric motors.

On June 24, 2016, DOE published a notice of proposed rulemaking (NOPR) proposing to revise its certification and enforcement regulations for electric motors and small electric motors. 81 FR 41377. DOE proposed to: (1) Move and amend certification and sampling provisions for electric motors to 10 CFR 429.12 and 10 CFR 429.63, (2) replace the currently used compliance certification number with a new manufacturer's identification number (3) move the sampling and certification testing provisions for small electric motors to 10 CFR 429.12 and 10 CFR 429.64, (4) add certification provisions specific to small electric motors to 10 CFR 429.64, (5) move and amend existing AEDM provisions for electric motors and for small electric motors to 10 CFR 429.70, (6) move and amend the administrative process for recognizing certification programs to new sections 10 CFR 429.73 and 10 CFR 429.75, (7) add an administrative process for recognizing testing laboratories, either directly or through recognition of accreditation organizations, to new sections 10 CFR 429.74 and 10 CFR 429.75, (8) move the electric motor labeling requirements from 10 CFR 431.31 to 10 CFR 429.76, (9) add labeling requirements for small electric motors, (10) add a definition for “independent” to describe how DOE would evaluate the independence of testing laboratories and certification programs, (11) revise the definition of basic model for electric motors and small electric motors, (12) add a definition for “equipment class”, (13) remove definitions related to accreditation as a result of the proposed changes regarding laboratory accreditation, (14) apply the enforcement procedure found at subpart C of part 429 to electric motors and small electric motors, (15) address how to treat electric motors and small electric motors that are capable of operation at multiple voltages, and (16) clarify the exclusion for small electric motors found at 42 U.S.C. 6317(b)(3).

DOE received negative comment on a variety of its proposals, and DOE had expected to solicit further comment on those issues. For the proposals on which DOE received supportive comment, DOE prepared a final rule, which was issued on January 11, 2017 (“pre-publication final rule”). On January 20, 2017, the heads of executive departments were directed to withdraw any rules immediately that were not yet published. 82 FR 8346 (January 24, 2017). Accordingly, DOE withdrew the pre-publication final rule from the Federal Register for further review. On March 9, 2017, NEMA requested that DOE not return the pre-publication final rule to the Federal Register for publication. The pre-publication final rule was never published in the Federal Register .

In the intervening time, DOE has undertaken a few different rulemakings and activities related to electric motors and small electric motors. For example, DOE published a final rule pertaining to test procedures for electric motors and small electric motor. 86 FR 4 (January 4, 2021). DOE also classified North Carolina Advanced Energy Corporation as a nationally recognized certification program. 85 FR 40270 (July 6, 2020).

In addition, Issue 14 from the NOPR is now being addressed through a new enforcement rulemaking. See Docket EERE-2019-BT-CE-0015 (available at https://www.regulations.gov/docket?D=EERE-2019-BT-CE-0015 ). On that issue, DOE published a notice of proposed rulemaking proposing changes to enforcement procedures for all products, including electric motors and small electric motors. 85 FR 53691 (August 31, 2020).

Over four years have passed since the drafting of the pre-publication final rule and even more time has passed since DOE received comment on its proposals. In addition, commenters opposed the publication of the pre-publication final rule in the Federal Register .

After consideration of comments and the prolonged interlude since the publication of DOE's proposals, the Department is withdrawing this rulemaking proposal. The purpose of this rulemaking was to provide more consistency in DOE's certification and enforcement regulations across all types of covered products and covered equipment. It was also intended to provide greater clarity with respect to a number of issues industry and test facilities had raised. While the Department believes that there is a benefit to addressing certification of electric motors and small electric motors, DOE also takes seriously industry concerns about the potential burden of this proposal. DOE also notes that the enforcement regulations will be addressed through a different rulemaking.

Accordingly, DOE withdraws the June 24, 2016 NOPR published at 81 FR 41377.

This document of the Department of Energy was signed on October 26, 2021, by Kelly Speakes-Backman, Principal Deputy Assistant Secretary and Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

On September 29, 2021, DOE published the notification of a webinar and availability of preliminary technical support document in the Federal Register soliciting public comment on its proposed amendments to the energy conservation standards for residential clothes washers. 86 FR 53886. Comments were originally due on December 13, 2021. On October 11, 2021, DOE received a comment from the Association of Home Appliance Manufacturers to extend the comment period by an additional 64 days to February 15, 2022. 1

DOE has reviewed the request and considered the benefit to stakeholders in providing additional time to review the preliminary analysis and gather information/data that DOE is seeking. Accordingly, DOE has determined that an extension of the comment period is appropriate and is hereby extending the comment period by an additional 45 days to January 27, 2022 for a total of a 120 day comment period.

This document of the Department of Energy was signed on October 19, 2021, by Kelly Speakes-Backman, Principal Deputy Assistant Secretary and Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0948; Project Identifier MCAI-2020-00394-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Kristi Bradley, Program Manager, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email kristin.bradley@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0065, dated March 20, 2020 (EASA AD 2020-0065), to correct an unsafe condition for all Leonardo S.p.A., Agusta S.p.A., Costruzioni Aeronautiche Giovanni Agusta Model A109A and A109AII helicopters. EASA advises of a report of internal corrosion on an M/R blade. Leonardo Helicopters advises that the corrosion was on the spar near the inertia weights between STA1250 and STA1630. Leonardo Helicopters further advises that the issue is related to design and production processes of the M/R blades. This condition, if not addressed, could result in failure of an M/R blade and subsequent loss of control of the helicopter.

Accordingly, EASA AD 2020-0065 requires inspecting M/R blades with part number (P/N) 109-0103-01-115 and depending on the results, corrective action. EASA AD 2020-0065 also prohibits installation of an affected M/R blade unless it passed the required inspection within 24 months prior to installation on a helicopter.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design.

The FAA reviewed Leonardo Helicopters Alert Service Bulletin No. 109-155, dated March 13, 2020 (ASB 109-155), for Leonardo S.p.a Model A109A and A109AII helicopters. This service information specifies procedures for X-ray inspecting M/R blades P/N 109-0103-01-115 and sending the films to Leonardo Helicopters S.p.a. for analysis. Depending on the outcome, ASB 109-155 specifies procedures for re-identifying the M/R blades.

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.

For each affected M/R blade, this proposed AD would require within 50 hours time-in-service or 3 months after the effective date of this AD, whichever occurs first, unless already done within the last 24 months for the M/R blade, and thereafter, at intervals not to exceed 24 months for the M/R blade, radiographic inspecting the M/R blade and accomplishing film analysis and repair in accordance with certain approved methods.

The compliance time in EASA AD 2020-0065 is time-in-service of the airframe, whereas the compliance time in this proposed AD would be time-in-service of the affected M/R blade as installed on the airframe. EASA AD 2020-0065 requires sending developed films to Leonardo Helicopters S.p.a. for analysis and contacting Leonardo for approved corrective action(s) instructions, whereas this proposed AD would require film analysis and repair of an affected blade in accordance with a method approved by the Manager, General Aviation & Rotorcraft Section, International Validation Branch, FAA; or EASA; or Leonardo S.p.a Helicopters' EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

The FAA considers this proposed AD interim action. The design approval holder is currently developing a modification that will address the unsafe condition identified in this proposed AD. Once this modification is developed, approved, and available, the FAA might consider additional rulemaking.

The FAA estimates that this AD, if adopted as proposed, would affect 28 helicopter of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.

Inspecting the M/R blades would take about 10 work-hours for an estimated cost of $850 per helicopter and $23,800 for the U.S. fleet, per inspection cycle. Sending the film for analysis, which is considered a reporting requirement in this proposed AD, would take about 1 work-hour for an estimated cost of $85 per helicopter and $2,380 for the U.S. fleet, per inspection cycle.

The FAA has no way of determining the costs pertaining to the film analysis or any necessary repairs.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0947; Project Identifier MCAI-2021-00195-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email andrea.jimenez@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0048, dated February 16, 2021 (EASA AD 2021-0048), to correct an unsafe condition for Airbus Helicopters (formerly Eurocopter, Eurocopter France, Aérospatiale) Model AS 350 B, AS 350 BA, AS 350 BB, AS 350 B1, AS 350 B2, AS 350 B3, AS 350 D, EC 130 B4, and EC 130 T2 helicopters; Model AS 355 E, AS 355 F, AS 355 F1, AS 355 F2, AS 355 N, and AS 355 NP helicopters; and Model SA 365 C1, SA 365 C2, SA 365 C3, SA 365 N, SA 365 N1, AS 365 N2, and AS 365 N3 helicopters; all serial numbers. Model AS 350 BB and SA 365 C3 helicopters are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this proposed AD therefore does not include those helicopters in the applicability.

This proposed AD was prompted by a report of increased vibration during flight by the crew of an Airbus Helicopters Model AS 365 helicopter. Subsequent investigation found a total loss of tightening torque of one screw connecting the MR pitch rod to the horn of its upper link, which led to abnormal wear of the screw and consequently increased the vibrations coming from the MR control chain to the pilot's flight controls. The MR pitch rod upper link installation is identical on Model AS 350, EC 130, AS 355, SA 365 and AS 365 helicopters, therefore, these models may be subject to the unsafe condition revealed on the Model AS 365 helicopter. The FAA is proposing this AD to address loss of tightening torque of the screws connecting the MR pitch rods to the horns of the upper links. This condition, if not addressed, could result in loss of one or more MR pitch rod upper links, possibly resulting in loss of control of the helicopter. See EASA AD 2021-0048 for additional background information.

EASA AD 2021-0048 requires the application of alignment markings on the screw, washer, nut, and horn on both sides of each MR pitch rod upper link, and repetitive visual inspections of the two alignment markings to determine if the markings are aligned on both sides. If, during any inspection the markings on one or both sides of a MR pitch rod upper link are found misaligned, the additional actions and corrective actions include the following.

• Measuring the tightening torque value of the nut of the pitch rod upper link and adjusting the nut if it does not meet the specified criteria.

• Inspecting the pitch rod upper link to determine the condition of the bush (bushing) and spherical bearing and to determine if the cups are tight (paint mark in place), and measuring the play. If there is seizing, carbide chips, or the cups are loose (paint mark not in place), the corrective actions include replacing the spherical bearing. If the play measurement is greater than the specified measurement the corrective action is replacing the rod end fitting. Additional actions include checking the bonding and condition of the retaining ring and inspecting the pitch rod bodies for evidence of any impact, scratch, strike, or corrosion.

• Inspecting the pitch rods for chipped finish paint, scratches, impacts, and cracking, and measuring the play. If paint is chipped the corrective action is repair (sanding the affected area and applying touch-up primer and paint). If there is any scratch, an impact with a depth equal to or greater than the specified measurement, or any crack, the corrective action is replacing the pitch rod. If the play measurement is greater than 0.25 mm or there is cracking, the corrective action is replacing the spherical bearing. An additional action, if a helicopter was involved in an incident, is inspecting the straightness of the rod body “R” and replacing the pitch rod if the straightness of the rod body is greater than 0.5 mm.

• Inspecting the pitch horn for any evidence of impact, scratch, corrosion, chipped paint, cracking, and any elongated attachment hole; and inspecting the bonding of the retaining ring and measuring dimension “X” of the retaining ring. If there is any evidence of impact, scratch, or corrosion, and the depth meets the specified criteria, the corrective actions include touching up the affected area with an abrasive cloth and applying a protective coating and a coat of primer. If there is any cracking, elongated attachment hole, or the impact, scratch, or corrosion depth exceeds the specified criteria, the corrective action is replacing the pitch horn. If paint is chipped the corrective actions include sanding the affected area and applying touch-up primer and paint. If the retaining ring has debonded the corrective action is to rebond the retaining ring. If dimension “X” of the retaining ring exceeds the specified criteria, the corrective action is replacing the retaining ring.

• Measuring the geometry of “G” of the pitch horn and replacing the pitch horn if the dimension is not within the specified range.

• Installing new split pins, nuts, washers, and a screw on the pitch rod upper link.

This material 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.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of these same type designs.

This proposed AD would require accomplishing the actions specified in EASA AD 2021-0048, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0048 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0048 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0048 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0048. Service information required by EASA AD 2021-0048 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0947 after the FAA final rule is published.

The FAA estimates that this AD, if adopted as proposed, would affect 1,266 helicopters of U.S. Registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA estimates the following costs to do any necessary actions that would be required based on the results of the proposed inspection. The agency has no way of determining the number of aircraft that might need these actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0945; Project Identifier MCAI-2021-01033-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Dan Rodina, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3225; email dan.rodina@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2021-11-23, Amendment 39-21585 (86 FR 40932, July 30, 2021) (AD 2021-11-23), for certain Airbus SAS Model A350-941 and -1041 airplanes. AD 2021-11-23 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations and, for certain airplanes, updating the hydraulic monitoring system to include additional redundancy. The FAA issued AD 2021-11-23 to address the overheat failure mode of the hydraulic engine-driven pump, which may cause a fast temperature rise of the hydraulic fluid, and, if combined with an inoperative fuel tank inerting system, could lead to an uncontrolled overheat of the hydraulic fluid, possibly resulting in ignition of the fuel-air mixture of the affected fuel tank.

Since the FAA issued AD 2021-11-23, the FAA has determined that new or more restrictive airworthiness limitations are necessary.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0209, dated September 15, 2021 (EASA AD 2021-0209) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes. EASA AD 2021-0209 refers to Airbus A350 Airworthiness Limitations Section (ALS), Part 5, “Fuel Airworthiness Limitations (FAL),” Revision 05, dated June 30, 2021, which includes updating the hydraulic monitoring system. Airplanes with an original airworthiness certificate or original export certificate of airworthiness issued after June 30, 2021, must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability. EASA AD 2021-0209 supersedes EASA AD 2020-0268, dated December 4, 2020 (which corresponds to FAA AD 2021-11-23).

This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to address the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane. See the MCAI for additional background information.

EASA AD 2021-0209 describes new or more restrictive airworthiness limitations related to fuel tank ignition prevention and fuel tank flammability reduction.

This material 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA has evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

This proposed AD would also require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, which are specified in EASA AD 2021-0209 described previously, as incorporated by reference. Any differences with EASA AD 2021-0209 are identified as exceptions in the regulatory text of this AD. This proposed AD would also require accomplishing a certain airworthiness limitation using the Airbus service information described previously.

This proposed AD would require revisions to certain operator maintenance documents to include new actions ( e.g., inspections) and Critical Design Configuration Control Limitations (CDCCLs). Compliance with these actions and CDCCLs is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (j)(1) of this proposed AD.

This proposed AD does not restate the requirements of AD 2021-11-23 due to an error in the applicability of that AD. The applicability of AD 2021-11-23 identified airplanes having an original airworthiness certificate or original export certificate of airworthiness issued “after” September 15, 2020, instead of “on or before” September 15, 2020. The affected airplanes are correctly identified in the applicability of this new proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0209 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0209 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0209 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0209.

Service information required by EASA AD 2021-0209 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0945 after the FAA final rule is published.

The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.

For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).

The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions ( e.g., inspections), intervals, or CDCCLs may be used unless the actions, intervals, and CDCCLs are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in the AMOCs paragraph under “Other FAA Provisions.” This new format includes a “New Provisions for Alternative Actions, Intervals, and CDCCLs” paragraph that does not specifically refer to AMOCs, but operators may still request an AMOC to use an alternative action, interval, or CDCCL.

The FAA estimates that this proposed AD affects 24 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate.

The FAA estimates the total cost per operator for the proposed maintenance or inspection program revision to be $7,650 (90 work-hours J $85 per work-hour).

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA issued an NPRM that proposed to amend 14 CFR part 39 by adding an AD that would have applied to certain Scotts-Bell Model 47, 47B, 47B3, 47D, 47D1, 47E, 47G, 47G-2, 47G-2A, 47G-2A-1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A, 47G-5, 47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47K helicopters. The NPRM published in the Federal Register on May 18, 2018 (83 FR 23240). The NPRM was prompted by reports of the throttle linkage separating from the engine carburetor shaft, which could result in loss of throttle control.

In the NPRM, the FAA proposed to require repetitively inspecting and adjusting the throttle linkage. The proposed actions were intended to address separation of the throttle linkage from an engine carburetor shaft, which could result in loss of throttle control and subsequent forced landing of the helicopter.

Since issuance of the NPRM, the FAA has not received any additional reports of the throttle linkage separating from the engine carburetor shaft. The FAA's assessment indicates that there have been few reports of the throttle linkage separating from the engine carburetor shaft in the more than 70-year operational history of the Model 47G-3B-1 helicopter. In addition, the FAA determined that in this incident the throttle linkage separating from the engine carburetor shaft resulted from maintenance actions that did not follow the established maintenance standards and were not performed by a certified mechanic. Based on this information the FAA concluded that an unsafe condition does not exist on the identified Scotts-Bell helicopter models that is likely to develop in other products of the same type design. Therefore, the FAA has determined that AD action is not appropriate.

Withdrawal of the NPRM constitutes only such action and does not preclude the FAA from further rulemaking on this issue, nor does it commit the FAA to any course of action in the future.

The FAA gave the public the opportunity to comment on the NPRM and received several comments from Scott's-Bell 47, Inc. You may examine the comments received in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-0440.

Scott's-Bell 47, Inc. requested that the applicability in the proposed AD be revised to include helicopter models that are listed in the “Serial Numbers Eligible” section of Type Certificate Data Sheets (TCDS) H-1, 2H1, and 2H3. The commenter noted that in the proposed AD only Scotts-Bell Model 47 helicopters are identified. The commenter stated that many other helicopter models are listed in TCDS H-1, 2H1, and 2H3 and provided an example that due to a conformity inspection TCDS H1 lists the Rebel Rotors serial number (S/N) B-101-R helicopter as eligible to operate as a Model 47D1. The commenter explained that the Rebel Rotors S/N B-101-R helicopter is not a Scott's-Bell Model 47D1 helicopter, and as the proposed AD was written, would not be captured in the applicability, despite the fact that it likely had the same unsafe condition addressed in the proposed AD. The commenter suggested that the applicability be changed to mirror what is in the Scott's-Bell 47, Inc. service information “All Helicopters listed on Type Certificate Data Sheets H-1, 2H1, and 2H3, which have Marvel Schebler carburetors models . . . installed.”

The FAA acknowledges this comment to the NPRM. However, because the FAA is withdrawing the NPRM, the commenter's request is no longer necessary.

Scott's-Bell 47, Inc. also requested that the compliance time in paragraph (e)(3) of the proposed AD be revised to state “Within 100 hours time-in-service or at the next annual or 100-hour inspection, whichever occurs first, and thereafter any time the throttle linkage connection is disassembled.” The commenter explained that, as written in the proposed AD, this compliance time does not address disassembly and, if disassembly were to occur after the first flight of the day and the helicopter was returned to service on the same day, the current wording would not require proper rigging to be performed for the second and subsequent flights of that day. The commenter suggested that its proposed wording would capture all variables and eliminate unnecessary re-rigging of the helicopter.

The FAA acknowledges this comment to the NPRM. However, because the FAA is withdrawing the NPRM, the commenter's request is no longer necessary.

Furthermore, Scott's-Bell 47, Inc. requested that paragraphs (e)(3)(i) and (ii) of the proposed AD be revised to include additional required actions. The commenter stated that paragraph (e)(3)(i) of the proposed AD requires operators to “adjust and secure the throttle linkage as specified in Appendix 1 of the Scott's-Bell Maintenance and Overhaul Instructions Temporary Revision . . . .” but other vital functions, including a functionality check after adjusting and securing, followed by applying anti-sabotage lacquer, are not included, and, therefore, would not be required. The commenter recommended that paragraph (e)(3)(i) be revised to “Adjust, secure, perform functionality check, and apply anti-sabotage lacquer to the throttle linkage, as specified in Appendix 1 of the Scott's-Bell Maintenance and Overhaul Instructions Temporary Revision that is applicable to your helicopter, as listed in Table 1 of Scott's-Bell Alert Service Bulletin 47-15-27 R1, dated November 1, 2016.”

In regard to paragraph (e)(3)(ii) of the proposed AD, the commenter proposed that this paragraph be revised to state “. . . and 47K helicopters, adjust, secure, perform functionality check and apply anti-sabotage lacquer to the throttle linkage using a method approved . . . .”

The FAA acknowledges this comment to the NPRM. However, because the FAA is withdrawing the NPRM, the commenter's request is no longer necessary.

Upon further consideration of the available information, the FAA has determined that the NPRM is unnecessary. Accordingly, the NPRM is withdrawn.

Since this action only withdraws an NPRM, it is neither a proposed nor a final rule. This action therefore is not covered under Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979).

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0570; Project Identifier 2019-SW-091-AD” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Kristi Bradley, Program Manager, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5485; email kristin.bradley@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain Leonardo S.p.a. Model AW169 helicopters. The NPRM published in the Federal Register on July 28, 2021 (86 FR 40371). In the NPRM, the FAA proposed to require modification of the pilot and co-pilot yaw pedal assemblies. The NPRM was prompted by EASA AD 2019-0252, dated October 10, 2019 (EASA AD 2019-0252), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Leonardo S.p.a. (formerly Finmeccanica S.p.A and AgustaWestland S.p.A) Model AW169 helicopters, all serial numbers. EASA advised that there was a report of a broken adjustable device that is part of the pilot and co-pilot yaw pedal assemblies. This condition, if not addressed, could result in failure of a yaw pedal adjuster, which could result in reduced yaw control of the helicopter.

Accordingly, EASA AD 2019-0252 required modification (rework) of the affected pilot and co-pilot assemblies and re-identification of each affected part after it has been modified. The modification included the installation of additional end stroke stops on the pilot and co-pilot pedal assemblies. EASA considered EASA AD 2019-0252 an interim action and stated that further EASA AD action may follow.

Since the NPRM was issued, EASA issued AD 2021-0199, dated August 27, 2021 (EASA AD 2021-0199), which supersedes EASA AD 2019-0252. EASA advises that three additional events have been reported where the universal joint of the adjusting mechanism on the yaw pedals failed. Prompted by these findings, Leonardo S.p.a. developed a new modification that introduces upgraded pilot and co-pilot pedal assemblies with an improved design, which removes the failure modes. Accordingly, EASA AD 2021-0199 requires modification (rework) of the affected pilot and co-pilot assemblies and re-identification of each affected part after it has been modified. The modification includes replacing the pedal main support assembly, adjuster screw assembly, knob assembly, and spring pin, and removing the additional end stroke stops that were installed on the pilot and co-pilot pedal assemblies using the modification specified in EASA AD 2019-0252. EASA AD 2021-0199 also provides an option to replace an affected part with a non-affected part instead of doing the modification.

In addition, the FAA revised the applicability of this proposed AD from Leonardo S.p.a. Model AW169 helicopters with an affected part installed (as specified in the NPRM), to all Leonardo S.p.a. Model AW169 helicopters. This revised applicability matches EASA AD 2021-0199.

The FAA gave the public the opportunity to participate in developing this proposed AD. The FAA received no comments on the NPRM or on the determination of the cost.

This helicopter has been approved by EASA and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design. Certain changes described above expand the scope of the NPRM. As a result, it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.

EASA AD 2021-0199 requires modification of the affected pilot and co-pilot assemblies and re-identification of each affected part after it has been modified. EASA AD 2021-0199 also provides an option to replace an affected part with a non-affected part instead of doing the modification. EASA AD 2021-0199 also prohibits the installation of affected parts.

This material 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.

This proposed AD would require accomplishing the actions specified in EASA AD 2021-0199, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use certain civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2021-0199 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0199 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0199 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0199. Service information specified in EASA AD 2021-0199 that is required for compliance with it will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0570 after the FAA final rule is published.

The FAA estimates that this AD, if adopted as proposed, would affect 10 helicopters of U.S. Registry. The FAA estimates the following costs to comply with this proposed AD.

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0944; Project Identifier MCAI-2020-00800-G” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Jim Rutherford, Aviation Safety Engineer, FAA, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0138, dated June 19, 2020 (referred to after this as “the MCAI”), to address an unsafe condition on Fiberglas-Technik R. Lindner GmbH & Co. KG Model ASTIR CS, ASTIR CS 77, ASTIR CS Jeans, CLUB ASTIR II, STANDARD ASTIR II, TWIN ASTIR, TWIN ASTIR TRAINER, GROB G 103 “TWIN II,” GROB G 103 A “TWIN II ACRO,” GROB G 103 C “TWIN III,” GROB G 103 C “TWIN III ACRO,” GROB G 103 C TWIN III SL, ASTIR CS 77 TOP, ASTIR CS JEANS TOP, and ASTIR CS TOP gliders. The MCAI states:

You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0944.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed Fiberglas-Technik Rudolf Lindner Anweisung/Instructions (A/I-G09), Revision 1, dated May 14, 2020. This service information provides instructions to inspect the elevator control pushrod for water and corrosion, replace the elevator control pushrod if any water or corrosion is found, and apply corrosion prevention if no water and no corrosion are found. 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 ADDRESSES .

The FAA also reviewed Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G09), Revision 1, dated May 14, 2020. This service information refers to the instructions in A/I-G09 to inspect and replace the elevator control pushrod on various gliders.

The FAA reviewed Grob TFE Service Bulletin TM 315-34, dated December 8, 1987. This service information provides effectivity, reason, and high-level instructions for inspecting and replacing the elevator control pushrod on certain Model G 103 A TWIN II ACRO gliders.

The FAA reviewed Grob TFE Repair Instructions No. 315-34 for Service Bulletin TM 315-34, dated December 8, 1987. This service information provides more detailed instructions for inspecting and replacing the elevator control pushrod on certain Model G 103 A TWIN II ACRO gliders.

This proposed AD would require inspecting the elevator control pushrod and replacing it if water or corrosion are found.

The MCAI applies to Model ASTIR CS 77, ASTIR CS Jeans, CLUB ASTIR II, STANDARD ASTIR II, TWIN ASTIR TRAINER, GROB G 103 C “TWIN III,” ASTIR CS 77 TOP, ASTIR CS JEANS TOP, and ASTIR CS TOP gliders. This proposed AD would not apply to these model gliders because they do not have an FAA type certificate.

The FAA estimates that this AD, if adopted as proposed, would affect 149 gliders of U.S. registry. The FAA estimates that it would take about 4 work-hours per glider to inspect the elevator control pushrod and require parts costing $100. The average labor rate is $85 per work-hour. Based on these figures, the FAA estimates the cost to inspect the elevator control pushrod on U.S. operators to be $65,560 or $440 per glider.

In addition, the FAA estimates that for gliders with water or corrosion within the elevator control pushrod, replacement would take about 8 work-hours and require parts costing $500. The average labor rate is $85 per work-hour. Based on these figures, the FAA estimates the replacement of this proposed AD to be $1,180 per glider.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Would not affect intrastate aviation in Alaska, and

(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

HHS issued the SUNSET final rule on January 19, 2021. 86 FR 5694. The SUNSET final rule provides, among other things, that all regulations, subject to certain exceptions, issued by the Secretary of the Department of Health and Human Services (Secretary) or his delegates or sub-delegates shall expire at the end of (1) five calendar years after the year that the SUNSET final rule first becomes effective, (2) ten calendar years after the year of the regulation's promulgation, or (3) ten calendar years after the last year in which the Department “Assessed” and, if required, “Reviewed” the regulation, whichever is latest. 1 The SUNSET final rule was scheduled to take effect on March 22, 2021. However, after a lawsuit seeking to overturn the SUNSET final rule was filed on March 9, 2021, HHS issued an administrative delay of effective date, effective as of March 19, 2021, which postponed the effective date of the SUNSET final rule, pending judicial review, until March 22, 2022. 86 FR 15404 (Mar. 23, 2021).

After reconsideration of the comments submitted on the SUNSET proposed rule (85 FR 70096 (Nov. 4, 2020)), HHS is now issuing this notice of proposed rulemaking to withdraw or repeal the SUNSET final rule.

We are proposing to withdraw or repeal the SUNSET final rule in its entirety.

The primary statutory authorities supporting this proposed rule are the general rulemaking authorities for the various substantive areas under the Department's umbrella, as well as a general authorization for agencies to issue regulations regarding the administrative processes to be followed by that agency. These provisions include: 21 U.S.C. 371(a); 42 U.S.C. 216; 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 2003; and 5 U.S.C. 301.

This proposed regulatory action would reduce the time spent by the Department performing retrospective assessments and reviews of its regulations as required by the SUNSET final rule, and time spent by regulated entities and other stakeholders, including the general public, small and large businesses, non-governmental organizations, Tribes and state and local governments, on comments related to these assessments and reviews. We monetize the likely reductions in time spent by the Department and the general public as cost savings. Our primary estimate of these cost savings in 2020 dollars, annualized over 10 years, using a 3% discount rate, totals $69.9 million. Using a 7% discount rate, we estimate $75.5 million in annualized cost savings. Table 1 reports these primary estimates alongside a range of estimates that capture uncertainty in the amount of time it will take the Department to perform each regulatory assessment and review, and uncertainty in the amount of time the public will spend on comments. The impact of the proposed withdrawal provisions is analyzed in the Preliminary Economic Analysis of Impacts for this proposed rule. We seek comment on these preliminary estimates and analysis.

As used in this preamble, the following terms and abbreviations have the meanings noted below.

The SUNSET final rule, if implemented, would significantly alter the operations of HHS with considerable repercussions for a diverse array of stakeholders. We note that the process to promulgate the rule was extremely unusual, if not unprecedented. The rule is expansive in scope and impact, faced considerable opposition from stakeholders (and very little support), and lacked a public health or welfare rationale for expediting rulemaking. In contrast to the Department's historical approach to rulemaking in these circumstances, HHS completed the rulemaking—from the publication of the proposal to publication of the final rule—in less than three months. Upon a thorough review of the rule, we find that, given the lack of a public health or welfare reason to expedite the rulemaking and other procedural shortcomings, the Department should now reconsider the commenters' significant objections to the proposal. Moreover, based on a reanalysis of the regulatory impact of the rule, we now believe that the rule rested on a flawed understanding of the resources required for this undertaking, which implicates the likelihood that HHS regulations would expire if the final rule were to go into effect. That in turn will require the Department to make resource allocation decisions which could impede the Department's routine operations and hamper its ability to carry out other key priorities and goals, particularly during an ongoing public health emergency. Now that we have reconsidered the public comments and the regulatory impact analysis, including a consideration of the impacts that are not quantified or monetized, we believe that the rule prioritized regulatory review over other Department operations to a degree that may negatively impact many stakeholders and the general public in a variety of ways. We disagree with that approach as a matter of policy and therefore are proposing to withdraw the rule in its entirety.

On November 4, 2020, HHS published a notice of proposed rulemaking entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET proposed rule). 85 FR 70096. Under the proposed rule, subject to certain exceptions, Department regulations would expire at the end of (1) two calendar years after the year that the SUNSET rule first became effective, (2) ten calendar years after the year of the regulation's promulgation, or (3) ten calendar years after the last year in which the Department “Assessed” and, if required, “Reviewed” the regulation, whichever was latest. Thus, under the SUNSET proposed rule, unless HHS assessed and, if required, reviewed most of its regulations within a certain timeframe specified in the rule (for most existing regulations, within two years) and every ten years thereafter, the regulations would automatically expire.

The SUNSET proposed rule also provided that if a review led to a finding that a regulation should be amended or rescinded, the Department must amend or rescind the regulation within a specified timeframe (generally two years). In addition, the SUNSET proposed rule contained certain publication requirements, including that (1) the Department publish the results of all “Assessments” and “Reviews,” including the full underlying analyses and data used to support the results, in the Federal Register , and (2) the Department announce the commencement of an “Assessment” or “Review” of a particular regulation on the agency website, with an opportunity for public comment. The SUNSET proposed rule provided that comments to the proposed rule had to be submitted by December 4, 2020, except for comments on the portion of the rule amending 42 CFR parts 400-429 and parts 475-499 (Medicare program regulations), which were to be submitted by January 4, 2021.

On November 16, 2020, HHS announced a public hearing, scheduled for November 23, 2020, to receive information and views on the proposed rule (Public Hearing). 85 FR 73007. Despite the short notice, over twenty interested parties provided oral comments at the Public Hearing. See Transcript, Public Hearing on the Securing Updated and Necessary Statutory Evaluations Timely Notice of Proposed Rulemaking (Nov. 23, 2020) (available at https://www.regulations.gov/document/HHS-OS-2020-0012-0501 ) (Public Hearing Transcript). All of the commenters, which included industry/trade organizations, medical organizations, and public interest organizations, 2 criticized the proposed rule in its substance, the rulemaking process, or both.

In addition to the oral comments, a wide range of stakeholders submitted over 500 comments on the proposed rule. Almost all of the comments opposed the proposal. Comments opposing the rule were submitted by, for example, health care and medical organizations; Federally Qualified Health Centers and advocates for beneficiaries of Federal health care programs; State Attorneys General and other state government representatives; Tribal governments and Tribal organizations; large industry associations and trade associations; consumer and public interest groups; and interested individuals. Only a handful of commenters supported the rule, and two of those comments were submitted by an individual who, under an agreement with HHS, also provided a draft regulatory impact analysis for the SUNSET final rule. See 86 FR 5737 n.210. Other commenters supporting the rule included independent business advocacy organizations and a nonprofit legal organization.

On December 18, 2020, the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget received the SUNSET final rule for review and clearance and posted on the OIRA dashboard for E.O. 12866 Regulatory review (Ref. 1). This preceded the January 4, 2021, conclusion of the comment period for the parts of the proposed rule relating to 42 CFR parts 400-429 and parts 475-499.

HHS issued the SUNSET final rule on January 19, 2021. 86 FR 5694. The final rule provides that all regulations issued by the Secretary or their delegates or sub-delegates in titles 21, 42, and 45 of the Code of Federal Regulations (CFR), subject to certain exceptions, shall expire at the end of (1) five calendar years after the year that the SUNSET final rule first becomes effective, (2) ten calendar years after the year of the regulation's promulgation, or (3) ten calendar years after the last year in which the Department “Assessed” and, if required, “Reviewed” the regulation, whichever is latest. Thus, the final rule contains the same basic expiration framework as the proposed rule, but extends the timeframe for assessment and any applicable review of most existing regulations from two calendar years to five calendar years. The final rule also provides for a one-time “continuation” of a regulation that is subject to expiration if the Secretary makes a written determination that the public interest requires continuation. The continuation period, stated in the determination, is not to exceed one year. In addition, the final rule contains exemptions for a small set of HHS regulations applicable to the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare & Medicaid Services (CMS). The final rule maintains the timeframe for amendment or rescission of regulations, and includes a new Federal Register publication requirement in addition to the publication requirements proposed in the SUNSET proposed rule. 3

On March 9, 2021, the County of Santa Clara and several other plaintiffs sued the Department seeking to overturn the SUNSET final rule under the Administrative Procedure Act (APA). Complaint, County of Santa Clara v. HHS , Case No. 5:21-cv-01655-BLF (N.D. Cal. Mar. 9, 2021) ( Santa Clara ) (Ref. 2).

On March 18, 2021, the Acting Secretary of HHS signed, pursuant to 5 U.S.C. 705 of the APA, an administrative delay of effective date (Administrative Delay Order), effective as of March 19, 2021, which extended the effective date of the SUNSET final rule until March 22, 2022. 86 FR 15404.

The Department has reexamined the SUNSET final rule in light of the allegations in the Santa Clara complaint, the many comments submitted to the docket and raised at the Public Hearing, and changed policy views in the current Administration. This review has considered the processes followed in issuing the rule, its policy goals and objectives, the projected effects and analysis of impacts in its implementation, and the legal evaluation of and support for its provisions, including whether the rule is consistent with HHS statutory obligations and its mission to promote and protect the public health. It should be noted at the outset that HHS already conducts retrospective reviews, and the Department is open to feedback regarding how to improve these existing processes. The purpose of this review, however, has been to reconsider whether the new requirements imposed in the SUNSET final rule would achieve the goals of retrospective review in a manner that best serves the Department's public health and welfare mission. As described further below, based on our review, we now believe that the SUNSET final rule should be withdrawn in its entirety. However, we request comment on whether, consistent with the goals of retrospective review as well as other current policy priorities and considerations discussed in this proposed rule, the Department should consider modifying, rather than withdrawing or repealing, the SUNSET final rule.

Our current view is that, to be consistent with the Department's usual practices when engaging in rulemaking, the Department should have engaged in a more robust consideration of the comments, should have more thoroughly examined the factual and legal basis of the rule, and should have given greater weight to the potential harms to stakeholders and the public health. Our thinking is informed by a reevaluation of the factual premises and conclusions in the SUNSET final rule that are central to the Department's analysis of the rule's implications and effects. In particular, based on a reanalysis of the regulatory impact of the rule, we now believe that the rule likely rested on a flawed understanding of the resources required for this undertaking, which implicates the likelihood that HHS regulations would expire, and which in turn will require the Department to make resource allocation decisions which could impede the Department's ability to carry out other key priorities. That diversion of resources will likely impede efforts to adopt new rules to address national priorities and advance equity for all, including historically underserved and marginalized communities. It is therefore potentially inconsistent with the current Administration's policies that aim to empower agencies to use appropriate tools to achieve those ends. In this section, we summarize the key considerations, addressed in greater detail throughout the preamble, that have led us to change our view of the overall merit of the SUNSET final rule and to propose to withdraw the rule in its entirety.

As an initial matter, based on our review, we have found that there were several procedural shortcuts taken in the rulemaking process which may have impeded full consideration of the commenters' significant objections to the proposal. The SUNSET final rule was issued on an unusually expedited timeline of less than three months for a rule of this significance, with potential impacts not just on small businesses but also the general public, larger businesses, Tribes, States, non-governmental organizations, and other regulated entities and stakeholders across a wide range of industrial sectors. The SUNSET rule was also unusually expansive in scope, requiring review and possibly regulatory or deregulatory activity across a variety of distinct substantive statutes  4 within the jurisdiction of a several operating divisions ( e.g., CMS, FDA, CDC, Substance Abuse and Mental Health Services Administration (SAMSHA), the Office for Civil Rights (OCR), and the Administration for Children and Families (ACF)). Furthermore, it appears that the comments were not adequately considered (as evidenced by the summary mention in the preamble to the SUNSET final rule, as discussed further elsewhere in this preamble), and, contrary to policy, the Department did not consult with tribal governments.

As for the substance, we note initially that the resources required to comply with the assessment and review requirements would be substantial. For each regulation covered by the SUNSET final rule, HHS agencies would need to: Collect data to conduct the relevant evaluation (which may require time for public notice and comment, and Office of Management and Budget (OMB) review and approval, under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., in addition to the time needed for data collection and analysis); engage subject matter experts and others to complete an assessment (and possibly a review); consult with state and local jurisdictions and Tribes; open and publicize public dockets for each assessment or review that the Department conducts; consider any comments to the public docket related to the evaluation; participate in interagency review; and publish the results of this process in the Federal Register , “including the full underlying analyses and data used to support the results.” 86 FR 5712. If warranted by the results of this process, HHS agencies would then need to complete a rulemaking to amend or rescind the regulation, which would require an additional investment of agencies' resources and public input. If the Department cannot complete this extensive process within the final rule's timeframes, the regulations would then automatically expire. In addition, after that lengthy process, the Department would likely then need to revise guidance documents associated with both expiring regulations and regulations still in effect.

