On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) (Pub. L. 116-136) was enacted to provide emergency assistance and health care response for individuals, families, and businesses affected by the coronavirus disease 2019 (COVID-19) pandemic. Section 1102 of the CARES Act temporarily permitted the Small Business Administration (SBA) to guarantee 100 percent of 7(a) loans under a new program titled the “Paycheck Protection Program,” pursuant to section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) (First Draw PPP Loans). Section 1106 of the CARES Act provided for forgiveness of up to the full principal amount of qualifying loans guaranteed under the Paycheck Protection Program (PPP).

On December 27, 2020, the Economic Aid to Hard-Hit Small Businesses, Nonprofits and Venues Act (Economic Aid Act) (Pub. L. 116-260) was enacted. The Economic Aid Act reauthorized lending under the PPP through March 31, 2021. The Economic Aid Act added a new temporary section 7(a)(37) to the Small Business Act, which authorizes SBA to guarantee additional PPP loans (Second Draw PPP Loans) to eligible borrowers under generally the same terms and conditions available under section 7(a)(36) of the Small Business Act through March 31, 2021. The Economic Aid Act also redesignated section 1106 of the CARES Act as section 7A of the Small Business Act, to appear after section 7 of the Small Business Act.

SBA, in consultation with the Department of the Treasury (Treasury), initially published an interim final rule implementing the PPP on April 15, 2020 and subsequently issued additional interim final rules. On January 14, 2021, SBA published interim final rules implementing the Economic Aid Act amendments to the PPP. 1 On February 5, 2021, SBA published an additional interim final rule implementing Economic Aid Act changes related to the forgiveness and review of PPP loans. 2 As described below, this interim final rule revises the consolidated interim final rule implementing updates to the PPP, the interim final rule on second draw PPP loans, and the consolidated interim final rule on loan forgiveness requirements and loan review procedures, to allow individuals who file an IRS Form 1040, Schedule C to calculate their maximum loan amount using gross income. This interim final rule also revises the consolidated interim final rule implementing updates to the PPP to remove the eligibility restriction that prevents businesses with owners who have non-financial fraud felony convictions in the last year from obtaining PPP loans and remove the eligibility restriction that prevents businesses with owners who are delinquent or in default on their Federal student loans from obtaining PPP loans. The changes apply to both First Draw PPP Loans and Second Draw PPP Loans.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Textron (type certificate previously held by Cessna Aircraft Company) Models 208 and 208B airplanes. The NPRM published in the Federal Register on September 22, 2020 (85 FR 59457). The NPRM was prompted by reports of loose elevator torque tube attach fasteners on low flight time Textron Model 208B airplanes. Textron identified a quality escape affecting certain serial-numbered Model 208 and 208B airplanes. Fastener holes in the inboard and outboard elevator torque tube connections may have been oversized and fasteners at the inboard and outboard torque tube connections may have been installed incorrectly.

In the NPRM, the FAA proposed to require repetitively inspecting the inboard and outboard elevator torque tube attachments for loose or incorrectly installed fasteners, replacing all fasteners if loose or incorrectly installed fasteners are found, and reporting the inspection results to the FAA. The NPRM also proposed optional actions to terminate the repetitive inspections. This condition, if not addressed, could result in failure of the elevator torque tube fasteners, leading to loss of elevator control and loss of controlled flight. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received no comments on the NPRM or on the determination of the costs.

The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed Task 27-30-00-290, Left and Right Elevator Torque Tube Attach Points (Borescope) Special Detailed Inspection, dated October 1, 2018, of the Cessna Model 208 Maintenance Manual (Task 27-30-00-290). This service information contains procedures for performing a detailed borescope inspection of the left and right elevator torque tube attach points. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

The FAA also reviewed Textron Aviation Mandatory Caravan Service Bulletin CAB-27-06, dated October 14, 2019 (CAB-27-06). This service information contains instructions for visually inspecting the left and right elevator torque tube attach points for the presence of loose rivets and replacing loose or incorrectly installed rivets.

Task 27-30-00-290 only specifies replacing loose fasteners. This AD requires replacement of all 48 fasteners if any single inboard or outboard elevator torque tube attach fastener is found loose or incorrectly installed. The FAA determined based on field evidence that identification of one loose fastener often indicates other fasteners may be affected.

CAB-27-06, which is not incorporated by reference in this AD, specifies performing an initial inspection within 800 flight hours or 12 months from date of receipt, whichever occurs first. This AD requires an initial inspection before the airplane accumulates 800 hours time-in-service (TIS) or within 200 hours TIS after the AD effectivity date, whichever occurs later.

CAB-27-06 also specifies, without sufficient data, that an inspection is not required for airplanes that have reached 4,000 hours. The FAA determined an inspection of high-time airplanes is necessary to verify whether these airplanes are affected. This AD requires a one-time visual inspection for airplanes that have already accumulated 4,000 hours TIS.

The FAA estimates that this AD affects 232 airplanes of U.S. registry.

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

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

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

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

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

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

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,

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

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

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

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0224R1, dated November 11, 2020 (EASA AD 2020-0224R1), to correct an unsafe condition for all Airbus Helicopters Model AS 350 B, AS 350 BA, AS 350 BB, AS 350 B1, AS350 B2, AS 350 D, AS 355 E, AS 355 F, AS 355 F1, AS 355 F2, and AS 355 N helicopters. EASA AD 2020-0224R1 revises EASA AD 2020-0224-E, dated October 16, 2020, to expand the list of serviceable parts (post-mod 075580).

This AD was prompted by two reports of large debonding of the T/R blade leading edge protection shields. According to EASA, the design and assembly procedure of the affected part (pre-mod 075580) is such that rapid debonding can occur if humidity/liquid water reaches the bonding surface between the leading edge and blade spar. The FAA is issuing this AD to prevent failure of the T/R blade, which could result in loss of tail rotor control and subsequent loss of control of the helicopter. See the EASA AD for additional background information.

EASA AD 2020-0224R1 specifies repetitively visually inspecting each T/R blade leading edge protection shield and repetitively tap inspecting each T/R blade leading edge. EASA AD 2020-0224R1 also prohibits the installation of an affected part and specifies a longer-term modification to replace each affected part with a serviceable part. EASA AD 2020-0224R1 states that replacing all affected parts with serviceable parts on a helicopter constitutes terminating action for the repetitive visual and tap inspections.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires accomplishing the actions specified in EASA AD 2020-0224R1, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD and except as discussed under “Differences Between this AD and the EASA AD.” Additionally, the owner/operator (pilot) may perform the required visual checks but must enter compliance with the applicable paragraph of this AD in the helicopter maintenance records in accordance with 14 CFR 43.9(a)(1) through (4) and 91.417(a)(2)(v). A pilot may perform these checks because they only involve visually checking affected T/R blade leading edge protection shields and bonding strips. This action can be performed equally well by a pilot or a mechanic. This check is an exception to the FAA's standard maintenance regulations.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2020-0224R1 will be incorporated by reference in the FAA final rule. This AD would, therefore, require compliance with EASA AD 2020-0224R1 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 the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2020-0224R1 that is required for compliance with EASA AD 2020-0224R1 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0095.

The EASA AD applies to all Model AS 350 B, AS 350 BA, AS 350 BB, AS 350 B1, AS350 B2, AS 350 D, AS 355 E, AS 355 F, AS 355 F1, AS 355 F2, and AS 355 N helicopters, whereas this AD applies to Model AS350B, AS350BA, AS350B1, AS350B2, AS350D, AS355E, AS355F, AS355F1, AS355F2, and AS355N helicopters with certain part-numbered T/R blades installed instead. This AD does not apply to Model AS 350 BB because this model is not FAA type-certificated. The EASA AD requires visually inspecting each T/R blade leading edge protection shield. This AD requires visually checking each T/R blade leading edge protection shield and bonding strip instead and allows a pilot to accomplish these visual checks. The EASA AD requires a longer-term modification of replacing each affected part with a serviceable part, whereas this AD does not. The FAA plans to publish a notice of proposed rulemaking to give the public an opportunity to comment on this longer-term requirement.

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

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 waiving notice and comment prior to adoption of this rule because the visual repetitive checks must be done before each flight and the initial instance of the repetitive tap inspections must be done within 30 hours time-in-service, a time period of up to about 1.5 months based on the average flight-hour utilization rate of these helicopters. Accordingly, the compliance time for the required actions is shorter than the time necessary for the public to comment and for publication of the final rule. Therefore, notice and opportunity for prior public comment are impracticable and contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated above, 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.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0095; Project Identifier MCAI-2020-01658-R” at the beginning of your comments. The most helpful comments reference a specific portion of the AD, 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 AD because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this 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 Kristi Bradley, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email kristin.bradley@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The 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 450 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Visually checking the T/R blades takes about 0.25 work-hour for an estimated cost of $21 per helicopter and $9,450 for the U.S. fleet, per inspection cycle. Tap inspecting the T/R blades takes about 0.5 work-hour for an estimated cost of $43 per helicopter and $19,350 for the U.S. fleet, per inspection cycle. Replacing a T/R blade takes about 12 work-hours and parts cost about $10,000 for an estimated cost of $11,020 per T/R blade.

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

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

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

For the reasons discussed above, I certify this regulation:

(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 issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to Robinson Model R66 helicopters with a T/R drive shaft assembly part number (P/N) D224-3 without B900-11 modification installed. The SNPRM published in the Federal Register on July 28, 2020 (85 FR 45360). The FAA preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on March 30, 2018 (83 FR 13706). The NPRM was prompted by two incidents of forward hanger bearing failure of the T/R drive shaft assembly because the bearing was undersized for its housing. Consequently, the bearing was spinning at a speed that caused excessive heating of the bearing during operation and led to the breakdown of the bearing's grease and ultimately seizure of the C647-16 bearing.

To correct this condition, Robinson initially issued R66 Service Bulletin SB-14, dated June 25, 2015 (SB-14), for certain serial-numbered helicopters, which specified installing a temperature recorder on the T/R drive shaft forward hanger bearing assembly and inspecting the temperature recorder during preflight checks and during each 100-hour inspection. If the bearing was found running hot, then Robinson advised upgrading the bearing to a newer design.

Following additional reports of overheating forward hanger bearing assemblies, Robinson superseded SB-14 with R66 Service Bulletin SB-20, dated November 7, 2016 (SB-20), which affected additional serial-numbered helicopters and specified modifying T/R drive shaft assembly P/Ns D224-3 and D224-4 by using kit Robinson KI-235 R66 TRDS Forward Yoke Assembly and Hanger Installation Kit Instructions, Revision A, dated June 23, 2015 (KI-235) and installing yoke assembly P/N D224-5. This installation has an improved, larger bearing that spins with less friction. SB-20 also specified inspecting the forward and aft sides of the hanger and damper bearings for a minimum of 0.5 inch in length of sealant on the junction of the black seal and bearing outer race and applying sealant if there was less than 0.5 inch in length of sealant.

Robinson revised SB-20 with R66 Service Bulletin SB-20A, dated June 6, 2017 (SB-20A), to clarify that helicopters with either T/R drive shaft assembly P/N D224-3 with modification B900-11 or P/N D224-4 installed include the upgraded bearing and do not require kit KI-235.

Robinson later revised SB-20A with R66 Service Bulletin SB-20B, dated December 20, 2017 (SB-20B), which updates writing practices and organizes the procedures into two separate sections, clarifies the “Rotorcraft Affected” section, and reduces the helicopters that need to perform the inspection and sealant application procedures to just helicopters without the latest version damper and housing bearings.

The NPRM proposed to require within 100 hours time-in-service (TIS) replacing an affected T/R drive shaft forward yoke assembly with T/R drive shaft yoke assembly P/N D224-5. The NPRM proposed to require inspections of the forward and aft sides of the hanger bearing and the damper bearing for sealant, and depending on the results of the inspections applying sealant. The SNPRM proposed to revise the NPRM by expanding the applicability, changing the proposed requirements, and correcting nomenclature. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA gave the public the opportunity to comment on the proposed rulemaking. The following presents the comments received on the SNPRM and the FAA's response to each comment.

Request: Robinson requested the FAA change the note to the Applicability paragraph to identify certain serial-numbered helicopters that had T/R drive shaft assembly P/N D224-4 installed during production and clarify that these helicopters are not affected by this AD. Robinson explained that the specified serial-numbered helicopters with T/R drive shaft assembly P/N D224-4 installed have the larger (hanger) bearing, which is not affected by this AD, and clarified that P/N D224-5 is a sub-assembly upgrade to P/N D224-4.

FAA Response: The FAA agrees and has revised that note in this final rule to identify the serial-numbered helicopters with T/R drive shaft assembly P/N D224-4 installed during production and clarify that this part-numbered T/R drive shaft assembly is not affected by this AD.

Request: Robinson requested that the FAA change the exception in paragraph (e)(1)(i) of this AD about not requiring the discarding of removed nuts and palnuts and stated that exception implies that the nuts and palnuts may be reused. Robinson explained that FAA Advisory Circular (AC) 43.13-1B Section 7-122 (d) specifies that these nuts should be discarded and referenced Robinson service information that specifies upgrading certain nuts any time maintenance is done. Robinson also stated that the KI-235 kit includes all required nuts and palnuts to replace discarded hardware.

FAA Response: The FAA disagrees. The FAA cannot require discarding of parts in an AD. Paragraph (d), section 7-122, of FAA AC 43.13-1B states that the removed nuts should never be reused and should be replaced with new ones when removed. Accordingly, the FAA has added language to the exception stating that this AD requires removing the affected parts from service.

The FAA has reviewed the relevant information, considered the comments received, and determined that an unsafe condition exists and is likely to exist or develop on other products of the same type design and that air safety and the public interest require adopting the AD requirements as proposed with the changes described previously. These changes are consistent with the intent proposed in the SNPRM for correcting the unsafe condition and will neither increase the economic burden on any operator nor increase the scope of the AD.

The FAA reviewed KI-235. This service information provides instructions for installing the newly designed yoke assembly, P/N D224-5.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA has reviewed SB-14, which specifies installing a temperature recorder on the T/R drive shaft forward hanger bearing assembly and inspecting the temperature during preflight checks and during each 100-hour inspection. If the temperature of the bearing is found running hot, then Robinson advises upgrading the bearing to a newer design (kit P/N KI-235). This service information also specifies adding a caution page to the Pilot Operating Handbook regarding the overheating bearing assemblies. This service information was superseded by SB-20.

