I. Background

DOE published a final rule in the Federal Register on March 15, 2023 (March 2023 Final Rule), amending the test procedure for television sets. 88 FR 16082. This correction addresses numbering errors in the amendatory language in that final rule.

The amendatory instructions in the March 2023 Final Rule amend § 430.3 by redesignating paragraphs (n) through (w) as paragraphs (o) through (x), respectively. 88 FR 16082, 16109. However, paragraph (p), which is being redesignated as (q) currently contains “Note 1 to paragraph (p)” and refers to “paragraphs (p)(1) through (9).” The amendatory instructions failed to revise this note to correctly refer to paragraph (q). Further, there is already another Note 1 within § 430.3 ( see § 430.3(e)), so the numbering of these notes in § 430.3 was not properly sequenced, and the note in newly redesignated § 430.3(q) should have been numbered as Note 2.

As published, the regulatory text in the March 2023 Final Rule may result in confusion due to incorrect section references. Because this final rule would simply correct errors in the text without making substantive changes in the March 2023 Final Rule, the changes addressed in this document are technical in nature.

DOE has concluded that the determinations made pursuant to the various procedural requirements applicable to the March 2023 Final Rule remain unchanged for this final rule technical correction. These determinations are set forth in the March 2023 Final Rule. 88 FR 16082, 16106-16109.

Pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b), DOE determines that notice and prior opportunity for comment on this rule are unnecessary and contrary to the public interest. Neither the errors nor the corrections in this document affect the substance of the March 2023 Final Rule or any of the conclusions reached in support of the final rule. For these reasons, DOE also determines that there is good cause to waive the 30-day delay in effective date in 5 U.S.C. 553(d).

In FR Doc. 2023-03986, appearing on page 16109 in the Federal Register of Wednesday, March 15, 2023, the following corrections are made:

This document of the Department of Energy was signed on March 28, 2023, by Francisco Alejandro Moreno, 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 .

Authority for This Rulemaking

The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Title 49, Subtitle VII, Part A, Subpart III, Section 44701, General requirements. Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing minimum safety standards required in the interest of safety for performance of aircraft engines. This regulation is within the scope of that authority because it creates new safety-related testing requirements for certification of aircraft turbofan engines.

The FAA is amending the airworthiness regulations related to engine bird ingestion testing in part 33 of title 14, Code of Federal Regulations (14 CFR) (notice of proposed rulemaking (NPRM) published at 83 FR 31479 on July 6, 2018). This final rule revises § 33.76 to create an additional bird ingestion test for turbofan engines. This new test ensures that engines can ingest the largest MFB required for bird ingestion testing into the engine core  1 at climb conditions. If the engine design is such that no bird material would be ingested into the engine core during the test at climb conditions, then the rule requires a different test at approach conditions.

The new testing required by this final rule consists of ingesting one MFB, equivalent to the largest bird required by § 33.76(c), for the engine inlet throat area of the engine being tested, 2 into the engine core, using either of the following climb or approach test conditions:

(1) Testing for bird ingestion on climb (referred to in this final rule as “climb flocking bird test”). The test bird must be fired at 261-knots (which is 250-knots indicated airspeed (KIAS)), with the mechanical engine fan speed set at the lowest expected speed when climbing through 3,000 feet altitude above mean sea level at International Standard Atmosphere (ISA) standard day conditions (hereafter referred to as MSL). After bird ingestion, the engine must comply with new post-test run-on requirements similar to those in § 33.76(d)(5) for large flocking birds, except that, depending on the climb thrust of the engine, during the first minute after bird ingestion the engine may produce less than 50 percent takeoff thrust.

(2) Testing for bird ingestion on approach (referred to in this final rule as “approach flocking bird test”). If the applicant determines, through testing or validated analysis, that no bird material will enter the core during the test at the climb condition, then the applicant must perform the approach flocking bird test. For the approach flocking bird test, the bird must be fired at 209-knots (which is 200-KIAS), with the mechanical engine fan speed set at the lowest fan speed expected when descending through 3,000 feet MSL on approach. Applicants are required to comply with post-test run-on requirements that are the same as the final six minutes of § 33.76(d)(5) post-test run-on requirements for the large flocking bird (LFB) test. While the FAA based the approach run-on requirements of this final rule on the LFB post-test run-on requirements, only the last six minutes of the test is required, since during approach the airplane will already be lined up with the runway.

Additionally, this final rule allows the climb flocking bird test to be combined with the § 33.76(c) test when the climb first stage (fan) rotor speed is no more than three percent different from the first stage rotor speed, as required by § 33.76(c)(1). This allows manufacturers of engines for airplanes, where the pilot does not pull back on the throttle during climb, to perform one fewer ingestion test. Since the fan rotor speed during climb will be the same as the fan rotor speed at takeoff thrust, the amount of bird material ingested into the core during the climb flocking bird test will depend on bird speed and not fan speed.

This final rule also allows the applicant to use objects other than birds to meet the new test requirements.

Over a 27-year period of analysis, the rule will result in present value net benefits of about $9.7 million at a seven percent discount rate with annualized net benefits of about $0.8 million. At a three percent discount rate, the 27-year present value net benefits is about $36.2 million with annualized net benefits of about $1.9 million.

The following table presents estimates of the quantified benefits, costs, and net benefits of the rule.

On January 15, 2009, US Airways Flight 1549 (Flight 1549), an Airbus A320, took off from La Guardia Airport in New York City. On climb, at approximately 2,800 feet above ground level (AGL) and approximately 230-KIAS, the airplane struck a flock of migratory Canada geese. Both of the airplane's engines ingested at least two birds, and both engine cores suffered major damage and total thrust loss.

The A320 series of airplanes ( i.e., A318/A319/A320/A321) and the similarly sized Boeing 737 series of airplanes are among the airplanes most frequently used by air carriers. 3 Most transport airplanes (including the A320) and many business jets use turbofan engines that are susceptible to bird ingestion damage, which, in some instances, has resulted in loss of greater than 50 percent takeoff thrust. In twin-engine airplanes, this amount of thrust loss in both engines can prevent the airplane from climbing over obstacles or maintaining altitude. Significant loss of thrust by more than one engine is a hazardous condition because it can prevent continued safe flight and landing.

As a result of the Flight 1549 accident, the FAA began studying how to improve engine durability related to core engine bird ingestion. 4 In response to a tasking from the FAA to review and study bird ingestion standards and guidance, the Aviation Rulemaking Advisory Committee (ARAC) established the Engine Harmonization Working Group (EHWG) under the Transport Airplane and Engine subcommittee. The EHWG developed a report, subsequently accepted by the ARAC, titled “Turbofan Bird Ingestion Regulation Engine Harmonization Working Group Report” (ARAC report), dated February 19, 2015. 5 The ARAC report concluded that modern fan blades (such as those on the Flight 1549 airplane engines) have relatively wider fan blade chords than those in-service when the FAA implemented the MFB ingestion test in 14 CFR 33.76(c) (65 FR 55848, September 14, 2000). The ARAC report also pointed out that the § 33.76(c) test is conducted with the engine operating at 100 percent takeoff power or thrust. This setting is ideal for testing the fan blades but does not represent the lower fan speeds used during the climb and approach phases of aircraft flight.

When an engine ingests a bird, the amount of bird material that enters the engine core depends on: (1) the width of the fan blade chord, (2) the airplane's speed, and (3) the rotational speed of the fan blades. The wider the chord of the fan blade and the lower the speed of the airplane, the longer the bird will remain in contact with the fan blade. As airplane speed increases, the bird spends less time on the fan blade. With higher fan speed, the bird will move radially faster away from the core. Thus, the longer the time in contact with the fan blade, from wider blades and lower airspeed, and increased centrifugal forces from a higher fan speed, the further outboard and away from the core the bird material will move. Therefore, a higher fan speed makes it less likely that bird material will enter the core during the § 33.76(c) test compared to the new climb flocking bird test. Conversely, a lower fan speed and higher airspeed, for a given fan blade width, make it more likely that the bird material will enter the core.

The § 33.76(c) test is conducted using 100 percent power or thrust and the most critical airspeed up to 1,500 feet AGL. Consequently, the § 33.76(c) test does not simulate lower fan speed phases of flight (such as climb and descent) during which a bird, if ingested, is more likely to enter the engine core. In addition, the higher airspeed in climb is not covered by the § 33.76(c) test. Therefore, the small and medium flocking bird test prescribed in § 33.76(c) does not fully provide the intended demonstration of core durability against bird ingestion for the climb and approach conditions.

As part of its report  6 on Flight 1549, the NTSB issued two relevant engine-related safety recommendations to the FAA:

(1) A-10-64: Modify the small and medium flocking bird certification test standard to require that the test be conducted using the lowest expected fan speed, instead of 100 percent fan speed, for the minimum climb rate.

(2) A-10-65: During re-evaluation of the current engine bird-ingestion certification regulations by the Bird Ingestion Rulemaking Database working group, specifically re-evaluate the large flocking bird certification test standards to determine if they should:

(a) Apply to engines with an inlet area of less than 2.5 square meters (3,875 square inches).

(b) Include an engine core ingestion requirement.

If re-evaluation determines the need for these requirements, incorporate them into 14 CFR 33.76(d) and require that newly certificated engines be designed and tested to these requirements.

The ARAC report addressed both NTSB safety recommendations. In response to NTSB safety recommendation A-10-64, the ARAC report recommended the test adopted in this final rule. The ARAC report found that its recommendation would also address the intent of NTSB safety recommendation A-10-65 since the kinetic energy of the bird in this final rule is of the same magnitude as a LFB test.

The FAA received comments on the NPRM from 12 commenters. Specifically, the FAA received comments from Pratt & Whitney U.S.A. (Pratt & Whitney); Honeywell International; Pratt & Whitney Canada Corporation (Pratt & Whitney Canada); The Boeing Company; General Electric (GE); Aerospace Industries Association (AIA); Rolls-Royce; Air Line Pilots Association, International (ALPA); the National Transportation Safety Board (NTSB), and three individuals. The FAA received supportive comments on the NPRM from the NTSB and one individual. While a number of commenters requested changes, commenters generally supported the proposal. The NTSB expressed general support for the NPRM and noted the proposed rule, when implemented, would satisfy the intent of NTSB Safety Recommendation A-10-64. 7

In the NPRM, the FAA proposed allowing applicants to combine the new climb flocking bird test with the existing § 33.76(c) test if the fan speed at climb is within 1 percent of the fan speed at takeoff. The purpose of the proposed 1 percent limit on the difference between the climb and takeoff fan speed was to ensure the combined test would apply only to engines designed such that the typical operational practice will be to maintain the throttle in the takeoff position through the climb phase. However, even with the throttle in the same position, both fan and core rotor speeds will change to some extent with altitude and aircraft speed.

AIA, Pratt & Whitney, Pratt & Whitney Canada, Honeywell International, The Boeing Company, GE, and one individual commented on the proposed allowance for combining the new test with the § 33.76(c) test. These commenters stated the proposed one percent difference in fan rotor speed at takeoff and climb conditions in § 33.76(e)(4) is too restrictive. Commenters further stated the in-service difference between climb and takeoff fan rotor speeds is in the range of three percent to five percent, and recommended the FAA allow applicants to combine the tests when the fan rotor speed difference was no greater than three percent.

This final rule allows combining the MFB test and the new test at climb condition when the difference in the climb and takeoff fan rotor speeds is no more than three percent. The NTSB accident report for the Flight 1549 accident states that Flight 1549 impacted birds at approximately 2,800 feet altitude AGL and ~82 percent fan speed; well below the maximum takeoff setting. 8 The ARAC report states that many air carriers operating transport category airplanes use reduced thrust or derated takeoff power settings. Operators may use reduced thrust or derated takeoff power settings because they may provide substantial benefits in terms of engine reliability, maintenance, and operating costs, while operating at lower fan speeds than the maximum takeoff thrust rating. Climb power settings on large transport airplanes are also significantly lower than maximum takeoff settings. Smaller jet aircraft with small throat inlets are not typically certified to perform reduced thrust or derated takeoffs ( i.e., all takeoffs are completed at max rated takeoff thrust), and climb power settings on most smaller corporate aircraft are typically close to the maximum takeoff thrust rating.

The FAA agrees with the commenters' recommendation to allow combining the new climb flocking bird test with the existing MFB test in § 33.76(c) when the difference between climb and takeoff fan rotor speeds is no more than three percent. It would be overly restrictive to limit the allowable variation to one percent when the in-service difference between climb and takeoff fan rotor speeds, with no change in throttle position, is typically in the range of three percent to five percent. As a result, § 33.76(e)(4) allows applicants to combine the existing MFB and new climb flocking bird tests if the engine's climb fan rotor speed is within three percent of the fan rotor speed required in the MFB test under § 33.76(c). Combining the tests when the fan rotor speed is within 3 percent will have no effect on the efficacy of the test because the bird for the test at climb condition will be fired at the higher bird speed and a fan rotor speed consistent with actual operations.

The NPRM proposed a bird speed of 250-knots for the new climb flocking bird test and 200-knots for the new approach flocking bird test. Honeywell International, The Boeing Company, AIA, Pratt & Whitney, and GE stated that the NPRM used “knots” and “knots indicated airspeed” (KIAS) inconsistently. Knots, KIAS, and knots true airspeed (KTAS) can refer to different physical speeds. The commenters also stated that the ARAC working group intended for the bird in the climb flocking bird test to be fired at the equivalent of 250-KIAS at an altitude of 3,000 feet MSL using ISA conditions, and 200-KIAS at an altitude of 3,000 feet MSL using ISA conditions for the approach flocking bird test. Therefore, to achieve consistency with the ARAC working group recommendation, the commenters concluded the climb and approach flocking bird tests should be performed with fan speeds representative of the lowest possible fan rotor speed at these conditions, and the bird velocities should be 261-KTAS for the climb flocking bird test, and 209-KTAS for the approach flocking bird test.

KIAS measures airspeed modified to account for the altitude pressure effect. KTAS is the speed of the aircraft relative to the air mass through which it is flying. During a bird ingestion event, KTAS is the effective speed of the bird relative to the aircraft. The NPRM did not specify the altitude at which KIAS was based. For the climb flocking bird test, 250-KIAS at 3,000 feet MSL equates to a bird speed of 261-KTAS at sea level. For the approach flocking bird test, 200-KIAS at 3,000 feet MSL equates to a bird speed of 209-KTAS at sea level. In this final rule, the FAA has revised the proposed § 33.76(e)(1)(i)(C) from “Ingestion must be at 250-knots bird speed,” to “Ingestion must be at 261-knots true airspeed.” The FAA also revised the proposed § 33.76(e)(2)(i)(C), from “Ingestion must be at 200-knots bird speed” to “Ingestion must be at 209-knots true airspeed.”

In the NPRM, the agency proposed that the engine must be stabilized during the test at the mechanical rotor speed of the first exposed fan stage or stages that, on a standard day, produce the lowest expected power or thrust required during climb through 3,000 feet AGL. MSL will establish more consistent test conditions than AGL because the flight conditions for the engine using AGL may vary based upon the ground level altitude above sea level. For example, 3,000 feet above Denver International Airport (5,434 feet above sea level) is 8,434 feet MSL; 3,000 feet above Boston Logan International Airport (19 feet above sea level) is 3,019 feet MSL. Using MSL defines the engine conditions consistent with the commenters' request that the standard refer to 3,000 feet at ISA conditions. The FAA has revised § 33.76(e)(1)(i)(A) for the climb flocking bird test to require the fan rotor speed to be set to the lowest expected power or thrust required during climb through 3,000 feet MSL instead of 3,000 feet AGL.

The NPRM proposed in § 33.76(e)(2)(i)(A) that the engine must be stabilized during the test at the mechanical rotor speed of the first exposed fan stage or stages when on a standard day the engine thrust is set at approach idle thrust when descending 3,000 feet AGL. The FAA also revised § 33.76(e)(2)(i)(A) for the approach flocking bird test to require the fan speed be set to the lowest expected power or thrust required during descent through 3,000 feet MSL instead of 3,000 feet AGL, based on the same rationale as the climb flocking bird test.

Finally, changing AGL to MSL will not result in different test conditions than those proposed in the NPRM. For turbofan engines, power or thrust is proportional to fan speed. The lowest fan speed for a given climb thrust at standard day conditions and 3,000 feet AGL is equivalent to 3,000 feet MSL. In addition, changing the altitude units to MSL makes the altitude reference consistent with the requirement to have the lowest fan speed at standard day conditions.

The NPRM preamble discussed the circumstances under which applicants could combine the proposed climb flocking bird test with the existing § 33.76(c) test; however, the proposed regulatory text in § 33.76(e)(4)(ii) provided that the proposed approach flocking bird test could also be combined with the § 33.76(c) test. Honeywell International and GE commented that proposed § 33.76(e)(4)(ii) should not be included in the final rule. Honeywell International further explained that there is no scenario where the fan speed at the approach condition will be within one percent, or even the recommended three percent, of the max takeoff thrust fan speed. The FAA agrees that applicants may only combine the climb flocking bird test with the § 33.76(c) test since the conditions of the approach flocking bird test are not consistent with the § 33.76(c) test. Therefore, in this final rule, § 33.76(e)(4) does not include a reference to the approach flocking bird test.

In the NPRM, the FAA proposed that either the climb or approach flocking bird test would be required for all turbofan engines in addition to the existing § 33.76(c) test. GE commented that engines with inlet areas of 3.90 square meters (6,045 square inches) or greater, known as Class A size engines, should be excluded from the requirement to perform the new test. Specifically, GE asserted that engines should be excluded when the applicant can show that the proposed type design for an engine has design features and functions consistent with the applicant's successful MFB ingestion based on field service experience and core ingestion compliance demonstrations with previously certified engine types. GE reasoned that the ARAC report shows that the data in the Aerospace Industries Association Bird Ingestion Working Group Interim Report contained no reported loss of power events associated with core bird ingestion into Class A size turbofan engines between 1999 and 2009. GE also stated that its recent compliance testing results provide clear evidence of core ingestion. Therefore, compliance with the MFB ingestion requirements found in § 33.76(c) will present an appropriate and operationally relevant MFB ingestion challenge for the largest size class of engines.

The FAA notes that between 2000 and 2009, there were between 12 and 20 million airplane flight cycles (a flight cycle includes a takeoff and landing) per year with Class D size engines (1.35m 2 -2.5m 2 inlet areas, the same size as the engines on the US Airways Flight 1549 airplane). During that same time, there were less than 2 million airplane flight cycles with Class A size engines per year. Along with the low overall number of engine power loss events, this low number of airplane flight cycles makes it difficult to statistically establish that the prior service history of Class A size engines between 2000 and 2009 is sufficient to prove that the airplane is protected from hazards due to engine core ingestion during climb, based on the engine inlet area alone.

Additionally, the ARAC report did not make an exception for Class A size engines or other engine sizes with relatively few core power loss events. Instead, section 5 of the ARAC report indicates that the § 33.76(c) core ingestion demonstration criteria did not adequately represent the most critical flight phase with respect to core ingestion due to the combination of high fan rotor speed and low aircraft speed. The ARAC report discusses the effects of rotor speed and low aircraft speed on core ingestion in paragraph 3.2.

With respect to GE's comment that signs of bird material are consistently found on the spinner or in the core inlet area after the § 33.76(c) test and therefore are a reliable indicator of the core flow path, the FAA does not concur. The ARAC report addressed this topic in paragraph 4.3, Differentiating Between Core Induced Power Loss vs. Material in the Core. The ARAC report stated:

It is believed that the presence of bird remains within the engine core is not a reliable indicator of significant core ingestion because bird strikes on aircraft structure other than the core intake area, such as the inlet lip, spinner cap, and radome, regularly result in some amount of avian material entering the core. 9

Based on the information in the ARAC report, the FAA determined that during a certification test, it is not possible to accurately measure the amount of bird material that entered the core, as opposed to bypassing the core. Testing the engine at the climb condition is the best way to ensure significant bird material enters the core. Therefore, consistent with the NPRM, this final rule does not except Class A engines.

The NPRM proposed that either the climb or approach flocking bird test would be required for all turbofan engines in addition to the existing § 33.76(c) test, regardless of the results of the § 33.76(c) test. GE commented that the approach flocking bird test proposed in the NPRM should not be required if bird material entered the core during the § 33.76(e)(1) climb flocking bird test or the § 33.76(c) test, because ingestion of bird material during the § 33.76(c) test would demonstrate sufficient core robustness against bird ingestion. In addition, GE commented that based on its experience, the core capability could be demonstrated using the § 33.76(c) test.

The ARAC found that bird velocity is predicted to have the greatest influence on the amount of bird ingested into the core for a given design. 10 Also, generally, for a given bird velocity, the amount of ingested bird material into the core is inversely proportional to the fan rotor speed. Therefore, the new climb flocking bird test in the new § 33.76(e)(1) will provide a more representative demonstration of core capability than the § 33.76(c) test due to the higher bird velocity and lower rotor fan speed required by the climb flocking bird test.

Additionally, the FAA proposed that the approach flocking bird test would only be required if testing or validated analysis shows that no bird material will be ingested into the engine core during the § 33.76(e)(1) climb flocking bird test. As stated in the NPRM, testing at the 200-KIAS (209-KTAS) approach condition would ensure that, if the engine is designed to centrifuge all bird material away from the core flow path at takeoff and climb conditions (which is beneficial), then engine core capability to ingest bird material would still be tested. This is because an engine that centrifuges bird material away from the core at the 250-KIAS (261-KTAS) climb condition may not be able to centrifuge away the same amount of bird material at the lower speed approach condition. The NPRM stated that the approach flocking bird test would only be required if testing or validated analysis shows that no bird material will be ingested into the engine core during the § 33.76(e)(1) climb flocking bird test. Consequently, the FAA did not change the rule as a result of comments seeking to exclude the approach flocking bird test if material entered the core during the § 33.76(c) test.

In the NPRM, the FAA proposed post-test bird ingestion run-on requirements for the new climb and approach flocking bird tests. Rolls-Royce, Honeywell International, The Boeing Company, AIA, Pratt & Whitney, and GE suggested the NPRM preamble description of the engine run-on requirements for the approach flocking bird test was confusing. The NPRM preamble stated that applicants would be required to comply with the same post-test run-on requirements as those for the final six minutes of the existing § 33.76(d)(5) post-test run-on requirements for LFB. The NPRM preamble also stated that the post-test run-on requirements for the proposed approach flocking bird test would consist of the final seven minutes of the existing LFB 20-minute post-ingestion run-on requirement.

The FAA clarifies that the phrase “final seven minutes” in the NPRM preamble included a 1-minute period after ingestion when the engine throttle must not be manipulated, followed by the final six minutes of the LFB run-on requirement. Consistent with the preamble discussion, the proposed regulatory text in § 33.76(e)(2)(iii) included a total of both the 1-minute delay after ingestion and the final six minutes of the LFB run-on. Therefore, in this final rule, the FAA adopts § 33.76(e)(2)(iii) as proposed.

Honeywell International, The Boeing Company, AIA, Pratt & Whitney, and GE commented that the NPRM preamble improperly described the § 33.76(c) bird speed requirement. The NPRM preamble stated that the MFB test is conducted using 100 percent power or thrust and 200-knots airspeed, simulating takeoff conditions. However, § 33.76(c) states that the critical bird ingestion speed should reflect the most critical condition within the range of airspeeds used for normal flight operations up to 1,500 feet AGL, but not less than V 1 minimum for airplanes. Therefore, while the NPRM preamble's description of the § 33.76(c) bird speed requirement was inaccurate, the proposed regulatory text was correct.

The NPRM preamble stated that it was unlikely that manufacturers would need to run multiple tests to meet the proposed test requirements. GE questioned the accuracy of this assertion, requesting that the FAA acknowledge the possibility that the proposal could result in two additional ingestion tests.

The FAA has determined that manufacturers are unlikely to have to run two additional tests because the agency expects that manufacturers will evaluate the design of their engines before testing and should be able to determine whether engines will centrifuge all bird material away from the engine core. In this final rule, a manufacturer may perform either the climb or approach test; however, they would perform the approach test only if testing or a validated analysis shows that no bird material will enter the engine core. By performing a validated analysis to determine whether an engine will centrifuge all bird material away from the engine core during the climb flocking bird test, a manufacturer will be able to know ahead of time whether to run either the climb or the approach flocking bird test. 11 Therefore, while it is possible that the final rule could result in two additional ingestion tests, it remains unlikely.

The FAA notes that the ARAC report found that various engine manufacturer simulation results have shown that, in general for a given bird velocity, the amount of ingested bird material into the core is inversely proportional to the fan rotor speed. 12 During the ARAC working group study, at least three different engine manufacturers who had conducted these simulations presented engineering analyses predicting how much bird material would enter the core after ingestion (See Figure 3.2.2 of the ARAC report). This indicated that industry has the capability to determine before the test, whether engines will centrifuge all bird material away from the engine core.

As noted by Honeywell International, AIA, and Pratt & Whitney, the NPRM incorrectly referred to the birds ingested into the engines of Flight 1549 as “Canadian geese” rather than “Canada geese.” The preamble to this final rule uses the term “Canada geese,” reflecting the proper bird identification. 13

The NPRM summarized the results of the FAA evaluation of the costs and benefits associated with the proposal. GE disagreed with the total benefits and costs of the proposed rule as described in the NPRM. The commenter expressed that the cost and benefit analyses do not include the additional incremental cost to develop and mature the technology to pass the additional certification test(s) and to conduct and pass the additional certification test(s).

The commenter's costs discussion shows that it is possible that the cost to design and develop engine blades and vanes to comply with the new rule could be significantly different from those estimated in the preliminary regulatory impact analysis. While the new test is intended to increase the amount of bird material entering the engine core relative to the existing § 33.76(c) test, the fundamental requirement for blades and vanes behind the fan to withstand foreign object damage from bird ingestion has not changed. Since § 33.76 at Amendment 20 (65 FR 55848, September 14, 2000), applicants have been required to aim the largest MFB at the engine core primary flow path. In addition, other regulations (such as § 33.78(a)(1) for hailstone ingestion) have also required applicants to account for potential impact damage when designing their core engine blades and vanes. The need for new engineering analysis, development tools, and methods when developing a new blade to meet this final rule's new test requirement will vary among manufacturers depending on the physical design of their engines, their development philosophy, and their tolerance for risk during the certification process. For example, an engine manufacturer who designs its engine so no material would enter the engine core during either the climb or approach condition could have zero developmental costs due to the new regulation. Others might desire or require additional developmental work to ensure a future engine would meet the new requirement. The FAA has revised the regulatory analysis to address the potential for pre-certification developmental costs.

GE also criticized the analysis as significantly underestimating production costs. The commenter stated that, for example, a production rate of nearly 3,000 engines per year should be used instead of the FAA estimate of 220 engines per year. The FAA contacted the commenter to clarify whether its comment was based on the belief that the FAA was estimating 220 affected engines would be produced per year in total. The FAA asked if the commenter believed that instead, the total number of engines produced by all engine manufacturers in one year should be closer to 3,000. The commenter responded that it thought the 220 engines produced per year were for all manufacturers. The commenter mentioned the CFM International LEAP engine production rate is nearly 3,000 engines per year as an example. Therefore, the commenter believes the total of 220 engines given in the benefits and costs analysis of the NPRM is too low.

The FAA clarifies that the 220 engines in its economic analysis are per new engine certification ( i.e., one certification for each manufacturer). More specifically, in the regulatory evaluation, the FAA estimated that three engines would be certified every year and two additional engines would be certified every three years. Additionally, the FAA assumed production of the engines would begin one year after certification. Finally, the FAA estimated that, on average, 220 engines would be produced per year, per certification. To calculate engines in-service that would be affected by this final rule, the FAA assumes the estimated average service life of an engine is about 16 years.

Therefore, in the first year of compliance, the FAA estimated five engines would be certified with 1,100 engines produced. In the second year, three more engines are certified, and in the following year, an additional 660 engines would be produced. In the third year, another three certifications occur with an additional 660 engines produced. In the fourth year, five engines would be certified with another 1,100 engines produced. After 10 years, the engines produced from the tenth year would be installed the following year and continue in-service for 16 years. The number of affected engines reach a maximum in the twelfth year and, with no attrition, there are 8,360 engines in-service until year 18 when the engines in operation begin to retire. After 27 years, all the affected engines would be retired. See “Table 1. Engine Certifications and Aircraft in Service Forecast” of the Regulatory Evaluation for details.

The FAA's estimate of 220 engines produced per year, per certification, is based on the average production rate per year, from 1989 to 2015, for the V2500 engine. The V2500 engine is installed on the Airbus A320 airplane and the MD-80 airplane. Larger engines like the GE90 (installed on the Boeing 777) would be produced at a lower average rate and smaller engines like the CF34 (regional jet) would be produced at a higher average rate.

The FAA compared the estimate of 220 engines per year against the data for engines previously certified to determine if the 220 estimate is too low. This rule only affects engines with a certification date of application after the effective date of the final rule and does not affect the CFM International LEAP engine. The data shows that the average production rate per year from 2008 to 2017 for the V2500 engine is 182 engines per year. Furthermore, the average production of certified engines from 2008 to 2017 is even less (108 engines per year). For this reason, the FAA's use of 220 engines per certification to estimate the operating cost of this rule is justified.

In the NPRM, proposed § 33.76(e)(1)(iii)(D) included the allowance that “Power lever movement in this condition is unlimited” for that segment of the climb flocking bird test. The FAA inadvertently omitted a similar allowance in proposed § 33.76(e)(2). To correct this omission and make the approach flocking bird test schedule consistent with the climb flocking bird test schedule, the FAA added “Power lever movement in this condition is unlimited” to the end of § 33.76(e)(2)(iii)(C) in this final rule.

The FAA modified the proposed test requirements in paragraphs (e)(1)(i)(B) and (e)(2)(i)(B) to § 33.76, to clarify that only one bird is required for the climb flocking bird test and approach flocking bird test added by this final rule.

Section 33.76(a)(5) allows applicants to substitute objects that are accepted by the Administrator for birds when conducting the existing bird ingestion tests. The FAA amended § 33.76(a)(5) by adding a reference to new § 33.76(e) for consistency with the allowance for other bird ingestion tests.

In order to be consistent with the existing wording in § 33.76(b) through (d), the FAA does not use the word “fan” in this final rule when describing the first exposed rotor stage in § 33.76(e)(1)(i)(A) and (D), (e)(2)(i)(A) and (D), and (e)(4).

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules, that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995; current value is $155 million). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule. The FAA suggests readers seeking greater detail read the full regulatory evaluation, a copy of which is available in the docket for this rulemaking.

In conducting these analyses, the FAA has determined that this final rule: (1) has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

The FAA is amending certain airworthiness regulations to add a new test requirement to the airworthiness regulation addressing engine bird ingestion. This final rule ensures that engines can ingest the largest MFB into the engine core at climb or approach conditions. The ingestion of MFB can cause thrust loss from core engine bird ingestion if enough bird mass enters the engine core, which in turn can cause an accident or flight diversion. This rule adds to the certification requirements of turbofan engines, a requirement that manufacturers must show that their engine cores can continue to operate after ingesting an MFB while operating at a lower fan speed associated with climb or approach. Engine manufacturers have the capability of producing such engines.

The FAA estimates the annualized cost of the rule to be $5.3 million, or present value $64.0 million over 27 years (discounted at 7 percent). 14 The FAA estimates the annualized benefits of the rule to be $6.1 million, or present value $73.7 million over 27 years (discounted at 7 percent). The following table summarizes the benefits and costs of this final rule. The FAA has revised the analysis of costs for the final rule based on information received during the public comment period (for details see section J. Regulatory Evaluation Costs).

Aircraft operators and engine manufacturers.

The benefit and cost analysis for the regulatory evaluation is based on the following assumptions:

• The analysis is conducted in constant dollars with 2020 as the base year.

• The FAA calculated the present value of the potential benefits by discounting the monetary values following the Office of Management and Budget guidance using a 7 percent and a 3 percent interest rate.

• The analysis period is 27 years with 10 years of new engine certifications.

• Based on the actual production numbers of a common airline engine, the FAA estimates that about 220 engines are produced per year per certification.

• Because of this final rule, the average fuel consumption will increase by $821 per year per aircraft.

The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the RFA requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the Act.

Two groups will be affected by this rule: aircraft operators and engine manufacturers.

The FAA has determined that this final rule will not have a significant economic impact on small aircraft operators. Operators will incur higher fuel burn costs due to an increase in engine weight (heavier blading, components, etc.), and consequently, an increase in total aircraft weight. The FAA estimates fuel burn costs of $750 per year per aircraft, which the FAA has determined will not result in a significant economic impact for small aircraft operators.