It appears that the SUNSET final rule made at least two errors in its justification for establishing this mandatory review process. First, based on the preliminary regulatory impact analysis for this proposed rule, it appears to have miscalculated the extent of the resources needed for this undertaking. In particular, we now believe that HHS underestimated the costs of complying with the rule at least by a factor of four. Second, and relatedly, it assumed that regulations would not simply expire. See, e.g., 86 FR 5710 (“HHS does not intend to allow a regulation to simply expire”); id. at 5712 (“the Department is committed to dedicating adequate resources to timely Assess and Review its regulations”); id. at 5714 (“the Department intends to timely complete the necessary Assessments and Reviews and has built in safeguards to mitigate the risk of inadvertent expiration”). Preventing the automatic expiration of regulations, however, would require prioritizing retrospective review above many other Department programs and missions. Based on our reconsideration and expert judgment, we no longer consider that resource prioritization to be in the best interests of the public health and well-being and therefore believe that this assumption—that no regulations would expire—was not well founded.

Because we now believe that the SUNSET final rule underestimated the burden on the Department and its agencies imposed by the regulatory review required by the rule and dismissed the likelihood that rules would expire, it similarly did not adequately acknowledge the difficult resource allocations decisions that the Department would confront in implementing the rule. With its finite set of resources, the Department would be faced with a quandary of how best to triage the needs of its existing programs (as well as new public health priorities) and the new regulatory review process under the SUNSET final rule. On the one hand, given the large scale of resources that would be required to conduct the required reviews, compliance with these new review requirements would lead to the diversion of resources from existing and new priority programs to the detriment of the other programs. This diversion of resources would degrade HHS' capabilities to carry out mission-critical objectives such as protecting the health of Americans, strengthening their economic and social well-being, and fostering sound, sustained advances in the sciences. On the other hand, the automatic expiration of regulations could also undermine mission-critical objectives. The Department's ability to redirect resources may be further complicated by statutory directives regarding programs and their funding as well as difficulties in finding, hiring, training, and transferring personnel to ensure adequate familiarity and technical expertise to conduct the analyses. Our reanalysis of the rule's regulatory impact, and particularly the estimated hours per assessment and review, indicates that such staffing measures likely would be needed in order to comply with the rule.

It is not feasible at this time to determine with any specificity how the Department would make these difficult choices on when to divert resources from existing programs, to the extent permitted by statute and logistics, and when to let regulations expire without review. However, as described elsewhere in this proposed rule, we now predict, contrary to the statements in the SUNSET final rule, that it is very likely that some regulations will automatically expire without substantive review.

This quandary has several implications. Both the potential for automatic expiration of rules, as well as the diversion of resources from existing regulatory programs, would create regulatory uncertainty, and that uncertainty could have several negative repercussions for stakeholders, including interference with planning, contracting, and product development. Further, the actual expiration of regulations could lead to confusion among stakeholders, undermine predictability and confidence in many sectors regulated by the Department, and could harm the public health in numerous ways, discussed in greater detail below.

Commenters suggested that the legal analysis in the SUNSET final rule wrongly concluded that the final rule was consistent with the APA's requirements. As discussed further below (in section V.D), under the APA, HHS must consider the relevant factors and provide an adequate basis and explanation in the rulemaking record for its decision. Commenters asserted that the Department did not adequately consider the potential harms of each affected regulation automatically expiring, such as the facts and circumstances that would no longer be addressed upon automatic expiration of that regulation. In light of that absence, among other things, there may be a plausible argument that HHS's justification was inadequate under the APA.

The SUNSET final rule is also based on policies that are contrary to several policy goals of the current Administration. The SUNSET final rule cited for support an Executive Order entitled “Reducing Regulation and Controlling Regulatory Costs” (E.O. 13771), which placed limits on agencies' ability to issue new regulations. 86 FR 5696 (citing 82 FR 9339 (Jan. 30, 2017)). President Biden, on his first day in office, issued an Executive order entitled “Revocation of Certain Executive Orders Concerning Federal Regulation,” which revoked E.O. 13771. 5 86 FR 7049 (Jan. 25, 2021) (E.O. 13992). As stated in E.O. 13992, the current Administration's policy is to equip executive departments and agencies with flexibility to use available tools such as robust regulatory action to confront the urgent challenges facing the Nation, including the coronavirus disease 2019 (COVID-19) pandemic, economic recovery, racial justice, and climate change. Accordingly, E.O. 13992 revoked “harmful policies and directives that threaten to frustrate the Federal Government's ability to confront these problems and empowers agencies to use appropriate regulatory tools to achieve these goals.” Id.

Upon review, we now believe that the burdens imposed by the SUNSET final rule could undermine the Department's ability to fulfill its public health and human services missions, promote national priorities, and confront the challenges facing the nation—contrary to the policies expressed in E.O. 13992. Although the Department is committed to exploring ways to improve its processes for conducting retrospective reviews under the Regulatory Flexibility Act (RFA) and identify and retire obsolete rules, the approach in the SUNSET final rule appears to go beyond what is needed to meet those objectives, as noted by several commenters at the Public Hearing. See, e.g., Public Hearing Transcript, Comments by the Consumer Federation of America, American Frozen Food Institute, and Disability Rights New Mexico. In essence, the SUNSET final rule would likely have led to a sharply diminished role for the Department in providing Federal leadership in public health and human services, a position with which the current Administration fundamentally disagrees.

Based on the many comments opposing the rule, the SUNSET final rule also appears to undercut the policy expressed on the first day of the current Administration in E.O. 13985 entitled “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which lays out the current Administration's policy for the Federal Government to “pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.” 86 FR 7009 (Jan. 25, 2021). In addition, on January 26, 2021, the current Administration issued a “Memorandum on Tribal Consultation and Strengthening Nation-to-Nation Relationships,” directing the heads of executive departments and agencies to make respect for Tribal sovereignty and self-governance, commitment to fulfilling Federal trust and treaty responsibilities to Tribal Nations, and regular, meaningful, and robust consultation with Tribal Nations cornerstones of Federal policy pertaining to American Indians and Alaska Natives. 86 FR 7491. The current administration also issued an E.O. titled “Strengthening Medicaid and the Affordable Care Act,” 86 FR 7793 (Feb. 2, 2021) (E.O. 14009), states that it is the policy of the Biden-Harris Administration for the Federal Government to protect and strengthen Medicaid and the ACA and to make high-quality healthcare accessible and affordable for every American. The E.O. directs HHS, among others, to examine its regulations, policies, and the like to ensure that they are consistent with the policy of providing high quality and accessible health care for all, and do not undermine protections for people with pre-existing conditions under the ACA, reduce coverage under or otherwise undermine Medicaid or the ACA, or undermine the Health Insurance Marketplace or the individual, small group, or large group markets for health insurance in the United States.

If implemented, we now believe that the SUNSET final rule could negatively impact diverse groups of stakeholders, including historically underserved, marginalized, and adversely affected communities, and undermine the Department's public health mission. For example, as discussed in more detail below, numerous commenters expressed concern about the anticipated impacts on various populations including children, the elderly, the disabled, those living in poverty, and communities marginalized by racism and prejudice, who could lose eligibility for programs and services if the regulations underpinning the eligibility requirements were to expire. Public commenters, including Tribes and tribal representatives, assert that the SUNSET final rule would threaten the regulatory underpinnings of the Indian health system, completely disrupt the ability of that system's mission to provide care to tribal communities, undermine the delivery of HHS public health and social service programs for tribal members, and generate a level of uncertainty that is the antithesis of the goals of the HHS Tribal Consultation Policy. 6 Furthermore, HHS now acknowledges that the SUNSET final rule does not provide for advance notice of regulations that might automatically expire, which we believe conflicts with the Department's policy to engage in meaningful consultation with Tribal Nations.

The primary statutory authorities supporting this proposed rule are the general rulemaking authorities for the various substantive areas under the Department's umbrella, as well as a general provision authorizing agencies to issue regulations regarding the administrative processes to be followed by that agency. These include:

• Section 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 371(a), which authorizes the Secretary to “promulgate regulations for the efficient enforcement of [the FD&C Act], except as otherwise provided in this section;”

• Section 215 of the Public Health Service Act (PHS Act), 42 U.S.C. 216, which provides that “The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall promulgate all other regulations necessary to the administration of the Service[ ];”

• Section 1102 of the Social Security Act, 42 U.S.C. 1302, which provides that the Secretary “shall make and publish such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions with which [they are] charged under this Act;”

• Section 1871 of the Social Security Act, 42 U.S.C. 1395hh, which provides that “the Secretary shall prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title;”

• 42 U.S.C. 2003, which provides that “the Secretary of Health and Human Services is also authorized to make such other regulations as [they] deem desirable to carry out the provisions of this subchapter [transferring to the Indian Health Service (IHS) the authority to provide health care services to American Indians and Alaska Natives];” and

• 5 U.S.C. 301, which provides that “[t]he head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public.”

Congress' grant of broad, discretionary rulemaking authority necessarily includes the authority not to promulgate—and therefore also to withdraw or repeal—a proposed or final rule. See Natural Res. Def. Council, Inc. v. SEC, 606 F.2d 1031, 1045 (D.C. Cir. 1979); see also 5 U.S.C. 551(5) (defining “rule making” to include formulating, amending, and repealing a rule).

The Department proposes to withdraw or repeal the SUNSET final rule based on the following concerns: (A) Implementation of the rule could create burdens on the Department and on stakeholders that would divert resources from pressing public health matters and thus harm the public; (B) both the possibility of automatic expiration of HHS regulations, and the actual expiration of HHS regulations, could harm the public; (C) the final rule may be harmful to small entities, inconsistent with Congress' intent in enacting the RFA, and unnecessary to achieve the RFA's objectives or to incentivize the Department to conduct reviews of regulations; and (D) ambiguity in the definitions and exceptions in the final rule may increase the burden of the regulation and the risk of regulations automatically expiring. In addition, questions were raised as to whether the final rule is consistent with the APA, which merit further consideration.

The framework set forth in the SUNSET final rule would create a tremendous economic and workload burden on the Department, and would pursue the objective of regulatory review at great expense to the public and to the small business community it purports to benefit. As explained in more detail below, these harms are likely to be greater than any benefits of the retrospective review framework in the SUNSET rule. Although the SUNSET final rule acknowledged the submission of a large number of comments stating that the rule would burden the Department, divert its personnel resources, and adversely affect the Department's ability to administer programs, and issue and modify regulations, the final rule essentially concluded that these concerns were outweighed by its finding that “widespread retrospective review is a worthwhile enterprise.” 86 FR 5705. As previously discussed, that finding was predicated on what we now believe to be a flawed understanding of the regulatory impact of the rule. Our reanalysis of the burden of the SUNSET rule fundamentally alters any evaluation of the merits of the rule and gives new force to the comments concerning the burden. Also, as discussed, this Administration has different policy goals than the previous Administration, and these differences impact how these various issues, concerns, and goals are weighed. We now believe that the SUNSET final rule did not give sufficient consideration and weight to the large number of comments, discussed immediately below, raising concerns regarding the burdens on the Department's ability to effectively carry out its missions.

Numerous commenters opposed the proposed rule out of concern that the burden and the diversion of resources to assessments and reviews would negatively impact public health activities. Several commenters referred to the burden imposed on the Department as “undue,” “unreasonable,” “unnecessary,” “onerous,” and “misguided.” In response to these comments on the proposed rule, the SUNSET final rule attempted to minimize these concerns by extending the period for the automatic expiration of regulations from two to five years, and ultimately concluded that its retrospective review scheme is sensible “even if it takes some time away from issuing new regulations.” 86 FR 5705. We now believe that assertion rested on a flawed understanding of the resources required to implement the SUNSET final rule. The rule did not explain how HHS could devote numerous employees to full-time retrospective review without compromising the Department's and its sub-agencies' many other crucial tasks, such as protecting the country from future pandemics or other public health emergencies. We now believe that the SUNSET final rule underestimated the rule's regulatory impact and failed to appreciate the scope of its effects on the Department, including that the rule could compromise some of the Department's most important initiatives.

Commenters also emphasized particular apprehension about the impact of the rule on the Department's ability to address public health emergencies such as COVID-19 and the opioid crisis. The SUNSET final rule ultimately concluded that the new retrospective review requirements would not hamper the response to the pandemic because by that time the COVID-19 Public Health Emergency “is likely to have subsided.” 86 FR 5748. However, as explained further below, many commenters expected that implementation of the rule—by diverting staff and resources—would create immediate disruption to programs essential to the COVID-19 response for patients, beneficiaries of HHS health programs, and the larger health system. Commenters also expected that these demands would continue to evolve during the remainder and aftermath of the current pandemic, and noted that the same problems could occur with other public health emergencies in the future. Bolstering the commenters predictions, the trajectory of the COVID-19 pandemic seems far less certain than when the SUNSET final rule was published.

HHS has reconsidered these comments and now believes that the Department must continue to remain flexible and focused on the management and utilization of HHS resources to address COVID-19 and its impacts as well as future public health emergencies. The challenges of the continued current public health emergency suggest a risk of future harm because the SUNSET rule provides no good cause exception to avert the expiration of a regulation in the event of a pandemic, a public health emergency, or another declared national emergency. Although the final rule added a provision to permit the Secretary to extend the period for assessments and reviews, the extension can only be applied one time, for up to one year, per each section of regulation, and the extension can only be exercised through a determination published in the Federal Register . 86 FR 5725. Given the brief extension available for the assessment and review and the potential duration of an emergency (as evidenced by the current 18-month plus duration of the COVID-19 pandemic), the final rule was likely incorrect to conclude that this option would be sufficient to avoid the diversion of resources and the automatic expiration of regulations in the event of a pandemic, emergency, or other development that prevents the Department from timely assessing or reviewing certain sections. Id. at 5726.

As noted in public comments, the SUNSET final rule imposes multiple types of burdens on the Department. First, the rule's assessment and review processes have substantial resource implications. Such processes require Department evaluations of regulations based on certain criteria, which would involve information collection and analysis (potentially including public notice and comment, and OMB review and approval, under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. ), engagement with subject matter experts, and consultation with state and local jurisdictions and Tribes. In addition, the Department would need to solicit and consider public comment related to those evaluations, participate in interagency review, and publish results in the Federal Register , including the full underlying analyses and data used to support the results. 7 Completing these steps for the thousands of regulations currently issued by the Department, and for future regulations, would be a colossal undertaking on any timeframe. But the SUNSET rule requires these processes on a compressed timeframe, meaning many assessments and reviews would need to occur simultaneously, thereby compounding the impact. Data collection may be infeasible under the timeframes required under the rule, which could compromise the quality and completeness of the work. As noted in the final rule, approximately 12,400  8 of the Department's estimated 18,000 sections in the CFR are over ten years old, and each of these are regulations that could automatically expire five years after the SUNSET final rule's effective date unless assessment and, as applicable, reviews are completed. 9 For example, under the timeline and definitions provided in the final rule, over 7,000 sections of the CFR that were promulgated by the FDA are more than ten years old, or would become more than ten years old during the first five years the rule would be in effect, representing over 95 percent of this agency's current regulations. Although there are limited categorical exceptions and some specific regulations excepted from the rule, the enumerated exceptions are very limited and likely would not make a meaningful difference in the burden on the agency, including because HHS has yet to assess the applicability of these exceptions. 10

Furthermore, this burden is recurring. As soon as the Department reviewed all the current rules, it would start having to review them again within a 10-year timeframe. And the expertise needed to conduct assessments and reviews and achieve the pace and scope set forth in the rule would require a reallocation of staff including subject matter experts, regulatory counsels, economists, and attorneys. This reallocation effort alone would entail a significant burden and would draw resources away from other public health and welfare activities.

Second, if a review concludes that a regulation should be amended or rescinded, the rule requires the Department to amend or rescind the regulation within two years of the date that the review results are published. The development of regulations is a deliberative and resource-intensive process that requires consideration of a wide range of factors, including current relevant facts, statutory obligations, and public-health and -welfare goals. Requiring the Department not only to assess and review its regulations, but also to amend or rescind them (in applicable circumstances) on a specific timeframe, amplifies the burden on the Department.

Third, as discussed further below, the SUNSET final rule contains ambiguities that would need to be clarified in order to operationalize the rule. This creates another hurdle to implementing the SUNSET final rule that is separate from the assessment, review, and rulemaking requirements. For example, under the rule, it is not clear when certain regulations would need to be assessed and whether the regulation falls within a categorical exception. The Department would need to develop processes and standard operating procedures to try to bring consistency and transparency to this process. While the Department expressed an intent to create a dashboard for monitoring assessments and reviews, the development, monitoring, and updating of this dashboard would add to the burden on HHS. Collectively, these activities would likely delay the initiation of assessments and further strain the Department's ability to prevent regulations from automatically expiring.

Fourth, the SUNSET rule imposes on HHS the task of determining where to redirect resources to support assessments and reviews and thereby preserve regulations. Multiple, complex considerations would likely be relevant to this effort, including public health and legal considerations. Furthermore, to the extent that any regulations would expire under the SUNSET final rule—which the Department now predicts would be likely—HHS would need to consider how to prioritize its assessment and review processes to manage that risk. Overall, the economic and workforce burdens imposed on the Department by the SUNSET final rule are significant.

As noted above, commenters opposed to the rule expressed concern that the diversion of resources would disrupt public health activities and social service programs administered by specific HHS operating divisions. For example, commenters expressed concern that, in order to review or assess regulations within the rule's timeframe, FDA staff could be diverted from the review of medical product applications, food additive petitions, efforts to promote medical product innovation, competition, and access to medicine, and the regulation of the food and medicine supply for humans and animals. Commenters also described impacts on the administration of HHS social services programs, expressing concern that there will not be enough time and staff to efficiently review regulations and to serve citizens at the same time, including those who depend on safety net programs under the auspices of the ACF such as Head Start and the Low Income Home Energy Assistance Program. Multiple commenters who advocate for mental health issues also opposed the diversion of staff resources away from programmatic work that addresses inequities in access to health and mental health care.

Commenters nationwide who represent state and county health departments, as well as legal and social service organizations who advocate for beneficiaries, individual beneficiaries themselves, and concerned citizens, expressed concern that the CMS would be hampered in the day-to-day administration of public health programs for millions enrolled in the Children's Health Insurance Program (CHIP), Medicaid, and Medicare. Some noted the burden of retrospective reviews could put a strain on the administration of the Affordable Care Act (ACA) and the development of new regulations and guidance to: Support health care coverage, innovation, and competition; enhance patient safety; and combat waste, fraud, and abuse. Commenters representing Federally Qualified Health Centers (FQHCs) expressed opposition to the rule because it would result in the diversion of resources from programs that support particular populations served by FQHCs such as Community Health Centers, Migrant Health Centers, Health Care for the Homeless, and Health Centers for Residents of Public Housing. Commenters representing or affiliated with American Indians and Alaska Natives described the potential impact of resource diversion from the administrative and operational activities of the IHS, which could diminish access to critical safety net programs for American Indians and Alaska Natives and decrease programmatic staff available to administer programs that provide critical protections for tribal youth. Some commenters also noted that the focus on the activities required by the SUNSET rule would impair the Department's ability to issue new regulations that would modernize the healthcare system, improve service delivery, and promote equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty.

Therefore, based on review of these comments and the Department's new cost estimates for the SUNSET rule, HHS now believes that the SUNSET final rule may have significantly underestimated the burden on the Department resources to comply with the rule and incorrectly evaluated the Department's ability to expend the necessary resources to prevent the automatic expiration of regulations. The Department also thinks it likely that these burdens would result in the diversion of significant resources from other HHS initiatives and priorities. The Department now believes that the harm and the costs resulting from this diversion are likely greater than any benefits of the retrospective review framework in the SUNSET rule. Department initiatives are each intended to further the health and well-being of Americans. Often, these respond to the most pressing issues of the day, which are diverse and range from foodborne illness to the opioid crisis to the COVID-19 global pandemic to dealing with humanitarian crises, such as the care and custody of unaccompanied children at the border. Redirecting resources away from these types of initiatives in order to fully implement the SUNSET rule could mean neglecting the areas of greatest public health need, contrary to the Department's mission. As discussed above, many commenters identified examples of important programs threatened by the diversion of resources of SUNSET final rule, and the Department agrees with those examples. Ultimately, the Department no longer believes that the analysis of existing regulations, which may have little practical effect in many cases, should be elevated over HHS's other important regulatory initiatives.

HHS has also reexamined the burden the SUNSET final rule places on stakeholders to prevent the automatic expiration of regulations and the final rule's estimation that “the cost of monitoring Assessments will be relatively trivial.” 86 FR 5744. The final rule describes “safeguards to mitigate the risk of inadvertent expiration,” such as enabling the public to submit comments requesting that the Department commence an assessment or review, and making a dashboard that would be available on an HHS website that would enable stakeholders to monitor the status of assessment and reviews of regulatory sections that may expire. Id. at 5714. Various public commenters, however, opined that it is inappropriate and unfair to place such a heavy burden on the public. More than one commenter posited that the automatic expiration of regulations resulting from the Department's failure to complete assessments and reviews would constitute a penalty to the regulated, and not the regulators.

Many commenters opposed to the rule expressed concern that the monitoring burden would be overwhelming, particularly for health care providers, public health advocates, caregivers, and beneficiaries, among other stakeholders, who would have to divert time and effort from providing direct health care. In addition, commenters representing a wide range of industry stakeholders anticipated a higher burden on small entities that would not have the personnel and resources to both monitor the status of thousands of regulations being assessed contemporaneously, and simultaneously provide comments about data and information that should be considered in an assessment or review. Similarly, commenters expressed concern that members of the general public would not have the ability or awareness to participate in the process envisioned, so that the construct would favor well-funded special interests who would have the resources to hire lawyers and lobbyists to advocate for their favored outcomes. Several commenters associated with trade associations and advocacy organizations described the immense effort that would be needed to engage organization membership and to research, draft, review, and submit consensus-driven comments with members and partner organizations. Some commenters noted that they expected the monitoring process to be chaotic as stakeholders seek the Department's prioritization of the assessment or review of regulations they are concerned might expire.

The Department believes that any retrospective review process should not impose an undue burden on the public. Based on these comments and the Department's new cost estimates for the SUNSET rule, the Department now believes that the SUNSET final rule likely underestimated the burden on stakeholders to monitor and comment on potentially expiring regulations.

HHS has given further consideration to the harms to the public health from the regulatory uncertainty created by the SUNSET final rule. Because of the above-described substantial burdens imposed on the Department by the breadth and scope of the regulatory review process required by the SUNSET final rule, the Department now acknowledges that, despite statements in the final rule that HHS did not intend to allow any regulations to simply expire, see, e.g., 86 FR 5710, it is unrealistic to assume that no regulations would automatically expire as a result of the final rule. In fact, given the complicated resource allocation decisions discussed above, HHS is unable to forecast the number or identity of specific regulations that may expire without a completed review and assessment. It may therefore be difficult for stakeholders to know which regulations will remain in place because that will depend on whether the Department will actually be able, and will choose, to complete each regulation's assessment and/or review by the assessment or the review deadline. The potential automatic expiration of large swathes of rules, or even one complex rule, without a reasoned justification such as a change in the governing law or a change in circumstances, could create uncertainty and unpredictability regarding regulatory programs going forward.

Several commenters supported the Department's efforts to explore ways to improve its processes for conducting retrospective reviews to reassess, update, and amend regulations. As discussed further in section V.3.C., HHS already exercises its authority to conduct retrospective reviews, and comments suggested improvements to achieve the goals of retrospective review productively and efficiently. However, as the comments explained, there is a stark difference, particularly from a planning standpoint, between thoughtful reconsideration of individual rules, with stakeholder participation and a reasoned justification, and automatic expiration of rules from lack of sufficient resources (by either or both stakeholders and the Department). Rather than the current baseline assumption that regulations will remain the same, absent a specific notice providing a basis for possible change, the new baseline would be uncertainty regarding the future validity of numerous regulations.

Commenters explained that the uncertainty created by the potential automatic expiration of countless rules could have numerous repercussions for stakeholders and for the public health. Public commenters explained the importance of a relatively steady regulatory environment. For example, several commenters explained that rules that implement HHS policies and programs, such as Medicaid and CHIP, establish the national standards for Federal/State partnership programs, so that States in turn can design processes and run programs on a day-to-day basis based upon these standards. Predictable and reliable communication and guidelines facilitate effective implementation of these programs, so that providers can understand what their obligations are, and beneficiaries can understand what they are entitled to receive. Further, many participants in the health care ecosystem have structured their financial arrangements and business operations to satisfy the myriad conditions set forth in the current regulations. The uncertainty regarding the future of those regulations could upset the assurance of regulatory continuity underlying those arrangements and therefore disrupt planning and entering into longer-term commitments. And, for programs that rely on Federal funding, commenters asserted that potentially expired regulations could impact the ability to apply for, or receive, funding sources governed by those rules, which in turn would disrupt longer-term planning.

Commenters also contended that the increased unpredictability of the future of regulations under the SUNSET final rule would impede product development and innovation. Commenters asserted that uncertainty in regulation would be particularly harmful for drug development: Because new therapeutic products may require decades to develop and review, and because this process is expensive, drug sponsors rely on a predictable regulatory environment to plan their development programs. For instance, FDA has extensive regulations that address standards for clinical trials and premarket submissions, requests for orphan designation, patent term restoration, and exclusivity determinations. Although statutory provisions govern these programs, the statute does not specify in detail the substance or processes for these premarket submissions. As a result, the potential for expiration of the regulations, which clarify the application pathway and requirements, could curtail drug development, including progress on cancer therapies and therapies for those with unmet medical needs. Similarly, one commenter noted that the development of digital health care platforms typically takes 5 to 10 years, and the developers will need to understand the regulatory environment in which they will be developing their business. Another commenter asserted that investments are made in industrial biotechnology innovations based on the assumption that regulations will be in place for at least 10 years; consequently, some emerging industrial biotechnology companies will have difficulty finding investors in the face of regulatory uncertainty. Thus, as one commenter opined, “[i]nstead of innovation, this rule could easily lead to stasis.”

We question whether the SUNSET final rule adequately considered the potential costs of regulatory uncertainty created by the rule. The final rule states that it “does not believe uncertainty among the regulated community will add significantly to the costs of this rulemaking” because “there is always a possibility that regulations could be amended or rescinded, even absent this rule.” 86 FR 5709. HHS now believes the final rule's automatic expiration of regulations could instead be more haphazard and unpredictable, and therefore more disruptive, than the existing possibility of targeted changes to regulations based on a reasoned justification such as a change in the governing law, technology, or other circumstances.

The Department also notes that E.O. 13563, “Improving Regulation and Regulatory Review,” which the SUNSET final rule cited for support, includes among general principles of regulation that our regulatory system “must promote predictability and reduce uncertainty.”  11 Upon reconsideration of the comments received, we now believe that, by introducing significant uncertainty about whether regulations will expire, the final rule may undermine these objectives.

After further consideration, HHS believes that, because the SUNSET rule failed to appropriately consider the likelihood that any regulations would expire, it likewise did not take into account the harm to stakeholders and the public health that could result from regulations expiring. The resources needed to prevent the automatic expiration of regulations are now estimated to be significantly higher than identified in the SUNSET final rule. Given statutory spending directives and other statutory obligations, it could be difficult, and in some cases prohibited, for the Department to redirect sufficient resources to prevent expiration of certain HHS regulations. Further, any attempt to divert the amount of resources necessary to prevent the expiration of regulations would degrade HHS' capabilities to carry out mission-critical objectives such as protecting the health of Americans, strengthening their economic and social well-being, and fostering sound, sustained advances in the sciences. As a result, these constraints make it likely that regulations could expire without review.

This expiration is unlike the standard processes that agencies undertake to change rules. In general, it is more common for rules to be amended to account for a change in statutory authority or change in relevant circumstances; they are not simply rescinded in their entirety without a rule-specific justification or an opportunity for the public to comment on that justification, including identifying harms associated with the repeal.

Because the final rule did not acknowledge the substantial risk of expiration of regulations, it did not examine the wide array of harmful effects that could arise in this situation including: Causing serious harm to millions of stakeholders who rely upon HHS programs, including underserved populations; upending established understandings across the public health spectrum as to how to comply with statutory requirements; and disrupting established industry standards that protect public health, create a level playing field for businesses, and boost consumer confidence.

The breadth and complexity of some regulatory programs with interdependent regulatory provisions, and their integration into programs run by State and local authorities, could magnify the repercussions of many automatically expiring regulations. For example, as one commenter explained, Medicare is the largest payor in the U.S. health care system and the largest piece of a system comprised of thousands of interlocking moving parts; thus, the entire health care system is impacted by the Medicare program and therefore relies on Medicare regulations to function. The Medicare regulations were not contemporaneously enacted and therefore are subject to different potential expiration dates under the SUNSET final rule. If some individual Medicare regulations not subject to exceptions in the SUNSET final rule begin to expire, it could be difficult for regulated entities to disentangle the downstream effects to ascertain the remaining regulatory requirements. The expiration of these regulations also increases the potential for bad actors to try to exploit the lack of regulations, potentially resulting in increased fraud and abuse.

Commenters explained that the confusion about what, if any, standards would govern in the event of a lapse in Federal regulations is likely to result in significantly increased regulatory complexity and implementation. Another commenter predicted that, if States will be directed to abandon expiring rules, and/or to suddenly implement new interpretations of statutory requirements in the event regulations automatically expire, they will be faced with enormous administrative costs such as computer system upgrades, staff training, amended services contracts, and public education on new requirements.

Commenters provided numerous examples of harms to stakeholders and the public health that could arise from the actual expiration of regulations. States Attorneys General commented that States depend on HHS to administer trillions of dollars in Federal funding to support their healthcare systems and the health and safety of their residents, which would be disrupted by the expiration of regulations. Many commenters expressed particular concern about the anticipated impacts on various communities including children, the elderly, the disabled, those living in poverty, the LGBTQ community, patients living with HIV/AIDS, tribal members, communities of color who are often more reliant upon HHS programming as a result of systemic racism, and people who live in rural areas who rely more heavily on federally funded HHS programs. According to the commenters, these individuals will suffer worse outcomes in terms of health and well-being if they were to lose eligibility for programs and services upon expiration of regulations. This loss in program coverage could in turn increase the economic costs to public assistance organizations, which would need to devote more time, energy, and resources to finding ways to assist individuals absent these protections from the Federal Government.

For example, commenters asserted that implementation of Medicaid and the ACA depends heavily on regulations to clarify coverage requirements, program implementation, and the obligations of state programs serving people with low incomes. As discussed above, Federal regulations play an important role in HHS' partnership with States in implementing Medicaid, which, as one commenter described, has helped communities respond to economic downturns, natural disasters, epidemics, and public health emergencies since the program was enacted in 1965. Another commenter described the importance of detailed Federal regulations in implementing the accountable care organization program, which increases the quality of care for Medicare beneficiaries while reducing unnecessary costs, and that expiration of the governing regulations would interfere with those program goals. Another example included regulations that protect Medicare beneficiaries from misleading and high-pressure marketing tactics; expiration of those regulations could end compliance and enforcement actions against these bad actors. If the governing regulations were to expire, HHS programs and other programs reliant on HHS regulations might be free to operate without standards, consistency, or accountability, which could lead to real harm to, for example, the millions of children who rely on those programs. Similarly, advocates for HIV services commented that the SUNSET rule's potential to cause confusion over the validity and enforceability of Medicaid regulations could lead to service and coverage delays, which, for people with HIV, can be detrimental, causing irreversible disease progression and prescription drug resistance. Commenters expressed concern regarding the expiration of other programs that support particular populations, which expiration could be devastating for the populations they serve. 12

Numerous tribes and tribal organizations commented that the Indian health system relies on a number of regulations that tribes have worked for decades on with the Department to promulgate on a government-to-government basis. These include the regulations governing the IHS, Tribal Self-Governance, and Indian specific provisions in the Medicaid, Medicare, CHIP, and ACA Health Insurance Marketplace regulations. Commenters asserted that the SUNSET final rule would threaten the regulatory underpinnings of the Indian health system and completely disrupt the ability of that system's mission to provide care to tribal communities.

Other commenters asserted that HHS regulations are essential to maintaining consumer confidence in the Nation's supply of consumer products, as well as a level playing field among industries. Some commenters noted that there are many rules setting industry standards that have remained untouched for years—not through neglect—but because they work as intended. For example, as described in several comments, the food industry relies on FDA regulations to provide clarity on statutory requirements, to maintain relationships of trust between all members of the supply chain, to protect public health by providing safe and nutritious food, and to support both domestic consumer and worldwide confidence in the safety of the U.S. food products. Under the FDA Food Safety Modernization Act (FSMA), FDA over the last decade has promulgated, with considerable stakeholder input, an extensive set of detailed regulations governing prevention of foodborne illness throughout the production and delivery in the global food supply. Industry members have devoted significant resources to develop food safety plans consistent with the new regulations and in many instances have made significant capital investments in equipment, personnel, and facilities. Expiration of the FSMA regulations (while FSMA's statutory obligations remain in effect) could create confusion and uncertainty with regard to what standards apply, particularly because the statute required rulemaking for implementation and interpretation of the food protection provisions. It also could create inefficiencies given the time and resources that have been invested by the industry in recent years to ensure the highest levels of compliance.

In addition to food safety regulations, commenters identified other longstanding food regulations—involving nutrition and food labeling and food ingredients—that set essential standards for the food industry. A food manufacturing association asserted that, if food regulations are rescinded, consumers may become distrustful of the U.S. food supply and, as a result, individual States might feel the need to pass their own laws and regulations, meaning manufacturers would have to comply with a patchwork of potentially conflicting new rules. Compliance with a patchwork of State rules nationally can be costly to industry, and those costs may be passed to consumers or may put food companies out of business, reducing competition and consumer options. Additionally, another commenter asserted that any loss in confidence in the safety of U.S. pet food could result in lost sales and new requirements by foreign regulators seeking assurances that the pet foods they import from the U.S. are safe.

Many other effective regulations, some of which are decades old, bring similar efficiencies to the industry by clarifying applicable statutory obligations. As a commenter explained, heavily regulated manufacturers benefit from regulatory certainty that provides clarity for manufacturers and fosters consumer confidence that the products are properly regulated. By contrast, if the regulations expire, disreputable companies will be tempted to cut corners to gain economic advantage over responsible companies, with the risk that consumers will be harmed and will lose confidence in the products. For example, as another commenter explained, color additive regulations, many of which are decades old, are fundamental to the industry's operation in the U.S., and provide confidence that color additives are safe in food, drugs, cosmetics, and medical devices. The expiration of those regulations could lead to significant confusion.

Commenters also explained that FDA issues many regulations relating to food, drugs, devices, cosmetics, and tobacco products that are essential to protecting the public health. To list just a few additional examples, these regulations provide: Safety standards for the blood supply, access to investigational treatments, protection of clinical trial participants, protection from harmful tobacco products, and good manufacturing practices that are the linchpin of many product supply chains. The expiration of these regulations could mean that regulated entities would be unsure how to comply with long-standing statutory requirements and may no longer be compelled to comply with long-standing safety standards.

Commenters also raised concerns that the SUNSET final rule could impede responses to public health emergencies. For example, the regulations established in 2006 to implement the Pandemic and All Hazards Preparedness Act took years to develop and have been essential to addressing the COVID-19 pandemic. The expiration of those rules could leave the Department unprepared to respond to future emergencies and result in unnecessary human suffering and loss of life.

HHS now believes that commenters have raised credible concerns that the SUNSET final rule would likely result in actual expiration of regulations and that these expirations would adversely impact them. Although these comments were raised regarding the SUNSET proposed rule, the SUNSET final rule discounted their seriousness, and did not give them sufficient consideration and weight. See 86 FR 5709. As discussed in greater detail elsewhere in this preamble, we now believe that the rejection of these comments was in error because, given the resources demands that would be required by the SUNSET final rule, the likelihood that regulations would automatically expire is high. Moreover, the potential automatic expiration of regulations would be contrary to the Department's role as the U.S. Government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

The SUNSET final rule imposes requirements beyond the requirements of the RFA. These additional requirements may not be consistent with Congressional intent. The SUNSET final rule asserts that it “implements Congressional intent for periodic review of regulations” and “closely tracks the RFA's goal of minimizing undue burden on small entities” 86 FR 5713-5714. Additionally, it asserts that, “assuming full compliance with the RFA, th[e] rule does not impose any additional burden on the Department beyond what was already called for in the RFA” because the RFA “already calls for the Department to assess which of its regulations have a significant economic impact upon a substantial number of small entities, and to review those regulations every ten years.” Id. at 5705. Many commenters disagreed with these assertions, and explained that the final rule would impose requirements beyond those set forth in the RFA. HHS remains committed to full compliance with the RFA, but, upon further consideration, HHS believes that the RFA does not require this final rule and finds the commenters' perspectives for repealing the rule worthy of further consideration.

First, commenters assert that the final rule exceeds the RFA's express requirements by mandating that the Department conduct assessments of thousands of HHS regulations within certain timeframes. Section 610 of the RFA is focused on the retrospective review of rules identified with a Significant Economic Impact Upon a Substantial Number of Small Entities (SEISNOSE). Section 610 contemplates periodic review of a subset of “rules issued by the agency which have or will have a [SEISNOSE]” and imposes certain public notice and comment procedures for such reviews. 13 Nothing in the express language of the statute requires the Department to conduct assessments of all HHS regulations in order to determine which regulations at time of reassessment have or will have a SEISNOSE. As one commenter noted, Congress “does not[ ] . . . hide elephants in mouse holes.” See Whitman v. Am. Trucking Ass'ns, 531 U.S. 457, 468 (2001). This principle suggests that it is unlikely that Congress intended to require widespread assessments of thousands of regulations via a requirement that the SUNSET final rule asserted was “implicit” in section 610. See 86 FR 5714. As explained below, commenters and the Small Business Administration (SBA) have identified numerous more targeted, efficient, and effective alternatives for identifying regulations that have or will have a SEISNOSE. 14

Second, principles of statutory construction do not support a broader reading of section 610 to require agencies to simultaneously consider all regulations and to do so on a recurring basis to determine whether they have or will have a SEISNOSE. Had Congress intended to mandate this broader reading, it would have done so when it enacted the RFA or during any one of the numerous times it has amended the RFA since enactment. 15 This principle holds particularly true for section 610(a) of the RFA, given that the provision explicitly directed a one-time simultaneous review of all SEISNOSE regulations that existed on the date of enactment. See, e.g., Salinas v. U.S. R.R. Retirement Bd., 141 S. Ct. 691, 698 (2021) (quoting Russello v. United States, 464 U.S. 16, 23 (1983) (“Where Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion.”).