The FAA has reviewed SB-20, SB-20A, and SB-20B, which specify upgrading the forward hangar bearing assembly of certain T/R drive shaft assemblies to the newer design with kit P/N KI-235 if not previously done. For certain installations, this service information contains procedures for inspecting for sealant and applying sealant to the damper and hanger bearings if needed to prevent seal rotation. This service information also specifies removing the caution page from the Pilot Operating Handbook regarding the overheating bearing assemblies that was added by SB-14.

SB-20 specifies replacing the yoke assembly and applying sealant to the bearing seals within the next 100 flight hours or by January 31, 2017, whichever comes first, and SB-20A and SB-20B continue the compliance time of no later than January 31, 2017. This AD does not have a calendar time compliance requirement. SB-20, SB- 20A, and SB-20B specify inspecting for sealant and applying sealant to the damper and hanger bearings if needed, while this AD does not.

The FAA estimates that this AD affects 290 helicopters of U.S. Registry. The FAA estimates that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.

Installing Robinson field kit KI-235 takes about 6 work-hours and parts cost about $950, for an estimated cost of $1,460 per helicopter. As an option, replacing an affected T/R drive shaft assembly P/N D224-3 with T/R drive shaft assembly P/N D224-4 takes about 5 work-hours and parts cost about $4,400, for an estimated cost of $4,825 per helicopter.

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

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

The FAA determined that this 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, I certify that this AD:

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

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

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

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

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0186, dated August 20, 2020 (EASA AD 2020-0186) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus Helicopters Model AS355E, AS355F, AS355F1, AS355F2, AS355N and AS355NP helicopters; and certain Model AS350B3 helicopters.

This AD was prompted by a report that, during an unscheduled post-flight inspection of the tail cone area of an Airbus Helicopters Model AS355NP helicopter, a crack was found in the spar of the upper part of the vertical fin and fractures were found in the two front attachment screws. Airbus Helicopters Model AS350B3 helicopters have a similar vertical fin configuration and are subject to comparable load levels as the affected Model AS355NP helicopter, therefore, this model may be subject to the same unsafe condition revealed on the Model AS355NP helicopter. The FAA is issuing this AD to address cracking in the spar of the upper part of the vertical fin and fractures in the front attachment screws. This condition could lead to in-flight separation of the upper part of the vertical fin, resulting in loss of control of the helicopter. See the MCAI for additional background information.

EASA AD 2020-0186 describes procedures for, among other actions, repetitive visual inspections of the right-hand side of the vertical fin spar for cracking and corrective action. The corrective action includes repair. EASA AD 2020-0186 also describes procedures for an optional modification, which terminates the repetitive inspections.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the aviation authority of another country, and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after evaluating all pertinent information and determining that the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

This AD requires accomplishing the actions specified in EASA AD 2020-0186, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD and except as discussed under “Differences Between this AD and the MCAI.”

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2020-0186 will be incorporated by reference in the FAA final rule. This AD would, therefore, require compliance with EASA AD 2020-0186 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 the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2020-0186 that is required for compliance with EASA AD 2020-0186 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0094.

Paragraph (2) of EASA AD 2020-0186 specifies doing repetitive cleaning and detailed inspections of the vertical fin spar and vertical fin upper attachments. The actions specified in paragraph (2) of EASA AD 2020-0186 are not required by this AD because the planned compliance time for those actions would allow enough time to provide notice and opportunity for prior public comment on the merits of those actions. The FAA is considering additional rulemaking to address the actions specified in paragraph (2) of EASA AD 2020-0186.

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

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 waiving notice and comment prior to adoption of this rule because cracking in the spar of the upper part of the vertical fin and fractures in the front attachment screws could lead to in-flight separation of the upper part of the vertical fin, resulting in loss of control of the helicopter. In addition, the initial inspection is required within 55 hours time-in-service, a time period of less than 3 months based on the average flight-hour utilization rate of these helicopters. Therefore, notice and opportunity for prior public comment are impracticable and contrary to 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.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0094; Project Identifier MCAI-2021-00100-R” at the beginning of your comments. The most helpful comments reference a specific portion of the AD, 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 AD because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this 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 Kathleen Arrigotti, Aviation Safety Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3218; email: kathleen.arrigotti@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The 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 650 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition action that would be required based on the results of any required or optional actions. The FAA has no way of determining the number of helicopters that might need this on-condition action:

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

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

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

For the reasons discussed above, I certify this regulation:

(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:

Authority for This Rulemaking

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 would modify the VOR Federal airway route structure in the eastern United States to maintain the efficient flow of air traffic.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2020-0941 in the Federal Register (85 FR 71292; November 9, 2020), modifying VHF Omni-directional Range Federal airway V-541 and removing V-49, in the vicinity of Decatur, AL. This will provide for the safe and efficient use of navigable airspace within the National Airspace System (NAS) while reducing NAVAID dependencies throughout the NAS as part of the FAA VOR Minimum Operation Network program. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently published in the Order.

This action amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020 and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this proposed rule. FAA Order 7400.11E 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 VOR Federal airway V-541 and removing V-49, in the vicinity of Decatur, AL, due to the planned decommissioning of the Decatur, AL, VOR/DME as part of the FAA VOR Minimum Operation Network program. The route changes are described below.

V-49: V-49 currently extends from the Vulcan, AL, VORTAC to the Nashville, TN, VORTAC. The airway is removed in its entirety.

V-541 : V-541 currently extends from the Gadsden, AL, VOR/DME to the Muscle Shoals, AL, VORTAC. The FAA straightens V-541 from the Gadsden VOR to the EDDIE intersection and removes the portion from the EDDIE intersection (INT Gadsden 318° T/316° M and Vulcan, AL, 029° T/027°M radials) to the Muscle Shoals VORTAC. This eliminates the dogleg that currently exists at AWPOJ, which is a Computer Notification Fix.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this action 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 modifying VOR Federal airway V-541 and removing V-49, in the vicinity of Decatur, AL, qualifies for categorical exclusion under the National Environmental Policy Act 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 cause 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. 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:

Authority for This Rulemaking

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 would modify the VOR Federal airway route structure in the eastern United States to maintain the efficient flow of air traffic.

The FAA published a notice of proposed rulemaking (NPRM) for Docket No. FAA-2020-0992 in the Federal Register (85 FR 70534; November 5, 2020), removing VHF Omni-directional Range Federal airway V-346 and V-400, in the vicinity of Beauce, Canada. NAV Canada has deleted the portions of both airways that resided in their airspace. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently published in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020 and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E 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 removing VOR Federal airway V-346 and V-4000, in the vicinity of Beauce, Canada, due to the planned decommissioning of the Beauce, Canada, VOR/DME navigational aid. The routes have already been removed by NAV Canada for those portions in Canada. The VOR Federal airway changes are outlined below.

V-346 : V-346 currently extends from Beauce, PQ, Canada, VOR/DME to Millinocket, ME, VOR/DME, excluding the airspace within Canada. The airway is removed in its entirety.

V-400: V-400 currently extends from Presque Isle, ME, VOR/DME to Beauce, PQ, Canada, VOR/DME, excluding the airspace within Canada. The airway is removed in its entirety.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and 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 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 proposed 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 removing VHF Omni-directional Range Federal airways V-346 and V-400, in the vicinity of Beauce, Canada, qualifies for categorical exclusion under the National Environmental Policy Act 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 cause 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. 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 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 D and Class E airspace at Four Corners Regional Airport, Farmington, NM, to ensure the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 78811, December 7, 2020) for Docket No. FAA-2020-1014 to modify the Class D and Class E airspace at Four Corners Regional Airport, Farmington, NM. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to the publication of the NPRM, the FAA discovered “The Proposal” section in SUPPLEMENTARY INFORMATION of the preamble for the NPRM contained incorrect verbiage. The section that discussed the Class E airspace designated as a surface area incorrectly stated “Within a 4.7-mile radius of Four Corners Regional Airport and within 1 mile each side of the Four Corners Regional ILS Localizer east course extending from the 4.7-mile radius to 5.6 miles east of the airport.”

However, the proposed regulatory text contained the correct verbiage which reads “That airspace extending upward from the surface within a 4.7-mile radius of the airport, and within 1.8 miles each side of the 086° bearing from the airport, extending from the 4.7-mile radius to 5.6 miles east of Four Corners Regional Airport.”

Class D, E2, and E5 airspace designations are published in paragraphs 5000, 6002, and 6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 modifies the Class D airspace at Four Corners Regional Airport, Farmington, NM. To properly contain IFR departures flying toward or over rising terrain an area is added to the eastern boundary of the Class D airspace.

This action also modifies the Class E airspace, designated as a surface area, to be coincident with the new Class D dimensions.

Additionally, this action modifies the Class E airspace extending upward from 700 feet above the surface. This airspace is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. The current configuration does not properly contain IFR aircraft performing instrument approaches to the airport. To properly contain IFR arrivals, the areas to the east and the west of the airport have been expanded.

This action also removes the Class E airspace extending upward from 1,200 feet above the surface. This area is wholly contained with the Denver en route airspace and duplication is not necessary.

Further, this action removes the Four Corners Regional ILS Localizer from the Class D and Class E2 text headers and airspace descriptions. The action also removes the Farmington VORTAC from the Class E5 airspace text header and airspace description. The navigational aids (NAVAIDs) are not needed to define the airspace. Removal of the NAVAIDs allows the airspace to be defined from a single reference point which simplifies how the airspace is described.

Lastly, this action implements several administrative corrections to the Class D, Class E2, and Class E5 airspaces' legal descriptions. This action removes the city name from the second line of Class D, Class E2, and Class E5 text headers. The legal descriptions for the Class D and Class E2 airspace contain the outdated term “Airport/Facility Directory.” this action updates the term to “Chart Supplement.” The airport's geographic coordinates in the Class D and Class E2 text headers do not match the FAA database; this action updates the geographic coordinates to “lat. 36°44′29″ N., long. 108°13′48″ W.”

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and 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, is non-controversial, and unlikely to result in adverse or negative comments. 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:

Authority for This Rulemaking

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 Mark Hoard Memorial Airport, Leoti, KS, to ensure the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 81167, December 15, 2020) for Docket No. FAA-2020-1072 to establish Class E airspace for Mark Hoard Memorial Airport, Leoti, KS. 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 designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 establishes Class E airspace extending upward from 700 feet above the surface at the Mark Hoard Memorial Airport, Leoti, KS. The airspace is designed to contain IFR arrivals descending below 1,500 feet above the surface, and IFR departures to 1,200 feet above the surface. The airspace contains the new instrument approach and departure procedures that were developed for the airport.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and 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, is non-controversial, and unlikely to result in adverse or negative comments. 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:

On February 10, 2021, President Biden signed Executive Order (E.O.) 14014, “Blocking Property With Respect to the Situation in Burma.” See 86 FR 9429 (Feb. 12, 2021). In E.O. 14104, the President declared a national emergency to address the threat posed to the United States by the situation in, and in relation to, Burma following a February 1, 2021 military coup, citing the military's overthrow of the country's democratically-elected government and arrest and detention of government leaders, human rights defenders, and journalists. See id. The United States had removed sanctions on Burma over the past decade based on progress toward democracy, and the reversal of that progress necessitated an immediate review of our sanction laws and authorities, followed by appropriate action. See President Biden's February 1, 2021 statement, available at https://www.whitehouse.gov/briefing-room/statements-releases/2021/02/01/statement-by-president-joseph-r-biden-jr-on-the-situation-in-burma/ .

In response to the February 1, 2021 Burmese military coup, on February 18, 2021, BIS took action under the Export Administration Regulations, 15 CFR parts 730-774 (EAR), and published a Federal Register notice announcing a more restrictive review policy for applications involving exports and reexports of items requiring a license under the EAR that are destined for Burma's military and security services and suspended the availability of certain license exceptions for items destined for Burma. See 86 FR 10011 (Feb. 18, 2021). Taken together, the measures set forth in the February 18, 2021 Federal Register notice and this final rule are consistent with recent actions taken by the Department of the Treasury's Office of Foreign Assets Control under E.O. 14104. Specifically, this rule: 1) moves Burma from Country Group B to the more restrictive Country Group D:1; 2) adds Burma to the countries subject to the national security licensing policy for certain military end uses and end users, and to the `military end use' and `military end user' restrictions; and 3) moves Burma from Computer Tier 1 to the more restrictive Computer Tier 3 in the (Computers) (APP) license exception.

As a general matter, during a four-year period following BIS's placement of Burma in Country Group B in December 2016, BIS did not maintain special controls on Burma. See 81 FR 94962 (Dec. 27, 2016). Applications for items requiring a license for export or reexport to Burma were generally subject to case-by-case review consistent with the licensing policies set forth in Part 742 and other applicable parts of the EAR. For purposes of License Exception Computers (APP) (Section 740.7 of the EAR) in August 2017, Burma was placed in Computer Tier 1, a relatively less-restrictive placement. See 82 FR 38764, 8/15/17.

Prior to December 2016, BIS had imposed more significant restrictions on exports and reexports to Burma as part of a broad U.S. Government-wide embargo in effect for nearly two decades that had restricted trade with or involving Burma under a national emergency declared by President Bill Clinton pursuant to Executive Order 13047 of May 20, 1997, in response to repression by the then-governing regime in Burma. This emergency was extended and expanded by Presidents George W. Bush and Barack Obama, who together issued five additional Burma-related Executive Orders. Between October 2007 and December 2016, Burma was located in Country Group D:1, Supp. No. 1 to Part 740 of the EAR. It was located in Computer Tier 3, a relatively restrictive placement, for purposes of License Exception Computers (APP) until August 2017. See 82 FR 38764, 8/15/17. BIS also maintained license requirements in part 744 (then § 744.22) ( see 72 FR 60248, October 24, 2007, as modified by 74 FR 770, January 8, 2009), for the export, reexport, or transfer (in country) of most items subject to the EAR, to persons listed in or designated pursuant to three of the Burma-related Executive Orders. Executive Order 13742 of October 7, 2016, terminated the national emergency declared in Executive Order 13047 and revoked that Executive Order and the other Burma-related Executive Orders.

Notwithstanding the EAR changes made following the October 2016 termination of the embargo, Burma continued to be located in Country Group D:3 (countries raising proliferation concerns related to chemical and biological weapons) and Country Group D:5 (U.S. arms-embargoed countries), consistent with § 126.1 of the International Traffic in Arms Regulations, 22 CFR parts 120-130.

On February 1, 2021, the Burmese military overthrew the democratically-elected government of Burma and detained President Win Myint and State Counsellor Aung San Suu Kyi and other parliamentarians affiliated with the National League for Democracy.