Similarly, the FAA has determined that this final rule will not have a significant economic impact on engine manufacturers. The FAA identified one out of five engine manufacturers that meet the Small Business Administration definition of a small entity. The annual revenue estimate for this manufacturer is about $75 million. 15 The FAA then compared this manufacturer's revenue with its annualized compliance cost. The FAA expects that the manufacturer's projected annualized cost would be 0.3 percent of its annual revenue, 16 which the FAA has determined is not a significant economic impact.

If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it has legitimate domestic safety objectives. Therefore, this final rule is in compliance with the Trade Agreements Act.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.

Section 1205 of the FAA Reauthorization Act of 1996 (110 Stat. 3213) requires the Administrator, when modifying 14 CFR regulations in a manner affecting intrastate aviation in Alaska, to consider the extent to which Alaska is not served by transportation modes other than aviation, and to establish appropriate regulatory distinctions. The FAA has determined that this rule would not affect intrastate aviation in Alaska.

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have federalism implications.

The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not a “significant energy action” under the Executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policy and agency responsibilities of Executive Order 13609, Promoting International Regulatory Cooperation. The agency has determined that this action will eliminate differences between U.S. aviation standards and those of other civil aviation authorities by ensuring that § 33.76 remains harmonized with European Union Aviation Safety Agency Certification Specification CS-E 800.

An electronic copy of a rulemaking document may be obtained by using the internet—

1. Search the Federal eRulemaking Portal ( www.regulations.gov );

2. Visit the FAA's Regulations and Policies web page at www.faa.gov/regulations_policies/; or

3. Access the Government Printing Office's web page at www.GovInfo.gov.

Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9680.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document, may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the internet, visit www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

The FAA invites you to send any written relevant data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2023-0655; Project Identifier MCAI-2022-01435-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, 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 final rule 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 regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to William Reisenauer, Aerospace Engineer, Avionics and Electrical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email 9-avs-nyaco-cos@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 2021-23-12, Amendment 39-21810 (86 FR 69984, December 9, 2021) (AD 2021-23-12), to address the effect of interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band) on all transport and commuter category airplanes equipped with a radio (also known as radar) altimeter. AD 2021-23-12 was prompted by a determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 5G C-Band. AD 2021-23-12 requires revising the limitations section of the existing AFM to incorporate limitations prohibiting certain operations, which require radio altimeter data to land in low visibility conditions, when in the presence of 5G C-Band interference as identified by NOTAMs. Transport Canada, which is the aviation authority for Canada, issued corresponding AD CF-2021-52, dated December 24, 2021, to prohibit certain flight operations requiring radio altimeter data in U.S. airspace affected by 5G C-Band wireless signals.

Since Transport Canada issued AD CF-2021-52, Transport Canada evaluated whether additional 5G-related hazards exist in certain Bombardier model airplanes. Bombardier has determined that 5G C-Band interference can result in unavailable or misleading radio altimeter information, adversely affecting the performance of the AFCS and FBW systems as follows:

• Erroneous radio altimeter information has the potential to cause incorrect gains on approach, flight guidance oscillation, and crew over-correction. The flight director uses the glideslope to linearize the angular deviation and if the radio altimeter erroneously changes to an incorrect value, the resulting pitch command may be inadequate, resulting in flight path oscillations.

• Misleading radio altimeter information can adversely impact the autothrottle function, resulting in early or late activation of the retard mode, leading to an inappropriate level of thrust. This may result in a low energy state or longer landing distance. This malfunction will increase pilot workload as the crew disconnects the autothrottle and overrides the throttle levers.

• In the event of a weight-on-wheels (WOW) signal failure in combination with a related Master Minimum Equipment List (MMEL) dispatch, interference may result in the radio altimeter deploying the two pairs of ground spoilers at heights above 7 feet AGL.

• In the event of a WOW signal failure in combination with certain related MMEL dispatch associated with Section 2 Crew Alerting System (CAS) message relief, a takeoff rotation delay is significant and could compromise safe flight and landing.

These effects may lead to increased flightcrew workload and adversely affect the safe operation of the airplane during takeoff, approach, and landing below 400 feet AGL. Accordingly, Transport Canada determined that additional actions are necessary to address the unsafe condition and issued AD CF-2022-61, dated November 4, 2022 (Transport Canada AD CF-2022-61) (also referred to after this as “the MCAI”), on all Bombardier, Inc., Model BD-700-2A12 airplanes. Transport Canada AD CF-2022-61 prohibits dispatch or release under certain MMEL items under Section 1, Line Replaceable Unit (LRU) Component Relief, and Section 2, Crew Alerting System (CAS) Message Relief. Transport Canada AD CF-2022-61 also requires revising the AFM with new limitations to prohibit autopilot and autothrottle operation below 400 feet AGL when in the presence of 5G C-Band interference as identified by NOTAMs.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0655.

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 described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires revising the existing AFM with new limitations to prohibit dispatch under specified MMEL items under Section 1, Line Replaceable Unit (LRU) Component Relief, and Section 2, Crew Alerting System (CAS) Message Relief and to prohibit autopilot and autothrottle operation below 400 feet AGL when in the presence of 5G C-Band interference as identified by NOTAMs.

The FAA considers this AD an interim action. If final action is later identified, the FAA might consider further rulemaking then.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 5G C-Band. Further, this interference can result in unavailable or misleading radio altimeter information, adversely affecting the performance of the AFCS, which could lead to increased flightcrew workload and adversely affect the safe operation of the airplane during takeoff, approach, and landing. The required actions to address the unsafe condition must be accomplished within 30 days, which is shorter than the time necessary to allow for public comment and for the FAA to publish a final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 52 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2023-0658; Project Identifier MCAI-2023-00315-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, 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 final rule 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 regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to Joseph Catanzaro, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7366; email 9-avs-nyaco-cos@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.

Transport Canada, which is the aviation authority for Canada, has issued Transport Canada Emergency AD CF-2023-12, dated February 23, 2023 (Transport Canada Emergency AD CF-2023-12) (also referred to as the MCAI), to correct an unsafe condition for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.

The MCAI states that since early 2021, there have been several unscheduled PW1500G engine removals due to CAS message L/R ENGINE FAULT with associated INFO message OIL DEBRIS ABOVE LIMIT being displayed, high vibration, or debris found on the magnetic chip collector of bearing compartment No. 3 (BC3). The investigation by Pratt & Whitney found that in most instances, the No. 3 bearings originated from a single manufacturing lot that have a possible defect.

In December 2022, an airplane experienced engine stall and uncommanded in-flight shutdown (IFSD) while in cruise. Prior to the IFSD event, the airplane had received advisory-level CAS message R ENGINE FAULT with associated INFO message 79 R ENGINE FAULT-OIL DEBRIS ABOVE LIMIT during the previous flight, and the fault was deferred in accordance with the approved minimum equipment list (MEL). The No. 3 bearing installed on the event engine was found to be from the suspect lot, and post-event inspection found metallic debris on the BC3 chip collector.

This AD is intended to prevent a No. 3 bearing failure. This condition, if not addressed, could result in unrecoverable engine failure or power loss for both engines and consequent reduced control of the airplane.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0658.

Transport Canada Emergency AD CF-2023-12 prohibits dispatch of an airplane with an affected engine having an applicable CAS message displayed, unless the BC3 chip collector and oil filter are inspected and any debris found is dispositioned. 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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in Transport Canada Emergency AD CF-2023-12 described previously, except for any differences identified as exceptions in the regulatory text of this 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, Transport Canada Emergency AD CF-2023-12 is incorporated by reference in this AD. This AD requires compliance with Transport Canada Emergency AD CF-2023-12 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in Transport Canada Emergency AD CF-2023-12 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 sections titled “Compliance” and “Corrective Actions” in Transport Canada Emergency AD CF-2023-12.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because a No. 3 bearing failure could result in unrecoverable engine failure or power loss for both engines and consequent reduced control of the airplane. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 84 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates it would take 2 hours for any required inspection and debris disposition at $85 per hour, for a total cost of $170 per engine.

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.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it modifies the Class E airspace at Boswell Airport, CA, to support IFR operations at the airport.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2022-1454 in the Federal Register (87 FR 76592; December 15, 2022), modifying Class E airspace extending upward from 700 feet above the surface at Boswell Airport, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E5 airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by modifying the Class E airspace extending upward from 700 feet above the surface at Boswell Airport, CA. The 6.6-mile radius airspace area encircling the airport is reduced to a 2.4-mile radius, as circling maneuvers are not authorized at the airport. The southeast extension of the airport is widened, shortened, and re-aligned to be within 2.1 miles either side of the 148° bearing from the airport, extending from the 2.4-mile radius to 6.7 miles southeast of the airport to better contain arriving IFR operations below 1,500 feet above the surface and departing IFR operations until they reach 1,200 feet above the surface. Additionally, a northern extension was added to the airspace description, which is 2.4 miles either side of the 346° bearing from the airport, extending from the 2.4-mile radius to 7.6 miles north of the airport to better contain arriving IFR operations below 1,500 feet above the surface and departing IFR operations until they reach 1,200 feet above the surface.

Finally, this action makes several administrative modifications to the airport's legal description. The airport name in line one of the text header is corrected from “Salyer Farms” to read “Corcoran, CA.” The airport name in line two of the text header is corrected from “Salyer Farms Airport” to “Boswell Airport.” Moreover, reference to the Salyer Farms nondirectional beacon has been removed from line 4 of the text header, as it is not needed to describe the airspace. The geographic coordinates for the airport are updated to match the FAA's database.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Vinita Municipal Airport, Vinita, OK, to support instrument flight rule operations at this airport.

The FAA published a NPRM for Docket No. FAA 2022-0759 in the Federal Register (87 FR 35691; June 13, 2022), establishing Class E airspace at Vinita, OK. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Vinita Municipal Airport, Vinita, OK.

This action supports the establishment of public instrument procedures at Vinita Municipal Airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it updates the information in the Greer, SC Class C airspace description.

During a review of the Greer, SC Class C airspace description, the FAA identified the need to update the name and ARP geographic coordinates for the Greenville-Spartanburg Airport, replace the outdated terms “Notice to Airmen” and “Airport/Facility Directory,” and update the title of “Greer Tower.”

Class C airspace areas are published in paragraph 4000 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by updating the Greer, SC Class C airspace description as published in FAA Order JO 7400.11G, Airspace Designations and Reporting Points. The name “Greenville-Spartanburg Airport” is changed to “Greenville-Spartanburg International Airport,” to match the Airport Master Record database, and the ARP geographic coordinates are updated from “lat. 34°53′56″ N, long. 82°12′49″ W” to “lat. 34°53′44″ N, long. 82°13′08″ W.” The ARP coordinates update is made to match the FAA's NASR database information. The airport name is removed from the first line in the text header of the description leaving just the city location of the airport. The city name is removed from the second line of the header leaving just the airport name on that line. These changes follow the current formatting standard. In the body of the Class C description, the outdated term “Notice to Airman” is replaced by “Notice to Air Missions.” The outdated term “Airport/Facility Directory” is replaced by “Chart Supplement.” The term “Greer Tower” is replaced by “Greer Airport Traffic Control Tower.”

This action consists of administrative changes only and does not affect the boundaries, altitudes, or operating requirements of the airspace. Therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of making administrative edits to the Greenville-Spartanburg International Airport Class C airspace description qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Smithville Crawford Municipal Airport, Smithville, TX, to support instrument flight rule operations at this airport.

The FAA published an NPRM for Docket No. FAA 2022-1443 in the Federal Register (87 FR 74055; December 2, 2022), establishing Class E airspace at Smithville, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 7.4-mile radius of Smithville Crawford Municipal Airport, Smithville, TX.

This action supports the establishment of public instrument procedures at Smithville Crawford Municipal Airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it establishes Class E airspace at New Coalinga Municipal Airport, Coalinga, CA, to support IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register for FAA-2022-1440 (87 FR 76429; December 14, 2022) to establish Class E airspace extending upward from 700 feet above the surface at New Coalinga Municipal Airport, Coalinga, CA. This action was to support the airport's transition from VFR to IFR operations. Interested parties were invited to participate in this rulemaking effort by submitting written comments to the FAA on the proposal. No comments were received.

Class E5 airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing Class E airspace at New Coalinga Municipal Airport, Coalinga, CA, extending upward from 700 feet above the surface within a 3.7-mile radius of the airport. In addition, Class E airspace extending upward from 700 feet above the surface is established within an area 1.9 miles each side of the 134° bearing from the airport, extending from the 3.7-mile radius to 9.4 miles southeast from the airport, and within 3.4 miles each side of the 346° bearing from the airport, extending from the 3.7-mile radius to 7.7 miles northwest of the airport. This airspace is designed to accommodate arriving IFR operations below 1,500 feet above the surface and departing IFR operations until they reach 1,200 feet above the surface, and will support the airport's transition from VFR to IFR operations.

The Class E5 airspace designation is published in paragraph 6005 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11 is published annually and becomes effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Delphi Municipal Airport, Delphi, IN, to support instrument flight rule operations at this airport.

The FAA published a NPRM for Docket No. FAA 2022-1117 in the Federal Register (87 FR 57158; September 19, 2022), establishing Class E airspace at Delph, IN. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Three (3) comments were received. Two (2) supporting the proposed action, and one (1) not applicable to the proposed action. No responses are provided.

Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022 and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Delphi Municipal Airport, Delphi, IN.

This action supports the establishment of public instrument procedures at Delphi Municipal Airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

I. Background

In the final rule which appeared in the January 6, 2023 Federal Register (88 FR 953), there were various inadvertent, technical, and typographical errors in the amendatory instructions. On February 3, 2023, at 88 FR 7357, the effective date was delayed in order to provide NOAA time to prepare technical corrections to the final rule. This document corrects those errors and applies those corrections as if they were included in the final rule that appeared in the January 6, 2023 Federal Register publication.

NOAA is publishing this correction to revise the regulatory instructions so that implementing regulations are not removed or otherwise altered in unintended ways that would create inaccuracies in the regulatory text and cause public confusion. This correction is effective on April 7, 2023, the date on which the final rule is effective.

Here is a summary of the corrections and correcting amendments NOAA is making.

On page 959, in the second column, § 922.5 is corrected so that it tracks without change, except for renumbering, existing regulatory text published at § 922.42 “Allowed activities”, as shown in the “Correction” section.

On page 965, in the third column, corrects amendatory instruction 14 to remove “Cruise ship” from § 922.81 to ensure consistent interpretation of like terms throughout the System.

On page 965, at the end of the third column, amendatory instruction 15 included an unnecessary and confusing internal cross reference in § 922.82(c) to subpart D, which sets forth procedures and criteria for issuance of National Marine Sanctuary (NMS) permits. Section 922.82(c) provides an exception to the prohibitions set forth in § 922.82(a) for activities necessary to respond to an emergency threatening life, property or the environment, whereas § 922.82(d) provides a separate, independent exception for activities executed in accordance with a permit issued in accordance with subpart D. Therefore, the internal cross-reference in § 922.82(c) is superfluous, and amendatory instruction 15 is corrected to remove the cross-reference in § 922.82(c) to subpart D and as shown in the “Correction” section.

This correction notice includes a new instruction that revises paragraphs § 922.84(a) and (j) that were inadvertently omitted from the January 6, 2023 final rule. These paragraphs govern the issuance of certifications in Greater Farallones NMS. For purposes of consistency and clarity, the date of sanctuary expansion is added to § 922.84(a), the internal cross-reference in § 922.84(a) to § 922.47, governing certifications, is updated and changed to § 922.10, and the internal cross-reference in § 922.84(j) to § 922.50, governing appeals, is updated and changed to § 922.37 in the regulatory text.

On page 966, in the second column, amendatory instruction 19 revises paragraph § 922.92(c) to include a reference to special use permits issued pursuant to subpart D that was inadvertently omitted from the final rule, and is included in the “Correction” section.

On page 966, in the third column, amendatory instruction 23 did not include a reference to special use permits issued pursuant to subpart D. Therefore, amendatory instruction 23 is corrected as shown in the “Correction” section.

On page 967, in the first column, amendatory instruction 27 included an unnecessary and confusing internal cross reference in § 922.112(d) to subpart D, which sets forth procedures and criteria for issuance of NMS permits. Section 922.112(d) provides an exception to the prohibitions set forth in § 922.112(b) for activities necessary to respond to an emergency threatening life, property or the environment, whereas § 922.112(d) provides a separate, independent exception for activities executed in accordance with a permit issued in accordance with subpart D. Therefore, the internal cross-reference in § 922.112(d) is superfluous, and amendatory instruction 27 is corrected to remove the cross-reference in § 922.112(d) to subpart D, as shown in the “Correction” section.

On page 967, in the first column, amendatory instruction 28 is corrected by updating the address provided at § 922.113(b), as shown in the “Correction” section below. A corresponding change to the “ATTN” line is made at § 922.83(b). On page 966, in the first column, amendatory instruction 16 is updated to correspond to reflect that there is now one Superintendent and one mailing address for both Greater Farallones National Marine Sanctuary and Cordell Bank National Marine Sanctuary.

On page 967, in the second column, amendatory instruction 30 inadvertently updated § 922.122(a)(7) by referencing an incorrect paragraph. NOAA meant to revise paragraph (a)(8), not paragraph (a)(7). Additionally, the instructions to § 922.122(f) inadvertently changed the applicable subparagraphs from (a)(2) through (11) to (a)(2) through (10), which is being restored to the original text, as shown in the “Correction” section below. Moreover, a new instruction is included in the regulatory text below for § 922.122(g), which will replace the reference § 922.49 with § 922.36 at subpart D.

On page 967, in the second column, amendatory instruction 31 updated paragraph § 922.123(a) by inadvertently changing the applicable subparagraphs from (a)(2) through (10) whereas the original text included the applicable subparagraphs from (a)(2) through (11). Amendatory instruction 31 is corrected as shown in the “Correction” section.

On page 967, in the third column, amendatory instruction 32 directed the Office of the Federal Register to revise the introductory text, paragraph (a), and the first sentence of paragraph (b) in 15 CFR 922.130. Regarding the revision of § 922.130(a), only the first sentence of § 922.130(a) was intended to be updated, and the remaining sentences in the paragraph were to remain unchanged. However, the instruction revised the first sentence and inadvertently deleted the rest of paragraph (a). The instruction should have revised the first sentence of paragraph (a) and then indicated that the remaining sentences in the paragraph were to remain unchanged. In order to retain the rest of paragraph (a) as described above, NOAA corrects the amendatory instruction as shown in the “Correction” section.

On pages 967-968, amendatory instruction 34 directed the Office of the Federal Register to revise paragraph (c)(1) and (d) through (f) in 15 CFR 922.132.

In paragraph (c)(1), NOAA inadvertently changed the applicable subparagraphs from (a)(2) through (12), which is restored through the regulatory text below. In addition, in a rulemaking on November 15, 2021 (86 FR 62901), NOAA updated the reference for applicable activities subject to this exemption for the purposes of Davidson Seamount Management Zone to be the 2021 Final Environmental Assessment for Monterey Bay National Marine Sanctuary Management Plan Review. NOAA retains that reference in this correction.

In paragraph (e), NOAA's intent was only to update references for authorizations from § 922.49 to § 922.36 of the new subpart D of part 922. NOAA inadvertently omitted existing text that referenced non-invasive introduced species of shellfish, as determined by NOAA and the State of California. The correct applicable subparagraphs and clarifying text is restored as shown in the “Correction” section below.

In paragraph (f), NOAA's intent was only to update references for certifications from § 922.47 to § 922.10 of the new subpart D of part 922. However, the instruction inadvertently omitted the existing text that referenced the disposal of dredged material that does not include the beneficial use of dredged material as defined by the site regulations. In order to retain the existing regulatory text, NOAA corrects the amendatory instruction as shown in the “Correction” section.

This correction includes a new instruction that revises paragraphs §§ 922.134(a)(2) and (b)(2) to conform to the consolidation to subpart D made in the January 6, 2023 final rule. This section pertains to review of certain State permits and leases. This correction adds a cross reference to the new section § 922.36 in consolidated subpart D and is corrected in the regulatory instructions.

On page 968, in the third column, amendatory instruction 38 for § 922.142(f) regarding the limitations on the issuance of permits for Stellwagen Bank NMS, is corrected by replacing the reference to the statute with reference to the issuance of special use permits pursuant to the new subpart D, as shown in the “Correction” section.

On page 969, in the first column, amendatory instruction 42 inadvertently updated § 922.152(a)(5) regarding the Olympic Coast NMS prohibition on drilling by changing “submerged lands” to “seabed”. As such, the instruction to revise § 922.152(a)(5) is removed. This correction also updates § 922.152(h) regarding the limitations on the issuance of permits for Olympic Coast NMS by replacing the reference to the statute with reference to the issuance of special use permits pursuant to the new subpart D, as shown in the “Correction” section.

On page 970, in the first column, amendatory instruction 47 updates § 922.162 of site-specific definitions for Florida Keys NMS, but inadvertently did not remove the terms “Seagrass” and “Vessel” as those terms have been moved to the program regulations at § 922.11. The instruction is corrected as shown in the “Correction” section.

On pages 972-973, amendatory instructions 53 and 56 are revised. The boundary description for Thunder Bay NMS is set forth in 15 CFR 922.190, and the boundary coordinates for the Thunder Bay NMS is set forth in Appendix A of 15 CFR 922, subpart R. This sanctuary was expanded in 2014 (79 FR 52960; September 5, 2014). The amendatory instructions to revise the boundary description in 15 CFR 922.190 and the table of boundary coordinates were inadvertently included in the final rule, when only the first sentence of the boundary description was only to be updated to read “3,247 square nautical miles (nmi 2 ) (4,300 sq. mi.).” NOAA is correcting the language in 15 CFR 922.190 in instruction 53 to accurately reflect this intended update, and removing instruction 56 to retain the existing regulatory descriptions at Appendix A of 15 CFR 922, subpart R, as shown in the “Correction” section.

This correction includes a new amendatory instruction 53a that revises paragraph § 922.193(d) referring to the applicability of the site-specific prohibitions to permits and to certifications issued for authorizations in existence on the effective date of the Thunder Bay NMS regulations. Subparagraph (d)(1) is revised to reference special use permits issued pursuant to the new subpart D, as shown in the regulatory section below. Also, subparagraph (d)(2) is removed and reserved since § 922.194 is no longer applicable and was removed and reserved.

This correction includes a new instruction that revises §§ 922.201(b) and 922.211(b) to conform to the consolidation to subpart D made in the January 6, 2023 final rule. This correction adds cross references to the new section § 922.11 on definitions in the program regulations that was not updated in the Mallows Bay-Potomac River and Wisconsin Shipwreck Coast NMS's site-specific regulations and appears in the regulatory section.

On page 973, in the second and third columns, respectively, amendatory instructions 57 and 59 correct §§ 922.205(a) and 922.215(a) by removing the phrase “under this section” from each instruction in the regulatory text below since the permit procedures are not included in those sections, but rather are now consolidated in Subpart D, as shown in the “Correction” section.

7. On page 973, in the second and third columns, respectively, amendatory instructions 58 and 60 did not revise §§ 922.206(a) and 922.216(a) to conform to the consolidation to subpart D made in the January 6, 2023 final rule. This correction adds cross references to the new subpart D for permitting in the program regulations that was not updated in the Mallows Bay-Potomac River and Wisconsin Shipwreck Coast NMS's site-specific regulations. In addition, the effective dates of each NMS designation are added through this correction. These changes are shown in the “Correction” section.

In FR Document 2022-28225 at 88 FR 953 in the issue of January 6, 2023 (delayed effective date at 88 FR 7357, February 3, 2023), on pages 959-973, the following corrections are made:

I. Overview

In this document, the Department promulgates a final rule (“rule”) granting the Director the authority and discretion to allow prisoners placed in home confinement under the CARES Act to remain in home confinement after the expiration of the covered emergency period. The Department published a proposed rule on this subject on June 21, 2022 (87 FR 36787), with a comment deadline of July 21, 2022.

On March 13, 2020, the President of the United States declared that a national emergency existed with respect to the outbreak of COVID-19, beginning on March 1, 2020. 2 COVID-19 is caused by an extremely contagious virus known as SARS-CoV-2 that has spread quickly around the world. 3 COVID-19 most often causes respiratory symptoms, but can also attack other parts of the body. The virus spreads when an infected person breathes out droplets and particles, and another person breathes in air that contains these droplets and particles, or they land on another person's eyes, nose, or mouth. 4 Individuals in close contact with an infected person—generally less than six feet apart—are most likely to get infected. Although COVID-19 often presents with mild symptoms, some people become severely ill and die. Older adults and individuals with underlying medical conditions are at increased risk of severe illness. 5

The U.S. Centers for Disease Control and Prevention (“CDC”) has recognized that the COVID-19 pandemic presents unique challenges for correctional facilities, such as those the Bureau manages. 6 These challenges include a high risk of rapid transmission due to congregate living settings, and a high risk of severe disease due to the high prevalence of pre-existing conditions and risk factors associated with severe COVID-19 illness in prison populations. Since the earliest days of the pandemic, Department and Bureau officials have worked in tandem to develop and implement a plan to mitigate the high risk of rapid transmission of COVID-19 in the Federal prison system.

In March 2020, several United States Senators urged the Attorney General and the Director to utilize available statutory authorities to transfer vulnerable prisoners to home confinement. 7 Transferring these vulnerable prisoners to home confinement would remove them from an environment in which contagious viruses thrive due to the inherent risks of congregate settings and the unique restrictions that correctional custody places on an individual's ability to maintain an appropriate social distance, as well as permit them to undertake other measures to protect themselves in ways they are not able to do in secure custody.

The Attorney General issued a memorandum on March 26, 2020, instructing the Director to prioritize the use of home confinement, where authorized, to protect the health and safety of inmates and Bureau staff by minimizing the risk of COVID-19 spread in Bureau facilities, while continuing to keep communities safe. 8 The Attorney General directed that the determination of whether to place an inmate in home confinement should be made on an individualized basis, considering the totality of the inmate's circumstances, statutory requirements, and a non-exhaustive list of discretionary factors:

• The age of the inmate and the vulnerability of the inmate to COVID-19;

• The security level of the facility housing the inmate, with priority given to inmates residing in low- and minimum-security facilities;

• The inmate's conduct in prison;

• The inmate's risk score under the Prisoner Assessment Tool Targeting Estimated Risk and Needs (“PATTERN”);  9

• Whether the inmate had a reentry plan that would help prevent recidivism and maximize public safety; and

• The inmate's crime of conviction and the danger the inmate would pose to the community. 10

The Attorney General's memorandum explained that some offenses would render an inmate ineligible for home confinement, and that other serious offenses would weigh more heavily against consideration for home confinement. It further explained that inmates who engaged in violent or gang-related activity while in prison, those who incurred a violation within the past year, or those with a PATTERN score above the “minimum” range would not receive priority consideration under the memorandum. 11

On March 27, 2020, the day after the Attorney General's first memorandum, the President signed into law the CARES Act, 12 which expanded the Director's authority and discretion to place inmates in home confinement in direct response to the COVID-19 pandemic during a “covered emergency period.” In relevant part, the CARES Act provides that the “covered emergency period” begins the date the President declared a national emergency with respect to COVID-19 and ends 30 days after the date on which the national emergency terminates. 13

On April 3, 2020, the Attorney General issued a second memorandum to the Director, finding that emergency conditions were materially affecting the functioning of the Bureau, and instructing the Director to use the expanded home confinement authority provided in the CARES Act to place in home confinement the most vulnerable inmates at the facilities most affected by COVID-19. 14 The Bureau subsequently issued internal guidance that adopted the criteria in the Attorney General's memoranda and prioritized for home confinement inmates who had served 50 percent or more of their sentences, or those who had 18 months or less remaining on their sentences and had served more than 25 percent of that sentence. 15 The Bureau later clarified that inmates with low or minimum PATTERN scores would qualify equally for home confinement, and that the factors assessed to ensure inmates were suitable for home confinement included verifying that an inmate's current or prior offense was not violent, not a sex offense, and not terrorism-related. 16 Since March 2020, the Bureau has significantly increased the number of inmates placed in home confinement under the CARES Act and other preexisting authorities. Between March 26, 2020, and January 23, 2023, the Bureau placed in home confinement a total of 52,561 inmates. 17 The majority of those inmates have since completed their sentences; as of January 23, 2023, there were 5,597 inmates in home confinement. 18 According to the Bureau, 3,434 of these inmates were placed in home confinement pursuant to the CARES Act. 19

An inmate placed in home confinement is not considered released from Bureau custody. Rather, the inmate continues serving their sentence at home in their community. These individuals must follow a set of rules designed to aid in their management, facilitate their reintegration into society, and support their rehabilitative efforts. For example, they are required to remain in the home during specified hours and are permitted to leave only for work or other preapproved activities, such as occupational training or therapy. Moreover, inmates in home confinement must submit to drug and alcohol testing and counseling requirements. Supervision staff monitor inmates' compliance with the conditions of home confinement by electronic monitoring equipment or, in a few cases for medical or religious accommodations, frequent telephone and in-person contact. 20 To remain in home confinement, inmates must comply with their agreed-upon conditions of supervision. 21

Section 12003(b)(2) of the CARES Act authorizes the Director to place inmates in home confinement, notwithstanding the time limits set forth in 18 U.S.C. 3624(c)(2), during and for 30 days after the termination of the national emergency declaration concerning COVID-19, provided the Attorney General has made a finding that emergency conditions are materially affecting the Bureau's functioning. By the Act's plain terms, the Director's authority to place an inmate in home confinement under the CARES Act expires at the end of the covered emergency period, or if the Attorney General revokes his finding.

The Act is silent, however, as to whether the Director has discretion to determine whether specific individuals placed in home confinement under the CARES Act may remain there after the expiration of the covered emergency period, or whether all inmates who are not eligible for home confinement under another authority must be returned to secure custody. The Department has concluded that the most reasonable interpretation of the CARES Act permits the Bureau to continue to make individualized determinations about the conditions of confinement for inmates placed in home confinement under the CARES Act, as it does with respect to all prisoners, 22 following the end of the covered emergency period. In its recent opinion, the Office of Legal Counsel (“OLC”) concluded that section 12003(b)(2) does not require the Bureau to return to secure custody inmates in CARES Act home confinement following the end of the covered emergency period. See Discretion to Continue the Home-Confinement Placements of Federal Prisoners After the COVID-19 Emergency, 45 Op. O.L.C. __ (Dec. 21, 2021) (“ Home-Confinement Placements” ). The Department hereby incorporates the analysis from that OLC opinion into the preamble of this final rule. Even if the relevant provision of the CARES Act were considered ambiguous, however, the Department's interpretation represents a reasonable one that would warrant deference under Chevron, U.S.A., Inc. v. Natural Resource Defense Council, Inc., 467 U.S. 837 (1984). 23

While the home confinement program under the CARES Act has been a measurable success, inmates and their families have sought assurance that those already in home confinement will not be abruptly returned to secure custody after the end of the covered emergency period. The Department remains sensitive to these concerns and agrees with the expressions of support from some Members of Congress for expanding the use of home confinement based on the needs of individual offenders. 24 With that in mind, the Department's interpretation is that any ambiguity in the CARES Act should be read to provide the Director with discretion to allow inmates placed in home confinement who have been successfully serving their sentences in the community to remain there, rather than require the Director to return such inmates to secure custody en masse without making an individualized assessment or identifying a penological, rehabilitative, public health, or public safety basis for the action. Although placements under the CARES Act were not made for reentry purposes, the Department concludes that the best use of Bureau resources and the best outcome for affected offenders is to allow the agency to make individualized assessments of CARES Act placements, with a focus on supporting inmates' eventual reentry into the community.

After publication of this final rule, the Department and the Bureau will work together to develop guidance to explain objective criteria the Bureau will use to make individualized determinations as to whether any inmate placed in home confinement under the CARES Act should be returned to secure custody. Providing the Bureau with discretion to determine whether any inmate placed in home confinement under the CARES Act should return to secure custody will bolster the Bureau's ability to efficiently manage its resources and nimbly address changing circumstances in the community, in relation to the needs and profiles of individual inmates.

This document and additional information concerning OFAC are available on OFAC's website: www.treas.gov/ofac.

On August 5, 2019, OFAC issued GL 29 to authorize certain transactions otherwise prohibited by Executive Orders (E.O.s) 13808 of August 24, 2017, “Imposing Additional Sanctions with Respect to the Situation in Venezuela” (82 FR 41155, August 29, 2017), and 13884 of August 5, 2019, “Blocking Property of the Government of Venezuela” (84 FR 38843, August 7, 2019). Also on August 5, 2019, OFAC issued GL 30 to authorize certain transactions otherwise prohibited by E.O. 13884. Also on August 5, 2019, OFAC issued GL 31 to authorize certain transactions otherwise prohibited by E.O.s 13850 of November 1, 2018, “Blocking Property of Additional Persons Contributing to the Situation in Venezuela” (83 FR 55243, November 2, 2018), and 13884.