Third, the SUNSET final rule's requirements for public notice and comment procedures—such as notifying the public on a Department-managed website when it commences the process of performing an assessment, publishing a notice in the Federal Register within a month of commencement, and issuing a notice in the Federal Register to publish the results of all assessments—appear to extend beyond the RFA's notice and comment and other requirements for retrospective reviews. HHS agrees with commenters that section 610 requires notice and comment procedures for retrospective review, but it does not require notice and comment procedures to determine which regulations have or will have a SEISNOSE. 16 Similarly, the RFA provides no basis for an expedited timeline as specified in the SUNSET final rule for the completion of reviews, which was noted by commenters. Section 610(a) of the RFA provides only that the reviews required under that section be conducted “within ten years” of specific dates.

Fourth, the automatic expiration of any rule issued by the Department simply because it was not timely assessed or, as applicable, reviewed, appears to be contrary to Congressional intent. Section 610 neither provides for automatic expiration of rules with a SEISNOSE nor presumptively applies automatic expiration dates to regulations. Rather, section 610 contemplates informed rescission or revision of rules only if they have or will have a SEISNOSE and if the Department has determined, based on a multi-factor review, that such rules should be rescinded or revised to minimize any SEISNOSE. Additionally, we note that section 611(a) provides a remedy for agency noncompliance with the requirements of section 610: Judicial review of such noncompliance and relief deemed appropriate by the reviewing court.

Fifth, the framework for regulations to automatically expire without any consideration of the statutory objectives the rule implements appears to be inconsistent with the RFA's intent to balance the objectives of the RFA with the objectives of statutes critical to public health. The RFA's legislative history explicitly states that Congress did not intend for the RFA's requirements to “undermine . . . important [regulatory] achievements,” specifically those in the area of public health. 126 Cong. Rec. 21,448, 21,451 (August 6, 1980). The legislative history further states that Congress intended “agencies to continue to enforce [substantive] laws in a fully effective fashion,” id. at 21,451, and that “environmental, health or safety catastrophes must never be made more likely because of flexible regulations.” Id. at 21,455. Indeed, Congress expressed this intent in section 610 itself by providing that rescission of regulations should only occur if “consistent with the stated objectives of applicable statutes.” 5 U.S.C. 610(a). 17

As described above, commenters argued that the monumental task of assessments would require diverting agency expertise and resources away from the Department's significant public health activities and would likely impair the Department's ability to respond to public health emergencies and administer critical public health programs. Commenters further argued that such results would undermine important public health statutory objectives and increase the likelihood of negative consequences for the public health. The RFA's legislative history explicitly addresses such concerns that the RFA “might require agencies to significantly compromise the objectives of underlying statutes authorizing rulemaking,” 126 Cong. Rec. 21,455, and, as noted above, emphasized that “[i]t is not the intent of regulatory flexibility legislation to undermine . . . important [regulatory] achievements,” id. at 21,451. Commenters also stated that the burden imposed on the Department by the final rule would impair the Department's ability to prevent the automatic expiration of regulations that would be imposed by the final rule, and, as discussed above, the actual expiration of regulations without any analysis would also undermine the objectives of those regulations' authorizing statutes contrary to Congressional intent.

HHS notes that the economic and workforce burdens impairing the Department's ability to achieve important statutory objectives related to its mission would also be inconsistent with the RFA's intent to enhance administrative efficiency in the achievement of such objectives. The RFA's legislative history emphasizes that “regulatory flexibility should be considered a means of improving administrative effectiveness in enforcing the regulatory statutes which the Congress has enacted rather than an additional bureaucratic burden.” 126 Cong. Rec. 21,456. One commenter noted that requiring the Department to conduct analyses of thousands of rules within a compressed time period, in addition to the already complex existing tasks of the Department, is not efficient. Although the final rule asserts that it “will contribute to `the efficient administration of' the Department's functions . . . because the Reviews called for by this final rule will take into account both the continued need for particular regulations, as well as whether the burden of those regulations on small entities can be minimized,” 86 FR at 5719, HHS now believes that the final rule could introduce greater inefficiencies if rules expire without any assessment or review of the need for the regulation or the impact of the regulation on small entities.

In summary, this rule is not mandated by the RFA and may not be consistent with Congressional intent. As a matter of policy, we are therefore reconsidering the benefits of an additional rule that exceeds the requirements of the RFA.

Commenters argued that the final rule will impose undue and disproportionate burdens on small entities that undermine the RFA's purpose of alleviating the regulatory burden on such entities. The RFA seeks to address the “unnecessary and disproportionately burdensome demands . . . [of uniform regulatory requirements] upon small [entities] . . . with limited resources.” 126 Cong. Rec. 21,449. After reconsidering the burden of the SUNSET final rule, the legislative history for the RFA, and the comments, it is now our view that implementation of the SUNSET final rule could harm small entities, contrary to Congressional intent in enacting the RFA. Below, we summarize the comments that discuss these issues in detail.

Commenters expressed concerns that the sudden expiration of regulations and the threat of sudden expiration of regulations would disproportionately burden small entities by creating regulatory uncertainty and a confusing regulatory landscape that would be difficult for these entities to navigate. Commenters also noted that the sudden expiration of rules could result in reputational harm with customers whose confidence relies on compliance with regulatory standards, and other outcomes that would be particularly damaging to small entities. For example, as discussed above, the expiration of certain regulations could create instances where regulations expire but statutory requirements continue to be applicable, leaving it unclear to small businesses how the Department intends to implement the statutory requirements. As another example, if, as suggested in the preamble to the final rule (86 FR 5712), guidance documents based on expired regulations would cease to have effect, the expiration of regulations could leave stakeholders without needed information in relevant guidance, including Small Entity Compliance Guides (SECG).

Although several commenters representing small business industry associations expressed support for the final rule based on the assumption that the assessments and reviews would lead to deregulatory actions that could benefit small businesses, the vast majority of commenters disagreed with that assumption and opposed the rule. These commenters expressed the concern that small entities who rely on regulations to level the playing field would suddenly lose the clarity provided by such regulations and associated guidance for industry, which would create confusion, costs, and vulnerability for small entities. Commenters noted that most small businesses would generally lack resources to monitor, understand, anticipate, and adapt to changes in the regulatory landscape caused by the automatic expiration framework. Congress's findings in the RFA's legislative history substantiate this concern, as Congress explicitly found that small entities often have limited access to regulatory expertise and capital as compared to larger businesses. See 126 Cong. Rec. 21,453.

Moreover, commenters also expressed concerns that the final rule's requirements and timelines would undermine small entities' ability to participate in assessments and reviews, which HHS notes is inconsistent with the RFA's intent to “give small businesses a greater opportunity to participate in shaping rules which would affect them.” 126 Cong. Rec. 21,451. Commenters explained that the frenetic pace and scope of simultaneous assessment of rules would impair small entities' ability to effectively engage in the final rule's assessment and review process and for HHS to identify and meaningfully address data and information related to impacts on these entities.

Although the final rule suggests that regulatory uncertainty created by the final rule would be offset by increases in trust in the Department's RFA compliance, and greater transparency about when regulations were adopted, HHS has reason to doubt that assertion. First, this assertion may not have taken into account the high burden on the public, including small businesses, to calculate and track the expiration of regulations, or to participate in the assessment and review processes. Second, HHS no longer finds it appropriate to rely on conclusions regarding “sunset reviews” in other jurisdictions, including foreign governments and U.S. State legislatures, given the final rule's acknowledgement that “[t]hese jurisdictions' sunset provisions do not all work identically to this final rule.” 86 FR 5747. Commenters pointed out that the experience of foreign governments with sunset provisions would not be applicable to HHS, because these governments are not bound by the requirements of the APA. Other entities also may not have the same resource constraints as HHS, for example, with respect to earmarked funds. Finally, as explained at length throughout this preamble, HHS is no longer confident that, by giving industry five years until any regulations expire, the SUNSET final rule would mitigate the negative effects of expiration. We welcome comments regarding the experience of state and foreign governments with these laws.

Overall, the Department's current assessment that implementation of the SUNSET final rule has the potential to harm small entities, contrary to Congressional intent in enacting the RFA, suggests that there are no clear beneficiaries of this rule. These conclusions call into question the fundamental basis and justification for the SUNSET rule.

Consistent with our assessment, discussed above, that the SUNSET final rule's impact exceeds the requirements of the RFA and could impose additional burdens on small entities, HHS now seriously questions the conclusion in the SUNSET final rule that simultaneous Department-wide assessments of thousands of regulations is an efficient way to achieve the RFA's objectives. Instead, HHS now believes more targeted alternatives suggested by commenters merit further consideration.

As commenters noted, there are more efficient and effective ways to identify rules that have or will have a SEISNOSE and require review. For example, the Department may request information or use other processes to seek input from small entities and the public to identify such rules in a more targeted way, and the public may use already-existing petition processes to ask HHS to issue, amend, or repeal a rule. Conducting the assessments required by the rule could amount to searching for a needle in a haystack, and would not provide an effective means for stakeholders to provide input or for HHS to consider and evaluate such input and other relevant information. As commenters who expressed support for retrospective review also noted, the quality of reviews is more important than quantity, and the final rule's framework would strain the Department without improving the quality of reviews.

Alternatives that employ a more targeted approach to identifying rules for review under section 610 of the RFA, which are less burdensome on the Department and stakeholders and incorporate meaningful participation by stakeholders, are consistent with guidance issued by the SBA's Office of Advocacy. That guidance explicitly recognizes that “[b]ecause of the breadth and volume of federal regulations, a review of all existing rules on a particular industry group can be an onerous task for a federal agency.”  18 Additionally, the guidance states that “[i]nsights about an existing regulation received from regulated entities and other interested parties should be a key component of a retrospective rule review,” and that “[b]y making the review process transparent and accessible, agencies are more likely to identify improvements that will benefit all parties at the conclusion of the review.”  19

A commenter noted that such alternatives are also consistent with the recommendations for best practices for retrospective review published by the Administrative Conference of the United States (ACUS), which is cited in the final rule, 20 whereas the automatic expiration framework is not. HHS now agrees that the targeted alternatives proposed by commenters are generally consistent with ACUS's recommendations, including the recommendation to prioritize retrospective reviews “[i]n light of resource constraints and competing priorities.”  21 Although the final rule asserts that certain of its provisions are consistent with ACUS recommendations, see, e.g., 86 FR 5726, the commenter further asserted that the automatic expiration framework is inconsistent with those recommendations, which do not endorse or reference sunset periods  22 and do recommend that retrospective review processes require consideration of and be tailored to the specific rule being reviewed. 23 ACUS issued new recommendations for periodic retrospective review in June 2021. 24 In the preamble to the recommendations, ACUS discusses the tradeoffs of periodic retrospective review, including the costs and time associated with collecting and analyzing data and the uncertainty created by the review process, and advises agencies to “tailor their periodic retrospective review plans carefully to account for these drawbacks.”  25 The consultant research report to ACUS on this topic specifically addresses the SUNSET final rule and notes:

HHS agrees that the more targeted alternatives suggested by commenters are likely to achieve the goals of retrospective review more efficiently. We are now reconsidering the SUNSET final rule's apparent position that a burdensome and widespread assessment is necessary to identify regulations that have or will have a SEISNOSE. For example, the final rule primarily emphasizes what it perceives as the general benefits of “widespread review” with little explanation of the specific benefits of widespread assessment. See, e.g., 86 FR 5698 (concluding that “it would not be unreasonable to think that the Department could make major improvements by conducting widespread review of its regulations, rather than merely reviewing the small number of regulations that interested parties ask the Department to consider revising”). 27 Additionally, the final rule concludes that “stakeholder input cannot be the only source of information to spur reviews” because such input would not reflect the “dispersed costs” that “consumers, small businesses, and the public” experience, given that those groups “often find it costly to organize and lobby on behalf of their own interests” and “[c]oncentrated interests” that “find it relatively easier” to do so would not take such costs into account. Id. at 5740. However, HHS now doubts this conclusion because, as explained above, HHS received numerous comments to the SUNSET proposed rule from a diverse array of consumers, small businesses, and the public asserting the undue burdens and costs that rule would impose.

As stated earlier, while the Department can explore ways to improve its processes, HHS does have a meaningful track record of retrospective regulatory review. As required by section 610 of the RFA, the Department conducts periodic reviews of regulations with impacts on small entities and provides notification of these reviews in the annual Unified Agenda of Regulatory and Deregulatory Actions. Among HHS's other recent retrospective review efforts are the Department's 2011 Plan for Retrospective Review of Existing Rules, an initiative developed in accordance with E.O. 13563 and E.O. 13610, Identifying and Reducing Regulatory Burdens. The Department used this plan from Fiscal Year 2012 through Fiscal Year 2016 as a framework for its retrospective review of existing significant regulations to identify those rules that can be potentially eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined. A number of commenters also specifically referenced a 2015 CMS initiative to modernize Medicaid Managed Care regulations for Medicaid and CHIP beneficiaries. We also note that the CMS Office of Burden Reduction and Health Informatics works, among other things, to eliminate overly burdensome and unnecessary regulations. More recently, in response to E.O. 13771, Enforcing the Regulatory Reform Agenda, HHS established a Regulatory Reform Task Force that oversaw an effort to evaluate existing regulations and make recommendations to the Secretary regarding their repeal, replacement, or modification, consistent with applicable law. HHS published summary reports of these reviews for Fiscal Years 2018-2020 on the HHS website (available at https://www.hhs.gov/about/budget/fy2021/performance/regulatory-reform/index.html ). These efforts demonstrate the Department's ongoing commitment to retrospective review, which could be upended rather than strengthened by the SUNSET final rule.

The SUNSET final rule asserts that the threat of regulations expiring is necessary because “it is nearly impossible to see how a satisfying comprehensive review could occur without a sunset provision,” 86 FR 5702, and concludes that the Department “needs to impose a strong incentive on itself to perform retrospective review.” Id. at 5697. HHS now believes that there are numerous regulatory efforts that take place within agencies that routinely involve the review of regulations. Agencies are often requested to provide technical assistance to Congress on proposed legislation which quite often requires, among other considerations, an assessment of the proposal's impact on current regulations. FDA also reviews regulations in the course of responding to certain citizen petitions submitted under 21 CFR 10.30, requesting changes in FDA regulations.

It is also common for new HHS regulations to amend, revise or modify sections of regulations in order to update, replace, or rescind requirements, or to add new definitions or clarifications, which inherently entail review of these sections. For example, the regulations FDA issued to implement FSMA  28 included both the addition of new sections of regulation and revisions and modifications to existing sections. Additionally, regulation provisions are reviewed to determine if guidance documents are needed to provide recommendations for complying with the regulation. This is particularly important when the regulation is necessarily general or broad to accommodate scientific and other innovation changes, and guidance is helpful to consider applicability of the regulatory provisions.

Upon reconsideration, as a matter of policy, HHS now seriously questions whether automatic expiration is an effective or necessary means to incentivize regulatory review. Commenters expressed concern that the automatic expiration of regulations would in fact create a strong incentive, under certain circumstances, to not conduct reviews and thus, allow the Department to effectively rescind such regulations without any justification, explanation, or the notice and comment procedures generally required for rescinding a rule. The Department is concerned that the SUNSET final rule could degrade confidence in our regulatory stewardship.

Among the evidence cited to explain the need for the SUNSET final rule was an artificial intelligence review of all HHS regulations that identified that 85% of regulations before 1990 had not been edited. 86 FR 5699. 29 However, the final rule incorrectly inferred that just because no edit has been made to a regulation, it has never been reviewed. There are numerous regulatory efforts that take place within agencies that involve the review of regulations without resulting in a change to the regulation. As noted above, some commenters explained that many rules setting industry standards have remained untouched for years—not through neglect, but because they work as intended. There have also been instances where an agency has included certain regulations on past Unified Agendas (UA) and yet never completed these proposals and thus these were eventually withdrawn from the UA. But this ultimate result does not mean that review did not occur. Often review of an existing regulation may result in an agency developing a draft of a new or amended regulation that, upon further deliberation or because of intervening events, the agency decides not to finalize.

The SUNSET final rule also credited this artificial intelligence review with the identification of broken links in regulations and regulations that require multiple paper copies and provided these as examples that show the need to “more firmly institutionalize retrospective review.” 86 FR 5699. HHS notes that the broken links and other typographical errors identified through this process were successfully addressed as part of the HHS “Regulatory Clean-Up Initiative,” a final rule published on November 16, 2020 (85 FR 72899) that made miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors in regulations issued by FDA, CMS, the Office of the Inspector General, and the ACF. In addition, FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies and replace them with requirements for a single submission in electronic format. 30 However, neither the assessment-and-review process required by the SUNSET rule, nor the threat of expiring regulations, were necessary to incentivize these actions. Rather, HHS now believes the Department's ability to efficiently undertake such regulatory housekeeping in the future could be undermined if staff were overwhelmed by the implementation of the SUNSET final rule.

Commenters questioned the legality of the SUNSET final rule under the APA, which may be an additional ground for reconsideration and repeal. Under the APA, agency action is unlawful and can be set aside by a court when it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” or “without observance of procedure required by law.” 5 U.S.C. 706(2)(A), (D). Commenter asserted that the SUNSET final rule may be vulnerable under these standards in light of its stated justification for the rule and the process it followed in promulgating the rule.

The APA requires an agency, in issuing a final rule, to “examine the relevant data and articulate a satisfactory explanation for its action including a `rational connection between the facts found and the choice made.' ” Motor Vehicle Mfrs. Ass'n v. State Farm, 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). That explanation must show that “the decision was based on a consideration of the relevant factors.” Id.

After a regulation is promulgated, the same process applies for amending or rescinding that regulation. 5 U.S.C. 551(5) (“rule making” encompasses the formulation, amendment, or repeal of a rule); Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 101 (2015) (“agencies use the same procedures when they amend or repeal a rule as they used to issue the rule in the first instance”). Thus, an agency must “present an adequate basis and explanation” for the amendment or repeal; if the agency has “entirely failed to consider an important aspect of the problem,” the rule is “normally . . . arbitrary and capricious.” State Farm, 463 U.S. at 41, 43. In particular, when an agency changes course, including by amending a regulation, “a reasoned explanation is needed for disregarding facts and circumstances that underlay or were engendered by the prior policy.” FCC v. Fox TV Stations, Inc., 556 U.S. 502, 515-16 (2009).

As discussed above, the SUNSET final rule establishes a retrospective review scheme and amends most of HHS's regulations “to apply expiration dates unless certain conditions are satisfied”— i.e., the completion of retrospective review. 86 FR 5716. To support this approach, the Department provided the rationale that “the benefits of retrospective review, and the need to strongly incentivize it, are so great that the risk of a regulation inadvertently expiring is justified by the benefit of institutionalizing retrospective review in this manner.” 86 FR 5723.

Several commenters questioned the validity of HHS's approach. Commenters asserted that HHS cannot amend or revoke a legislative rule in a rulemaking that does not address the particulars of that legislative rule because it did not contain any particularized consideration of the regulations subject to expiration, such as the facts, circumstances, and policies originally motivating the promulgation of these regulations. In the preamble to the SUNSET final rule, the Department acknowledged the submission of a large number of comments stating that the rule would violate the APA on this ground. 86 FR 5715. The Department rejected these arguments and asserted that the rulemaking was permissible by comparing the global amendment to an amendment to a specific rule to add an expiration date, or to amending a definition of a term that is more widely applicable to a set of regulations. See 86 FR 5703-04. We now question the relevance of that comparison: Because of the differences in scope, scale, and effect, it is far more likely that HHS could consider the relevant factors and produce the record needed to support the rulemaking for these more targeted amendments, in contrast to the global amendment proposed in the SUNSET final rule. The Department also addressed these comments by asserting that it had “considered the relevant factors” and “considered each individual Department regulation” in connection with deciding whether to exempt the regulation from the scope of the SUNSET final rule. 86 FR 5703, 5718. However, these statements were conclusory; the final rule did not contain particularized consideration of the rules that were amended. Because of this absence, the Department arguably did not adequately consider the factors relevant to the amendments as required under the APA.

These questions are particularly pronounced in the circumstance that the SUNSET final rule leads to the automatic repeal of a regulation. As reflected elsewhere in this preamble, the Department believes that at least some amended regulations are likely to expire. In the event of such expiration, the Department would be changing course on a policy embodied in a regulation. As noted above, such a change needs to be supported by a reasoned explanation.

In addition, the Department is concerned that the exemptions in the SUNSET final rule may not have been adequately justified. The Department exempted certain FDA regulations, for example, on the basis that they create product identities and are being reviewed under other processes. 86 FR 5731. It is not clear that the stated reasoning supports the exemption decisions or their scope. For example, it is not clear why other FDA regulations that are similar, such as those codifying the standards for human blood and blood products, were excluded.

When HHS promulgated the SUNSET final rule, as discussed above, it provided a 30-day comment period for most comments. Many commenters asserted that the amount of time was inadequate under the APA, in light of the scale and complexity of the SUNSET proposed rule and in the absence of any public health or welfare emergency basis for the expedited timeline. The SUNSET final rule acknowledged the many comments received objecting to the length of the comment period, but concluded that the comment period was sufficient based primarily on the numerous comments received from a diverse array of stakeholders. 86 FR 5705-06.

The APA does not specify a duration for comment periods in the context of notice-and-comment rulemaking, but agencies must provide “adequate time for comments.” Fla. Power & Light Co. v. United States, 846 F.2d 765, 771 (D.C. Cir. 1988). The timing considerations will vary depending on the nature of the proposal and its impact on the public. Generally, the comment period for issuing new Department regulations is at least sixty days and can be longer depending on the issue and complexity. The SUNSET final rule was determined by OIRA to be an economically significant regulatory action. 86 FR 5737. Furthermore, the SUNSET final rule was vast in scope and impact, affecting thousands of regulations. In light of that, the Department believes commenters raised credible concerns that they could not adequately consider the rule in the time that was allotted for comments for the SUNSET proposed rule, and, as a result, the procedure may be vulnerable under the APA. 31

The SUNSET final rule states that “it is crucial to the proper function of this final rule that the Department and public clearly understand the scope and timing of the Assessment and Review process.” 86 FR 5721. However, upon reconsideration, the Department has found many ambiguities that could impede the ability of the Department and the public to determine the scope and timing of the assessment and review process. This confusion may increase the burden on stakeholders trying to navigate the assessment and review process. Process ambiguities also increase the risk of the automatic expiration of HHS regulations due to inadvertent noncompliance or misapplication of the requirements.

The final rule was revised to use the term “Section” rather than “Regulation” to refer to a section of the CFR. The preamble explained that this revision would enhance process clarity because “it is clear when a section of the CFR was first promulgated.” Id. However, in making this revision, the Department failed to consider that the rule also requires that assessments and reviews be performed on all sections of the CFR that HHS issued as part of the same rulemaking (and any amendments or additions that may have been issued thereafter). As a result, for any rulemakings that include revisions or cross-references to previously promulgated sections of regulations alongside newly promulgated sections of regulations, the scope and timing of the assessment process prescribed in the SUNSET final rule could be ambiguous.

For example, the FDA rulemaking “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (Preventive Controls for Human Food) was published on September 17, 2015 (80 FR 55907), and therefore would be expected by stakeholders to be less than ten years old. However, in addition to new sections first promulgated in 2015, the rule also included revisions to sections of the CFR that were first promulgated in 1975, 1979, 1986, 1995, 1997, 2001, 2004, and 2008. Under the final rule, it is not clear how the Department would determine when to assess CFR parts and sections that are comprised of pieces initially promulgated at various times.

Commenters also expressed concern about ambiguity in the categorical exceptions described in the proposed rule and included in the final rule. 32 Numerous commenters noted the lack of examples provided, and stated the lack of clarity for the categorical exceptions would leave the public unable to know which regulations would be eligible for the exceptions. Accordingly, some commenters stated that stakeholders would face a burden to conduct their own legal analysis.

Upon reexamination, the final rule may have failed to provide additional meaningful examples of these exceptions and only offered unspecific direction that categorical exceptions would be “rare” or only applicable to “a very small category.” See 86 FR 5731. The Department now recognizes the possibility that this lack of clarity could delay the completion of the assessment process and place further strain on the resources and effort needed to avoid the expiration of regulations.

In addition, many commenters stated that it was improper for the final rule to exclude the SUNSET rule itself from the requirements of paragraph (c) of each of the codified provisions, meaning that under the rule, the rule itself is not subject to assessment, review, or expiration. The final rule based this exemption on an assumption that the SUNSET rule would not “directly impose on the public costs that exceed benefits” because no rules would expire due to lack of assessment or review. 86 FR 5730. The Department now believes, as described above, that this assumption was likely incorrect.

We have examined the impacts of the proposed withdrawal or repeal rule under E.O. 12866, E.O. 13563, the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed withdrawal or repeal rule is a significant regulatory action as defined by E.O. 12866.

The RFA requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed withdrawal or repeal rule would result in cost savings to regulated entities, we propose to certify that the proposed withdrawal or repeal rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any 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 $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed withdrawal rule would result in an expenditure in at least one year that meets or exceeds this amount.

The proposed withdrawal or repeal rule would withdraw or repeal the SUNSET final rule. This proposed regulatory action would reduce the time spent by the Department performing retrospective assessments and reviews of its regulations, and time spent by the general public on comments related to these assessments and reviews. We would monetize the likely reductions in time spent by the Department and the general public as cost savings. Our primary estimate of these cost savings in 2020 dollars, annualized over 10 years, using a 3% discount rate, totals $69.9 million. Using a 7% discount rate, we estimate $75.5 million in annualized cost savings. Table 1 reports these primary estimates alongside a range of estimates that capture uncertainty in the amount of time it will take the Department to perform each assessment and review, and uncertainty in the amount of time the public will spend on comments.

In addition to these monetized effects, the proposed withdrawal or repeal rule would also reduce regulatory uncertainty and regulatory confusion anticipated under the SUNSET final rule. It would also reduce the time spent by the Department on other activities that we have not monetized or quantified, such as the time developing SECGs, and would reduce the time spent by the public monitoring regulations undergoing assessment or review and set to expire. The proposed withdrawal rule or repeal would also result in forgone information as a result of not performing the assessments and reviews.

We request comment on our estimates of costs and benefits of this proposed withdrawal or repeal rule.

On January 19, 2021, HHS issued the “Securing Updated and Necessary Statutory Evaluations Timely” final rule. Under the SUNSET final rule, all HHS regulations less than ten years old, with certain exceptions, will cease to be effective ten years after issuance, unless HHS performs an assessment of the regulation and a more detailed review of those regulations that have a significant economic impact upon a substantial number of small entities. The final rule also provides for regulations older than ten years to cease to be effective unless assessed and reviewed within an initial five-year period. HHS published a regulatory impact analysis (SUNSET RIA) alongside the final rule, providing estimates of the likely impact of the policy on Departmental resources and time spent by the general public related to these efforts. Following the initiation of litigation, HHS issued an administrative delay of effective date, effective as of March 19, 2021, which extended the effective date of the final rule by one year to March 22, 2022. For the purposes of this analysis, we refer to the January 19, 2021, final rule and March 19, 2021, administrative delay collectively as the SUNSET final rule.

The SUNSET final rule establishes automatic expiration dates for the Department's regulations, and a recurring assessment and review process that it can follow to avoid such expirations. The SUNSET final rule's RIA likely underestimates both the time commitment of a credible assessment and review process, and the time spent by the general public commenting on regulations undergoing assessment and review. Given the volume of regulations affected, our revised expectations of the time commitment necessary to conduct credible assessments and reviews, the timeframes for completing these retrospective analyses, and subsequent regulatory actions anticipated as a result of these analyses, it is likely that regulations will automatically expire without substantive review. The potential for regulations to automatically expire introduces regulatory uncertainty, with potential negative repercussions for stakeholders. The actuality of having regulations expire automatically could lead to regulatory confusion among stakeholders and harm the public health in numerous ways, as described in the preamble to the proposed withdrawal rule. This proposed withdrawal or repeal rule is therefore needed to improve the functioning of Government and to reduce the costs to the Department and the general public associated with the SUNSET final rule.

The purpose of the proposed withdrawal or repeal rule is to revoke the SUNSET final rule. If finalized, this regulatory action would directly address the potential harm from the automatic expiration of the Department's regulations. The proposed withdrawal or repeal rule would generate cost savings to the Department from reductions in staff time spent on assessments and reviews, and on related activities. It would also generate cost savings to the general public by reducing time spent on public comments related to these assessments and reviews, and on other activities, such as monitoring potentially expiring regulations. The proposed withdrawal rule would also reduce any regulatory uncertainty from the potential automatic expiration of rules.

We adopt a baseline that assumes the requirements of the January 19, 2021, SUNSET final rule  33 remain in place over the period of our analysis, accounting for a one-year administrative delay of effective date. 34 The SUNSET RIA contains monetized estimates of the costs to the Department to perform retrospective analyses of existing regulations and the costs to the public to monitor and respond to anticipated regulatory actions taken by the Department following these retrospective analyses. For the purpose of estimating the time spent on retrospective analyses under the baseline of this analysis, we maintain the assumption in the SUNSET RIA that the Department will satisfy the requirements of the SUNSET final rule and no regulations will automatically expire. 35 We also maintain various assumptions in the SUNSET RIA relating to the timing of the effects and treatment of the one-year waiver provision that allows the Secretary to make one-time, case-by-case exceptions to the automatic expiration of a rule. We also maintain the SUNSET RIA's choice of a 10-year time horizon for the analysis and adopt a base year of 2022 for discounting purposes. In this section, we reconsider several other assumptions underlying the cost estimates in the SUNSET RIA, and discuss additional cost drivers not identified and monetized in the analysis. These revised estimates inform our baseline scenario of no further regulatory action.

We adopt the SUNSET RIA's estimate of 17,200 regulations potentially subject to the SUNSET final rule that would need to be assessed in the first ten years. For each of these regulations, the Department will need to perform an assessment to determine whether the regulation imposes a significant economic impact on a substantial number of small entities. The SUNSET RIA estimates that roughly five regulations on average are part of the same rulemaking and could be assessed at one time. We maintain this assumption and terminology, which results in a total of 3,600 assessments in the first ten years. The SUNSET RIA assumes that 11% of these assessments, or 396, impose a significant economic impact on a substantial number of small entities, but reduces this figure to 370 to account for rulemakings that are likely to be reviewed for reasons other than the SUNSET final rule. This adjustment similarly reduces the estimate of the number of rulemakings impacted by the SUNSET final rule to 3,574.

For each of these 370 rulemakings, the Department will need to perform a review, which includes a retrospective regulatory flexibility analysis. The SUNSET RIA distinguishes between the 44 rulemakings that predate the Regulatory Flexibility Act and are unlikely to have an existing prospective regulatory flexibility analysis, and the remaining 326 rulemakings that are assumed to have an existing prospective analysis. The SUNSET RIA also estimates there will be 160 rulemakings assessed to have a significant impact on a substantial number of small entities that have not previously been identified as having a significant economic impact. An Agency will need to perform a review of these rulemakings under the SUNSET final rule.

The SUNSET final rule provides for an initial five-year period for the Department to address regulations older than ten years. We maintain the assumption in the SUNSET RIA that assessments and reviews required in the first five years will be completed evenly across this time period, and that the remaining assessments and reviews will be completed evenly across the next five-year time period. Table D1 presents the yearly count of assessments and reviews anticipated under the baseline scenario. These figures are broadly consistent with the figures contained in the SUNSET RIA; however, unlike that analysis, we do not reduce the number of assessments under the SUNSET final rule by the number of reviews performed, since these assessments occur first and serve to identify regulations requiring review.

The SUNSET RIA contains estimates of the time per assessment and time per review performed under the SUNSET final rule. For each assessment, the SUNSET RIA assumes that it will require between 3 and 10 hours to assess a rulemaking. For each review, the SUNSET RIA assumes that it will require between 250 and 500 hours to review rulemakings that predate the RFA, and between 40 and 100 hours to review rulemakings that postdate the RFA.

The Department now believes the SUNSET RIA likely underestimates the time necessary to credibly assess whether a regulation imposes a significant economic impact on a substantial number of small entities. The SBA Office of Advocacy published “A Guide for Government Agencies: How to Comply with The Regulatory Flexibility Act,” detailing a step-by-step approach for analysts. 36 For each of the 3,574 rulemakings requiring an assessment under the SUNSET final rule, an Agency will need to define the problem and describe the regulated entities, estimate economic impacts by size categories, and determine which size categories incur significant impacts. The SBA guide presents a two-page checklist containing the elements of an adequate certification. In practice, when performing a threshold analysis, analysts will face novel conceptual issues and data challenges, both of which require thoughtful consideration and professional judgement. Furthermore, SBA indicates that it is not sufficient to rely on an assessment made at the time a regulation was published:

We assume that, under the baseline scenario of the SUNSET final rule, the Department will follow the recommendations in the SBA guidance, and will perform a credible threshold analysis for each rulemaking to assess whether it imposes a significant economic impact on a substantial number of small entities. Each assessment will likely require time by an economist or other analyst to perform and document the threshold analysis, with input from at least one subject matter expert on the area of the regulation. Recognizing the need to fully respond to all the requirements, we modify the assumption in the SUNSET RIA and adopt an estimate of 40 to 100 hours to complete a credible threshold analysis for each rulemaking requiring an assessment.

As described earlier, the SUNSET RIA contains two estimates for the time necessary to perform a retrospective analysis. For rulemakings published before the RFA was enacted, the SUNSET RIA assumes between 250 and 500 hours per review. For rulemakings published after the RFA was enacted, the SUNSET RIA assumes that a prospective regulatory flexibility analysis is available and further assumes that this will reduce the time necessary to complete a review, adopting a range of 40 and 100 hours per review. For the 160 rulemakings newly found to have a significant impact, the SUNSET RIA assumes that it will take between 40 and 100 hours to complete a review. The Sensitivity Analysis Section of the SUNSET RIA acknowledges that “[o]ne commenter noted that conducting a retrospective analysis can be as time-consuming and expensive as a prospective regulatory analysis, suggesting the Department's estimates of the time and expense of Reviews may be understated.” Upon further consideration, the Department believes that the commenter is likely correct.

For the analysis of this proposed withdrawal rule, we adopt the SUNSET RIA estimate of 250 to 500 hours for all retrospective analyses, regardless of when the underlying rulemaking was published. If previously published prospective or retrospective regulatory flexibility analyses are generally available, analysts may be able to build off of these previous analytic efforts when developing a retrospective analysis under the SUNSET rule. All else equal, this would suggest the average time per retrospective may be closer to the lower-bound estimate of 250 hours. If these analyses are not generally available, this would suggest an average time per retrospective closer to the upper-bound estimate of 500 hours. We do not address the assumption in the SUNSET RIA that a prospective regulatory flexibility analysis is available for every rulemaking published after the RFA was enacted, because it does not impact the estimate of the overall time spent on reviews under the baseline scenario. Our approach also allows us to ignore the apparent internal inconsistency in the SUNSET RIA underlying the time per review of the 160 rulemakings that are newly assessed to have a significant impact.

The SUNSET RIA is not clear on what activities are included in its estimates of the time per review other than the time spent developing a retrospective analysis. We interpret the magnitudes of these estimates to exclude a consideration of time spent on activities other than drafting the retrospective analysis. For example, the agency may need to conduct a study or survey to gather data to inform its analyses. We therefore include an additional 250 hours to 500 hours per review to account for this omission. This estimate reflects time spent by the Department by subject matter experts, lawyers, and other reviewers informing the retrospective analysis and providing feedback on draft analyses. It also reflects time spent by economists and other analysts developing the retrospective analysis to respond to this feedback, and time spent reading and incorporating evidence from other sources, including public comments. Table D2 summarizes the assumptions in the SUNSET RIA and our revised assumptions for the proposed withdrawal rule of the time per assessment and time per review performed under the baseline scenario of the SUNSET final rule. Combining the time spent on retrospective analysis and on other related activities, we estimate that each review will take between 500 and 1,000 hours to complete.

Under the SUNSET final rule, the Department would create a docket on www.Regulations.gov for each assessment or review that the Department is conducting. The public would then be able to submit comments to the dockets of each rulemaking being assessed or reviewed. The SUNSET RIA includes a discussion of the costs to the stakeholders to monitor and comment on regulations as they are undergoing assessment and review; however, the analysis assigns no costs to the Department associated with setting up these dockets or engaging with the comments. The analysis also does not monetize any other costs associated with operationalization of the SUNSET final rule, which also requires developing a schedule for activities associated with the SUNSET final rule, publishing monthly updates, and establishing a website dashboard to help the public monitor the Department's progress.

When estimating the impact on the public, the SUNSET RIA first estimates that 53 rulemakings will be rescinded and another 159 rulemakings amended as a result of the retrospective analyses initiated as a result of the SUNSET final rule, monetizing the time spent by the public responding to those 212 rulemakings. The SUNSET RIA assumes that, for each of the 53 rulemakings rescinded following a review completed under the SUNSET final rule, the public will submit 243 comments; and for each of the 159 rulemakings amended, the public will submit 486 comments. This will result in an estimated 90,153 comments, for which the SUNSET RIA assumes that each commenter will spend between 5 and 15 hours. Presumably, this estimate is inclusive of finding out that the rulemaking is likely to be rescinded or amended, reading and understanding the rulemaking, completing further research, communicating with other stakeholders, identifying concerns, and drafting and submitting comments. The Preamble to the SUNSET final rule anticipates that the Department will create on its website a dashboard that shows its progress on its Assessments and Reviews. Therefore, we assume that any reduction in the time spent by the public attributable to this dashboard is accounted for in these time estimates. For the purposes of this analysis, we adopt the SUNSET RIA's assumption about the time spent per comment.

The SUNSET RIA's discussion of the timing assumptions suggests the public will wait until the retrospective is complete and an Agency has announced it intends to rescind or amend a rulemaking before commenting. Furthermore, for the remaining 3,388 rulemakings subject to the SUNSET final rule that will be available for public comment prior to an Agency assessment or review, the SUNSET RIA assumes the public will offer no comments. These assumptions appear at odds with the decision to invite public comment during both the assessment and review processes. Furthermore, as discussed by the SBA, 37 “[i]nsights about an existing regulation received from regulated entities and other interested parties should be a key component of a retrospective rule review. By making the review process transparent and accessible, agencies are more likely to identify improvements that will benefit all parties at the conclusion of the review.”

Upon further consideration, the Department finds it more likely that the public will comment on rulemakings undergoing assessment and review rather than wait until learning the specific rulemakings that will be rescinded or amended as a result of these assessment and reviews. We adopt the SUNSET RIA's estimate of 486 comments per rulemaking, but instead apply this to the 570 rulemakings that, following a threshold analysis in an assessment, an Agency will begin to review. We believe that the public will submit fewer comments for rulemakings undergoing an assessment, and adopt an assumption of 25 comments per assessment. Table D3 summarizes a comparison of the assumptions in the SUNSET RIA and in the baseline analysis of this proposed withdrawal rule of the comments per assessment and review, and for the subsequent regulatory actions to rescind or amend rulemakings.