In response to this coup, as noted above, BIS issued a Federal Register notice effective February 18, 2021, adopting a more restrictive license application review policy of a presumption of denial for items subject to the EAR that require a license for export and reexport and that are destined for Burma's Ministry of Defense, Ministry of Home Affairs, armed forces, or security services. BIS also suspended the use of four license exceptions set forth in part 740 of the EAR that would otherwise have generally been available to Burma as a result of its Country Group B placement: Shipments of Limited Value (LVS) (§ 740.3); Shipments to Group B Countries (GBS) (§ 740.4); Technology and Software under Restriction (TSR) (§ 740.6); and Computers (APP) (§ 740.7).

This rule strengthens export controls on Burma consistent with the policy concerns described in BIS's February 18, 2021 notice. The actions in this rule support the United States Government's efforts to promote an immediate return to democracy in Burma, to underscore to Burma's security forces there must not be violence against civilians, and to stand in solidarity with the people of Burma, who continue to voice their desire for democracy, peace, and rule of law. In particular, this rule enhances the U.S. Government's efforts to ensure that items subject to the EAR are not available to Burma's military and security services. These measures also address the foreign policy and national security concerns that formed the basis for the issuance of E.O. 14104 of February 10, 2021.

The rule removes Burma from EAR Country Group B in supplement no. 1 to part 740 (Country Groups) and moves it into the more restrictive Country Group D:1. This action makes certain license exceptions or portions of license exceptions unavailable for Burma, or imposes conditions on the use of such license exceptions, including as follows:

• Shipments of Limited Value (LVS) (§ 740.3). This license exception is no longer available for Burma due to Burma's removal from Country Group B.

• Shipments to Group B Countries (GBS) (§ 740.4). This license exception is no longer available for Burma due to Burma's removal from Country Group B.

• Technology and Software under Restriction (TSR) (§ 740.6). This license exception is no longer available for Burma due to Burma's removal from Country Group B.

• Temporary Imports, Exports, Reexports, and Transfers (in-country) (TMP) (§ 740.9). Paragraph (b) (Exports of items temporarily in the United States) of this license exception places restrictions on shipments of national security (NS) controlled items to D:1 countries, and thus the provisions in paragraph (b) that would authorize exports of NS-controlled items to Country Group B (but not Country Group D:1) are no longer available for shipments destined to Burma.

• Servicing and Replacement Parts and Equipment (RPL) (§ 740.10). This license exception authorizes certain items to be returned to Country Group B ( see (a)(4) (Reexports), and (b)(3)(ii)(C) (return of defective or unacceptable equipment)). These two paragraphs are no longer available for the return of such items to Burma due to Burma's removal from Country Group B.

• Aircraft, Vessels, and Spacecraft (AVS) (§ 740.15). Paragraph (b) of this license exception authorizes exports and reexports of certain equipment and spare parts for permanent use upon a vessel or aircraft, except for vessels registered in a D:1 country or aircraft registered in, owned or controlled by, or under charter or lease to a country included in Country Group D:1, or a national of any of these countries. With the publication of this rule, Burma is a D:1 country, and restrictions in this paragraph are applied to exports for vessels registered in Burma, or aircraft registered in, owned or controlled by, or under charter or lease to Burma or a Burmese national. Paragraph (c) of this license exception authorizes certain exports to U.S. or Canadian vessels, planes and airline installations or agents except for exports to D:1 countries and for aircraft located in, or owned, operated or controlled by, or leased or chartered to a D:1 country. Burma is now subject to all D:1-related specified restrictions set forth in paragraph (c) of § 740.15.

• Additional Permissive Reexports (APR) (§ 740.16(j)). Paragraph (j) of this license exception authorizes certain reexports of nuclear non-proliferation controlled items except when also controlled for NS reasons when destined to a D:1 country. Burma is now a D:1 country and will thus no longer be eligible for reexports of NS-controlled items under this provision.

• Encryption commodities, technology, and software (ENC) (§ 740.17). Paragraph (b)(2)(iv)(B) of this license exception places restrictions on certain encryption technology exports to users in D:1 countries. These restrictions shall apply to users in Burma now, due to Burma's placement in Country Group D:1.

The restrictions on the export, reexport, and transfer (in-country) of certain microprocessors to military end uses and end users in Country Group D:1, pursuant to § 744.17 (Restrictions on certain exports, reexports, and transfers (in-country) of microprocessors and associated “software” and “technology” for `military end uses' and to `military end users'), apply to transactions to Burma now that it is in Country Group D:1 as a result of this rule. Furthermore, the restrictions in § 744.7 (Restrictions on certain exports to and for the use of certain foreign vessels or aircraft) on certain exports and reexports to vessels and aircraft located in ports in a D:1 country now apply to exports and reexports to Burma, and restrictions in that section that apply to aircraft located in, or owned, operated or controlled by, or leased or chartered to, Country Group D:1 or a national of such country, now apply to aircraft located in, or owned, operated or controlled by, or leased or chartered to Burma or a Burmese national. Finally, the addition of Burma to Country Group D:1 expands the applicability of § 736.2(b)(3), General Prohibition Three, by imposing licensing requirements for reexports of foreign-produced direct products of certain U.S.-origin technology and software to Burma.

Burma remains in Country Groups D:3 (countries raising proliferation concerns related to chemical and biological weapons) and D:5 (U.S. arms-embargoed countries). See supplement no. 1 to part 740 of the EAR.

As noted below, this rule adds Burma to the countries subject to the military end use and end user controls, and associated licensing policies, in § 744.21. This rule also adds Burma to the list of countries subject to the licensing policy in § 742.4(b)(7) (NS-controlled items) of the EAR. The license review policy for NS-controlled items in § 742.4(b)(7) applies to transactions with the other countries included in § 744.21, and now applies to Burma as well.

This rule adds Burma to the countries subject to the `military end use' and `military end user' (MEU) restrictions in § 744.21 of the EAR. In addition to the license requirements for items specified on the Commerce Control List (CCL), § 744.21 prohibits the export, reexport, or transfer (in-country) without a license of items subject to the EAR that are listed in supplement no. 2 to part 744—List of Items Subject to the Military End Use or End User License Requirement of § 744.21—to the People's Republic of China (China), the Russian Federation, or Venezuela, and with the publication of this rule, Burma, in certain circumstances. Such exports, reexports, or transfers (in-country) require a license if, at the time of the export, reexport, or transfer (in-country), the exporter, reexporter, or transferor (in-country) has “knowledge,” as defined in § 772.1 of the EAR that the item is intended, entirely or in part, for a `military end use,' or `military end user,' in Burma, China, the Russian Federation, or Venezuela. Applications submitted for the export or reexport to Burma, or transfer within Burma, of an item in supplement no. 2 to part 744 under this section will be reviewed with a presumption of denial.

This rule also adds a reference to Burma in supplement no. 7 to part 744—`Military End User' List but does not add any entities located in Burma to the list of Military End Users (MEU List) at this time. The MEU List notifies the public that certain entities are subject to the military end-user prohibitions in § 744.21 of the EAR. BIS may add entities located in Burma to the MEU List in the future.

This rule also corrects a typo in the last sentence of the introductory text to supplement no. 7 to part 744. The correction removes the phrase `supplement no. 2 to part 744' from the last sentence of the introductory text and adds in its place the phrase `supplement no. 7 to part 744'. Supplement no. 7 to part 744 is the correct supplement reference in the context of this sentence. With this correction, the last sentence correctly states that “. . . license application procedure and license review policy for entities specified in supplement no. 7 to part 744 is specified in § 744.21(d) and (e).”

This rule moves Burma from Computer Tier 1 to Computer Tier 3 under License Exception Computers (APP), § 740.7. This change limits the use of that license exception for exports and reexports to, or transfers (in-country) within, Burma. The placement of Burma in Country Group D:1 by this rule and movement of Burma into Computer Tier 3 supersedes the suspension of four License Exceptions announced as part of the February 18, 2021 notice, as the prior suspension was linked to Burma's placement at the time in Country Group B and in Computer Tier 1.

On August 13, 2018, President Donald J. Trump signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852) that provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute 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 final rule has been designated to be a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866.

2. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

3. Pursuant to section 1762 of the Export Control Reform Act of 2018 (50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

4. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

5. Notwithstanding any other provision of law, no person may be required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves a collection currently approved by OMB under control number 0694-0088, Simplified Network Application Processing System. The collection includes, among other things, license applications, and carries a burden estimate of 42.5 minutes for a manual or electronic submission for a total burden estimate of 31,878 hours. BIS expects the burden hours associated with this collection to not significantly increase with the publication of this rule.

Shipments of items that may no longer be made under No License Required (NLR) or license exception as a result of this action and were on dock for loading, on lighter, laden aboard an exporting or transferring carrier, or en route aboard a carrier to a port of export or reexport on April 7, 2021, pursuant to actual orders for export to Burma, reexport to Burma, or transfer (in country) within Burma may proceed to their destination under the prior authorization.

Accordingly, parts 740, 742, and 744 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

The Entity List (15 CFR, subchapter C, part 744, Supplement No. 4) identifies entities reasonably believed to be involved in, or to pose a significant risk of being or becoming involved in, activities contrary to the national security or foreign policy interests of the United States. The Export Administration Regulations (EAR) (15 CFR parts 730-774) impose additional license requirements on, and limit the availability of most license exceptions for exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License review policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document adding entities to the Entity List. BIS places entities on the Entity List pursuant to part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote. The Departments represented on the ERC have approved these changes to the Entity List.

BIS is making additions to the Entity List as part of a broader U.S. Government response to the February 1, 2021 coup by the military in Burma, which overthrew Burma's democratically-elected government, and the military's subsequent arrest and detention of government leaders, human rights defenders, and journalists. On February 10, 2021, President Biden signed Executive Order (E.O.) 14014, “Blocking Property With Respect to the Situation in Burma” (E.O. 14104) in which he declared a national emergency to address the threat posed to the United States by the situation in, and in relation to, Burma following the coup. See 86 FR 9429 (Feb. 12, 2021).

Since February 10, 2021, BIS has taken action under the EAR to strengthen export controls on Burma and address the foreign policy and national security concerns that formed the basis for the issuance of E.O. 14104. On February 18, 2021, BIS published a rule in the Federal Register adopting a more restrictive review policy of a presumption of denial for license applications involving items subject to the EAR that require a license for export and reexport and that are destined for Burma's Ministry of Defence, Ministry of Home Affairs, armed forces, or security services. The February 18, 2021 rule also suspended the availability in part or in full of four license exceptions in part 740 of the EAR for items destined for Burma. See 86 FR 10011 (Feb. 18, 2021). As part of an additional final rule, BIS imposed additional restrictions on Burma, including by removing the country from Country Group B, and placing it in the more restrictive Country Group D:1, and by adding it to the list of countries subject to defined `military end use' and `military end user' restrictions. See supp. no. 1 to part 740 and §§ 742.4 and 744.21 of the EAR.

In this rule, BIS is taking additional steps in response to the situation in Burma. BIS is adding four entities, including specifically identified aliases, to the Entity List under the destination of Burma: The Ministry of Defence, the Ministry of Home Affairs, Myanmar Economic Corporation, and Myanmar Economic Holdings Limited. The actions in this rule support the United States Government's efforts to promote a return to democracy in Burma. In particular, this rule enhances the U.S. Government's efforts to ensure that items subject to the EAR are not available to Burma's Ministry of Defence and the Ministry of Home Affairs, the entities responsible for the coup, or the two commercial entities owned and operated by the Ministry of Defence, Myanmar Economic Corporation and Myanmar Economic Holdings Limited, which provide revenue for the Ministry of Defence.

The departments represented on the ERC reviewed and applied § 744.11(b) (Criteria for revising the Entity List) in making the determination to add these four entities to the Entity List. Under paragraph (b), persons for whom there is reasonable cause to believe, based on specific and articulable facts, that they have been involved, are involved, or pose a significant risk of being or becoming involved in activities that are contrary to the national security or foreign policy interests of the United States, along with those acting on behalf of such persons, may be added to the Entity List. Paragraphs (b)(1) through (5) of § 744.11 provide an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States. For each of the four entities identified below, the ERC made the requisite determination based on the standard set forth in § 744.11(b). The four entities added to the Entity List in this rule are involved in activities that are contrary to the national security and foreign policy of the United States by being involved in, or supporting, the military coup in Burma.

For the four entities added to the Entity List in this final rule, BIS imposes a license requirement for all items subject to the EAR and a license review policy of presumption of denial. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule. The acronym “a.k.a.” (also known as) is used in entries on the Entity List to identify aliases, thereby assisting exporters, reexporters, and transferors in identifying entities on the Entity List.

For the reasons described above, this final rule adds the following four entities to the Entity List.

• Ministry of Defence;

• Ministry of Home Affairs;

• Myanmar Economic Corporation; and

• Myanmar Economic Holdings Limited.

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on March 8, 2021, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).

On August 13, 2018, President Donald J. Trump signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852) that provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). 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 determined to be not significant for purposes of Executive Order 12866.

Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications, and carries a burden estimate of 42.5 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule.

This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

Pursuant to section 1762 of the Export Control Reform Act of 2018, this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2020, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.

Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-084 for SENTINEL (lufenuron and milbemycin oxime) Flavor Tabs, NADA 141-204 for the SENTINEL Flavor Tabs and CAPSTAR (nitenpyram) Flea Management System, and NADA 141-333 for SENTINEL SPECTRUM (lufenuron, milbemycin oxime, and praziquantel) Chews to Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. Also, Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 has informed FDA that it has transferred ownership of, and all rights and interest in, A 200-348 for ECOMECTIN (ivermectin) Cattle Pour-On to Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. The animal drug regulations will be amended to reflect these changes of sponsor.

FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations:

• The entries in 21 CFR 510.600(c), 520.304, and 520.812 for Dechra Veterinary Products LLC are being amended to reflect the firm′s current drug labeler code.

• The entries in 21 CFR 510.600(c) for Cronus Pharma Specialities India Private Ltd. are being amended to reflect the firm's current address.

• Conditions for use in 21 CFR 520.100 for use of amprolium crumbles in calves are being removed because no approved NADA exists for this dosage form product.

• The regulations in part 526 (21 CFR part 526) for intramammary dosage form drugs are being amended to reflect a current format and improve readability.

• The section in part 529 (21 CFR part 529) for sevofluorane anesthetic gas is being redesignated to reflect a current organizational scheme for dosage form new animal drugs.

• Cross references in part 556 (21 CFR part 556) to related approved uses of new animal drugs are being amended as conforming changes to improve the accuracy of the regulations.

• The table in 21 CFR 558.4 is being amended to reflect the correct format for displaying assay limits for component drugs in fixed-ratio, combination drug Type A medicated articles and Type B and Type C medicated feeds.