On November 22, 2019, OFAC incorporated the prohibitions of E.O.s 13808, 13850, and 13884, as well as any other Executive orders issued pursuant to the national emergency declared in E.O. 13692 of March 8, 2015, “Blocking Property and Suspending Entry of Certain Persons Contributing to the Situation in Venezuela,” into the Venezuela Sanctions Regulations, 31 CFR part 591 (VSR). Subsequently, OFAC issued one further iteration of GL 30 and two further iterations of GL: on February 2, 2021, OFAC issued GL 30A, which superseded GL 30 and authorized certain transactions otherwise prohibited by E.O. 13850 and E.O. 13884; on January 4, 2021, OFAC issued GL 31A, which superseded GL 31; and on January 9, 2023, OFAC issued GL 31B, which superseded GL 31A.

Each GL was made available on OFAC's website ( www.treas.gov/ofac ) when it was issued. The text of GLs 29, 30, 30A, 31, and 31A is provided below. (GL 31B was published in a prior issue of the Federal Register .)

This document and additional information concerning OFAC are available on OFAC's website: www.treas.gov/ofac.

On August 5, 2019, OFAC issued GLs 32 and 33 to authorize certain transactions otherwise prohibited by Executive Order (E.O.) 13884 of August 5, 2019, “Blocking Property of the Government of Venezuela” (84 FR 38843, August 7, 2019). On September 9, 2019, OFAC issued GL 34 to authorize certain transactions otherwise prohibited by E.O. 13884. Subsequently, OFAC issued one further iteration of GL 34: on November 5, 2019, OFAC issued GL 34A, which superseded GL 34. Also on November 5, 2019, OFAC issued GL 35 to authorize certain transactions otherwise prohibited by E.O. 13884.

Each GL was made available on OFAC's website ( www.treas.gov/ofac ) when it was issued. The text of these GLs is provided below.

(a) Except as provided in paragraph (b) of this general license, individuals who are U.S. persons residing in Venezuela are authorized to engage in transactions involving the Government of Venezuela prohibited by Executive Order (E.O.) of August 5, 2019 that are ordinarily incident and necessary to their personal maintenance within Venezuela, including payment of housing expenses, acquisition of goods or services for personal use, payment of taxes or fees, and purchase or receipt of permits, licenses, or public utility services.

(b) This general license does not authorize any transaction or dealing otherwise prohibited by E.O. of August 5, or E.O. 13850 of November 1, 2018, E.O. 13835 of May 21, 2018, E.O. 13827 of March 19, 2018, E.O. 13808 of August 24, 2017, or E.O. 13692 of March 8, 2015, each as amended by E.O. 13857 of January 25, 2019, or any part of 31 CFR chapter V, or any transactions or dealings with any blocked person other than the Government of Venezuela persons described in paragraph (a) of this general license.

(a) Except as specified in paragraph (c), the receipt of, and payment of charges for, services rendered involving the Government of Venezuela in connection with overflights of Venezuela or emergency landings in Venezuela by aircraft registered in the United States or owned or controlled by, or chartered to, persons subject to U.S. jurisdiction are authorized.

(b) Except as specified in paragraph (c), persons subject to U.S. jurisdiction are authorized to engage in all transactions involving the Government of Venezuela necessary to provide air ambulance and related medical services, including medical evacuation from Venezuela, for individuals in Venezuela.

(c) This general license does not authorize any transactions or dealings otherwise prohibited by Executive Order (E.O.) of August 5, 2019, or E.O. 13850 of November 1, 2018, E.O. 13835 of May 21, 2018, E.O. 13827 of March 19, 2018, E.O. 13808 of August 24, 2017, or E.O. 13692 of March 8, 2015, each as amended by E.O. 13857 of January 25, 2019, or any part of 31 CFR chapter V, or any transactions or dealings with any blocked person other than the Government of Venezuela persons described in paragraphs (a) and (b) of this general license.

(a) Except as provided in paragraph (c) of this general license, all transactions and activities prohibited by Executive Order (E.O.) 13884 involving one or more individuals who meet the definition of the “Government of Venezuela,” as defined in E.O. 13884, including all transactions that involve property in which such individuals have an interest, are authorized, provided that the individuals are one or more of the following:

(1) United States citizens;

(2) Permanent resident aliens of the United States;

(3) Individuals in the United States who have a valid U.S. immigrant or nonimmigrant visa, other than individuals in the United States as part of Venezuela's mission to the United Nations; or

(4) Former employees and contractors of the Government of Venezuela.

(b) Except as provided in paragraph (c), all transactions necessary to unblock property or interests in property that were blocked solely pursuant to E.O. 13884, including the return or processing of funds, for individuals described in paragraph (a) of this general license are authorized.

(c) This general license does not authorize:

(1) The unblocking of any property blocked pursuant to E.O. 13884, or any part of 31 CFR chapter V, except as authorized by paragraph (a) or (b); or

(2) Any transactions or dealings otherwise prohibited by E.O. 13884, or E.O. 13850 of November 1, 2018, E.O. 13835 of May 21, 2018, E.O. 13827 of March 19, 2018, E.O. 13808 of August 24, 2017, or E.O. 13692 of March 8, 2015, each as amended by E.O. 13857 of January 25, 2019, or any part of 31 CFR chapter V, or any transactions or dealings with any blocked person, including persons meeting the definition of the “Government of Venezuela” in E.O. 13884, other than the individuals described in paragraph (a) of this general license.

(d) U.S. persons unblocking property pursuant to paragraph (a) or (b) of this general license are required, within 10 business days from the date the property is unblocked, to file a report detailing the information required by 31 CFR 501.603(b)(3)(ii), with the Office of Foreign Assets Control, Office of Compliance and Enforcement, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Freedman's Bank Building, Washington, DC 20220, or via email to OFACReport@treasury.gov.

(a) Except as provided in paragraph (d) of this general license, all transactions and activities prohibited by Executive Order (E.O.) 13884 involving one or more individuals who meet the definition of the “Government of Venezuela,” as defined in E.O. 13884, including all transactions that involve property in which such individuals have an interest, are authorized, provided that the individuals are one or more of the following:

(1) United States citizens;

(2) Permanent resident aliens of the United States;

(3) Individuals who have a valid U.S. immigrant or nonimmigrant visa, other than individuals in the United States as part of Venezuela's mission to the United Nations;

(4) Former employees and contractors of the Government of Venezuela; or

(5) Current employees and contractors of the Government of Venezuela who provide health or education services in Venezuela, including at hospitals, schools, and universities.

(b) Except as provided in paragraph (d) of this general license, all transactions and activities prohibited by E.O. 13884 related to the receipt by an individual described in paragraph (a) of this general license of salary, pension, annuity, or other employment-related payments or benefits from a person meeting the definition of “Government of Venezuela” in E.O. 13884 and blocked solely pursuant to E.O. 13884 are authorized.

(c) Except as provided in paragraph (d), all transactions necessary to unblock property or interests in property that were blocked solely pursuant to E.O. 13884 for individuals described in paragraph (a) of this general license and transactions described in paragraph (b) of this general license, including the return or processing of funds, are authorized.

(d) This general license does not authorize:

(1) The unblocking of any property blocked pursuant to E.O. 13884, or any part of 31 CFR chapter V, except as authorized by paragraph (a), (b) or (c);

(2) Any transactions or dealings otherwise prohibited by E.O. 13884, or E.O. 13850 of November 1, 2018, E.O. 13835 of May 21, 2018, E.O. 13827 of March 19, 2018, E.O. 13808 of August 24, 2017, or E.O. 13692 of March 8, 2015, each as amended by E.O. 13857 of January 25, 2019, or any part of 31 CFR chapter V, or any transactions or dealings with any blocked person, including persons meeting the definition of the “Government of Venezuela” in E.O. 13884, other than the individuals described in paragraph (a) of this general license, and the transactions described in paragraphs (b) and (c) of this general license; or

(3) Any transactions or dealings with, or the unblocking of any property or interests in property of, any person included on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List).

(e) U.S. persons unblocking property pursuant to paragraph (a), (b), or (c) of this general license are required, within 10 business days from the date the property is unblocked, to file a report detailing the information required by 31 CFR 501.603(b)(3)(ii), with the Office of Foreign Assets Control, Office of Compliance and Enforcement, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Freedman's Bank Building, Washington, DC 20220, or via email to OFACReport@treasury.gov.

(f) Effective November 5, 2019, General License 34, dated September 9, 2019, is replaced and superseded in its entirety by this General License No. 34A.

(a) Except as provided in paragraph (b) of this general license, U.S. persons are authorized to pay taxes, fees, and import duties to, and purchase or receive permits, licenses, registrations, certifications, and public utility services from, the Government of Venezuela, to the extent such transactions and activities are prohibited by Executive Order (E.O.) 13884, where such transactions are necessary and ordinarily incident to such persons' day-to-day operations.

(b) This general license does not authorize any transaction or dealing otherwise prohibited by E.O. 13884, or E.O. 13850 of November 1, 2018, E.O. 13835 of May 21, 2018, E.O. 13827 of March 19, 2018, E.O. 13808 of August 24, 2017, or E.O. 13692 of March 8, 2015, each as amended by E.O. 13857 of January 25, 2019, or any part of 31 CFR chapter V, or any transactions or dealings with any blocked person other than the transactions described in paragraph (a) of this general license.

(c) Except as provided in paragraph (d) of this general license, U.S. persons who make one or more payments authorized by this general license in U.S. dollars to the Government of Venezuela are required to file reports, as set forth in paragraph (e) of this general license, with the Office of Foreign Assets Control (OFAC) and the Department of State's Office of Sanctions Policy and Implementation. Such reports must include: the names and addresses of the entity or entities remitting payment and the Government of Venezuela entity or entities receiving payment; the amount of funds paid to the Government of Venezuela; the type and scope of activities conducted, such as the relevant type of taxes, fees, or duties paid; and the dates of payment.

(d) U.S. financial institutions are not required to submit reports regarding any payments that they process on behalf of customers or other third parties that are authorized pursuant to this general license.

(e)(1) U.S. persons required to report to OFAC and the Department of State pursuant to paragraph (c) of this general license, must submit reports:

(i) By February 10, 2020, an initial report detailing all transactions and activities conducted pursuant to this general license from November 5, 2019 through February 3, 2020; and

(ii) (A) By August 10th of each year, detailing all transactions and activities conducted pursuant to this general license from January 1st through June 30th of the relevant year; and

(B) By February 10th of each subsequent year, detailing all transactions and activities conducted pursuant to this general license from July 1st through December 31st of the relevant year.

(2) Reports, which must reference General License 35, are to be sent to OFAC via email to OFACReport@treasury.gov or mailed to: Office of Foreign Assets Control, Office of Compliance and Enforcement, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Freedman's Bank Building, Washington, DC 20220, and to the Department of State via email to GL35reporting@state.gov or mailed to: U.S. Department of State, 2201 C Street NW, WHA-AND HIST-4915 Washington, DC 20520.

I. Discussion of Public Comments and Changes

On Friday, November 29, 2019 (84 FR 65718-65727), the Department of Defense published a proposed rule titled “TRICARE; Reimbursement of Ambulatory Surgery Centers and Outpatient Services Provided in Cancer and Children's Hospitals” for a 60-day public comment period. Eleven public comments were received. This section responds to those public comments.

Comment: Several commenters expressed concern that this change in reimbursement methods and rates might lead to access to care issues because providers might opt out of providing services because the Medicare rate is lower than the previously paid TRICARE rates. One commenter urged the Defense Health Agency (DHA) to “take a more granular examination of changes in reimbursement that will occur as the result of the proposed alignment and take steps to ensure that any procedures that are being performed in significant volume in ASCs do not experience a reduction in reimbursement.” Another commenter recommended that DHA should not adopt the Medicare ASC fee schedule (FS) because Medicare patients have different needs from those seen under TRICARE. The commenter requested DHA to consider differences in procedure types performed on TRICARE patients, in part because this commenter found that their TRICARE patients “tend to undergo Orthopedic and ENT surgeries at a much higher rate than our Medicare patients do.”

Response: We appreciate the commenters' concerns regarding the potential impact of adopting Medicare's ASC FS in the TRICARE program. As discussed in the notice of proposed rulemaking, we are adopting the Medicare ASC system because, first, TRICARE is statutorily obligated to reimburse like Medicare where practicable, second, the current TRICARE ASC system is based primarily on Medicare's retired ASC reimbursement system, and finally, the TRICARE rates are difficult to update and in some cases anomalous. The Medicare ASC rates, which TRICARE is adopting, are based on assessments made each year by the Centers for Medicare and Medicaid Services (CMS) of the appropriate level of reimbursement for ASCs. In contrast to adopting a system that CMS will update each year for the appropriate level of reimbursement for each ASC surgery, over one-half of the procedures under the current TRICARE ASC system have rates and groups based on assignments made prior to 2001. DHA has found that TRICARE's current patchwork system can produce reimbursement anomalies, particularly in comparison to Medicare's ASC rates and Outpatient Prospective Payment System (OPPS) rates. For example, we compared the January 2020 TRICARE ASC rates with Medicare ASC rates for 40 high-volume, higher-cost procedures and found that for one-fifth of the cases, the Medicare ASC rate is more than 40 percent higher than the current TRICARE ASC rate and that in only one quarter of the cases are the Medicare ASC rates within 10 percent of the TRICARE rates. In two cases, the TRICARE ASC rate is even greater than the OPPS rate, which is anomalous. These anomalies would be corrected using the Medicare ASC rates.

We agree with the commenter that it is important to look at the impact of proposed reimbursement changes for high-volume codes. DHA did this type of analysis prior to publishing the notice of proposed rulemaking and we have now used data from 2019 to examine the impact of reimbursement changes on high-volume ASC procedures as suggested by the commenter. We selected all TRICARE ASC procedures with 660 or more claims in the January-June 2019 period plus any other procedures that were among the highest 10 in terms of TRICARE ASC allowed amounts in 2019. The combined group of 40 high-volume, high-cost surgical procedures accounted for over 71 percent of all TRICARE ASC surgery claims and 63 percent of all TRICARE ASC allowed amounts in the January-June 2019 period.

We found that the maximum allowable Medicare ASC rates in January 2020 were higher than the current TRICARE ASC rates for almost half (43 percent) of the 40 high-volume, high cost procedures, including 3 of the 6 highest-volume TRICARE ASC surgeries. We also found that the Medicare rates for an additional one-eighth of the 40 procedures had Medicare ASC rates that were only slightly less (0 to 9 percent) than the current TRICARE ASC rates. On average, the Medicare rates for the 40 high-volume, high-cost procedures were 14 percent lower than the January 2020 TRICARE ASC rates. Thus, we were re-assured that for over half of the high-volume, high-cost procedures, the Medicare rates will represent either an increase or a small decrease compared with the TRICARE ASC rates.

We disagree with the commenter that DHA should ensure that none of the high-volume procedures experience a reduction in reimbursement rates. Even though there will be an overall reduction in TRICARE reimbursement rates, many codes will have higher rates and the benefits of adopting an updated, internally-consistent reimbursement system outweigh the disadvantages of reduced rates for some ASC surgeries. In addition, it is not practical for DHA to have TRICARE pay different amounts for procedures in ASCs compared to Medicare solely because a procedure is common.

We also disagree with the comment that Medicare ASC rates are not appropriate for TRICARE patients because the patients have different needs. First, the TRICARE population is generally younger and healthier on average than Medicare patients. Second, DHA has already adopted the use of the Medicare OPPS and the Medicare Physician Fee Schedule, with Medicare rates, and Medicare's ASC FS rates are simply a hybrid of those two systems' rates. Furthermore, many of the procedures that DHA has added to the TRICARE ASC FS in the last few years were priced based on the Medicare ASC FS rate. Fourth, there is nothing unique about freestanding ASCs that make Medicare rates inappropriate due to beneficiary characteristics compared to those payment systems. Fifth, we have no evidence that the Medicare ASC rates are too low because TRICARE beneficiaries generally do not require more costly care than Medicare beneficiaries. Sixth, the fact that a procedure is more common in one population than another does not, in itself, argue for different payment rates because procedures are billed by specific Common Procedural Terminology (CPT) code. As the commenter suggested, we did examine the change in maximum reimbursement rates for ear nose and throat (audiology and respiratory) surgeries and orthopedic (musculoskeletal) surgeries. We found that almost one-quarter of the 40 high-volume, high-cost TRICARE surgical procedures are ENT or orthopedic and that the maximum TRICARE reimbursement rate would decrease by 6 percent for ENT surgeries and by 4 percent for orthopedic surgeries. In comparison, the rates would decrease by an average of 14 percent for all 40 surgeries. Thus, our analysis of the high-volume, high-cost procedures for TRICARE ASC patients indicates that although the mix of TRICARE and Medicare ASC surgeries is different, the types of surgeries identified by the commenter as being more common among the non-Medicare population will have modest reductions and smaller reductions than for other procedures. For all these reasons, DHA concludes that adopting the Medicare ASC rates is appropriate for TRICARE patients.

Comment: One commenter requested that DHA evaluate including non-opioid pain management medications in the list of covered ancillary services for ASC reimbursement, as Medicare did in 2019.

Response: DHA intends to adopt Medicare's ASC FS rules, payment rates, and addenda, including their list of ancillary procedures allowed to be paid outside the packaged procedure rate (Addendum BB, ASC Covered Ancillary Services). Currently, as finalized in the CY 2021 OPPS/ASC final rule (86 FR 63484), Medicare has approved four such substances including Exparel ( C9290; Injection, bupivacaine liposome, 1 mg ), Omidria ( J1097; Phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml ), Zynrelef ( C9088; Instillation, bupivacaine and meloxicam, 1 mg/0.03 mg ), and Xaracoll ( C9089; Bupivacaine, collagen-matrix implant, 1 mg ). These codes can be found in Addendum BB of the Medicare ASC FS rule files, with a payment rate given.

Comment: One commenter suggested that DHA should update the Medicare ASC rates for inflation using the hospital market basket update factor for CY 2023, not the CPI-U.

Response: We agree with the commenter that DHA should use the hospital market basket adjusted for productivity update factor for CY 2023, which aligns with Medicare and is practicable to adopt under the TRICARE program. The TRICARE updates will match the method that CMS uses each year to update the Medicare ASC rates. Therefore, we have revised the rule accordingly.

Comment: One commenter indicated that the proposed rule did not describe cost-sharing for ASC care under the new reimbursement methodology.

Response: TRICARE's cost sharing structure varies by type of service (IP vs OP), type of beneficiary (active duty dependent versus retiree), and by type of enrollment (Prime vs. Select). The cost sharing for ASC care has been established by regulation and the cost sharing structure for ASC care will not be affected by TRICARE's adoption of the Medicare ASC rates. Most active duty family members in Prime pay no cost sharing for ASC care and those enrolled to Select generally pay $25 per surgery. Most retirees and their family members in Prime pay $67 per surgery (in 2022) and most Select enrollees pay 20 percent of the allowed amount for in-network ASC care and 25 percent of the allowed amount for out-of-network ASC care. Given that there will be a reduction in TRICARE allowed amounts under the Medicare ASC rates, most TRICARE retirees enrolled in Select will see reduced cost sharing, another benefit of adopting the new ASC system.

Comment: One commenter stated that the adoption of OPPS reimbursement for CCHs will have an undesirable financial impact on their Children's hospital and other Children's Hospitals that serve large TRICARE populations. Their concerns include that Medicare payments have been historically below cost, and that changes to the TRICARE fee structure, when combined with Medicare's rates, pose a significant threat to their ability to service military families. The suggestions ranged from continuing to reimburse Children's Hospitals at billed charges or “grandfathering” certain facilities that are in close proximity to military bases that treat a disproportionate share of TRICARE beneficiaries.

Response: DHA agrees that some children's hospitals will have reduced TRICARE payments due to the rule's provisions although DHA's analysis also indicates that some children's hospitals will see large increases in their TRICARE payments.

The proposed rule contained a provision for a General Temporary Military Contingency Payment Adjustment (GTMCPA) which will allow children's hospitals and cancer hospitals that meet certain criteria to receive additional payments for services which will be paid under OPPS. The criteria will not be based on criteria similar to those specified under TRICARE's OPPS for GTMCPAs. These criteria, which have been tailored for CCHs, will include: (1) 10 percent or more of the hospital's revenue is from TRICARE for care of ADSMs/ADDs; (2) the hospital having 10,000 or more TRICARE visits that would fall under the OPPS payment system for ADSMs/ADDs annually; and (3) the hospital being deemed as essential for TRICARE operations. Hospitals that meet these criteria will be eligible to receive up to 115 percent of the hospital's costs for OPPS services. These provisions can be implemented for children's hospitals without jeopardizing access for TRICARE beneficiaries, because of the ability of children's hospitals to apply for a GTMCPA.

Comment: Several commenters remarked that the lack of a transition period between the current TRICARE ASC reimbursement and the adoption of the Medicare rates may mean that there would be an immediate access to care effect, exacerbated by the abrupt change in fees. One commenter suggested a three year transition period, to allow ASCs time to adjust to the new rates. Another commenter suggested that without a transition, some beneficiaries would be forced to use higher-cost options, such as hospital outpatient departments, which would reduce DHA's expected savings from adopting the new ASC rates.

Response: DHA is adopting the new ASC reimbursement system to be consistent with Medicare's, as required by statute, which states that TRICARE institutional service payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply under Medicare. DHA has concluded that it is practicable for TRICARE to adopt Medicare's ASC rates. DHA is not adopting the Medicare ASC rates in order to reduce TRICARE costs. DHA recognizes that there will be both increases and decreases in TRICARE maximum allowed amounts using the Medicare ASC rates. Although DHA expects a decrease in total TRICARE payments for ASCs, DHA also expects that these savings would be reduced if TRICARE beneficiaries increase their use of hospital outpatient departments (HOPDs).

As noted in the proposed rule, DHA considered a transition period but decided against one because the overall impact of the new system is small (for the 40 high-volume, high-cost procedures a reduction of 14 percent) and because there are many ASC procedures that will have rate increases under the new Medicare ASC system (over 40 percent of the high-volume surgeries). In addition, DHA has reviewed carefully Medicare Payment Advisory Committee (MedPAC's) most recent assessment of Medicare's ASC rates. The March 2022 MedPAC report to Congress found that there has been growth in the number of ASCs and that the number of Medicare beneficiaries using ASCs had increased from 2015 to 2019, which MedPAC states are both indicators of adequate access to ASCs. MedPAC also found in its March 2022 report that ASCs had adequate access to capital. As a result, MedPAC concluded that access to ASCs was adequate and that indicators of payment adequacy for ASCs were positive. Given that TRICARE will be adopting the Medicare ASC rates, DHA finds MedPAC's conclusions to be particularly relevant to issues of access and payment adequacy.

DHA also notes that even if some ASCs denied access to TRICARE beneficiaries for some surgeries, TRICARE beneficiaries would be largely protected from access problems because these patients could have their surgeries performed in HOPDs.

One commenter argued that a transition period would allow ASCs a chance to budget for the rate decreases and potential revenue loss. However, since rates will be decreased by a modest amount (14 percent for the 40 high-volume, high-cost surgeries) and because TRICARE beneficiaries are typically a small percentage of ASCs total revenue, as evidenced by the fact that 2019 TRICARE payments to ASCs (approximately $250 M) were less than 5 percent of the 2019 Medicare payments to ASCs ($5.2B), we have determined that a transition is not warranted. The TRICARE updates will match the method that CMS uses each year to update the Medicare ASC rates. In addition, as noted above, the rates for almost half the high-volume ASC surgeries will increase under the Medicare ASC rates. A transition would mean that the full rate increases would not go into effect for a number of years.

Comment: Several commenters suggested that DHA should maintain CPT code 41899 (unlisted dentoalveolar structures) in the TRICARE ASC fee schedule, even though it is not payable under Medicare's ASC fee schedule. Commenters added that dental procedures are commonly performed on TRICARE beneficiaries and are needed for TRICARE's pediatric population with special needs, who may require anesthesia when undergoing dental procedures. One commenter expressed concerns that removing CPT code 41899 from the TRICARE ASC fee schedule will result in TRICARE beneficiaries losing access to this code, without providing any explanation.

Response: While DHA intends to adopt Medicare's ASC payment rules, to the extent practicable, we do recognize that in the case of dental care, an exception may be required, as Section 702 of the John Warner National Defense Authorization Act (NDAA) for Fiscal Year 2007 provides that, institutional and anesthesia services may be covered for both hospital and in-out surgery settings related to dental care for pediatric and certain other patients. Generally, Medicare does not pay for unlisted procedure codes in a freestanding ASC according to 42 CFR 416.166(c), because CMS must ensure that procedures allowed in an ASC are not a safety risk and that a patient would not typically be required to stay overnight or have active medical monitoring. However, we recognize that CPT 41899 is commonly utilized to bill for the facility fees associated with dental care for pediatric and certain other patients, who may require anesthesia during dental procedures. We agree that CPT 41899 is appropriate in an ASC setting and we have added this exception to the ASC list of covered surgical procedures, in accordance with Section 702 of NDAA for Fiscal Year 2007. For covered dental services as defined in § 199.4 of this part, this rule will permit reimbursement for the ASC facility fee for dental procedures that are excluded from Medicare's ASC list, such as CPT 41899 (including subsequent codes, if renumbered or renamed). The TRICARE payment for such covered dental procedures without an ASC rate would be based on the same rate under the TRICARE OPPS. DHA will not maintain a separate ASC list to accommodate this exception; instead the TRICARE contractors will be instructed to reimburse the procedure code at the OPPS rate. This approach ensures access in freestanding facilities while implementing a practicable solution to accommodate the needs of our younger population.

In this final rule, after consideration of public comments, we are revising our proposed rule and adopting the method that CMS uses each year to update the Medicare ASC reimbursement rates to update the TRICARE ASC payment system, instead of specifying a specific method, such as consumer price index for all urban consumers (CPI-U). We are also revising the criteria for CCHs to apply for the GTMCPA. Clarifications have been made regarding DHA's intention to reimburse like Medicare, where practicable.

We are making changes to the ASC provider participation agreement, adding a new “hold harmless” provision under § 199.6(b)(4)(x)(B)( 1 )( ii ) and ( iii ) that will prohibit ASC facilities from billing TRICARE beneficiaries for non-covered procedures, unless the beneficiary agreed in advance in writing to pay for the services. The advanced notice would inform TRICARE beneficiaries about potential costs prior to receiving services, which will protect beneficiaries from unintended liability. Incorporating the “hold harmless” provision is appropriate because providers have a responsibility of knowing whether specific services or items are covered, as required by § 199.6(a). Providers seeking authorized provider status and payment from the Federal Government through programs such as TRICARE have a responsibility to familiarize themselves with, and comply with program requirements. Therefore, the provider should be held financially responsible for failing to properly inform TRICARE beneficiaries about patient costs before services are rendered. While the ASC facility charges would be denied, the professional charges for the non-ASC procedure or service could potentially be reimbursed.

Corrections have been made to the regulations text at § 199.14(a)(6)(ii) to reflect the current version of the regulation, because the proposed rule used an older version. Therefore, we are only revising the current version of § 199.14(a)(6)(ii)(A) to specifically include CCHs as being added to the OPPS controlled reimbursements, as they have been excluded to date; we are revising § 199.14(a)(6)(ii)(E) to specifically exclude CCHs from the any Temporary Transitional Payment Adjustments (TTPAs) under § 199.14(a)(6)(ii)(E)( 1 ) and ( 2 ); we are revising § 199.14(a)(6)(ii)(E)( 3 ) to specifically name the additional available military contingency payment adjustment as a “general temporary military contingency payment adjustment (GTMCPA)” to further distinguish it from the TTPAs, and have added specific criteria for CCHs to qualify for GTMCPA; and, we are inserting a new § 199.14(a)(6)(ii))(E)( 4 ) which provides CCHs with annual hold-harmless adjustments to OPPS payments. Finally, we have permitted a limited exception to allow payment for covered dental care by revising § 199.14(d) to address how covered dental procedures will be reimbursed in the absence of a Medicare ASC payment rate. All other aspects of the proposed rule remained the same.

The purpose of this rule is to finalize TRICARE regulation modifications necessary to implement for Ambulatory Surgery Centers (ASC) and Cancer and Children's Hospitals (CCHs) the statutory requirement that payments for TRICARE institutional services “shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under [Medicare].” Although Medicare's reimbursement methods for ASC and CCHs are different, it is prudent to finalize adopting both the Medicare ASC system and the Outpatient Prospective Payment System (OPPS) with hold-harmless adjustments (meaning the provider is not reimbursed less than their costs) for CCHs simultaneously to align with our statutory requirement to reimburse like Medicare at the same time. This rule sets forth the regulatory modifications necessary to implement TRICARE reimbursement methodologies similar to those applicable to Medicare beneficiaries for outpatient services rendered in ASCs and cancer and children's hospitals.

1. TRICARE is adopting the Medicare reimbursement methodology for ASCs. Currently, TRICARE reimburses surgical services performed in TRICARE authorized ambulatory surgery settings ( i.e., freestanding ASCs and other TRICARE providers exempt from the TRICARE OPPS reimbursement methodology including cancer and children's hospitals) institutional facility costs on the basis of prospectively determined amounts, in accordance with 32 Code of Federal Regulations (CFR) 199.14(d). The current system was modeled after Medicare's previous ASC reimbursement system. TRICARE's current reimbursement system for services provided in these ambulatory surgery settings is based on Medicare's retired system, and is difficult to update. Adoption of Medicare's ASC reimbursement system will bring TRICARE reimbursement for ambulatory surgery care into alignment with the statutory requirement that payment methods for institutional care be, to the extent practicable, in accordance with the same reimbursement rules used by Medicare.

2. TRICARE is adopting the Medicare payment methodology for outpatient services provided in CCHs. In a final rule, published December 10, 2008, (73 FR 74945-74966), TRICARE adopted Medicare's payment methodology for outpatient hospital services-the Outpatient Prospective Payment System (OPPS). Under Medicare, CCHs were held harmless and were paid the full amount of the decrease they experienced (as prior to OPPS the hospital had been paid 100 percent of their costs) after the implementation of OPPS, under section 1833(t) (7) of the Social Security Act. These payments are transitional outpatient payments (TOPs). Because of the complexity and because of the administrative burden/expense of calculating and maintaining the TOPs, TRICARE opted to totally exempt CCHs from OPPS initially. The agency is now revisiting the exemption of CCHs from OPPS. In this final rule, TRICARE is adopting the Medicare methodology for reimbursement of outpatient facility services (including ambulatory surgery) rendered in a cancer or children's hospital, with modifications to address the administrative burden and complexity. The DHA now has the capability, and it is feasible, to adopt these reimbursement provisions with a modification that the hold-harmless provisions will be calculated and paid annually, rather than in monthly interim payments.

1. Adopting Medicare's Ambulatory Surgical Center Reimbursement System for TRICARE Authorized Ambulatory Surgery Centers. Per Title 10 United States Code (U.S.C.), section 1079(i) (2), TRICARE's payment methods for institutional care shall be determined, to the extent practicable, in accordance with the same reimbursement rules used by Medicare. Under this final rule, TRICARE will reimburse ASCs for ambulatory surgical services using a method similar to Medicare's ASC reimbursement methodology. Under the TRICARE ASC reimbursement method, payment for a TRICARE patient will be made at the lower of the billed charge or the Medicare-determined ASC payment rate with applicable TRICARE cost-sharing provisions. The TRICARE ASC reimbursement method would include payment for all facility services associated with the surgical procedure that are included in the payment methodology by Medicare, but would exclude certain services also excluded by Medicare under the ASC reimbursement methodology ( e.g., certain ancillary services and implantable devices with pass-through status).

2. Adopting Medicare's Outpatient Prospective Payment System (OPPS) for Cancer and Children's Hospitals. In a final rule, dated December 10, 2008 (73 FR 74945-74966), TRICARE adopted Medicare's payment methodology for outpatient hospital services—the outpatient prospective payment system (OPPS). Under Medicare, CCHs were held harmless and were paid the full amount of the decrease they experienced after the implementation of OPPS, under section 1833(t) (7) of the Social Security Act. These payments are transitional outpatient payments (TOPs). Because of the complexity and because of the administrative burden/expense of calculating and maintaining the TOPs, TRICARE opted to totally exempt CCHs from the TRICARE OPPS reimbursement methodology initially.

Ten years after the implementation of OPPS, the agency is now revisiting the exemption of cancer and children's hospitals from OPPS. This final rule with comment period finalizes the adoption of the Medicare methodology for reimbursement of outpatient facility services rendered in a cancer or children's hospital, with modifications to address the administrative burden and complexity that initially led the agency to exclude these facilities from OPPS. DHA now has the capability, and it is feasible, to adopt Medicare's reimbursement provisions with two modifications: (1) that the hold-harmless provisions will be calculated annually, rather than in monthly interim payments; and (2) that the agency will use the hospital's cost-to-charge ratio (CCR) rather than the payment-to-cost ratio. With adoption of OPPS for cancer and children's hospitals, these institutions will no longer be considered TRICARE ambulatory surgery sites for application of the TRICARE ASC reimbursement methodology.