As described earlier, the SUNSET RIA envisions the Department identifying and rescinding 53 rulemakings and amending 159 rulemakings following completed reviews under the SUNSET final rule. Upon further reflection, the Department no longer believes it was appropriate to unambiguously attribute to the SUNSET rulemaking subsequent regulatory actions of this nature in the context of a regulatory impact analysis. Even if the challenging attribution questions could be resolved, we believe that the SUNSET RIA understates the impact of the SUNSET rule since it implicitly assumes that the Department would not have to spend any time to develop and publish subsequent regulatory actions to rescind or amend existing regulations. This unstated assumption is difficult to justify. Since these anticipated regulatory actions relate to regulations that have a significant economic impact on a substantial number of small entities, we expect that these actions will need to involve subject matter experts, legal review, policy coordination, Departmental clearance, and a communications strategy to bring transparency to the process. For certain regulatory actions, we anticipate the need for review by the Office of Management and Budget. We have not attempted to estimate the time associated with developing these regulatory actions.

To quantify the likely effect of the SUNSET final rule on the Department, we multiply the number of assessments and number of reviews from Table D1 by the assumptions relating to the time per assessment and time per review described in Table D2. To quantify the likely effect of the SUNSET final rule on the public, we multiply the figures in Table D1 by the assumptions relating to the comments per assessment and comments per review described in Table D3. This gives us estimates for the number of comments, which we then multiply by the time estimates per comment, described above, to estimate the total time spent by the public. Table D4 presents yearly estimates of hours spent related to assessments performed under the SUNSET final rule to the Department and the public. Table D5 presents comparable figures related to reviews. Table D6 presents the total time anticipated under the SUNSET rule related to assessments and reviews.

This action is directed to the public in general. This action may, however, be of interest to those persons who manufacture (including import), distribute in commerce, process, use, or dispose of cigarettes. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth the facts which it is claimed establish that it is necessary to initiate the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the Federal Register . A petitioner may commence a civil action in a U.S. district court seeking to compel initiation of the requested proceeding within 60 days of a denial or, if EPA does not issue a decision, within 60 days of the expiration of the 90-day period.

TSCA section 21(b)(1) requires that the petition “set forth the facts which it is claimed establish that it is necessary” to initiate the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly incorporates the statutory standards that apply to the requested actions. Accordingly, EPA has relied on the standards in TSCA section 21 and in the provisions under which actions have been requested in evaluating this TSCA section 21 petition.

Under TSCA section 6(a), EPA must determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If unreasonable risk to health or the environment is determined, EPA has the authority and obligation to issue a rulemaking placing one or more requirements to the extent necessary so that the chemical substance or mixture no longer presents an unreasonable risk. EPA may eliminate the unreasonable risk of a chemical substance or mixture by regulating manufacture, processing, distribution in commerce, commercial use or disposal of the chemical substance, including by prohibiting, limiting volume, limiting a particular use, restricting concentration, requiring warning and instruction labeling, requiring record-keeping of exposures, notification of end-users, and/or replacement or repurchase by issuance of rulemaking to manufacturers, processors, distributors in commerce, users, and disposers.

TSCA section 3(2) excludes from the definition of a “chemical substance” “any mixture,” “tobacco or any tobacco product,” as well as “any food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.” 15 U.S.C. 2602(2). In addition, TSCA section 3(10) defines “mixture” as “any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.”

TSCA section 26(h) requires EPA, in carrying out TSCA sections 4, 5, and 6, to make science-based decisions using “scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science,” while also taking into account other considerations, including the relevance of information and any uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires that decisions under TSCA sections 4, 5, and 6 be “based on the weight of scientific evidence.” 15 U.S.C. 2625(i). TSCA section 26(k) requires that EPA consider information that is reasonably available in carrying out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).

On August 2, 2021, EPA received a TSCA section 21 petition (Ref. 1) from William D. Bush (the petitioner) that requests EPA take several actions under TSCA section 6. The petition asks EPA to determine “that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment” and seeks the issuance of a rule or order to “eliminate the hazardous chemicals used in a mixture with tobacco; including and not limited to the toxic substance inclusions resulting from tobacco growing or handling techniques,” and to “develop material techniques of biodegradation to counter or reduce” environmental risk from current disposal methods of cigarettes. The petition also requests “any other prudent methods of toxic mixture substance control [EPA] may see due and fit.”

The petition requests that EPA determine that “chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment.” With respect to actions under TSCA section 6, TSCA section 21 provides only for the submission of a petition seeking the initiation of a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6(a). The purpose of a TSCA section 6 risk evaluation is to determine whether a chemical substance or mixture presents an unreasonable risk to health or the environment under the conditions of use. To initiate a TSCA section 6 risk evaluation, however, the chemical substance or mixture must be designated a high priority for risk evaluation. Prioritization of high priority substances for risk evaluation under TSCA section 6(b) is an activity distinct from rulemaking under TSCA section 6(a). Because TSCA section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for “chemical mixtures contained within cigarettes,” this Federal Register document does not address this specific request.

The petition requests that EPA “[o]rder by [r]ule that the manufacturing producers of cigarettes eliminate the hazardous chemicals used in a mixture with tobacco.” TSCA section 21 provides for the submission of a petition to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA sections 4, 5(e), or 5(f). As the petitioner is seeking issuance of a rule under TSCA section 6, this Federal Register document addresses this request.

The petition asks EPA to “[o]rder by [r]ule that [c]igarette manufacturers develop new product designs which eliminate or reduce the cigarette `butt' disposal risks to the environment.” TSCA section 21 provides for the submission of a petition seeking issuance of a rule under TSCA section 6. However, the requirements listed in TSCA section 6(a) do not allow the Agency to compel a manufacturer to alter existing or develop new product designs. To the extent that the prohibitions and restrictions on manufacturing, processing, or distribution in commerce available in TSCA sections 6(a)(1) and (2) could be interpreted as affecting the design of a product, such issues are described in Unit III.B. To the extent that EPA may apply the TSCA section 6(a)(6) requirement to prohibit or otherwise regulate a manner or method of disposal of a chemical substance, mixture, or article, such a requirement would only apply to a “manufacturer or processor or . . . any other person who uses, or disposes of, it for commercial purposes” and not the unspecified “consumer market disposal methods” cited in the petition. Therefore, this Federal Register document does not address this specific request.

The petition requests that EPA exercise “any other prudent methods of toxic mixture substance control” that the Agency deems “due and fit.” As a regulatory body, EPA cannot deviate from the statutory remedies established under TSCA section 21. Therefore, a solicitation for EPA to exercise “any other prudent methods” that the Agency deems “due and fit” does not adequately identify an objective that is executable within TSCA section 21. Therefore, this Federal Register document does not address this specific request.

To support the request for an order by rule that the manufacturing producers of cigarettes eliminate the hazardous chemicals used in a mixture with tobacco, the petitioner offers information relating to the structure and content of cigarettes, human and environmental health impacts related to smoking cigarettes, and human and environmental health impacts to discarding cigarette butts (Ref. 1, pp. 2-4). Of 18 points included in that discussion, eight are attributed to an article on the toxicity of cigarette butts and their chemical components for fish (Ref. 2); these points are discussed in detail below. For the remaining ten points, the petitioner does not provide, and EPA could not identify, a reference to support the information presented, which generally applied to the human health and environmental impacts related to smoking cigarettes.

Regarding the eight points attributed to the article on the toxicity of cigarette butts, the petitioner points to estimates of the number of and volume of cigarette butts discarded worldwide (Ref. 1, p. 3, points 9, 10, and 11), as well as the general nature of chemicals in cigarettes and cigarette filters and how such chemicals enter aquatic ecosystems and become “acutely toxic to fish and microorganisms” (Ref. 1, p. 3-4, points 14, 15, and 17). The petitioner also points to the use of “Environmental Protection Agency standard acute fish bioassays” in the analysis of “cigarette butt-derived leachate . . . for aquatic toxicity” and that “[i]n laboratory experimentation, the chemicals that leached from a single cigarette butt (soaked for 24 hours in a liter of water) released enough toxins to kill 50 percent of the saltwater and freshwater fish exposed to it for 96 hours” (Ref. 1, p. 3-4, points 16 and 18).

In addition, the petitioner includes a summary of the findings and policy section of the Pollution Prevention Act (42 U.S.C. 13101) (Ref. 1, pp. 4-5), though TSCA section 21 does not provide an avenue for recourse under such Act. The petitioner states “pollution should be prevented or reduced at the source whenever feasible; pollution that cannot be prevented should be recycled in an environmentally safe manner, whenever feasible; pollution that cannot be prevented or recycled should be treated in an environmentally safe manner whenever feasible; and disposal or other release into the environment should be employed only as a last resort and should be conducted in an environmentally safe manner” and that “source reduction is fundamentally different and more desirable than waste management and pollution control.”

The petitioner also provides two claims: (1) “[t]oxic [c]hemicals added to and included in [c]igarettes are unreasonable;” and (2) “[c]igarette [d]isposal presents a clear unreasonable risk to the [e]nvironment.” (Ref. 1, pp. 5-6). To support the former claim, the petitioner makes general references to, but does not cite or provide for reference United States v. Philip Morris USA Inc., 449 F. Supp. 2d 1 (D.D.C. 2006). To support the latter claim, the petitioner states that “research studies of toxic waste entering the environment are clear in identifying cigarette butts as a major hazardous waste emission,” but does not cite or provide any reference to such studies.

After careful consideration, EPA has denied this TSCA section 21 petition. A copy of the Agency's response, which consists of the letter to the petitioner and this document, is posted on the EPA petition website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cigarettes. The response, the petition (Ref. 1), and other information is available in the docket for this TSCA section 21 petition. B. What was EPA's reason for this response?

TSCA section 21 does provide for the submission of a petition seeking the initiation of a proceeding for the issuance of a rule under TSCA section 6(a). The petition must “set forth the facts which it is claimed establish that it is necessary to issue” the requested rule. 15 U.S.C. 2620(b)(1). When determining whether the petition meets that burden, EPA will consider whether the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the environment under TSCA section 6(a). 15 U.S.C. 2605(a).

EPA evaluated the information presented in the petition and considered that information in the context of the applicable authorities and requirements of TSCA sections 6, 21, and 26. Notwithstanding that the burden is on the petitioner to present “the facts which it is claimed establish that it is necessary” for EPA to initiate the rule or issue the order sought, EPA nonetheless also considered relevant information that was reasonably available to the Agency during the 90-day petition review period. As detailed further in this Unit, EPA finds that the petitioner has not met its burden as defined in TSCA sections 6(a) and 21(b)(1) because the petitioner because cigarettes are not a product that can be regulated under TSCA section 6(a). These deficiencies, among other findings, are detailed in this document.

As previously discussed, TSCA section 6(a) authorizes EPA to determine if a chemical substance or mixture in manufacturing, processing, distribution in commerce, use, disposal, or any combination of these activities presents an unreasonable risk of injury to health or the environment. If unreasonable risk to health or the environment is determined, then EPA must, by rule, issue regulations apply one or more of the following requirements to the extent necessary to that the chemical substance no longer presents such risk. However, TSCA section 3(2)(B), which defines “chemical substance,” excludes “tobacco or any tobacco product.” According to section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA), “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” 21 U.S.C. 321(rr)(1). Section 900(3) of the FFDCA establishes that a “cigarette” is “a product that . . . is a tobacco product . . . and . . . includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco,” and section 901(b) of the FFDCA makes clear that FDA has authority over “all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.” 21 U.S.C. 387(3) and 387a(b). Finally, cigarette butts are not considered as a separate item from a cigarette or tobacco product. (See, e.g., FFDCA sections 904(a)(1) (“the tobacco, paper, filter, or other part of each tobacco product”) and 907(a)(1)(A) (“a cigarette or any of its component parts (including the . . . filter, or paper)”). 21 U.S.C. 387d(a)(1) and 387g(a)(1)(A). EPA thus determined that a “cigarette” is a “tobacco product,” and, therefore, is not a “chemical substance.” Similarly, EPA determined that “tobacco” is not a “chemical substance.” Therefore, EPA cannot issue a rule pursuant to TSCA section 6(a) to apply requirements to tobacco or cigarettes.

TSCA section 3(2)(B) also excludes “any mixture” from the definition of “chemical substance.” TSCA section 3(10) defines “mixture” generally as “any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction” (emphasis added). Because the petition references “hazardous chemicals used in a mixture with tobacco” and the Agency determined that “tobacco” is not a “chemical substance,” EPA determined that a combination of chemicals with tobacco is not a mixture as defined by TSCA section 3(10). Therefore, EPA cannot issue a rule pursuant to TSCA section 6(a) to apply requirements to “hazardous chemicals used in a mixture with tobacco.”

Additionally, to the extent that the petition referenced the Pollution Prevention Act (42 U.S.C. 13101), the Agency reiterates that TSCA section 21 does not provide an avenue for recourse under such Act.

EPA denied the request to issue of a rule under TSCA section 6(a) because TSCA section 3(2)(B) excludes from the definition of “chemical substance” “any mixture” and “tobacco or any tobacco product.” Because the Agency determined a cigarette (including a cigarette butt) to be a tobacco product, such products are not chemical substances and cannot be subject to a rule issued under TSCA section 6(a). Because EPA also determined that a combination of chemicals with tobacco is not a mixture as defined by TSCA section 3(10), such a combination cannot be subject to a rule issued under TSCA section 6(a).

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

This is a summary of Commission's Eighth Further Notice of Proposed Rulemaking, in WP Docket No. 07-100; FCC 21-106, adopted on September 30, 2021 and released on October 1, 2021. The full text of the Eighth Further Notice of Proposed Rulemaking, including all appendices, is available for inspection and copying during normal business hours in the FCC Reference Information Center, 45 L Street NE, Washington, DC 20554, or by downloading the text from the Commission's website at https://docs.fcc.gov/public/attachments/FCC-21-106A1.pdf. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to FCC504@fcc.gov or calling the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. In this Eighth Further Notice, we propose to revisit the structure of the 4.9 GHz band to maximize public safety use while exploring options that could spur innovation, improve coordination, and drive down costs in the band. Specifically, we seek to establish a nationwide framework for coordinating access to the band. We believe that a comprehensive and integrated approach that emphasizes public safety needs represents a superior path to unlocking the potential of the 4.9 GHz band rather than pursuing a state-centered approach that could lead to a patchwork of incompatible uses. Similarly, we believe a nationwide approach will promote a robust equipment market, drive down prices and costs, spur innovation, and increase the likelihood of interoperable communications and consistent interference protection. We also explore potentially allowing non-public safety use of the band to encourage a more robust and innovative equipment market, provided that non-public safety use can occur without causing harmful interference to public safety operations in the band. As part of this vision, we seek comment on how best to meet the needs of public safety in this band and on establishing a database that would contain consistent and reliable information about what spectrum is available and where and how it is being used. Our goal is to provide greater certainty and predictability to stakeholders seeking to plan and invest in 4.9 GHz deployments and enable spectrum users to coordinate shared use of the band to avoid conflicts. In addition, we seek comment on a range of technical issues, eligibility issues, and other measures intended to increase use of the band.

2. We note that this proceeding has an extensive record, which we intend to draw upon as needed to develop a cohesive set of nationwide rules to maximize use of the band, including protection for public safety operations. We encourage commenting parties to assist us by providing input on the new ideas proposed herein and by submitting additional new proposals or by modifying previous proposals. To the extent that commenters wish to reiterate any proposals that have been previously introduced into the record, commenters should demonstrate that the proposals align with our approach and priorities for the band as described in this Eighth Further Notice. We preserve our flexibility to consider and adopt proposals from prior stages of this proceeding that the Commission has not specifically rejected.

3. As noted above, the band is currently home to 3,541 licensees. We recognize that these licenses represent a significant investment of scarce public safety resources, so as we explore ways to enhance the usage of the band, we are cognizant that we must protect these investments.

4. We seek comment in this Eighth Further Notice on how to ensure public safety licensees have efficient and interference-free access to the band. Numerous commenters have addressed this issue, and several have expressed support for various approaches to protecting public safety licensees from interference. For instance, the National Public Safety Telecommunications Council (NPSTC) argues that interference protection, whether “done manually or through some potential future automated frequency coordination approach,” must be incorporated into the management of the band to protect incumbents “against interference and signal degradation.” We agree, and we tentatively conclude that incumbent public safety licensees as well as future public safety users should be protected from harmful interference, both in the near term and on a forward-looking basis, subject to other requirements and conditions that we may adopt in this proceeding.

5. NPSTC recommends “use of the threshold degradation approach in the ANSI/TIA-10 [American National Standards Institute/Telecommunications Industry Association] standard to minimize interference to incumbent fixed operations,” which NPSTC notes “encompass many of the public safety operations” in the band. We seek comment on the feasibility of NPSTC's proposal to use the TIA-10 standard to minimize interference to incumbents that deploy fixed facilities. Are there alternatives to the TIA-10 standard which could be used to guard against interference between licensees deploying fixed point-to-point (P-P) links and point-to-multipoint (P-MP) hubs? Under Part 90, contour overlap analysis is often the basis for determining if an applicant's proposed facilities would likely cause interference to an incumbent operator. Would contour overlap analysis requirements be useful for certain 4.9 GHz band deployments, and if so, what service and interference contour values would be appropriate? We also seek comment on what standards would be appropriate for incumbents deploying non-fixed, geographic-area operations or ad-hoc temporary operations. Commenters are encouraged to address how their proposals would support our tentative conclusion to protect both existing and future public safety licensees in the band as well as interact with potential new non-public safety operations in the band, with specific attention to the licensing and sharing models addressed below.

6. In the Sixth Further Notice of Proposed Rulemaking ( Sixth Further Notice ) (83 FR 20011), the Commission stated that it believed many concerns public safety users have about the 4.9 GHz band could be addressed if more complete technical information were available to all affected parties. We therefore seek comment on collecting more granular data on 4.9 GHz operations in our licensing database and combining that with a formal coordination structure to improve interference mitigation efforts and bolster public safety confidence in the band. Today, licensees in the 4.9 GHz band only provide our Universal Licensing Service (ULS) database with control points and geographic area of operations. More robust information on public safety operations in the band could help improve predictability for public safety operations and facilitate robust, non-interfering access to the band for non-public safety entities. Therefore, we tentatively conclude that additional information is required, and we seek comment on whether to continue using ULS or to transition to a third-party licensing database to accommodate the additional information. For instance, in the Sixth Further Notice, the Commission proposed to maintain ULS as the comprehensive licensing database for the 4.9 GHz band and proposed to modify ULS as necessary to accept the necessary licensing data. Since ULS can readily accommodate additional information, we seek comment on these proposals. We seek comment on requiring incumbents and future applicants to supply complete microwave path data for links, and to license base stations (currently authorized under the geographic license scheme) on a site-by-site basis.

7. In the Sixth Further Notice, the Commission proposed “to require incumbent licensees and new applicants to provide technical information that will enhance frequency coordination and help mitigate the possibility of interference, while permitting more new users.” We seek comment on this proposal to require incumbents and future applicants in the 4.9 GHz band to submit more information in ULS. Would collecting this data improve the level of interference protection licensees receive in the band? We seek comment on whether collecting this data would create a more predictable and transparent spectrum environment for any current and future users of the band, including potential non-public safety users. To what extent does not having this data currently listed in ULS lead to additional interference or uncertainty in the band? In particular, should licensees specify channels they are using for their operations? In the Sixth Further Notice, the Commission also proposed to add the 4.9 GHz band to the ULS microwave schedule for P-P, P-MP, and proposed to “uncouple base and mobile stations from geographic licenses and instead require that base and mobile technical parameters be entered on the existing location and technical data schedules.” We seek comment on these ULS schedule proposals and ask commenters to address whether ULS's existing schedules are sufficient for collecting the additional data.

8. What is the burden on incumbents and applicants who would need to submit detailed site-based information, and does the benefit of having additional technical data listed in ULS outweigh that burden? For instance, the Commission estimates the average burden for each applicant completing FCC Form 601 and associated schedules to be 1.25 hours, which includes “the time to read the instructions, look through existing records, gather and maintain required data, and actually complete and review the form or response.” Is this estimate accurate for incumbents or new applicants who would need to submit the additional technical information described above with their Form 601 application? What is the interplay of these potential new data collection requirements with potential sharing mechanisms, discussed below, that would facilitate shared public safety and non-public safety use of the band?

9. Are there alternatives to collecting additional technical data in ULS for the 4.9 GHz band? For instance, would a database managed by a third party offer advantages over requiring incumbents and new applicants to submit additional information via ULS? If so, what are those advantages and what would be the cost of having a third party administrator manage a database to collect the information needed to increase interference protection in the 4.9 GHz band? How would the transition from ULS to a third-party database be implemented? Who would pay that cost and how would those costs impact public safety given that public safety entities are subject to no filing fees in ULS? In other words, would a third-party managed database increase costs on public safety licensees in the band and would those costs outweigh any derived benefits? Commenters that support the use of a third party band manager are encouraged to consider how such a system could work with the various methods of introducing non-public safety operations to the band described below. If we were to pursue this option, who would be suitable to manage the database? How should we select the administrator?

10. Regardless of whether ULS or a third-party database is used to collect technical detail on 4.9 GHz deployments, incumbent licensees with geographic licenses would need time to submit the requisite information. In the Sixth Further Notice, the Commission proposed giving incumbent geographic licensees one year to identify in ULS P-P links, P-MP hubs, fixed receivers, base stations, and mobiles that are not currently licensed site-by-site. The Commission sought comment on whether the status of a license should become secondary if the incumbent licensee does not meet the one-year deadline. Most parties commenting on this issue concurred with this time period. We seek comment on whether a one-year timetable is still appropriate for incumbent geographic licensees to submit technical data on their deployments into a database, and whether any deterrent, such as the risk of forfeiting primary status, is needed to ensure compliance. On the other hand, given that the purpose of collecting additional technical data is to provide increased interference protection to incumbent licensees, does this benefit provide sufficient incentive for licensees to comply with a timetable requirement?

11. The record generated in response to the Sixth Further Notice demonstrates that the public safety community employs this band for a wide variety of uses. As we strive to develop a national framework for this band, we seek to encourage uses that enable collaboration and mutual aid between multiple licensees, for instance, in response to larger incidents and emergencies. To that end, we seek comment on whether to adopt any technical standards for the 4.9 GHz band that would promote interoperability in the band. In other private land mobile radio (PLMR) frequency bands used by public safety, the Commission designates certain channels for interoperability communications, and in some instances, it also specifies technical requirements for equipment designed to transmit on those channels. The goal is to ensure that public safety officials from different agencies can communicate on designated interoperability channels regardless of the make or model of their radio equipment.

12. We seek comment on whether any interoperability requirements are needed for the 4.9 GHz band. For example, should we designate a band segment or certain channels in the band for interoperable communications? If so, how much spectrum would sufficiently address public safety needs and how should interoperable spectrum be administered to optimize those resources for their primary purpose? For example, should state interoperability coordinators, regional planning committees, or individual agencies administer the use of interoperable 4.9 GHz spectrum? In addition, if we were to set aside spectrum for public safety interoperability purposes, should we also specify technical standards for equipment intended to operate on those channels? Would such a requirement invigorate or stifle innovation and equipment options? Parties discussing interoperability for the 4.9 GHz band should explain if and how the benefits of any such requirements outweigh associated costs. How should interoperability requirements apply to non-public safety entities if we expand eligibility for the band beyond public safety (as discussed below)? What technical and licensing conditions should apply to non-public safety licensees to ensure interoperable and interference-free operations? How could the introduction of non-public safety operations into the band help foster a broader interoperable device marketplace? Should we allow the marketplace to adopt voluntary interoperability standards in lieu of requirements specified in the Commission's rules? If so, how could a voluntary industry standard promote interoperability between all eligible users of the band?

13. An important element of public safety spectrum use, particularly where spectrum is shared with non-public safety users, is ensuring that public safety will have immediate and reliable access to spectrum whenever and wherever it is required for mission-critical operations. We therefore seek comment on affording public safety licensees priority access to the 4.9 GHz band, including the ability to preempt any non-public safety operations that may be authorized in the band.

14. The Association of Public-Safety Communications Officials-International, Inc. (APCO) states in its 2015 report that, while it supports an approach to the band which fosters development in the commercial sector of “more cost effective equipment,” any such solution must afford “priority and preemption for public safety users in a shared environment.” We note that there are other instances where public safety users are afforded priority network access and the ability to preempt the operations of other users in emergency circumstances. If we open the 4.9 GHz band to non-public safety users, as discussed below, we seek comment on whether public safety priority and preemption should be elements of any sharing model we ultimately adopt. We seek comment on this approach and how best to accomplish that goal in the 4.9 GHz band.

15. For instance, we seek comment below on whether excess capacity leasing or a dynamic spectrum sharing system could effectively enable sharing between public safety and non-public safety. If so, to what extent and by what method could these sharing models ensure priority and preemption for public safety operations? Are priority and preemption sufficient tools to ensure public safety mission-critical operations access to the band under an excess capacity or dynamic spectrum sharing scheme? How would priority and preemption work under other spectrum sharing models?

16. If we adopt rules for public safety priority and preemption, we seek comment on the types of mission-critical public safety operations that should have priority over other public safety as well as non-public safety operations. Given the wide range of possible deployments in the 4.9 GHz band, both geographically and in terms of type of use, how should public safety licensees with overlapping operating areas determine priority and preemption rights and whether certain deployments or types of communications should have priority? For instance, should emergency mobile deployments at an incident scene be able to preempt fixed P-P links that may be operating on a primary basis? Does the primary status of a license or deployment have any bearing on priority and preemption? How do two overlapping licensees that both have primary status determine priority if they seek to use the same channel at the same time? We seek comment on how to ensure that mission-critical communications maintain consistent priority, no matter what deployment form they may take.

17. Finally, we seek comment on the technical feasibility of building priority and preemption algorithms into 4.9 GHz networks and equipment to enable authorized public safety users to obtain priority and preempt use of the spectrum if necessary. In contrast to instances where public safety and non-public safety operate on a single shared network, 4.9 GHz licensees operate on disparate networks. How does this affect the availability of priority and preemption solutions? Is there a demand in the equipment marketplace for priority and preemption tools, and if not, should we require 4.9 GHz band equipment to include such tools? What equipment security requirements could we impose to avoid unauthorized signaling of priority? What would be the cost of incorporating priority and preemption algorithms into equipment?

18. Regardless of what eligibility rules or sharing model we may ultimately adopt, we anticipate that the future of this band includes a robust public safety presence. We tentatively conclude that a nationwide, coordinated approach to the management of the spectrum will not only increase the utility of this band for public safety, but will also promote greater public safety use of the band by providing greater certainty with regards to the availability of the spectrum and interference protection. In this section, we explore ways to make the spectrum environment more attractive to existing and future public safety users.

19. We seek comment on requiring formal frequency coordination in the 4.9 GHz band to support interference protection and increase public safety confidence in using the band. As noted above, our rules currently allow licensees in the 4.9 GHz band to deploy base stations, mobile units, and temporary fixed stations anywhere within the licensee's jurisdiction without formal frequency coordination. Rather, our rules direct licensees to informally coordinate with other users in the band by cooperating in “the selection and use of channels in order to reduce interference and make the most effective use of the authorized facilities.”

20. The Commission previously contemplated frequency coordination as a means to encourage increased public safety use of the band. In 2009, the Commission noted that, “[w]ithout a specific coordination procedure in place, interference issues may arise between co-primary permanent fixed stations or other co-primary users of the band.” In the Sixth Further Notice, the Commission stated that “neither self-coordination nor a notice-and-response coordination procedure is likely to be sufficient to ensure interference protection to primary users in a mixed use environment.” APCO argues in its 2015 report that “new frequency coordination procedures designed to improve usage, performance, and interference protection” would increase interest in the band by the public safety community and “provide incentives for equipment vendors to direct investment into this market.”

21. Therefore, in this Eighth Further Notice, we tentatively conclude that some form of formal frequency coordination, whether through a coordination method discussed in this subsection and/or a dynamic spectrum sharing model as discussed further below, is necessary to support interference protection and increase public safety confidence in using the band. We seek comment on this tentative conclusion. Would mandatory frequency coordination provide certainty and incentives for public safety to increase its use of the band? Would it encourage equipment manufacturers to invest in developing new and low cost equipment for the band? If we adopt frequency coordination requirements, should they also apply to applications for non-public safety uses, insofar as such uses are permitted? If so, what criteria should coordinators apply to ensure that proposed non-public safety uses will not interfere with public safety operations?

22. If we adopt formal frequency coordination for the 4.9 GHz band, what type of frequency coordination would most effectively promote innovative use of the band while protecting against interference? In certain spectrum bands under Part 90, applicants seeking to license a new frequency or modify existing facilities must demonstrate that their application was coordinated by a Commission-certified frequency coordinator. The certified frequency coordinator recommends the most appropriate frequency for the proposed operation. Another type of frequency coordination that does not rely on certified frequency coordinators is used for applicants in the fixed microwave service. Part 101 requires that an applicant coordinate proposed facilities with existing licensees and other applicants whose facilities could be affected by the new proposal, i.e., “notice-and-comment” type frequency coordination. We seek comment on whether Part 90 type frequency coordination, Part 101 type frequency coordination, or a combination of the two would be best suited for the 4.9 GHz band. Should Part 101 type coordination apply only to P-P or P-MP deployments in the 4.9 GHz band since those deployments are similar to deployments licensed under Part 101 of the Commission's rules, or could it apply to additional deployments? What are the costs associated with Part 101 type coordination, including the time and effort to identify all incumbent licensees who must be notified, and how do those costs compare to Part 90-type frequency coordination? Do the benefits of frequency coordination outweigh any associated costs? Furthermore, below we seek comment on a Spectrum Access System (SAS) managed shared access model to facilitate non-public safety use of the band. Therefore, we seek comment on whether a SAS model could be used either in lieu of, or in parallel with, frequency coordination methods discussed above.

23. Next, we seek comment on how formal frequency coordination would apply to temporary or ad hoc deployments in the 4.9 GHz band. In particular, we seek comment on how to balance the need for public safety agencies to deploy temporary or ad hoc operations while protecting licensees with permanent deployments from interference. We also seek comment on what interference standard(s) should be the basis for any frequency coordination method adopted for the 4.9 GHz band. We seek comment on whether to incorporate the technical standard for frequency coordination into our rules, or rely on either an industry-agreed standard or frequency coordinator consensus. What should be the process for permitting Commission review of any disputes arising from the frequency coordinator's actions, and how should Commission staff resolve such disputes?

24. If we adopt a coordination approach for the 4.9 GHz band that requires use of certified frequency coordinators, what criteria should the Commission use to certify coordinators? Should eligibility be limited to coordinators already approved to coordinate Public Safety Pool frequencies, or should it be open to other parties? Should prospective coordinators be required to demonstrate a specific level of technical expertise with respect to 4.9 GHz operations in order to be certified?

25. We seek comment on the concept of designating a single entity to serve as a nationwide band manager or licensee for the 4.9 GHz band. Assigning spectrum management responsibility to a single nationwide entity might simplify the task of developing a national framework for the band, and has been supported by some commenters. However, this approach would also represent a marked departure from the approach that we have applied to the band up to this point, and it raises a variety of significant policy, legal, and operational questions.

26. We seek comment on the concept of designating a single nationwide band manager that would be responsible for developing a nationwide framework for the band. For example, the Commission has adopted band manager rules for the 700 MHz Guard Bands, and the Wireless Telecommunications Bureau has permitted certain entities to engage in band manager activities via waiver request for the 220 MHz band. What entities would be appropriate for such a role in the 4.9 GHz band? How would the Commission differentiate between competing proposals to become the single nationwide band manager? If we were to pursue a nationwide band manager approach, we seek comment on appropriate rules or guidelines to define how the band manager would be authorized to select and manage users of the band. Would a band manager's duties be limited to merely developing a nationwide framework, or would a band manager take a more active role in evaluating applications? Would a band manager decide who can use the spectrum? Should we impose reporting requirements on a 4.9 GHz band manager, and, if so, what should those reports address and how often should they be filed with the Commission? What would be an appropriate level of compensation for the band manager? If the Commission moves forward with dynamic spectrum sharing, could one or more dynamic spectrum sharing system administrators assume the role of band manager, and would such designation be appropriate?

27. We also seek comment on establishing a national license for the 4.9 GHz band. If we were to adopt this approach, what rights and responsibilities over the band should be associated with the national license, and what rights should be reserved for state, local, tribal, or regional public safety licensees? As proposed above, we envision that incumbent licensees in the band would retain spectrum rights and would be entitled to protection of their facilities. Would all other spectrum rights be invested in the national licensee? If yes, what obligation should the national licensee have to ensure access to the band by sub-national public safety entities? If we were to allow public safety and non-public safety sharing of the band as discussed further below, would the national licensee be responsible for management or oversight of the sharing process? Finally, if we were to establish a national license, what process should we establish for accepting applications and selecting a licensee? What qualifications or attributes should be required to be eligible to apply for the license? If more than one entity applied to be the national licensee, how would the Commission adjudicate between competing applications?

28. Our current 4.9 GHz licensing regime is loosely based on a voluntary regional planning framework. Section 90.1211(a) of the Commission's rules provides that each Regional Planning Committee (RPC) may submit a plan with guidelines to be used for sharing 4.9 GHz spectrum within the RPC region. The rules list elements to be included in regional plans and provide instructions for plan modifications. Although the Commission originally set a deadline for all RPCs to submit 4.9 GHz regional plans, it subsequently stayed the deadline and made plan submission voluntary. To date, only 10 out of 55 RPC regions have submitted 4.9 GHz regional plans.

29. In the Sixth Further Notice, the Commission stated its belief that RPCs should play an integral role in shaping use of the 4.9 GHz band through regional planning. The Commission proposed to allow RPCs to submit 4.9 GHz band regional plans, which could include region-specific technical guidelines. APCO noted that the Sixth Report and Order (85 FR 76469) abandoned these proposals, and in the latest round of comments, NPSTC and the American Association of State Highway and Transportation Officials (AASHTO) suggest that active RPCs could serve a valuable role in helping to manage the 4.9 GHz band in their regions.

30. As we endeavor to establish a nationwide spectrum management framework for the 4.9 GHz band, we seek comment on whether RPCs should play a continued or expanded role. Should we continue to make the filing of regional plans optional, or should we require RPCs to file regional plans? In light of the fact that only 10 of 55 RPCs have filed voluntary plans, what resources would RPCs need to ensure that plans were filed for all regions? If we were to adopt frequency coordination requirements for the band as discussed above, would RPCs have the technical expertise and resources to serve as coordinators? To what degree is regional planning consistent with our goal of establishing a national framework for management of the band that would encourage development of standardized equipment and promote interoperability? Should we develop a standardized template to ensure that all regional plans are consistent and support a nationwide approach? Should we allow RPCs to file alternative regional plans that vary from a standardized approach? In the proposal that it filed in 2013, NPSTC stated that “a single national plan for 4.9 GHz will meet most regions' needs,” but “some regions will need some different parameters to better meet needs of users in their regions.” Is this a viable approach in today's environment?

31. We seek comment on ways to incentivize public safety use of the latest commercially available technologies, particularly 5G. As a general matter not limited to any particular spectrum band, what is the path for public safety to use 5G? Would public safety agencies be able to deploy custom 5G networks themselves, with the aid of consultants and contractors as necessary? What commercial 5G offerings are available to public safety, and what are the priority and preemption capabilities of such solutions? We also seek comment on the value, utility, and potential of the commercially available technologies, such as 5G, to public safety. For instance, the Public Safety Spectrum Alliance (PSSA) asserts that 5G functionality is expected to be the future of public safety cellular communications because it will support new high-speed applications that leverage rich media, such as augmented and virtual reality, and video streaming, while also offering extremely low latency, allowing true real-time data streaming and transfer necessary for use of autonomous vehicles, bomb and hazardous material detection and remediation, and mobile video surveillance capabilities. Nokia states that “[n]ew technologies enabled by 5G can also allow for network slicing that can provide greater certainty for enhanced security and other quality of service metrics that may be required for public safety incumbent use cases as well as certain potential . . . [commercial] use cases.” We seek comment on PSSA's and Nokia's views. What capabilities and applications could 5G and other advanced technologies enable for public safety? We seek comment on any public safety use cases supported by 5G and other advanced technologies.

32. In the Sixth Report and Order, the Commission noted that some countries have considered, or are considering, allocating the 4.9 GHz band for 5G, and noted that successful international harmonization efforts could provide further advantages in the availability and price of equipment, thus potentially increasing its utility for flexible use. The Seventh Further Notice of Proposed Rulemaking ( Seventh Further Notice ) (85 FR 76505) specifically sought comment on whether 5G wireless operators, among others, could put the 4.9 GHz spectrum to use. Some commenters support further exploration of potential 5G deployments in the 4.9 GHz band. PSSA states that “as spectrum falling within the mid-band, 4.9 GHz is significantly better suited [than the 700 MHz band public safety broadband spectrum] to offer 5G capabilities.” We seek comment on the potential for the 4.9 GHz band to support applications enabled by 5G technology, including but not limited to the examples suggested by PSSA and Nokia. Is development of 5G in the band technically feasible, and what are the potential benefits and costs of such development? Could the technical capabilities of 5G technology promote more intense use of the 4.9 GHz band by public safety entities? In the context of our objectives to establish a national framework that ensures public safety priority, how can we create conditions in the 4.9 GHz band that will encourage deployment of 5G and subsequent innovative technologies? As in other spectrum bands, our strong preference is to adhere to a technology-neutral policy for the band and strive for operational flexibility. Do any of the existing 4.9 GHz rules in part 90 ( i.e., subpart Y) impede or discourage 5G deployments?

33. We also seek comment on commercial interest in the 4.9 GHz band for 5G, whether for public safety offerings, for non-public safety, or a sharing combination. Could commercial 5G providers and operators put 4.9 GHz spectrum to use? Could 5G technology also enhance opportunities for shared public safety and non-public safety use of the band? If so, how?

34. Although we seek comment above on certain prominent proposals from the Sixth Further Notice, the Commission proposed several other technical rule changes to increase utilization of the 4.9 GHz band. We incorporate these proposals by reference. In particular, the Commission proposed to (1) expand the channel aggregation bandwidth limit from 20 to 40 megahertz; (2) accord primary status for all P-P and P-MP links on Channels 14-18 of the band plan; (3) limit temporary P-P operation to thirty days maximum over a given path over a one-year period; (4) raise the minimum antenna gain for P-P antennas to 26 dBi; (5) require all 4.9 GHz geographic licensees to place at least one base or temporary fixed station in operation within 12 months of license grant; (6) reduce the construction period for fixed P-P stations from 18 months to 12 months; and (7) allow manned aeronautical mobile, not including unmanned aeronautical systems (UAS), and robotic use in the lowest five megahertz of the band with altitude and other technical limitations. The Commission also sought comment on how to encourage voluntary implementation of technical standards for the band and on power limits and emission masks. We seek comment on these proposals and open issues, and seek comment on whether we should include any of them going forward as part of our proposed national framework.