• Three tabular entries in 21 CFR 558.68 are being amended to reflect the approved conditions of use of certain feed use combinations, which had been removed in error.

• Typographical errors are being corrected wherever they have been found.

This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. This rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of the conditions of use of an approved or conditionally approved new animal drug and the name and address of the drug's sponsor in a “notice, which upon publication shall be effective as a regulation.” A notice published pursuant to section 512(i) is not subject to the notice-and-comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act (21 U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).

This document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as follows:

The final regulations (TD 9926) that are the subject of this correction are issued under section 1446 of the Code.

As published, November 30, 2020 (85 FR 76910), the final regulations (TD 9926) contain an error that needs to be corrected.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

On November 6, 1991 (56 FR 56694), EPA designated and classified the following counties in the Atlanta Area as a Serious ozone nonattainment area for the 1-hour ozone national ambient air quality standards (NAAQS): Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Henry, Paulding, and Rockdale (the Atlanta 1979 1-hour ozone Area). TCMs were implemented in the 13 counties comprising the Atlanta 1979 1-hour ozone Area. Because the Atlanta 1979 1-hour ozone Area failed to attain the 1-hour ozone NAAQS by November 15, 1999, EPA issued a final rulemaking action (68 FR 55469) on September 26, 2003, to reclassify the area to a Severe ozone nonattainment area. Subsequently, the Atlanta 1979 1-hour ozone Area attained the 1-hour ozone NAAQS, and thus EPA redesignated the nonattainment area to attainment for the 1-hour ozone NAAQS. See 70 FR 34660 (June 15, 2005). The 1979 1-hour ozone NAAQS was revoked, effective June 15, 2005. See 69 FR 23951 (April 30, 2004).

On April 30, 2004 (69 FR 23858), EPA designated the following 20 counties in the Atlanta Area as a Marginal nonattainment area for the 1997 8-hour ozone NAAQS: Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Henry, Newton, Paulding, Rockdale, Spalding, and Walton (Atlanta 1997 8-hour ozone Area). The Atlanta 1979 1-hour ozone Area is a subset of this 20-county area. EPA reclassified the Atlanta 1997 8-hour ozone Area as a Moderate nonattainment area on March 6, 2008, because the area failed to attain the 1997 8-hour ozone NAAQS by the required attainment date of June 15, 2007. See 73 FR 12013. Subsequently, the Atlanta 1997 8-hour ozone Area attained the 1997 8-hour ozone standard, and on December 2, 2013, EPA redesignated the-Atlanta 1997 8-hour ozone Area to attainment for the 1997 8-hour ozone NAAQS. See 78 FR 72040. The 1997 8-hour ozone NAAQS was revoked, effective April 6, 2015. See 80 FR 12264 (March 6, 2015).

On May 21, 2012 (77 FR 30088), EPA designated the following 15 counties as Marginal nonattainment for the 2008 8-hour ozone NAAQS: Bartow, Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Henry, Newton, Paulding, and Rockdale (Atlanta 2008 8-hour ozone Area). The Atlanta 1979 1-hour ozone Area is a subset of the Atlanta 2008 8-hour ozone Area. The Atlanta 2008 8-hour ozone Area did not attain the 2008 8-hour ozone NAAQS by the attainment date of July 20, 2015, and therefore on May 4, 2016, EPA reclassified the area from a Marginal nonattainment area to a Moderate nonattainment area for the 2008 8-hour ozone standard. See 81 FR 26697. Subsequently, on July 14, 2016, EPA determined that the Atlanta 2008 8-hour ozone Area attained the 2008 8-hour ozone standard. See 81 FR 45419 (determination that the area attained the standard, also known as a Clean Data Determination). EPA redesignated the Atlanta 2008 8-hour ozone Area to attainment for the 2008 8-hour ozone NAAQS. See 82 FR 25523.

On October 26, 2015 (80 FR 65292), EPA revised the 8-hour ozone standard from 0.075 parts per million (ppm) to 0.070 ppm. Subsequently, on June 4, 2018 (83 FR 25776), EPA designated the following seven Atlanta counties as Marginal nonattainment for the 2015 8-hour ozone NAAQS: Bartow, Clayton, Cobb, Dekalb, Fulton, Gwinnett, and Henry (Atlanta 2015 8-hour ozone Area). The seven counties comprising the Atlanta 2015 8-hour ozone Area were also part of the 13-county Atlanta 1979 1-hour ozone Area. Areas designated as Marginal nonattainment must attain the standard by August 3, 2021. Although the attainment date is August 3, 2021, Marginal areas must show attainment using air quality data for years 2018 through 2020. Preliminary data indicates that the Atlanta Area will be able to attain the 2015 8-hour ozone NAAQS by the August 3, 2021, attainment deadline. 1

On September 16, 2019, Georgia submitted a SIP revision requesting removal of certain TCMs from the Georgia SIP. The following TCMs have been approved into the Georgia SIP: High Occupancy Vehicle (HOV) Lanes; High Occupancy Toll Lanes; Atlantic Station; Express Bus Routes; Improvements/Expansion of Bus Service; Park and Ride Lots; Transit Signal Preemption; Clean Fuel Buses; Clean Fuels Revolving Loan Program; Intersection Upgrade, Coordination and Computerization; ATMS/Incident Management; Regional Commute Options & HOV Marketing; Transportation Management Associations; Transit Incentives; and University Rideshare Programs. See 63 FR 23387 (April 29, 1998), 63 FR 34300 (June 24, 1998), 64 FR 13348 (March 18, 1999), 64 FR 20186 (April 26, 1999), 65 FR 52028 (August 28, 2000), 77 FR 24397 (April 24, 2012), and Table 1, Appendix A, Table 2-1 and Table 2-2 of Georgia's September 16, 2019, SIP revision. Georgia is requesting removal of all the TCMs that are approved into the SIP except for Intersection Upgrade, Coordination and Computerization.

Georgia's September 16, 2019, SIP revision includes a demonstration that two offset measures—school bus replacements and rail locomotive conversions—obtain the necessary emissions reductions to make up for the increases in nitrogen oxides (NO X ) and volatile organic compounds (VOC) emissions resulting from the TCM removals. Removing the TCMs will not worsen air quality because Georgia's offsets provided compensating, equivalent, and contemporaneous emissions reductions to negate the increases in emissions from NO X and VOC. More information on the offsets is provided below.

The Georgia Environmental Protection Division (GA EPD) has a school bus early replacement program and a locomotive conversion program. School bus replacement projects that were completed in 2018 using Diesel Emissions Reduction Act funding have resulted in NO X emissions reductions. Specifically, eighty-five older school buses (built in 1999-2005) in Fulton County were replaced with 2018 engine model year school buses. The Locomotive Conversion Program consists of two components in the Atlanta Area: (1) The conversion of three older Norfolk Southern Railway, Inc., traditional switcher locomotives into newly-available low emissions engine technology and (2) Norfolk Southern Railway, Inc.'s conversion of two switchers into “slugs” which are driven by electrical motors whose electricity is received from companion “mother” locomotives. The offsets available from both the school bus replacements and locomotive conversions total 38.85 tons per year (tpy) of NO X . As there are 31.99 tpy of equivalent NO X associated with removing the TCMs, the annual NO X decreases from the school bus replacements and locomotive conversions will offset the removal of the TCMs with 6.86 tpy excess NO X emissions offset that will remain available. As further detailed in EPA's June 30, 2020, notice of proposed rulemaking (NPRM), the school bus replacements and locomotive conversions were more than what was needed to compensate for the amount of NO X and VOC increases associated with removing the TCMs.

Georgia's September 16, 2019, SIP revision also included an update to the on-road emissions inventory and associated 2030 MVEBs due to the removal of the TCMs. The on-road emissions inventory and safety margin allocation for the year 2030 were updated but the MVEB totals themselves remained unchanged. See Table 1 below.

In the June 30, 2020, NPRM (85 FR 39135), EPA proposed to approve the September 16, 2019, SIP revision. The details of Georgia's submittal and the rationale for EPA's action are further explained in the NPRM.

EPA received three comments on the proposal. Overall, the commenters disagreed with EPA's proposal to approve removal of the TCMs from the Georgia SIP. EPA has summarized and responded to these adverse comments below.

Comment 1: A Commenter disagrees with EPA's proposal, asserting that Georgia EPD does not have “a very good reason for its request,” making the request seem “very arbitrary and capricious.” The Commenter goes on to discuss the expense to install the TCMs and the usable lifespans of the TCMs and questions the State's objective in removing the TCMs, while also acknowledging that EPA has “no purview” over the monetary costs of the TCMs. The Commenter mentions that there is not enough analysis to determine whether removal of the TCMs “will allow the state to meet [the] NAAQS” and questions the use of school bus fleets to offset the potential increase in emissions as a result of removal of certain TCMs from the SIP. Additionally, the Commenter mentions that the State failed to consider the increases in other pollutants such as carbon monoxide (CO) as a result of the retirement of the express bus fleets.

Response 1: EPA disagrees with the Commenter's assertions that this action is arbitrary and capricious and that there is not enough analysis to determine whether removal will allow the state to meet the NAAQS. With respect to the Commenter's assertion that Georgia EPD “does not have a very good reason for its request,” EPA notes that, with respect to SIPs, “each State is given wide discretion in formulating its plan,” so long as the revision is consistent with the applicable requirements of the CAA, including section 110(l). See Union Elec. Co. v. EPA, 427 U.S. 246, 250 (1976); see also Alabama Envtl. Council v. EPA, 711 F.3d 1277, 1280 (11th Cir. 2013), Sierra Club v. EPA, 939 F.3d 649, 673 (5th Cir. 2019), and Alaska Dep't of Envtl. Conservation v. EPA, 540 U.S. 461, 470 (2004). CAA section 110(l) provides that the Administrator cannot approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the CAA. Pursuant to section 110(k), EPA must approve a SIP revision that meets all applicable CAA requirements, including section 110(l).

In EPA's June 30, 2020, NPRM, the Agency provided specific analysis and rationale supporting its proposed approval of Georgia's September 16, 2019, SIP revision that demonstrates compliance with the CAA, including section 110(l). As Georgia is in nonattainment only for the 2015 8-hour ozone NAAQS, Georgia was only required to obtain offsets to ensure that the TCM removals would not affect attainment of the 2015 8-hour ozone NAAQS. Georgia provided a technical analysis including modeling showing that removal of the TCMs would not impact attainment or maintenance of any NAAQS, and that Georgia secured offsetting, contemporaneous, compensating, equivalent, emissions reductions for the 2015 8-hour ozone NAAQS. EPA reviewed Georgia's analysis and agrees with the methodology and the results. EPA is not aware of any information, and the Commenter did provide a demonstration or other information, that is contrary to EPA's analysis and proposed finding that Georgia's September 16, 2019, SIP revision complies with CAA section 110(l).

With respect to the offsets related to school buses, Georgia provided data and calculations regarding emission reductions attributable to school bus replacements in the September 16, 2019, SIP submittal, which was included in Georgia's 110(l) demonstration, and the Commenter did not provide any information indicating that these data and calculations are erroneous. 4 As discussed above and further in the June 30 2020, NPRM, the school buses are only a part of the emissions reductions that Georgia used to offset the increase in emissions due to the removal of the TCMs, and between the locomotive and school bus offsets, Georgia has secured more than enough offsets to support removal of the TCMs.

Although the Commenter asserts that Georgia failed to consider the increases in other pollutants due to the retirement of the express bus fleets, the Atlanta Regional Commission's (ARC)  5 activity-based modeling and Georgia's motor vehicle emissions modeling calculated the emissions associated with the removal of the TCMs pertaining to transit buses. Further, Georgia considered all pollutants in its analysis, but provided more detail with respect to pollutants that are likely to be increased due to the removal of the TCMs, specifically ozone and ozone precursors (NO X and VOCs). Additional discussion regarding VOCs, NO X , and particulate matter (PM) was included because VOC and NO X emissions are also precursors for PM, and NO X is also a precursor for nitrogen dioxide. The TCMs were not designed to reduce emissions of sulfur dioxide (SO 2 ), CO, and PM 10 , and do not reduce SO 2 , CO, and PM 10 emissions. See the June 30, 2020, NPRM for more detail.

With respect to the Commenter's assertions specific to CO, EPA disagrees. Removing the fleet of express buses as a TCM from the Georgia SIP will not cause a violation of the CO NAAQS. The transit bus fleet in the Atlanta area is mostly comprised of compressed natural gas and diesel, which have low CO emissions. Further, there has never been a designated CO nonattainment area in Georgia. Additionally, the current level of the CO NAAQS is 9 ppm on an 8-hour average and 35 ppm on a 1-hour average; the Atlanta Area's current design values for 2018-2019 are 2.0 ppm for the 8-hr average and 2.2 ppm for the 1-hour average, which equates to 78 percent and 94 percent below the standard, respectively.

Comment 2: A Commenter states that EPA should not remove the TCMs from the Georgia SIP, that removal of the controls will create an inconsistent regulatory environment that is contrary to the CAA, and that removal of the TCMs would give Georgia an unfair advantage. The Commenter also notes that the Georgia Department of Transportation (GDOT) issued a draft environmental impact statement (EIS) “for the Georgia SIPs” but that it was “delayed because of legal reasons.”

Response 2: EPA disagrees with the Commenter's assertions and is not clear on how the removal of the TCMs creates an inconsistent regulatory environment or gives Georgia an unfair advantage. The Agency notes that TCMs were adopted into the SIP as part of the State's discretion to implement measures to attain and maintain the NAAQS. The CAA requires each state to have a SIP, which is a federally-enforceable plan that identifies how the state will attain and maintain the NAAQS. As discussed previously, states have wide discretion in determining the control measures they choose to utilize in achieving and maintaining the NAAQS. A state has the option of revising its SIP so long as state and Federal requirements governing SIPs are met.

It is unclear from the comment how an EIS relates to this action or what draft EIS the Commenter is referring to. To the extent the Commenter suggests that the SIP or this SIP revision should have gone through an EIS process, EPA also disagrees. Generally, actions taken under the CAA are exempted from the National Environmental Policy Act of 1969 (NEPA), including this SIP action. See 15 U.S.C. 793(c)(1).

Comment 3: A Commenter contends that EPA cannot remove the TCMs from the Georgia SIP without “input and concurrence” from GDOT and the Georgia Department of Environmental Management. The Commenter goes on to assert that the SIP must be amended to ensure compliance with all Federal and state laws that address the construction of new facilities, the application of engineering standards, procedures or practices for new facilities, and must ensure the “highest level of protection,” specifically referencing the “Georgia Environmental Protection Act, as revised,” the CAA, and Federal requirements from the “Federal Aviation Act and Federal Motor Carrier Safety Improvement Act, as revised.”