3. Transition Period. When implementing the ASC fee schedule, Medicare included a four-year transition which blended the payment rates of the old methodology with the new for those procedures that were paid under both methods. We evaluated the feasibility of including a similar transition, where, the TRICARE-allowed amount would be 75 percent of the old rate and 25 percent of the new rate in year one; 50 percent of the old rate and 50 percent of the new rate in year two; and 25 percent of the old rate and 75 percent of the new rate in year three. In the fourth year the rate would be 100 percent of the new rate. However, many of the services reimbursed under TRICARE's current ASC reimbursement methodology have lower rates under Medicare, so providers would have to wait for higher reimbursements under the new system.

Therefore, we are finalizing a no transition period for the implementation of the ASC reimbursement system. Some providers may see substantialincreases in reimbursement, and a transition period would not be beneficial for these providers. Additionally, because alternative locations are available for these services ( e.g., Hospital Outpatient Departments), concerns regarding access to care are unfounded.

Similarly, we are finalizing no transition period for cancer and children's hospitals, with the rationale that providers will be held harmless under this reimbursement system. CCHs will receive, at a minimum, one hundred percent of their costs, or the OPPS payment, whichever is higher. Because many CCH providers will receive payment increases, a transition period would not be beneficial for them.

Although this rule will be effective near fiscal year 2024, the overall economic impact of the rule is estimated based on an analysis of expected outcomes had the rule been implemented during calendar year (CY) 2021. Such analysis may be used to provide a reasonable estimate of future economic impact.

The economic impact of adopting Medicare's payment methodology for ASCs is anticipated to result in total cost-savings to the DoD of approximately $10 million for CY 2021.

The economic impact of the proposal to adopt OPPS for CCHs, including the hold harmless provisions will be reduced payments to these providers of approximately $35 million per year if implemented in 2021.

We estimate that the effects of the provisions that would be implemented by this final rule would have an impact of increased cost-savings to the DoD of approximately $45 million, offset by an estimate $1.5 million in administrative costs to implement these changes.

Medicare replaced their previous ASC system on January 1, 2008. Medicare's reimbursement system for ASCs uses OPPS relative payment rates as a guide. OPPS rates are reduced by a factor to account for the fact that ASCs have lower overhead costs than hospitals. In 2012, Medicare's ASC rates averaged 61 percent of the OPPS rates paid to acute care hospitals for surgical procedures. Under Medicare, ASCs are paid the lesser of the billed charge or the standard ASC reimbursement rate, a method which we are finalizing under the TRICARE program.

Under Medicare, the standard payment rate for ASC covered surgical procedures is calculated as the product of the ASC conversion factor and the ASC relative payment weight for each separately payable procedure or service. Payments are then geographically adjusted using wage-index values. Payments may also be adjusted for multiple surgical procedures or when surgical procedures are started and then discontinued.

Like Medicare, we are finalizing our approach to make a single payment to ASCs for covered procedures, which includes the facility services furnished in connection with the covered procedure ( e.g., nursing services, certain drugs, surgical dressings, and administrative services). We are also finalizing our approach to separately reimburse for ancillary services that are integral to a covered service ( e.g., drugs and biologicals that are separately paid under OPPS; radiology services that are separately paid under OPPS; brachytherapy services; implantable devices with OPPS pass-through status; and corneal tissue acquisition), similar to Medicare. The TRICARE ASC payment system will not reimburse for services of individual professional providers, Durable Medical Equipment (DME), non-implantable prosthetics, ambulance services, or independent laboratory services. These services will be reimbursed using other payment systems, which include the CMAC, Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) Fee Schedule and the Ambulance Fee Schedule. If there is no payment rate under the ASC reimbursement system for services that are medical in nature (such as office visits and diagnostic tests), the ASC will be reimbursed as though services were furnished in a physician's office utilizing the TRICARE CMAC methodology, with no additional payment for facility charges.

This regulatory action finalizes a definition for ASCs, which will mirror Medicare's, with exceptions made for TRICARE's pediatric patients. Medicare defines an ASC as, “a distinct entity that operates exclusively for the purpose of furnishing outpatient surgical services to patients”; in this action we are finalizing our proposal to adopt a definition at 32 CFR 199.2 that defines ASCs as those that meet the definition of an ASC under 42 CFR 416.2, including the requirement that they must participate in Medicare as ASCs per 42 CFR 416.25, with exceptions for ASCs that do not have an agreement with Medicare due to the specialty populations they serve. Medicare also requires the provider to have an agreement with CMS; we are finalizing as proposed that in lieu of separate certification by TRICARE, the ASC will simply provide evidence of a valid agreement with Medicare. While the terms of the agreement with Medicare will not apply to TRICARE, only those providers with an agreement with Medicare (or those providers that meet certain exceptions as noted below), are eligible for reimbursement for ambulatory surgery services provided in ASCs. We are finalizing our approach to accept Medicare's determination of a facility as an ASC. If the facility meets the definition of an ASC at 42 CFR 416.2 and has an agreement with Medicare as an ASC, they will be considered a TRICARE authorized ASC and subject to all requirements for authorized institutional provider status under 32 CFR 199.6. ASCs must also enter into a participation agreement with TRICARE, to ensure that the ASC accepts the TRICARE reimbursement rate, and meets all other conditions of coverage. Additionally, due to the differences between the TRICARE and Medicare populations, there may be ASCs that specifically serve pediatric populations. As such, these ASCs may not routinely enter into agreements with Medicare. Therefore, we are finalizing the proposal to allow certain pediatric ASCs without a valid Medicare participation agreement to be eligible for reimbursement under TRICARE's ASC system, when such facilities are accredited by the Joint Commission, the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), or other accrediting body as authorized by the Director, DHA and published in the implementing instructions. Additionally, the ASC must enter into a participation agreement with TRICARE to receive reimbursement for covered services provided to TRICARE beneficiaries. This provision will not negatively affect access to care, as ambulatory surgery services are also available in hospital outpatient departments. The flexibility offered to pediatric specialty ASCs is sufficient to serve the unique needs of our patient population, while still ensuring the program complies with the requirements of 10 U.S.C. 1079(i). TRICARE-authorized pediatric ASCs will be subject to the same reimbursement system as finalized in this regulatory action.

Section 32 CFR 199.6(b)(4)(x)(B)( 1 ) currently includes specific requirements for ambulatory surgery centers. With this regulatory action, we are changing the regulations text at § 199.6(b)(4)(x)(B)( 1 ) to state that ASCs participating in Medicare meet all program requirements to be an authorized TRICARE provider. However, for ASCs that do not participate in Medicare (due to the specialized nature of the patients they treat, i.e., pediatric patients) but are otherwise accredited by an accrediting body as approved by the Director, DHA, must continue to meet all the requirements stated. All ASCs must also enter into participation agreements with TRICARE.

Medicare identifies and maintains a list of surgical procedures that may be performed in an ASC. This list is updated at least annually by Medicare. The ASC list of covered procedures indicates those procedures which are covered and paid for if performed in the ASC setting. The ASC list is comprised of those surgical procedures that CMS has determined do not pose a significant safety risk and are not expected to require an overnight stay following the surgical procedure. Procedures on the Medicare Hospital Outpatient Prospective Payment System (HOPPS) inpatient-only list (42 CFR 419.22(n)) are not eligible for designation and coverage as ASC surgical procedures. Procedures that are reported utilizing unlisted category I Current Procedural Technology® codes are also excluded from the ASC list. TRICARE is adopting the Medicare ASC List, in its entirety, including any updates made by Medicare to the list in the future, without any deviations (except for certain covered dental procedures) from the ASC List, as maintained and updated by CMS. No separate TRICARE ASC list would be maintained; the TRICARE program would rely upon CMS's determinations regarding those procedures determined to be appropriate in an ASC setting. The maintenance of a separate ASC List for TRICARE is unnecessary as adoption of Medicare's list is practicable, and maintenance of a separate list would be extremely complex for the agency and providers to review, maintain, and update. We invited comments on this approach, especially from facilities that specialize in care for young adult, pediatric, and other specialized populations not routinely covered by Medicare. We reviewed procedures that would commonly be performed on pediatric patients and found that these were generally included on the Medicare ASC list. These procedures included: adenoidectomy; myringotomy; nasal endoscopy; tonsillectomy; circumcision; inguinal and umbilical hernia repair; eye muscle repair; syndactyly repair; and hypospadias repair. Fowler-Stephens Orchiopexy is not listed on Medicare's ASC list, but is priced in OPPS.

If an ASC provides a surgical service not listed as covered on Medicare's ASC list, except for certain dental procedures, we are finalizing our proposal to deny the ASC facility charges, similar to Medicare. However, related professional services may be reimbursed utilizing TRICARE's allowable charge methodology. TRICARE finalizes the adoption of the Medicare requirement that facility charges may be reimbursed for only those services on the “ASC List.” We are confident that there will be no access to care concerns with this approach, as surgical care continues to be available in hospital outpatient departments, and in inpatient settings, as appropriate. However, we are allowing an exception to this list for dental procedures covered under § 199.4 of this part, as Section 702 of the NDAA for Fiscal Year 2007 provides that, institutional and anesthesia services may be covered for both hospital and in-out surgery settings related to dental care for pediatric and certain other patients. In the case that a dental procedure is performed and the procedure is not listed as covered on Medicare's ASC list ( e.g., CPT Code 41899), the TRICARE contractors may make payment for that procedure at the OPPS rate. For example, CPT 41899 under OPPS is currently assigned to ambulatory payment classification (APC) 5161, which has a CY 2022 base-rate of $216; therefore, TRICARE's payment in an ASC setting would also be $216.

We are finalizing as proposed that, like Medicare, the following items currently fall within the scope of ASC facility services. Future modifications made by Medicare to the services included in the ASC payment will be adopted by TRICARE in the implementing instructions. ASCs must incorporate charges for packaged services into the charges reported for the separately payable services with which they are provided to ensure appropriate payment.

Covered ASC facility services include:

(1) Nursing, technician, and related services;

(2) Use of the facility where the surgical procedures are performed;

(3) Any laboratory testing performed under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate of waiver;

(4) Drugs and biologicals for which separate payment is not allowed under the hospital outpatient prospective payment system (OPPS);

(5) Medical and surgical supplies not on pass-through status under subpart G of 42 CFR part 419;

(6) Equipment;

(7) Surgical dressings;

(8) Implanted prosthetic devices, including intraocular lenses (IOLs), and related accessories and supplies not on pass-through status under subpart G of 42 CFR part 419;

(9) Implanted DME and related accessories and supplies not on pass-through status under subpart G of 42 CFR part 419;

(10) Splints and casts and related devices;

(11) Radiology services for which separate payment is not allowed under the OPPS, and other diagnostic tests or interpretive services that are integral to a surgical procedure;

(12) Administrative, recordkeeping and housekeeping items and services;

(13) Materials, including supplies and equipment for the administration and monitoring of anesthesia; and

(14) Supervision of the services of an anesthetist by the operating surgeon.

CMS may make further changes and refinements to the items included within the ASC reimbursement system. TRICARE will adopt all future modifications and refinements to this system made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing our approach to allow separate payment for covered ancillary items and services that are integral to a covered surgical procedure, consistent with Medicare. CMS defines these services at 42 CFR 416.61.

CMS may make further changes and refinements to the ancillary services that are paid separately within this reimbursement system. TRICARE will adopt all future modifications and refinements to this system made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing our approach that the TRICARE payment for surgical dressings, supplies, splints, casts, appliances, and equipment ( e.g., gowns, masks) will mirror Medicare's payment. Currently, these items are included in the payment for the surgical procedure. TRICARE will adopt all future modifications and refinements to the payment for these supplies and equipment provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

ASC facility payment for a surgical procedure includes payment for drugs and biologicals that are usually not self-administered and that are considered to be packaged into the payment for the surgical procedure under OPPS. Similar to Medicare, we are finalizing our approach to allow separate payment to ASCs for drugs and biologicals that are furnished integral to an ASC covered surgical procedure and that are separately payable under OPPS, as defined by Medicare. TRICARE will adopt all future modifications and refinements to the payment for drugs and biologicals provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

Simple diagnostic tests that are generally included in facility charges may be considered facility services ( e.g., urinalysis, hematocrit levels). Diagnostic tests performed by the ASC other than those generally included in the facility's charge are not covered by this reimbursement system. ASCs with laboratories certified as independent laboratories under Medicare may bill for tests, or alternatively, the ASC may make arrangements with an independent laboratory or other laboratory to perform the diagnostic tests it requires prior to surgery. Payment for these diagnostic and therapeutic items will be made under the existing provisions of 32 CFR 199.14. TRICARE will adopt all future modifications and refinements to the payment for diagnostic and therapeutic items provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing our approach that these items will be considered a facility service and no separate reimbursement will be made, similar to Medicare. TRICARE will adopt all future modifications and refinements to the payment for these blood and blood products provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing as proposed that anesthetic agents that are not paid separately under OPPS, as well as materials necessary for administration will be included in the facility payment. TRICARE will adopt all future modifications and refinements to the payment for anesthesia provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing our approach that the payment for implantable DME will be included in the payment for the covered surgical procedure, with the exception of OPPS pass-through devices which are paid separately. TRICARE will adopt all future modifications and refinements to the payment for implanted DME provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

This final rule finalizes the adoption of Medicare's payment provisions for IOLs and NTIOLs provided during or subsequent to cataract surgery in ASCs. As such, the payment for IOLs will be included in the ASC payment for the associated surgical procedure, except for NTIOLs designated by Medicare, and covered by TRICARE. NTIOLs may be subject to a payment adjustment, as determined by Medicare, and adopted by TRICARE. TRICARE will adopt all future modifications and refinements to the payment for IOLs and NTIOLs provided in ASCs, as made by CMS, unless found to be impracticable, as approved by the Director, DHA.

We are finalizing our approach to make a single payment to ASCs for covered procedures, which will include the facility services furnished in connection with the covered procedure ( e.g., nursing services, certain drugs, surgical dressings, and administrative services), when the services are rendered by a provider described in the finalized definition of an ASC in 32 CFR 199.2. This payment will be the lower of the ASC payment rate or the billed charge. We are finalizing our approach to adopt the Medicare ASC payment rates, without making any TRICARE-specific adjustments or modifications to Medicare rates.

We are finalizing our approach to allow separate payment for ancillary services that are integral to a covered service ( e.g., drugs and biologicals that are separately paid under OPPS; radiology services that are separately paid under OPPS; brachytherapy services; implantable devices with OPPS pass-through status; and corneal tissue acquisition). Like OPPS, payment under this system will not include reimbursement for services of individual professional providers, DME, non-implantable prosthetics, ambulance services, or independent laboratory services. These services will be reimbursed using other payment systems like the Medicare Physician Fee Schedule (similar to CHAMPUS Maximum Allowable Charges, or CMAC), DMEPOS Fee Schedule, and the Ambulance Fee Schedule.

We are also finalizing our proposal that covered ancillary services (including OPPS pass-through devices) that are contractor-priced under Medicare's ASC reimbursement system will be priced under TRICARE utilizing the allowable charge methodology for procedures paid outside of the OPPS under 32 CFR 199.14(j)(1).

Some items are paid the same amount in ASCs as they are paid under OPPS. These items include drugs and biologicals paid separately under OPPS when they are integral to covered surgical procedures and brachytherapy sources where prospective rates are available. Corneal tissue acquisition payment is based on acquisition cost or invoice.

The actual payment to ASCs requires a comparison between billed charges and the ASC payment rate for each separately payable procedure and service. Reimbursement is based on the lower of the ASC payment rate or the billed charge. Ancillary services should be billed on the same claim as the related ASC procedure. Should Medicare modify this process in the future, TRICARE will adopt all modifications, unless deemed to be impracticable, as approved by the Director, DHA.

We are finalizing as proposed that the labor related adjustments to the ASC payment rates will be based on Medicare's methodology, currently the Core-Based Statistical Area methodology. The adjustment for geographic wage variation will be made based on a 50 percent labor share, subject to change by CMS. There is no adjustment for geographic wage differences for: corneal tissue acquisition; drugs and devices with pass-through status under OPPS; brachytherapy sources; payment adjustment for NTIOLs; and separately payable drugs and biologicals. We are adopting this methodology, as well as any future refinements or adjustments made by Medicare to the labor-related share, the items and services subject to wage adjustments, and the methodology by which wage adjustments are made, unless determined to be impracticable by the Director, DHA.

Since CY 2012, Medicare has applied an annual update to ASC payments based on the CPI-U reduced by the productivity adjustment. The proposed rule planned to adopt these annual updates. However, effective for CY 2019 through CY 2023, Medicare adopted the hospital market basket update reduced by the productivity adjustment to update ASC payments. DHA will adopt the update factors used in the Medicare ASC rates each year.

This final rule with comment period finalizes the adoption of Medicare's payment provisions for terminated procedures, as well as the adoption of all future refinements and adjustments. Currently, this process is as follows:

1. Payment will be denied when an ASC submits a claim for a procedure that is terminated before the patient is taken into the treatment or operating room.

2. Payment will be made at 50 percent of the rate if a surgical procedure is terminated due to the onset of medical complications after the patient has been prepared for surgery and taken to the operating room but before anesthesia has been induced or the procedure initiated.

3. Full payment will be made for a surgical procedure if a medical complication arises which causes the procedure to be terminated after anesthesia has been induced or the procedure initiated.

We are finalizing the adoption of Medicare's payment provisions for multiple procedures, as well as the adoption of all future refinements and adjustments. When multiple procedures are performed in the same operative session that are subject to the multiple procedure discount, 100 percent of the highest paying surgical procedure on the claim is paid, plus 50 percent of the applicable payment rates for the other ASC covered surgical services. In determining the ranking of the procedures for the discounting, the lower of the billed charge or the ASC payment amount will be used.

The ASC payment may be reduced for certain procedures when provided in conjunction with a specific pass-through device. We are finalizing our proposal to adopt this methodology, and accept the code pairs as assigned and updated by CMS, as well as any other future refinements or adjustments to this methodology.

Reduced payments are made for certain procedures when a specified device is furnished without cost or for which either a partial or full credit is received ( e.g., device recall). We are finalizing as proposed to adopt this methodology as well as any other future refinements or adjustments to this methodology.

ASCs may furnish and be paid under alternate established reimbursement methodologies for services not considered ASC facility services. For example, ASCs may be reimbursed the CMAC rate for a physician office visit; facility charges are not allowed. If there is no ASC payment for services that are medical in nature (such as office visits and diagnostic tests), the ASC is reimbursed as though the service was performed in a physician's office, with no additional payment for facility charges. Surgical services that do not have an established reimbursement rate under this system may not be reimbursed in an ASC setting.

We are finalizing as proposed, no transition period, since many providers will see increases in payments under this reimbursement methodology.

Medicare utilizes the ASC Quality Reporting program (ASCQR), under which ASCs must submit data on quality measures to receive the full payment update each year. ASCs that do not submit the required data have their payment update reduced by 2 percent. Performance on these measures does not impact ASC payments. For 2016, the measures included:

Medicare contracts with outside entities to collect this quality data. Because the TRICARE program represents a small fraction of the ASC services rendered as a whole, we are finalizing our proposal to provide the full ASC update to all ASCs, regardless of whether they report quality data. Collecting information regarding which ASCs report quality data and which do not, and building that information into the reimbursement system in a timely manner will be impracticable for the program. However, TRICARE may utilize this data, which is publicly reported at data.medicare.gov, for future initiatives related to reimbursement for ASCs. The ASCQR may lead to a value based purchasing (VBP) program for ASCs in the future; however, there were no specific proposals in Medicare's most recent ASC final rule (2016). TRICARE will adopt reimbursement modifications to the ASC reimbursement system related to VBP, if determined to be practicable by the Director, DHA. Such changes will be incorporated into the implementing instructions, as appropriate.

This final rule implements the adoption of Medicare's reimbursement methodology for outpatient services rendered in cancer and children's hospitals, with modifications made due to the administrative complexity of the Medicare system, as well as finalizes a combined OPPS and cost-reimbursement system. We are finalizing as proposed to pay these hospitals under TRICARE's existing OPPS, and then reimburse the hospitals the higher of the OPPS payment or one hundred percent of the hospital-specific costs for those same services, based on the hospital-specific outpatient cost to charge ratio (CCR), through an annual adjustment. We are also finalizing as proposed to change the regulations text at § 32 CFR 199.14(a)(6) to include cancer and children's hospitals as providers subject to OPPS, and will further describe how these providers will be held harmless under the finalized methodology.

We are finalizing our proposal that cancer and children's hospitals that were specifically excluded in TRICARE's OPPS final rule at 73 FR 74945, and are currently held harmless from OPPS under Medicare, will be subject to the provisions of this final rule.

While Medicare provides reimbursement through TOPs for the difference between OPPS and hospital-specific costs on a monthly basis, we are finalizing our approach to make these payments on an annual basis. This approach reduces the administrative complexity of the system and makes the system practicable to adopt for TRICARE's comparatively smaller beneficiary population. A precedent can be found in TRICARE's implementation of the reimbursement system for SCHs; the TRICARE contractors perform a year-end comparison of the primary methodology with the Diagnosis Related Group (DRG)-based payment methodology, and provide reimbursement where the DRG-based payment amount would have been higher than the primary methodology.

Additionally, Medicare holds CCHs harmless by calculating their pre-Balanced Budget Act (BBA) amount. The pre-BBA amount is an estimate of what the provider would have been paid during the CY for the same services under the Medicare system that was in effect prior to OPPS. This amount is calculated by multiplying the provider's payment-to-cost ratio (PCR), based on the provider's base year cost report (generally CY 1996), times the reasonable costs the provider incurred during a calendar year to furnish the services that were paid under the OPPS. However, we are finalizing as proposed to simply hold the hospital harmless based on their costs; with costs defined as the product of multiplying the hospital's total charges for covered OPPS services for a twelve-month period by the hospital-specific outpatient CCR. This modification still holds the hospital harmless and ensures payment at costs, and is also practicable to adopt for TRICARE's comparatively smaller beneficiary population, and addresses issues of administrative complexity which led the agency to exempt CCHs in the original implementation of OPPS. Additionally, for cancer hospitals, Medicare has adopted an additional adjustment, mandated by the Patient Protection and Affordable Care Act (PPACA), which applied an additional payment adjustment to account for higher costs incurred by cancer hospitals. Because TRICARE is not subject to the PPACA and due to the administrative complexity of the calculation, we are not adopting this additional adjustment to adjust for the average payment-to-cost ratio for cancer hospitals.

For cancer and children's hospitals, we are finalizing the annual process as follows:

Step One: Identify the costs of the hospital by multiplying the total billed charges for OPPS services on claims paid during the 12-month period by the most-recent hospital-specific outpatient CCR.

Step Two: Add together total TRICARE payments, cost-shares, and deductibles applied for all Ambulatory Payment Classifications (APCs), as well as outlier payments and transitional pass-through payments for drugs, biologicals and/or devices for those same claims paid during the year as those in Step One. If the result of Step 2 is greater than Step 1, no payment is warranted because the hospital was reimbursed more from OPPS than their costs. If the result of Step 2 (OPPS payments) is less than Step 1 (hospital's costs), the hospital will be issued a payment equal to 100% of the difference between the hospital's costs and actual payments.

Adjustments may be made in subsequent years for claims not processed to completion. The implementing instructions will contain the full instructions for calculation and payment of hold-harmless payments.

We are finalizing as proposed, no transition period, as providers will be held harmless. Generally transitions are performed when providers may be exposed to payments that are below their costs; however, through the annual adjustments, providers are assured that they will receive reimbursements for their costs.

Under this system, at the discretion of the Director, DHA, CCHs may be eligible for GTMCPAs that will ensure network adequacy during military contingency operations, in accordance with the implementing instructions issued by the Director, DHA. These GTMCPAs will be issued in the same manner as those that are made currently under TRICARE's OPPS.

The criteria for applying for the GTMCPA, which have been tailored for CCHs, will include: (1) 10 percent or more of the hospital's revenue is from TRICARE for care of ADSMs/ADDs; (2) having 10,000 or more TRICARE visits that would fall under the OPPS payment system for ADSMs/ADDs annually; and (3) being deemed as essential for TRICARE operations. Hospitals that meet these criteria will be eligible to receive up to 115 percent of the hospital's costs for OPPS services.

DoD has examined the impacts of this final rule as required by Executive Orders 12866 (September 1993, Regulatory Planning and Review), 13563 (January 18, 2011, Improving Regulation and Regulatory Review); the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354); the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated as a “not significant” regulatory action, and not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB) under the requirements of these Executive Orders.

Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100 million or more or have certain other impacts. This final rule is not a major rule under the Congressional Review Act.

The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. For purposes of the RFA, hospitals are considered to be small entities, either by being nonprofit organizations or by meeting the Small Business Administration (SBA) identification of a small business (having revenues of $41.5 million or less in any one year). Likewise, the vast majority of ASCs are considered small businesses according to the SBA's size standards of having total revenues of $16.5 million or less in any one year. For purposes of the RFA, we have determined that 70 percent of ASCs would be considered small entities according to the SBA size standards. We have also determined that 100 percent of CCHs would be considered small entities under the RFA definition because they qualify as a nonprofit organization or governmental jurisdiction, even though almost all have revenues above the $41.5 million SBA size standard. Therefore, the Assistant Secretary of Defense for Health Affairs certifies this final rule would have a significant impact on a substantial number of small entities. The Regulatory Flexibility Analysis is included in the preamble of this rule.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold level is approximately $140 million. This final rule will not mandate any requirements for State, local, or tribal governments or the private sector.

This rule will not impose significant additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3502-3511). Existing information collection requirements of the TRICARE and Medicare programs will be utilized. We do not anticipate any increased costs to hospitals because of paperwork, billing, or software requirements since we are adopting Medicare's methodologies with which the ASCs and hospitals are already familiar.

This rule has been examined for its impact under Executive Order 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.

It has been determined that this rule does not have a substantial effect on Indian tribal governments. This rule does not impose substantial direct compliance costs on one or more Indian tribes, preempt tribal law, or effect the distribution of power and responsibilities between the federal government and Indian tribes.

The TRICARE ASC reimbursement system encompasses all ASCs that meet Medicare's definition of an ASC with a Medicare agreement, and those ASCs that due to the nature of the population they serve ( i.e., pediatric patients) do not have a Medicare agreement but are otherwise accredited by an accrediting body as approved by the Director, DHA. The TRICARE OPPS reimbursement system encompasses all Medicare-classified cancer and children's hospitals that are also authorized for TRICARE except for hospitals in States that are paid by Medicare and TRICARE under a waiver that exempts them from Medicare's or TRICARE's OPPS, respectively. Currently, only Maryland hospitals operate under such a waiver.

The alternatives that were considered, the changes that we are proposing, and the reasons that we have chosen these options are discussed below:

This final rule with comment period finalizes paying ASCs on the basis of the Medicare ASC fee schedule, with no exceptions to the list of procedures considered appropriate by Medicare to be performed in an ASC. This approach was adopted because TRICARE is statutorily obligated to pay like Medicare where practicable. Medicare covers approximately 3,400 procedures under the ASC payment system. The ASC list is comprised of those surgical procedures that CMS has determined do not pose a significant safety risk and are not expected to require an overnight stay following the surgical procedure. We anticipate no impact to access to care by adopting Medicare's approach.

We have also determined that no transition period is necessary. First, as we have noted earlier, historically transitions are done to protect providers from payments below their costs. However, in this case, while revenues would decrease for some providers, some providers may see increases in reimbursement, and a transition period would not be beneficial for these providers. Second, because alternative locations are available for these services (Hospital Outpatient Departments), concerns regarding access to care are unfounded. Third, TRICARE payments to ASCs will be equal to Medicare's. The Medicare Payment Advisory Committee (MedPAC) is an independent congressional agency which advises the U.S. Congress on issues affecting the Medicare program. MedPAC's “March 2022 Report To Congress: Medicare Payment Policy”, indicates that available indicators of payment adequacy for ASC services are generally positive. Fourth, the number of outpatient surgeries performed in ASCs under TRICARE is very small in comparison to Medicare and the industry. If TRICARE had the Medicare reimbursement system in place during CY 2019, TRICARE would have spent approximately $250 million on ASC services. In contrast, ASCs received over $5.2 billion in Medicare payments and beneficiaries' cost sharing in 2019. In aggregate, the TRICARE ASC claims are a very small percentage of the industry's claims, so the change to reimbursement in the aggregate, is small. Finally, the 2022 MedPAC report determined that there was sufficient access to ASCs by Medicare beneficiaries, as evidenced by the continued growth and expansion of ASCs. Given that TRICARE ASC rates will be equal to Medicare ASC rates, we do not anticipate access problems for TRICARE beneficiaries.

Under the method discussed in this final rule, TRICARE's payments to CCHs would decrease by approximately $35 million. Our analysis has shown that the expected impact on specific hospitals vary widely. Of the 35 CCHs with the highest allowed amounts in 2021, 14 hospitals would have their payments reduced by more than 15 percent, and six hospitals would have their payments increased by more than 15 percent. The median hospital in this group of 35 CCHs would have had its TRICARE reimbursement for the services covered by this rule reduced by two percent had the rule been implemented in 2021.

It is practicable to adopt OPPS for these institutional providers, with annual hold harmless provisions.

We are also finalizing as proposed, no transition period. CCHs will receive, at a minimum, one hundred percent of their costs, or the OPPS payment, whichever is higher. Historically, transitions are done to protect providers from payments below their costs. However, in this case, the providers will be held-harmless, so no transition is necessary.

Accordingly, 32 CFR part 199 is amended as follows:

The Coast Guard will enforce the special local regulations in 33 CFR 100.1103, Table 1 to § 100.1103, Item number 1 for the Blessing of the Fleet regulated area from 10 a.m. to noon on April 30, 2023. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within Northern California, § 100.1103, specifies the location of the regulated area for the Blessing of the Fleet Boat Parade which encompasses portions of the San Francisco Bay. During the enforcement period, the regulated area will be in effect in the navigable waters, from surface to bottom, defined by a line drawn from Bluff Point on the southeastern side of the Tiburon Peninsula to Point Campbell on the northern edge of Angel Island, and a line drawn from Peninsula Point to the southern edge of the Tiburon Peninsula to Point Stuart on the western edge of Angel Island.

During the enforcement period, under the provisions of 33 CFR 100.1103(b), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander (PATCOM) or any other Official Patrol, defined as a Federal, State, or local law enforcement agency on scene to assist the Coast Guard in enforcing the regulated area. During the enforcement period, if you are the operator of a vessel that participates in the marine event within the regulated area, you must follow the parade route established by the marine event sponsor, and comply with directions from the Patrol Commander or other Official Patrol. The PATCOM or Official Patrol may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via Local Notice to Mariners. If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners or other marine broadcast may be used to grant general permission to enter the regulated area.

The Coast Guard will enforce the special local regulations in 33 CFR 100.1103, Table 1 to § 100.1103, Item number 2 for the Opening Day on San Francisco Bay regulated area from noon to 3 p.m. on April 30, 2023. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within Northern California, § 100.1103, specifies the location of the regulated area for the Opening Day on San Francisco Bay Boat Parade which encompasses portions of the San Francisco Bay. During the enforcement period, the regulated area will be in effect in the navigable waters, from surface to bottom, defined by a line drawn from Fort Point; thence easterly approximately 5,000 yards; thence easterly to the Blossom Rock Bell Buoy; thence westerly to the Northeast corner of Pier 39; thence returning along the shoreline to the point of origin.

During the enforcement period, under the provisions of 33 CFR 100.1103(b), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander (PATCOM) or any other Official Patrol, defined as a Federal, State, or local law enforcement agency on scene to assist the Coast Guard in enforcing the regulated area. During the enforcement period, if you are the operator of a vessel that participates in the marine event within the regulated area, you must follow the parade route established by the marine event sponsor, be capable of maintaining an approximate speed of 6 knots, and comply with directions from the Patrol Commander or other Official Patrol. The PATCOM or Official Patrol may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners. If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners or other marine broadcast may be used to grant general permission to enter the regulated area.

The Captain of the Port Sector Ohio Valley (COTP) is establishing, amending, and updating its current list of recurring special local regulations codified under 33 CFR 100.801 in Table no. 1, for the COTP Ohio Valley zone.

On January 19th, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Sector Ohio Valley Annual and Recurring Special Local Regulations Update (86 FR 69602). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to those recurring regulated areas. During the comment period that ended February 21, 2023, no comments were received.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to ensure the safety of the events occurring in March.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Coast Guard is amending and updating the special local regulations under 33 CFR part 100 to include the most up to date list of recurring special local regulations for events held on or around navigable waters within the Sector Ohio Valley AOR. These events include marine parades, boat races, swim events, and others. The current list under 33 CFR 100.801 requires amending to provide new information on existing special local regulations, include new special local regulations expected to recur annually or biannually, and to remove special local regulations that are no longer required. Issuing individual regulations for each new special local regulation, amendment, or removal of an existing special local regulation creates unnecessary administrative costs and burdens. This rulemaking reduces administrative overhead and provides the public with notice through publication in the Federal Register of the upcoming recurring special local regulations.

As noted above, we received no comments on our NPRM published January 19, 2023. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. This rule amends and updates part 100 of 33 CFR by revising the current table for Sector Ohio Valley, and by adding eight new recurring security zones, removing four security zones, and amending eleven security zones as described in the NPRM. Vessels intending to transit the designated waterway through the safety zone will only be allowed to transit the area when the COTP, or designated representative, has deemed it safe to do so or at the completion of the event.

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

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

The Coast Guard expects the economic impact of this rule to be minimal, and therefore a full regulatory evaluation is unnecessary. This rule establishes special local regulations limiting access to certain areas under 33 CFR 100 within Sector Ohio Valley's AOR. The effect of this rulemaking will not be significant because these special local regulations are limited in scope and duration. Deviation from the special local regulations established through this rulemaking may be requested from the appropriate COTP and requests will be considered on a case-by-case basis. Broadcast Notices to Mariners and Local Notices to Mariners will inform the community of these special local regulations so that they may plan accordingly for these short restrictions on transit. Vessel traffic may request permission from the COTP Ohio Valley or a designated representative to enter the restricted areas.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 00 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of special local regulations related to marine event permits for marine parades, regattas, and other marine events. It is categorically excluded from further review under paragraph L(61) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

In a document published in the Federal Register (FR) on January 12, 2023, VA proposed to amend its medical regulations at §§ 17.108, 17.110, 17.111, and 17.4600 of title 38, Code of Federal Regulations (CFR) to exempt from copayments veterans who submit documentation to VA to demonstrate they are either Indian or urban Indian, as those terms are defined in section 4 of the Indian Health Care Improvement Act (further codified at 25 U.S.C. 1603(13) and (28)), for hospital care or medical services received on or after January 5, 2022. 88 FR 2038. VA also proposed retroactive reimbursement for copayments already paid by these veterans for such care provided on or after January 5, 2022. VA provided a 30-day comment period, which ended on February 13, 2023. Forty-four comments were received, of which one was a duplicate comment, for a total of forty-three unique comments. Nine commenters expressed support for the proposed rule in whole. VA appreciates these commenters' support and does not further address their comments below. The remaining commenters expressed concerns with the proposed rule in whole or in part, and their comments are addressed below by topic. As explained in more detail below, VA makes changes to the rule based on the comments.

VA received several comments alleging that this copayment exemption is discriminatory and unfair to those veterans who are not Indian or urban Indian. Commenters asserted that the proposed rule gives preference based on ethnicity or race and questioned why VA is not eliminating copayments for other veterans based on race, ethnicity, or sex. One commenter was neutral on the proposed rule, but asked VA to clarify why it was providing this copayment exemption to this group of veterans over other races. Some of these commenters also alleged that this rulemaking is part of a current political agenda. VA makes no changes to the rule based on these comments.

Pursuant to section 1710(f) and (g) of title 38, United States Code (U.S.C.), VA must charge certain veterans a copayment for hospital care, nursing home care, and medical services furnished by VA, unless otherwise exempted under law. As VA explained in the proposed rule, Congress mandated that VA exempt from copayments for hospital care or medical services those veterans who are Indian or urban Indian, as such terms are defined in section 4 of the Indian Health Care Improvement Act (codified in 25 U.S.C. 1603). This mandate is codified in law at 38 U.S.C. 1730A (as amended by section 3002 of the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 (the “Act”), Pub. L. 116-315).

The underlying bill, the Native American PACT Act (H.R. 4908) which became part of the Act, was separately passed by the U.S. House of Representatives on September 22, 2020. In support of this legislation, Democratic and Republican representatives explained Congress's rationale for introducing and passing this legislation. Representative Mark Takano explained, in pertinent part:

See House Congressional Record dated September 22, 2020, H4678-4679.

Representative David P. Roe further stated, in pertinent part:

Thus, the Congressional record is clear that Congress's rationale for exempting Indian and urban Indian veterans from copayments was based on fulfilling the promise this country made to Tribal nations as part of its trust and treaty responsibilities to provide American Indians and Alaska Natives with free health care, increasing access to care, and supporting parity for the provision of care by VA and other Federal agencies. Furthermore, on numerous occasions, the United States Supreme Court specifically has upheld legislation that singles out American Indians or Alaska Natives for particular and special treatment. See, for example, Morton v. Mancari, 417 U.S. 535 (1974).

To comply with the mandate in 38 U.S.C. 1730A, VA proposed to revise its regulations to exempt from copayments those veterans who are Indian or urban Indian as defined in 25 U.S.C. 1603(13) and (28). Unless explicitly allowed by law, VA cannot exempt from copayments other groups of veterans. See 38 U.S.C. 1710(f) and (g). Contrary to commenters' assertions, this copayment exemption for such individuals was not based on discrimination or VA showing preference for certain races or ethnicity, it was a requirement of law.

In response to those commenters who suggest that this is part of a current political agenda, the copayment exemption mandated by section 1730A was signed into law by then President Trump on January 5, 2021. As reflected in the excerpts from the Congressional record related to H.R. 4908 discussed further above, there was also bipartisan Congressional support for exempting Indian and urban Indian veterans from copayments. See also, Tester, Moran Introduce Bipartisan Bill to Increase Native American Veterans' Access to VA Health Care, Eliminate Copays, Nov. 18, 2020, https://www.veterans.senate.gov/2020/11/tester-moran-introduce-bipartisan-bill-to-increase-native-american-veterans-access-to-va-health-care-eliminate-copays .

Some commenters requested VA clarify in the rulemaking that the copayment exemption under 38 U.S.C. 1730A is due to the Federal government's trust responsibility. VA's specific statutory authority and mandate for the copayment exemption is 38 U.S.C. 1730A as amended by section 3002 of the Act. However, as discussed above, the Congressional history for this copayment exemption illustrates that Congress proposed this legislation in part based on a trust responsibility with American Indian and Alaska Native communities. As discussed below, VA considered this trust responsibility in the response to comments received that suggested VA exempt copayments for all urgent care visits.

One commenter supported using a definition of Indian used by the Indian Health Service (IHS) as such definition is familiar to Tribal members and would provide consistency, avoid confusion, and improve the tribes' ability to notify Tribal members of changes. Another commenter suggested that American Indian and Alaska Native veterans from a federally or State recognized Tribe or a Native Nation, or who are descendants of a Tribal or Native Nation member should be eligible for this copayment exemption. VA does not make any changes to the rule based on these comments.

VA is using the definitions of Indian and urban Indian required by law for purposes of this rulemaking. Section 1730A of 38 U.S.C. was amended to add a copayment exemption for veterans who are either Indian or urban Indian, as further defined in 25 U.S.C. 1603(13) and (28). 88 FR 2038-2039. Paragraph 13 of section 1603 defines the term Indians or Indian as any person who is a member of an Indian Tribe, as that term is further defined in section 1603(14), except that, for the purpose of 25 U.S.C. 1612 and 1613, such terms shall mean any individual who: (1) irrespective of whether he or she lives on or near a reservation, is a member of a Tribe, band, or other organized group of Indians, including those tribes, bands, or groups terminated since 1940 and those recognized now or in the future by the State in which they reside, or who is a descendant, in the first or second degree, of any such member; (2) is an Eskimo or Aleut or other Alaska Native; (3) is considered by the Secretary of the Interior to be an Indian for any purpose; or (4) is determined to be an Indian pursuant to regulations promulgated by the Secretary of Health and Human Services.

Paragraph 28 of section 1603 defines the term urban Indian as any individual who resides in an urban center (as such term is further defined in section 1603(27)) and who meets at least one or more of the four criteria in the definition of Indian in 25 U.S.C. 1603(13) (as described above in a previous paragraph regarding the definition of Indians or Indian). Thus, these definitions apply to those eligible for the provision of healthcare by IHS and include those individuals the commenter references, such as members of federally and State recognized tribes and descendants of such members.

To the extent the commenters are suggesting VA expand eligibility beyond those defined as Indian or urban Indian in 25 U.S.C. 1603(13) and (28), VA is unable to do so as the statute is clear that VA must use those definitions.

Several commenters had a variety of concerns related to the proposed requirement that veterans submit documentation to demonstrate they meet the definition of Indian or urban Indian. These commenters suggested that instead VA allow such veterans to self-attest that they meet the definition of Indian or urban Indian. As explained in more detail below, their concerns focused on evaluating and verifying documentation, the benefits of self-attestation, the Tribal consultation process, and acceptable forms of documentation. VA makes no changes to the rule based on these comments for the reasons explained below.

Some commenters were concerned that VA does not have the capability to receive, process, evaluate, and validate the documentation that VA proposes to require veterans submit in order to verify that they meet the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28). The commenters were particularly concerned given the diversity and volume of potential documents.

VA will be able to properly evaluate the submitted documents to determine if a veteran meets the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28). VA will have dedicated staff to perform this function who will receive robust training on the types of acceptable documentation and how to properly evaluate and verify such documentation. This will include input and guidance from VA's own Tribal experts, such as its Office of Tribal Government Relations and Office of Tribal Health. Collecting and evaluating documentation to determine an individual's membership in a Tribe is something that other agencies, such as IHS and the Bureau of Indian Affairs (BIA), as well as many American Indian and Alaska Native health organizations do. In fact, VA intends to mirror how IHS makes these determinations. VA does not believe it will be an undue burden on VA staff to perform these tasks. Other commenters were concerned that VA verifying and determining the legitimacy of the documents will usurp Tribal sovereignty. Another commenter also stated that there should not be an administrative burden put on Tribal enrollment staff to document a veteran's status as Indian or urban Indian.

While there are 574 federally recognized tribes that may have different types of documentation, VA will defer to American Indian and Alaska Native Tribal governments regarding the documentation they issue to members of their Tribe. VA will accept such documentation as proof that a veteran meets the definition of Indian or urban Indian in 25 U.S.C. 1603(13) and (28) for purposes of this copayment exemption. VA will not require American Indian and Alaska Native Tribal governments to issue specific documentation for the purpose of demonstrating that a member of the Tribe meets the definition of Indian or urban Indian. Therefore, VA will not be usurping Tribal sovereignty or imposing additional burdens on American Indian and Alaska Native Tribal governments to issue documentation other than what they already issue members of their Tribe. A Tribe's existing documentation of an individual's status as a member of a Tribe will be sufficient. Requiring submission of documentation also shows respect for American Indian and Alaska Native Tribal governments and acknowledges that the tribes determine who are members.

Some commenters supported self-attestation because they stated that other agencies use self-attestation. VA agrees that it is important for VA to understand how other agencies determine an individual's status as an Indian or urban Indian under 25 U.S.C. 1603(13) and (28). VA learned that IHS, BIA, and other American Indian health organizations require documentation in order to be eligible for their benefits and services. Therefore, for purposes of Federal benefits and services, tribes are familiar with providing their members with documentation and their members are familiar with providing documentation to Federal agencies to receive health care benefits.

Some commenters raised concerns that some Indian and urban Indian veterans may face barriers in obtaining documentation due to homelessness, financial instability, moving during military service, and lack of resources or culturally competent representation which can discourage these veterans from seeking the copayment exemption. VA believes that submission of documentation will not be a burden on most such veterans since they already have this documentation or could easily obtain it. In addition, VA staff will be available to provide veterans with information on documentation that VA will accept for purposes of this copayment exemption and can assist veterans with reacquiring documentation they may have lost. VA will also proactively communicate with American Indian and Alaska Native veterans about this copayment exemption and how they may apply. Additionally, VA is engaged in a robust effort to educate all stakeholders about this copayment exemption and is committed to continued engagement with its stakeholders about how best to implement and educate others about the rule.

Some commenters opined that self-attestation increases access to health care without compromising the integrity of VA's services. Other commenters stated that despite VA's concern that self-attestation may present an unreasonable risk that VA would provide the copayment exemption to veterans who do not meet the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28), self-attestation would not present an unreasonable risk and that VA failed to provide any evidence of such unreasonable risk. The commenters further stated that existing authorities, such as 38 U.S.C. 6103 and 18 U.S.C. 1035, can help minimize risk of misrepresentation of a veteran's status as Indian or urban Indian in self-attestations.

VA believes that self-attestation could result in veterans who are not eligible for the benefit erroneously receiving the benefit. VA has a responsibility to ensure that only those who are eligible for this copayment exemption receive it. As explained in the proposed rule, requiring documentation rather than self-attestation would allow VA to ensure, through audits, that it is fulfilling its duty to only exempt those veterans who are eligible pursuant to section 1730A. 88 FR 2040.

VA is unable to audit the information provided in a self-attestation without additional documentation to support the self-attestation. Therefore would not be in a position to establish that a veteran accurately attested to being an Indian or urban Indian on the VA Forms 10-10EZ or 10-10EZR without obtaining additional information if it were to adopt self-attestation. In this regard, while VA Forms 10-10EZ and 10-10EZR previously had a question about whether a veteran meets these definitions of Indian or urban Indian, that question was removed in February 2023. The current VA Form 10-10EZ does have a question on race, which includes American Indian or Alaska Native. However, VA Form 10-10EZR does not. Regardless, if VA used either of these questions to establish a veteran met the definition of Indian or urban Indian, there would be no way to audit that attestation without requesting additional documentation. Requiring documentation allows VA to audit whether a veteran meets the definition of Indian or urban Indian in 25 U.S.C. 1603(13) and (28) without the need to later collect more information.

If VA allowed self-attestation only, it could result in those who are ineligible receiving the copayment exemption, and VA failing to fulfill its responsibilities under the law. While VA acknowledges that under certain existing authorities it is a violation of Federal law to knowingly or willingly make a false statement related to benefits, some veterans may genuinely believe they meet the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28), but simply do not. Therefore, it would not be clear that these veterans were knowingly or willingly making a false statement or representation, and it is not certain that they would be deterred from indicating on the VA Form 10-10EZ that they meet the definition.

Several commenters recommended VA allow veterans to initially self-attest they meet the definitions of Indian or urban Indian, after which the veteran can submit necessary documentation to show they meet the definitions within a certain period of time, which, as one of the commenters opined, could be extended if there was a good faith effort on the veteran's part to acquire the documentation. These commenters opined that this will allow VA to implement a policy where it can verify or review documentation later while ensuring that American Indian and Alaska Native veterans receive this copayment exemption immediately and do not encounter a barrier to care. One of these commenters suggested that if VA needs an additional document from a veteran who self-attests, the copayment exemption should remain in place until an appeal is completed.

VA will be providing reimbursement retroactive to January 5, 2022, to eligible veterans after VA reviews the submitted documentation and updates the veteran's record to make them exempt from copayments. Therefore, VA does not believe allowing for self-attestation followed by documentation is necessary. These veterans will be reimbursed for copayments for care provided on or after January 5, 2022, regardless of when they submit their documentation. Thus, any hardship based on when they submit documentation will be reduced by VA's reimbursement once documentation is received.

As discussed above, VA also does not believe that veterans should experience undue burden submitting documentation as they likely already have it or can easily obtain it, particularly as the documentation VA will accept includes those commonly issued by American Indian and Alaska Native Tribal governments to members of their tribes and are required by IHS to receive healthcare services.

Additionally, allowing veterans to self-attest that they meet the definition of Indian or urban Indian and then provide additional documentation at a later date would create administrative and logistical challenges for VA and potential hardships for the veterans. If VA were to exempt a veteran based on self-attestation with additional documentation to follow at a later date, VA would have the added responsibility of tracking this preliminary eligibility and, in cases where a veteran did not submit the required additional documentation, VA would have to follow up with the veteran to request the documentation, potentially on several occasions. If VA ultimately does not receive acceptable documentation from the veteran, VA would have to collect from the veteran any copayments that had been inappropriately exempted, resulting in an added burden to VA and potential hardship for the veteran.

Several commenters alleged that VA mischaracterized or misrepresented the information it requested and received during Tribal consultation related to this rulemaking. These commenters opined that the questions posed by VA as part of Tribal consultation were narrower in scope than the definitions of Indian and urban Indian in 25 U.S.C. 1603 and incorrectly framed the statutory language that authorizes the exception. These commenters also opined that VA's statement in the proposed rule that it published a notice regarding the documentation that VA can use to identify veterans who meet the definitions of Indian or urban Indian under 38 U.S.C. 1730A was inaccurate. These commenters further stated that this did not provide American Indian and Alaska Native Tribal government leaders with the opportunity to fully consider the extent of American Indian and Alaska Native veterans eligible for the copayment exemption or provide feedback on documentation that may be required to determine eligibility for the copayment exemption. The commenters were concerned that VA inappropriately and misleadingly claimed that American Indian and Alaska Native Tribal governments supported requiring all American Indian and Alaska Native veterans to submit documentation to determine eligibility for the copayment exemption although VA never posed this question during Tribal consultation. Thus, these commenters opined that VA improperly relied upon the feedback received during consultation to support its decision to require veterans submit documentation for purposes of this copayment exemption.

In the Federal Register Notice (FRN) dated April 1, 2021, VA referenced the definitions of Indian and urban Indian as defined in 25 U.S.C. 1603(3). Moreover, in the supplementary section of the FRN, VA explained the changes made to 38 U.S.C. 1730A by section 3002 of the Act to exempt from copayments those who are Indian or urban Indian as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603). 86 FR 17267 (April 1, 2021). VA further stated that it was seeking input from Tribal governments, Indians, and urban Indians regarding documentation that can be used by VA's health care system to identify those veterans who are Indians or urban Indians (as defined in 25 U.S.C. 1603). Id. VA further notes that section 1603(13) defines Indian, in pertinent part, to mean any person who is a member of an Indian Tribe. Thus, with regards to information that VA was seeking to determine eligibility for this copayment exemption, the FRN was not narrower than the statutory authority.

Additionally, VA asked for input on specific documentation, as well as other information or documentation that is available for determining if a veteran is a member of an Indian Tribe, potential sources of the information or documentation, and how VA should determine whether a veteran is a member of an Indian Tribe (whether through documentation, self-certification, other methods). Id.

As VA explained in the proposed rule, the majority of comments received during the Tribal consultation session and in the 30-day period after it, in which written comments could be submitted to VA, supported documentation, with some commenters providing examples of documentation VA could use. However, several commenters supported self-attestation. To the extent that the request was not clear, VA provided an opportunity to submit comments during the April 29, 2021 Tribal consultation and for a period of 30 days after such Tribal consultation and to submit comments on the proposed rule. VA has taken all comments received into consideration when establishing the final rule.

One commenter appeared to oppose the submission of documentation to demonstrate a catastrophically disabled veteran meets the definition of Indian or urban Indian for purposes of copayment exemption under 38 U.S.C. 1730A.

While not entirely clear, it appears this commenter believes that VA is requiring veterans who are catastrophically disabled and are also Indian or urban Indian to submit documentation to show such status. VA clarifies that section 1730A requires copayment exemption for two different groups of veterans: (1) veterans who are catastrophically disabled and (2) veterans who are Indian or urban Indian as defined in 25 U.S.C. 1603. A veteran can qualify under either category for this copayment exemption, but does not need to qualify under both.

For a veteran to be eligible for this copayment exemption as a catastrophically disabled veteran under 38 U.S.C. 1730A(b)(1), they must undergo examination and be found by VA to have a permanent severely disabling injury, disorder, or disease that compromises the ability to carry out the activities of daily living to such a degree that the individual requires personal or mechanical assistance to leave home or bed or requires constant supervision to avoid physical harm to self or others. See 38 CFR 17.36(e). In order to be eligible for this copayment exemption as an Indian or urban Indian under 38 U.S.C. 1730A(b)(2), the veteran must provide documentation establishing that they meet the definition of Indian or urban Indian as defined in 25 U.S.C. 1603(13) and (28).

However, a catastrophically disabled veteran who also meets the definition of Indian or urban Indian as defined in 25 U.S.C. 1603(13) and (28) does not need to provide additional documentation that demonstrates they are Indian or urban Indian unless they are interested in a copayment exemption for more than three urgent care visits in a calendar year. This is discussed in more detail below. VA is not otherwise adding an additional requirement for catastrophically disabled veterans. Some commenters supported accepting identification and verification issued by American Indian and Alaska Native Tribal governments, such as Tribal identifications cards, for purposes of this copayment exemption. Another commenter recommended VA expand the list of acceptable documentation to include Tribal government verification, Tribal enrollment or identification cards, Tribal letters, kinship reports, and other documentation that promotes a veteran's ability to receive copayment exempt benefits.

As explained in the proposed rule, VA will defer to American Indian and Alaska Native Tribal governments with respect to the documentation they issue to show who is a member of their Tribe. 88 FR 2039. This may include some of the documents that the commenters listed such as Tribal identification and enrollment cards, Tribal letters, and other documentation issued by tribes to demonstrate an individual is a member of their Tribe. VA will issue additional communications that provide veterans with examples of acceptable documents so that veterans know the documentation they may submit to demonstrate that they meet the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28) and are eligible for this copayment exemption. However, in this rulemaking, VA has provided a description of the types of acceptable documents rather than an enumerated list of all acceptable documents to allow for additional documents if developed by American Indian and Alaska Native Tribal governments.

While one of these commenters suggested VA accept kinship reports, VA declines to include that in the description of acceptable documents as those would not demonstrate that a veteran meets the definition of Indian or urban Indian under 25 U.S.C. 1603(13) and (28). That same commenter also suggested VA accept other documentation that promotes a veteran's ability to receive copayment exempt benefits but did not provide examples of what those other documents may be. To the extent they are suggesting VA accept documentation other than those consistent with VA's description of acceptable documentation, VA declines to do so as the categories of acceptable documentation align with the statutory definition of Indian or urban Indian in 25 U.S.C. 1603(13) and (28).

Several commenters suggested that VA accept specific documents issued by entities, such as IHS, Tribal Health Programs (THP), and Urban Indian Organizations (UIO) that provide health care to American Indians and Alaska Natives. Suggested documents include proof of prior visit, health care records, patient registration record, and other records that show eligibility status. One commenter suggested VA improve coordination and interoperability of systems to allow sharing of records between VA and IHS for purposes of determining a veteran is eligible for this copayment exemption.

As explained directly above, while VA will not include in the regulations an enumerated list of documents that may be submitted to demonstrate that a veteran meets the definition of Indian or urban Indian as defined in 25 U.S.C 1603(13) and (28), the documents suggested by these commenters also appear problematic because it appears that some individuals who are eligible to receive healthcare from IHS, THP, and UIO do not meet the definition of Indians or urban Indians in 25 U.S.C. 1603(13) and (28). See 42 CFR 136.12. Relying on documents that may be issued to individuals who received care from IHS, THP, or UIO but that do not meet the section 1603(13) and (28) definitions essentially would allow these organizations, rather than VA, to make determinations that veterans meet the definition of Indian or urban Indian when they may not.

VA makes no changes based on these comments.

Several commenters, including Tribal Nations, intertribal organizations, Tribal health boards, and Indian health clinics, together serving hundreds of Tribal Nations, suggested VA waive all copayments for all health care services provided to veterans who meet the definition of Indian or urban Indian in 25 U.S.C. 1603(13) and (28). VA has authority to exempt copayments of hospital care and medical services pursuant to 38 U.S.C. 1730A. VA has distinct authority related to copayments for the hospital care and medical services provided to veterans through the urgent care benefit under 38 U.S.C. 1725A. VA interprets the comments to request additional exemptions both beyond hospital care and medical services pursuant to section 1730A and section 1725A. We will address both scenarios below and will make changes to the rule based on the comments related to urgent care.

One Tribal Nation asserted that there should be no limitation on the exemption for copayments as VA should not be more restrictive than the statutory authority. Another of these commenters further noted that copayment exempt elder care services are important since obtaining such care through VA will lighten the burden on IHS and Tribal health care providers, particularly as Tribal members are having longer lifespans. VA interprets these comments to mean that VA should provide a copayment exemption for all services furnished by VA even if they are not hospital care and medical services.

Section 1730A explicitly exempts copayments for hospital care and medical services. VA has interpreted those terms consistent with their statutory definitions in 38 U.S.C. 1701(5) and (6) and in 38 CFR 17.30(a).

Section 1701(5), in pertinent part, defines hospital care to include medical services rendered in the course of the hospitalization of any veteran, and travel and incidental expenses pursuant to the provisions of 38 U.S.C. 111.

Section 1701(6) defines medical services to include, in addition to medical examination, treatment, and rehabilitative services, the following: (1) surgical services; (2) dental services and appliances as described in 38 U.S.C 1710 and 1712; (3) optometric and podiatric services; (4) preventive health services; (5) noninstitutional extended care services, including alternatives to institutional extended care that the Secretary may furnish directly, by contract, or through provision of case management by another provider or payer; (6) in the case of a person otherwise receiving care or services under chapter 17, wheelchairs, artificial limbs, trusses, and similar appliances, special clothing made necessary by the wearing of prosthetic appliances, and such other supplies or services as the Secretary determines to be reasonable and necessary; (7) travel and incidental expenses pursuant to 38 U.S.C. 111; and (8) chiropractic services.

Consistent with section 1701(6), VA has defined medical services in 38 CFR 17.30(a) to include, in addition to medical examination, treatment, and rehabilitative services: (1) surgical services, dental services and appliances as authorized in 38 CFR 17.160 through 17.166, optometric and podiatric services, (in the case of a person otherwise receiving care or services under this chapter) the preventive health care services set forth in 38 U.S.C. 1701(9), noninstitutional extended care, wheelchairs, artificial limbs, trusses and similar appliances, special clothing made necessary by the wearing of prosthetic appliances, and such other supplies or services as are medically determined to be reasonable and necessary; (2) consultation, professional counseling, marriage and family counseling, training, and mental health services for the members of the immediate family or legal guardian of the veteran or the individual in whose household the veteran certifies an intention to live, as necessary in connection with the veteran's treatment; and (3) transportation and incidental expenses for any person entitled to such benefits under the provisions of 38 CFR 70.10.

Section 3002 of Public Law 116-315 amended 38 U.S.C. 1730A to include Indian and urban Indian veterans as covered veterans who are exempted from making copayments for the receipt of hospital care or medical services. That law requires VA to apply the copayment exemption to hospital care and medical services as those terms are defined in statute; section 1701(5) and (6) of title 38 of United States Code. Thus, VA interprets 38 U.S.C. 1730A to refer only to hospital care and medical services as defined in 38 U.S.C. 1701(5) and (6) and is exempting Indian and urban Indian veterans from copayments under 17.108, 17.110, and 17.111 for inpatient hospital care, outpatient medical care, medication, noninstitutional extended care including adult day health care, noninstitutional respite care, and noninstitutional geriatric evaluation, respectively. Therefore, these veterans would still be required to pay copayments for domiciliary care, institutional respite care, institutional geriatric evaluation, and nursing home care. See 38 U.S.C. 1730B.

Several commenters expressed concern with VA's proposal to charge a copayment for urgent care after the third visit for this group of veterans. Some commenters, including Tribal Nations, intertribal organizations, Tribal health boards, and Indian health clinics, together serving hundreds of Tribal Nations, specifically recommended VA exempt all urgent care visits from copayments as they explained that charging for urgent care visits after the first three visits in a calendar year is contrary to Congressional intent and the Federal government's trust responsibility. Some of these commenters asserted that veterans may delay or forgo needed care if they are charged a copayment for urgent care visits beyond the first three visits in a calendar year, especially as primary care is often less accessible than urgent care for American Indians and Alaska Natives. Relatedly, other commenters suggested VA exempt copayments for all urgent care as such care fills gaps where primary care is scarce or nonexistent, and copayments for such care can be a barrier for those who have to travel far for needed care, such as those in Alaska. One of these commenters suggested that alternatively, VA could exempt copayments for urgent care beyond three visits in a calendar year when an American Indian or Alaska Native veteran has to travel more than 100 miles or travel more than two or three hours for urgent care. Another commenter recommended VA extend the copayment exemption for urgent care visits beyond the initial three in a calendar year if extenuating circumstances warrant additional urgent care visits, such as when a medical appointment is canceled and cannot be rescheduled within the time that the veteran may need to address their medical issue. One commenter also recommended all urgent care visits at Indian health care providers and IHS, THP, or UIO facilities be exempt from copayments.

VA considered these comments and has decided not to finalize its proposal to exempt only the first three urgent care visits from copayments for Indian or urban Indian veterans. Instead, VA will exempt all urgent care visits from copayments for such veterans. As explained in the proposed rule, VA has discretion under 38 U.S.C. 1725A to determine the appropriate copayment for urgent care visits, after the first two visits, for veterans who are otherwise exempt from copayments for VA care. Section 1725A(f)(1)(B) provides that an eligible veteran not required to pay a copayment under this title may access walk-in care (urgent care) without a copayment for the first two visits in a calendar year. For any additional visits, a copayment at an amount determined by the Secretary may be required. VA has previously utilized the authority provided under section 1725A to require copayments for all veterans, irrespective of their priority group enrollment, level of service-connected disability, or designation as catastrophically disabled, after the first three visits in a calendar year because the copayment is designed to encourage appropriate use of the benefit. 88 FR 2041. However, based on the comments received, VA has determined that eligible Indian and urban Indian veterans will not be required to pay a copayment for urgent care visits under section 1725A.

As explained above, Congress decided to adopt a copayment exemption for Indian and urban Indian veterans in recognition of this country's promise to Tribal nations as part of its trust and treaty responsibilities to provide American Indians and Alaska Natives with free health care, to increase access to care, and to support parity for the provision of care by VA and other Federal agencies. As Representative Takano explained, the “Federal Government has a legal and moral obligation to uphold its treaty obligations to Tribal nations, which include the provision of healthcare.” Likewise, Representative Roe explained that the copayment exemption upholds “the United States Government's longstanding trust and treaty responsibilities to the Native American communities.” Our unique responsibilities to this community counsel in favor of exempting Indian and urban Indian veterans from all urgent care copayments.

In addition, as the commenters explained, primary care is often less accessible than urgent care for American Indians and Alaska Natives, who often have to travel long distances to receive primary care. As a result, Indian and urban Indian veterans in some cases may find it necessary to use urgent care more than three times in a year, including in circumstances where primary care is not a meaningfully available alternative. Charging a copayment for those visits could deter this population from seeking necessary care. VA recognizes that the current copayment rules for urgent care are designed to encourage veterans to seek care from their primary care provider first, when VA can provide the needed care, and to utilize urgent care when prompt treatment is necessary to prevent the condition from becoming emergent. But for Indian and urban Indian veterans, that is often not a reasonably available option.

Several studies document that American Indian and Alaska Native people are disproportionally affected by chronic health conditions and die at higher rates than other Americans. 1 Native Americans, particularly those living in rural areas, face significant barriers in accessing health care. 2 The United States Government has taken several steps to make health care more accessible, including strengthening the Indian health care system, granting greater management control of health care resources to Tribes, and removing cost sharing requirements for other federally delivered health care services.

This rule will also promote parity in how other Federal agencies address copayment rules for Indian and urban Indian veterans—which, as explained above, was one goal of Congress in adopting the copayment exemption. In the United States, Indians are generally exempted from all cost-sharing in health plans. This includes through the Indian Health Service (IHS), Medicare, and the Marketplace. Under section 1402 (d)(1) of the Patient Protection and Affordable Care Act Public Law 111-148, issuers of qualified plans must eliminate all cost-sharing, including copayments and deductibles for Indians if they obtain insurance through the Health Insurance Exchange. There is also no cost sharing for any Indian for any item or service obtained directly through IHS, Indian Tribe, Tribal organization, urban Indian organization or through referrals under contract health services without regard to income. Section 2902 of the Affordable Care Act also made permanent the reimbursement for all Medicare Part B services provided by IHS hospitals and clinics.

For the reasons stated above, in recognition of the Government's trust responsibility, comments received from Tribes, and to ensure parity with other Federal health plans, VA will eliminate all copayments for urgent care visits regardless of the provider of the urgent care services for Indian and urban Indian veterans under 38 U.S.C. 1725A. For these reasons VA will also reimburse these veterans copayments for all urgent care visits going back to January 5, 2022.

VA notes that we intend to conduct further consultation and to publish a public request for information to obtain additional input from veterans on topics such as primary care access, the use of urgent care under section 1725A, and its role in health care delivery for all veterans.

One commenter recommended the changes to the regulations take effect immediately. The Administrative Procedure Act (APA), codified in part at 5 U.S.C. 553, generally requires that agencies publish substantive rules in the Federal Register for notice and comment and provide not less than 30 days before the rules become effective An agency may bypass the APA's 30-day delay requirement if good cause exists, 5 U.S.C. 553(d)(3), or if the rule “recognizes an exemption or relieves a restriction,” 5 U.S.C. 553(d)(1). As this rule recognizes a copayment exemption, VA finds that it can publish this final rule with an immediate effective date and forgo the 30-day delay requirement. 38 U.S.C. 553(d)(1).