35. While we emphasize the importance of public safety operations in the 4.9 GHz band, we also recognize that introducing non-public safety operations in the band may help to foster innovation and drive down equipment costs, thereby making more intensive public safety use of the spectrum a possibility. To that end, we seek comment on expanding use of the band to non-public safety entities, subject to appropriate safeguards to protect public safety operations. We also seek comment on ensuring a cohesive and predictable shared spectrum landscape that would also allow for planning and investing in the band by public safety and non-public safety users alike.

36. In this Eighth Further Notice, we seek comment on whether and how to allow non-public safety entities access to the 4.9 GHz band for non-public safety operations, with particular emphasis on expanding use of the band under a nationwide framework. We seek comment on whether it is in the public interest to open the band to non-public safety uses, and under what terms. We seek comment on whether such a policy has the potential to not only promote efficient use of valuable mid-band spectrum, something which we have recognized repeatedly is in the public interest, but also to reduce equipment costs and spur innovation, which will benefit public safety users as well. We also seek comment on any costs public safety may incur if the band is shared with other users, such as in the need to replace equipment or modify usage. Would use of the band by non-public safety entities make it less reliable for public safety agencies that use the band for critical safety of life communications? If so, how can we address these concerns?

37. If we decide to allow non-public safety use of the 4.9 GHz band, we seek comment on how best to do so. Given that all public safety licenses issued for the 4.9 GHz band to date allow full access to its entire 50 megahertz and the public safety operations that it hosts are of critical importance, we recognize that any sharing regime will be complex. During earlier stages of this proceeding, several stakeholders put forth proposals to permit non-public safety use of the band, some of which have received qualified support from public safety stakeholders.

38. As part of these different potential non-public safety use frameworks, we seek comment on the types of non-public safety operations which should be permitted, and the types of entities that should be eligible for access. Should we allow all types of commercial use, but limit the types of users? For example, the Commission has previously recognized that railroad, power, and petroleum entities use radio communications “as a critical tool for responding to emergencies that could impact hundreds or even thousands of people.” Therefore, we seek comment on whether critical infrastructure (CII) eligible entities should be permitted access to the band in a way distinct from other classes of non-public safety users. We also seek comment on whether shared CII access to the band will sufficiently increase use of the band nationwide to encourage innovation and impact equipment costs.

39. We seek comment on these possible alternatives, in particular on the interplay of different elements of the possible approaches to improve access to the band and facilitate non-public safety use. In other words, these components should not be viewed as mutually exclusive and, indeed, any comprehensive framework that we may adopt will likely include elements of multiple access models and licensing approaches discussed below. Commenters that support opening the band for non-public safety applications are encouraged to submit detailed proposals—including cost-benefit analyses—on these issues, incorporating elements of different options discussed below and explaining why they are preferable to alternatives.

40. We seek comment below on possible sharing mechanisms, non-public safety licensing approaches, and leasing regimes that could be used to provide shared access to the band for non-public safety users while protecting—and, potentially, improving—critical public safety operations. These options are not exclusive of one another ( e.g., excess capacity leasing could be combined with a dynamic sharing mechanism) and commenters are encouraged to submit detailed proposals addressing how a comprehensive sharing regime could be implemented.

41. One potential means of sharing the band between public safety and non-public safety users involves leasing of excess capacity on public safety networks to non-public safety users. For example, a public safety licensee which has constructed a network of fixed sites for its operations, but only uses that network in emergencies, could lease the use of that network when no such emergency is occurring. Alternatively, a public safety licensee could work with a commercial wireless operator to construct a dual-use system pursuant to its license. Are such excess capacity leasing arrangements feasible for this band and, if so, could they provide potential benefits to public safety licensees? Could such leasing arrangements facilitate more robust deployment of 4.9 GHz public safety networks? What types of non-public safety entities would be interested in leasing excess capacity from public safety licensees? Commenters that support excess capacity leasing should address the specific costs and benefits of such a regime, giving particular consideration to the non-exclusive nature of the public safety licenses in this band, the current and potential future coordination mechanisms discussed herein, and the wide range of different uses this band hosts.

42. If we choose to implement an excess capacity leasing regime, we seek comment on how that regime should be implemented and how the rights of public safety and non-public safety entities should be managed. Given the importance of public safety operations in the band, should we ensure priority and preemption for such operations vis-à-vis non-public safety lessees? If so, how can we best do so? What specific rule-based mechanisms should we implement to ensure a consistent and publicly accountable leasing system? How should we address the overlapping rights of different public safety licensees in the band to ensure a stable and predictable spectrum environment for public safety operations? If we designate a single nationwide band manager, as discussed above, could that entity have a role in facilitating leased access to excess capacity on public safety networks? Alternatively, could these issues be addressed by utilizing a SAS, as discussed below? Specifically, could a SAS be used to manage leases and coordinate access for lessors and lessees? How would such a system work within the Commission's existing leasing rules?

43. In the Seventh Further Notice, the Commission sought comment on whether a dynamic spectrum access system could be used to facilitate non-public safety use of the band alongside public safety access. The Commission noted that such opportunistic use of spectrum is permitted in several other spectrum bands using a variety of different automatic sharing systems that rely on databases to ensure protection of other users. We expand on the Commission's earlier inquiry and seek comment on whether a dynamic frequency coordinator—such as the SAS used to coordinate access to the Citizens Broadband Radio Service in the 3.55-3.7 GHz band (3.5 GHz band)—could be used to facilitate sharing between public safety and non-public safety users.

44. In the 3.5 GHz band, SASs currently are used to protect several types of incumbent operations—including critical Department of Defense radar systems, fixed satellite service earth stations, and incumbent terrestrial wireless licensees—as well as two tiers of users in the Citizens Broadband Radio Service. A similar system could be used to protect public safety operations in the 4.9 GHz band. Would a SAS be the most appropriate system to coordinate dynamic spectrum sharing in this band? Or would another model, like the Automatic Frequency Coordination system in the 6 GHz band, be more appropriate? For either system, what, if any, modifications would be necessary to address the unique needs of public safety users in the 4.9 GHz band? What would be the costs associated with such a system, both its setup and its implementation going forward, and how would those costs compare to the cost of traditional Part 90 frequency coordination? Who would be responsible for those costs? Should the Commission maintain the system, or should it contract the responsibility to a third-party?

45. If we implement a SAS-based authorization model in the band, we seek comment on how best to use the unique capabilities of the SASs to protect public safety users, authorize non-public safety operations, and mitigate potential interference between and among various tiers of users in the band. Most importantly, could a SAS protect public safety operations—including possible operations over potential nationwide interoperability spectrum—while providing meaningful access to the band for non-public safety users? We also seek comment on how implementing dynamic spectrum sharing in this band would impact public safety confidence in the band, particularly given the efforts discussed above to increase the visibility of public safety deployments in the band in order to enable protection and clear access rights.

46. We also seek comment on how public safety licensees could best be incorporated into a SAS-driven dynamic spectrum sharing regime while protecting the rights of public safety users and ensuring an interference-free operating environment. Specifically, should public safety licensees be required to inform the SAS of their operations, with the system protecting these operations by only permitting non-public safety use of other frequencies in the band? Or should the SAS also be responsible for assigning frequencies to public safety operations based on their needs? If the latter, to what extent and by what method should the SAS ensure priority and preemption for public safety operations? Should the SAS treat future public safety deployments differently than pre-existing deployments? Is a SAS managed model consistent with our earlier tentative conclusion that frequency coordination is in the public interest for this band? What, if any, requirements should we put in place to protect non-public safety operations from one another?

47. We note that the feasibility of dynamic sharing could depend on factors such as how intensely incumbents are currently using the spectrum, the types of existing services these incumbents are using ( e.g., mobile vs. fixed), and the ability of dynamic sharing systems to register, detect, and coordinate existing systems. We seek comment on these and other characteristics in the 4.9 GHz band that would affect dynamic sharing, whether a dynamic spectrum sharing model is appropriate for this band, and, if so, what type of dynamic sharing is most appropriate. Commenters should also discuss the impacts of the different possible changes to the band that the Commission is considering as part of its efforts to standardize public safety operations and ensure greater visibility into deployments in order to provide greater protections for those operations, such as coordination requirements and a licensing database. How could a dynamic spectrum access system take advantage of those efforts?

48. Finally, we seek comment on whether to segment the 4.9 GHz band to enable non-public safety uses while also protecting public safety operations. Would combining such a segmentation of the band with a dynamic spectrum sharing system enable reliable spectrum access both for public safety operators and for non-public safety users, while also ensuring efficient use of spectrum that public safety is not actively using? For example, could we reserve some portion of the band for public safety use on a primary basis, and only permit non-public safety use of this portion via a dynamic spectrum sharing system, while making the remainder of the band available for non-public safety access? Could we grant public safety licensees some form of preemption rights, which would allow public safety access to the entire 4.9 GHz band in the case of an emergency, but limit public safety access to only a portion of the band at other times? If we do segment the band, should we require devices to be operable across the entire 4.9 GHz band, as we did in the 3.5 GHz band? Would segmenting the band—coupled with a band wide operability requirement—help to spur innovations in the equipment marketplace in the band to the benefit of public safety users?

49. Given the non-exclusive nature of 4.9 GHz band licenses, we seek comment on whether alternative methods of sharing are preferable to dynamic sharing. Would implementing licensing and technical rules be sufficient to enable non-public safety use without causing harmful interference to those public safety operations that would remain in the band? For example, we could require sensing capabilities for non-public safety equipment, or limit emissions to levels below that which could cause harmful interference to public safety operations. What would be the necessary requirements to allow for purely technical protection measures? Would such limitations prevent the other benefits of opening this band to non-public safety use, such as fostering innovation and lowering equipment costs, from being realized? Such rules could be different for urban or rural areas, in recognition of the different uses of the band in those locations, as discussed above.

50. We seek comment on whether a frequency coordination requirement imposed on public safety operations, as discussed above, would enable similar requirements to be placed on non-public safety operations and thereby enable shared access. What requirements would we need to impose on non-public safety operations to enable full protection for public safety users, and what information would coordinators need from non-public safety operations to ensure such protection? Would we require non-public safety operators to modify their systems based on new public safety deployments, or only to protect incumbents at the time they deploy? What, if any, requirements should we put in place to protect non-public safety operations from one another?

51. In the event we determine that allowing non-public safety operations in the 4.9 GHz band is in the public interest, we will have to decide on the appropriate framework under which to authorize such operations. Below, we seek comment on a number of different licensing regimes which could be combined with one another and with the sharing regimes discussed above to create a comprehensive, nationwide framework for non-public safety operations in the band.

52. We seek comment on allowing non-public safety users to access the band on a licensed, non-exclusive basis. Methods that have been used in other bands include: (1) Traditional site-based Part 90 secondary licensing, such as in the PLMR bands; (2) the “license light” licensing model used in the 3650-3700 MHz Service prior to its incorporation into the Citizens Broadband Radio Service; and (3) the licensed-by-rule General Authorized Access (GAA) tier of the Citizens Broadband Radio Service. Such approaches have been successfully used to make spectrum available to a wide variety of operators with relatively low barriers to entry vis-à-vis exclusive licensing models. Would a non-exclusive licensing approach be well-suited to the 4.9 GHz band? Could such an approach facilitate significant non-public safety use in the band while protecting important public safety operations? How should the system treat future public safety deployments, as opposed to incumbents? Could a non-exclusive licensing approach help to promote technological innovation in the band, including the equipment marketplace, to the benefit of public safety and non-public safety users? Commenters that support implementing a non-exclusive licensing model for non-public safety users in the band are encouraged to provide detailed proposals, including details on any sharing or authorization mechanism needed to facilitate such an approach.

53. While exclusive use licenses are often the preferred method of allocating spectrum to commercial use, given the non-exclusive nature of existing public safety licenses, the ongoing importance of public safety operations in the band, and the fact that nearly all of the U.S. is covered by at least one public safety license, assigning such licenses in the 4.9 GHz band may prove to be a challenge. But exclusive use licenses offer several important benefits, and, as such we seek comment on a variety of ways that exclusive use licenses could be utilized to facilitate non-public safety use in this band.

54. Would exclusive use licenses potentially increase current and future licensees' willingness to invest heavily in the band? Exclusive use licenses may be subject to mutually exclusive applications, which would be resolved by competitive bidding. Would this increase the likelihood that new licensees will be those entities that are most highly motivated to invest in the band? The Commission's competitive bidding systems generally facilitate the aggregation of licenses when it is economically efficient to do so. Would this make it more likely that licensees aggregating licenses in competitive bidding will invest in developing and deploying networks in this band? Given these potential benefits, we seek comment on whether this band is well-suited to exclusive use licensing and, if so, how to achieve it.

55. Overlay Licensing. Overlay licenses would grant new non-public safety entrants the right to use the band in ways that would not cause harmful interference to public safety users at any given time, but would be exclusive as to other non-public safety users. Such a licensing framework could be combined with different access models—including spectrum manager models, competitive bidding, and dynamic database-driven sharing models—and could be coupled with relocation or re-banding of some existing operations to increase the amount of spectrum available to the overlay licensee. This approach could provide the flexibility to allow new non-public safety operations in the band while safeguarding public safety users.

56. We seek comment on whether we should utilize overlay licenses to facilitate non-public safety use of the 4.9 GHz band. We also seek comment on how to assign such licenses and how to structure the rules governing them. How would an overlay license work in concert with potential new technical, interoperability, and coordination rules for public safety licensees that we seek comment on here? What technical or coordination rules would be required for non-public safety operations, as distinct from those required of public safety licensees? How would overlay licenses work with potential future public safety operations, as opposed to incumbents?

57. We also seek comment on the impact of this approach on use of the band. Would other users of the band spur innovation and expand the type, and lower the price, of 4.9 GHz equipment available to public safety entities? What types of entities should be eligible for overlay licenses? Would overlay licenses provide new licensees with sufficient spectrum access to justify investment in equipment and broadband and mobile applications? If more spectrum access than is currently available is needed to motivate investment, can overlay licensees reasonably expect to obtain sufficient spectrum access by negotiation with incumbents? What conditions would be necessary for such negotiations to be successful? Is it possible that such access negotiations would both provide new overlay licensees with sufficient and reliable bandwidth while maintaining current incumbent operations? We seek comment on any other considerations regarding the use of overlay licensing for the 4.9 GHz band.

58. Exclusive Use Licenses for Specified Frequencies. We seek comment on whether licenses providing exclusive use of specified frequencies, e.g., designated channels, would be more beneficial for the 4.9 GHz band than overlay licenses. Depending on the use of the band by underlying incumbent licensees, overlay licenses may not enable the use of uniform frequencies across geographic areas by new licensees. However, enabling the exclusive use of uniform frequencies likely would require any incumbent public safety operations using the frequencies to cease. We seek comment on possible mechanisms for relocation or repacking of such operations. We seek comment below on the use of an incentive auction model to enable this effort. But we similarly seek comment on any alternatives to relocate or repack public safety incumbents as needed.

59. What are the benefits and costs to this approach and how could it be implemented? How would licensing specified frequencies for exclusive use work in concert with other proposals to increase use of the band, such as the new technical and coordination rules for public safety operations or dynamic spectrum sharing, and which would it rule out?

60. Unlicensed access allows a wide range of different users the ability to access spectrum, especially in rural or underserved areas and often at lower price points than through licensed services. This framework permits users to support innovative use cases and applications that can be tailored for each area, especially through Wi-Fi, Bluetooth, and other widely used technologies. Because the Commission permits unlicensed operations on a variety of spectrum bands, users are able to both match available capacity to their spectrum needs and choose the band(s) that are best suited to their particular coverage requirements. The Commission previously sought comment on unlicensed operations in this band. We recognize that both the demand for unlicensed spectrum and the unlicensed spectrum landscape have continued to evolve. We seek updated information on the potential use of the 4.9 GHz band for unlicensed access. To what extent is the band desirable for such use, given the presence of public safety incumbents and amount of spectrum available? What use cases could the 4.9 GHz band host? Is this band suitable to provide the types of applications users are demanding in terms of capacity and coverage requirements? Are there particular unlicensed applications and protocols that are well-suited for the 4.9 GHz band? We seek comment below on possible sharing mechanisms, which could operate in concert with unlicensed use, but what technical or licensing rules would be required in order to enable such use, regardless of sharing mechanism?

61. Technical Flexibility. In the context of establishing a nationwide approach, we also seek comment on the feasibility of implementing different technical rules ( e.g., maximum power levels) for the band to account for different public safety and non-public safety needs in different scenarios. We note that the record in this proceeding indicates that there may be varying use cases and opportunities for use in a nationwide framework. For example, public safety usage of the band is greater in urban areas than rural ones. At the same time, there may be differences in non-public safety use of this band in rural areas, particularly to accommodate wireless broadband. Would it be in the public interest to adopt flexibility in the technical rules for the 4.9 GHz band to accommodate these different needs, consistent with our decision to pursue an integrated, nationwide approach to the band? For example, in other proceedings we have adopted different power levels for urban and rural deployments. Should we take a similar approach here as part of a nationwide framework? Would this approach help foster efficient use, encourage innovation, and improve the equipment marketplace for the band? How would we define the different areas within our nationwide framework, and how would we ensure these definitions remain up-to-date as use of the band evolves?

62. Incentive Auction. In addition to its standard authority to conduct competitive bidding to assign licenses, the Commission has statutory authority to conduct incentive auctions, in which it offers incumbent licensees a share of the proceeds from the auction of new licenses made available by the incumbents relinquishing their spectrum usage rights. Should the Commission consider an incentive auction to encourage public safety licensees to relocate their operations (or modify them in some way to reduce the amount of spectrum they require) in order to enable greater non-public safety use of the band? How would we structure an incentive auction within the Commission's existing statutory authority that would result in enough clear spectrum to attract new licensees and serve the public interest? What alternate options are available to public safety licensees which accept incentive auction payments? Would the current 4.9 GHz licensees, many of which are governmental entities, be legally or practically equipped to participate in the reverse phase of an incentive auction? Would their incentives align with the public interest? How would we have to modify our incentive auction structure here, given the non-exclusive rights of the current licensees? Should any incumbent public safety licensees choosing not to participate in the incentive auction be required to be repacked into a portion of the band or otherwise modify their operations to enable coexistence with new non-public safety licensees? What is the likelihood that enough existing licensees would be willing to relinquish their spectrum usage rights so that the Commission then could offer enough new licenses to stimulate investment in the band?

63. Digital Equity and Inclusion. Finally, the Commission, as part of its continuing effort to advance digital equity for all, including people of color, persons with disabilities, persons who live in rural or Tribal areas, and others who are or have been historically underserved, marginalized, or adversely affected by persistent poverty or inequality, invites comment on any equity-related considerations and benefits (if any) that may be associated with the proposals and issues discussed herein. Specifically, we seek comment on how our proposals may promote or inhibit advances in diversity, equity, inclusion, and accessibility, as well the scope of the Commission's relevant legal authority.

64. This Eighth Further Notice of Proposed Rulemaking may contain new or modified information collection(s) subject to the Paperwork Reduction Act of 1995. If the Commission adopts any new or modified information collection requirements, they will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other federal agencies will be invited to comment on the new or modified information collection requirements contained in this proceeding. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, we seek specific comment on how we might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

65. The Regulatory Flexibility Act of 1980, as amended (RFA), requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) concerning potential rule and policy changes contained in the Eighth Further Notice of Proposed Rulemaking. The IRFA is contained in Appendix C in the Eighth Further Notice of Proposed Rulemaking.

66. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must: (1) List all persons attending or otherwise participating in the meeting at which the ex parte presentation was made; and (2) summarize all data presented and arguments made during the presentation.

67. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda, or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the Commission's rules. In proceedings governed by § 1.49(f) of the rules or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

68. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the Eighth Further Notice of Proposed Rulemaking (Eighth Further Notice). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments as specified in the Eighth Further Notice. The Commission will send a copy of the Eighth Further Notice, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the Eighth Further Notice and IRFA (or summaries thereof) will be published in the Federal Register .

69. In the Eighth Further Notice, we seek comment on a nationwide framework to encourage greater use and improved spectrum efficiency of the 4940-4990 MHz (4.9 GHz) band. We seek comment to implement changes to our policies and regulations that promote optimal use, innovation, and investment. The Fifth Further Notice of Proposed Rulemaking (77 FR 45558) and Sixth Further Notice of Proposed Rulemaking in this proceeding enabled the Commission to develop a record on several issues, including 4.9 GHz coordination, eligibility, licensing, band plan, power and antenna gain, aeronautical mobile use, and standards. The Sixth Report and Order and Seventh Further Notice of Proposed Rulemaking, however, sought to establish a new framework to expand access to the band by providing states the opportunity to lease 4.9 GHz band spectrum to commercial entities, critical infrastructure industry, including electric utilities, and other stakeholders. In addition, the Seventh Further Notice sought comment on new state-based licensing regime for public safety operations in the 4.9 GHz band, including a centralized structure of state oversight and coordination of public safety operations in the band.

70. In the Eighth Further Notice, we revisit the structure of the 4.9 GHz band to promote public safety use and encourage a robust market for equipment. Specifically, we focus on establishing a nationwide framework that will avoid breaking up the 4.9 GHz band into a patchwork of state leases. We believe that a nationwide approach will promote robust equipment market, lower costs, and increase the likelihood of interoperable communications and consistent interference protection. To achieve this vision, we seek comment on establishing a database with consistent and reliable information about what spectrum is available where or how it is being used—providing certainty and predictability to plan and invest in 4.9 GHz deployments. Further, we seek comment on certain prominent proposals from the Sixth Further Notice, such Universal Licensing System (ULS) information submissions, non-public safety access, dynamic spectrum sharing, and frequency coordination in the 4.9 GHz band, as well as on several other Commission proposals involving technical rule changes to increase utilization of the 4.9 GHz band and we incorporate these proposals by reference into the Eighth Further Notice. We believe that by implementing a nationwide framework that reflects public safety input, we can ensure that public safety continues to be prioritized in the band while opening up the band to additional uses that will facilitate increased usage and encourage a more robust market for equipment and greater innovation, and at the same time protect against harmful interference.

71. The proposed action is authorized pursuant to Sections 1, 4(i), 4(j), 4(o), 301, 303(b), 303(g), 303(r), 316, 332, and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 154(o), 301, 303(b), 303(g), 303(r), 316, 332, and 403.

72. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

73. Small Businesses, Small Organizations, Small Governmental Jurisdictions. Our actions, over time, may affect small entities that are not easily categorized at present. We therefore describe here, at the outset, three broad groups of small entities that could be directly affected herein. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, according to data from the SBA's Office of Advocacy, in general a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States which translates to 30.7 million businesses.

74. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2018, there were approximately 571,709 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.

75. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate that there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 general purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, we estimate that at least 48,971 entities fall into the category of “small governmental jurisdictions.”

76. Private Land Mobile Radio Licensees. Private land mobile radio (PLMR) systems serve an essential role in a vast range of industrial, business, land transportation, and public safety activities. Companies of all sizes operating in all U.S. business categories use these radios. Because of the vast array of PLMR users, the Commission has not developed a small business size standard specifically applicable to PLMR users. The closest applicable SBA category is Wireless Telecommunications Carriers (except Satellite) which encompasses business entities engag ed in radiotelephone communications. The appropriate size standard for this category under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, U.S. Census Bureau data for 2012 shows that there were 967 firms that operated for the entire year. Of this total, 955 firms had employment of 999 or fewer employees and 12 had employment of 1,000 employees or more. Thus under this category and the associated size standard, the Commission estimates that the majority of PLMR licensees are small entities.

77. According to the Commission's records, a total of approximately 393,490 licenses comprise PLMR users. Of this number there are a total of 3,541 PLMR licenses in the 4.9 GHz band. The Commission does not require PLMR licensees to disclose information about number of employees, and does not have information that could be used to determine how many PLMR licensees constitute small entities under this definition. The Commission however believes that a substantial number of PLMR licensees may be small entities despite the lack of specific information.

78. Frequency Coordinators. Neither the Commission nor the SBA has developed a small business size standard specifically applicable to spectrum frequency coordinators. The closest applicable SBA category is Business Associations which comprises establishments primarily engaged in promoting the business interests of their members. The SBA has developed a small business size standard for “Business Associations,” which consists of all such firms with gross annual receipts of $7.5 million or less. For this category, U.S. Census Bureau data for 2012 shows that there were 14,996 firms that operated for the entire year. Of these firms, a total of 14,229 had gross annual receipts of less than $5 million and 396 firms had gross annual receipts of $5 million to $9,999,999.

79. There are 13 entities certified to perform frequency coordination functions under Part 90 of the Commission's rules. According to U. S. Census Bureau data approximately 95% of business associations have gross annual receipts of $7.5 million or less and would be classified as small entities. The Business Associations category is very broad however, and does not include specific figures for firms that are engaged in frequency coordination. Thus, the Commission is unable to ascertain exactly how many of the frequency coordinators are classified as small entities under the SBA size standard. Therefore, for purposes of this IRFA under the associated SBA size standard, the Commission estimates that a majority of the 13 FCC-certified frequency coordinators are small.

80. Regional Planning Committees. Neither the Commission nor the SBA has developed a small business size standard specifically applicable to Regional Planning Committees (RPCs) and the National Regional Planning Council (NRPC). As described by the NRPC, “[NRPC] is an advocacy body formed in 2007 that supports public safety communications spectrum management by [the RPCs] in the 700 MHz and 800 MHz NPSPAC public safety spectrum as required by the Federal Communications Commission.” The NRPC states that RPCs “consist of public safety volunteer spectrum planners and members that dedicate their time, in addition to the time spent in their regular positions, to coordinate spectrum efficiently and effectively for the purpose of making it available to public safety agency applicants in their respective region.” According to Commission data, there are 55 RPCs. The Commission has not developed a small business size standard specifically applicable to RPCs and the NRPC. The closest applicable industry with a SBA small business size standard is Wireless Telecommunications Carriers (except Satellite) which encompasses business entities engaged in radiotelephone communications. Under the SBA small business size standard, a business employing no more than 1,500 persons is considered small. For this industry, U.S. Census Bureau data for 2012 shows that there were 967 firms that operated for the entire year. Of this total, 955 firms had employment of 999 or fewer employees and 12 had employment of 1,000 employees or more. Thus using the SBA size standard, we estimate that all of the RPCs and the NRPC can be considered small.

81. Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing. This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment. The SBA has established a small business size standard for this industry of 1,250 employees or less. U.S. Census Bureau data for 2012 show that 841 establishments operated in this industry in that year. Of that number, 828 establishments operated with fewer than 1,000 employees, 7 establishments operated with between 1,000 and 2,499 employees and 6 establishments operated with 2,500 or more employees. Based on this data, we conclude that a majority of manufacturers in this industry are small.

82. Wireless Telecommunications Carriers (except Satellite). This industry comprises establishments engaged in operating and maintaining switching and transmission facilities to provide communications via the airwaves. Establishments in this industry have spectrum licenses and provide services using that spectrum, such as cellular services, paging services, wireless internet access, and wireless video services. The appropriate size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, U.S. Census Bureau data for 2012 show that there were 967 firms that operated for the entire year. Of this total, 955 firms employed fewer than 1,000 employees and 12 firms employed of 1,000 employees or more. Thus under this category and the associated size standard, the Commission estimates that the majority of Wireless Telecommunications Carriers (except Satellite) are small entities.

83. The nationwide framework described in the Eighth Further Notice may impose new or additional reporting or recordkeeping and/or other compliance obligations on small entities, if adopted. The reporting or recordkeeping and/or other compliance obligations generally fall into two categories: Technical requirements and eligibility/governance criteria. Potential information collections and compliance requirements that are technical in nature may include costs associated with compensating engineering or technical staff or consultants or attorneys which the Commission is unable to quantify at this time. The purpose of the information collections is to ensure that future operations protect incumbent operations from interference, and to make it feasible to identify the source of any actual interference that may occur, as well as maximize use of the 4.9 GHz band. We discuss these potential requirements below.

84. Licensing Database and Frequency Coordination. The Eighth Further Notice seeks comment on requiring base and mobile stations, permanent fixed P-P transmitters and receivers, and permanent fixed P-MP transmitters and receivers in the 4940-4990 MHz band to be licensed individually on a site-by-site basis for interference protection and frequency coordination purposes which would impose a one-time information collection requirement on existing 4.9 GHz band licensees. The information collected would include technical parameters such as transmitter and receiver antenna coordinates, azimuth (direction), polarization, beamwidth, physical dimensions, gain, and height above ground, as well as transmit details such as power, channel, emission, and would be collected on Form 601 in the Commission's Universal Licensing System database. We expect that there will not be any application fees associated with this information collection for public safety entities because they are exempt from application fees pursuant to 47 CFR 1.1116(b). To the extent non-public safety access is permitted in the band however, non-public safety entities would incur application fee costs.

85. The Eighth Further Notice also seeks comment on requiring formal frequency coordination in the 4.9 GHz band to support interference protection and increase public safety confidence to use the band. If formal frequency coordination is adopted, we have requested comment on the criteria and type of certification the Commission should use to certify coordinators which may impose reporting and recordkeeping obligations. The selected frequency coordinators could be subject reporting recordkeeping obligations associated with coordination for the 4.9 GHz band. Additionally, licensees could be subject to requirements to submit information to frequency coordinators and subject to compliance costs associated frequency coordination.

86. Facilitating Non-Public Safety Access to the Band. The Eighth Further Notice seeks comment various methods of enabling non-public safety access to the 4.9 GHz band alongside public safety access, including tiered licensing, a dynamic spectrum access system, and overlay licenses. For any of these methods, either the Commission or a third party would collect information from non-public safety users that wish to access the 4.9 GHz band. Such users may be classified as small businesses, small organizations, small governmental jurisdictions; PLMR licensees; and wireless telecommunications carriers (except satellite). The information collected would likely be equivalent to information collected on Form 601 of the Commission's Universal Licensing System database. For the dynamic spectrum access system method, a third party database would collect certain licensing and operational information from incumbent public safety 4.9 GHz band PLMR licensees. The amount of information collected, the means, and the frequency of such collection depends on whether the dynamic spectrum access system database would draw existing sources of such information, such as information contained in the Commission's Universal Licensing System. The Eighth Further Notice also seeks comment on the potential use of an incentive auction as part of the discussion on granting exclusive access rights which would have recordkeeping and data submission obligations.

87. Nationwide Licensee or Band Manager. The Eighth Further Notice seeks comment on designating a nationwide band manager that would be responsible for developing a nationwide framework for the 4.9 GHz band. If adopted, a one-time information collection may take the form of a band manager application and a proposed nationwide framework describing how different types of entities may operate within the 4.9 GHz band.

88. Regional Planning Committees. The Eighth Further Notice seeks comment on a requiring regional planning committees (RPCs) to file regional plans, which could impact reporting and recordkeeping obligations for RPCs. Under the Commission's existing rules in the 4.9 GHz licensing regime, the filing of regional plans by RPCs is voluntary. Sections 90.1211(b) and (c) of the Commission's rules detail certain information that must be submitted in regional plans and provide instructions for plan modifications. In the Eighth Further Notice, we inquire whether to develop a standardized template to ensure that the information submitted in all regional plans is consistent and supports a nationwide approach, and whether to allow RPCs to file alternative regional plans that vary from a standardized approach.

89. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others ): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for such small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”

90. The Commission's reliance on technical and eligibility requirements utilized in other public safety and PLMR spectrum bands as the basis of inquiries in Eighth Further Notice potentially provides regulatory policies and frameworks that small entities are operationally familiar with and may therefore minimize any substantial economic impact if similar requirements are adopted in this proceeding. To assist in the Commission's evaluation of the economic impact on small entities as a result of the actions that have been proposed in this proceeding, and the options and alternatives for such entities, the Commission has raised questions and sought comment on these matters in the Eighth Further Notice. As part of the inquiry, the Commission has specifically requested that commenters include costs and benefit analysis data in their comments. Additionally, we are seeking comment on proposals in the Sixth Further Notice, which include inquiries and requests for information on the impacts for small entities and courses of action that might be considered to accommodate the resources small entities. For example, as part of the proposed information collection requirement to make information available to frequency coordinators to ensure that these operations are protected from interference, the Sixth Further Notice proposed a one-year deadline for licensees to complete this information collection after final rules in this proceeding become effective. Before the deadline, the Commission would waive frequency coordination requirements. After one year, the information collection would be subject to frequency coordination requirements, including frequency coordination fees. The Commission also sought comment on whether the status of a license should become secondary if the incumbent licensee does not meet the one-year deadline. The Sixth Further Notice sought comment on whether small entities should have a lengthier deadline, and what showing the Commission should require from licensees to attest that they qualify as small entities. The Sixth Further Notice also asked whether the Commission should require small entities to file attestations by the one-year deadline or accept attestations after the deadline at the time they eventually complete the information collection.

91. The Commission is hopeful that the comments it receives will specifically address matters impacting small entities and include data and analyses relating to these matters. Further, while the Commission believes the rules that are eventually adopted in this proceeding should benefit small entities, whether public safety or non-public safety, by giving them more options for gaining access to valuable spectrum, the Commission expects to more fully consider the economic impact and alternatives for small entities following the review of comments filed in response to the Eighth Further Notice. The Commission's evaluation of this information will shape the final alternatives it considers, the final conclusions it reaches, and any final actions it ultimately takes in this proceeding to minimize any significant economic impact that may occur on small entities.

None.

92. Accordingly, it is ordered, pursuant to the authority found in sections 4(i), 4(j), 302, 303(b), 303(f), 303(g), 303(r), 309(j) and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 302a, 303(b), 303(f), 303(g), 303(r), 309(j), and 405, that this Eighth Further Notice of Proposed Rulemaking is hereby adopted.

93. It is further ordered that, pursuant to applicable procedures set forth in §§ 1.415 and 1.419 of the Commission's Rules, 47 CFR 1.415, 1.419, interested parties may file comments on the Eighth Further Notice of Proposed Rulemaking on or before 30 days after publication in the Federal Register , and reply comments on or before 60 days after publication in the Federal Register .

94. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Eighth Further Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis to the Chief Counsel for Advocacy of the Small Business Administration.

DoD is proposing to amend the DFARS to implement section 1006 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232), as amended by section 1011 of the NDAA for FY 2020 (Pub. L. 116-92). Section 1006 applies to accounting firms that provide financial statement auditing to DoD in support of the audit under 31 U.S.C. 3521 or audit remediation services in support of the Financial Improvement and Audit Remediation Plan described in 10 U.S.C. 240b. DoD, as a matter of policy, is extending this requirement to firms other than accounting firms that provide such services. Such firms, when responding to a solicitation or awarded a contract for the acquisition of covered services, must disclose to DoD before any contract action (including award, renewals, and modifications) the details of any disciplinary proceedings with respect to the accounting firm or its associated persons before any entity with the authority to enforce compliance with rules or laws applying to audit services offered by the accounting firm. Section 1011 amended section 1006 to require any disclosures to be treated as confidential to the extent required by the court or agency in which the proceeding occurred and to be treated in a manner consistent with any protections or privileges established by any other provision of Federal law.

DoD received input from one respondent in response to the early engagement opportunity posted on the Defense Acquisition Regulations System web page for the NDAA for FY 2019. The input was considered in the formulation of the proposed rule. The rule is expected to have a minor impact as it is expected to apply to approximately a dozen firms.

DoD proposes to add a new paragraph (d) to DFARS 237.270, Acquisition of audit services; a new solicitation provision 252.237-70XX, Preaward Transparency Requirements for Firms Offering to Support Department of Defense Audits—Representation and Disclosure; and a new contract clause at 252.237-70YY, Postaward Transparency Requirements for Firms that Support Department of Defense Audits. The provision will not be included in the annual representations and certifications, because it affects very few offerors and requires update every time an offer is submitted.

For audit remediation services, both accounting and non-accounting firms are able to bid on and perform this work. Section 1006 of the NDAA for FY 2019 only requires that accounting firms providing financial statement auditing or audit remediation services to DoD provide the details on any disciplinary proceedings with respect to the accounting firm or its associated persons. DFARS 237.270(d)(1) specifies that, as a matter of policy, DoD proposes to require this information from any offeror responding to a DoD solicitation for such services, in order to have a level playing field for the competition.

DFARS 237.270(d)(2) specifies that this requirement applies to solicitations and contracts for financial statement auditing required under 31 U.S.C. 3521(e) (as explicitly stated in the statute) and clarifies that the covered audit remediation services are those in support of the Financial Improvement and Audit Remediation Plan described in 10 U.S.C. 240b (based on a reading of section 1006 in conjunction with section 1002 of the same NDAA for FY 2019).

DFARS 237.270(d)(3) clarifies that the “associated persons” referred to in section 1006 include principals and employees. Federal Acquisition Regulation (FAR) 2.101 defines “principals” to mean an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity.

The solicitation provision at DFARS 252.237-70XX only requires reporting of disciplinary proceedings within the last 3 years that are not yet fully adjudicated or settled or that were fully adjudicated or settled against the offeror. Postaward, prior to each subsequent contract action, the proposed clause at DFARS 252.237-70YY requires contractors to report any changes in previously reported proceedings and any newly initiated proceeding that has not yet been adjudicated or settled, or has been fully adjudicated or settled against the contractor. The provision and the clause each require that the disclosure shall, at a minimum, include the entity hearing the case, the case or file number, and a brief description of the allegation or conduct at issue, and if fully adjudicated or settled, a brief description of the outcome.

The proposed provision and clause also include assurance that the Government will safeguard and treat as confidential all statements provided pursuant to this provision where the statement has been marked “confidential” or “proprietary” by the offeror or contractor. Statements so marked will not be released by the Government to the public pursuant to a request under the Freedom of Information Act, 5 U.S.C. 552, without prior notification to the offeror or contractor and opportunity for the offeror or contractor to claim an exemption from release. The Government will treat any statement provided pursuant to this provision and clause as confidential to the extent required by any other applicable law.

Consistent with the determinations that DoD made with regard to application of the requirements of section 1006 of the NDAA for FY 2019, as amended by section 1011 of the NDAA for FY 2020, DoD does not intend to apply the requirements of section 1006 of the NDAA for FY 2019 to contracts at or below the SAT, but does intend to apply the rule to contracts for the acquisition of commercial items, excluding COTS items.

41 U.S.C. 1905 governs the applicability of laws to contracts or subcontracts in amounts not greater than the simplified acquisition threshold. It is intended to limit the applicability of laws to such contracts or subcontracts. 41 U.S.C. 1905 provides that if a provision of law contains criminal or civil penalties, or if the Federal Acquisition Regulatory Council makes a written determination that it is not in the best interest of the Federal Government to exempt contracts or subcontracts at or below the SAT, the law will apply to them. The Principal Director, Defense Pricing and Contracting (DPC), is the appropriate authority to make comparable determinations for regulations to be published in the DFARS, which is part of the FAR system of regulations. DoD does not intend to make that determination. Therefore, this rule will not apply at or below the simplified acquisition threshold.