Response 3: EPA agrees with the Commenter's assertion that Georgia's removal of the TCMs is subject to “input” from various agencies such as GDOT, and notes that the environmental agency for Georgia is GA EPD, the author of the September 16, 2019, SIP revision. Specifically, 40 CFR part 93 governs transportation conformity requirements pursuant to CAA section 176(c) and requires interagency consultation for certain actions. The interagency consultation process, set forth in 40 CFR 93.105, is a process in which Federal, state, and local jurisdictions consult on the status of air quality and transportation projects. The Atlanta interagency consultation group consists of transportation and air quality partners such as the Federal Highway Administration-GA Division, US EPA Region 4, GA EPD, GDOT, the ARC, Metropolitan Atlanta Rapid Transit Authority (MARTA), the Georgia Regional Transportation Authority, and several others. Before submitting the September 16, 2019, SIP revision requesting removal of the TCMs from the Georgia SIP, GA EPD consulted with the Atlanta interagency consultation group (which includes GDOT). None of the Atlanta Interagency Consultation partners expressed objection to the removal of the TCMs from the Georgia SIP.

In addition, EPA disagrees with the Commenter's other assertions. The removal of TCMs from Georgia's SIP does not involve the construction of new facilities. EPA's review and approval of SIPs is restricted to compliance with the CAA, rather than compliance with the Georgia Environmental Protection Act or the Federal Aviation Act and Federal Motor Carrier Safety Improvement Act. As discussed in more detail above and in the NPRM, states have discretion as to the contents of their plans, EPA must approve SIPs that meet the CAA requirements, and Georgia's September 16, 2019, SIP revision meets CAA requirements.

EPA is taking final action to approve Georgia's September 16, 2019, SIP revision to remove certain TCMs from the Georgia SIP that are applicable within the Atlanta Area. This approval updates Georgia's 2008 8-hour ozone standard Maintenance Plan, specifically the on-road emissions inventory and the associated 2030 MVEBs, and measures offsetting the emissions increases due to removal of the TCMs. EPA is also determining that this SIP revision will not interfere with any requirement concerning attainment or any other applicable CAA requirement.

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

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

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 7, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:

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 Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0665 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 May 7, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0665, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-10008-38), 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 9E8803) by IR-4, Rutgers, the State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.441 be amended by establishing tolerances for residues of the herbicide quizalofop ethyl convertible to 2-methoxy-6-chloroquinoxaline, expressed as quizalofop ethyl, in or on carinata at 1.5 parts per million (ppm); cottonseed subgroup 20C at 0.1 ppm; fruit, pome, group 11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13 07F at 0.1 ppm; fruit, stone, group 12-12 at 0.1 ppm; pennycress, meal at 2 ppm; pennycress, seed at 1.5 ppm; and sunflower subgroup 20B at 3 ppm. Additionally, the petition requested, upon approval of the above tolerances, to remove the existing tolerances in 40 CFR 180.441(a) in or on cotton, undelinted seed at 0.1 ppm and sunflower, seed at 1.9 ppm. That document referenced a summary of the petition prepared by AMVAC Chemical Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Two comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA corrected several tolerance definitions and is not establishing a tolerance on pennycress, meal, as proposed by the petitioner. The reasons for these changes are explained in Unit IV.D.

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 quizalofop ethyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with quizalofop ethyl follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a number of tolerance rulemakings for quizalofop ethyl, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to quizalofop ethyl and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological Profile. For a discussion of the Toxicological Profile of quizalofop ethyl, see Unit III.A. of the February 23, 2018 rulemaking (83 FR 8006) (FRL-9972-30).

Toxicological Points of Departure/Levels of Concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Unit III.B. of the December 1, 2016 rulemaking (81 FR 86581) (FRL-9950-89).

Exposure Assessment. Much of the exposure assessment remains the same, although updates have occurred to accommodate exposures from the petitioned-for tolerances. These updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C. of the February 23, 2018 rulemaking.

EPA's dietary exposure assessments have been updated to include the additional exposure from the new uses of quizalofop ethyl on brassica carinata; fruit, pome, group 11-10; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F; fruit, stone, group 12-12; and pennycress and the crop subgroup expansions for cottonseed subgroup 20C and sunflower subgroup 20B. The assessment used the same assumptions as the February 23, 2018 final rule concerning tolerance level residues and default processing factors for all processed commodities except sunflower oil, where an empirical factor was used.

Updated average percent crop treated values were used for the following crops that are currently registered for quizalofop-ethyl: Beans, green: 2.5%; canola: 5%; cotton: 1%; dry beans/peas: 15%; peas, green: 2.5%; soybeans: 2.5%; sugar beets: 1%; and sunflowers: 5%; and 100% crop treated for other registered and new uses of quizalofop ethyl.

Anticipated residue and PCT information. 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.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic 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 one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that Conditions a, b, and c discussed above 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 quizalofop-ethyl may be applied in a particular area.

Drinking water, non-occupational, and cumulative exposures. Drinking water exposures and residential (non-occupational) exposures are not impacted by the new uses, and thus have not changed since the last assessment. EPA's conclusions concerning cumulative risk remain unchanged from the February 23, 2018 rulemaking.

Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D. of the February 23, 2018 rulemaking for a discussion of the Agency's rationale for that determination.

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

An acute dietary exposure assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD: They are 92% of the cPAD for all infants less than 1-year old, the population subgroup with the highest exposure estimate. Quizalofop-ethyl is classified as a Category D chemical, i.e. “Not Classifiable as to Human Carcinogenicity;” therefore, quantification of chronic risks using a non-linear approach will adequately account for all chronic toxicity, including any potential carcinogenicity that would result from exposure. There are no registered or new uses of quizalofop ethyl that would result in residential exposure, therefore the aggregate risk estimates are equivalent to the chronic dietary (food and water) risk estimates and are not of concern.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to quizalofop ethyl residues. More detailed information about the Agency's analysis can be found at http://www.regulations.gov in the documents titled “Quizalofop-P-ethyl. Human-Health Risk Assessment in Support of the Proposed New Uses on Carinata, Pennycress, Pome Fruit (Group 11-10), Stone Fruit (Group 12-12), and Small Vine-climbing Fruit, Except Fuzzy Kiwifruit (Subgroup 13-07F); and Use Expansions for Sunflower and Cottonseed (Subgroups 20B and 20C)” in docket ID number EPA-HQ-OPP-2019-0665.

For a discussion of the available analytical enforcement method, see Unit IV.A. of the February 23, 2018 rulemaking.

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 has not established MRLs for quizalofop ethyl.

Although two comments were submitted to the docket in response to the May 8, 2020 Notice of Filing, only one specifically related to this tolerance action. The commenter requested that EPA deny IR-4's request for tolerances for quizalofop ethyl on cotton sunflower seeds out of a concern for the general health impacts of pesticides.

Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that the quizalofop ethyl tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.

The commodity definition for carinata has been revised to brassica carinata, seed; and brassica carinata, meal. The tolerance for brassica carinata, seed will be established at 1.5 ppm; and the tolerance for brassica carinata, meal will be established at 2 ppm. EPA is not establishing a tolerance for pennycress, meal as requested by the petitioner because the glucosinolates in pennycress meal restrict its use to a livestock feedstuff, not a human food. EPA's current practice is to set tolerances for livestock feedstuffs only if they are significant, which is not the case for pennycress meal.

Therefore, tolerances are established for residues of quizalofop ethyl convertible to 2-methoxy-6-chloroquinoxaline, expressed as quizalofop ethyl, in or on brassica carinata, meal at 2 ppm; brassica carinata, seed at 1.5 ppm; cottonseed subgroup 20C at 0.1 ppm; fruit, pome, group 11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.1 ppm; fruit, stone, group 12-12 at 0.1 ppm; pennycress, seed at 1.5 ppm; and sunflower subgroup 20B at 3 ppm. Upon establishment of the above tolerances, the established tolerances for cotton, undelinted seed at 0.1 ppm; and sunflower, seed at 1.9 ppm will be removed as they are superseded by the new tolerances on subgroups 20C and 20B, respectively.

This action establishes tolerances under FFDCA section 408(d) in response to petitions 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (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 tolerances 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:

On November 26, 2019, we published in the Federal Register (84 FR 65067) a proposed rule to remove Bradshaw's lomatium from the List of Endangered and Threatened Plants ( i.e., to “delist” the species). Please refer to that proposed rule for a detailed description of the Federal actions concerning this species that occurred prior to November 26, 2019.

In response to public comments and in the process of developing this final rule, we have made the following changes from our November 26, 2019, proposed rule (84 FR 65067):

• We added language in the final post-delisting monitoring plan to indicate that additional Bradshaw's lomatium populations may be visited upon occasion, as time and resources allow, to provide for a “spot check” on the status of additional populations that are outside of the 18 priority sites identified for regular visits during the post-delisting monitoring period. These abbreviated field visits may collect information through assessment of population abundance, photo points, and/or evaluation of management practices and habitat condition.

• We incorporated into the preamble to this final rule mention of the recently developed MOU among the U.S. Army Core of Engineers, the Bureau of Land Management, the Natural Resource Conservation Service and the Service, to provide for the long-term conservation of Bradshaw's lomatium, regardless of listing status.

• We made minor editorial changes in the preamble of this final rule, including revising our description of how we develop and implement recovery plans, adding additional discussion about which recovery criteria were met, inserting an updated description of our regulatory and analytical frameworks, updating our description of how we determine species status throughout all or a portion of the species' range, and making minor textual updates to our assessment of Bradshaw's lomatium's status throughout a portion of its range.

A thorough review of the taxonomy, life history, and ecology of Bradshaw's lomatium is presented in the document “Species Status Assessment Report for Bradshaw's lomatium ( Lomatium bradshawii (Rose ex. Math.) Mathias & Constance) Version 1.0” (SSA report) (Service 2018), which is available at http://www.regulations.gov in Docket No. FWS-R1-ES-2019-0013, under Supporting Documents. The SSA report documents the results of our comprehensive biological status review for Bradshaw's lomatium, and has undergone peer review. The SSA report does not represent any decision by the Service regarding the status of Bradshaw's lomatium under the Act (16 U.S.C. 1531 et seq. ). It does, however, provide the scientific basis that informed our most recent 5-year status review, which resulted in a recommendation that the species should be removed from the List. The SSA report also served as one of the bases for this final rule and our regulatory decision, which involves the further application of standards within the Act and its implementing regulations and policies.

In this final rule, we present only a summary of the key results and conclusions from the SSA report; the full report is available at http://www.regulations.gov, as referenced above.

Bradshaw's lomatium is a perennial herb in the carrot or parsley family (Apiaceae) that is endemic to wet prairie habitats in western Oregon's Willamette Valley and adjacent southwestern Washington. These seasonally wet habitats may be flooded in the spring, or have soils saturated at or near the surface due to factors such as heavy precipitation in winter and spring, flooding, and poor drainage. A high light environment is important for Bradshaw's lomatium to complete its life cycle and reproduce, as reduced sunlight is associated with lower flower and seed production (Alverson 1993, unpublished data). This species is often associated with tufted hairgrass ( Deschampsia cespitosa ), and frequently occurs on and around the small mounds created by senescent tufted hairgrass plants. In wetter areas, Bradshaw's lomatium occurs on the edges of tufted hairgrass or sedges in patches of bare or open soil. In drier areas, it is found in low areas, such as small depressions, trails, or seasonal channels, with open, exposed soils. Self-fertilization is rare in Bradshaw's lomatium (Kaye and Kirkland 1994, p. 8), indicating that pollinator-mediated outcrossing is required for reproduction. Over 30 species of solitary bees, flies, wasps, and beetles have been observed visiting the flowers (Kaye 1992, p. 3; Kaye and Kirkland 1994, p. 9; Jackson 1996, pp. 72-76). Bradshaw's lomatium does not reproduce asexually and depends exclusively on seeds for reproduction (Kaye 1992, p. 2), but does not maintain a persistent seed bank in the soil. Although some fruit survives in the soil for 1 year, the seeds are not viable (Kaye et al. 2001, p. 1376). Further information on the basic biology and ecology of Bradshaw's lomatium is summarized in the SSA report (Service 2018, entire).

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the List.

Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species, or to delist a species, is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.

There are many paths to accomplishing recovery of a species, and recovery may be achieved without all of the criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the definition of an endangered species or a threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all of the guidance provided in a recovery plan.

In 2010, we finalized the revised recovery plan for Bradshaw's lomatium (Service 2010). The recovery plan states that Bradshaw's lomatium could be considered for downlisting to threatened status when there are 12 populations and 60,000 plants distributed in such a way as to reflect the species' historical geographic distribution, when the number of individuals in the populations have been stable or increasing over a period of 10 years, when sites are managed to meet established habitat quality guidelines, when a substantial portion of the species' habitat is protected for conservation, and when populations are managed to ensure maintenance of habitat and to control threats.

The recovery plan states that, in addition to the criteria described above, Bradshaw's lomatium could be considered for delisting when there are 20 populations and 100,000 plants properly distributed, genetic material is stored in a facility approved by the Center for Plant Conservation, and post-delisting monitoring plans and monitoring agreements are in place. Given our current understanding of this species, the criteria addressing abundance, distribution, and site management and protection are the most important in assessing recovery. Accordingly, these criteria are the basis of our analysis of resiliency, redundancy, and representation, and the focus of the discussion that follows. The remaining two criteria have also been met; genetic material is preserved at the Institute of Applied Ecology seed bank, and post-delisting monitoring plans and agreements are in place (see Post-Delisting Monitoring).

To reflect the historical distribution of Bradshaw's lomatium, the species' range was divided into eight recovery zones (Southwest Washington, Portland, Salem West, Salem East, Corvallis West, Corvallis East, Eugene West, and Eugene East), and targets for number of populations and number of plants for each zone were established based on historical presence, to the extent known (Service 2010, pp. IV-1—IV-6, IV-31—IV-34).

Two of the recovery zones (Portland and Salem West) are within the range of Bradshaw's lomatium, but do not have population targets for the species based on a lack of historical occurrence data. These recovery zones were nonetheless retained because if any populations of Bradshaw's lomatium were to be discovered or introduced within these zones, they could be considered as contributing to the recovery criteria for the species (under the category “Additional Populations”).