One commenter expressed concern about the cost of this rulemaking and disagreed with VA's assertion that this rule would not result in an unfunded mandate. VA makes no changes based on this comment. As stated in the proposed rule, unfunded mandates apply to any rule that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This rule will not result in an expenditure by State, local, and Tribal governments, or by the private sector of $100 million or more (adjusted annually for inflation) in any one year. As explained in the regulatory impact analysis accompanying the proposed rule, VA estimated a 5-year impact of a loss of revenue to VA in the amount of approximately $20.4 million dollars and a 10-year impact of a loss of revenue to VA in the amount of approximately $50 million. This rulemaking does not require any expenditures by any State, local, or Tribal governments, as this rule only waives copayments for VA health care to certain veterans. VA refers the commenter to the regulatory impact analysis accompanying this rulemaking for a detailed analysis of the estimated costs for this rule.

One commenter suggested VA spend time on the Paperwork Reduction Act (PRA) rather than the proposed rule, particularly as they opined that the proposed rule is redundant, repetitive, and not concise. However, the commenter did not recommend any specific changes to the rulemaking. VA considers this comment outside the scope of the rulemaking and makes no changes based on it.

Another commenter suggested that in future rulemakings that have an associated information collection subject to PRA, VA coordinate with the Office of Management and Budget (OMB) to allow tribes and Tribal organizations to actively participate in the rulemaking process through the submission of a written comment with sufficient time and notice. As part of the proposed rule, the public, to include tribes and Tribal organizations, had the opportunity to submit comments on the information collection associated with this rulemaking, which is the case for all proposed rules that have an associated information collection. As VA explained in the proposed rule, a comment is best assured of having its full effect if OMB receives it within 30 days of publication of the proposed rule. Additionally, VA conducted Tribal consultation prior to the proposed rule and provided American Indian and Alaska Native Tribal governments and others the opportunity to provide VA with feedback about how VA could confirm a veteran meets the definitions in 25 U.S.C. 1603(13) and (28), including documentation that could or should be submitted for purposes of this copayment exemption. Consistent with VA policy, VA will continue to conduct Tribal consultations on issues that impact veterans who are members of tribes. The commenter did not recommend any changes to the rulemaking. VA makes no changes based on this comment.

Some commenters requested that VA host an urban confer and/or an additional Tribal consultation on this rule and the documentation requirements. While we consider this comment outside the scope of the rule, VA conducted Tribal consultation prior to the proposed rule and provided American Indian and Alaska Native Tribal governments and others the opportunity to provide VA with feedback on information and documentation that VA could use to identify veterans who are members of a Tribe. Additionally, as part of the rulemaking process, VA provided the public, including American Indian and Alaska Native Tribal governments, veterans, and Indian health organizations, the opportunity to comment on its proposed rule. VA seriously considered all comments received during the consultation and public comment process and made changes to the rule based on comments received by the tribes. VA does not believe it is necessary to conduct additional Tribal consultation or an urban confer on this rulemaking. As explained earlier in this preamble, VA is engaged in a robust effort to educate all stakeholders about this copayment exemption and is committed to continued engagement with its stakeholders about how best to implement and educate others about the rule. VA makes no changes to the rule based on these comments.

Several commenters made suggestions related to VA's implementation of this rule, including ensuring staff has adequate training and expertise to review documentation; ensuring determinations on eligibility for the copayment exemption are made by those who have specialized training and requisite subject matter expertise; conducting outreach to veterans, VA facilities, community providers, and active duty servicemembers (when they leave service); providing veterans with clear guidance and assistance on acceptable documentation; providing a defined process and timeline for identifying the copayments that will be reimbursed; and sharing data with Indian country on the utilization of the copayment exemption.

While VA considers these comments outside the scope of this rulemaking since they concern internal VA processes not appropriate for regulation, VA considered them while creating the implementation plan for the copayment exemption. Initially, VA will provide information to veterans on the types of acceptable documentation that may be submitted for this copayment exemption and will communicate information on this copayment exemption to all veterans, including those who are American Indian and Alaska Native. VA will also have a website that provides information on the copayment exemption, including a list of acceptable documentation. VA will have designated staff that will have the necessary subject matter expertise and training to properly review the submitted documentation to confirm eligibility for the copayment exemption. Frontline staff at VA facilities will be expected to direct veterans to VA's website explaining the benefit and acceptable documentation as well as direct them to specific employees who can further address any questions veterans may have. VA will also work towards ensuring that active duty servicemembers transitioning out of military service are made aware of this copayment exemption. As part of implementation, VA is determining how it will collect and analyze data related to this copayment exemption. As part of that effort, VA intends to reach out to American Indian and Alaska Native Tribal governments and will consider sharing utilization with them as appropriate. VA is developing a process for issuing reimbursements to veterans who are eligible for such reimbursements retroactive for covered services provided on or after January 5, 2022. As the time for processing these reimbursements will be dependent on the volume of veterans who are determined to be eligible for this copayment exemption, VA will be unable to provide specific timeframes for reimbursement. However, VA will make every effort to process reimbursements as quickly as possible. VA makes no changes to the regulations based on these comments.

One commenter recommended that VA retain copies of the documentation once it is submitted and update its records to identify the veteran as Indian or urban Indian and exempt them from future copayments. VA considers this comment outside the scope of the rule. However, VA will retain documentation submitted by veterans and once VA receives acceptable documentation, VA will update the veteran's VA records to ensure that VA does not charge eligible veterans copayments for covered care. VA makes no changes based on this comment.

One commenter stated that veterans should have access to culturally relevant services and care, and VA should work closely with Urban Indian Health Organizations or Tribal Health Organizations. While VA considers this comment outside the scope of the rule, VA is committed to working with partner stakeholders to better serve Indians and urban Indian veterans when possible. Future engagements with these stakeholders may foster the opportunity for new and expanded partnerships. VA makes no changes to the rule based on this comment.

Some commenters raised concerns regarding lack of access to culturally competent representation to assist American Indian and Alaska Native veterans relating to their benefits claims. These commenters further alleged VA has refused to work with or accredit UIO as claims representatives. VA considers these comments outside the scope of the rule and makes no changes based on them.

VA is making several minor technical edits to the language it previously proposed. VA is also making a substantive edit to address the exemption for all urgent care visits for Indian and urban Indian veterans.

After the proposed rule published for public comment, VA published an interim final rule that amended several of VA's medical regulations, including 38 CFR 17.110(c). 88 FR 2536 (January 17, 2023). Section 17.110 was revised by the January 17, 2023, rulemaking to include paragraph (c)(13), “[m]edication for an individual as part of emergent suicide care as authorized under 38 CFR 17.1200-17.1230.” Thus, in this final rule on the copayment exemption for Indian and urban Indian Veterans, VA will add paragraph (c)(14) to § 17.110 to refer to a veteran who meets the definition of Indian or urban Indian, as defined in 25 U.S.C. 1603(13) and (28), for medications provided on or after January 5, 2022. VA will use the exact same language that it proposed as § 17.110(c)(13) in the proposed rule but it will be in paragraph (c)(14) instead and all references to paragraph (c)(13) as proposed will now reference paragraph (c)(14). VA is making no changes to the substantive language.

VA is also making minor technical edits to the language proposed in §§ 17.108(d)(14), 17.110(c)(13), 17.111(f), and 17.4600(d)(1)(ii). In those proposed paragraphs, VA explained that in order to demonstrate that a veteran meets the definition of Indian or urban Indian, the veteran must submit to VA any of the documentation listed in the subparagraphs that follow the paragraph. However, VA finds it necessary to replace the word “listed” with the word “described” to more accurately reflect that the acceptable documentation identified in these regulations is a description rather than an exhaustive list of documents. These changes have no substantive impact on provision of benefits or services to veterans.

We are also making minor revisions to the language proposed in §§ 17.108(d)(14)(ii), 17.110(c)(13)(ii), 17.111(f)(11)(ii), and 17.4600(d)(1)(ii)(B). In those proposed paragraphs, we explained that acceptable documentation includes documentation showing that the veteran, irrespective of whether they live on or near a reservation, is a member of a Tribe, band, or other organized group of Indians terminated since 1940 and those recognized now or in the future by the State in which they reside, or who is a descendant, in the first or second degree, of any such member.

However, VA now revises that language in the final rule to state that such documentation includes documentation showing that the veteran is a member of a Tribe, band, or other organized group of Indians. Thus, the language in §§ 17.108(d)(14)(ii), 17.110(c)(14)(ii) (formerly paragraph (c)(13)(ii) but revised as explained further above), 17.111(f)(11)(ii), and 17.4600(d)(1)(ii)(B) (formerly paragraph (d)(1)(ii)(B) but revised as explained further below) will read as follows: documentation showing that the veteran, irrespective of whether they live on or near a reservation, is a member of a Tribe, band, or other organized group of Indians, including those tribes, bands, or groups terminated since 1940 and those recognized now or in the future by the State in which they reside, or who is a descendant, in the first or second degree, of any such member.

The language VA proposed in §§ 17.108(d)(14)(i), 17.110(13)(i), 17.111(f)(11)(i), and 17.4600(d)(1)(ii)(A) described documentation issued by a federally recognized Indian Tribe that shows that the veteran is a member of the Tribe, which was intended to cover the part of the definition of Indian in 25 U.S.C. 1603(13)(A) regarding membership in a Tribe, band, or other organized group of Indians. Documents described in §§ 17.108(d)(14)(i), 17.110(c)(13)(i) (revised in this final rule as paragraph (c)(14)(i) per the discussion further above), 17.111(f)(11)(i), and 17.4600(d)(1)(ii)(A) (revised in this final rule as paragraph (d)(4)(i)(A) per the discussion further below) could overlap with the revised language to §§ 17.108(d)(14)(ii), 17.110(c)(14)(ii), 17.111(f)(11)(ii), and 17.4600(d)(1)(ii)(B) described above. However, to ensure VA is consistent with the language in the definition of Indian in 25 U.S.C. 1603(13)(A), VA will revise the language proposed in §§ 17.108(d)(14)(ii), 17.110(c)(13)(ii) (revised in this final rule as paragraph (c)(14)(ii) per the discussion further above), 17.111(f)(11)(ii), and 17.4600(d)(1)(ii)(B) (revised in this final rule as paragraph (d)(4)(i)(B) per the discussion further below), as explained in the previous paragraph. These changes have no substantive impact on provision of benefits or services to veterans.

Additionally, we are making minor revisions to the language proposed in §§ 17.108(d)(14)(i), 17.110(c)(13)(ii) (revised in this final rule as paragraph (c)(14)(ii) per the discussion further above), 17.111(f)(11)(i), and 17.4600(d)(1)(ii)(A) (revised in this final rule as paragraph (d)(4)(i)(A) per the discussion further below) to remove the hyphen between “federally-recognized” and replacing it with space so that the language in those paragraphs states “federally recognized”. This is a minor edit to ensure the appropriate use of the term. These changes have no substantive impact on provision of benefits or services to veterans.

VA is also making minor revisions to capitalize the term “Tribe” throughout §§ 17.108(d)(14), 17.110(c)(14), 17.111(f)(11), and 17.4600(d)(4), as VA did not capitalize such term in the proposed regulatory text for such sections. Capitalizing the term “Tribe” is consistent with the Government Publishing Office Style Guide.

Finally, VA is making additional edits to the language it proposed as part of the urgent care regulation in 38 CFR 17.4600(d) to accommodate comments and expand the copayment exemption to all urgent care visits. The language in paragraph (d)(1) is amended so that it states, “Except as provided in paragraphs (d)(2) through (4) of this section.” This change will accommodate the new exception for Indian and urban Indian to be copayment exempt for all urgent care visits.

VA is amending the language that was proposed in paragraph (d)(1)(ii) and adding it as a new paragraph (d)(4)(i) in 38 CFR 17.4600. The language in paragraph (d)(1)(ii) of the proposed rule stated that a veteran would be required to pay a copayment for urgent care “[a]fter three visits in a calendar year if such eligible veteran meets the definition of Indian or urban Indian, as defined in 25 U.S.C. 1603(13) and (28). To demonstrate that they meet the definition of Indian or urban Indian, the veteran must submit to VA any of the documentation listed in paragraphs (A) through (F)”. The first sentence of (d)(4)(i) will now read “If an eligible veteran meets the definition of Indian or urban Indian, as defined in 25 U.S.C. 1603(13) and (28), they are exempt from copayments for all urgent care visits.” In addition, we revise the second sentence in paragraph (d)(4)(i) to state “To demonstrate that they meet the definition of Indian or urban Indian, the veteran must submit to VA any of the documentation described in paragraphs (d)(4)(i)(A) through (F) of this section:”. This change will be consistent with the language proposed in the changes to §§ 17.108, 17.110, and 17.111 and to clarify that we are referring to paragraphs (A) through (F) of paragraph (d)(4)(i) of § 17.4600. This revised language also includes the change from “listed” to “described” as explained further above as well the new paragraph designation. This change has no substantive impact on provision of benefits or services to veterans.

VA is adding this revised language as a new paragraph (d)(4)(i) instead of as proposed paragraph (d)(1)(ii) because paragraph (d)(1), except as provided in paragraph (d)(2) or (3), explains when an eligible veteran is obligated to pay a copayment of $30 to VA. Since VA is expanding the copayment exemption to all urgent care visits, the revised language is added as an exception to the copayment requirement in paragraph (d)(1).

Further, the language in paragraph (d)(4)(i) of the proposed rule is added as new paragraph (d)(4)(ii), and to be consistent with the structural changes described above, the references to paragraph (d)(1)(ii) are revised to paragraph (d)(4)(i). This change has no substantive impact on provision of benefits or services to veterans.

The Administrative Procedure Act (APA), codified in part at 5 U.S.C. 553, generally requires that agencies publish substantive rules in the Federal Register and provide a 30-day delay before the rule becomes effective. However, an agency may bypass the APA's 30-day delay requirement if the rule “recognizes an exemption or relieves a restriction,” 5 U.S.C. 553(d)(1). This rule recognizes an exemption, in particular, a copayment exemption for Indian and urban Indian veterans, and will therefore not have the 30-day delay before it becomes effective.

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this final rule is a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This rule will not cause a significant economic impact on small entities since this exemption is limited to individual veterans who VA determines to be Indian or urban Indian. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and Tribal governments, or on the private sector.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Government agencies must seek approval from the Office of Management and Budget (OMB), which assigns a control number for each collection of information it approves. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays currently valid OMB control number (5 CFR 1320.8(b)(3)(vi)).

This final rule includes provisions constituting new collections of information under the Paperwork Reduction Act of 1995 that require approval by OMB. Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for review.

Sections 17.108, 17.110, 17.111, and 17.4600 contain new collections of information. OMB has filed a comment on these information collections that were submitted in conjunction with the proposed rule. OMB requested that VA develop a cover form as part of these information collections. Such cover form would accompany the veteran's documentation demonstrating that they meet the definition of Indian or urban Indian and would include the veteran's name and contact information. VA has developed such cover form and submitted it to OMB for review and approval as part of these information collections. VA anticipates these information collections to be approved 30 days after publication of the final rule.

This information will be collected from veterans to determine if they meet the definition of Indian or urban Indian as defined in 25 U.S.C. 1603(13) and (28) for purposes of exempting such veterans from copayments for certain health care. Veterans will submit documentation that demonstrates that they meet these definitions of Indian or urban Indian. VA estimates that 25,000 veterans will submit their documentation one time. The estimated average burden per response is 15 minutes. VA estimates the annual cost to all respondents will be $175,062.50 per year (6,250 burden hours × $28.01 per hour). To estimate the total information collection burden cost, VA used the Bureau of Labor Statistics mean hourly wage for hourly wage for “00-0000 All Occupations” of $28.01 per hour. This information is available at https://www.bls.gov/oes/current/oes.nat.htm.

If OMB does not approve the collections of information as requested, VA will immediately remove the provisions containing the collections of information or take such other action as directed by OMB. Notice of such OMB approval will be published in a future Federal Register document.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, approved this document on March 29, 2023, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as set forth below:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0671 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before June 5, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0671, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/send-comments-epa-dockets.

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

In the Federal Register of August 30, 2022 (87 FR 52868) (FRL-9410-04-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E8933) by Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 63141. The petition requested that 40 CFR 180.435 be amended by establishing tolerances without U.S. Registration for residues of deltamethrin, (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-, in or on the raw agricultural commodity, Crop Subgroup 6C (Pea and bean, dried, shelled, except soybean) at 0.07 parts per million (ppm). That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing tolerances for two subgroups in the recently revised Legume vegetable crop group 6-22 instead of Crop Subgroup 6C (Pea and bean, dried, shelled, except soybean) as requested by the petitioner.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for deltamethrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with deltamethrin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicology database for deltamethrin is complete except for the subchronic inhalation study which the Hazard Science and Policy Council (HASPOC) recommended to require (TXR 0058335, Z. Staley, 09/30/2022).

Deltamethrin is a member of the pyrethroid class of insecticides. Pyrethroids have historically been classified into two groups, Type I and Type II, based on chemical structure and toxicological effects. Deltamethrin is a Type II pyrethroid. Type II pyrethroids, which contain an alpha-cyano moiety, produce a syndrome in rats that includes pawing, burrowing, salivation, hypothermia, and coarse tremors leading to choreoathetosis (CS-syndrome). The adverse outcome pathway (AOP, identified using a weight-of-evidence approach based on the Bradford-Hill criteria) shared by pyrethroids involves the ability to interact with voltage-gated sodium channels (VGSCs) in the central and peripheral nervous systems, leading to changes in neuron firing and ultimately, neurotoxicity.

Deltamethrin has been evaluated for a variety of effects in experimental toxicity studies. Neurotoxicity was observed throughout the database, and effects were seen across species, sexes, exposure durations, and routes of administration. Clinical signs characteristic of Type II pyrethroids, such as increased salivation, altered mobility/gait, and tremors, were seen in experimental toxicology studies including neurotoxicity studies (acute and subchronic) in rats, subchronic and chronic studies in dogs and rats, and developmental and reproduction studies in rats. In addition to the clinical signs noted above, increased sensitivity to external stimuli, abnormal vocalization, and decreased fore- and hind-limb grip strength were commonly observed in the database.

Deltamethrin did not have any adverse effects on fetuses or offspring in the prenatal developmental studies in rats and rabbits, therefore there was no evidence of quantitative or qualitative susceptibility in these studies. However, qualitative susceptibility was observed at high doses in the developmental neurotoxicity (DNT) and 2-generation reproduction studies because the effects in the offspring were more severe than the maternal effects. In the DNT study, an increased incidence of vocalization when handled was observed during FOB observations on PND 4 for male pups and decreased pre- and post-weaning body weight was observed in pups of both sexes. In maternal animals, only decreased body weight and body weight gain were observed, and no adverse FOB effects were observed despite having undergone the same neurological measurements as the pups, including FOB analysis. In the 2-generation reproduction study, treatment-related effects in the parental animals at the high dose were limited to lesions on the head, neck, or forelimbs, and alopecia in the males and ataxia and hypersensitivity in the females during gestation. At the high dose in the F1 generation, there were increased pup mortalities (PND 8-14) and clinical findings observed early in the post-weaning period ( i.e., impaired righting reflexes, hyperactivity, splayed limbs, vocalization, and excessive salivation). There was no increase in mortality or clinical signs in the F2 generation. Decreased body weight was observed in the adult P and F1 generations, and decreased pup weight was observed in both the F1 and F2 pups.

In a 21-day dermal toxicity study, no systemic toxicity was observed up to the limit dose. There was also no toxicity observed following acute dermal exposure to deltamethrin up to a dose of 2,000 mg/kg/day. The dermal absorption value for deltamethrin is 11.3%.

There was no evidence of immunotoxicity in the available studies with deltamethrin.

There was no evidence of carcinogenicity in the combined chronic/carcinogenicity study in rats or the carcinogenicity study in mice. In a battery of mutagenicity studies, there was no evidence of a mutagenic effect.

Specific information on the studies received and the nature of the adverse effects caused by deltamethrin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document “Deltamethrin Human Health Risk Assessment for the Proposed Tolerances on Vegetable, Legume, Pulse, Bean, Dried Shelled, Except Soybean, Subgroup 6-22E and Vegetable, Legume, Pulse, Pea, Dried Shelled, Subgroup 6-22F, without U.S. Registration” (hereinafter “Deltamethrin Human Health Risk Assessment”) at 29-34 in docket ID number EPA-HQ-OPP-2022-0671.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (PODs) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks .

A summary of the toxicological endpoints for deltamethrin used for human risk assessment can be found on pages 17-18 in the “Deltamethrin Human Health Risk Assessment”.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to deltamethrin, EPA considered exposure under the petitioned-for tolerances as well as all existing deltamethrin tolerances in 40 CFR 180.435. EPA assessed dietary exposures from deltamethrin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for deltamethrin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in American (NHANES/WWEIA). As to residue levels in food, the acute dietary exposure is partially refined; the residue inputs were a combination of tolerance-level residues, Pesticide Data Program (PDP) monitoring data, and mosquito adulticide residue values. As deltamethrin is registered for use as a mosquito adulticide, residue estimates for the adulticide use were included in the dietary exposure assessment. EPA used percent crop treated (PCT) for some commodities as described below and 100 PCT for the other commodities.

ii. Chronic exposure. A chronic dietary risk assessment is not required for deltamethrin because repeated exposure does not result in a POD lower than that resulting from acute exposure. Therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, EPA performed a chronic dietary exposure assessment for use in the aggregate assessment, since there are residential exposures for deltamethrin that need to be aggregated with background exposure from dietary sources. In the aggregate human health risk assessment, the average or chronic exposure estimates are combined with the appropriate residential exposure estimates and compared to the POD for deltamethrin.

In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, the chronic dietary exposure is partially refined; the residue inputs consisted of a combination of tolerance level residues, PDP monitoring data, mosquito adulticide residue values, and Food Handling Establishment (FHE) residue values. EPA used percent crop treated (PCT) estimates for some commodities and 100 PCT for the other commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that deltamethrin is not likely to be carcinogenic to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area and the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

For the dietary assessment, the following PCT assumptions were made:

The maximum PCT estimates used in the acute dietary risk assessment for the following crops that are currently registered for deltamethrin were: apples, 2.5%; carrots, 5%; cucumbers, 5%; soybeans, 2.5%; and watermelons, 10%. In addition, EPA used a value of 9% as an estimate of the percentage of the orange crop that might be imported. EPA assumed 100 PCT for all other commodities included in the acute assessment.

The average PCT estimates used in the chronic dietary risk assessment for the following crops that are currently registered for deltamethrin were: apples, 1%; globe artichokes, 5%; carrots, 1%; cotton, 1%; cucumbers, 1%; leeks, 1%; onions, 1%; potatoes, 1%; pumpkins, 2.5%; rapeseed, 2.5%; shallot, 1%; squash, 1%; sunflowers, 5%; and watermelons, 1%. EPA assumed 100 PCT for all other commodities included in the chronic assessment.

In the chronic assessment, for the commodities that are only covered by the FHE tolerance, the assumption was made that there was a 4.65% chance that a food item consumed by a person contained deltamethrin residues as a result of treatment at some point in an FHE.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5%, respectively. The maximum PCT figure is the highest observed maximum value reported within the recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which deltamethrin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for deltamethrin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of deltamethrin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment .

The deltamethrin limit of solubility is 0.20 ppb. EPA used 0.20 ppb as the estimated drinking water concentration (EDWC) for both the acute and chronic dietary assessments because the concentration of deltamethrin in water cannot exceed the limit of solubility.

Although a chronic dietary endpoint was not identified for deltamethrin, a chronic dietary exposure assessment was performed to provide background exposure for the aggregation with short-term residual exposure.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

There are no proposed residential uses associated with the proposed use on imported peas and beans. However, deltamethrin is currently registered for the following uses that could result in residential exposures: Indoor (spot, crack and crevice) and outdoor (turf, garden and trees) environments, pet collars, paint preservative, impregnated mosquito net, and wide area mosquito and fly control.

In the previous risk assessment, all residential handler scenarios (adults only) resulted in inhalation risk estimates greater than the LOC ( i.e., MOEs ≥ 1,000), with MOEs ranging from 1,200 to 850,000, which are not of concern. No risk estimates of concern were identified for residential post-application exposure scenarios (children's incidental oral). The MOEs ranged from 290 to 1,500,000 and were greater than the LOC of 100.

Although there are no residential uses associated with the proposed tolerances, the aggregate human health risk assessment was updated to include the additional dietary exposure expected from residues in peas and beans. EPA selected only the most conservative, or worst- case, residential adult and child scenarios to be included in the aggregate estimates, based on the lowest overall MOE ( i.e., highest exposure and risk estimates). The adult worst-case residential handler exposure estimate resulted from adults fastening (applying) pet collars treated with deltamethrin to large dogs. The children's (1 to <2 years old) worst-case residential exposure estimate resulted from hand-to-mouth (post-application) exposure to residues from perimeter/spot treatments on carpeting.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide .

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

The Agency has determined that the pyrethroids and pyrethrins share a common mechanism of toxicity https://www.regulations.gov ; EPA-HQ-OPP-2008-0489-0006. As explained in that document, the members of this group share the ability to interact with voltage-gated sodium channels ultimately leading to neurotoxicity. In 2011, after establishing a common mechanism grouping for the pyrethroids and pyrethrins, the Agency conducted a cumulative risk assessment (CRA) which is available at https://www.regulations.gov; EPA-HQ-OPP-2011-0746. In that document, the Agency concluded that cumulative exposures to pyrethroids (based on pesticidal uses registered at the time the assessment was conducted) did not present risks of concern. For information regarding EPA's efforts to evaluate the risk of exposure to this class of chemicals, refer to https://www.epa.gov/used-pesticide-products/registration-review-pyrethrins-and-pyrethroids .

Deltamethrin is included in the pyrethroids/pyrethrins cumulative risk assessment. No dietary, residential, or aggregate risk estimates of concern have been identified in the single chemical assessment. In the cumulative assessment, residential exposure was the greatest contributor to the total exposure. Dietary exposures make a minor contribution to the total pyrethroid exposure. The dietary exposure assessment performed in support of the pyrethroid cumulative was much more highly refined than that performed for deltamethrin. The minor increase in dietary exposure to deltamethrin residues, as a result of the proposed tolerance, would make an insignificant contribution to cumulative exposure.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Deltamethrin did not have any adverse effects on fetuses or offspring in the prenatal developmental studies in rats and rabbits. However, qualitative susceptibility was observed at high doses in the developmental neurotoxicity (DNT) and 2-generation reproduction study. In the DNT study, an increased incidence of vocalization when handled was observed during FOB observations on PND 4 for male pups and decreased pre- and post-weaning body weight was observed in pups of both sexes. In maternal animals, only decreased body weight and body weight gain were observed despite undergoing the same neurological measurements as the pups, including FOB analysis. In the 2-generation reproduction study, treatment-related effects in the parental animals at the high dose were limited to lesions on the head, neck, or forelimbs, and alopecia in the males and ataxia and hypersensitivity in the females during gestation. At the high dose in the F1 generation, there were increased pup mortalities (PND 8-14) and clinical findings observed early in the post-weaning period ( i.e., impaired righting reflexes, hyperactivity, splayed limbs, vocalization, and excessive salivation). There was no increase in mortality or clinical signs in the F2 generation. Decreased body weight was observed in the adult P and F1 generations, and decreased pup weight was observed in both the F1 and F2 pups.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10X to 1X with the exception of inhalation exposure scenarios, for which the 10X FQPA Safety Factor was retained as a database uncertainty factor. That decision is based on the following findings:

i. The toxicity database for deltamethrin is complete, except for a subchronic inhalation study that HASPOC recommended not to waive (TXR 0058335, Z. Staley, 09/30/2022). Studies that are available to inform the FQPA SF include developmental toxicity studies in rats and rabbits, a reproduction study in rats, an acute neurotoxicity (ACN) study, a subchronic neurotoxicity (SCN) study, and developmental neurotoxicity (DNT) studies.

ii. There is evidence of neurotoxicity in the deltamethrin toxicology database. As with other pyrethroids, deltamethrin causes neurotoxicity from interaction with sodium channels leading to clinical signs of neurotoxicity. These effects are well characterized and adequately assessed by the body of data available to the Agency, therefore, there is no residual uncertainty regarding neurotoxicity.

iii. There were no indications of fetal toxicity in any of the guideline studies, including developmental studies in the rat and rabbit, a developmental neurotoxicity study in rats, and a 2-generation reproduction study in rats. There was evidence of increased juvenile qualitative susceptibility at high doses observed in both the DNT and 2-generation reproduction studies. In the DNT study, increased vocalization was observed during FOB handling of pups on PND 4 at the same dose where decreased body weight and body weight gain were observed in maternal animals (16.1 mg/kg/day). No findings were observed in the maternal animals during FOB handling in the DNT. In the 2-generation reproduction study, the P generation showed limited clinical signs of neurotoxicity and decreased body weights at the highest dose tested (21.2/23.5 mg/kg/day, M/F). Effects observed in the F1 generation at the same dose included decreased pup weight, increased pup mortality between PND 8-14, increased pup mortality within the first 8 days post-weaning, and additional clinical signs of neurotoxicity not observed in the parental generation. The increased mortality and additional clinical signs were considered evidence of qualitative sensitivity in juveniles.

iv. There are no residual uncertainties identified in the exposure databases. The dietary exposure assessments are based on a combination of robust monitoring data and field trial residue levels that account for parent and metabolites of concern, processing factors, and percent crop treated assumptions. Furthermore, conservative, upper-bound assumptions were used to determine exposure through drinking water and residential sources, such that these exposures have not been underestimated.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to deltamethrin will occupy 26% of the aPAD for children 3 to 5 years old, the population group receiving the greatest exposure.

Acute aggregate risk of exposure to deltamethrin results from exposure to residues in food and drinking water alone. Therefore, acute aggregate risk estimates are equivalent to the acute dietary risk estimates, which are below the level of concern of 100% of the aPAD. Acute aggregate risk estimates are not of concern for the general U.S. population or any population subgroup.

2. Chronic risk. Based on the data summarized in Unit III.A., there is no increase in hazard with increasing dosing duration. As a result, there is no increase in toxicity with repeated/chronic dietary exposures; therefore, the acute aggregate assessment is protective of potential chronic aggregate exposures.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Deltamethrin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to deltamethrin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOEs of 260 for children 1 to 2 years old. Because this MOE is greater than the LOC of 100 for dietary and children's hand-to-mouth exposure, the short-term aggregate risk estimate for children 1 to 2 years old is not of concern. The combined short-term food, water and residential exposures for adults results in an aggregate risk index (ARI) of 1.2, which is greater than EPA's level of concern of an ARI of 1, so these risks are also not of concern. EPA used an ARI approach for the adult short-term risk because the level of concern for dietary exposure (100) is different than the level of concern for inhalation exposure (1,000).

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because toxicity does not increase with repeated dosing, intermediate-term risk is covered by the assessments for short-term exposures.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, deltamethrin is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to deltamethrin residues.

Adequate enforcement methodology (gas chromatography with electron capture detection (GC/ECD) method) is available in PAM Volume II (Section 180.422) is available to enforce the tolerance expression. Two other GC/ECD methods are also available for enforcing deltamethrin tolerances in plant commodities.

The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for deltamethrin in or on the raw or processed agricultural commodities, Pulses (group) at 1 ppm. The Codex MRL is much higher and is based on a post-harvest use. EPA cannot harmonize the tolerance of 0.07 ppm because of the large difference in the values which would limit its usefulness as an enforcement tool. However, EPA will be harmonizing with the Canadian MRL of 0.07 ppm for the equivalent subgroups.

FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a tolerance that varies from that sought by the petition. EPA is establishing tolerances for two subgroups in the recently revised Legume vegetable crop group 6-22 instead of Crop Subgroup 6C (Pea and bean, dried, shelled, except soybean) (See Pesticides; Expansion of Crop Grouping Program VI, (87 FR 57627) (September 21, 2022) (FRL-5031-13-OCSPP). The revised subgroups “Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E” and “Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F” include all commodities in the original crop subgroup 6C while also aligning with the updated crop groups.

Therefore, tolerances are established for residues of deltamethrin, (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-, in or on the raw or processed agricultural commodities, Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E and Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.07 ppm. As a housecleaning activity, EPA is removing the first footnote to the table in paragraph (a)(1) because it is unnecessary and included in the second footnote.

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

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

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

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

Why we need to publish a rule. Under section 10(j) of the Endangered Species Act (16 U.S.C. 1531 et seq. ), a population of a threatened or endangered species may be designated as an experimental population prior to its reintroduction. Experimental populations can be designated only by issuing a rule (hereafter referred to as a “10(j) rule”).

What this document does. This rule will designate sihek ( Todiramphus cinnamominus ) introduced to Palmyra Atoll as a nonessential experimental population on the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations at 50 CFR 17.11(h) with a rule set forth at 50 CFR 17.84.

The basis for our action. Based on the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that introducing sihek to Palmyra Atoll, with the regulatory provisions in this final rulemaking, will further the conservation of the species. The nonessential experimental population status is appropriate for the introduced population because we have determined that it is not essential to the continued existence of the species in the wild.

In the making of our finding that this action will further the conservation of the species, we evaluate any possible adverse effects on the captive population of sihek, the likelihood that any such experimental population will become established and survive in the foreseeable future, the relative effects that establishment of an experimental population will have on the recovery of the species, and the extent to which the introduced population may be affected by existing or anticipated Federal or State actions or private activities within or adjacent to the experimental population area. This rule also identifies the boundaries of the experimental population, explains our rationale for why the population is not essential to the continued existence of the species, describes management restrictions, protective measures, or other special management concerns of that population, and explains our rationale for determining that the habitat for sihek has been indefinitely altered or destroyed, currently a requirement under section 10(j) of the Act, and our regulations in title 50 CFR 17.81, for introducing a species outside its historical range.

Peer review and public comment. To ensure that our findings were based on scientifically sound data, assumptions, and analysis—and consistent with our Policy for Peer Review in Endangered Species Act Activities (59 FR 34270, July 1, 1994), and additional guidance (USFWS in litt. 2016)—we invited six objective and independent specialists to review our proposed rule. We received three responses. We also considered all comments and information received during the public comment period. All comments received during the peer review process and the public comment period have been incorporated into this final rule or are addressed below in Summary of Comments and Recommendations.

On August 31, 2022, we published in the Federal Register a proposed rule to establish a nonessential experimental population of sihek on Palmyra Atoll (87 FR 53429, August 31, 2022). The comment period on the proposed rule was open for 30 days, through September 30, 2022. Comments on the proposed rule are addressed below under Summary of Comments and Recommendations.

Species listed as endangered or threatened are afforded protection primarily through the prohibitions in section 9 of the Act. Section 9 of the Act, among other things, prohibits take of endangered wildlife. “Take” is defined by the Act as harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve federally listed species and protect designated critical habitat. Section 7 mandates that Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also requires that Federal agencies, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.

The Act was amended in 1982 to include section 10(j), which allows for the designation of reintroduced populations of listed species as “experimental populations.” The provisions of section 10(j) were enacted to ameliorate concerns that reintroduced populations will negatively impact landowners and other private parties, by giving the Secretary greater regulatory flexibility and discretion in managing the reintroduced species to encourage recovery in collaboration with partners, especially private landowners. Under section 10(j) of the Act, and our regulations in title 50 of the Code of Federal Regulations at 50 CFR 17.81, the Service may designate an endangered or threatened species that has been or will be released within its probable historical range as an experimental population. The Service may also designate an experimental population for an endangered or threatened species outside of the species' probable historical range in extreme cases when the Director of the Service finds that the primary habitat of the species within its historical range has been unsuitably and irreversibly altered or destroyed. All experimental populations are classified as “nonessential” unless we determine that the loss of the experimental population would be likely to appreciably reduce the likelihood of the survival of the species in the wild. The sihek population we are establishing on Palmyra Atoll is designated as nonessential.

The nonessential experimental population (NEP) designation allows us to develop tailored “take” prohibitions that are necessary and advisable to provide for the conservation of the species. The protective regulations adopted for an experimental population in a section 10(j) rule contain the applicable prohibitions and exceptions for that population and apply to all areas described for the nonessential population.

Section 7(a)(2) of the Act requires that Federal agencies, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or adversely modify its critical habitat. For the purposes of section 7 of the Act, we treat an NEP as a threatened species when the population is located within a National Wildlife Refuge or unit of the National Park Service. When NEPs are located outside of a National Wildlife Refuge or National Park Service unit, for the purposes of section 7 we treat the population as proposed for listing and only sections 7(a)(1) and 7(a)(4) of the Act apply. In these instances, a section 10j rule provides additional flexibility in managing the nonessential population because Federal agencies are not required to consult with us under section 7(a)(2) for an NEP. Section 7(a)(1) requires Federal agencies to use their authorities to carry out programs for the conservation of listed species. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed.

Section 10(j)(2)(C)(ii) of the Act states that critical habitat shall not be designated for any experimental population that is determined to be nonessential. Accordingly, we do not designate critical habitat in areas where we establish an NEP.

Before authorizing the release as an experimental population of an endangered or threatened species, and before authorizing any necessary transportation to conduct the release, the Service must find that the release will further the conservation of the species. In making such a finding, the Service uses the best scientific and commercial data available to consider the following factors (see 50 CFR 17.81(b)):

(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 Donor Stock Assessment and Effects on Donor Population, 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 Importance of the NEP to Recovery Efforts, below); and

(4) the extent to which the introduced population may be affected by existing or anticipated Federal or State actions or private activities within or adjacent to the experimental population area (see Management, below).

Furthermore, as set forth at 50 CFR 17.81(c), all regulations designating experimental populations under section 10(j) of the Act must 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 (see Location and Boundaries of the NEP Area, 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 or Nonessential?, below);

(3) management restrictions, protective measures, or other special management concerns for 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, 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 Monitoring and Evaluation, below).

Under 50 CFR 17.81(d), the Service must consult with appropriate State fish and wildlife agencies, local governmental entities, 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 Service, the affected State and Federal agencies, and persons holding any interest in land that may be affected by the establishment of an experimental population.

We listed sihek as an endangered species under the Act on August 27, 1984 (49 FR 33881). At the time of listing, sihek was known as the Guam Micronesian kingfisher ( Halcyon cinnamomina cinnamomina ). On June 23, 2015 (80 FR 35860), we updated our List of Endangered and Threatened Wildlife (50 CFR 17.11) to reflect new taxonomic information indicating that the Guam Micronesian kingfisher ( Halcyon cinnamomina cinnamomina ) is now considered the Guam kingfisher ( Todiramphus cinnamominus ). Throughout this document, we refer to the species as sihek because that is the locally used common name on Guam. We designated critical habitat for sihek on October 28, 2004 (69 FR 62944), consisting of 376 ac (153 ha) on northern Guam. We finalized the Native Forest Birds of Guam and Rota of the Commonwealth of the Northern Mariana Islands Recovery Plan in 1990 and the Revised Recovery Plan for Sihek or Guam Micronesian Kingfisher ( Halcyon cinnamomina cinnamomina ) in 2008 (73 FR 67541, November 14, 2008).

Sihek is a sexually dimorphic (the sexes are outwardly different in appearance) forest kingfisher (Baker 1951, p. 229). The adult male has a brown head, neck, upper back, and underparts. A black line extends around the nape (back of the neck), and the eye ring is black. The lower back, lesser and underwing coverts, and shoulder feathers are greenish-blue, and the tail is blue. The bill is black. The female's markings are similar to the adult male, but the upper breast, chin, and throat are paler, and the remaining underparts are white instead of cinnamon. Sihek are relatively small, about 8 inches (in) (20 centimeters (cm)) in length (Del Hoyo et al. 2001, p. 220). Adult sihek range in weight from 1.7-3.0 ounces (oz) (53 to 85 grams (g)) (Baker 1951, p. 228; Jenkins 1983, p. 21).

Sihek is a nonmigratory species endemic to Guam and historically occurred in all habitats throughout Guam except pure savanna and wetlands (Marshall 1949, p. 210, Baker 1951 p. 229; Jenkins 1983, pp. 22-23). They were described as “fairly common” by Baker (1951, p. 229). However, the population declined rapidly in the mid-twentieth century due primarily to predation by the brown treesnake. The last remaining wild sihek were taken into captivity between 1984 and 1986, and sihek were considered extinct in the wild by 1988 (Wiles et al. 2003, p. 1357). For more than 30 years, the species has existed only in captivity, as discussed further in the Recovery Efforts to Date section, below.

Sihek are socially monogamous, and breeding activity appears to be concentrated from December to July (Marshall 1949, p. 210; Baker 1951, p. 228; Jenkins 1983, p. 23). They nest in cavities, with nests documented in a variety of trees, including Ficus spp. (banyan), Cocos nucifera (coconut), Artocarpus spp. (breadfruit), Pisonia grandis (umumu), and Tristiropsis obtusangula (faniok) (Baker 1951, p. 228; Jenkins 1983, p. 24; Marshall 1989, p. 473). Both male and female sihek incubate eggs and brood and feed nestlings (Jenkins 1983, p. 24). Eggs are white, and reported clutch sizes from wild populations (n=3) were either one or two eggs (Baker 1951, p. 228; Jenkins 1983, p. 24; Marshall 1989, p. 474). Incubation, nestling, and fledgling periods for sihek in the wild are unknown. However, incubation and nestling periods of captive birds averaged 22 and 33 days, respectively (Bahner et al. in litt. 1998, p. 21).

Sihek feed entirely on animal matter including skinks (Scincidae), geckos (Gekkonidae), various insects, segmented worms (Annelida), and hermit crabs ( Coenobita spp.) (Marshall 1949, p. 210; Baker 1951, pp. 228-229; Jenkins 1983, pp. 23-24). Seale (1901, p. 45) also reported that sihek were known to prey on the chicks of domestic fowl, and Marshall (1949, p. 210) noted fish scales in the stomach contents of collected sihek. They typically forage by perching motionless on exposed branches or telephone lines and swooping down to capture prey off the ground with their bill (Jenkins 1983, pp. 23-34). They will also capture prey off nearby foliage and have been observed gleaning insects from bark (Maben 1982, p. 78).

Relatively little is known about the habitat use of sihek. Mature forests with appropriate nest sites were probably an important component for successful reproduction and survival. Sihek are cavity nesters and apparently requires large, standing dead trees. Nest trees were reported as averaging 43 centimeters (17 inches) in diameter (Marshall 1989, p. 475). Sihek also appear to require diverse vegetative structure capable of providing a wide range of both invertebrate and vertebrate prey as well as exposed perches and areas of open ground for foraging (USFWS 2002, p. 63739). Good-quality sihek habitat would therefore provide a combination of closed canopy forest with large, standing dead trees for nesting, and areas of open understory or forest edges for foraging (Jenkins 1983, pp. 22-23; Marshall 1989, pp. 475-476; USFWS 2002, p. 63739).

Records of distributions and intraspecific territorial behaviors for sihek suggest they maintained exclusive year-round territories (Jenkins 1983, pp. 24-25). Little else is known about their movement ecology. On the island of Pohnpei, Micronesian kingfishers ( Todiramphus reichenbachii ), a species from the same genus as sihek, demonstrated an average territory size of 8.1 hectares (ha) (20 acres (ac)) and showed stable boundaries within and between years (Kesler and Haig 2007, p. 387); birds dispersing from their home territory were observed to establish new territories a maximum distance of 4,501 feet (1,372 meters) from the original site (Kesler and Haig 2007, p. 389). Sihek is an island endemic that has not been observed flying over open ocean.

The primary cause of sihek's extinction in the wild was due to predation by the introduced brown treesnake (USFWS 2008, p. 21). Individuals of this invasive species probably arrived on Guam prior to 1950 as stowaways on shipping materials (Savidge 1987, p. 662). Brown treesnakes were likely introduced in southern Guam and expanded their range, reaching the northernmost point of the island by 1968 (Savidge 1987, p. 663). Sihek were last recorded from southern Guam in the 1970s (Drahos 1977, pp. 153-154), and by 1985, Marshall (1989, p. 476) reported only 30 sihek in the northern part of the island. Sihek were considered extinct in the wild by 1988 (Wiles et al. 2003, p. 1357). The continued island-wide presence of brown treesnakes on Guam currently precludes consideration of Guam as a viable reintroduction site for sihek. Future reintroductions to Guam could be considered only if brown treesnakes were suppressed or eradicated at a scale that would allow for the survival of a reintroduced population of sihek.

Other factors that likely impacted sihek on Guam include predation by feral cats (Felis catus ), rats ( Rattus spp.), and monitor lizards ( Varanus tsukamotoi ), habitat degradation from development and typhoons, human persecution, contaminants, and competition with and harassment by black drongos ( Dicrurus macrocercus ) (USFWS 2008, pp. 16-17). Our Revised Recovery Plan for Sihek or Guam Micronesian Kingfisher (USFWS 2008, pp. 16-26) provides further description of these threats.

Criteria for reclassifying sihek from an endangered to threatened species (“downlisting”) include the establishment of two subpopulations on Guam (one in the north and one in the south) of at least 500 individuals each that are stable to increasing over at least 5 consecutive years; the protection and management of habitat sufficient to achieve the population criteria; and the management of brown treesnakes and other introduced predators at levels sufficient to meet the population criteria. The criteria to delist (remove protections of the Act for) the sihek include two subpopulations on Guam of at least 1,000 individuals each (one in the north and one in the south) that are stable or increasing, with sufficient habitat and predator control to support the population criteria (USFWS 2008, pp. 40-43). Our recovery plan acknowledged that the interim step of introducing sihek outside of its historical range may be necessary before we are able to reestablish sihek populations on Guam (USFWS 2008, p. 40).

Over the past 30 years, the Service has worked with a number of stakeholders to provide habitat protection in support of recovering Guam's native species. The habitat protections described below were intended for federally listed species on Guam in anticipation of the eventual ability to control brown treesnakes and allow the reintroduction of sihek and other locally extinct species. In 1993, the U.S. Air Force, U.S. Navy, and the Service entered into a memorandum of understanding to create the Guam National Wildlife Refuge. As per the terms of the memorandum of understanding, the two military branches entered into cooperative agreements with the Service in 1994 to designate Department of Defense lands as overlay units in the Guam National Wildlife Refuge ( i.e., these overlay units of Refuge lands are under the jurisdiction of the Department of Defense but managed by the Service as part of the Refuge). Currently the Guam National Wildlife Refuge includes 152 ha (376 ac) of lands under the jurisdiction of the Service and 9,300 ha (22,980 ac) of overlay lands under the jurisdiction of the U.S. Navy and U.S. Air Force, and all are managed by the Service as the Refuge.

Additionally, the Government of Guam established four reserves for habitat protection. These lands are under the jurisdiction of the CHamoru Land Trust Commission of the Government of Guam. The Commission has the authority to change the status of these lands to non-conservation areas as they deem appropriate. Please see the Revised Recovery Plan for Sihek or Guam Micronesian Kingfisher (USFWS 2008, pp. 33-37) for further description and maps of the Department of Defense and Government of Guam protected areas.

More recently, the Department of Defense and the Service entered into two agreements to protect or manage habitat for sihek and other federally listed species on Guam. A 2020 memorandum of understanding between Joint Region Marianas and the Service outlined a mutual understanding regarding the intentions and future considerations of a Department of Defense readiness and environmental protection integration initiative to address conservation of upland vegetation communities for sihek as well as other federally listed species on Guam (USFWS 2020). In 2015 a memorandum of agreement between the Department of the Navy and the Service designated 2,118 ha (5,234 ac) of habitat for the recovery and survival of sihek in Northern Guam in response to loss of habitat described in the Service's 2015 Marine Corps Relocation Biological Opinion (USFWS 2015, entire).

We currently lack adequate tools to eradicate brown treesnakes from Guam, and the continued presence of brown treesnakes throughout the landscape prevents the successful reestablishment of sihek on Guam in the foreseeable future. However, there is incremental progress in addressing this threat. Since 2010, the interagency Brown Treesnake Technical Working Group has advanced landscape-scale brown treesnake suppression capabilities with the development and refinement of an aerial delivery system for toxicant baiting, comprising an automated bait manufacturing system and an automated dispensing module for applying baits from aircraft. Aerial toxicant baiting has recently been evaluated in both fenced and non-fenced 55-ha (136-ac) sites; brown treesnake suppression, but not eradication, has been validated using this technique (Siers et al. in litt. 2020, p. 4). Further, simulated aerial baiting for brown treesnake eradication within a 5-ha (12-ac) brown treesnake exclusion area indicates that some brown treesnake size classes do not consume baits and additional control tools are needed to achieve suppression objectives and/or eradication (Siers et al. in litt. 2020, p. 4).

Island-wide eradication of invasive vertebrates has been achieved on 965 islands for various taxonomic groups (see Keitt et al. 2011, http://diise.islandconservation.org/ ); however, snake eradication efforts are rare, and there is only one other documented ongoing effort to eradicate snakes from an island ( http://diise.islandconservation.org/ ). Additional technological and methodological advancements along with community engagement are still needed to achieve landscape-scale eradication of brown treesnakes on Guam. The aerial delivery system tools are operational, but full operational implementation of the aerial suppression program will require further understanding of site-specific effects of the technology and development of efficient monitoring protocols. Therefore, while technological advances to control brown treesnakes show promise as a tool, they currently do not control snakes to a level sufficient to allow the return of sihek to Guam before significant declines in the captive population of sihek are likely to occur, discussed further below. Thus, interim conservation measures for sihek are necessary to reduce its extinction risk while brown treesnake suppression and eradication methods are perfected and implemented.

In 1983, the Association of Zoos & Aquariums (AZA) initiated the Guam Bird Rescue Project in response to the widespread decline of Guam's native birds. Sihek was one of the Guam birds selected under this program for captive (ex situ) conservation efforts (Hutchins et al. in litt. 1996, p. 4). Between 1984 and 1986, 29 sihek were translocated from Guam to several zoos in the mainland United States. The program was established with the intent of being a short-term rescue but due to the continued presence of brown treesnakes on Guam, ultimately led to an ongoing breeding program. By 1990, the ex situ population increased to 61 sihek in 12 mainland zoos. Currently, an estimated 139 sihek are held at 25 AZA institutions and in a facility at the Guam Department of Agriculture's Division of Aquatic and Wildlife Resources (DAWR) (Newland, S., in litt. 2022a).

A Species Survival Plan Program for sihek, developed by the AZA, has been in place since 1986. In general, Species Survival Plan Programs are established to oversee the population management of species within AZA-accredited facilities. The plans typically include a population studbook and an annual breeding and transfer plan to ensure the genetic and demographic health of the population. The donor population is carefully managed through the Species Survival Plan Program to ensure the population's long-term viability.

Sihek are relatively difficult to manage in zoos because of their aggressive territorial behavior and moderately expensive diet. In addition, little forward progress toward a recovery program in the wild has led to few new institutions willing to hold or breed the species, which ultimately limits population growth. The small founding population, as well as the limited ability to increase the population beyond its current size, has serious implications for long-term survival of sihek.

Two separate population viability analyses (PVAs) demonstrated rapid declines in the population under current conditions (Johnson et al. in litt. 2015, p. 8; Trask et al. 2021, p. 6). Without changes to management practices that increase reproduction ( i.e., reproductive output stays the same), the sihek population is predicted to decline to below 100 individuals by the year 2040 (Johnson et al. 2015, p. 8); and with a slight decrease in reproductive output of just 7 percent, the population is projected to decrease to 25 individuals by 2040 (Johnson et al. 2015, p. 9). One of the PVAs incorporated an inbreeding coefficient into their models and demonstrated, among other things, a rapid decline in the population without an increase in reproductive output such that in 50 years the mean population size is projected to decline to approximately 30 individuals (Trask et al. 2021, entire). The ex situ population of sihek is therefore sensitive to even slight reductions in reproductive output and is at a heightened risk of extinction due to small population dynamics in their existing limited breeding and holding space. However, a small increase in average annual reproductive output (from 2.54 hatchlings per female per year to 2.70 hatchlings per female per year) could support long-term (50-year) sihek population viability as well as a release program (Trask et al. 2021, p. 6).

Breeding facilities for sihek are currently at capacity. Without the ability to release sihek, the species' population growth is constrained. The sihek's current small population size puts the species at risk from stochastic environmental events ( e.g., disease outbreaks in the ex situ population or changes in the ability of facilities to house and breed sihek) and demographic threats ( e.g., sex-ratio biases, as well as from genetic threats from increasing rates of loss of genetic diversity and accumulation of inbreeding). Further, maintaining the species entirely under captive environmental conditions puts the species at risk from genetic adaptations to captivity (Frankham 2008, entire). This situation could result in individuals having reduced fitness under wild conditions and could negatively impact the success of efforts to ultimately recover the species on Guam.

No efforts have been made to reintroduce sihek to its native range on Guam due to the continued presence of brown treesnakes, the primary threat that caused its extinction in the wild. Further, until recently, the ex situ population of sihek was not large enough to sustain a release program. Analyses have shown that, with captive management aimed at increasing reproductive output, the ex situ population can support the releases for an experimental population on Palmyra Atoll (Trask et al. 2021 p. 7).

The NEP area for sihek occurs outside the species' historical range and encompasses the 618 ac (250 ha) of emergent land distributed among the 25 islands that make up Palmyra Atoll (Collen et al. 2009, p. 712), and inclusive of the lagoons surrounding those islands. The islands vary in size from approximately 0.24 to 242 ac (0.1 to 97.9 ha). Palmyra Atoll is located in the Northern Line Islands, approximately 1,000 miles (1,609 km) south of Honolulu, Hawaii, and 3,647 miles (5,869 km) east of Guam (5°53′ N latitude, 162°05′ W longitude). Palmyra Atoll is considered a wet atoll with high humidity, typically greater than 90 percent, and temperatures between 75 and 81 °F (24-27 °C) and rainfall averages 175 inches (in) (444.5 centimeters (cm)) per year (Hathaway et al. 2011, p. 6), without a specific rainy season. Temperatures on Guam are slightly higher, ranging 75-90 °F (24-32 °C), with rainfall averaging 98 in (249 cm), with the greatest rainfall occurring between July and November ( https://www.weather-us.com/en/guam-usa-climate ).

The closest landmass is more than 144 mi (232 km) from Palmyra. Given this and the fact that sihek are an island endemic not known to undertake long-distance flights over open ocean, it is extremely unlikely that sihek would move outside of the NEP area and survive. Also, no other kingfisher species occur on Palmyra Atoll, thus all kingfishers on the atoll will be members of the NEP.

Palmyra Atoll is currently owned and managed by the Service, The Nature Conservancy, and the Cooper family. The majority of the islands (390 ac (158 ha)), waters, and the coral reefs surrounding Palmyra Atoll, up to 12 nautical miles to sea, are owned by the United States and managed by the Service as a National Wildlife Refuge. Palmyra Atoll National Wildlife Refuge was established in 2001 to protect, restore, and enhance migratory birds, coral reefs, and threatened and endangered species in their natural setting. The Nature Conservancy owns two islands, Cooper and Menge (226 ac (91.5 ha)), and cooperatively manages the atoll with the Service. Home Island (1.8 ac (0.71 ha)) is under private fractional ownership by the Cooper family, and the Service provides stewardship for this island, providing it the same protections as Refuge property (Kropidlowski, in litt. 2021). Palmyra Atoll is also part of the Pacific Remote Islands Marine National Monument, which was established in 2009 and is co-managed by the Service and the National Oceanic and Atmospheric Administration.

In late 2020, we established a recovery team for sihek whose purpose is to assist the Service in developing and implementing a conservation strategy for reestablishing sihek in the wild. Members of this team developed a phased approach whereby learning sites (sites used to test conservation translocation procedures as well as demographic and behavioral responses of target species) help achieve the overarching objectives of reducing global sihek extinction risk, while also refining techniques to establish viable wild populations on Guam. Based on habitat suitability, food resource availability, and willing partners, we have identified Palmyra Atoll as a learning site.

The best available scientific data indicate that the introduction of sihek into suitable habitat is biologically feasible and would promote the conservation of the species. Coarse-scale modeling indicated Palmyra could support up to 15 breeding pairs (Laws and Kesler in litt. 2011, p. 65). We evaluated the ecological suitability of Palmyra Atoll and concluded sufficient habitat conditions and food resources are available to support the small number of sihek needed for a temporary training site (USFWS unpublished data). No known predators of sihek occur on the Atoll. Further, we developed a release and monitoring program that includes interventions such as supplemental feeding if needed to increase the chances of survival. We assessed the potential environmental impacts of introducing sihek and designating the population as an NEP on Palmyra in an environmental assessment (USFWS 2023) (See National Environmental Policy Act section, below). To minimize risk to the ecosystem on Palmyra Atoll associated with the introduction, we will monitor for potential environmental impacts as part of the release program (see Monitoring and Evaluation, below).

The effects of Federal, State, or private actions and activities on Palmyra Atoll that are ongoing and expected to continue are not likely to adversely affect the sihek within the NEP area. Public access to Palmyra Atoll is extremely limited and available in only the following ways: (1) working for, contracting with, or volunteering for the Service or The Nature Conservancy; (2) conducting scientific research via Service special use permits; (3) invitation through the Service or The Nature Conservancy; or (4) by private recreational sailboat or motorboat. With prior approval by the Service, privately owned vessels are permitted to access the Palmyra Atoll National Wildlife Refuge. A maximum of two vessels are allowed at one time. Access to Cooper Island must be arranged and secured through The Nature Conservancy. Activities currently occurring in the NEP area, and those likely to occur, are not likely to impede the introduction effort. Current activities on Palmyra Atoll include an ongoing rainforest restoration project, operation of a research station, and limited recreation. The rainforest restoration project includes control of nonnative coconut trees, and opportunistic planting and seeding of native tree species. The Nature Conservancy manages a research station, and visiting scientists are required to obtain a permit from the Service to ensure compatibility with the mission of the Refuge. The Nature Conservancy also provides guided recreational activities (fishing, kayaking) to a small number of visitors to the Atoll. No significant development is planned on the Atoll for the foreseeable future.

This nonessential experimental population of sihek on Palmyra Atoll will promote the conservation and recovery of the species. The International Union for the Conservation of Nature's Guidelines for Reintroduction and Other Conservation Translocations (2013, p. 4) identifies several criteria to consider prior to undertaking a reintroduction, including “strong evidence that the threat(s) that caused any previous extinction have been correctly identified and removed or sufficiently reduced.” Although the basic habitat components required by sihek on Guam are still present, they have been made unavailable to sihek due to the ongoing and pervasive threat of brown treesnakes (see Recovery Efforts to Date ). Innovations in brown treesnake management show promise for controlling their populations at a landscape level but not within the time needed before we expect deleterious declines in the ex situ sihek population. The current captive-only sihek population is at high risk of extinction, and a moderate decline in reproductive output is likely to have long-term negative consequences on the survival probability for this species (see Captive-Breeding Efforts and Reintroduction ). The number of breeding institutions participating in sihek management is limited and declining (Newland in litt. 2021b), further increasing the risk of reduced breeding effort and its associated population decline. Advancements in brown treesnake control show promise for reintroducing sihek to its native range on Guam in the future and that remains a recovery goal, but current control methods are not likely to be able to eradicate this threat prior to substantial forecasted declines in the sihek population.

Introducing a species outside its historical range per our current regulation at 50 CFR 17.81 requires the Service to find that a species' primary habitat has been irreversibly altered or destroyed. While sihek's primary habitat on Guam has not been irreversibly altered or destroyed in perpetuity, we interpret the meaning of “irreversibly altered or destroyed” in the context of the unique conditions facing sihek and the very limited current alternatives to prevent its extinction. The habitat on Guam has been irreversibly altered and destroyed for a period of time meaningful to the survival of the species. The ex situ population of sihek is extremely vulnerable to rapid population decline and extinction risk under current reproductive conditions (Johnson et al 2015, p. 8, Trask et al. 2021, p. 6) such that increased reproductive output is paramount for population viability (Trask et al 2021, p. 7). Holding and breeding space at breeding institutions is limited, preventing growth of the ex situ population. Methods to control brown treesnakes on Guam are not sufficient to prevent significant predation on native bird species at this time and prevents us from releasing sihek there presently. Improvements in landscape-scale snake management are under development and are making incremental progress but will not be available for use prior to expected significant declines in the sihek population. Because of the immediate need to increase reproductive output and due to the continued presence of brown treesnakes on Guam, we find that sihek's habitat on Guam is irreversibly altered or destroyed for the purpose of this action, that is, until management of snakes at a landscape level makes it suitable for reintroduction and recovery.

We are releasing sihek onto Palmyra Atoll, which is outside its historical range, for the following purposes: (1) invigorate the ex situ conservation program to increase reproductive output by increasing breeding space at existing facilities and/or recruiting additional facilities to join the ex situ conservation program; and (2) develop and refine release and monitoring methods to be applied when reestablishing a population on Guam to recover the species. Release of sihek on Palmyra Atoll will improve the likelihood of successful reintroduction and recovery on Guam by: (1) providing the opportunity to develop and test release and monitoring techniques, (2) providing information on sihek's ability to survive in the wild, (3) assessing how much human intervention is required to support a wild population, (4) increasing the global population of sihek as an extension of the ex situ population as well as invigorating the breeding program, and (5) potentially serving as a source of wild-hatched birds for future releases on Guam or other sites.

When we establish experimental populations under section 10(j) of the Act, we must determine whether that population is essential or nonessential to the continued existence of the species. This determination is based solely on the best scientific and commercial data available. We consider an experimental population essential if its loss would be likely to appreciably reduce the likelihood of survival of that species in the wild (50 CFR 17.80(b)). We are designating the population of sihek on Palmyra Atoll as nonessential for the following reasons:

(1) No populations of sihek occur in the wild currently;

(2) the experimental population area is too small to support a self-sustaining wild population of sihek (Laws and Kesler 2011, p. 63) and is intended only as a temporary training site ( i.e., approximately 10 or more years) for us to improve release techniques, monitoring, and adaptive management for population establishment on Guam, when its habitat is available; and

(3) loss of the experimental population would not preclude other recovery options, including future efforts to establish sihek populations elsewhere.

In addition, we evaluated the potential impacts of the establishment of the experimental population on the ex situ population. Establishment of the experimental population will not affect the potential to establish a future, self-sustaining, wild population of sihek on Guam for the following reasons:

(1) The majority of the sihek population will remain in an ex situ population distributed among 25 facilities, where they are carefully managed according to the Species Survival Plan Program (Newland in litt. 2021a); and

(2) only a small number of individuals will be removed from the ex situ population for release on Palmyra Atoll, and these removals are expected to have minimal impact on the survival of the ex situ population (see Donor Stock Assessment and Effects on Donor Population, below).

As mentioned above in Importance of the NEP to Recovery Efforts, the introduction on Palmyra Atoll will further the conservation of sihek both in terms of improving the status of the ex situ population and in increasing the likelihood of success in establishing wild populations. In the near term, we anticipate that the introduction of sihek to Palmyra Atoll will invigorate the ex situ breeding program and result in more breeding space at existing facilities, more institutions joining the program, or both, ultimately resulting in a larger population if additional institutions join. Space is a limiting factor for this extinct-in-the-wild species, and demonstrating our continued efforts to recover it in the wild will likely increase interest in the species (Newland in litt. 2022b). In the longer term, the information gathered from observing the species under wild conditions, development of suitable release and monitoring methods, and assessment of how much human intervention might be needed to support a wild population will improve future release efforts. Lastly, wild-hatched sihek could be a complementary source, alongside captive-bred birds, for translocation to Guam or other sites.

Late-stage nestlings or recent fledglings will be flown to Palmyra Atoll where they will be held in release aviaries for up to 1 month. Three sets of three flight aviaries will be established across Palmyra Atoll at, or close to, locations where habitat appears most suitable. During this time, sihek will undergo acclimation and training to respond to supplementary feeding signals. Prior to release, all sihek will be fitted with a radio transmitter consistent with the Bird Banding Laboratory of North America's guidelines that transmitters be no more than 3 percent of a bird's body weight (Gustafson et al. 1997).

Release from aviaries will be via opening of a panel in the aviary wall to allow individuals to come and go freely. We will monitor each sihek daily, immediately after release and throughout their first year of release. Once released, sihek will be exposed to conditions in the wild that the species has not encountered in more than 30 years. While still being held in pre-release aviaries on Palmyra Atoll, we will provide natural prey items as much or as often as necessary so the sihek can learn to forage on multiple food sources. Further, sihek will be trained to come to feeders through reinforcement with a whistle, thus allowing for a way to provide supplemental food if needed. We will also conduct a thorough health assessment on each individual prior to release to ensure they are in good body condition. After release, we will monitor sihek daily, and if an individual is sick or injured, we may intervene and bring it back under human care temporarily.

After the first year, we may reduce the intensity of monitoring if few or no problems are observed. Sihek monitoring will cover a range of components, including general behavior (maintenance, foraging, locomotion, conspecific interactions); health (weights collected remotely at feeding stations, fecal samples, and semiannual capture and assessment); and breeding (pairing, territoriality, nest excavation, nest building, egg laying and clutch size, hatch date, nestling survival, and fledge success). Additional details of the release procedures are provided in the Sihek Management Plan (Andrews et al. in litt. 2022).

The donor population for the introduction of sihek to Palmyra Atoll is the ex situ population of sihek. This population is distributed among 25 breeding facilities in the U.S. mainland and on Guam (24 AZA institutions and 1 Guam Division of Aquatic and Wildlife Resources (DAWR) facility), with the population being managed through the Sihek Species Survival Plan Program (see Captive-Breeding Efforts ). The most recent population count documented 139 birds (Newland in litt. 2022a). The population size remains below the target of 200 individuals identified in the 2020 Species Survival Plan Program (Newland et al. 2020, p. 2) in large part due to limited holding capacity across the breeding facilities. Recent funding for the construction of another facility at Brookfield Zoo, as well as for the transfer to and maintenance of sihek at that facility, has allowed for growth of the population. The current Species Survival Plan Program coordinator is actively seeking additional AZA institutions to participate in the sihek breeding effort, and this solicitation will likely be aided by releases to Palmyra Atoll and the recent progress in recovery planning for the species.

Population models indicate that an increase in breeding ( i.e., production of hatchlings) is required to ensure the sustainable removal of individuals from the ex situ population for release to Palmyra (Johnson et al. 2015, p. 13, and Trask et al. 2021, p. 6). We have observed measurable population increases when there has been focused management to increase productivity in the ex situ population. Between 2004 and 2013, the sihek population increased from 61 birds to a peak of 157 birds because of increased reproductive output using multiple clutching (when a breeding pair is induced to produce more than one clutch of eggs per year by removing and artificially incubating the first clutch of eggs) (Newland et al. in litt. 2020, pp. 4-5). The best available information indicates that increasing ex situ reproductive output to rates seen between 2004 and 2013 is likely to support a release program on Palmyra without negatively impacting the long-term viability of the species (Trask et al. 2021, p. 6).

Only a small number of sihek will be removed from the ex situ population for release on Palmyra Atoll. We plan to remove up to 9 in the first year, and fewer than 9 in subsequent years, to ultimately achieve a target of 10 breeding pairs. The release cohort will consist of hatch-year sihek that will be reared under pathogen- and vector-free conditions. All individuals will be health-screened prior to release. Release cohorts will consist of sihek that are relatively unrelated to each other ( i.e., sihek with low mean kinship), and that have a relatively low individual inbreeding coefficient. In addition to genetic considerations for released individuals, retaining maximum genetic diversity within the ex situ population is a priority; therefore, individuals identified as genetically valuable ( i.e., with a low mean kinship coefficient, such that they are genetically underrepresented in the ex situ population) will be retained in the ex situ population. We will assess selection of individuals in release cohorts for follow up translocations based on both the sex ratio and genetics of the introduced population on Palmyra Atoll, as well as that of the donor population.

Species Survival Plan Program annual reports (see Captive-Breeding Efforts ) will continue throughout the releases and will be reviewed to ensure that removal of individuals for release will not be detrimental to the stability of the ex situ population. If negative impacts on the donor population are detected, we will pause releases while donor population health is improved. Given the careful management of the donor population, the ability to increase its productivity via multiple clutching, and the relatively small number of sihek that will be released annually, negative impacts to the donor population are expected to be minimal.

We will collaborate with Guam DAWR, Zoological Society of London, AZA, Palmyra Atoll National Wildlife Refuge, and The Nature Conservancy on releases, monitoring, coordination, and other tasks as needed to ensure successful introduction of the species to Palmyra Atoll. A few specific management considerations are addressed below.

Incidental Take: Experimental population rules contain specific prohibitions and may provide exceptions regarding the taking of individual animals under the Act. The specific prohibitions and exceptions we adopt in this final rule are compatible with most routine human activities anticipated in the NEP area ( e.g., resource monitoring, invasive species management, and research; see Importance of the NEP to Recovery Efforts, above). Section 3(19) of the Act defines “take” as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” “Incidental take” is further defined as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity. Incidental take of sihek within the experimental population area will be allowed, provided that the take is unintentional and not due to negligent conduct.

Special Handling/Intentional Take: Employees of the Service, Guam DAWR, The Nature Conservancy, Zoological Society of London, AZA facilities holding sihek, and authorized agents acting on behalf of the Service or these other entities may intentionally take sihek through handling sihek for scientific purposes; relocating individuals or bringing individuals into captivity for the purposes of increasing sihek survival or fecundity; aiding sick or injured sihek; salvaging dead sihek; disposing of a dead specimen; or aiding in law enforcement investigations involving the sihek. Any other person would need to acquire a permit from the Service for these activities.

Interagency Consultation: For purposes of section 7(a)(2) of the Act, section 10(j) of the Act and our regulations (50 CFR 17.83) provide that nonessential experimental populations are treated as species proposed for listing under the Act except on National Park Service and National Wildlife Refuge System lands, where they are treated as threatened species for the purposes of section 7(a)(2) of the Act. We will address our section 7(a)(2) consultation obligations for sihek within the Palmyra National Wildlife Refuge through a programmatic intra-Service consultation completed prior to releasing birds. Any activities outside of those analyzed in our programmatic consultation that may affect sihek within the NEP area will be addressed through future individual intra-Service section 7 consultations.

Public Awareness and Cooperation: On November 18, 2021, in cooperation with Guam DAWR, we engaged the Governor of Guam and constituents to inform them of our plans to introduce sihek to Palmyra Atoll. We coordinated closely with the co-manager of Palmyra Atoll (The Nature Conservancy) throughout the planning process, and we expect our coordination with them will continue through the duration of the project. We publicized availability of the proposed rule (87 FR 53429, August 31, 2022) and the opportunity for comment with a press release ( https://fws.gov/story/2022-08/usfws-proposes-experimental-population-sihek-palmyra-atoll ). We also sent letters to 14 conservation partners, notifying them of the availability of the proposed rule and requesting comments.

We will monitor the health, habitat use, behavior, foraging activity, movement, breeding, and survival of all sihek released and hatched at Palmyra Atoll. We will attempt to weigh sihek daily at supplementary feeding platforms with inbuilt scales. Passive collection of fecal material from these supplementary feeding platform visits will be screened for gastrointestinal parasite loads and examination of diet. We will attempt to capture individuals twice each year for a more thorough physical examination (weight, condition, ectoparasite load, feather fault bar analysis). During these captures, we will take a blood sample, which will be stored in ethanol for later diagnostics of blood parasites, and a blood smear made for visual examination of blood parasites and white blood cell count analysis. Further, we will collect a fecal sample opportunistically and a cloacal swab for later bacterial culture.

Once each sihek is released, we will track it and attempt to log its location at least once daily to document post-release movement patterns and territory establishment. Individuals will be located via radio transmitter tracking or visual searches. During observations, we will record behaviors including maintenance, perching, ingestion, excretion, locomotion, vocalizations, and interactions. We will record food items whenever feeding is observed in free-flying sihek.

We will attempt to closely monitor all breeding attempts to determine timing of pairing, nest building, egg laying and clutch size, hatch date, nestling survival, and fledge success. Unhatched eggs will be collected for analysis of fertility and embryo development. Recovered dead nestlings will be necropsied in the field and samples taken for later laboratory analysis for cause of death. Where possible, surviving nestlings will be weighed every third day throughout development until banding age. During banding, we will collect a range of samples as specified above for adult health sampling.

We will create a resighting history for each sihek released or hatched into the population. We intend to monitor sihek and their prey species with the full-time presence of staff on Palmyra, at least until intensive monitoring shows: (1) sihek are foraging independently and exhibiting behaviors typical of Todiramphus species; and (2) sihek are not having undesirable impacts on prey species populations (undesirable impacts are discussed further in the sections below). If the two situations described above occur, then we may reduce staffing to less than full time and monitor sihek and the environment less intensively. If undesirable impacts on prey species populations are not resolvable, we would evaluate whether this was an unacceptable impact requiring termination of the program. Unacceptable impacts are discussed below, in Exit Strategy.

As Palmyra Atoll is outside the native range of the sihek, introduction of sihek to Palmyra Atoll could have potential impacts on native species. The International Union for the Conservation of Nature, Species Specialist Commission, Invasive Species Specialist Group recognizes several different mechanisms of impact that introduced species (that others have sometimes called alien species) can have on native ecosystems (Pagad et al. 2015, pp. 130-132). These include impacts through predation, competition, hybridization, or transmission of disease-causing pathogens to native species (Blackburn et al. 2014, pp. 4-7).

To assess the potential impacts that sihek may have on Palmyra Atoll and the mechanisms through which these impacts may occur, researchers on the recovery team conducted an environmental impact assessment, based on the Environmental Impact Classification for Alien Taxa (EICAT) (Blackburn et al. 2014, entire) and the Generic Impact Scoring System (Nentwig et al. 2010, entire). This process involved consulting with a range of relevant experts (n=19), who were asked to provide their judgment on the level of impact that sihek may have through each potential impact mechanism. Impact levels were described in a range from the lowest level of “minimal,” where effects are negligible, to the highest level of “massive,” where impacts result in local extinction(s) and community-level changes are irreversible. We evaluated the relative risk of competition, hybridization, predation impacts, and disease transmission in an environmental assessment. Based on our analysis in the environmental assessment, we conclude there is no risk of competition or hybridization, and there are sufficient measures in place to prevent disease transmission from the introduction. In addition, the planned intensive monitoring will be sufficient to detect, and provide a timely response to, potential impacts of the sihek on the recipient ecosystem on Palmyra Atoll.

In the EICAT assessment, experts considered predation by sihek to be the most likely impact of sihek introduction to Palmyra (although the magnitude of this factor was judged to be moderate at most). The EICAT assessment experts' scoring generally assessed the introduction of a novel avian predator. Therefore, we will focus post-release environmental monitoring on potential sihek prey species that are native to Palmyra Atoll. We will obtain sihek diet information through behavioral observation and fecal samples, as described above (Release Procedures and Monitoring and Evaluation). This information will highlight major components of sihek post-release diet and help guide more focused monitoring.

At a minimum, we will coordinate with The Nature Conservancy and Palmyra National Wildlife Refuge to carry out annual monitoring on a range of suitable prey items, as described above. We will use the most appropriate survey methods for different taxa. If dietary and behavioral observations of released sihek suggest a particular prevalence and abundance of specific prey items that are of conservation concern, we will establish more frequent monitoring surveys. We will analyze post-release monitoring data to obtain estimates of abundance and density for reference taxa. These estimates will then be compared with pre-release monitoring data, collected in the weeks prior to release, with estimates from paired locations across the island in a before-after, control-impact experimental design. In the event we find estimated impacts to be unacceptably high, such as preferential prey selection for one species such that it has population-level effects, we will activate an appropriate response (see Exit Strategy, below).

Our present monitoring plan relies on a combination of targeted prey species surveys and information from existing monitoring of released birds. Our monitoring approach balances the negative impacts of frequent invasive surveys with the need to identify serious negative consequences of the sihek releases on the recipient site. Active monitoring will be for 2 years after the first release, and we will regularly assess results through monthly summaries, analyses at 6-month intervals, and annual predictive modeling. After the first 2 years, we will determine whether to continue at full intensity, reduce the intensity of our monitoring, or discontinue monitoring. Factors that will impact our decision making regarding monitoring include evidence of:

• Sihek prey selection for a single species, which could indicate population impacts to that species;

• detection of significant changes in abundance of prey in areas with sihek compared with areas without sihek; or

• shifts in community composition and diversity that differ significantly between areas with sihek and areas without sihek.

If any undesirable impacts are causally linked to the introduction of sihek, we will weigh the benefits and risks in consultation with the recovery team and The Nature Conservancy to determine whether to continue ongoing management, adopt risk mitigation strategies, or terminate the program (see Exit Strategy, below).

Annual reports summarizing monitoring and management activities will be developed by the Zoological Society of London in collaboration with the Service, The Nature Conservancy, and the Sihek Recovery Team.

Depending on the circumstances, the Service may either terminate or pause the release program to address identified issues before possibly resuming. These scenarios and the Service's expected response are detailed below.

The Service will terminate the release program on Palmyra Atoll if:

(1) Monitoring indicates the benefits from the Palmyra population (including learning and refining release and support strategies for eventual releases on Guam) no longer outweigh the risks to the species or the welfare of the NEP or ex situ population; or

(2) monitoring shows unacceptable impacts on the ecosystem that can be clearly causally linked to the introduction of sihek.

In addition to these “must terminate” scenarios, the Service may also terminate the release program:

(3) When the purposes of the program have been realized ( e.g., we have developed successful release and monitoring methodologies to apply to future release efforts or we have demonstrated sihek can survive and reproduce in the wild without human intervention, see Importance of the NEP to Recovery Efforts), although we do not anticipate this scenario until 10 or more years after the first release.

The Service may also temporarily suspend the program to address issues that arise before program termination under any of the three scenarios above. The monitoring team will summarize information they collect on a regular basis and will share it with the recovery team and the managers of Palmyra Atoll (the Service and The Nature Conservancy). If results indicate the program is approaching scenario (1) or (2) above, then the Service, in consultation with the recovery team and The Nature Conservancy, will determine if terminating the program is the best way to avoid these outcomes, or whether the program should be paused, and adaptive steps taken to address them before resuming the program.

Regular monitoring and reporting will also inform progress toward achieving program goals and scenario (3) above: The Service will determine—in consultation with the recovery team and The Nature Conservancy—when the purpose of the NEP has been achieved such that the program can come to an end. When the Service terminates the program, the Service will also address what will happen with any remaining individuals in the NEP, i.e., whether they will be relocated to captivity, relocated to other suitable habitat, or remain on Palmyra, based on the circumstances at the time of termination.

In the proposed rule published on August 31, 2022 (87 FR 53429), we requested that all interested parties submit written comments on the proposal by September 30, 2022. In addition, in accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and updated guidance issued on August 22, 2016 (USFWS 2016, entire), we solicited peer review of our proposed rule from six knowledgeable individuals with scientific expertise in conservation translocation, endangered species management, Pacific Island birds, and Guam native bird species. We received responses from three peer reviewers. We also contacted appropriate Federal and State agencies, local experts, and organizations, and other interested parties and invited them to comment on the proposal.

We reviewed all comments received from the public and peer reviewers for substantive issues and new information regarding the establishment of an experimental population of sihek on Palmyra Atoll. Comments on these issues and information are addressed in the following summary and have been incorporated into this final rule as appropriate. Changes other than minor word changes for clarification or correction incorporated into the final rule are summarized in the Summary of Changes from the Proposed Rule section, below.

All peer reviewers expressed support for the introduction of an experimental population of sihek with an associated 10(j) rule and agreed that the action is likely to contribute to the conservation of the species. Comments from peer reviewers resulted in updates in two areas of this final rule (see Summary of Changes from Proposed Rule).

(1) Comment: One peer reviewer indicated their support for establishing a 10(j) experimental population because of the negative consequences of maintaining a species solely in captivity, including risks associated with small population size and inbreeding depression.

Response: Recent population viability models (Johnson et al. 2015 in litt and Trask et al. 2021) have demonstrated rapid declines in the captive population if the reproductive rate remains the same. Breeding facilities are currently at capacity, and the sihek's population growth is constrained. The establishment of an experimental population of sihek on Palmyra Atoll will provide an opportunity to increase the sihek population, and to expose a portion of this population to habitat conditions in the wild for the first time in more than 30 years.

(2) Comment: Multiple reviewers commented that, at present, sihek habitat on Guam is compromised by the continued presence of brown treesnakes. They stated that, nevertheless, good progress is being made towards the eventual eradication of brown treesnakes such that future restoration of sihek to Guam remains an attainable goal.

Response: Reestablishing populations of sihek on Guam is an essential component of the recovery strategy for sihek, as expressed in the recovery criteria of the sihek recovery plan (USFWS 2008, pp. 42-43). We presently cannot release sihek within their historical range due to the continued presence of brown treesnakes. The establishment of an experimental population on Palmyra Atoll will allow us the needed testing of field techniques for the future reintroduction of sihek on Guam, once landscape-scale management of brown treesnakes is implemented and effective. In recent years, technological advances to control brown treesnakes show promise as a tool to control snakes at a landscape level. However, they are not yet sufficient to protect sihek from unsustainable predation, and therefore it is not possible to reintroduce sihek to Guam before significant declines in the ex situ population are expected to occur. Thus, the establishment of an experimental population on Palmyra Atoll helps reduce sihek extinction risk while brown treesnake control methods are refined and implemented.

(3) Comment: One reviewer stated that releasing sihek onto Palmyra Atoll as an experimental population is reasonable and scientifically sound. They went on to state that considerable work has been conducted to assess the suitability of Palmyra for Guam kingfishers, and to consider the possibilities of negative consequences to the fauna of Palmyra. The reviewer further stated that the process of introducing, managing, and monitoring sihek on Palmyra would provide invaluable knowledge for doing so eventually on Guam. As a result, the reviewer stated that the 10(j) experimental population of sihek will greatly increase the probability of success for a future Guam reintroduction.

Response: Introducing a species outside its historical range has inherent risks, both to the species and the ecosystem into which it is being introduced. We evaluated the extinction risk to sihek and determined the experimental population on Palmyra Atoll would further the species' recovery by increasing the worldwide population, developing and refining release techniques, and establishing a source of wild-adapted birds for future releases. We also evaluated the suitability of Palmyra Atoll for sihek through an assessment of prey availability and habitat suitability based on available information. We will monitor sihek and prey species to evaluate potential impacts to their populations. If negative changes in populations are causally linked to sihek and are undesirable, we will weigh the benefits and risks in consultation with the recovery team and The Nature Conservancy to determine whether to continue ongoing management, adopt risk mitigation strategies, or terminate the program (see Exit Strategy, above).

(4) Comment: One reviewer commented that successfully establishing a population of sihek on Palmyra would not only allow the species to exist in the wild again, allowing for beneficial behaviors and adaptations to be maintained, but would also be an important source of individuals for the reintroduction of sihek to Guam when conditions allow. Additionally, the process of introducing, managing, and monitoring sihek on Palmyra would provide invaluable knowledge for doing so eventually on Guam. Therefore, the reviewer stated that the 10(j) experimental population of sihek will greatly increase the probability of success for a future Guam reintroduction.

Response: The successful establishment of the experimental population on Palmyra will advance conservation and recovery of the species. .

(1) Comment: Several commenters shared their support for the proposed 10(j) experimental population as a first step toward recovering the sihek.

Response: In our efforts to further the conservation of sihek, we will learn valuable information that will inform future release efforts, including release techniques, behavior in wild conditions, and monitoring methods. We will also increase the number of sihek in existence and have a small population of wild birds to potentially help source future translocation efforts. Without the forethought of those who brought sihek into captivity and the effort of the institutions that have managed the populations during this time, the sihek would have been lost.

(2) Comment: One commenter noted the importance of involving CHamoru scientists and cultural practitioners in the development and implementation of the project.

Response: The Service values incorporating biological and cultural perspectives of the CHamoru people in sihek recovery efforts. At the beginning of translocation site selection and project development in 2019, the Service held a workshop on Guam to receive input and feedback from cultural leaders. The intent of the workshop was to acknowledge and better understand the significant connection the sihek has with the CHamoru people and their culture. We recognize that the release of sihek is about much more than saving a species. Given the sihek's cultural and biological importance to Guam, the Service developed several objectives for connecting with the community that are reflected in work plans that complement this 10(j) regulatory process under the Act. Throughout project planning, in coordination with our partners, we actively sought out local and indigenous community involvement. Today, the Service continues to work with the Guam DAWR, scientists, cultural practitioners, and the public as we collaborate to return the sihek back to the wild. At the time of introduction, due to limited transportation infrastructure and the distance of Palmyra Atoll from Guam, accommodating more local involvement or protocols may be challenging. The Service welcomes continued discussions with the CHamoru community to address scientific and cultural protocols for the sihek.

(3) Comment: One commenter noted the importance of an outreach program on Guam to increase awareness of sihek and to engender support for the establishment of an experimental population on Palmyra Atoll.

Response: A partner on Guam was awarded a nationally competitive grant to assist with Guam outreach efforts. It is a multifaceted, multiyear outreach program to be implemented prior to and concurrent with the Service's sihek release and monitoring projects. The program was developed by the Service's partners and Guam-based collaborators with expertise in science and education, as well as with CHamoru language and culture. This outreach will engage 40 teachers, train high school students, and engage more than 2,000 fourth-grade students in the first year. This program will also empower students and teachers to take action to protect the sihek and Guam's natural resources, while promoting an appreciation of the sihek's cultural significance. A CHamoru Sihek Storybook will be produced in the CHamoru language, along with a sihek activity book, and a website with updateable sihek resources and student contributions. A sihek-focused curriculum will be created and shared with teachers and students.

The outreach program is designed to increase awareness of the sihek's story: its threats, the status and importance of the sihek captive population, and future goals of the sihek recovery project. Expanding its reach beyond schools and with the public, the outreach program will share information at island-wide events and through local media and will enable the Service and its partners to showcase outreach milestones and successes.

(4) Comment: One commenter expressed concern about our proposal to decrease ecosystem and prey monitoring if we detect negligible impacts from the introduction of sihek and suggested that we further define “unacceptable” impacts.

Response: Many potential prey species occur on Palmyra Atoll, and we have relatively little knowledge about what sihek will preferentially feed upon after release, other than using general assumptions about prey size and Todiramphus biology. Detecting the impact of released sihek on prey species and the recipient ecological community is likely to require a relatively large sample size, replicated in space and time, to achieve sufficient statistical power. Our monitoring plan relies on a combination of targeted prey species surveys and information from monitoring released birds. Our monitoring approach balances the negative impacts of frequent invasive surveys with the need to identify serious negative consequences of the sihek releases on the recipient site. Active monitoring will occur for at least 2 years after the first release, and we will regularly assess results through monthly summaries, more in-depth analyses at 6-month intervals, and annual predictive modeling. After the first 2 years, we will determine whether to continue at full intensity, downscale, or discontinue monitoring.

In this final rule we have clarified that we will evaluate if impacts are undesirable relative to sihek predation on local species for purposes of our monitoring strategy based on the following factors:

• sihek prey selection for a single species, which could indicate population impacts to that species;

• detection of significant changes in abundance of prey in areas with sihek compared with areas without sihek; or

• shifts in community composition and diversity that differ significantly between areas with sihek and areas without sihek.

If any undesirable impacts are causally linked to the introduction of sihek, we will weigh the benefits and risks in consultation with the recovery team and The Nature Conservancy to determine whether to continue ongoing management, adopt risk mitigation strategies, or terminate the program (see Exit Strategy, above).

As to the commenter's request that we provide specific definitions for “unacceptable” impacts that require termination of the program, we are unable to define specific, quantitative parameters to do so. Rather, through our continued monitoring and coordination and consultation with the recovery team and The Nature Conservancy, we expect to keep ahead of any potential negative impacts to the ecosystem as a result of the introduction in order to adaptively respond before termination would be required.

(5) Comment: One commenter stated that the removal of eggs from the captive population would have a deleterious impact and increase extinction risk, particularly if the released individuals do not survive.

Response: We intend to introduce a small number of sihek to Palmyra Atoll: 9 individuals in the first year, with additional, likely smaller, cohorts of birds in subsequent years to reach a target population of 20 birds. Evaluation has shown that a small increase in the average annual reproductive output (from 2.54 hatchlings per female per year to 2.70 hatchlings per female per year) could support long-term (50-year) sihek population viability as well as a release program (Trask et al. 2021, p. 6). Further, we would remove eggs from captive-breeding pairs during incubation, and allow the pair to lay another clutch, thus replacing the birds removed from the ex situ (captive) population, which will—from a demographic standpoint—negate the loss of these individuals. The ex situ population is the only population of sihek in the world, so we will monitor it closely to ensure that there are no negative impacts to its viability and potential growth. We have included triggers for pausing or ending the release program; a negative impact to the ex situ population is one of the triggers for enacting one of those strategies.

(6) Comment: One commenter noted that the captive (ex situ) sihek population is small, and that measures will need to be in place to ensure the introduced population on Palmyra can survive.

Response: We recognize the importance of ensuring the integrity of the captive (ex situ) population of sihek and implementing measures to maximize the odds that the introduced population on Palmyra survives. Only a small number of sihek will be removed from the ex situ population (up to nine in the first year), and the best available information indicates the ex situ population can support this program without negative impacts to its viability. Once released on Palmyra, sihek will be exposed to conditions in the wild—conditions that the species has not encountered in more than 30 years. While still being held in pre-release aviaries on Palmyra Atoll, we will provide natural prey items as necessary so the sihek can learn to forage on multiple food sources. Further, birds will be trained to come to feeders through reinforcement with an associated sound, thus allowing supplemental food provisioning if needed. We will also conduct a thorough health assessment of each individual prior to release to ensure they are in good body condition. After release, we will monitor individuals daily. If a bird is sick or injured, we may intervene and bring it in under veterinary care as needed.

(7) Comment: One commenter was concerned that sihek might consume prey items with residual amounts of rodenticide from the 2011 eradication of rats from Palmyra Atoll.

Response: Amplification of toxicants through the food chain can be a concern in predator eradication programs. A study to evaluate potential impacts on Palmyra Atoll (Wegmann et al. 2019, entire) collected samples of numerous species, including potential sihek prey items, and tissue analyses showed no residue in invertebrates or geckos 3 years after the rat eradication. Thus, secondary exposure to rodenticide through consumption of exposed prey items is highly unlikely.

(8) Comment: One commenter expressed concern that sihek might consume prey items that have ingested rodenticides used to prevent rats from reinvading Palmyra Atoll.

Response: Rodents were eradicated from Palmyra in 2011, and efforts to reduce the likelihood of reintroduction include a limited use of rodenticide when planes or ships arrive at the Atoll. Rodenticide is applied only around the points of entry (runway and dock), and baits are contained within bait boxes (Wegmann in litt. 2022a). This application occurs for two days prior to a plane or ship arriving and remains in place for four days after the arrival of a plane and for 16 days after the arrival of a ship. The bait stations are monitored for rodent signs, and hermit crabs ( Coenobita brevimanus and C. perlatus ) on which sihek feed. The bait stations are placed on “crab-resistant” platforms to minimize entry by crabs, so very few crabs access the bait stations, and those that are found weigh generally around 2.8 oz (80g), which is well outside the size class of prey that sihek can take (Wegmann in litt. 2022b, Andrews et al. 2022, p. 19). Further, research showed no residue in invertebrates 3 years after the rat eradication (Wegmann et al. 2019). As a result, secondary exposure to rodenticide through consumption of exposed crustaceans is highly unlikely. If this unlikely scenario occurs, we will evaluate methods to further minimize such exposure risk ( e.g., improving the stations to further reduce the ability of crabs to enter), while balancing the need to prevent the reinvasion of Palmyra by rodents. We would also consider the use of non-toxicant biosecurity methods.

(9) Comment: Three commenters were concerned about potential predation of sihek by brown treesnakes on Palmyra Atoll.

Response: No brown treesnakes occur on Palmyra Atoll. Sihek released on Palmyra Atoll will not be exposed to any predation pressure as no known predators of sihek occur on the Atoll.

(10) Comment: One commenter was concerned with introduced sihek competing with other species on Palmyra Atoll, such as black drongo.

Response: Black drongos occur on Guam but do not occur on Palmyra Atoll.

No other native or nonnative species on Palmyra Atoll share the same diet or habitat preferences as the sihek. Thus, sihek will not directly compete with any species on Palmyra Atoll.

Comments received by the public and peer reviewers resulted in updates in two areas from the proposed rule to the final rule. In the final rule preamble, we:

• Provide more detail regarding how we will determine if releasing sihek on Palmyra Atoll will have undesirable impacts to prey species (see Ecosystem Impacts ); and

• Provide more detail regarding management of released sihek (see Release Procedures).

Based on the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that releasing sihek onto Palmyra Atoll with the regulatory provisions in this rulemaking will further the conservation of the species. We find that the continued presence of the brown treesnake on Guam means that sihek's native habitat has been unsuitably and irreversibly altered or destroyed for the foreseeable future such that the introduction of sihek to Palmyra Atoll outside of its probable historical range is warranted and consistent with our regulations at 50 CFR 17.81. We define the foreseeable future as the period of time before significant declines in the ex situ population of sihek are likely to occur. The nonessential experimental population status is appropriate for the introduced population; the potential loss of the experimental population would not appreciably reduce the likelihood of the survival of the species in the wild because there are currently no sihek remaining in the wild.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA 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. E.O. 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 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. 601 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. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that this rule does not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

The areas that are affected under this rule are restricted to Palmyra Atoll. Because of the regulatory flexibility for Federal agency actions provided by the NEP designation and the exemption for incidental take in the rule, we do not expect this rule to have significant effects on any activities within Federal, State, or private lands within the NEP area. In regard to section 7(a)(2) of the Act, the sihek population will be treated as proposed for listing, and, therefore, Federal action agencies are not required to consult on their activities, except on National Wildlife Refuge System lands, where the NEP will be treated as a threatened species for the purposes of section 7 of the Act.

Section 7(a)(4) of the Act requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed for listing. However, because the NEP is, by definition, not essential to the survival of the species, and no sihek exist in the wild outside of the NEP area that could be impacted, conferring will likely never be required for the sihek population within the NEP area. Furthermore, the results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. Section 7(a)(1) of the Act 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 NEP area. On National Wildlife Refuge System lands within the NEP area, the sihek would be treated as a threatened species for the purposes of section 7 of the Act. As a result, and in accordance with our regulations, some modifications to proposed Federal actions within National Wildlife Refuge System lands may occur to benefit the sihek, but we do not expect projects to be substantially modified because these lands are already administered in a manner that is compatible with sihek conservation.

This rule broadly authorizes incidental take of the sihek within the NEP area. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity, such as habitat management, infrastructure maintenance, and other activities in the NEP area that are in accordance with Federal, Tribal, State, and local laws and regulations. Intentional take for authorized data collection or recovery purposes by authorized personnel are also allowed under the NEP designation. Other forms of intentional take would require a section 10(a)(1)(A) recovery permit under the Act.

The only private landowners on Palmyra Atoll are The Nature Conservancy and the Cooper family. The principal activities on private property near the release site are associated with scientific field station operations, including the operation of a landing strip for aircraft, and some limited recreation. The presence of the sihek is not likely to significantly affect the use of lands for these purposes because no new or additional economic or regulatory restrictions will be imposed upon private landowners due to the presence of the sihek. Therefore, this rulemaking is not expected to have any significant adverse impacts to activities on private lands within the NEP area.

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

(1) This rule does 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 are not affected because the NEP designation does not place additional requirements on any city, county, or other local municipalities.

(2) This rule will 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). This NEP designation for sihek does not impose any additional management or protection requirements on the States or other entities.

In accordance with Executive Order 12630, the rule does not have significant takings implications. When introduced populations of federally listed species are designated as nonessential experimental populations, the Act's regulatory requirements regarding the introduced population are significantly reduced. This rule would allow for the taking of sihek when such take is incidental to an otherwise legal activity.

A takings implication assessment is not required because this rule: (1) Would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This 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, we have considered whether this rule has significant federalism effects and have determined that a federalism assessment is not required. This rule does 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 rule with the affected resource agencies in Guam. Achieving the recovery goals for this species will contribute to its eventual delisting. No intrusion on Territory policy or administration is expected, roles or responsibilities of Federal or Territory governments would not change, and fiscal capacity would not be substantially directly affected. The rule operates to maintain the existing relationship between the Territory and the Federal Government and is being undertaken in coordination with the Territory of Guam. We have coordinated closely with the Guam Department of Agriculture in the preparation of this rule. Therefore, this rule does not have significant federalism effects or implications to warrant the preparation of a federalism assessment pursuant to the provisions of Executive Order 13132.

In accordance with Executive Order 12988 (February 7, 1996, 61 FR 4729), the Office of the Solicitor has determined that this rule would not unduly burden the judicial system and meets the requirements of sections (3)(a) and (3)(b)(2) of the Order.

This 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 parts 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.

In compliance with all provisions of the National Environmental Policy Act of 1969 (NEPA), we have analyzed the impact of this final rule. In cooperation with The Nature Conservancy, we prepared an environmental assessment, and we determined based on that assessment that the proposed action of implementing the introduction of sihek to Palmyra Atoll will not have a significant impact on the environment, which we documented in a finding of no significant impact (FONSI) (USFWS 2023).

Executive Order 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no statement of energy effects is required.

A complete list of all references cited in this rule is available upon request from the Pacific Islands Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ) or online at https://www.regulations.gov in Docket No. FWS-R1-ES-2022-0061.

The primary author of this rule is Megan Laut of the Pacific Islands Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

Wendi Weber, Acting Director of the U.S. Fish and Wildlife Service, approved this action on February 13, 2023, for publication. On March 19, 2023, Martha Williams, Director of the U.S. Fish and Wildlife Service, authorized the undersigned to sign the document electronically and submit it to the Office of the Federal Register for publication as an official document of the U.S. Fish and Wildlife Service.

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