10 U.S.C. 2375 exempts contracts and subcontracts for the acquisition of commercial items (including COTS items) from provisions of law enacted after October 13, 1994, that, as determined by the Under Secretary of Defense for Acquisition and Sustainment (USD(A&S)), set forth policies, procedures, requirements, or restrictions for the acquisition of property or services unless—

• The provision of law—

○ Provides for criminal or civil penalties;

○ Requires that certain articles be bought from American sources pursuant to 10 U.S.C. 2533a or that strategic materials critical to national security be bought from American sources pursuant to 10 U.S.C. 2533b; or

○ Specifically refers to 10 U.S.C. 2375 and states that it shall apply to contracts and subcontracts for the acquisition of commercial items (including COTS items); or

• USD(A&S) determines in writing that it would not be in the best interest of the Government to exempt contracts or subcontracts for the acquisition of commercial items from the applicability of the provision.

This authority has been delegated to the Principal Director, DPC.

Although sections 1006 and 1011 do not refer to 10 U.S.C. 2375 or state that these sections apply to contracts and subcontracts for the acquisition of commercial items, the types of audit services targeted by the law generally are commercial services. If commercial items are exempted, the statutes will be without effect, undermining the overarching public policy purpose of the law. Therefore, DoD has determined that it is in the best interest of the Federal Government to apply the rule to contracts for the acquisition of commercial items, excluding COTS items, as defined at FAR 2.101.

Executive Orders (E.O.s) 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, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.

As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of interim or final the rule with the form, Submission of Federal Rules Under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the Federal Register . This rule is not anticipated to be a major rule under 5 U.S.C. 804.

DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule is expected to apply to approximately a dozen entities. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

DoD is proposing to amend the DFARS to implement section 1006 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232), as amended by section 1011 of the NDAA for FY 2020 (Pub. L. 116-92), and DoD policy to provide a level playing field among firms that provide audit services, whether accounting firms or other than accounting firms.

Section 1006 applies to accounting firms that provide financial statement auditing or audit remediation services to DoD in support of the audit under 31 U.S.C. 3521 or audit remediation services in support of the Financial Improvement and Audit Remediation Plan described in 10 U.S.C. 240b. Such firms, when responding to a solicitation or awarded a contract for the acquisition of covered services, must disclose to DoD before any contract action (including award, renewals, and modifications) the details of any disciplinary proceedings with respect to the accounting firm or its associated persons before any entity with the authority to enforce compliance with rules or laws applying to audit services offered by the accounting firm. DoD policy extends this requirement to firms other than accounting firms, in order to provide a level playing field in competitive acquisitions.

DoD estimates there are 12 respondents that submit offers and 10 respondents that receive award of one or more contracts covered by this rule. Of the estimated 12 respondents, DoD further estimates that only two of these respondents are small entities.

This rule proposes to add a solicitation provision and a contract clause that require details of any disciplinary proceedings with respect to the firm or its associated persons before any contract action on a covered contract in support of DoD audits.

The rule does not duplicate, overlap, or conflict with any other Federal rules.

DoD considered applying the rule to only accounting firms, but that would create a situation in which the rule would not apply to other firms that also provide these services, leading to unfair competitions. Applying the rule to other than accounting firms does not create a significant burden for small entities. DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2019-D010), in correspondence.

The rule contains information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. chapter 35). Accordingly, DoD has submitted a request for approval of a new information collection requirement concerning Requirement for Firms Used to Support Department of Defense Audits (DFARS Case 2019-D010) to OMB. The DFARS rule adds a new documentation submission and reporting requirement.

A. Public reporting burden for this collection of information is estimated to average approximately 0.27 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

The annual reporting burden estimated as follows:

Respondents: 18.

Responses per respondent: 23.

Total annual responses: 414.

Preparation hours per response: 0.27 hours, approximately.

Total response burden hours: 113.

B. Request for Comments Regarding Paperwork Burden. Written comments and recommendations on the proposed information collection, including suggestions for reducing this burden, should be sent to Ms. Susan Minson at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503, or email Susan_M._Minson@omb.eop.gov, with a copy to the Defense Acquisition Regulations System, Attn: Mr. David E. Johnson, OUSD(A&S)DPC/DARS, Room 3B938, 3060 Defense Pentagon, Washington, DC 20301-3060. Comments can be received from 30 to 60 days after the date of this notice, but comments to OMB will be most useful if received by OMB within 30 days after the date of this notice.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the DFARS, and will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Acquisition Regulations System, Attn: Mr. David Johnson, OUSD(A&S)DPC/DARS, Room 3B938, 3060 Defense Pentagon, Washington, DC 20301-3060, or email osd.dfars@mail.mil. Include DFARS Case 2019-D010 in the subject line of the message.

Therefore, 48 CFR parts 212, 237, and 252 are proposed to be amended as follows:

The additions read as follows:

DoD is proposing to revise the DFARS to implement paragraph (a)(2) of section 831 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283). Section 831(a)(2) amends 10 U.S.C. 2302e(a) to revise the type of contract line items or options that may be included, without additional competition, in contracts initially awarded from the competitive selection of a proposal resulting from a broad agency announcement (BAA).

When awarding a contract that results from the competitive selection of a proposal received in response to a BAA, 10 U.S.C. 2302e(a) permits the inclusion of certain contract line items or contract options that would not otherwise be covered under the general solicitation authority of a BAA. These contract line items or contract options: (1) Must be for certain services related to the technology developed under the contract, or the delivery of initial or additional items created as a result of the work performed under the contract; and (2) are subject to the quantity, term, and dollar value limitations expressed at 10 U.S.C. 2302e(b).

10 U.S.C. 2302e is intended to help streamline the process for moving technologies from science and technology into production and to enable the transition of technology for faster fielding by allowing the performance of certain work to continue while a follow-on or production contract is awarded.

Section 831(a)(2) amends 10 U.S.C. 2302e to replace “provision of advanced component development, prototype” with “development and demonstration.” As a result, when awarding a contract that results from the competitive selection of a proposal received in response to a BAA, contracting officers may now include a contract line item or contract option for the “development and demonstration” of technology developed under the contract. This revision provides a broader scope of effort and funding for which these contract line items and contract options can be awarded.

This proposed rule reflects the authority provided by section 831(a)(2) and clarifies for contracting officers that a contract line item or contract option included in an award pursuant to 10 U.S.C. 2302e is not limited to the funding types used for the general solicitation authority of a BAA, which are listed at DFARS 235.016.

This rule does not create any new solicitation provisions or contract clauses. It does not impact any existing solicitation provisions or contract clauses.

The proposed rule impacts DoD acquisition planning decisions for contract awards that will result from the competitive selection of a proposal in response to a BAA for which DoD intends to include a contract line item or option for the development and demonstration of technology developed under the contract. The proposed rule broadens the scope of effort for which these contract line items and contract options can be awarded and the type of funding that may be used to fund these line items or options. This proposed rule also helps streamline the process for moving technologies developed under such contracts from science and technology into production.

Executive Orders (E.O.s) 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, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.

As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the Federal Register . This rule is not anticipated to be a major rule under 5 U.S.C. 804.

DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule primarily affects the acquisition planning decisions made internally by DoD. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

The reason for this proposed rule is to implement paragraph (a)(2) of section 831 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283).

The objective of this rule is to revise the type of contract line items or options that may be included, without additional competition, in contracts initially awarded from the competitive selection of a proposal resulting from a broad agency announcement (BAA). When awarding such a contract, contracting officers may now include a contract line item or contract option for the “development and demonstration” of technology developed under the contract. This revision provides a broader scope of effort and funding for which these contract line items and contract options can be awarded, which in turn helps streamline the process for moving technologies developed under such contracts from science and technology into production. The legal basis for the rule is paragraph (a)(2) of section 831 of the NDAA for FY 2021.

Based on data from the Federal Procurement Data System for FY 2018 through FY 2020, on average, DoD annually awards 300 contracts to 200 unique small entities using the competitive selection of proposals resulting from a BAA.

This rule does not impose any new reporting, recordkeeping, or other compliance requirements. This rule does not duplicate, overlap, or conflict with any other Federal rules. There are no significant alternatives to this rule that would accomplish the objective of the statute.

DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2021-D025), in correspondence.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR parts 217, 234, and 235 are proposed to be amended as follows:

Under section 10(j) of the ESA, the USFWS may designate a population of an endangered or threatened species as an experimental population prior to its reintroduction. Experimental populations can only be designated by issuing a rule.

On January 12, 1998, we published a final rule (63 FR 1752) adopting regulations that designate a nonessential experimental population of the Mexican wolf. On January 16, 2015, we published a final rule (80 FR 2512; the “2015 10(j) rule”) revising those experimental population regulations based on two decades of implementing Mexican wolf reintroduction in the Mexican Wolf Experimental Population Area (MWEPA) in portions of Arizona and New Mexico. The 2015 10(j) rule expanded the geographic boundaries of the MWEPA, established new management zones with provisions for initial release and translocation of Mexican wolves, revised and added allowable forms of take, and clarified definitions. On March 31, 2018, the District Court of Arizona remanded the 2015 10(j) rule to the USFWS to redress specific components of the rule in a new revised experimental population rule ( Center for Biological Diversity v. Jewell, No. 4:15-cv-00019-JGZ (D. Ariz.) (March 31, 2018) (“March 31, 2018, Order”)). The 2015 10(j) rule has remained, and will remain, in effect while we address the remand.

This document proposes revisions to the experimental population designation of Mexican wolves in the MWEPA in response to the March 31, 2018, Order. We propose to modify the population objective, establish a genetic objective, and temporarily restrict three of the forms of take of Mexican wolves in the MWEPA that we adopted in the 2015 10(j) rule. Proposed revisions also include a new essentiality determination. We are not proposing or analyzing any changes to the 2015 10(j) rule beyond the scope of the March 31, 2018, Order. Finally, we have also updated the 2015 10(j) rule determinations with current data and information. If adopted as proposed, this rule will designate Mexican wolves in the MWEPA as a nonessential experimental population on the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (CFR) at 50 CFR 17.11(h) with a revised rule issued under section 10(j) of the ESA at 50 CFR 17.84(k).

Based on the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that releasing Mexican wolves into the MWEPA, with the proposed revised regulatory provisions described in this document, will further the long-term conservation and recovery of the species. The proposed nonessential experimental population status is appropriate for the reintroduced population because we have determined that it is not essential to the continued existence of the species in the wild.

In making our finding that this rule would further the conservation and recovery of the species, we evaluate any possible adverse effects on extant Mexican wolf populations, the likelihood that the experimental population would become established and survive in the foreseeable future, the relative effects that establishment of the experimental population would have on the recovery of the species, and the extent to which the reintroduced population could be affected by existing or anticipated Federal, State, or Tribal actions or private activities within or adjacent to the experimental population area. We specifically evaluate how our proposed revisions to the population objective, establishment of a genetic objective, and revisions to the take provisions further the conservation of the species by aligning the designation and management of the experimental population with USFWS's long-term conservation and recovery goals for the Mexican wolf. In addition, we identify the geographic boundaries of the MWEPA as defined in the 2015 10(j) rule and note that we are not proposing geographic revisions to the boundaries of the MWEPA, the management zones, or the phasing of the Arizona portion of the MWEPA. We also explain our rationale for why the population is not essential to the continued existence of the species in the wild, and we describe management restrictions, protective measures, or other special management concerns for Mexican wolves. Last, we explain a proposed process for periodic review and evaluation of the success or failure of the experimental population and its effect on the conservation and recovery of the species.

To ensure that we consider the environmental impacts associated with this proposed rule, we have prepared a draft supplemental environmental impact statement (DSEIS) pursuant to the National Environmental Policy Act of 1969, as amended (NEPA; 42 U.S.C. 4321 et seq. ). On April 15, 2020, we published our notice of intent to prepare the DSEIS (85 FR 20967); that document opened the public scoping process under NEPA from April 15, 2020, to June 15, 2020, to seek public input on the issues under remand by the March 31, 2018, Order. We used the information gathered during scoping to inform our DSEIS and used the analyses in the DSEIS to inform this proposed rule. The comments we received are available online at http://www.regulations.gov in Docket No. FWS-R2-ES-2020-0007.

We are seeking comments from the public on the proposed revisions to the 2015 10(j) rule described in this document and our associated DSEIS. We want to ensure that any final rule is as effective as possible. Therefore, we request comments or information from other concerned governmental agencies, Native American Tribes, the scientific community, industry, and any other interested parties concerning this proposed rule. Your comments should be as specific as possible.

We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. The comments we receive and any supporting documentation we used in preparing this proposal will be available for public inspection at http://www.regulations.gov. All comments, including commenters' names and addresses, if provided to us, will become part of the supporting record.

We will consider comments and information we receive during the public comment period on the proposed rule as we prepare our final rule and final SEIS. Accordingly, the final rule and final SEIS may differ from this proposal and the DSEIS. Please note that submissions merely stating support for, or opposition to, the actions under consideration, without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 10(j)(2)(B) of the ESA (16 U.S.C. 1531 et seq. ) and our regulations at 50 CFR 17.81 direct that our determinations and findings regarding designation of experimental populations be made utilizing the best scientific and commercial data available.

We are specifically seeking comments on the proposed revisions to the 2015 10(j) rule described in this document and the associated DSEIS, including:

• The effect of the proposed revised population objective on the recovery of the Mexican wolf, including the extent to which the proposed revision supports the MWEPA population in contributing to recovery;

• The effect of the proposed genetic objective on the recovery of the Mexican wolf, including the extent to which the proposed revision supports the MWEPA population in contributing to recovery;

• The effects of the proposed temporary restriction of three of the take provisions on the recovery of the Mexican wolf;

• The effects of the proposed revisions (population objective, genetic objective, and take provisions) on public, Tribal, and private lands with management activities such as ranching and livestock production, hunting, guiding, and other land uses; and

• Scientific information pertinent to our proposed determination to (re)designate the experimental population for the Mexican wolf in the MWEPA as nonessential.

We have scheduled three public information sessions and two public hearings on this proposed rule. We will hold the public information meetings and public hearings on the dates and at the times listed above under Public information sessions and public hearings in DATES . We are holding the public information sessions and the public hearings via the Zoom online video platform and via teleconference so that participants can attend remotely. Options for participation include: (1) Listen to and view one of the information sessions and one of the hearings via Zoom, or (2) listen to the information sessions and hearings by telephone. For security purposes and to ensure as many members of the public can participate as possible within the capacity of our Zoom and telephone lines, registration for the information sessions and hearings is required. To listen and view the information sessions or hearings via Zoom, listen to the information sessions or hearings by telephone, or provide oral public comments at the public hearing by Zoom or telephone, you must register. We ask that individuals register for only one public information session and one public hearing. For information on how to register, visit https://www.fws.gov/southwest/es/mexicanwolf/10j-revision. If applicable, interested members of the public not familiar with the Zoom platform should view the Zoom video tutorials ( https://support.zoom.us/hc/en-us/articles/206618765-Zoom-video-tutorials ) prior to the public information sessions and public hearings.

The public hearings will provide interested parties an opportunity to present verbal testimony (formal, oral comments) regarding this proposed rule and the DSEIS. While the public information sessions will be an opportunity for dialogue with the USFWS, the public hearings are not: They are a forum for accepting formal verbal testimony. In the event there is a large attendance, the time allotted for oral statements may be limited. Therefore, anyone wishing to make an oral statement during the public hearings for the record is encouraged to provide a prepared written copy of their statement to us through the Federal eRulemaking Portal, or U.S. mail (see ADDRESSES , above); providing an oral comment is not required for submission of a written comment. There is no limit on the length of written comments submitted to us. Anyone wishing to make an oral statement at a public hearing must register before the hearing ( https://www.fws.gov/southwest/es/mexicanwolf/10j-revision ). The use of virtual public hearings is consistent with our regulations at 50 CFR 424.16(c)(3).

The USFWS is committed to providing access to the public information sessions and public hearing for all participants. Live audio via telephone or computer speakers and closed captioning via Zoom will be available during public information sessions and public hearings. We will post a full audio and video recording and transcript of the public hearings online at https://www.fws.gov/southwest/es/mexicanwolf/10j-revision after the hearings. Persons with disabilities requiring reasonable accommodations to participate in a public information session and/or hearing should contact the person listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the date of the information session and/or hearing to help ensure availability. We will post an accessible version of the USFWS public information session presentation online at https://www.fws.gov/southwest/es/mexicanwolf/10j-revision prior to the date of the first public information session (see DATES , above).

The 1982 amendments to the ESA (16 U.S.C. 1531 et seq. ) included the addition of section 10(j), which allows for the designation of populations of listed species planned to be reintroduced as “experimental populations.” Under section 10(j) of the ESA and our regulations at 50 CFR 17.81, the USFWS may designate a population of endangered or threatened species that will be released into suitable habitat outside the species' current range (but within its probable historical range, absent a finding by the Director of the USFWS in the extreme case that the primary habitat of the species has been unsuitably and irreversibly altered or destroyed) as an experimental population.

In accordance with 50 CFR 17.81(b), before authorizing the release as an experimental population (including eggs, propagules, or individuals) of an endangered or threatened species, and before authorizing any necessary transportation to conduct the release, the USFWS must find by regulation that such release will further the conservation of the species. In making such a finding, the USFWS uses the best scientific and commercial data available to consider:

(1) Any possible adverse effects on extant populations of a species as a result of removal of individuals, eggs, or propagules for introduction elsewhere (see Possible Adverse Effects on Wild and Captive Breeding Populations, below);

(2) The likelihood that any such experimental population will become established and survive in the foreseeable future (see Likelihood of Population Establishment and Survival, below);

(3) The relative effects that establishment of an experimental population will have on the recovery of the species (see How Does the Experimental Population Contribute to the Conservation of the Species?, below); and

(4) The extent to which the introduced population may be affected by existing or anticipated Federal, State, or Tribal actions or private activities within or adjacent to the experimental population area (see Actions and Activities that May Affect the Introduced Population, below).

Furthermore, under 50 CFR 17.81(c), all regulations designating experimental populations under section 10(j) shall provide:

(1) Appropriate means to identify the experimental population, including, but not limited to, its actual or proposed location, actual or anticipated migration, number of specimens released or to be released, and other criteria appropriate to identify the experimental population(s) (see Location and Boundaries of the Proposed Experimental Population, below);

(2) A finding, based solely on the best scientific and commercial data available, and the supporting factual basis, on whether the experimental population is, or is not, essential to the continued existence of the species in the wild (see Is the Experimental Population Essential to the Continued Existence of the Species in the Wild?, below);

(3) Management restrictions, protective measures, or other special management concerns of that population, which may include but are not limited to, measures to isolate and/or contain the experimental population designated in the regulation from natural populations (see Management Restrictions, Protective Measures, and Other Special Management, below); and

(4) A process for periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species (see Review and Evaluation of the MWEPA Population, below).

Under 50 CFR 17.81(d), the USFWS shall consult with appropriate State game and fish agencies, local governmental entities, Tribal governments, affected Federal agencies, and affected private landowners in developing and implementing experimental population rules. To the maximum extent practicable, section 10(j) rules represent an agreement between the USFWS, the affected State and Federal agencies, and persons holding any interest in land that may be affected by the establishment of an experimental population.

Under 50 CFR 17.81(f), the Secretary of the Interior (Secretary) may designate critical habitat as defined in section 3(5)(A) of the ESA for an essential experimental population. No designation of critical habitat will be made for nonessential experimental populations. In those situations where a portion or all of an essential experimental population overlaps with a natural population of the species during certain periods of the year, we will not designate critical habitat for the area of overlap unless implemented as a revision to critical habitat of the natural population for reasons unrelated to the overlap itself.

Under 50 CFR 17.82, any population determined by the Secretary to be an experimental population will be treated as if it were listed as a threatened species for purposes of establishing protective regulations with respect to that population. The protective regulations adopted for an experimental population will contain applicable prohibitions, as appropriate, and exceptions for that population.

Under 50 CFR 17.83(a), any experimental population designated for a listed species (1) determined not to be essential to the survival of that species and (2) not occurring within the National Park System or the National Wildlife Refuge System will be treated for purposes of section 7 (other than paragraph (a)(1)) of the ESA as a species proposed to be listed under the ESA as a threatened species.

Under 50 CFR 17.83(b), any experimental population designated for a listed species that either (1) has been determined to be essential to the survival of that species or (2) occurs within the National Park System or the National Wildlife Refuge System as now or hereafter constituted will be treated for purposes of section 7 of the ESA as a threatened species. Any biological opinion prepared pursuant to section 7(b) of the ESA and any agency determination made pursuant to section 7(a) of the ESA will consider any experimental and nonexperimental populations to constitute a single listed species for the purposes of conducting the analyses under such sections.

On January 16, 2015, we published a final rule (80 FR 2488) listing the Mexican wolf as endangered. Previously, on January 12, 1998, we published a final rule (63 FR 1752) adopting regulations that designate a nonessential experimental population of the Mexican wolf in Arizona and New Mexico as the Mexican Wolf Experimental Population Area (MWEPA). The Mexican wolf is treated as endangered wherever it is found except where included in the MWEPA.

The Mexican wolf is also protected by State laws in the United States and by federal law in Mexico. In Arizona, the gray wolf, including the Mexican wolf subspecies, is identified as a Species of Greatest Conservation Need (Arizona Game and Fish Department 2012). The gray wolf, including the Mexican wolf subspecies, is listed as endangered in New Mexico (Wildlife Conservation Act, 17-2-37 through 17-2-46 New Mexico Statutes (NMSA) 1978; List of Threatened and Endangered Species, 19.33.6 New Mexico Administrative Code (NMAC) 1978) and Texas (Texas Parks and Wildlife Code, chapter 68). In Mexico, the status of the Mexican wolf was updated from “probably extinct in the wild” to “endangered” in November 2019, via federal regulations (Norma Oficial Mexicana NOM-059-SEMARNAT-2010) (Secretaría de Medio Ambiente y Recursos Naturales [SEMARNAT; Federal Ministry of the Environment and Natural Resources] 2010).

On April 28, 1976, we published a final rule (41 FR 17736) listing the Mexican wolf as endangered under the ESA. On March 9, 1978, we published a final rule (43 FR 9607) reclassifying the entire gray wolf species in North America south of Canada as endangered, except in Minnesota where we listed it as threatened. The March 9, 1978, gray wolf listing rule subsumed the Mexican wolf subspecies listing but stated that we would continue to recognize the Mexican wolf as a valid biological subspecies for purposes of research and conservation.

On April 1, 2003, we published a final rule (68 FR 15804) revising the classification of gray wolves by establishing three gray wolf distinct population segments (DPSs), including the Mexican wolf in the Southwestern DPS. Subsequently, in 2008, two federal district courts overturned this rule, and the USFWS considered the gray wolf to have reverted to its listing status prior to the April 1, 2003, rule (see 73 FR 75356; December 11, 2008).

On January 16, 2015, we published a final rule (80 FR 2488) listing the Mexican wolf as endangered. This final rule created a separate entry for the Mexican wolf on the List of Endangered and Threatened Wildlife so that the subspecies was no longer subsumed in the gray wolf listing. In effect, the Mexican wolf has been protected as endangered since 1976.

On January 12, 1998, we published a final rule (63 FR 1752) designating a nonessential experimental population of the Mexican wolf in portions of Arizona and New Mexico. We began releasing captive wolves into the wild in the MWEPA later that year. On January 16, 2015, we published a final rule (80 FR 2512; the “2015 10(j) rule”) revising the January 12, 1998, experimental population designation to improve the conservation and management of the Mexican wolf in the MWEPA.

Our designation of the MWEPA in 1998, and our 2015 revisions to that MWEPA designation, necessitated analysis of our proposed actions under NEPA. On December 20, 1996, we released the final environmental impact statement titled, “Reintroduction of the Mexican Wolf within its Historic Range in the Southwestern United States,” and on November 25, 2014, we released our subsequent “Environmental Impact Statement for the Proposed Revision to the Regulations for the Nonessential Experimental Population of the Mexican Wolf.”

On March 31, 2018, the District Court of Arizona remanded the 2015 10(j) rule to the USFWS ( Center for Biological Diversity v. Jewell, No. 4:15-cv-00019-JGZ (D. Ariz.) (March 31, 2018) (“March 31, 2018, Order”)). In response to the remand, we began the process to revise the 2015 10(j) rule and develop the DSEIS. On April 15, 2020, we published our notice of intent to prepare the DSEIS (85 FR 20967); that document opened the public scoping process under NEPA to seek public input on the issues under remand.

In addition to our rulemaking actions, the USFWS has developed two recovery plans for the Mexican wolf: The 1982 Mexican Wolf Recovery Plan (USFWS 1982), and the 2017 Mexican Wolf Recovery Plan, First Revision (USFWS 2017a) (revised recovery plan). The revised recovery plan supersedes the original plan and provides a comprehensive strategy and long-term conservation and recovery goals for the USFWS Mexican wolf recovery program. Following completion of the revised recovery plan, we conducted a 5-year status review for the Mexican wolf under section 4(c)(2)(A) of the ESA in 2018 (see 83 FR 25034; May 31, 2018).

For more detailed information on previous Federal actions concerning the Mexican wolf through 2015, including petition findings and other 5-year reviews, refer to the final rule to list the Mexican wolf as endangered (80 FR 2488; January 16, 2015) and the 2015 10(j) rule (80 FR 2512; January 16, 2015). We note that on November 3, 2020, the USFWS published a final rule (85 FR 69778) removing the gray wolf from the List of Endangered and Threatened Wildlife ( i.e., “delisting” the gray wolf). That rule provides additional information on previous Federal actions for the gray wolf. The subspecies listing for the Mexican wolf and the Mexican wolf experimental population designation are not affected by the USFWS November 3, 2020, final rule to delist the gray wolf. All previous actions for the Mexican wolf and gray wolf are also available on the Environmental Conservation Online System at https://ecos.fws.gov/ecp; type “gray wolf” and “Mexican wolf” into the Search Tool.

In addition to the information sources identified above, questions about previous Federal actions can be directed to the Mexican Wolf Recovery Program, U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The United States and Mexico have collaborated on Mexican wolf recovery since the mid-1970s. The early focus of the binational recovery effort was to save the Mexican wolf from extinction through the establishment of a captive breeding population (USFWS 1982, p. 28). The captive population held 369 Mexican wolves in approximately 55 facilities in the United States and Mexico as of June 30, 2020 (Scott et al. 2020, p. 7). Although housed in numerous facilities, captive Mexican wolves are managed as a single population through the routine transfer of wolves among institutions for breeding events or other management needs. The captive population is maintained in accordance with stringent genetic and population objectives established by the Species Survival Program (SSP). Reintroduction of the Mexican wolf to the wild began in 1998 and 2011 for the United States and Mexico, respectively (see USFWS 2017a, pp. 5-8 for additional information on both reintroductions).

The USFWS revised recovery plan (see Previous Federal Actions, above) provides the binational long-term recovery strategy for the Mexican wolf, including recovery criteria and recovery actions (USFWS 2017a). The revised recovery plan strategy recommends establishing and maintaining a minimum of two resilient, genetically diverse Mexican wolf populations distributed across ecologically and geographically diverse areas in the subspecies' range in the United States and Mexico (USFWS 2017a, p. 10). Recovery criteria for downlisting and delisting the Mexican wolf address threats related to the extinction risk associated with small population size, loss of gene diversity and related genetic issues, and human-caused mortality (USFWS 2017a, pp. 18-25). Criteria will need to be met in both countries for threats across the range of the Mexican wolf to be lessened and alleviated sufficiently to consider delisting the Mexican wolf. The revised recovery plan provides for evaluations at 5 and 10 years after plan implementation to ensure progress toward recovery (USFWS 2017a, pp. 26-27). Site-specific actions to alleviate threats, as well as other actions necessary to manage Mexican wolves across their range, are provided (USFWS 2017a, pp. 28-34). A separate recovery implementation strategy provides detailed activities for the USFWS and our partners to contribute to the recovery actions (online at https://www.fws.gov/southwest/es/mexicanwolf/ ). We intend for the MWEPA population to serve as the population to meet recovery criteria in the United States, and Mexico is pursuing recovery in the Sierra Madre Occidental in northern Mexico. (See Current Range in the United States and Mexico, below, for additional information.)

The revised recovery plan provides an important foundation for our proposed revisions to the 2015 10(j) rule. While we intended for the 2015 10(j) rule to improve the efficacy of reintroduction and contribute to the conservation of the Mexican wolf, we were simultaneously aware that at that time (2015) we did not have a full vision of recovery with which to align the revised experimental population designation. The USFWS recognized this shortcoming in the 2015 10(j) rule (80 FR 2512, January 16, 2015, pp. 2514-2515). We are proposing revisions to the 2015 10(j) rule that address the March 31, 2018, Order by aligning the MWEPA designation with the long-term conservation and recovery strategy and criteria in the revised recovery plan.

In addition to publishing the 2015 10(j) rule and finalizing the revised recovery plan in 2017, we have taken a number of steps to advance the recovery of the Mexican wolf:

First, we have strengthened our collaborative management framework with Federal, State, county, and Tribal partners. We initiated a new Memorandum of Understanding for Mexican Wolf Recovery and Management (June 24, 2019) (USFWS 2019; 2019 MOU). Signatories to the 2019 MOU as of August 12, 2021, include: White Mountain Apache Tribe; Arizona Game and Fish Department; New Mexico Department of Game and Fish; U.S. Department of Agriculture Wildlife Services and U.S. Department of Agriculture Forest Service; Bureau of Land Management—Arizona and Bureau of Land Management—New Mexico; National Park Service; Catron County, New Mexico; and Graham, Greenlee, Gila, and Navajo Counties in Arizona, as well as the Eastern Arizona Counties Organization. The 2019 MOU establishes a framework for a long-term, scientific approach to reintroducing and managing Mexican wolves in Arizona and New Mexico to contribute to the recovery of the Mexican wolf pursuant to the revised recovery plan. The 2019 MOU includes signature by agencies and counties that were not signatories of the previous version at the time of the 2015 10(j) rule, representing a broadened base of expertise and logistical support to manage Mexican wolves in the MWEPA and engage with local communities and the public.

The USFWS and our domestic partners have also strengthened our binational recovery collaboration with Mexico. Since the completion of the revised recovery plan in 2017, the USFWS and our partners have increased the extent of our technical support and communication at staff, management, and leadership levels. We have collectively engaged in coordination with the captive breeding facilities to ensure wolves are available for release in both countries in support of achieving recovery criteria. The USFWS and our partners have also provided wild wolves from the MWEPA to Mexico for release (see Possible Adverse Effects on Wild and Captive Breeding Populations, below, for additional information on releases in Mexico). In April 2019, the USFWS, Arizona Game and Fish Department, New Mexico Department of Game and Fish, the federal government of Mexico (Dirección General de Vida Silvestre and the Dirección de Especies Prioritarias para la Conservación), and other partners requested endorsement by the Executive Table of the Canada/Mexico/U.S. Trilateral Committee for Wildlife and Ecosystem Conservation and Management for strengthened collaboration to implement recovery actions on both sides of the border. In 2019, the Arizona Game and Fish Department was awarded $75,000 through the USFWS Recovery Challenge grant program to assist Mexico's Mexican wolf reintroduction. The Arizona Game and Fish Department is also awarded funds of approximately $250,000 annually for Mexican wolf recovery implementation through the USFWS Cooperative Endangered Species Conservation Fund Traditional Section 6 grant program.

The USFWS and our partners continue to intensively manage and monitor the status of Mexican wolves in the MWEPA and now specifically track progress toward achieving the recovery criteria in the revised recovery plan for the United States. Numerous field staff from multiple agencies, including law enforcement, conduct daily management activities throughout the MWEPA. These activities include: Monitoring and data collection of wolf locations and activity; conducting or assisting with proactive or responsive management measures to address wolf-livestock or wolf-human conflicts; releasing wolves; providing vaccinations or other medical care; coordinating Mexican wolf transfers between SSP facilities or with Mexico; investigating wolf mortalities; and education and outreach in local communities and with the media. We summarize these activities in quarterly and annual reports and in our annual initial release and translocation plans available on our website at https://www.fws.gov/southwest/es/mexicanwolf /. We use the data and information we collect to adapt our management to ensure continued progress toward recovery.

The USFWS and our partners have also tested the technique of cross-fostering (placing captive-born pups into wild dens to be raised with the wild litter) as a release method to increase gene diversity in the MWEPA since 2014. Between 2014 and 2021, we have cross-fostered 78 pups, including placing 72 pups from captive dens into wild dens, and 6 pups from one wild den to another wild den. We have increased the number of pups we cross-foster, from 2 pups in 2014 to 22 pups in 2021 based on our success with the management technique, the number of captive litters that align with the birth of wild litters, and the staffing capacity of our program and partner agencies (USFWS files).

The USFWS and our partners have also increased efforts to address wolf-livestock conflict, which is one of the primary sources of concern in local communities. The USFWS, our partners, and livestock owners and operators implement a number of proactive management techniques to reduce wolf-livestock conflict, including increasing the number and geographic coverage of range riders, using fladry (strips of fabric mounted along fencelines to deter wolves) in calving areas, harassing or hazing Mexican wolves using scare devices and noise, manipulating Mexican wolf pack movements using food caches, moving cattle away from dens, and other activities (USFWS 2018, pp. 25-27). The USFWS provides depredation compensation and funding for proactive management to eligible States and Tribes through its Wolf Livestock Demonstration Project grants. The Arizona Livestock Loss Board provides depredation compensation for Arizona operators. Several nongovernmental organizations also contribute substantial financial and logistical resources to address and reduce livestock conflict. (See our annual reports for information on funding related to livestock depredations and proactive management, as well as additional information about the Mexican Wolf/Livestock Council, online at: https://www.fws.gov/southwest/es/mexicanwolf/. )

Our efforts across the recovery program are showing success in the MWEPA. The minimum population count in 2020 of 186 wolves, including 20 breeding pairs (defined as a pair that produced pups, at least one of which survived to the end of the year), continues a trend of steady population growth, nearly doubling in size over the last 5 years (see our online population estimate at https://www.fws.gov/southwest/es/mexicanwolf/ ). This growth lessens the severity of demographic threats to the population, as described in Summary and Rationale for Proposed Changes to the Experimental Population Designation in Relation to Recovery, below. Mexican wolves have expanded their range significantly under the 2015 10(j) rule, from a range of 7,255 square miles (mi 2 ) (18,790 square kilometers (km 2 )) in 2014, the year prior to our expansion of the MWEPA, to 19,495 mi 2 (50,492 km 2 ) in 2020 (USFWS files). This demonstrates progress in our recovery strategy to expand the geographic distribution of the Mexican wolf (USFWS 2017a, pp. 11, 24). We also recorded a minor increase in gene diversity and decrease in population mean kinship (a measure of the relatedness of an individual to the population) from 2020 to 2021 (USFWS files). These measures of the genetic status of the MWEPA population document the positive impact that recent cross-fostering events are having, and we expect to document continued progress as we continue our efforts to decrease genetic threats to the Mexican wolf, as described in Summary and Rationale for Proposed Changes to the Experimental Population Designation in Relation to Recovery, below.

The Mexican wolf ( Canis lupus baileyi ) is a subspecies of gray wolf that historically occurred in portions of the southwestern United States and central and northern Mexico. Mexican wolves are the smallest extant gray wolf in North America, weighing between 50 to 90 pounds. They are typically a patchy black, brown to cinnamon, and cream color, with primarily light underparts (80 FR 2488, January 16, 2015, p. 2490).

Mexican wolves are social predators that live in packs ranging in size from two wolves to more than a dozen wolves. Mexican wolf packs establish a territory, or area, within which pack members hunt and find shelter. Mexican wolves predominantly prey on elk, but other sources of prey include deer, small mammals, and birds. Mexican wolves are also known to prey and scavenge on livestock (USFWS 2017b, pp. 12-19).

The historical range of the Mexican wolf has been the subject of scientific inquiry and debate for several decades, primarily related to the northern and possibly western extent of the range. The USFWS recognizes concordance in the scientific literature depicting the Sierra Madre of Mexico and southern Arizona and New Mexico as Mexican wolf core historical range, and continues to recognize the expanded historical range per Parsons (1996, p. 106) that extends into central New Mexico and Arizona (see our summary in USFWS 2017b, pp. 10-12, and in our final rule to list the Mexican wolf as an endangered subspecies (80 FR 2488, January 16, 2015)). We continue to monitor the scientific literature for ongoing exploration of this topic.

The current range of the Mexican wolf in the wild includes only those areas where they have been reintroduced from captivity and the surrounding areas to which they have naturally expanded: T he MWEPA in the United States and a portion of the Sierra Madre Occidental mountain range in northern Mexico. Mexican wolves inhabit approximately 19,495 mi 2 (50,492 km 2 ) of the MWEPA as of the end of 2020 (USFWS files). The MWEPA is 153,871 mi 2 (398,524 km 2 ), with approximately 32,244 mi 2 (83,512 km 2 ) of suitable habitat that occurs on various land ownership types, but primarily U.S. Forest Service (USFS) land (USFWS 2014, chapter 3, p. 11). The MWEPA is within the probable historical range of the Mexican wolf (see Historical Range, above).

Mexican wolves in the northern Sierra Madre Occidental in the states of Sonora and Chihuahua in Mexico are approximately 130 miles (mi) (209 kilometers (km)) south of the U.S.-Mexico border. The Sierra Madre Occidental is the longest mountain range in Mexico, extending from northern Mexico south to the State of Jalisco. In the northern portion of the mountain range, there are approximately 7,305 mi 2 (18,922 km 2 ) of suitable Mexican wolf habitat, with limited habitat connectivity to a second area to the south containing approximately 9,728 mi 2 (25,196 km 2 ) of suitable habitat. Suitable Mexican wolf habitat in the Sierra Madre Oriental, a mountain range to the east, has also been identified (Martínez-Meyer et al. 2020, entire), but releases have not taken place in this area as of February 2021. The MWEPA designation stops at the U.S.-Mexico border; the wolves in Mexico are not part of the experimental population.

Wolves are considered habitat generalists that can occupy areas where prey populations and human tolerance support their existence (Fritts et al. 2003, pp. 300-301). Accordingly, we consider suitable habitat for Mexican wolves to be forested areas with adequate wild ungulate prey and low levels of human development and livestock density. In the MWEPA, Mexican wolves inhabit evergreen pine-oak woodlands ( i.e., Madrean woodlands), pinyon-juniper woodlands ( i.e., Great Basin conifer forests), and mixed-conifer montane forests ( i.e., Rocky Mountain, or petran forests) that are inhabited by elk, mule deer, and white-tailed deer (USFWS 2017b, p. 14). Mexican wolves in the MWEPA move within their territories daily to hunt and find shelter. Pack home range size can vary significantly. For example, in 2018, we documented a home range of approximately 57 mi 2 (148 km 2 ) for the Dark Canyon pack and 552 mi 2 (1,352 km 2 ) for the Tsay O Ah pack, with an average home range size of approximately 210 mi 2 (544 km 2 ) across 24 packs or pairs (USFWS 2018, p. 22; also see USFWS 2017b, p. 13). Individual juvenile Mexican wolves sometimes disperse beyond their pack's territory to find a mate and establish a new territory. We track Mexican wolves' movements via radio telemetry and global positioning system radio collars to document pack home ranges, occupied range, and dispersal events.