The expression of recovery criteria in terms of population abundance, numbers of populations, and distribution across recovery zones reflects a foundational principle of conservation biology: That there is a positive relationship between the relative viability of a species over time and the resiliency, redundancy, and representation of its constituent populations (Shaffer and Stein 2000, pp. 307-310; Wolf et al. 2015, entire). To look at it another way, extinction risk is generally reduced as a function of increased population abundance (resiliency), numbers of populations (redundancy), and distribution or geographic or genetic diversity (representation). The recovery criteria laid out in the recovery plan for Bradshaw's lomatium were, therefore, informative for our review of the status of the species, as that analysis leans upon these measures of viability to assess the current and future status of the species (Service 2018, pp. 1-2).

The downlisting criteria for number and distribution of populations and numbers of plants were intended to help identify the point at which imminent threats to Bradshaw's lomatium had been ameliorated so that the populations were no longer in immediate risk of extirpation; the delisting criteria for number and distribution of populations and numbers of plants were intended to identify the point at which the species was unlikely to become in danger of extinction. In our analysis, only populations with moderate to high overall condition and with more than 200 plants were considered to have met the recovery criteria, as populations with lower overall condition or abundance were considered too high risk to be counted toward recovery. An estimated 11,276,253 plants in 17 populations meet this standard (Service 2018, p. 39, updated based on Wilderman 2018, entire), an increase from approximately 25,000 to 30,000 individuals in 11 populations at listing in 1988. An additional 1,361 plants, distributed among 7 populations, comprise the grand total number of known Bradshaw's lomatium plants. In total, 24 populations occur on 71 distinct sites that are owned by a mix of Federal, State, and local governments; nongovernmental organizations (NGOs); and private citizens. Multiple sites are considered to be part of the same population when those sites are within a defined pollinator flight distance of 3 kilometers (km) (2 miles (mi)) of each other. The current population estimate is the combined count data from all sites; for some sites the plant count was the result of a full census (54 sites), while for others it was derived by visual estimate or calculated from count subsamples that were then extrapolated over the total area of the site (17 sites). The increase in known populations and number of plants over time is due to a combination of population augmentation and introductions, improved habitat management, and increased survey effort across the range of the species. Bradshaw's lomatium has been the focus of concentrated recovery efforts since it was listed in 1988. We now estimate there are likely more plants across the range of Bradshaw's lomatium than we have accounted for because not all areas of suitable habitat within the range of the species have been surveyed, and recent visits to previously unsurveyed areas have resulted in the identification of formerly unknown populations ( e.g., Service 2018, p. 10).

In our SSA report, we evaluated and ranked the resiliency of each population of Bradshaw's lomatium using the following criteria: (1) Population size, (2) current habitat conditions, (3) protection of the site from development, and (4) site management to restore and maintain appropriate habitat condition. Using these criteria, each population was given a rank of high, moderate, or low condition (Service 2018, pp. 26-30). The resiliency score for each population incorporates the degree to which the primary threats to the species have been addressed at each site as well as recovery criteria (population size and habitat quality), site protection (addressing habitat loss), and site management (addressing woody encroachment and invasive species). For details on evaluation and ranking of population condition, see the SSA report (Service 2018, pp. 26-43).

The table below summarizes our current knowledge of the abundance and distribution of Bradshaw's lomatium relative to the downlisting and delisting criteria presented in the recovery plan for the species (from Service 2018, p. 39, updated based on Wilderman 2018, entire). Because the table below summarizes only the abundance and distribution data for the species, the information in the table must be considered in conjunction with the five-factor analysis of threats to arrive at the status determination for Bradshaw's lomatium.

Based on the most recent count, the number of plants counted towards recovery is 11,276,253, with an additional 1,361 plants occurring in populations with fewer than 200 individuals, which we did not count toward recovery. Of the total number of known plants, an estimated 10,790,658 occur in a single population in southwestern Washington. The other approximately 486,956 plants are within 23 populations in Oregon. If we consider only the populations in moderate or high condition, and with more than 200 plants ( i.e., those we are counting toward recovery and presented in the table), we estimate there are 485,595 plants within Oregon populations. These populations are distributed from southeast of Salem, Oregon, south to Creswell, Oregon, both east and west of the Willamette River. The greatest density of populations occurs in the southern portion of the Willamette Valley near Eugene, Oregon.

Therefore, the most recent counts of Bradshaw's lomatium identify nearly 500,000 individuals in 23 known populations across the historical range of the species in Oregon and distributed among 69 known sites under various types of land ownership. We considered the abundance and distribution of Bradshaw's lomatium without including the roughly 10.8 million individuals concentrated in a single population (made up of 2 sites) in southwestern Washington to ensure our evaluation considered the abundance and distribution of the species across its entire range and also to ensure our overall evaluation was not unduly influenced by this single extremely large population. Of the 71 known sites, 51 are in public ownership, are within a public right-of-way, or are owned by a conservation-oriented NGO. Of the 20 remaining sites, 9 are under conservation easement or are enrolled in the Service's Partners for Fish and Wildlife Program (Service 2018, pp. 30-35, 36, 38, Appendix A). The remaining 11 sites are on private lands and are not currently under any formal protection agreements.

The figure below shows the results of this assessment across the range of the species. Of the 24 known populations, 4 are in low condition, 9 are in moderate condition, 10 are in high condition, and 1 is in unknown condition due to a lack of data (Service 2018, pp. 36-39). Populations occur in all recovery zones that have population goals. As noted above, the Portland and Salem West Recovery Zones contain no known current populations, were not assigned specific targets by the Recovery Team, and have no documented historical occurrences of the species within them.

Based on this information, we conclude Bradshaw's lomatium is much more numerous than at the time of listing and is distributed throughout its known historical range. Across the 23 populations in Oregon, greater than 99 percent of known Bradshaw's lomatium plants are found on sites receiving some degree of protection from development such as public lands, conservancy lands, or private lands with conservation easements (Service 2018, Appendix A). Two sites in southwestern Washington collectively comprise the single largest population of the species with millions of plants. The vast majority of plants in the southwestern Washington population occur on private property that is not under formal protection, but over the years the site has been consistently managed in a manner conducive to supporting the largest population of Bradshaw's lomatium known. The other portion of the population in southwestern Washington, owned by the Washington Department of Natural Resources (WDNR), contains approximately 658 plants. The WDNR has been actively protecting, managing, and augmenting this smaller portion of the southwestern Washington population, and they are currently working to further expand protection at this site. Furthermore, the WDNR is working to conserve the sizeable Bradshaw's lomatium site that is on private land.

Due to ongoing threats from woody encroachment and the spread of nonnative, invasive plants, sites containing Bradshaw's lomatium require regular management to maintain the open prairie conditions that support robust populations. Management activities may include, but are not limited to, herbicide application, mowing, and prescribed fire. Although guarantee of management into perpetuity exceeds the requirements of the Act in evaluating whether a species meets the statutory definition of endangered or threatened, it is necessary to evaluate whether current and expected future management is sufficient to maintain resilient populations of Bradshaw's lomatium into the foreseeable future. Across the range of Bradshaw's lomatium, 75 percent of sites receive some form of management as described above, accounting for greater than 99 percent of known Bradshaw's lomatium plants. Sites receiving management span all ownership types. Rangewide, 58 percent of sites have a management plan with goals for the conservation of Bradshaw's lomatium, or with goals for maintenance of the wet prairie habitat upon which this species depends. Sites with management plans include those owned by the U.S. Army Corps of Engineers, Bureau of Land Management, the Service, The Nature Conservancy, and privately owned sites covered by the Natural Resources Conservation Service's Wetland Reserve Program (Service 2018, pp. 30-35, Appendix A).

Although not considered as a basis for this delisting, a memorandum of understanding (MOU) among the Bureau of Land Management, the Natural Resources Conservation Service, the U.S. Army Corps of Engineers, and the Service has been developed with the express purpose of providing for the long-term conservation and sustained recovery of Bradshaw's lomatium (Service et al. 2020, entire). Together these agencies own or manage at least 35 of the 71 known Bradshaw's lomatium sites. The MOU describes the ongoing commitment of the cooperating management agencies to maintain wet prairie habitats containing Bradshaw's lomatium populations at a sufficient quality to support the resilience of those populations, to the best of their abilities, irrespective of any change in the species' legal status and its standing under the Act. This MOU did not enter into our consideration of the delisting of Bradshaw's lomatium. However, it is added evidence of the strength of the ongoing collaborative efforts of conservation partners dedicated to the recovery of the native prairie species and ecosystems of the Willamette Valley.

These and other data that we analyzed indicate that most threats identified at listing and in the recovery plan are reduced in areas occupied by Bradshaw's lomatium. The status of the species has improved primarily due to: (1) Discovery of previously unknown populations; (2) reestablishment and augmentation of populations over the 30 years since the species was listed; (3) improvement in habitat management; and (4) an increase in protection from development.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an “endangered species” or a “threatened species.” The Act defines an endangered species as a species that is in danger of extinction throughout all or a significant portion of its range, and a threatened species as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects. We consider these same five factors in delisting (removal from the Federal Lists of Endangered and Threatened Wildlife and Plants) or downlisting (reclassification from endangered to threatened) a species (see 50 CFR 424.11(c) through (e)).

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term foreseeable future extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be downlisted or delisted under the Act. It does, however, provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket FWS-R1-ES-2019-0013 on http://www.regulations.gov.

To assess the viability of Bradshaw's lomatium, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency supports the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, large pollution events); and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate changes). In general, the more resilient and redundant a species is and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision.

In this discussion, we review the biological condition of Bradshaw's lomatium and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

We consider 25 to 50 years to be a reasonable period of time within which reliable predictions can be made for potential stressors and responses for Bradshaw's lomatium. This period of time is sufficient to observe population trends for the species, based on its life history characteristics, and captures the terms of many of the management plans that are in effect at Bradshaw's lomatium sites; it is also the length of time over which we conclude we can make reliable prediction about the anticipated effects of climate change. Although information exists regarding potential impacts from climate change beyond a 50-year timeframe, the projections depend on an increasing number of assumptions, and thus become more uncertain with increasingly long timeframes. We, therefore, use a maximum timeframe of 50 years to provide the best balance of scope of impacts considered versus the certainty of those impacts being realized.

At the time of listing, the primary threats to Bradshaw's lomatium were habitat loss due to land use conversion for agriculture or urbanization and the invasion of prairie vegetation by various woody plant species (53 FR 38449-38450; September 30, 1988). The listing rule did not find that overutilization for commercial, recreational, scientific, or educational purposes posed a threat to Bradshaw's lomatium. The listing rule noted that several parasitic organisms (a fungus, spittle bug, and two aphids) could potentially have negative effects on smaller, stressed populations of the plant (but not the species as a whole) and questioned whether inbreeding depression might pose a threat to the species since the populations known at the time appeared to be small and isolated from one another. The rule noted that further study was required to determine the significance of any such threats. Finally, the listing rule noted that State and Federal regulations existing at the time did not adequately protect the plant from habitat loss or other potential threats (53 FR 38450; September 30, 1988). By the time the recovery plan was developed in 1993, these same threats were still considered relevant (Service 1993, p. 12). There are three potential threats that were either not known or considered at the time of listing: (1) Competition from nonnative, invasive plant species; (2) potential impacts resulting from the effects of climate change; and (3) predation by voles ( Microtus spp.), which has been observed within Bradshaw's lomatium sites. Subsequently, we conducted a 5-year status review based on the SSA report for Bradshaw's lomatium that includes an analysis of all factors known to affect the viability of the species (Service 2018, entire).

As discussed in our 2018 SSA report, the threat of habitat loss from land conversion for agriculture and urbanization has decreased since the time of listing due to land protection efforts. Although a few privately owned sites are still at risk, land use conversion is no longer considered a significant threat to the viability of Bradshaw's lomatium due to the number of sites now receiving some degree of protection from development (Service 2018, pp. 36-39, Appendix A). In Oregon, which supports 23 of the 24 known populations of the species, greater than 99 percent of known Bradshaw's lomatium plants occur on sites protected through public or NGO ownership, through designation as a right-of-way, or by conservation easements on private lands. In Washington, one of two sites that support Bradshaw's lomatium is owned by the WDNR, and the State is actively working toward the conservation of the very large adjacent site that supports the majority of known individuals of the species. As the threat posed to Bradshaw's lomatium from habitat loss is no longer considered significant, we additionally no longer consider State or Federal protections to be inadequate to address this threat.

The present threat to Bradshaw's lomatium from modification of habitat due to invasion of prairies by nonnative, invasive plants and by woody species has been reduced in many populations due to active habitat management using herbicides, mowing, and prescribed fire, but ongoing habitat management is required to maintain these improvements. As noted above, across the range of Bradshaw's lomatium, 75 percent of the known sites receive active management that benefits the species, and 58 percent of total sites have a management plan in place with goals for the conservation of Bradshaw's lomatium, or for maintenance of the wet prairie habitat upon which it depends (Service 2018, pp. 36-39, Appendix A). Based on the high proportion of sites protected or managed, the history of positive management observed to date, and ongoing efforts to further restore and protect wet prairie habitats, we have confidence that management of Bradshaw's lomatium sites will continue to provide adequate protection to the species in the long term. This confidence is affirmed by the MOU committing to long-term conservation of Bradshaw's lomatium on Federal lands regardless of its listing status. We found no evidence that negative impacts due to parasitic organisms constitute a threat to the viability of Bradshaw's lomatium. Predation by voles appears to vary year to year, and can substantially reduce aboveground biomass and reproduction in years when vole abundance is high. However, the effect on populations is estimated to be minimal over time as long as there is sufficient time for Bradshaw's lomatium to regenerate taproot reserves between vole outbreaks (Drew 2000, pp. 54-55), and no consistent long-term declines attributable to vole predation have been reported (Service 2018, p. 20).

Concerns over the possibility of inbreeding depression expressed at the time of listing are now reduced due to a subsequent study indicating that overall genetic diversity in Bradshaw's lomatium is relatively high for a rare species (Gitzendanner and Soltis 2001, pp. 352-353), and is greater than that found in other rare Lomatium species (Gitzendanner and Soltis 2000, p. 787), although the most disjunct population in southwestern Washington showed relatively lower genetic diversity than less geographically isolated populations (Gitzendanner and Soltis 2001, p. 353). The threat of inbreeding depression is further considered reduced since we now understand Bradshaw's lomatium to be primarily an outcrossing species (which promotes increased genetic diversity), rather than an obligate self-pollinating species as was believed at the time of listing (Service 2018, pp. 7, 20).