Mexican wolf life history is similar to that of other gray wolves (see USFWS 2010, pp. 32-41). In the wild, Mexican wolves live on average 4 to 5 years, although we have documented wolves living to 14 years (USFWS files). Mexican wolves reach sexual maturity around 2 years of age and have one reproductive cycle per year. Typically only one female and one male (the main breeding pair) breed in a pack and produce pups; however, there have been instances in the wild of a secondary female being bred and having pups within the same pack. Mexican wolves in the wild are generally born between early April and early May, with an average litter size of 4.65 pups (USFWS files).

For a detailed description of the Mexican wolf, see our discussion under Subspecies Information in our final rule to list the Mexican wolf as endangered (80 FR 2488, January 16, 2015, pp. 2489-2492) or the biological report for the Mexican Wolf (USFWS 2017b).

The Mexican wolf is listed as endangered due to the individual and cumulative effects of excessive human-caused mortality, including illegal killing; genetic issues including inbreeding, loss of heterozygosity, and loss of adaptive potential; and demographic stochasticity (decreases in survival or reproduction) associated with small population size (80 FR 2488, January 16, 2015; see also USFWS 2017a, p. 9, and USFWS 2017b, pp. 23-34, for additional discussion of these threats). We have established a comprehensive strategy and suite of actions in our revised recovery plan to diminish these threats sufficiently such that the Mexican wolf can be considered for delisting when rangewide recovery criteria are met. Under the guidance of the recovery plan, the 2015 10(j) rule, and other program documents, the USFWS and our partners manage the MWEPA to lessen and alleviate threats to the experimental population. Our proposed revisions to the 2015 10(j) rule will also lessen and alleviate threats to the Mexican wolf, as explained in the following discussion.

We are proposing revisions to the MWEPA designation to ensure that it contributes to the long-term conservation and recovery of the Mexican wolf. We are using the revised recovery plan as the foundation of our proposed revisions because it provides our strategy and criteria for Mexican wolf recovery. We are proposing to modify the population objective, establish a genetic objective, and temporarily restrict three take provisions from the 2015 10(j) rule as follows, and for the following reasons:

We propose to revise the population objective for the MWEPA at 50 CFR 17.84(k)(9)(iii) by deleting the following three sentences: Based on end-of-year counts, we will manage for a population objective of 300 to 325 Mexican wolves in the MWEPA in Arizona and New Mexico. So as not to exceed this population objective, we will exercise all management options with preference for translocation to other Mexican wolf populations to further the conservation of the subspecies. The USFWS may change this provision as necessary to accommodate a new recovery plan.

We propose to replace the deleted language with the following two sentences: Based on end-of-year counts, we will manage to achieve and sustain a population average greater than or equal to 320 wolves in Arizona and New Mexico. In order to achieve the current demographic recovery criteria for the United States, this average must be achieved over an 8-year period, the population must exceed 320 Mexican wolves each of the last 3 years of the 8-year period, and the annual population growth rate averaged over the 8-year period must be stable or increasing.

Under this proposed population objective, we would continue to manage Mexican wolves in the MWEPA to maintain a population average greater than or equal to 320 wolves until delisting occurs. After delisting, the States of Arizona and New Mexico and the Tribes in Arizona and New Mexico would obtain management authority and responsibility to maintain the Mexican wolf at or above recovered levels.

When we established the population objective in the 2015 10(j) rule, we explained that the USFWS may change this provision as necessary to accommodate a new recovery plan (80 FR 2512, January 16, 2015, p. 2563; 50 CFR 17.84(k)(9)(iii)). Now, our proposed revised population objective for the MWEPA is based on the recovery criteria in the revised recovery plan, which was developed subsequent to the 2015 10(j) rule. During the development of the revised recovery plan, we gathered data on the Mexican wolf population in the MWEPA for the purpose of conducting population viability analysis modeling. Several previous population and habitat viability analysis models served as springboards for our effort (Carroll et al. 2006; Carroll et al. 2014). We updated or replaced data sets used in previous studies to ensure model parameterization reflected our current knowledge of Mexican wolves in the MWEPA (as opposed to gray wolf populations in other geographic areas, as used in previous studies). For example, we updated datasets on mortality rates, the frequency and effects of disease, female pairing, and the effect of inbreeding on the likelihood of producing pups, all of which are important factors in projecting future population abundance and persistence. We incorporated more than 15 years of wild Mexican wolf data in the modeling effort and made conservative choices in parameterization to ensure model results would not overestimate the growth or probability of persistence of simulated populations (Miller 2017, entire).

During the recovery planning process, we used the population viability analysis model to explore management scenarios that would achieve at least a 90 percent likelihood of persistence of the MWEPA population over a 100-year period to alleviate the threat of demographic stochasticity (USFWS 2017a, pp. 20-22). The threat of demographic stochasticity due to small population size means that at smaller population sizes, a population is more susceptible to uncertain demographic events such as changes in birth or death rates that could lead toward extirpation of the population. As a population grows, this threat diminishes and the likelihood of population persistence increases (see our discussion at USFWS 2017a, pp. 13, 20-22; USFWS 2017b, pp. 35-36; Miller 2017, entire; USFWS 2019, pp. 63-68). The combined elements of the demographic recovery criteria for the United States that our proposed population objective is based upon—that the population must maintain an average greater than or equal to 320 wolves over an 8-year period, that the population must exceed 320 wolves in each of the last 3 years of the 8-year period, and that the annual growth rate averaged over the 8-year period must be stable or increasing—provides for a 90 percent likelihood of persistence of the MWEPA population over a 100-year period (USFWS 2017a, p. 19).

The data and analyses we used as the basis of the demographic recovery criteria in the revised recovery plan were not available when we established the population objective in the 2015 10(j) rule (see discussion of available scientific studies at 80 FR 2512, January 16, 2015, p. 2517). We established the upper limit of the population objective in the 2015 10(j) rule because we did not have an up-to-date recovery plan to provide context for the contribution of the MWEPA to recovery; in other words, we did not know how many wolves may be needed for recovery or how those wolves should be distributed geographically between different populations. The revised recovery plan now provides clear direction for the MWEPA population's contribution to recovery, and we recognize that an upper limit of 325 in the MWEPA is not consistent with being able to adequately alleviate the threat of demographic stochasticity to the Mexican wolf. Although “300 to 325” and “an average of 320” sound very similar, a range of 300 to 325 with an upper limit of 325 does not ensure at least a 90 percent likelihood of persistence over 100 years, because the upper limit combined with the absence of additional specifications of the population's behavior (exceeding 320 wolves in each of the last 3 years of the 8-year period, and that the annual growth rate averaged over the 8-year period must be stable or increasing) result in a population with an extinction risk of more than 10 percent over 100 years.

As we continue to manage for an average population size greater than or equal to 320 Mexican wolves in the MWEPA after the proposed population objective is reached, we would expect the population to fluctuate between the mid-300s to low 400s. Although a larger (more than low 400s) population size may be possible due to natural population growth, we would expect that population growth would slow down or stabilize in the mid-300s to low 400s in response to our future management actions such as reduced food caching, translocation of wolves to Mexico in support of their recovery goals, or removals for various management purposes.

We continue to collect and analyze data on the experimental population and to survey the scientific literature for additional information pertinent to managing the MWEPA population in a manner consistent with recovering the Mexican wolf. Since the completion of the revised recovery plan, we have not observed life-history events or population trends in Mexican wolves in the MWEPA (such as changes in reproductive or mortality rates, for example) that cause us to reconsider the validity of the data used or the results of the population viability analysis that provided the foundation for our development of recovery criteria in the revised recovery plan. One published study critiqued the recovery criteria in the revised recovery plan, including the population viability analysis modeling used to develop the criteria (Carroll et al. 2019). The study explored how the modeling for the revised recovery plan differed from previous modeling and criteria-setting efforts for the Mexican wolf. The study identified six parameterization differences that varied across modeling efforts, grouping those parameters as biological (for example, the effects of disease), management-related (for example, the number of releases from captivity), or both biological and management-related (for example, the proportion of packs receiving supplemental feeding). The study examined how normative (values-based) and scientific decisions related to setting the values for and function of these parameters in a population viability analysis model affect model results, including the degree to which uncertainty surrounding specific parameters can influence scenario projections. The study recommended establishing a recovery strategy and recovery criteria that buffer against uncertainty and claimed that our approach did not do so. For example, the paper recommended inclusion of an independent human-caused mortality criterion to buffer against uncertainty in the parameterization of wolf mortality rates, in addition to a demographic recovery criterion based on extinction risk, as opposed to our approach of tying our human-caused mortality criterion to our demographic criterion (USFWS 2017a, p. 20). The study also critiqued the level of risk tolerance considered acceptable by the USFWS for the recovery of the Mexican wolf as too high, and ultimately claimed that political influence led to increased risk tolerance in establishing recovery criteria.

We acknowledge the authors' characterization that some decisions in population viability analysis modeling and the establishment of recovery criteria contain a normative element, such as what level of extinction risk is acceptable for recovery or the degree to which supplemental feeding is an appropriate management intervention during species recovery. We also acknowledge that recovery criteria could be formulated differently than those contained in the revised recovery plan to articulate when threats have been alleviated sufficiently to delist the Mexican wolf. However, these acknowledgements do not alter our position that the population viability analysis modeling conducted for the revised recovery plan constitutes the best available information upon which to base a revised population objective for the Mexican wolf in the MWEPA, because it is based on up-to-date Mexican wolf data and reflects realistic management scenarios (such as incorporating supplemental feeding). Our proposed population objective would remove the upper limit of 325 wolves; lead to a more robust population of wolves in the MWEPA; allow for annual population fluctuations while ensuring stable population performance; and alleviate the threat of demographic stochasticity consistent with the recovery needs of the Mexican wolf.

We propose to establish a genetic objective for the MWEPA to address genetic threats to the experimental population. We did not include a genetic objective in the 2015 10(j) rule; rather, we provided a recommendation in the preamble of the rule for the release of Mexican wolves from captivity at a level that would achieve a minimum of 1 to 2 effective migrants per generation entering the population, depending on its size, over the long term. The rule went on to say that in the more immediate future, we may conduct additional releases in excess of 1 to 2 effective migrants per generation to address the high degree of relatedness of wolves in the current Blue Range Wolf Recovery Area (80 FR 2512, January 16, 2015, p. 2517). We are now proposing to modify our approach in the 2015 10(j) rule in two ways:

First, we propose to revise the language to state that the USFWS and designated agencies will conduct a sufficient number of releases into the MWEPA from captivity to result in at least 22 released Mexican wolves surviving to breeding age. Second, we propose to codify this release statement at 50 CFR 17.84(k)(9)(v). We expect to achieve this proposed objective by 2030, as described below in Modification of Three Allowable Forms of Take of Mexican Wolves .

Similar to the discussion above of the population objective, our proposed establishment of a genetic objective is based on information and analyses conducted subsequent to the 2015 10(j) rule that are included in the revised recovery plan. When we developed our genetic criterion in the revised recovery plan, we determined that wild populations contributing to recovery should represent approximately 90 percent of the genetic diversity available in the captive population to consider genetic threats sufficiently abated (USFWS 2017a, p. 13). The reason for this is that the gene diversity in the captive population is higher than either wild population in the United States or Mexico; therefore, releasing captive wolves will add beneficial gene diversity to the experimental population as some of the released wolves breed and produce offspring in the MWEPA. Increasing gene diversity in the MWEPA to approximately 90 percent of the gene diversity available in the captive population will reduce the incidence of inbreeding depression, and over a longer timeframe, it will aid Mexican wolves' ability to respond and adapt to various and changing environmental conditions (USFWS 2017a, p. 22). In addition, releasing captive wolves makes room in captive facilities for additional captive breeding events, which enables the captive population to maintain, or slow the loss of, genetic diversity in captivity and continue supporting the wild populations in the United States and Mexico during the recovery process (Scott et al. 2020, p. 9).

As we explored model scenarios during the recovery planning process to alleviate genetic threats to the Mexican wolf by releasing captive wolves to the wild, we recognized that not all wolves released from captivity would survive to breeding age, and due to wolves' social structure, not all wolves that survive to breeding age would breed (Miller 2017, pp. 9-10). Based on survival and mortality data of different age classes of Mexican wolves (pups, subadults, adults), we determined that at least 22 released Mexican wolves surviving to breeding age by 2035 would result in a sufficient portion of those wolves breeding to result in approximately 90 percent of the genetic diversity of the captive population being represented in the wild (USFWS 2017 a, pp. 22-24). Our proposal to revise the release recommendation in the 2015 10(j) rule by establishing a genetic objective would contribute to the recovery of the Mexican wolf because our proposal aligns with the genetic recovery criterion in the revised recovery plan and would therefore alleviate genetic threats consistent with the recovery needs of the Mexican wolf (see Recovery Efforts, above, and USFWS 2017a, pp. 5, 7, 9, 13-14, 22-23; USFWS 2017b, pp. 26-29).

Our proposed revision would result in a larger number of released wolves entering the MWEPA in a shorter time period than the release recommendation in the 2015 10(j) rule, which reflects our improved understanding of the number and timing of releases needed to adequately reduce genetic threats. Under our 2015 10(j) rule, we intended to release 35 to 50 captive wolves by 2035 (see USFWS 2014, Appendix D, pp. 3, 12); however, in our revised recovery plan, we estimated we would need to release at least 70 wolves to achieve our genetic criterion in the revised recovery plan. Because we are conducting releases via cross-fostering, a method for which we are uncertain of the number of releases needed to achieve at least 22 released wolves surviving to breeding age, we have aggressively pursued releases in the last few years. We expect that the survival of cross-fostered pups in their first years is similar to wild-born pups (approximately 50 percent). As of the spring of 2021, we have released 72 Mexican wolves from captivity to the wild via cross-fostering, and we have documented a minimum of 7 out of 30 released pups surviving to breeding age. Pups released in 2020 (20 pups) and 2021 (22 pups) had not yet reached breeding age in the spring of 2021, and are therefore not eligible to be included in the total number of released pups that could have survived to breeding age in 2021 (30 pups). We will continue to document our progress annually toward at least 22 released wolves surviving to breeding age and will adjust our ongoing release plans accordingly.

We note that our proposed genetic objective shifts our previous language in the 2015 10(j) rule from tracking “effective migrants,” which means an animal that comes from outside the population and successfully reproduces within the population, to instead tracking captive animals released to the MWEPA that “survive to breeding age” and have the opportunity to contribute genetically to the population. This proposed revision in language tracks our population viability analysis modeling approach in the revised recovery plan directly, and it appropriately addresses the need to increase gene diversity in the MWEPA population because it results in the representation of approximately 90 percent of the gene diversity available in the captive population entering the MWEPA (USFWS 2017a, pp. 22-24).

As stated earlier, we propose to codify this release statement at 50 CFR 17.84(k)(9)(v) and refer to it as a genetic objective. Establishment of a genetic objective strengthens this feature of our management because the genetic objective becomes part of the MWEPA regulations. In addition, we propose annual benchmarks for achieving the number of released wolves that survive to breeding age by 2030 in Modification of Three Allowable Forms of Take of Mexican Wolves, below, which will drive expedient progress toward recovery and ensure that progress toward releasing captive wolves keeps pace with expected population growth.

We propose to modify three allowable forms of take of Mexican wolves at 50 CFR 17.84(k)(7) by temporarily restricting their use while we make progress toward increasing Mexican wolf gene diversity in the MWEPA. The three forms of allowable take from the 2015 10(j) rule we propose to modify are: Take on non-Federal land in conjunction with a removal action (§ 17.84(k)(7)(iv)(C)), take on Federal land (§ 17.84(k)(7)(v)(A)), and take in response to an unacceptable impact to a wild ungulate herd (§ 17.84(k)(7)(vi)). We are proposing to temporarily restrict these forms of take because they can result in the loss of released Mexican wolves whose gene diversity could have contributed to alleviating genetic threats had they survived and reproduced during the timeframe of the genetic recovery criterion in the United States (see Establishment of a Genetic Objective, above). Temporarily restricting these potential sources of take will support the success of these wolves during a critical period in the recovery effort (that is, as we focus our management on alleviating threats and achieving recovery criteria). Therefore, we propose to add the following language to § 17.84(k)(7)(iv)(C) and § 17.84(k)(7)(v)(A):

( 1 ) Until the USFWS has achieved the genetic objective for the MWEPA set forth at paragraph (k)(9)(v) of this section by documenting that at least 22 released wolves have survived to breeding age in the MWEPA, the USFWS or a designated agency may issue permits only on a conditional, annual basis according to the following provisions: Either

( i ) Annual release benchmarks (here, the term “benchmark” means the minimum cumulative number of released wolves surviving to breeding age since January 1, 2016, as documented annually in March) have been achieved based on the following schedule:

( ii ) Permitted take on non-Federal land [under § 17.84(k)(7)(iv)], or on Federal land [under § 17.84(k)(7)(v)], during the previous year (April 1 to March 31) did not include the lethal take of any released wolf or wolves that were or would have counted toward the genetic objective set forth at paragraph (k)(9)(v) of this section.

( 2 ) After the USFWS has achieved the genetic objective set forth at paragraph (k)(9)(v) of this section, the conditional annual basis for issuing permits will no longer be in effect.

In addition, we propose to add the following language to § 17.84(k)(7)(vi):

(E) No requests for take in response to unacceptable impacts to a wild ungulate herd may be made by the State game and fish agency or accepted by the USFWS until the genetic objective at paragraph (k)(9)(v) of this section has been met.

Once we reach the proposed genetic objective at § 17.84(k)(9)(v), gene diversity of released wolves will have integrated into the population through breeding events between released and wild wolves such that released wolves will no longer represent a pool of unique gene diversity; in other words, as more released wolves survive and breed in the wild, the contribution of released wolves to the overall gene diversity of the MWEPA diminishes. Therefore, our approach to the temporary restriction of these take provisions is to ensure we are protective of released wolves during the time we are achieving the proposed genetic objective. Once we have reached the proposed genetic objective, we would remove these temporary restrictions in recognition that take (including removal) of released wolves would not have the potential to hinder the recovery of the Mexican wolf. In the near term, restricting these take provisions contingent upon achieving the proposed genetic objective would provide synergistic support toward the recovery of the Mexican wolf. The benchmarks we are proposing reflect the targets established in the revised recovery plan for 9 released wolves to be surviving to breeding age in 2022 and 16 released wolves to be surviving to breeding age in 2027 (USFWS 2017a, pp. 26-27), and would result in 22 released wolves surviving to breeding age 5 years prior to the scenarios we explored in the population viability analysis modeling for the revised recovery plan. This schedule will ensure that strong progress to alleviate genetic threats is occurring.

Simultaneous with our intention to increase and protect the gene diversity of the MWEPA population and alleviate genetic threats to the Mexican wolf, we continue to recognize that these three allowable forms of take can provide the USFWS, State fish and game agencies, domestic animal owners and their agents, and livestock owners and their agents with a management tool for resolving wolf conflict situations. We expect that over time, and especially as the experimental population grows numerically, multiple conflict situations may occur simultaneously in different locations within the MWEPA. The USFWS considers the issuance of take permits on Federal and non-Federal land to serve as a management tool because the permits may provide for conflicts to be resolved without the participation of the USFWS or a designated agency's personnel, allowing for limited agency resources to be used in the most efficient manner. We have, therefore, integrated flexibility into the temporary restrictions we are proposing for permitted take on Federal and non-Federal land by recognizing that if an annual release benchmark toward the genetic objective is not achieved, and permitted take in the previous year did not result in the take of any released wolf or wolves, the permits are not the reason for missing the benchmark, nor are they negatively impacting gene diversity. (For example, the USFWS could miss the benchmark because we had not conducted adequate releases during a prior year due to logistical constraints.) In this context, we do not want to unnecessarily restrict a management tool that can be used to address conflicts if its use is not exacerbating a threat or hindering our progress toward recovery.

Our proposed revision to the provision for take in response to an unacceptable impact to a wild ungulate herd (§ 17.84(k)(7)(vi)) does not include a conditional approach such as we have incorporated into our proposed revisions for take on Federal and non-Federal land due to our uncertainty surrounding the extent of take that could occur under this provision. We are uncertain as to the number or frequency of future authorizations the USFWS may issue to a State or designated agency to remove wolves due to an unacceptable impact to a wild ungulate herd because we do not know when ( e.g., at what number of wolves or wolf density) wolf predation on a localized herd could result in an ungulate decline that is deemed unacceptable based on State management goals. Further, the level of removal ( i.e., number of wolves, timing, and duration) that could be requested by the State agency would depend on the level of ungulate decline occurring within the context of the State's management goals for that herd, as well as other pertinent factors, but would more likely result in authorized removal of one or more packs of wolves rather than an individual wolf. Removal of an entire pack or packs could result in removing multiple released Mexican wolves at once that could count toward our genetic objective. Therefore, we recognize that the likelihood of take of a released wolf or wolves may be higher under this take provision than the other two take provisions we are proposing to revise. On the other hand, take under this provision could result in the translocation of Mexican wolves rather than permanent removal or lethal take, and, in those cases, no loss of gene diversity in the MWEPA would occur. Due to these uncertainties, our proposed revision to this take provision does not include any contingencies to use this provision during the temporary restriction period (that is, from now until the proposed genetic objective at § 17.84 (k)(9)(v) is met).

Our final consideration as we evaluate our proposed restriction of these three take provisions is our recognition that this rule needs to serve the conservation and recovery of the Mexican wolf prior to, but also potentially after, the recovery criteria for the United States in the revised recovery plan have been met. Recovery of the Mexican wolf as envisioned by the revised recovery plan is contingent upon achieving recovery criteria for the population in the United States and the population in Mexico in order to adequately alleviate threats rangewide. Therefore, ongoing management of Mexican wolves in the United States under the ESA may occur after the MWEPA achieves the criteria for the United States if Mexico has not yet achieved its set of recovery criteria. These three take provisions will contribute to efficient, flexible management of a recovered population in the MWEPA until delisting occurs. We expect to remove the proposed temporary restrictions on these three take provisions after the genetic objective has been met. At that time, gene diversity will have been sufficiently improved to alleviate genetic threats, and the USFWS and our partners will be managing to achieve or maintain the demographic criteria. (We do not expect the MWEPA population to reach the demographic and genetic criteria simultaneously.) After the genetic objective has been met, we would expect to use these allowable forms of take in a manner consistent with achieving all recovery criteria in the United States and maintaining the experimental population at recovered levels until rangewide delisting is appropriate.

The Mexican wolf experimental population is located in the MWEPA, as designated in the 2015 10(j) rule (80 FR 2512, January 16, 2015, p. 2558). The boundaries of the MWEPA are the portions of Arizona and New Mexico that are south of Interstate Highway 40 (I-40) to the international border with Mexico (see map at 50 CFR 17.84(k)(4)). The boundaries of the MWEPA are consistent with the recovery strategy established in the revised recovery plan, which states that we will continue to focus on one large Mexican wolf population south of I-40 in Arizona and New Mexico in the United States (USFWS 2017a, p. 11).

We consider the experimental population in the MWEPA to be wholly separate geographically from any nonexperimental populations of the same (sub)species. Based on the USFWS definition of a gray wolf population (see 59 FR 60252, November 22, 1994), which we have used for the Mexican wolf, there is a population of Mexican wolves in the northern Sierra Madre Occidental, Mexico, approximately 130 miles (209 km) south of the U.S.-Mexico international border. At the end of 2020, Mexico reported 30 to 35 Mexican wolves in the wild, including two breeding pairs that each successfully raised at least two young annually for 2 consecutive years (Carlos Lopez 2020, pers. comm.). While we acknowledge that the populations are geographically located within dispersal range of one another, interconnectivity between the MWEPA and the Mexico population is currently low, and future connectivity is expected to be similarly low as explained below. For the MWEPA to not be considered wholly geographically separate, regular dispersal from one population to the other population would need to occur ( e.g., semifrequent dispersal events throughout the year), potentially including interbreeding between populations. Since 2015, four wolves dispersed from Mexico into the United States. Of those wolves, one was removed from the MWEPA due to depredation behavior, two dispersed back across the border into Mexico naturally, and one died of unknown causes (USFWS files). Based on radio-collar data, none of these dispersing wolves encountered other wild wolves during the dispersal event, nor have breeding events between Mexican wolves from the two populations occurred since the reintroduction in Mexico began. We are not aware of any Mexican wolves from the MWEPA that have dispersed into Mexico. One wolf in the MWEPA dispersed very close to the U.S.-Mexico border before turning around and moving back towards its territory in the MWEPA (USFWS files).

In the revised recovery plan and accompanying population viability analysis model, we hypothesized that successful dispersal (a dispersal event that does not end in mortality during dispersal) between the MWEPA and the current reintroduction area in northern Mexico would be infrequent (about one wolf every 12 to 16 years) (USFWS 2017a, p. 14; Miller 2017, pp. 47-49). The low level of estimated connectivity is based on potentially high levels of mortality associated with wolf dispersal events (Miller 2017, p. 9), low habitat quality across the borderlands (USFWS 2017a, pp. 12, 14; also see Martínez-Meyer 2017, p. 59), and the construction of the border wall, which includes a variety of deterrents and structures, some of which are impermeable to Mexican wolves (USCBP 2020). The demographic and genetic recovery criteria we developed were robust in the face of low expected connectivity across the border (Miller 2017, pp. 47-49), meaning that independent populations would be able to achieve the standards for threat alleviation we consider necessary for recovery either through dispersal between populations or through releases from captivity or translocations across the border, as described in Summary and Rationale for Proposed Changes to the Experimental Population Designation in Relation to Recovery, above. Since the publication of the revised recovery plan, we have not observed a frequency of dispersal events suggesting that interconnectivity will be higher than what we previously estimated in our revised recovery plan and accompanying population viability analysis models.

In the 2015 10(j) rule, we stated that the experimental population in the MWEPA was wholly separate geographically from any nonexperimental population of Mexican wolves because the Mexican wolves in Mexico did not yet meet the definition of a population (80 FR 2512, January 16, 2015, p. 2549). We stated that if a population was successfully established in Mexico, an occasional dispersal event between the populations could occur. We also stated that interconnectivity between the two population could benefit recovery by providing genetic interchange between populations (80 FR 2512, January 16, 2015, p. 2550), which we subsequently restated in the revised recovery plan (USFWS 2017a, pp. 14-15). Although a second population of Mexican wolves does now exist in the wild in Mexico, we maintain our finding that the MWEPA population is wholly separate geographically from any nonexperimental population of Mexican wolves due to the lack of functional (regular or semi-frequent, or resulting in interbreeding) interconnectivity between the populations now or likely in the future.

The MWEPA is a large area in Arizona and New Mexico that includes Federal, State, Tribal, and private land. The MWEPA consists of three management zones that define areas for initial releases (the release of wolves from captivity to the wild) and translocations, and that allow wolf dispersal and occupancy (see definitions of Zone 1, Zone 2, and Zone 3 at 50 CFR 17.84(k)(3) and the map of the MWEPA designated area at 50 CFR 17.84(k)(4)). The MWEPA also includes a phased approach to translocations, initial releases, and occupancy of Mexican wolves west of Highway 87 in Arizona (see 50 CFR 17.84(k)(9)(iv)). We are not proposing to modify the management zones or phased approach, including the phasing evaluation periods, in this proposed rule. Regarding the phasing, we note that the minimum annual population count in 2019 (the year of the first phasing evaluation) was 163 Mexican wolves, which exceeded the 5-year phasing benchmark of reaching a population size greater than 150 Mexican wolves five years after February 17, 2015. We have not moved into Phase 2 at this time but may do so prior to the 8-year evaluation if agreed upon between the USFWS and participating State game and fish agencies.

The USFWS and our partners release Mexican wolves into the MWEPA using several different management strategies, including the cross-fostering of captive pups into wild dens as a form of initial release; the initial release of adult or sub-adults individually, as pairs with and without pups, or as multigenerational packs; and translocations of wild wolves from one location to another. All methods of release can serve as useful strategies to manage the experimental population, and each has benefits and challenges within the context of our management needs at any point in time. In recent years, we have used cross-fostering as our primary release strategy because our initial attempts at cross-fostering have proven to be a successful method. Importantly, it is a more accepted technique among the local public, our stakeholders, and our State partners than releases of adult wolves or a family group into an unoccupied area, although some members of the public continue to strongly support the release of adult pairs or packs. We may still release adult wolves or family groups under certain conditions, but we expect to use cross-fostering as the primary release strategy to address the genetic needs of the experimental population.

Each year, we develop an initial release and translocation plan (available online at https://www.fws.gov/southwest/es/mexicanwolf/ ) with our partners that provides our objectives related to initial releases, translocations, and any targeted or potential removals ( e.g., to prevent the breeding of highly related wolves) for the upcoming year. We base our near-term plans on the existing conditions in the MWEPA, the status of the captive population and availability of suitable adult wolves and/or pups for release, logistical considerations such as staffing for the USFWS and our partners, and our current and anticipated progress toward recovery.

We intend to continue releasing Mexican wolves from captivity into the MWEPA primarily to increase the gene diversity of the experimental population (see Summary and Rationale for Proposed Changes to the Experimental Population Designation in Relation to Recovery, above). In addition, we may release or translocate wolves for other management purposes such as replacing a mate for a breeding pair due to a wolf mortality. As explained above in Overview of the Proposed Experimental Population, we release Mexican wolves in the MWEPA in accordance with our management zones and phasing provisions. We intend to release a sufficient number of captive Mexican wolves to the MWEPA to ensure that at least 22 released wolves survive to breeding age, although we do not know the exact number of releases this will require, because it is dependent on the survival of released wolves. Based on the data we used in the revised recovery plan on first year mortality of wolves released from captivity into the MWEPA, we explained in the revised recovery plan that we will need to release at least 70 wolves, beginning with wolves released after December 31, 2015, in order for at least 22 to survive to breeding age and meet the genetic recovery criterion for the United States (USFWS 2017a, p. 23). We stated that, “The number of releases required may increase or decrease if the survival of released wolves changes” (USFWS 2017a, p. 23). At the time of the revised recovery plan, we had little experience with the cross-foster release technique (2014-2016); therefore, our estimate of first-year release survival and the number of releases needed to achieve the criterion was not derived from cross-foster data.

If we continue to primarily use cross-fostering as a release technique to improve gene diversity in the MWEPA, the number of pups surviving to breeding age in a given year will reflect the cross-fostered pups placed in dens 2 years prior, or earlier, that have reached breeding age. This is because it takes 2 years from placement of the pup into a den for it to reach breeding age. Comparatively, adult or sub-adult releases have a lag of 1 year, as they would count as surviving to breeding age the year after their release. Therefore, our annual tally of released wolves surviving to breeding age will have a lag that reflects the age of the animals we have released. Currently, we estimate that cross-fostered Mexican wolf pups have similar survival to wild-born Mexican wolf pups (approximately 50 percent); however, more data are needed to enable us to predict the number of cross-fostered pups we will need to release in order to reach our genetic criterion in the revised recovery plan, which is also our proposed genetic objective in this proposed rule (see discussion under Establishment of a Genetic Objective, above). We note that any pups that have been cross-fostered from one wild den to another wild den (four pups as of spring of 2021) that reach breeding age will not count toward our genetic objective because they do not increase gene diversity in the MWEPA.

Prior to release from captivity into the wild, Mexican wolves receive permanent identification marks and radio collars (if appropriate for the age and size of the wolf), and their DNA profile is recorded to assist with ongoing pedigree analyses of the population. While not all Mexican wolves are radio-collared, we currently attempt to maintain at least two radio collars per pack in the wild. Radio collars allow the USFWS to monitor reproduction, dispersal, survival, pack formation, depredations, predation, and other important biological metrics. We will continue monitoring Mexican wolves while they are listed under the ESA and for at least five years after delisting. A majority of wild Mexican wolves may not have radio collars as the population grows.

Any Mexican wolf found outside of the MWEPA would have either dispersed out of the MWEPA or across the border from Mexico. A combination of identification mechanisms, such as identification marks, radio collars, DNA analysis, and ongoing monitoring will make identification of the population of origin probable. It is possible that gray wolves could disperse from other regions such as the northern Rocky Mountains into Arizona and New Mexico. These gray wolves are typically larger in size and may have distinctive coats, such as all black or white, that make them distinguishable from Mexican wolves, in addition to any identification mechanisms from the management areas from which they dispersed.

The MWEPA has been the cornerstone of Mexican wolf recovery in the United States since its designation in 1998. Then, as now, the MWEPA is the only place in the United States where a population of Mexican wolves exists in the wild. The experimental population remains the focus of our recovery efforts in the United States and plays a significant role in the long-term conservation and recovery of the Mexican wolf. Specifically, the USFWS intends for the MWEPA population to achieve the recovery criteria for the United States population provided in the revised recovery plan (USFWS 2017a, pp. 18-25) (see Recovery Efforts, above). As such, we are proposing population and genetic objectives for the MWEPA that would reduce threats consistent with the recovery needs of the Mexican wolf. Also, we are proposing to temporarily restrict the use of three take provisions in support of achieving the genetic objective and furthering Mexican wolf conservation and recovery.

Adverse effects on extant populations of the Mexican wolf, including the captive population and the wild population in Mexico, as a result of removal of individuals for introduction into the MWEPA will not occur for the following reasons:

The Mexican wolf reintroduction in the MWEPA was established beginning in 1998 using Mexican wolves bred and housed in captivity because no wild Mexican wolves existed for translocation into the MWEPA. We continue to use captive animals for release into the MWEPA today. As of June 30, 2020, 369 captive Mexican wolves were managed as a single captive population across 55 participating facilities (Scott et al. 2020, p. 7). The primary purpose of the captive-breeding program is to supply wolves for reestablishing Mexican wolves into the wild. Mexican wolves selected for release from the captive-breeding program are genetically well-represented in the captive population, thus minimizing any adverse effects on the genetic integrity of the remaining captive population. The Mexican Wolf SSP maintains detailed lineage information on each captive Mexican wolf and establishes annual breeding objectives to maintain the genetic diversity of the captive population (Scott et al. 2020, entire). The Mexican Wolf SSP meets with the agencies responsible for Mexican wolf reintroduction in the United States and Mexico annually to discuss release objectives for the year ahead.

The captive population remains capable of supporting both the U.S. and Mexico populations of wild Mexican wolves. Over the course of the reintroduction from 1998 to December 31, 2020, we have released 146 captive wolves to the MWEPA, including the release of 51 wolves (1 adult, 50 pups) between January 1, 2015, and December 31, 2020, to improve gene diversity (USFWS files). For clarity, only releases subsequent to December 2015 count toward the genetic criterion in the revised recovery plan (USFWS 2017a, p. 23). Mexico has released 49 captive wolves between 2011 and February 24, 2021 (USFWS files). This proposed rule recommends a higher number of releases to the wild than the 2015 10(j) rule (see Release Procedures, above) but that is well within the current capacity of the captive program (Miller 2017, p. 42). Releases from the SSP facilities can benefit the captive-breeding program by freeing up space for additional breeding of Mexican wolves in captivity, which can slow the loss of genetic diversity (Scott et al. 2020, p. 9; also see Mechak et al. 2016, pp. 1-15). Based on our proposed revisions described in this document, we will release a sufficient number of captive Mexican wolves to the MWEPA such that at least 22 survive to breeding age and the gene diversity in the MWEPA represents approximately 90 percent of the gene diversity available in captivity.

No wolves have been removed from the wild in Mexico for translocation ( i.e., release) into the MWEPA since Mexico began releasing wolves to the wild in 2011. We do not need to translocate wolves from the wild Mexico population into the United States to assist the growth or stability of the MWEPA population due to the growth already occurring in the MWEPA population. We recognize that Mexico is still in the early phases of establishing a population, and at its current small size, it could not support occasional or frequent removal of wolves for translocation to the United States. In the biological report that accompanies the revised recovery plan, we investigated release scenarios with various levels of translocation of Mexican wolves from the United States to Mexico, but not the reverse, for this reason (Miller 2017, pp. 16-38). We recognize the importance of supporting Mexico in achieving the recovery criteria in Mexico, and we would not request removal of wolves from Mexico for translocation to the United States unless it were beneficial for both populations. If we requested translocation of Mexican wolves from Mexico, it would be on a very limited basis for a specific reason, such as to improve gene diversity in the recipient population and reduce mean kinship in the donor population. Therefore, any translocations from Mexico to the United States would be sufficiently rare and assessed for mutual benefit so as to have no adverse impacts on the wild population in Mexico. We will continue to rely on the captive population for our release needs in the MWEPA.

As we stated in the 2015 10(j) rule, the experimental population has consistently demonstrated signs of establishment, such as wolves establishing home ranges and reproducing (80 FR 2512, January 16, 2015, p. 2551). Since the publication of the 2015 10(j) rule, the population has continued to exhibit these signs. 2020 marked the 19th year in which wild-born Mexican wolves bred and raised pups in the wild (USFWS files), demonstrating sustained natural reproduction. The population has exhibited steady growth under the 2015 10(j) rule, from a minimum of 112 to 186 wolves from the end of 2014 through 2020. During the same time period, the number of breeding pairs increased from 9 to 20, and the population expanded geographically from 7,255 mi 2 (18,790 km 2 ) to 19,495 mi 2 (50,492 km 2 ) (USFWS 2014; USFWS files). Substantial areas of high-quality habitat remain unoccupied in the MWEPA, allowing for continued geographic expansion of the population as it increases numerically.

As discussed in Threats/Causes of Decline, above, we actively manage to lessen or alleviate threats to the Mexican wolf throughout the MWEPA. Also, as discussed in Recovery Efforts, above, we continue to demonstrate our commitment to the recovery of the Mexican wolf through our use of regulatory tools, evolving field techniques, law enforcement, and partnerships and outreach. Based on the biological characteristics of the population, including its demonstrated growth and expansion, coupled with the ongoing intensive management and monitoring efforts of the USFWS and our partners, and our demonstrated adaptive and collaborative management approach, the population in the MWEPA is established and the likelihood of survival is extremely high.

Continuing the effort to reestablish the experimental population will have significant, direct, immediate, and long-term measurable benefit to the recovery of the Mexican wolf. As discussed above in Recovery Efforts, the revised recovery plan states that recovery of the Mexican wolf will be achieved when two self-sustaining populations—one in the United States and one in Mexico—have been established and safeguarded from threats as provided for by the recovery criteria and actions in the plan. The USFWS intends for the experimental population in the MWEPA to serve as the population that will achieve the recovery criteria for the United States. Our proposed population objective, genetic objective, and temporary restriction of three take provisions are intended to ensure that the experimental population in the MWEPA supports our efforts to achieve the long-term conservation and recovery of the Mexican wolf.

Consistent with our findings in the past (63 FR 1752, January 12, 1998, p. 1755; 80 FR 2512, January 16, 2015, p. 2551), we do not foresee that the introduced population will be adversely affected by existing or anticipated Federal or State actions or private activities. We expect that anticipated Federal, State, or Tribal actions or private activities will not negatively affect the experimental population's ability to increase numerically or continue to expand into suitable habitat in the MWEPA, but some activities could affect individual wolves.