The potential threat posed to Bradshaw's lomatium from the effects of climate change is difficult to predict. The primary threat to the species from the effects of climate change is likely reduced moisture availability due to warmer temperatures and alterations to precipitation patterns resulting in increased evapotranspiration (Bachelet et al. 2011, p. 414; Steel et al. 2011, pp. 43; Kaye et al. 2013, p. 18. The vulnerability of Bradshaw's lomatium to the effects of climate change, assessed over a range of potential future emissions scenarios, has been ranked as anywhere from low to moderate (Steel et al. 2011, pp. 25, 89) to highly vulnerable (Kaye et al. 2013, p. 20). Possible effects of climate change on Bradshaw's lomatium include increased reproduction after increased early precipitation, temporal shifts in life cycle completion to earlier in spring (earlier germination and seed set), increased mortality, and decreased recruitment (USFWS 2018, p. 43). We assessed the potential impacts of climate change on Bradshaw's lomatium projected out over a period up to 50 years in the future. Published assessments provide only qualitative appraisals of the potential response of Bradshaw's lomatium to the effects of climate change; therefore, we characterized a “worst case” future scenario in terms we could use in our analysis of future condition. In consultation with species experts and conservation partners, we defined the worst case scenario as one where increased mortality and decreased recruitment culminate in a 50 percent reduction of all populations. We considered this to be a conservative approach, in that the actual effects on populations size are likely to be more moderate. Even in the face of such a severe population reduction, the species is anticipated to remain viable as indicated by appreciable levels of resiliency, redundancy, and representation. We estimated that populations currently in low condition or with very low abundance may be extirpated due to the combined effects of climate change impacts and stochastic events; this translated to an estimated loss of up to five small populations, with other populations reduced in size. However, even with a presumed 50 percent reduction in abundance, at least 14 to 16 populations of Bradshaw's lomatium in moderate or high condition are expected to remain on the landscape with ongoing management. We do not anticipate any significant effect on representation, that is, the ability of the species to adapt to changing environmental conditions over time (Service 2018, pp. 42-46).

When multiple stressors co-occur, one may exacerbate the effects of the other, leading to effects not accounted for when each stressor is analyzed individually. The full impact of these synergistic effects may be observed within a short period of time or may take many years before they are noticeable. For example, high levels of predation on Bradshaw's lomatium during vole outbreaks can cause large temporary population declines but are not generally considered a significant threat to long-term viability; populations that are relatively large and well-distributed should be able to withstand such naturally occurring events. However, the relative impact of predation by voles may be intensified when outbreaks occur in conjunction with other factors that may lessen the resiliency of Bradshaw's lomatium populations, such as prolonged woody species encroachment; extensive nonnative, invasive plant infestations; or possible hydrological alterations resulting from the effects of climate change.

Although the types, magnitude, or extent of potential cumulative impacts are difficult to predict, we are not aware of any combination of factors that is likely to co-occur with significant negative consequences for the species. We anticipate that any negative consequence of co-occurring threats will be successfully addressed through the same active management actions that have contributed to the ongoing recovery of Bradshaw's lomatium and that are expected to continue into the future. The best scientific and commercial data available indicate that Bradshaw's lomatium is composed of multiple populations, primarily in moderate to high condition, which are sufficiently resilient, well distributed, protected, and managed such that they will be robust in the face of potential cumulative effects to which they may be exposed.

Overall, we conclude that under current conditions, most populations of Bradshaw's lomatium are resilient, because they have abundant numbers of individuals. There are redundant populations of Bradshaw's lomatium, meaning that multiple populations occur in most recovery zones, indicating that the species has the ability to minimize potential loss from catastrophic events. The concern at the time of listing about a possible genetic bottleneck has been alleviated by genetic studies demonstrating that Bradshaw's lomatium has relatively high genetic diversity for a rare species. Also, with populations distributed across the known historical range of the species (Service 2018, p. 40), Bradshaw's lomatium has likely retained much of its adaptive capacity ( i.e., representation). We also considered the potential future conditions of Bradshaw's lomatium, taking into account the current condition and additional stressors not considered at the time of recovery plan development ( e.g., the effects of climate change). Projecting 25 to 50 years into the future, under a conservative estimate that conditions could potentially worsen such that all existing populations are reduced by half, the species would retain its resiliency and redundancy. With an estimated 14 to 16 populations in moderate or high condition expected to remain on the landscape with ongoing management, representation was not anticipated to be affected (Service 2018, p. 44). As noted earlier, the degree to which threats to the species have been successfully addressed is incorporated into the evaluation of population resiliency at each site ( i.e., site protection and management actions were considered in the scoring of each population's current condition; Service 2018, p. 28). The continuation of these conservation measures was an assumption of our projection.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future condition of the species. Our assessment of the current and future conditions encompasses and incorporates the threats individually and cumulatively. Our current and future condition assessment is iterative because it accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.

See the SSA report (Service 2018, entire) for a more detailed discussion of our evaluation of the biological status of Bradshaw's lomatium and the influences that may affect its continued existence. Our conclusions are based upon the best available scientific and commercial data and the expert opinions of the species status assessment team members.

In the proposed rule published in the Federal Register on November 26, 2019 (84 FR 65067), we requested that all interested parties submit written comments on our proposal to delist Bradshaw's lomatium by January 27, 2020. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices inviting general public comment were published in The Oregonian. We did not receive any requests for a public hearing. All substantive information provided during the comment period has either been incorporated directly into this final rule or is addressed below.

We received three comments from the public on our November 26, 2019, proposed rule. One of these generally opposed the delisting of Bradshaw's lomatium but did not provide substantive comments to respond to or address. The remaining two provided substantive comments on the proposed rule or the draft post-delisting monitoring plan, and are addressed below.

Comment (1): One commenter expressed concerns that Federal delisting of Bradshaw's lomatium would likely result in a petition for State delisting as well, resulting in a potential threat from the inadequacy of regulatory mechanisms to require habitat maintenance for the species (Factor D). The commenter states that habitat management benefitting this conservation-reliant species may not necessarily continue after delisting, which would again expose populations of Bradshaw's lomatium to the threat of habitat degradation through encroachment of woody vegetation and nonnative plants. In particular, the commenter argued that if only 58 percent of total sites have a management plan with conservation goals for Bradshaw's lomatium or wet prairie habitat, a “worst case” future scenario could leave the remaining 42 percent of sites unmanaged, or under-managed, in terms of habitat maintenance. Overall, the commenter suggested that more measures are needed to formalize the commitment of landowners to continue Bradshaw's lomatium habitat management efforts to ensure habitat for the species remains protected from degradation following delisting, with particular emphasis on non-Federal public sites and the large population in Washington.

Our Response: Our evaluation of the level of protection and active management provided to populations of Bradshaw's lomatium, required to effectively ameliorate the threat of habitat degradation now and into the future, was one of our primary considerations in determining the appropriate status of the species. As described in the November 26, 2019, proposed rule (84 FR 65067) and in Appendix A of the SSA report, our information indicates that in Oregon, where 69 of the 71 sites of Bradshaw's lomatium are found, nearly 99 percent of Bradshaw's lomatium individuals now receive protection from further habitat loss and fragmentation due to land ownership by Federal, State, or other public entities, or by NGOs, or due to protections through management agreements or conservation easements on private lands. Nearly all of these management commitments are long-term or perpetual (61), and the short-term management agreements (8) are renewable. Of the 71 total known sites, 51 are in public ownership and 9 have either a conservation easement or Partners for Fish and Wildlife agreement in place. There are only 11 sites on privately owned lands without a formal agreement in place, but even without formal protections, several of these are managed such that they provide habitat for Bradshaw's lomatium, and they support relatively few plants overall. The 58 percent of sites with a management plan mentioned by the commenter refers only to those sites that have a plan specific to Bradshaw's lomatium or the maintenance of wet prairie habitat; even without such a plan, many of these sites do have management plans, and the majority of sites experience some degree of habitat protection and management that benefits the species, even if that benefit is incidental to, and not focused specifically on, Bradshaw's lomatium. Based on all of these considerations, we do not foresee a future in which it is likely that up to 42 percent of sites would be unmanaged or under-managed, as the commenter suggests.

The largest single population of Bradshaw's lomatium plants, located in southwestern Washington, is privately owned, and WDNR continues to actively pursue avenues for the perpetual conservation and management of this site. However, as noted above and as described earlier in this document, even without formal protections, the regular mowing that occurs at this site on a consistent basis year after year has provided for the most vast and robust population of the species known, the owners have voluntarily placed signs to alert the public to the presence of the plant, and the site faces no known threats.

The fact that the majority of Bradshaw's lomatium sites are in some form of public or NGO ownership, or under conservation easement or other agreement, gives us confidence that appropriate habitat management is likely to continue into the foreseeable future. The MOU committing to long-term conservation of Bradshaw's lomatium on Federal lands regardless of its listing status, recently developed by the U.S. Army Corps of Engineers, Bureau of Land Management, Natural Resources Conservation Service, and the Service, which collectively own or manage at least 35 of the 71 known Bradshaw's lomatium sites, further adds to this confidence (Service et al. 2020, entire). As noted above, this MOU did not enter into our consideration of the potential delisting of Bradshaw's lomatium. However, it offers further support for our confidence in the strength of the established conservation alliances for the preservation of prairie species and ecosystems in the Willamette Valley, and the likelihood that these efforts are likely to continue. Monitoring under the post-delisting monitoring plan (see our response to Comment (2), below) is designed to confirm that appropriate management continues and that degradation of habitat for the species does not follow delisting.

Details about the State of Oregon's criteria for delisting plants from the State Endangered Species List can be found in Oregon Administrative Rule (OAR) 603-073-0030. Under this OAR, when a plant is removed from the Federal list, it is not automatically removed from the State list, but must undergo review if delisting is initiated. This review process can take years. Removal from the State list is, therefore, not necessarily imminent. In addition, the habitat protections afforded listed plants by both Federal and State laws are limited. Under the provisions of both the Act and Oregon State law (see OAR 603-073-0090 and Oregon Revised Statute (ORS) 564.120), listed plants are protected by prohibitions from certain activities (for example, cutting, digging, damaging, destroying; transport and sale) but nothing in either law requires the maintenance of habitat for listed plants. We, therefore, would not expect State delisting of Bradshaw's lomatium to have much practical effect on the maintenance of habitat for the species or protection from habitat degradation.

After the protections of the Act no longer apply, we are planning for a 6-year post-delisting monitoring period to ensure Bradshaw's lomatium's status does not deteriorate. If a substantial decline in the species (numbers of individuals or populations) or an increase in threats is detected during that period, we will implement measures to halt the species' decline so that re-proposing it as an endangered or threatened species is not needed. The objective of the post-delisting monitoring plan is to verify that Bradshaw's lomatium remains secure from the risk of extinction after the protections of the Act have been removed. The plan is specifically designed to detect any significant declines in Bradshaw's lomatium populations, should any occur, with reasonable certainty and precision (see also our response to Comment (2), below).

Comment (2): One commenter expressed concerns that the draft post-delisting monitoring plan prioritizes monitoring of only 18 sites, or about 25 percent of all known sites, which could leave the status of most sites unknown and possibly allow a serious decline in critical populations to be missed. The commenter recommended including more sites, and choosing those sites based on their recovery value; including smaller, more vulnerable populations that play an important role in terms of species viability (redundancy or representation) as a priority for monitoring; and prioritizing sites for monitoring that lack management plans or are otherwise at high risk of being threatened following delisting. With regard to some of the smaller populations that are contributing to recovery, the commenter suggested that population trend information be presented in addition to measures of plant abundance.

In addition, this commenter suggested expedited site visits to additional lower priority sites after delisting. These visits could include collection of data that is informative but less time-consuming to collect, such as identifying whether management is continuing, identifying whether flowering plants are present, photo monitoring, and estimating population size-class.

Our Response: Monitoring a representative subsample of sites as outlined in the draft post-delisting monitoring plan will give us an early indication if declines are occurring or if threats such as habitat degradation are resurgent. Limited resources preclude our ability to completely survey all of the known Bradshaw's lomatium sites each year; thus, we endeavored to craft a post-delisting monitoring plan that would effectively capture trends in population size, habitat quality, and management direction across a representative sample of sites.

The 18 priority sites for post-delisting monitoring have been selected to represent the full geographic range of the species, a variety of ownerships (informative regarding habitat management; see below), and a range of population sizes. We specifically designed post-delisting monitoring to address whether, and what type of, management has occurred on the site in the previous year, as well as the ownership status of the site, precisely because Bradshaw's lomatium is a conservation-reliant species and is so dependent on appropriate habitat management. Conservation programs offered through the Service's Partners for Fish and Wildlife Program and various Farm Bill programs administered through the Natural Resources Conservation Service will continue to be available to private landowners for the long-term maintenance and protection of important Bradshaw's lomatium populations on private lands after the species is delisted. As described in the post-delisting monitoring plan, a 6-year post-delisting monitoring period will provide time for sites to undergo two to three management cycles, allowing monitoring efforts to identify potential deficiencies in management outcomes.

The sites chosen for monitoring include representation from all of the recovery zones across the range of the species, different land ownerships, and different population sizes (ranging from as few as 83 individuals to nearly 75,000). The monitoring history of sites was an important consideration in their selection for post-delisting monitoring; to the extent possible we chose sites that have already been monitored for long periods of time and have established population trends, which allows us to build on this existing data set and provides a more robust analysis of trend information post-delisting. The plan calls for post-delisting monitoring to follow methods previously used at each site so that reliable long-term trends can be determined based on standardized data collection.

Of the 18 sites, 4 are privately owned, and only 2 of those are without conservation and management agreements. Fourteen of the 18 sites are on Federal, State, municipal, or other conservation ownership with active management plans. The 18 priority sites are just that: The priority sites for monitoring. Additional sites may be monitored as resources allow, and the post-delisting monitoring plan specifically allows for future modification as needed or appropriate. We have incorporated the commenter's recommendation to add expedited site visits and abbreviated data collection at additional sites as time and opportunity allows, which would provide for an occasional check on the status of other Bradshaw's lomatium populations, into our final post-delisting monitoring plan.

Through the implementation of the post-delisting monitoring plan, the implementation of the aforementioned MOU, and the continued work of the various native plant work groups and conservation partnerships focused on the recovery of native plants, we conclude that sufficient monitoring is in place to detect any significant changes in the populations of Bradshaw's lomatium. If data show that the species is declining, or if one or more factors that have the potential to cause a decline are identified, we may continue monitoring beyond the 6-year period and modify the post-delisting monitoring plan based on an evaluation of the results, or reinitiate listing if necessary.

Section 4(g)(2) of the Act directs the Service to make prompt use of its emergency listing authorities under section 4(b)(7) of the Act to prevent a significant risk to the well-being of any recovered species. While not specifically mentioned in section 4(g) of the Act, authorities to list species in accordance with the process prescribed in sections 4(b)(5) and 4(b)(6) of the Act may also be used to reinstate species on the List, if warranted.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of “endangered species” or “threatened species.” The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. For a more detailed discussion on the factors considered when determining whether a species meets the definition of an endangered species or a threatened species and our analysis on how we determine the foreseeable future in making these decisions, please see Regulatory and Analytical Framework, above.

After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we found that the known range of Bradshaw's lomatium was considered dramatically reduced when we listed it as an endangered species in 1988; at that time, we estimated that there were 11 small populations that included a total of roughly 25,000 to 30,000 individuals. In addition, the species faced threats from habitat loss due to land conversion for agriculture and urbanization, as well as natural succession to woody species dominance due to loss of historical disturbance regimes. As such, the species was perceived to be upon the brink of extinction. Bradshaw's lomatium has been the subject of intensive recovery efforts since it was listed under the Act 30 years ago, and the discovery of new, previously unknown populations; success in augmentation and habitat restoration and management efforts; and the protection of Bradshaw's lomatium populations and habitats on public lands and on private lands through conservation easements and management agreements with NGOs and other parties have led to a significant reduction in threats and improvement in the status of the species since listing.

Recovery goals for delisting Bradshaw's lomatium were set at a minimum of 20 populations with a total of 100,000 individual plants distributed across the species' historical range. Under current conditions, 24 populations of Bradshaw's lomatium are distributed throughout the species' historical range; if we consider only those populations in high or moderate condition and containing at least 200 individuals as contributing to recovery, 17 such populations occur throughout the range of the species (see table, above). Considering only those 17 populations in high or moderate condition and with greater than 200 plants, the most recent counts demonstrate an estimated 485,595 known individuals are distributed throughout the historical range of the species (this count does not include the southwestern Washington population to ensure our evaluation was not unduly influenced by this single extremely large population).

Our analysis of current population condition on the basis of plant abundance, habitat quality, management, and protection from development resulted in rankings of 10 populations in high condition overall, 9 populations in moderate condition, and 4 populations in low condition. Therefore, we are significantly less concerned about small population sizes or limited distribution of the species than we were at the time of listing. The increase in known populations is due in large part to increased survey efforts and incidental discovery of more occupied habitat, leaving open the potential of finding even more populations of Bradshaw's lomatium in the future.

Acquisition by conservation NGOs, or enrollment into conservation easement programs, of sites containing Bradshaw's lomatium populations has substantially reduced the risk of habitat and population losses due to land use conversion (Factor A). In addition, population augmentation or introduction, combined with ongoing active management of woody encroachment and of nonnative, invasive plant infestations, has ameliorated the threat posed by these processes (Factor A) and increased the resilience of many Bradshaw's lomatium populations on protected sites. Other potential threats identified at the time of listing have either never materialized (parasitism by other organisms (Factor C), negative effects of inbreeding depression (Factor E)) or have been addressed through other means ( i.e., habitat protections and management, addressing Factor D).

Since listing, we have become aware of the potential for the effects of climate change (Factor E) to affect organisms and ecosystems, including potentially Bradshaw's lomatium. We considered the potential consequences of climate change and evaluated a range of future scenarios, including one with up to a 50 percent reduction in the size of all known populations across the range of the species. Even in the face of such a severe population reduction, the species retained appreciable levels of resiliency, redundancy, and representation such that we do not consider the effects of climate change to pose a threat such that it would place the species at risk of extinction in the future (Service 2018, pp. 42-46). To be conservative, our analysis of future conditions did not consider that ongoing efforts to improve population sizes and habitat quality have the potential to further increase the number of resilient populations of Bradshaw's lomatium. Many stressors to the species are being addressed through habitat management and population augmentation, but ongoing management is necessary to maintain resilient populations throughout the species' range.

In sum, significant impacts at the time of listing such as habitat loss due to land use conversion and woody encroachment that could have resulted in the extirpation of all or parts of populations have been either eliminated or reduced since listing. An assessment of likely future conditions, including the status of known stressors, management trends, and possible impacts of climate change, finds that although populations may decline in abundance, at least 14 to 16 populations across the range of the species are expected to maintain high or moderate resiliency over a timeframe of 25 to 50 years into the future (Service 2018, pp. 42-46). We, therefore, conclude that the previously recognized impacts to Bradshaw's lomatium from present or threatened destruction, modification, or curtailment of its habitat or range (specifically, habitat development for agriculture or urbanization and invasion of prairie vegetation by various woody plant species) (Factor A); disease or predation (specifically, parasitism by insects and predation by voles) (Factor C); the inadequacy of existing regulatory mechanisms (Factor D); and other natural or manmade factors affecting its continued existence (specifically, genetic isolation, inbreeding depression, and the effects of climate change) (Factor E) do not rise to a level of significance, either individually or in combination, such that the species is in danger of extinction now or likely to become so within the foreseeable future. Overutilization for commercial, recreational, scientific, or educational purposes (Factor B) was not a factor in listing and based on the best available information, we conclude that it does not constitute a threat to Bradshaw's lomatium now or in the foreseeable future. The Service recognizes that woody encroachment and nonnative, invasive plant species are stressors with ongoing impacts to Bradshaw's lomatium, but finds that current and expected trends in site protection and habitat management are sufficient to prevent these stressors from constituting a threat to the species such that it would meet the definition of an endangered species or a threatened species. Thus, after assessing the best available information, we determine that Bradshaw's lomatium is not in danger of extinction now or likely to become so in the foreseeable future throughout all of its range.

Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. Having determined that Bradshaw's lomatium is not in danger of extinction or likely to become so in the foreseeable future throughout all of its range, we now consider whether it may be in danger of extinction or likely to become so in the foreseeable future in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is significant, and (2) the species is in danger of extinction now or likely to become so in the foreseeable future in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range. In undertaking this analysis for Bradshaw's lomatium, we choose to address the status question first—we consider information pertaining to the geographic distribution of both the species and the threats that the species faces to identify any portions of the range where the species is endangered or threatened. We considered whether the threats to Bradshaw's lomatium are geographically concentrated in any portion of the species' range at a biologically meaningful scale. We examined the following threats: Habitat loss from land conversion or invasion of prairies by nonnative, invasive, and woody species; parasitic organisms; predation by voles; inadequate State or Federal protections; inbreeding depression; climate change; and the cumulative effects of these threats.

The threat of habitat loss from land conversion and invasion of prairies by nonnative, invasive, and woody species has decreased in all portions of the range since the time of listing, due to land protection efforts and active habitat management. Of the two sites that comprise the sole population of Bradshaw's lomatium in southwestern Washington, one is located on a privately owned golf course and contained approximately 10.8 million Bradshaw's lomatium plants at the most recent survey. This site currently has high-quality habitat. Current management at the site, as in past years, supports open, wet prairie conditions (Service 2018, pp. 29, 57), primarily through mowing. Although no formal protections are in place that would prevent future development, we have no information to indicate that it is likely the site would be developed or that habitat management will change in any way that would substantially impact Bradshaw's lomatium. In addition, the areas occupied by Bradshaw's lomatium are within wetlands, which may have protections from development under State or Federal law. Based on the current protections of the other Washington site, a preserve owned and managed by the WDNR, the lack of any present threat of destruction or degradation at the privately owned golf course site, and ongoing appropriate management at both sites, we have confidence that habitat at these sites will continue to support Bradshaw's lomatium for the foreseeable future. In Oregon, greater than 99 percent of known Bradshaw's lomatium plants occur on sites protected through public or NGO ownership, through designation as a right-of-way, or by conservation easements on private lands. Rangewide, 75 percent of the known sites receive active management that benefits the species. Thus, we have found no evidence that the present or threatened destruction, modification, or curtailment of habitat (Factor A) is concentrated within any portion of Bradshaw's lomatium's range, or will be within the foreseeable future.

We found no evidence that negative impacts due to parasitic organisms constitute a threat to the viability of Bradshaw's lomatium in any part of its range, now or in the foreseeable future.

Predation by voles appears to vary year to year and can substantially reduce aboveground biomass and reproduction of Bradshaw's lomatium in years when vole abundance is high. However, the effect on populations is found to be minimal over time, as long as there is sufficient time for Bradshaw's lomatium to regenerate taproot reserves between vole outbreaks (Drew 2000, pp. 54-55), and no consistent long-term declines attributable to vole predation have been reported (Service 2018, p. 20). The best available information does not indicate that predation is concentrated with any portion of the range of Bradshaw's lomatium, or will be within the foreseeable future (Factor C).

Current State and Federal protections appear adequate to address the loss of Bradshaw's lomatium habitat throughout its range, and we do not foresee changes to these protections in the foreseeable future (Factor D). As described above, we do not consider habitat loss to be concentrated within any portion of its range. Of the two known sites containing Bradshaw's lomatium in southwestern Washington, one is protected through ownership by the WDNR. Although the second, larger site lacks formal protection, it faces no currently known threat of habitat loss or degradation, either now or within the foreseeable future. Additionally, the WDNR continues to make efforts to provide additional conservation at the site. Bradshaw's lomatium remains listed as endangered by the State of Washington.

Concerns over the possibility of inbreeding depression expressed at the time of listing are now reduced due to a subsequent study indicating that overall genetic diversity in Bradshaw's lomatium is relatively high for a rare species (Gitzendanner and Soltis 2001, pp. 352-353), and is greater than that found in other rare Lomatium species (Gitzendanner and Soltis 2000, p. 787). Although the most disjunct population in southwestern Washington showed relatively lower genetic diversity than less geographically isolated populations (Gitzendanner and Soltis 2001, p. 353), the threat of inbreeding depression is considered reduced, as we now understand Bradshaw's lomatium to be primarily an outcrossing species (which promotes increased genetic diversity), rather than an obligate self-pollinating species as was believed at the time of listing (Service 2018, pp. 7, 20). We have no information indicating that inbreeding depression constitutes a threat to the viability of Bradshaw's lomatium in any part of its range, now or in the foreseeable future.

In our SSA report, we assessed the potential impacts of climate change on Bradshaw's lomatium projected up to 50 years in the future, and conservatively evaluated a future scenario in which the potential negative effects of climate change were such that all populations were reduced in size by up to 50 percent. Under such a scenario, we estimated that populations currently in low condition or with very low abundance may be extirpated due to the combined effects of climate change impacts and stochastic events; this translated to an estimated loss of up to five small populations, with other populations reduced in size. However, even with a presumed 50 percent reduction in abundance, at least 14 to 16 populations of Bradshaw's lomatium in moderate or high condition are expected to remain throughout the range with ongoing management. We, therefore, have no information to indicate that other natural or manmade factors pose a threat to the continued existence of Bradshaw's lomatium (Factor E), now or within the foreseeable future, in any portion of the range.

Although the types, magnitude, or extent of potential cumulative impacts are difficult to predict, we are not aware of any combination of factors that are likely to co-occur with significant negative consequences for the species within any portion of its range. We anticipate that any negative consequence of co-occurring threats will be successfully addressed through the same active management actions that have contributed to the ongoing recovery of Bradshaw's lomatium and that are expected to continue into the future.

We found no concentration of threats in any portion of Bradshaw's lomatium's range at a biologically meaningful scale. Therefore, no portion of the species' range can provide a basis for determining that the species is in danger of extinction now or likely to become so in the foreseeable future in a significant portion of its range, and we find the species is not in danger of extinction now or likely to become so in the foreseeable future in any significant portion of its range. This is consistent with the courts' holdings in Desert Survivors v. Department of the Interior, No. 16-cv-01165-JCS, 2018 WL 4053447 (N.D. Cal. Aug. 24, 2018), and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d, 946, 959 (D. Ariz. 2017).

Our review of the best available scientific and commercial information indicates that Bradshaw's lomatium does not meet the definition of an endangered species or a threatened species in accordance with sections 3(6) and 3(20) of the Act. Therefore, we are removing Bradshaw's lomatium from the List of Endangered and Threatened Plants.

This rule revises 50 CFR 17.12(h) to remove Bradshaw's lomatium from the Federal List of Endangered and Threatened Plants. On the effective date of this rule (see DATES , above), the prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, no longer apply to this species, and Federal agencies are no longer required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect Bradshaw's lomatium. There is no critical habitat designated for this species, so there will be no change to 50 CFR 17.96.

Section 4(g)(1) of the Act requires the Secretary of the Interior, through the Service and in cooperation with the States, to implement a monitoring program for not less than 5 years for all species that no longer meet the definition of endangered or threatened and, therefore, have been delisted. The purpose of this post-delisting monitoring is to verify that a species remains secure from risk of extinction after the protections of the Act have been removed. The monitoring is designed to detect the failure of any delisted species to sustain itself without the protective measures provided by the Act. If, at any time during the monitoring period, data indicate that the protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing under section 4(b)(7) of the Act. Section 4(g) of the Act explicitly requires us to cooperate with the States in post-delisting monitoring programs, but we remain responsible for compliance with section 4(g) of the Act and, therefore, must remain actively engaged in all phases of post-delisting monitoring. We also seek active participation of other entities that are expected to assume responsibilities for the species' conservation post-delisting.

We prepared a post-delisting monitoring plan for Bradshaw's lomatium. The plan discusses the current status of the species and describes the methods for monitoring the species subsequent to its removal from the Federal List of Endangered and Threatened Plants. The final post-delisting monitoring plan is available at http://www.regulations.gov under Docket No. FWS-R1-ES-2019-0013. We will work closely with our partners to maintain the recovered status of Bradshaw's lomatium and ensure post-delisting monitoring is conducted and future management strategies are implemented (as necessary) to benefit Bradshaw's lomatium.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), need not be prepared in connection with regulations pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We have determined that no Tribes will be affected by this rule because no Tribal lands, sacred sites, or resources will be affected by the removal of Bradshaw's lomatium from the List of Endangered and Threatened Plants.

A complete list of all references cited in this rule is available on the internet at http://www.regulations.gov under Docket No. FWS-R1-ES-2019-0013 or upon request from the State Supervisor, Oregon Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff of the Oregon Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

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

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season allowance of the 2021 Pacific cod TAC apportioned to catcher/processors using hook-and-line gear in the Western Regulatory Area of the GOA is 588 metric tons (mt) as established by the final 2021 and 2022 harvest specifications for groundfish in the GOA (86 FR 10184, February 19, 2021).

In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the A season allowance of the 2021 Pacific cod TAC apportioned to catcher/processors using hook-and-line gear in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 588 mt and is setting aside the remaining 0 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using hook-and-line gear in the Western Regulatory Area of the GOA.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by catcher/processors using hook-and-line gear in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 2, 2021.