We expect Mexican wolves in the MWEPA to primarily occupy forested areas on Federal lands due to the availability of prey in these areas and supportive management regimes. We expect the majority of the Mexican wolf population to occur on Federal lands within Zones 1 and 2 of the MWEPA, but we also recognize that Mexican wolves may seek to inhabit suitable habitat on Tribal or private lands or may disperse through or occasionally occupy less-suitable habitat of various land ownership types in Zones 2 and 3.

Zone 1, the area where Mexican wolves may be initially released from captivity or translocated, is comprised of the Apache, Gila, and Sitgreaves National Forests; the Payson, Pleasant Valley, and Tonto Basin Ranger Districts of the Tonto National Forest; and the Magdalena Ranger District of the Cibola National Forest. The USFS manages these areas to sustain the health, diversity, and productivity of the Nation's forests and grasslands to meet the needs of present and future generations. The National Forests are responsible for developing and operating under a land and resource management plan, which outlines how each of the multiple uses on the forest will be managed. The USFS is a signatory to the 2019 MOU and actively participates in daily management of the experimental population (see Is the Experimental Population Essential to the Continued Existence of the Species in the Wild? below, for additional discussion of the USFS's role and contributions to the management and recovery of the Mexican wolf in the MWEPA). We anticipate that individual Mexican wolves or wolf packs may be affected by actions and activities associated with ranching activities on public land, because wolves that depredate livestock or display nuisance behavior may be hazed or removed.

Zone 2 of the MWEPA contains a matrix of land ownerships, including Federal ( e.g., USFS, Bureau of Land Management, Department of Defense), State, private, and Tribal lands. A variety of actions and activities may occur throughout this zone, such as recreation, agriculture and ranching, urban and suburban development, and military operations. Similar to Zone 1, we anticipate that individual Mexican wolves or wolf packs may be affected by actions and activities occurring on private or Tribal land in Zone 2, such as ranching operations, because wolves that depredate livestock or display nuisance behavior may be hazed or removed. We will continue to establish management actions in cooperation with private landowners and Tribal governments to support the recovery of the Mexican wolf on private and Tribal lands, and we will continue our efforts to support programs that fund depredation compensation and preventative/proactive management activities aimed at reducing wolf-livestock conflicts.

Road and human densities have been identified as potential limiting factors for colonizing wolves in the Midwest and Northern Rocky Mountains due to the mortality associated with these landscape characteristics (Mladenoff et al. 1995, entire; Oakleaf et al. 2006, pp. 558-561). Vehicular collision in particular is not identified as having a significant impact on the Mexican wolf population, although it may contribute to the overall vulnerability of the population due to its small population size and cumulative effects of multiple factors, including inbreeding and illegal shooting of wolves (80 FR 2488, January 16, 2015, p. 2503). We recognize that human and road densities in the MWEPA are within the recommended levels for Mexican wolf colonization, and are expected to remain so in the future; therefore, we see the impact to the population from actions related to human development as minimal within the areas we expect Mexican wolves to primarily inhabit in Zones 1 and 2. More information about vehicular collisions can be found in the final rule determining endangered status for the Mexican wolf (80 FR 2488, January 16, 2015).

The border wall along the southern boundary of the MWEPA in Zones 2 and 3 may affect Mexican wolves that try to disperse southward from the MWEPA or northward from Mexico. We expect these dispersal occurrences to be fairly rare, as discussed in Location and Boundaries of the Proposed Experimental Population, above. Such occurrences will only be affected if dispersal activity is blocked or altered by the border wall.

The location of the experimental population is the MWEPA, as defined at 50 CFR 17.84(k). Mexican wolves will move throughout the MWEPA in their daily feeding and sheltering activities. We can identify Mexican wolves based on the permanent identification marks we give them prior to release, or by radio collar, DNA analysis, or visual observation.

The ESA instructs us to determine whether a population is essential to the continued existence of an endangered or threatened species. Our regulations define “essential experimental population” as an experimental population whose loss would be likely to appreciably reduce the likelihood of survival of the species in the wild (50 CFR 17.80(b)). The USFWS defines “survival” as the condition in which a species continues to exist in the future while retaining the potential for recovery (USFWS and National Marine Fisheries Service 1998). Inherent in our regulatory definition of “essential experimental population” is the impact the potential loss of the experimental population would have on the species as a whole (49 FR 33885; August 27, 1984). All experimental populations not meeting this bar are considered “nonessential” (50 CFR 17.80(b)).

We designated the Mexican wolf experimental population in the MWEPA as nonessential in 1998 (63 FR 1752; January 12, 1998). The March 31, 2018, Order instructs us to make a new essentiality designation because our geographic expansion of the MWEPA in the 2015 10(j) rule would result in Mexican wolf occupancy outside of areas previously considered when we made our 1998 essentiality determination. We now propose to maintain the designation of the experimental population in the MWEPA as nonessential based on the following information and considerations:

Reestablishing a species, is by its very nature, an experiment for which the outcomes are uncertain. However, it is always our goal to successfully reestablish a species in the wild so that the species can be recovered and removed from the Federal List of Endangered and Threatened Wildlife. This is consistent with the ESA's requirements for section 10(j) experimental populations. Specifically, the ESA requires experimental populations to further the conservation of the species. At 16 U.S.C. 1532(3), the ESA defines conservation as the use of all methods and procedures which are necessary to bring any endangered or threatened species to the point at which the measures provided pursuant to the ESA are no longer necessary. In short, experimental populations serve the species' recovery.

The importance of an experimental population to a species' recovery does not mean the population is “essential” under section 10(j) of the ESA. All efforts to reestablish a species are undertaken to move that species toward recovery. If importance to recovery was equated with essentiality, no reestablished populations of a species would qualify for nonessential status. This interpretation would conflict with Congress' expectation that “in most cases, experimental populations will not be essential” (H.R. Conference Report No. 835, supra at 34; 49 FR 33885, August 27, 1984). Therefore, although we have indicated that we will manage the MWEPA population to achieve the recovery criteria for the U.S. population of Mexican wolves, the MWEPA population's importance to recovery does not equate with the MWEPA being designated as essential.

In the final rule published on January 12, 1998 (63 FR 1752), we determined that the experimental population was not essential to the survival of the species in the wild based on the current and expected future availability of Mexican wolves in captivity that would be available for release to the wild. Just prior to the 1998 designation, the captive program included 148 animals in 44 facilities in the United States and Mexico. We stated in the 1998 designation that the captive population had doubled in size over the previous 3 years, demonstrating its reproductive potential to replace reintroduced wolves that died (63 FR 1752, January 12, 1998, p. 1753). While we expected that some wolves would die after removal from the captive population, we also expected that the captive population had the capacity to support another reintroduction attempt in the extreme event that the entire population died. We established an expectation from the earliest days of the reintroduction that wolves released to the wild would be genetically redundant to wolves in captivity, such that no unique genes would be lost if released wolves did not survive. This approach ensured the genetic integrity of the captive population and the survival of the subspecies. We stated that the genetic management of the captive population would be conducted by the American Zoo and Aquarium Association's SSP program, using state-of-the-art technology and being guided by an expert advisor specializing in small population management.

Now, taking into consideration our expansion of the MWEPA in the 2015 10(j) rule and the growth of the MWEPA population since the reintroduction began, we maintain our position that the captive population serves as a safeguard for the survival of the Mexican wolf in the wild. Although the revised geography of the MWEPA results in Mexican wolves occupying new areas south of I-40 in Arizona and New Mexico south to the international border with Mexico, wolves that may occupy any area within the revised MWEPA are part of the same experimental population we initiated in 1998. Our previous rationale stands for this now enlarged area: Even if the entire population in the MWEPA died, which is extremely unlikely (see Likelihood of Population Establishment and Survival, above), animals from captivity would be available to reintroduce to the wild to reestablish the population. In fact, the captive population is more capable of producing genetically redundant wolves for release than it was in 1998, due to its increased size. As of June 30, 2020, the captive population housed 369 wolves in 55 facilities (Scott et al. 2020, p. 7). Many of the facilities that house and breed wolves in captivity have been doing so for two to three decades, demonstrating a firm commitment as a partner in this effort and gaining considerable experience in husbandry and rearing techniques. The SSP continues to annually meet or exceed its goal to maintain a captive population of 300 wolves. The captive population could be expanded beyond its current size with the addition of more participating facilities that would enable more wolves to be placed into breeding situations (Scott et al. 2020, p. 7).

In addition to the capacity of the captive population to produce the number of wolves that would be necessary to reinitiate a reintroduction, the SSP continues to demonstrate rigorous management of the genetic integrity of the captive population. The SSP prioritizes the breeding of select individuals, and multiple facilities and institutions within the SSP invest in gamete collection and preservation for use in promising assisted reproductive technologies that allow individual wolves to contribute genetically to the population after their death (Scott et al. 2020, pp. 82-83). The rigorous management of the captive facilities combined with the increasing exploration of and potential to use reproductive technologies further strengthen our position that the captive population has the current capacity and demonstrated record of accomplishment to produce Mexican wolves for release to ensure the survival and recovery of the Mexican wolf in the wild.

We propose our designation in recognition that the gene diversity of the captive population will slowly decline over time. The 2020 SSP masterplan for the Mexican wolf states, “Currently this population could maintain only 75% gene diversity for 59 years and would be expected to maintain 72.3% after 100 years (Scott et al. 2020, p. 9).” We acknowledge that the captive population is based on a small number of founders with no possibility of new Mexican wolf founders that could add gene diversity, which limits the gene diversity of the captive Mexican wolf population and any wild population initiated with captive wolves. We also acknowledge that limited breeding capacity due to the number of captive facilities available for breeding coupled with the social structure of the species (not all wolves are breeders) will affect the rate of loss of gene diversity in the captive population over time (Scott et al. 2020, p. 9). However, these factors do not make the captive population unfit to serve as a source for additional reintroductions because the breeding of underrepresented founders, the addition of facilities for breeding events, and the use of reproductive technologies can be increased in order to slow the loss of gene diversity in the captive population. That is, the rate of gene loss can be controlled to a large degree by the management of the captive population. Loss of gene diversity in the captive population would limit future reintroduction potential if it occurred to such an extent that inbreeding effects were observed and resulted in wolves unfit for release. At the current time there is no indication of this, nor is there a specific degree of gene loss at which we have certainty this would occur. Therefore, while we recognize that gene diversity limitations have and will continue to persist, they are not occurring to a degree that curtails our ability to consider a future reintroduction of Mexican wolves to the wild or for those wolves to retain the potential for recovery.

We also note the reintroduction of Mexican wolves in Mexico beginning in 2011, which has resulted in the establishment of a second population of wild Mexican wolves. This effort is a central part of the recovery effort for the Mexican wolf and is not dependent demographically on dispersal of wolves from the MWEPA for its establishment, although translocations from the United States may be undertaken for various management purposes. A loss of wolves in the MWEPA would not disable Mexico's ability to achieve recovery; meanwhile, the MWEPA population could be re-established.

We note that when the MWEPA was designated in 1998 (see 63 FR 1752; January 12, 1998), the Mexican wolf was protected as endangered through the gray wolf listing (see 43 FR 9607; March 9, 1978). We indicated our intent in that rule to conserve subspecies such as the Mexican wolf (43 FR 9607, March 9, 1978, pp. 9609-9610). As such, our designation of an experimental population of the Mexican wolf was in relation to the Mexican wolf subspecies, not the gray wolf species. Therefore, our rationale for designating the MWEPA as nonessential was also in relation to the Mexican wolf subspecies only and did not take into consideration other gray wolf populations (63 FR 1752; January 12, 1998). In 2015, we published a final rule (80 FR 2488; January 16, 2015) listing the Mexican wolf as an endangered subspecies to make its listing independent of the gray wolf species listing. This change in listing, from being part of a species-level listing to a subspecies listing, does not alter our above rationale related to the role of the captive population in our essentiality determination because, consistent with our original designation, we continue to consider the designation of the MWEPA in relation to the Mexican wolf subspecies.

As described in this proposed rule, the USFWS and our partners have over two decades of management experience that support our position that we could successfully reinitiate a reintroduction. In 1998, we stated that in the event of the loss of the entire population, future reintroductions would be possible if the reasons for initial failure were understood (63 FR 1752, January 12, 1998, p. 1754). Not only have we not experienced any such initial failure, we have demonstrated success in growing the population to a minimum of 186 wild wolves. Along the way, we have engaged in adaptive management to hone effective release techniques and identify successful release locations and timing; we have developed and implemented depredation avoidance techniques; we have expanded our partnership network to bring additional expertise and capacity to bear; we have solidified our recovery goals and revised our management regulations; and we continue to integrate new technologies as they become available to track and monitor wolves and collect data. We are better informed and equipped now, and will be in the future, to initiate and manage a reintroduction than we were in 1998.

In addition to considering our logistical potential to conduct a new reintroduction and the degree to which the recovery potential of the Mexican wolf would be retained in such circumstances based on the status of the captive population, our finding of whether a population is essential is also made with our understanding that Congress enacted the provisions of the ESA's section 10(j) to mitigate fears that reestablishing populations of endangered or threatened species into the wild would negatively impact landowners and other private parties. Congress recognized that flexible rules could encourage recovery partners to actively assist in the reestablishment and hosting of such population on their lands (H.R. Conference Report. No. 97-567, at 8(1982)). Although Congress allowed experimental populations to be identified as either essential or nonessential, they noted that most experimental populations would be nonessential (H.R. Conference Report No. 835, supra at 34; see 49 FR 33885, August 27, 1984). Mexican wolves, due to their status as a top predator, have created significant dissension and concern in local communities. In this regard, we note that we are in a unique position in making this finding as an extension of an existing experimental population, as opposed to a new population designation in another geographic area. Because of this, we consider it even more important to maintain the existing partnerships and management arrangements that we have built over the last two decades of the reintroduction because they enhance our ability to address local concerns and contribute to the recovery progress of the Mexican wolf. Our intent to establish a collaborative management scheme for the reintroduction has been evident since 1998, when we discussed the role of cooperating agencies in the management, identification, and monitoring of the reintroduced population (63 FR 1752, January 12, 1998, p. 1754). Currently, we manage the reintroduction pursuant to the 2019 MOU with a host of Federal and State agencies, a Tribe, and several counties and local governments, each of which plays a unique and important role. We recognize that changing course to an essential designation could result in challenges in maintaining these partnerships.

Section 7 of the ESA, titled Interagency Cooperation, outlines the procedures for Federal interagency cooperation to conserve Federally listed species and designated critical habitats. Section 7(a)(1) directs the Secretaries of the Interior and Commerce to review other programs administered by them and utilize such programs to further the purposes of the ESA. It also directs all other Federal agencies to utilize their authorities in furtherance of the purposes of the ESA by carrying out programs for the conservation of species listed pursuant to the ESA. This section of the ESA makes it clear that all Federal agencies should participate in the conservation and recovery of listed endangered and threatened species. Under this provision, Federal agencies often enter into partnerships and memoranda of understanding with the USFWS to implement and fund conservation agreements, management plans, and recovery plans for listed species.

The primary land management agency within the MWEPA is the USFS, which manages land under a multiple use mandate. The USFS is a signatory to the 2019 MOU for Mexican Wolf Recovery and Management. According to the 2019 MOU, the USFS will provide a liaison to the Interagency Field Team (IFT) to: (1) Serve as the primary liaison between the IFT and USFS on all Mexican wolf issues that pertain to USFS-managed lands, USFS permittees, and other users; (2) provide coordination between the various USFS district rangers/wildlife staff/regional office and the IFT on wolf-related activities and issues; (3) provide assistance and input on IFT issues and priorities; and (4) facilitate obtaining necessary USFS authorizations, permits, environmental analyses, and closure orders.

The USFS has implemented proactive conservation efforts for the Mexican wolf on a multiple use landscape. The USFS districts work closely with the IFT and meet at least four times per year to coordinate the following:

• Review locations of current wolf territories and den/rendezvous sites to coordinate with planned land management actions (including range, fire, timber, recreation) and mitigate potential impacts;

• Coordinate with each district in developing a district-specific livestock carcass removal strategy so that carcasses can be removed from grazing allotments when appropriate to reduce potential wolf/livestock conflict;

• Attend annual operating instructions meetings with range conservationists and individual livestock permittees to review allotment-specific wolf information and develop conflict reduction strategies;

• Update the district range conservationist when depredations occur and explore strategies to reduce conflicts;

• Update livestock permittees approximately every 2 weeks on new wolf locations on their allotments with the intent of reducing wolf/livestock conflicts, encouraging proactive measures, and improving information exchange with the wolf biologist(s) assigned to that area;

• Coordinate with nongovernmental organizations for funding of proactive measures in areas with high depredation rates; and

• Coordinate to help ensure successful implementation of cross-fostering efforts on USFS lands to reach genetic recovery goals.

For the ESA's section 7 consultation purposes, section 10(j) requires the following:

• Any nonessential experimental population located outside a National Park or National Wildlife Refuge System unit is treated as a proposed species for the purposes of section 7 (conference may be conducted);

• Any essential population is treated as a threatened species for purposes of section 7 consultation (standard consultations are conducted);

• Critical habitat may be designated for essential experimental populations (standard consultations are conducted), but not for nonessential experimental populations; and

• All populations of the species (including populations designated as experimental) are considered to be a single listed entity when making jeopardy determinations or other analyses in a section 7 consultation.

By definition, a “nonessential experimental population” is not essential to the continued existence of the species. Therefore, no proposed action impacting a population so designated could lead to a jeopardy determination for the entire species. Because the USFS is implementing their section 7(a)(1) responsibilities, is a signatory to the 2019 MOU along with 13 other agencies and entities, and is implementing conservation measures, it is appropriate for the Mexican wolf to be treated as a proposed species for the purposes of section 7 under the nonessential designation.

For Mexican wolves that occur outside the MWEPA due to dispersal activity, the ESA prohibits activities that “take” endangered and threatened species unless a Federal permit allows such “take.” Along with our implementing regulations at 50 CFR part 17, the ESA provides for “take” permits and requires that we invite public comment before issuing these permits. A permit issued by us under section 10(a)(1)(A) of the ESA authorizes activities otherwise prohibited by section 9 for scientific purposes or to enhance the propagation or survival of the affected species, including acts necessary for the establishment and maintenance of experimental populations. Our regulations regarding implementation of section 10(a)(1)(A) permits are found at 50 CFR 17.22 for endangered species.

We have developed a section 10(a)(1)(A) permit to allow for certain activities with Mexican wolves that occur both inside and outside the MWEPA. If Mexican wolves travel outside the MWEPA, we intend to capture and return them to the MWEPA or place them in captivity.

The USFWS will measure the success, failure, and effects of releases, translocations, proactive management, removals, and other management actions by monitoring, researching, and evaluating the status of Mexican wolves and their offspring in the MWEPA. Using adaptive management principles, the USFWS will continue to modify subsequent management actions and strategies depending on what we learn and the status of the population. We will prepare periodic progress reports, annual reports, and publications, as appropriate, to evaluate our progress. The reviews and progress reports we foresee completing in the future include: Quarterly updates and annual reports; five-year status evaluations pursuant to section 4(c)(2) of the ESA, with the next evaluations occurring in 2023 and 2028; 5- and 10-year recovery progress evaluations pursuant to the revised recovery plan, during which we will assess progress toward recovery based on data through 2022 and 2027 for the 5- and 10-year evaluations, respectively, and which will result in the publication of our evaluations in 2023 and 2028; the phasing evaluations for western Arizona as established in the 2015 10(j) rule, which occurred in 2020 and will occur in 2023; and an evaluation of this revised rule approximately 5 years after implementation begins, which would be based on data through the annual population count in 2027 and which we will synchronize with our 2027 recovery plan evaluation to ensure we conduct a wholistic review of the experimental population within the context of recovery, for publication in 2028.

In accordance with 50 CFR 17.81(d), to the maximum extent practicable, this proposed rule represents an agreement between the USFWS, the affected State and Federal agencies, and persons holding any interest in land that may be affected by the establishment of this experimental population. We invited 60 Federal and State agencies, local governments, and Tribes to participate as cooperating agencies in the development of the DSEIS, 24 of which signed a memorandum of understanding (MOU). The purpose of this MOU was for the signatory entities to contribute to the preparation of the DSEIS that analyzes the proposed revisions to the regulations for the MWEPA. The revisions proposed in this rule directly reflect the input of State game and fish agencies, local governmental entities, and affected Federal agencies.

In April 2020, we notified the Tribal governments of all the Native American Tribes in Arizona and New Mexico of our intent to prepare a proposed revised 10(j) rule and DSEIS. We held several Tribal working group meetings to provide opportunity for input, discuss the current status of the DSEIS development, and address issues raised by the Tribes. We also provided updates and opportunities for Tribal input to our process during Tribal coordination meetings convened by the Arizona Ecological Services Field Office in Phoenix, Arizona, and the New Mexico Ecological Services Field Office in Albuquerque, New Mexico.

Due to the difficulty of conducting in-person meetings during the COVID-19 pandemic, we conducted most meetings related to this process via virtual video or telephone meetings. We met with affected Federal and State agencies, representatives from local and Tribal governments, and stakeholder groups representing interested parties to discuss the proposed rule and DSEIS. We met with the Arizona Game and Fish Department and New Mexico Department of Game and Fish to collect data for the biological resources and economics analyses and to discuss proposed revisions. We coordinated regularly to discuss their issues and recommendations.

In addition to the coordination provided specific to the development of the proposed rule and DSEIS, we note that we also conduct the management and recovery of the Mexican wolf within an interagency framework that is defined by our 2019 MOU (see Recovery Efforts, above).

Numerous other entities and individuals provided comments during scoping or at other times during our process that did not reflect the best available scientific and commercial information or contribute to the conservation and recovery of the species. It is not practicable for this proposed rule to represent an agreement between the USFWS and all persons holding any interest in land that may be affected by the revision to the designation of this experimental population. We reviewed approximately 87,000 public scoping comments to develop this proposed rule and the DSEIS. We will hold virtual public meetings and hearings during the public comment period for this proposed rule and the DSEIS (see DATES and ADDRESSES , above), and we will consider all comments we receive during the open public comment period in the development of our final rule and final SEIS.

In accordance with joint policy published in the Federal Register on July 1, 1994 (59 FR 34270), we will seek the expert opinions of at least three appropriate and independent specialists regarding this proposed rule. We have provided copies of this proposed rule to three or more appropriate and independent specialists in order to solicit comments on the scientific data and assumptions we used. The purpose of such review is to ensure that the final determination is based on scientifically sound data, assumptions, and analyses. As directed by the USFWS Peer Review Policy dated July 1, 1994 (59 FR 34270), and a recent memo updating the peer review policy for listing and recovery actions (August 22, 2016), we will invite peer reviewers to comment on our methods and conclusions, and provide additional information, clarifications, and suggestions to improve the final determination. We will consider their comments and information on proposed modifications during preparation of a final rule. Accordingly, the final decision may differ from this proposal.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The Executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 801 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities. We certify that this proposed rule would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include such businesses as manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and forestry and logging operations with fewer than 500 employees and annual business less than $7 million. To determine whether small entities may be affected, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

Importantly, the impacts of a rule must be both significant and substantial to prevent certification of the rule under the Regulatory Flexibility Act and to require the preparation of an initial regulatory flexibility analysis. If a substantial number of small entities are affected by the proposed rule, but the per-entity economic impact is not significant, the USFWS may certify. Likewise, if the per-entity economic impact is likely to be significant, but the number of affected entities is not substantial, the USFWS may also certify.

In our 2015 10(j) rule, we found that the experimental population would not have significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act. The 2015 10(j) rule expanded the geographic boundaries of the MWEPA, established new management zones with provisions for initial release and translocation of Mexican wolves, revised and added allowable forms of take, and clarified definitions. We concluded that the rule would not significantly change costs to industry or governments. Furthermore, the rule produced no adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. enterprises to compete with foreign-based enterprises in domestic or export markets. We further concluded that no significant direct costs, information collection, or recordkeeping requirements were imposed on small entities by the action and that the rule was not a major rule as defined by 5 U.S.C. 804(2) (80 FR 2512, January 16, 2015, pp. 2553-2556).

Under this proposal, we would modify the population objective, establish a genetic objective, and temporarily restrict three of the forms of take of Mexican wolves in the MWEPA that we adopted in the January 16, 2015, final rule. We are proposing these revisions to ensure the long-term conservation and recovery of the Mexican wolf. In addition, we are proposing to maintain the nonessential designation for the experimental population. We are not proposing to revise the geographic boundaries of the MWEPA.

Because of the regulatory flexibility for Federal agency actions provided by the MWEPA's 10(j) designation, we continue to expect this rule not to have significant effects on any activities within Federal, State, or private lands within the experimental population. In regard to section 7(a)(2) of the ESA, except on National Park Service and National Wildlife Refuge System lands, the population is treated as proposed for listing, and Federal action agencies are not required to consult on their activities. Section 7(a)(4) of the ESA requires Federal agencies to confer (rather than consult) with the USFWS on actions that are likely to jeopardize the continued existence of a species. However, because a nonessential experimental population is, by definition, not essential to the survival of the species, conferencing is unlikely to be required within the MWEPA. Furthermore, the results of a conference are strictly advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. In addition, section 7(a)(1) of the ESA requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the experimental population area. As a result, and in accordance with these regulations, if we adopt this rule as proposed, some modifications to the Federal actions within the experimental population area may occur to benefit the Mexican wolf, but we do not expect projects on Federal lands to be halted or substantially modified as a result of these regulations.

However, this proposed rule would allow a larger population of Mexican wolves to occupy the MWEPA, which has the potential to affect a greater number of small entities involved in ranching and livestock production, particularly beef cattle ranching (business activity code North American Industry Classification System (NAICS) 112111), sheep farming (business activity code NAICS 112410), and outfitters and guides (business activity code NAICS 114210). Small entities in these sectors may be affected by Mexican wolves depredating on, or causing weight loss of, domestic animals (particularly beef cattle), or preying on wild native ungulates, respectively. We have updated our assessment to small entities in the DSEIS.

Small businesses involved in ranching and livestock production may be affected by Mexican wolves depredating on domestic animals, particularly beef cattle. Direct effects to small businesses could include foregone calf or cow sales at auctions due to depredations. Indirect effects could include impacts such as increased ranch operation costs for surveillance and oversight of the herd, and weight loss of livestock when wolves are present. Ranchers have also expressed concern that a persistent presence of wolves may negatively impact their property and business values. We do not foresee a significant economic impact to a substantial number of small entities in the ranching and livestock production sector based on the following information:

The small size standard for beef cattle ranching entities and sheep farms as defined by the Small Business Administration are those entities with less than $1.0 million in average annual receipts ( http://www.sba.gov/content/summary-size-standards-industry-sector ). We consider close to 100 percent of the cattle ranches and sheep farms in Arizona and New Mexico to be small entities. The 2017 Census of Agriculture reports that there were 7,057 cattle and calf operations and 7,509 sheep farms in Arizona, and 10,880 cattle and calf operations and 4,047 sheep farms in New Mexico.

Of the approximately 18,000 cattle ranches in Arizona and New Mexico, 12,334 occur in counties in the MWEPA (2017 Census of Agriculture data by county). These operations account for approximately 69 percent of the total for both States. The actual number of ranches within the project area is far less than this estimate because several counties extend beyond the borders of the project area or the ranches occur in areas where we do not expect wolf occupancy due to low habitat suitability. The Agricultural Census does not report sub-county farms or inventory, so relying on the county numbers is the best available data for estimating the number of potentially affected small ranching operations.

Cattle ranches vary significantly in herd size, with classifications ranging from a herd of 1 to 9 animals, to those with more than 2,500 animals (2017 Census of Agriculture). Over 80 percent of these ranches have fewer than 50 head of cattle.

We assessed whether a substantial number of entities would be impacted by this proposed rule by estimating the annual number of depredations we expect to occur within the project area when the Mexican wolf population will be at its largest. Between 1998 and 2019, on average, there were 151 total depredations (confirmed and unconfirmed) by Mexican wolves in any given year, which equates to 1.7 cow/calves killed for every Mexican wolf. Based on this, we estimate the average number of cattle killed (both confirmed and unconfirmed) in any given year for 320 wolves will be 544 individuals. We expect the experimental population to grow from its current minimum population estimate of 186 wolves to an 8-year average population of 320. Assuming that one cow is depredated per ranch, we expect the number of affected ranches to increase from 151 ranches to 544 ranches when the wolf population reaches 320 individuals. At this point, if each expected depredation affects a unique ranch, then a total of approximately four percent of ranches in the area would be impacted.

To the extent that some cattle ranches will most likely not be impacted by wolf recovery because they are not located in suitable habitat but are included in the total estimate of potentially affected ranches because the Agricultural Census does not provide data at a sub-county level, this estimate could understate the percentage of ranches potentially affected. However, for other reasons, this estimate could very well overstate the percentage of cattle ranches affected as we recognize that annual depredation events have not been, and may not be, uniformly distributed across the ranches operating in occupied wolf range. Rather, wolves seem to concentrate in particular areas, and to the extent that livestock are targeted by the pack for depredations, some ranch operations will be disproportionately affected. Therefore, it is more likely that fewer than 544 ranches may experience more than one depredation, rather than each of 544 ranches experiencing one depredation.

Compared to the 2017 total inventory of estimated ranch cattle (259,192) for the project area of the Blue Range Wolf Recovery Area (BRWRA), both confirmed and unconfirmed depredations per 100 Mexican wolves account for 0.2 percent of the herd size. The economic cost of Mexican wolf depredations in this time period has been a small percentage of the total value of the livestock operations. With a population objective of an average of 320 Mexican wolves in the MWEPA, the expected value of 544 cattle (174.3 cattle killed per 100 Mexican wolves on average for any year) at auction based on a weighted average market value for a depredated cow/calf of $1,094.72 ($2020), the total annual impact would be $595,500. If depredations uniquely affect a separate operation, then a total of 544 operations would incur an expected corresponding loss of $1,095.

Small businesses involved in ranching and livestock production could also be indirectly affected by weight loss of livestock due to the presence of Mexican wolves. For example, livestock may lose weight because wolves force them off suitable grazing habitat or away from water sources. Livestock may try to protect themselves by staying close together in protected areas where they are more easily able to see approaching wolves and defend themselves and their calves. A consequence of such a behavioral change would likely be weight loss, especially if the wolves are allowed to persist in the area for a significant amount of time because the cattle would be afraid to spread out to find more lucrative forage areas. Weight loss could also occur if the presence of wolves causes the herd to move around more rapidly as they try to keep away from wolves. Based on Ramler et al. 2014, weight loss of cattle is associated with the ranches that have suffered depredations. Therefore, we would expect the same ranches—that is, 544 ranches or fewer—that are impacted by depredations to potentially be impacted by weight loss of their cattle. Because wolves' tendency to prey on cattle is localized, we would not expect all 544 ranches and their associated herds to be impacted.

Using a mid-point estimate of 6 percent weight loss for calves at the time of auction, we calculated the impact on 2019 model ranches assuming that wolf presence pressures were allowed to persist throughout the foraging year. Based on mean market prices, a 6 percent weight loss for the herd at the time of sale could result in a profit loss of $3,079 to $16,613 depending on the size of the ranch. Under such a scenario, an affected ranch could incur a 20 percent loss in profit using the model ranch assumptions discussed in the report. This, however, is likely an overestimate of impacts that would occur, as once wolves are detected in an area, a variety of proactive and reactive management tools are available to the landowner or the USFWS and our designated agencies such that wolf presence would not persist throughout a foraging year.

This proposed rule is based on alternative one in our DSEIS. Under this alternative, the experimental population regulations would continue to offer several forms of harassment and take of Mexican wolves on Federal and non-Federal land to address conflict situations between wolves and livestock, although we are also proposing to temporarily restrict two of these until we reach the proposed genetic objective of 22 released wolves surviving to breeding age. The regulations would also continue to provide for initial release of captive wolves into suitable habitat in Zones 1 and 2, and we have demonstrated our intention to reduce nuisance behavior associated with adult releases by using the cross-fostering technique. Further, depredation compensation programs are available to offset some of the economic impacts of livestock depredations (see Recovery Efforts, above); these payments fully offset the impacts of confirmed depredations for some operators but do not fully offset impacts for all operators, such as those who experience unconfirmed losses for which payment is not provided.

Based on the preceding information, we find that the impact of direct and indirect effects of Mexican wolf depredations on livestock is not significant and substantial. That is, if impacts are evenly spread, less than 5 percent of small ranches in the MWEPA will be impacted, which we do not consider to be a substantial number. If impacts are disproportionately felt (several ranchers bear the burden of the depredations), the number of affected ranches will be even less (not substantial), but the impact to those affected may be significant depending on the number of cattle on the ranch and other characteristics.

Our proposed revision of the experimental designation may also impact small business entities associated with big game hunting, due to wolves' predation on wild ungulates, specifically elk, in the MWEPA. Effects to small businesses in this sector could occur from impacts to big game populations, loss of hunter visitation, or a decline in hunter success, leading to lost income or increased costs to guides and outfitters. We would expect impacts to big game hunting to potentially occur from the increased number of wolves in the MWEPA under our proposed population objective or from the temporary restriction of the provision for take in response to an unacceptable impact to a wild ungulate herd. Negative impacts to the big game hunting economic sector would be most likely to occur during the period that this take provision is restricted because State agencies would not be able to request the removal of wolves if they are causing ungulate herds to fall below management goals ( i.e., an unacceptable impact).

As we describe in the DSEIS, we do not have a high degree of certainty as to when impacts to ungulates may occur, but we speculate based on information from gray wolves in other geographic areas that impacts will not occur prior to the wolf-to-1,000-elk ratio reaching above 4 wolves to 1,000 elk (potentially around 2024). We expect to meet our proposed genetic objective by 2030, resulting in the temporary restriction of this take provision for not more than 6 years. After the proposed genetic objective is reached and the restriction on this take provision would be lifted, the States could request the removal of wolves causing unacceptable impacts, which would result in mitigation of any reduction in hunting revenue occurring in that area. Currently, we do not have information suggesting that impacts have occurred. No observable impact on wild ungulates due to wolves has been documented, nor reductions in big game hunting. In Arizona, total harvest of elk and percent success of hunters increased from 2012 to 2017 (the most recent year for which we have data) (Hunt Arizona 2011 and 2017, Survey, Harvest and Hunt Data for Big and Small Game), and stayed stable or increased slightly in New Mexico from 2012 to 2019 (NMDGF files).

For the above reasons and based on currently available information, we certify that, if adopted as proposed, the proposed revision to the existing nonessential experimental population designation of the Mexican wolf would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(1) This proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act that, if adopted, this rulemaking would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. Small governments would not be affected because the experimental designation would not place additional requirements on any city, county, or other local municipalities.

(2) This proposed rule would not produce a Federal mandate of $100 million or greater in any year ( i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). The proposed revisions to the MWEPA would not impose any additional management or protection requirements on the States or other entities.

In accordance with Executive Order 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), this proposed rule does not have significant takings implications. When reestablished populations of federally listed species are designated as nonessential experimental populations, the ESA's regulatory requirements regarding the reestablished listed species within the experimental population are significantly reduced. In the 1998 final rule (63 FR 1752; January 12, 1998), we stated that one issue of concern is the depredation of livestock by reintroduced Mexican wolves, but such depredation by a wild animal would not be a taking under the 5th Amendment. One of the reasons for the experimental population is to allow the agency and private entities flexibility in managing Mexican wolves, including the elimination of a wolf when there is a confirmed kill of livestock.

A takings implication assessment is not required because this proposed rule would not effectively compel a property owner to suffer a physical invasion of property and would not deny all economically beneficial or productive use of the land or aquatic resources. Damage to private property caused by protected wildlife does not constitute a taking of that property by a government agency that protects or reintroduces that wildlife. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of a listed species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132 (Federalism), we have considered whether this proposed rule has significant federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this proposed rule with the affected resource agencies in New Mexico and Arizona. Achieving the population objective for the MWEPA, which serves as one of the recovery criteria for the Mexican wolf, will contribute to the rangewide recovery of the species, which will contribute to its eventual delisting and its return to State management. No intrusion on State policy or administration is expected, roles or responsibilities of Federal or State governments will not change, and fiscal capacity will not be substantially or directly affected. This proposed rule would operate to maintain the existing relationship between the State and the Federal Government. Therefore, this proposed rule does not have significant federalism effects or implications to warrant the preparation of a federalism summary impact statement under the provisions of Executive Order 13132.

In accordance with Executive Order 12988 (February 7, 1996; 61 FR 4729), we have determined that this proposed rule will not unduly burden the judicial system and will meet the requirements of sections (3)(a) and (3)(b)(2) of the Order.

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relatives with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we have notified the Native American Tribes within and adjacent to the nonessential experimental population area about the proposed rule and DSEIS. They have been advised through written contact, including informational mailings from the USFWS and email notifications to attend video and teleconference informational sessions, and will be provided an opportunity to comment on the DSEIS and proposed rule. If future activities resulting from this proposed rule may affect Tribal resources, the USFWS will communicate and consult on a government-to-government basis with any affected Native American Tribes in order to find a mutually agreeable solution.

This proposed rule does not contain any new collection of information that requires approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). OMB has previously approved the information collection requirements associated with permitting and reporting requirements associated with native endangered and threatened species, and experimental populations, and assigned the following OMB control numbers:

• 1018-0094, “Federal Fish and Wildlife Permit Applications and Reports—Native Endangered and Threatened Species; 50 CFR 10, 13, and 17” (expires 01/31/2024), and

• 1018-0095, “Endangered and Threatened Wildlife, Experimental Populations, 50 CFR 17.84” (expires 9/30/2023).

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have prepared a draft supplemental environmental impact statement (DSEIS) pursuant to the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) in connection with this proposed rule to revise the Mexican wolf experimental population designation. The purpose of the DSEIS is to identify and disclose the environmental consequences resulting from the proposed action of revising the existing experimental population designation of the Mexican wolf. On April 15, 2020, we published a notice of intent (85 FR 20967) to prepare the DSEIS, which opened a public scoping period from April 15, 2020, to June 15, 2020. We used the information gathered during scoping to inform the DSEIS and this proposed rule.

Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare statements of energy effects when undertaking certain actions. This proposed rule is not expected to significantly affect energy supplies, distribution, or use because the actions contemplated in this proposed rule involve the reintroduction of Mexican wolves. Mexican wolves reintroduced in the MWEPA do not change where, when, or how energy resources are produced or distributed. Because this action is not a significant energy action, no statement of energy effects is required.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, or other appropriate recommendations.

A complete list of all references cited in this proposed rule is available at http://www.regulations.gov at Docket No. FWS-R2-ES-2021-0103, or upon request from the Mexican Wolf Recovery Program, U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this document are the staff members of the Mexican Wolf Recovery Program (see FOR FURTHER INFORMATION CONTACT ).

The authorities for this action are the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq. ) and the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ).

Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

The revisions and additions read as follows: