The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain GEnx-1B64, GEnx-1B64/P1, GEnx-1B64/P2, GEnx-1B67, GEnx-1B67/P1, GEnx-1B67/P2, GEnx-1B70, GEnx-1B70/75/P1, GEnx-1B70/75/P2, GEnx-1B70/P1, GEnx-1B70/P2, GEnx-1B70C/P1, GEnx-1B70C/P2, GEnx-1B74/75/P1, GEnx-1B74/75/P2, GEnx-1B76/P2, GEnx-1B76A/P2 (GEnx-1B), GEnx-2B67, GEnx-2B67B, and GEnx-2B67/P (GEnx-2B) model turbofan engines. The NPRM published in the Federal Register on September 9, 2022 (87 FR 55328). The NPRM was prompted by a manufacturer investigation that revealed that certain HPT stage 2 disks, forward seals, and stages 6-10 compressor rotor spools were manufactured from powder metal material suspected to contain iron inclusion. Further investigation by the manufacturer determined that the iron inclusion is attributed to deficiencies in the manufacturing process. The investigation by the manufacturer also determined that certain GEnx-1B and GEnx-2B HPT stage 2 disks, forward seals, and stages 6-10 compressor rotor spools made from billets manufactured using the same process may have reduced material properties and a lower fatigue life capability due to iron inclusion, which may cause premature fracture and uncontained failure. In the NPRM, the FAA proposed to require replacement of certain HPT stage 2 disks, forward seals, and stages 6-10 compressor rotor spools with parts eligible for installation. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from four commenters. The commenters were Air Line Pilots Association, International (ALPA), American Airlines, GE Aviation, and The Boeing Company (Boeing). ALPA, American Airlines, and Boeing supported the proposed AD without change. GE Aviation requested a change to the proposed AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

GE Aviation requested that the FAA add alternate part numbers (P/Ns) to Table 1 to paragraph (c) of this AD. GE Aviation explained that the forward seal and stages 6-10 compressor rotor spool may have reworked P/Ns that occur after entry into service. While the P/Ns provided in the NPRM are the best information available as to current P/Ns, GE requested that the FAA add certain alternate P/Ns to Table 1 to paragraph (c), Applicability, of this final rule to ensure compliance.

The FAA agrees for the reasons provided and has revised Table 1 to paragraph (c), Applicability, of this AD as requested by GE Aviation.

The FAA reviewed the relevant data, considered any comments received, 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. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed GE GEnx-1B Service Bulletin 72-0505, Revision 02, dated April 5, 2022. The FAA also reviewed GE GEnx-2B Service Bulletin 72-0444, Revision 02, dated April 5, 2022. This service information describes procedures for removing the HPT stage 2 disk, forward seal, and stages 6-10 compressor rotor spool. These documents are distinct since they apply to different engine models.

The FAA estimates that this AD affects 3 engines installed on airplanes of U.S. registry. The FAA estimates that 0 engines installed on airplanes of U.S. registry require replacement of the forward seal or HPT stage 2 disk.

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

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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2017-18-05, Amendment 39-19014 (82 FR 41331, August 31, 2017) (AD 2017-18-05). AD 2017-18-05 applied to all Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP airplanes. The NPRM published in the Federal Register on September 19, 2022 (87 FR 57155). The NPRM was prompted by a report of damage at the lower trailing edge panels of the left wing and a broken fuse pin of the landing gear beam end fitting. The NPRM was further prompted by the need for new ultrasonic testing (UT) inspections for cracking of the fuse pin, and the determination that additional airplanes are subject to the unsafe condition. In the NPRM, the FAA proposed to continue to require repetitive replacement, or repetitive magnetic particle or surface high frequency eddy current (HFEC) inspections, of certain fuse pins, and applicable on-condition actions. The NPRM also proposed the option for repetitive replacement of certain corrosion-resistant (stainless) steel (CRES) and steel alloy fuse pins at the wing landing gear beam end fitting; and repetitive magnetic particle inspections, or repetitive HFEC and UT inspections, for cracking of the fuse pin, and applicable on-condition actions. The NPRM also proposed to revise the applicability by adding Model 747-8F and 747-8 series airplanes.

The FAA is issuing this AD to address cracking in the fuse pin of the wing landing gear beam end fitting. A broken fuse pin will not support the wing landing gear beam, causing damage to the surrounding structure, including flight control cables and hydraulic systems, which could result in loss of controllability of the airplane.

The FAA received a comment from Air Line Pilots Association, International, who supported the NPRM without change.

The FAA reviewed the relevant data, considered any comments received, 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. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Service Bulletin 747-57A2360, Revision 1, dated February 9, 2022. This service information specifies procedures for, depending on airplane configuration, the optional repetitive replacement of certain steel alloy fuse pins or CRES fuse pins with new or serviceable fuse pins at the wing landing gear beam end fitting; and repetitive magnetic particle inspections, or repetitive surface HFEC and UT inspections, for cracking and corrosion of the fuse pin of the wing landing gear beam end fitting, and applicable on-condition actions. On-condition actions include replacement with steel alloy or CRES fuse pins; and magnetic particle, surface HFEC, and UT testing inspections for cracks; and replacement of cracked fuse pins. 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 estimates that this AD affects 207 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 and inspections that would be required based on the results of the required inspections. The FAA has no way of determining the number of aircraft that might need these replacements and inspections:

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 FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1570; Project Identifier MCAI-2022-01269-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

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

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0195, dated September 23, 2022 (EASA AD 2022-0195) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A310-203, -203C, -204, -221, -222, -304, -308, -322, -324, and -325 airplanes. Model A310-203C and -308 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The MCAI states that new or more restrictive airworthiness limitations tasks related to the trimmable horizontal stabilizer actuators (THSA) are necessary to address fatigue cracking, damage, or corrosion in principal structural elements. EASA AD 2022-0195 specifies that it requires tasks (limitations) already in Airbus A310 Airworthiness Limitations Section (ALS), Part 4, System Equipment Maintenance Requirements (SEMR), Revision 03, dated August 28, 2017, that is required by EASA AD 2017-0202, dated October 12, 2017 (which corresponds to FAA AD 2018-18-21, Amendment 39-19400 (83 FR 47054, September 18, 2018) (AD 2018-18-21)), and that incorporation of EASA AD 2022-0195 invalidates (terminates) prior instructions for that task. This AD therefore terminates the limitations for the corresponding tasks, as required by paragraph (g) of AD 2018-18-21.

This AD also terminates all actions for AD 2016-15-01, Amendment 39-18592 (81 FR 47696, July 22, 2016) (AD 2016-15-01) (which corresponds to EASA AD 2015-0081, dated May 7, 2015), for Model A310 series airplanes only. AD 2016-15-01 requires inspecting THSA part numbers, serial numbers, and flight cycles on certain THSAs; and repetitive replacement of certain THSAs. Since that AD was issued, Airbus published Airbus A310 ALS Part 4 SEMR, Revision 03, and incorporated the tasks and limitations of the AD.

This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address the effects of aging on airplane systems. Such effects could change system characteristics, leading to an increased potential for failure of certain life-limited parts. See the MCAI for additional background information.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1570.

EASA AD 2022-0195 describes new or more restrictive airworthiness limitations for airplane structures and safe life limits. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires accomplishing the actions specified in EASA AD 2022-0195 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

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

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0195 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0195 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 EASA AD 2022-0195 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0195. Service information required by EASA AD 2022-0195 for compliance will be available at regulations.gov under Docket No. FAA-2022-1570 after this AD is published.

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

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

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

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

There are currently no domestic operators of these products. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the foregoing reason(s), 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 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.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the FAA recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

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

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

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1568; Project Identifier MCAI-2022-00910-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Hassan Ibrahim, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3653; email Hassan.M.Ibrahim@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

ANAC, which is the aviation authority for Brazil, has issued ANAC AD 2022-07-01, effective July 11, 2022 (ANAC AD 2022-07-01) (also referred to as the MCAI), to correct an unsafe condition for certain Embraer S.A. Model ERJ 190-300 and -400 airplanes. The MCAI states that the manufacturer has received reports of friction marks on the engine fire extinguishing system tube, in the region of the aft fairing of the LH pylon, caused by a small clearance between parts and the displacement of the engine fire extinguishing tube and LH pylon access panel. The damage on the engine fire extinguishing system tube is a latent failure, which may prevent the LH engine fire extinguishing system of the airplane from performing correctly. The MCAI specifies rework of the retainer of the LH pylon access panel, inspection and replacement, as applicable, of the LH engine fire extinguishing system tube, and installation of a support.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1568.

ANAC AD 2022-07-01 specifies procedures for rework of the retainer of the LH pylon access panel, general visual inspection for existing damage (friction marks) and replacement, as applicable, of the LH engine fire extinguishing system tube, and installation of a support. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires accomplishing the actions specified in ANAC AD 2022-07-01 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, ANAC AD 2022-07-01 is incorporated by reference in this AD. This AD requires compliance with ANAC AD 2022-07-01 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Service information required by ANAC AD 2022-07-01 for compliance will be available at regulations.gov under Docket No. FAA-2022-1568 after this AD is published.

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

There are currently no domestic operators of these products. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the forgoing reason(s), 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 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.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates 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 actions. The FAA has no way of determining the number of aircraft 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.

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1569; Project Identifier MCAI-2022-01267-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

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

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0193, dated September 23, 2022 (EASA AD 2022-0193) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A310-203, -203C, -204, -221, -222, -304, -308, -322, -324, and -325 airplanes. Model A310-203C and -308 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The MCAI states that new or more restrictive airworthiness limitations tasks related to the center fuselage are necessary to address fatigue cracking, damage, or corrosion in principal structural elements. EASA AD 2022-0193 specifies that it requires tasks (limitations) already in Airbus A310 Airworthiness Limitations Section (ALS), Part 2, Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 03, dated December 14, 2018, that is required by EASA AD 2019-0091 (which corresponds to FAA AD 2019-20-06, Amendment 39-19759 (84 FR 55859, October 18, 2019) (AD 2019-20-06)), and that incorporation of EASA AD 2022-0193 invalidates (terminates) prior instructions for those tasks. This AD therefore terminates the limitations for the corresponding tasks, as required by paragraph (g) of AD 2019-20-06.

This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address the effects of aging on airplane systems. Such effects could change system characteristics, leading to an increased potential for failure of certain life-limited parts. See the MCAI for additional background information.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1569.

EASA AD 2022-0193 describes new or more restrictive airworthiness tasks for airplane structure (center fuselage). This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness tasks, which are specified in EASA AD 2022-0193 described previously, as incorporated by reference. Any differences with EASA AD 2022-0193 are identified as exceptions in the regulatory text of this AD.

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

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0193 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0193 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 EASA AD 2022-0193 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0193. Service information required by EASA AD 2022-0193 for compliance will be available at regulations.gov under Docket No. FAA-2022-1569 after this AD is published.

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

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

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

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

There are currently no domestic operators of these products. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the foregoing reason(s), 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 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.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the FAA recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the total cost per operator to be $7,650 (90 work-hours × $85 per workhour).

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

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

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1571; Project Identifier MCAI-2022-01359-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Dat Le, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone (516) 228-7317; email Dat.V.Le@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0211, dated October 17, 2022 (EASA AD 2022-0211) (also referred to as the MCAI), to correct an unsafe condition for certain Airbus SAS Model A350-1041 airplanes. The MCAI states that during the A350-1041 type certification follow-up activity, it was determined that the loads for the rudder oscillatory failure case were not calculated properly. This condition, if not corrected, could result in rudder oscillations leading to unacceptably high loads on the fuselage, which could compromise the structural integrity of the airplane.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1571.

EASA AD 2022-0211, dated October 17, 2022, specifies procedures for installing the software integrated modular avionics, core processing input output modules, avionics Batch 7A—Part 1 (SW1) and PRIMary flight control computers (PRIM) SW standard P13.1.2 (SW2) updates. 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 ADDRESSES .

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

This AD requires accomplishing the actions specified in EASA AD 2022-0211 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0211 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0211 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 EASA AD 2022-0211 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0211. Service information required by EASA AD 2022-0211 for compliance will be available at regulations.gov under Docket No. FAA-2022-1571 after this AD is published.

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

There are currently no domestic operators of these products. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the forgoing reason(s), 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 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.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.

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

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

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the Federal Register on September 8, 2022 (87 FR 54922). The NPRM was prompted by a report indicating that a crack was found in one of the holes of the wing rear spar lower chord at the MLG aft fitting at WBL 157 on a Model 737-400 airplane. In the NPRM, the FAA proposed to require repetitive open hole HFEC inspections or surface HFEC and UT inspections for cracking of the wing rear spar lower chord at the MLG aft fitting at a certain WBL, and applicable on-condition actions. The FAA is issuing this AD to address cracking in the rear spar lower chord at a fastener common to the MLG aft support fitting. This condition, if not addressed, could result in the inability of the rear spar lower chord to sustain limit loads, resulting in reduced structural integrity of the airplane and possible loss of control of the airplane.

The FAA received comments from The Air Line Pilots Association, International (ALPA), who supported the NPRM without change. The FAA received comments from an individual that were outside the scope of this rulemaking.

The FAA received an additional comment from Boeing. The following presents the comment received on the NPRM and the FAA's response.

Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE does not affect the actions specified in the proposed AD.

The FAA concurs with the commenter. The FAA has redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

Boeing requested that a reference to “paragraph (h) of this AD” within paragraph (h) of this AD be corrected to read “paragraph (i) of this AD.” Boeing noted that the reference should be to the exceptions stated in paragraph (i) of this AD.

The FAA agrees with the request to correct the error. The reference to “paragraph (h) of this AD” within paragraph (h) of this AD has been corrected to read “paragraph (i) of this AD.”

The FAA reviewed the relevant data, considered any comments received, 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. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Requirements Bulletin 737-57A1353 RB, dated February 10, 2022. This service information specifies procedures for repetitive open hole HFEC inspections or surface HFEC and UT inspections for cracking, and applicable on-condition actions. On-condition actions include installing fasteners and repair. 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 estimates that this AD would affect 69 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 fastener installations that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need these installations:

The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this AD.

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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain GEAC M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-11S, M601F, H75-100, H75-200, H80, H80-100, H80-200, H85-100, and H85 200 model turboprop engines. The NPRM published in the Federal Register on September 27, 2022 (87 FR 58466). The NPRM was prompted by AD 2022-0034, dated March 4, 2022, issued by the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union (referred to after this as “the MCAI”). The MCAI states that occurrences of cracks in dilution tube weld areas of the combustion chamber outer liner have been reported. These cracks can lead to crack propagation, possibly resulting in part separation, loss of engine power, and reduced control of the aircraft.

In the NPRM, the FAA proposed to require initial and repetitive BSIs of the dilution tube weld areas of the combustion chamber outer liner and, depending on the results of the inspections, corrective action in accordance with the service information. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1239.

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

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. 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. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.

The FAA reviewed GEAC Alert Service Bulletin (ASB) ASB-H75-72-40-00-0056 [01], ASB-M601E-72-40-00-0113 [01], ASB-H80-72-40-00-0099 [01], ASB-M601D-72-40-00-0081 [01], ASB-M601F-72-40-00-0064 [01], ASB-M601Z-72-40-00-0063 [01], and ASB-H85-72-40-00-0045 [01], (single document; formatted as service bulletin identifier [revision number]), dated February 16, 2022. This service information specifies procedures for BSIs of the dilution tube weld areas of the combustion chamber outer liner and replacement of the combustion chamber outer liner.

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 estimates that this AD affects 33 engines installed on 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 agency has no way of determining the number of aircraft 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.

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:

Comments Invited

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-1567; Project Identifier MCAI-2022-00099-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Dat Le, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone (516) 228-7317; email Dat.V.Le@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0015, dated January 26, 2022 (EASA AD 2022-0015) (also referred to as the MCAI), to correct an unsafe condition for certain Airbus SAS Model A350-941 and A350-1041 airplanes. The MCAI states that due to a production quality issue, HECF patches may not have been installed at all required locations of the upper and lower wing covers. This condition, combined with a pre-existing undetected incorrect installation of an adjacent fastener and associated nut-cap, if not detected and corrected, could create an ignition source for the fuel vapor inside the fuel tanks, which, in case of a lightning strike of high intensity in the area, could possibly result in ignition of the fuel-air mixture in the affected fuel tank and consequent loss of the airplane. EASA AD 2022-0015 requires a one-time detailed inspection of the affected areas and, depending on findings, accomplishment of applicable corrective action(s).

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1567.

EASA AD 2022-0015 specifies procedures for a one-time detailed inspection of the affected areas for missing HECF patches and, depending on the inspection results, accomplishment of applicable corrective actions including installing missing HECF patches. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

This AD requires accomplishing the actions specified in EASA AD 2022-0015 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0015 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0015 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 EASA AD 2022-0015 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0015. Service information required by EASA AD 2022-0015 for compliance will be available at regulations.gov under Docket No. FAA-2022-1567 after this AD is published.

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

There are currently no domestic operators of these products. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the forgoing reason(s), 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 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.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-14-20, Amendment 39-21647 (86 FR 38214, July 20, 2021) (AD 2021-14-20). AD 2021-14-20 applied to all The Boeing Company Model 737 airplanes. The NPRM published in the Federal Register on July 7, 2022 (87 FR 40460). The NPRM was prompted by reports of latent failures of the cabin altitude pressure switches, and the determination that using certain adapters while performing a functional test may lead to false failures of the cabin altitude pressure switches. In the NPRM, the FAA proposed to retain the repetitive functional tests and on-condition actions, and specify certain adapter requirements for the functional tests. The FAA is issuing this AD to address the unexpectedly high rate of latent failure of both pressure switches on the same airplane, which could result in the cabin altitude warning system not activating if the cabin altitude exceeds 10,000 feet, resulting in hypoxia of the flightcrew, and loss of control of the airplane.

The FAA received a comment from the Air Line Pilots Association (ALPA), who supported the NPRM without change.

The FAA received additional comments from four commenters, including United Airlines, Delta Air Lines, American Airlines, and Boeing. The following presents the comments received on the NPRM and the FAA's response to each comment.

Delta Air Lines (DAL) asked that the FAA revise note 1 to paragraph (g) of the proposed AD to call out equivalent applicable Boeing 737 Aircraft Maintenance Manual (AMM) procedures, in addition to calling out the procedures in the 737 Task Card. DAL stated that the 737 Task Cards called out in Note 1 to paragraph (g) of the proposed AD are not easily accessible to the maintenance personnel performing the tasks on the aircraft. DAL added that the AMM procedure is more commonly used and easily accessed by the Aircraft Maintenance Technician, so the addition of the reference to the AMM procedure avoids potential confusion when the maintenance task is being performed.

The FAA agrees with the commenter's request for the reasons provided. The FAA has revised Note 1 to paragraph (g) of this AD to include the equivalent applicable Boeing 737 Aircraft Maintenance Manual procedures referenced in Delta's comment.

DAL noted that Boeing 737-600/700/800/900 Aircraft Maintenance Manual (AMM) is identified in note 1 to paragraph (g) of the proposed AD as “Airplane Maintenance Manual” instead of “Aircraft Maintenance Manual.”

The FAA has corrected the reference accordingly.

United Airlines (UAL) asked that the interval established in the Maintenance Review Board (MRB) be eventually re-established. UAL stated that tooling was determined to be a significant contributor to inconsistencies in the testing of the cabin altitude test switch. UAL added that AD 2021-14-20 would be superseded by the proposed AD to require improved AMM content defining appropriate tooling. In light of these published AMM improvements, UAL recommended a return to the interval established in the MRB.

The FAA does not agree with the commenter's request. Boeing provided the fleet data collected from AD 2021-14-20 and the trend data after operators incorporated the improved AMM content. The FAA evaluated this data and determined through risk analysis that the interval established in the MRB was unacceptable. Therefore, the FAA has not changed this AD in this regard.

American Airlines (AA) stated that the FAA should remove the hose length requirement of “25 to 40 ft” specified in figure 1 to paragraph (g) of the proposed AD. AA stated that the hose length requirement is an unnecessary restriction. AA added that a longer or shorter hose should not significantly affect the application of a controlled vacuum, and therefore should not affect the accuracy of the cabin altitude pressure switch functional test.

The FAA does not agree with the commenter's request. There are instructions to use a Barfield Pitot Hose, or equivalent 25- to 40-foot hose, to standardize the equipment that operators use while performing the cabin altitude warning switch functional test and to prevent false test failures. There is potential concern that a hose longer than 40 feet could have a kink in the hose that may be unnoticed by the operator, which could result in a false test failure. The FAA has not changed this AD in this regard.

Boeing asked that the proposed AD not specify particular adapters for use during performance of the pressure switch functional test. Boeing stated that the proposed AD should instead direct operators to use only those adapters listed in the current Boeing AMM revision or subsequent revisions. Boeing added that if new or improved adapters become available and/or the AMM adapter list is modified, an alternative method of compliance (AMOC) will have to be approved to add them as approved adapters for the AD, which is not an efficient resolution.

The FAA does not agree to require operators to use only those adapters listed in the existing Boeing AMM revision or subsequent revisions. Figure 1 to paragraph (g) of this AD shows the same list of adapters identified in the current Boeing AMM. Approval of an AMOC to use new or improved adapters would not be necessary if the adapters meet the specifications in either paragraph (g)(2)(i) or (ii) of this AD. Therefore, the FAA has not changed this AD in this regard.

The FAA reviewed the relevant data, considered any comments received, 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. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA estimates that this AD affects 2,693 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 on-condition actions required based on the results of the functional test. The FAA has no way of determining the number of aircraft that might need these actions:

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

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

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 Coast Guard will enforce a safety zone for the Crescent City Countdown Club/New Year's Celebration fireworks display, from December 31, 2022 at 11:30 p.m. through January 1, 2023 at 12:30 a.m., to provide for the safety of life on the navigable waterways during this event. Our regulation for annual fireworks displays and other events in the Eighth Coast Guard District, 33 CFR 165.801, as updated by Federal Register Document 83 FR 55488, identifies this safety zone on Mississippi River MM 93.5-96.5, New Orleans, LA. During the enforcement period, as reflected in § 165.801(a) through (d), entry into this zone is prohibited unless authorized by the Captain of the Port or a designated representative.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via Marine Safety Information Bulletin and Broadcast Notice to Mariners.

VA is drafting regulations to implement the PACT Act. Prior to the promulgation of those regulations, VA is providing sub-regulatory guidance to claims processors in the form of a Policy Letter. The Policy Letter, as it will be provided to claims processors, can be found as a supporting document at https://www.regulations.gov.

On August 10, 2022, Public Law 117-168, the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022, or the Honoring our PACT Act of 2022, was signed into law. This historic, multifaceted law, which triggers changes to disability compensation examination requirements when there is evidence a Veteran has participated in a toxic exposure risk activity, expands presumptive locations associated with radiation exposure, expands presumptive conditions and locations associated with herbicide exposure, amends the statute involving certain benefits for Persian Gulf War Veterans, establishes presumptive conditions associated with exposure to burn pits and other toxins, and provides an avenue for a claimant-elected reevaluation of previously denied dependency and indemnity compensation (DIC) claims that can result in retroactive effective dates for benefits.

Although the PACT Act does not explicitly require VA to implement its provisions through regulations, VA currently is drafting regulations to codify the statutory changes in regulation and to address any gaps and ambiguity in the statutory language. Due to the time required to promulgate regulations, VA will implement the law and begin processing PACT Act-related claims on January 1, 2023, based on the sub-regulatory guidance contained in the Policy Letter associated with this Notice. The issuance of this Policy Letter has the benefit of allowing VA to operationalize the PACT Act and deliver earned benefits to Veterans and their dependents as quickly as possible while simultaneously continuing efforts to promulgate the implementing regulations. Nothing in this guidance affects or alters section 804 of the Camp Lejeune Justice Act of 2022.

The PACT Act contains nine titles, each containing multiple sections. Not all titles and sections impact compensation, pension and/or death benefits, as the law also addresses matters such as the expansion of health care eligibility and requirements for research studies. This Policy Letter focuses on the titles and sections that impact eligibility for disability compensation and survivor benefits. The Policy Letter provides guidance to claims processors for implementing the provisions of sections 102, 203, 204, 302, 303, 401, 402, 403, 404, 405 and 406 of this law.

Denis McDonough, Secretary of Veterans Affairs, approved this document on November 15, 2022, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

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

On September 19, 2022 (87 FR 57161), the EPA proposed to approve the following amended rules into the California SIP.

We proposed to approve these amended rules because we determined that they comply with the relevant CAA requirements. More specifically, we evaluated the amended rules and determined that they remain enforceable, that they implement reasonably available control measure (RACM)-level controls, and that they would not interfere with any applicable requirement concerning attainment or reasonable further progress (RFP) or any other requirement of the CAA. In our proposed rule, we also evaluated the specific contingency measure provisions in the rules ( i.e., paragraph (b)(6) of SDCAPCD Rule 67.0.1 and section 4.3 of SJVUAPCD Rule 4601) and concluded that the provisions meet the requirements for contingency measures under CAA sections 172(c)(9) and 182(c)(9). While we found that the rules meet the requirements for stand-alone contingency measures, we indicated that we are not making any determination at this time as to whether these individual contingency measures are sufficient in themselves for their respective nonattainment areas to fully comply with the contingency measure requirements under CAA sections 172(c)(9) and 182(c)(9). As noted in the proposed rule, we will be taking action on the contingency measure SIP elements for San Diego County and San Joaquin Valley in separate rulemakings. Our proposed action contains more information on the rules and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received one germane comment, and that one comment was supportive of the proposed action.

No comments were submitted that change our assessment of the rules as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the CAA, the EPA is fully approving these rules into the California SIP. Upon the effective date of this final rule, the February 10, 2021 version of SDCAPCD Rule 67.0.1 and the April 16, 2020 version of SJVUAPCD Rule 4601 will replace the previously approved versions of these rules in the California SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SDCAPCD and SJVUAPCD rules identified in section I. of this preamble. These rules concern emissions of VOC from architectural coating operations. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

• 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 (Public Law 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 Clean Air Act; and

• The state did not evaluate environmental justice considerations as part of its SIP submittal. There is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 21, 2023. 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).)

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2002-0021. All documents in the docket are listed on the https://www.regulations.gov/ website. Although listed, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov or in hard copy at the EPA Docket Center, Room 3334, WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742.

Organization of this document. The information in this preamble is organized as follows:

Categories and entities potentially regulated by this action are shown in Table 1 of this preamble.

In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at https://www.epa.gov/stationary-sources-air-pollution/site-remediation-national-emission-standards-hazardous-air. Following publication in the Federal Register , the EPA will post the Federal Register version of the action and key technical documents at this same website.

A redline version of the regulatory language that incorporates the finalized changes in this action is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2002-0021).

Under Clean Air Act (CAA) section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit (the court) by February 21, 2023. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. This section also provides a mechanism for the EPA to reconsider the rule if the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within the period for public comment or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule. Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, WJC South Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

On October 8, 2003, the EPA promulgated emission standards for control of certain hazardous air pollutants (HAP) from site remediations located at major sources of HAP—the 2003 Site Remediation NESHAP (68 FR 58172); 40 CFR part 63, subpart GGGGG. The 2003 Site Remediation NESHAP applied only to volatile organic HAP. 68 FR 58175. The 2003 Site Remediation NESHAP exempted site remediations performed under CERCLA authority as a remedial action or a non-time-critical removal action and site remediations under a RCRA corrective action conducted at a treatment, storage, and disposal facility (TSDF) that is either required by a permit issued by the EPA or a State program authorized by the EPA under RCRA section 3006; required by orders authorized under RCRA; or required by orders authorized under RCRA section 7003. 68 FR 58172 and 58176; 40 CFR 63.7881(b)(2) and (3). (This document refers to these exemptions as the “CERCLA and RCRA exemptions”; however, it should be noted that the scope of these exemptions is narrower than the full scope of remediations that may be conducted under, or in relation to, CERCLA or RCRA authority.) The NESHAP also specified that site remediations are not subject to subpart GGGGG unless they are co-located at a facility with one or more other stationary sources that emit HAP and meet the affected source definition specified for a source category that is regulated by another subpart under part 63. 40 CFR 63.7881(a)(2). (This document refers to this as the “co-location” criterion.)

The CERCLA and RCRA exemptions were based on the EPA's conclusion that the requirements of these specific types of remediations under CERCLA and RCRA are “functionally equivalent” to the HAP emissions control requirements of the 2003 Site Remediation NESHAP. 68 FR 58176. EPA reasoned that these programs use remediation approaches that would generally address the protection of public health and the environment from air pollutants emitted from remediation activities on a site-specific basis. Further, in both programs, the public is given an opportunity to participate in the decision-making process, and both programs are subject to Federal oversight and enforcement authority. 68 FR 58184-85. However, the EPA did not make a determination in promulgating the RCRA and CERCLA exemptions that the kinds of emissions controls, including monitoring, recordkeeping and reporting requirements, that are implemented in the CERCLA and RCRA programs were at least as stringent as the requirements of the CAA, including that RCRA and CERCLA requirements met the maximum achievable control technology (MACT) standard established pursuant to CAA section 112(d). Nor did EPA identify a statutory basis for exempting these sources from CAA section 112 requirements.

Following promulgation of the 2003 Site Remediation NESHAP, on October 8, 2003, the EPA Administrator received a petition for reconsideration of certain aspects of the final rule from the Sierra Club, the Blue Ridge Environmental Defense League, and Concerned Citizens for Nuclear Safety. This petition stated that the EPA (1) lacked the statutory authority to promulgate the CERCLA and RCRA exemptions, and (2) had a duty to set standards for each listed HAP that petitioners alleged were emitted from the source category, specifically referring to heavy metal HAP, not just the volatile organic HAP listed in table 1 of the subpart. In addition, petitioners filed a petition for review of the 2003 Site Remediation NESHAP in the court, Sierra Club et al. v. EPA, No. 03-1435. The parties agreed to place this case in abeyance pending EPA's review of the petition for reconsideration.

On November 29, 2006, the EPA promulgated technical amendments to the 2003 Site Remediation NESHAP (71 FR 69011), but did not resolve, address, or respond to the issues in the petition for reconsideration. On October 14, 2014, the court ordered the parties in Sierra Club et al. v. EPA to show cause why the case should not be administratively terminated, and on November 13, 2014, the parties filed a joint response informing the court that they were actively exploring a new approach to the issues raised in the petition. On March 25, 2015, the EPA issued a letter  1 to the petitioners granting reconsideration on the issues raised in the petition and indicated that the agency would issue a Federal Register document initiating the reconsideration process (see Docket ID EPA-HQ-OAR-2002-0021-0150). The letter noted that the issue of regulation of heavy metal HAPs should be considered separately and as a part of the statutorily required risk and technology review (RTR). The petition for reconsideration and EPA's 2015 letter granting reconsideration are available for review in the rulemaking docket (Docket ID No. EPA-HQ-OAR-2002-0021-0024 and EPA-HQ-OAR-2002-0021-0150). On May 13, 2016, the EPA proposed to revise subpart GGGGG by removing the CERCLA and RCRA exemptions, as well as to remove the “co-location” condition in the NESHAP and requested comment on those proposed revisions (81 FR 29821).

Subsequently, on September 3, 2019 (84 FR 46138), the EPA proposed amendments to the Site Remediation NESHAP related to the RTR which was conducted as required under CAA sections 112(d)(6) and 112(f). In the 2019 proposal, the EPA used the opportunity to request additional comment regarding the implementation of the NESHAP under a scenario in which the CERCLA and RCRA exemptions were removed. Specifically, the EPA sought additional comments on whether subcategorization may be appropriate or whether there were other methods of distinguishing among appropriate requirements for CERCLA or RCRA-exempt sources, including how applicability, monitoring, recordkeeping, reporting, and compliance demonstration requirements could be structured so that formerly exempt sources would be able to comply with the Site Remediation NESHAP effectively and efficiently while also meeting the requirements of RCRA and/or CERCLA. 84 FR 46167-69. The EPA explained that it would take comments on these topics but act upon the exemptions at a later date.

Separately, in accordance with our March 25, 2015, letter, the RTR action reviewed the issue of whether heavy metals or other inorganic HAP may be emitted from this source category. We proposed that there is a lack of data indicating such HAP are emitted from this source category but requested comment seeking additional data. 84 FR 46161.

The EPA finalized the RTR on July 10, 2020 (85 FR 41680). We made clear that we were not acting on the CERCLA and RCRA exemptions, 85 FR 41683, and we finalized our proposed determination that there was a lack of data to support the assertion that inorganic and metal HAP are emitted from the site remediation source category and so we did not establish emissions standards for these HAP for the source category (85 FR 41690 and 41694-95).

The EPA proposed and finalized three key changes to the Site Remediation NESHAP in the RTR rulemaking (85 FR 41680). First, we revised leak detection thresholds for certain valves and pumps under the technology review required by CAA section 112(d)(6), see 85 FR 41690-91. Second, the rule addressed the startup, shutdown, and malfunction (SSM) case law under CAA section 112(d)(2) and (3) by adding a set of work practice requirements under CAA section 112(h) to monitor certain pressure release devices (PRDs) for actuation, 85 FR 41691-94. Third, the rule established a work practice standard also related to SSM with respect to planned routine maintenance of control systems on storage tanks, 85 FR 41695-96.

On September 8, 2020, Concerned Citizens for Nuclear Safety, Louisiana Environmental Action Network, and Sierra Club filed a petition for review of EPA's final RTR action in the court, Concerned Citizens for Nuclear Safety v. EPA, No. 20-1344 (D.C. Cir.). On that same date, Sierra Club filed a petition for reconsideration of the RTR, identifying as grounds for reconsideration the continued existence of the CERCLA and RCRA exemptions, and whether the Site Remediation NESHAP should regulate non-organic HAPs. [EPA-OAR-HQ-2002-0021-0050]

In this action, we are finalizing the May 13, 2016, proposal to remove the CERCLA and RCRA exemptions from the Site Remediation NESHAP and are addressing comments submitted in response to both the 2016 proposal and the 2019 RTR proposal on the exemptions issue. In the same 2016 action, we proposed to remove the criterion in 40 CFR 63.7881(a)(2) that an affected site remediation is only subject to the NESHAP if it is co-located with a facility that is a major source already subject to regulation under at least one other NESHAP in 40 CFR part 63. Based on our review of the public comments, as discussed in this action, we are not finalizing the proposal to remove the co-location criterion in this action.

We are not addressing in this action the second issue raised in the 2020 petition for reconsideration, i.e., whether the EPA has a duty to set standards for non-organic HAP emissions from site remediation activities. The EPA will address that issue in a separate rulemaking.

Section 112 of the CAA establishes a regulatory process to address emissions of HAP from stationary sources. CAA section 112(d) requires the Agency to promulgate technology-based NESHAP for each category or subcategory of major sources listed pursuant to CAA section 112(c). “Major sources” are defined in CAA section 112(a) as sources that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP.

This action finalizes the EPA's determinations pursuant to the reconsideration of certain aspects of the 2003 Site Remediation NESHAP, and amends, as proposed, the Site Remediation NESHAP to remove the CERCLA and RCRA exemptions at 40 CFR 63.7881(b)(2) and (3). For affected sources that are existing sources, we are finalizing a compliance date of 18 months from the effective date of the final amendment removing the CERCLA and RCRA exemptions (see section III.C. for further discussion). We define existing sources, for purposes of this action, as those site remediations that commenced construction or reconstruction on or before May 13, 2016, the date of publication of the proposal to remove the exemptions. New sources, for purposes of this action, are those site remediations that commenced construction or reconstruction after May 13, 2016. Any new sources that would have formerly been exempted by 40 CFR 63.7881(b)(2) or (3) must comply with the NESHAP as of the date this document is published in the Federal Register . CAA section 112(d)(10), (i)(1).

The EPA is not finalizing the proposed amendment to remove the requirement that an affected site remediation be co-located with a facility that is regulated by other NESHAP. Our reasoning for this decision is explained in section III.B of this document. In the following subsections, we introduce and summarize the final amendments to the Site Remediation NESHAP. For each issue, this section provides a description of what we proposed and what we are finalizing, the EPA's rationale for the final decisions and amendments, and a summary of key comments and responses. For all comments not discussed in this preamble, comment summaries and the EPA's responses can be found in the comment summary and response document available in the docket.

As discussed in the May 13, 2016, notice of proposed rulemaking on reconsideration of the NESHAP (81 FR 29821), the 2003 Site Remediation NESHAP exempted site remediations performed under the authority of CERCLA and those conducted under a RCRA corrective action or other required RCRA orders. The exemptions were based on the EPA's conclusion that the requirements of these programs consider the same HAP emissions as the 2003 Site Remediation NESHAP and, in addition, these programs provide opportunities for public involvement through the Superfund Record of Decision process and the RCRA permitting process for corrective action cleanups. The EPA concluded that these programs serve as the functional equivalent of the establishment of NESHAP under CAA section 112. Petitioners asserted that the public lacked an opportunity to comment on the functional equivalence conclusion. In the May 13, 2016, proposal, we proposed to amend the rule by removing 40 CFR 63.7881(b)(2) and (3) and solicited comment. In the proposal, we explained that on reconsideration we agreed with petitioners that the Agency lacked statutory authority under the Clean Air Act to exempt affected sources in a listed source category from otherwise applicable NESHAP requirements on the “functional equivalence” basis articulated in the 2003 final rule. 81 FR 29824. We further explained that the requirements of the Site Remediation NESHAP are appropriate and achievable at all subject site remediations, including those conducted under CERCLA or RCRA authority. Id. Also, as noted above, on September 3, 2019 (84 FR 46138), as part of the statutorily required RTR, the EPA proposed amendments to the Site Remediation NESHAP. In the 2019 proposal, the EPA used the opportunity to request additional comment regarding the implementation of the NESHAP under a scenario in which the CERCLA and RCRA exemptions were removed.

Through the 2016 and 2019 proposals for the site remediation source category, the EPA solicited and received comments both in favor of and in opposition to the removal of the CERCLA and RCRA exemptions. The key comments and our responses are summarized below.

Comment: Several commenters stated that the EPA failed to provide a sufficient basis and purpose for the rule amendments as required by CAA section 307(d)(3). These commenters stated that nothing in CERCLA, RCRA, or the CAA has changed that would make the CERCLA and RCRA exemptions improper. The commenters also stated that since the agency does not expect any HAP reductions from the proposed changes (and in light of the 2019 risk assessment showing no adverse risks), there is no basis for these amendments. Several of these commenters stated that the EPA did not provide a basis for the proposed changes other than that the agency signed a consent agreement with the Sierra Club, noting that the proposal does not discuss why the agency's original conclusion that a RCRA/CERCLA-managed site remediation is the “functional equivalent” of the site remediation standard was incorrect or why that finding should be changed. One commenter also stated that CERCLA and RCRA provide ample safeguards for protecting public health and welfare with regard to HAP emissions, as evidenced by the EPA's estimate that there would be no further HAP reductions with the proposed changes. The commenter stated that due to this, the removal of the CERCLA and RCRA exemptions does not satisfy the CAA's intent to list sources which cause or significantly contribute to air pollution which might “reasonably be anticipated to endanger the public health or welfare.”

Response: The EPA disagrees that the CERCLA and RCRA exemptions are proper. As explained in the preamble to the 2016 proposed rule, see 89 FR 29823-29824, the basis and purpose of the proposed rule amendments are to meet the obligations of the CAA to establish NESHAP for all sources in the listed source category. The site remediation source category was listed under CAA section 112(c)(1). Once a source category is listed, CAA section 112(c)(2) mandates that the EPA “shall establish emission standards under subsection [112](d).” CAA section 112(d) in turn mandates the establishment of emission standards “for each category or subcategory of major sources and area sources.” While CAA section 112(d)(1) allows for distinguishing among classes, types, and sizes of sources in establishing emission standards, nothing in CAA section 112 authorizes the EPA to exempt certain sources entirely from emissions standards based on regulation under some other statute. Congress has made clear through the plain language of CAA section 112 that the development and implementation of NESHAPs promulgated pursuant to CAA section 112 is a mandatory mechanism for regulation of HAP emissions across all major sources of such emissions. e.g., National Lime Association v. EPA, 233 F.3d 625, 633-34 (D.C. Cir. 2000) (finding that section 112(d)(1) requires EPA to set emissions standards for all listed HAP emitted from each listed major source category or subcategory). This holds true for the site remediation source category notwithstanding that the RCRA and CERCLA programs may also address air pollutant emissions from disposal and remediation activities.

While we originally promulgated exemptions from the NESHAP for certain facilities, including facilities where site remediations were performed under authority of CERCLA or RCRA, we have re-evaluated the legal basis for these exemptions and determined that they should be removed. In response to the petition for reconsideration received pursuant to section 307(d)(7)(B) of the CAA in 2003 from the Sierra Club, the Blue Ridge Environmental Defense League, and Concerned Citizens for Nuclear Safety (which is available in the docket for this action), we have reconsidered the exemptions in the rule for these sources and our rationale for this approach. 2 We have determined, as explained above, that there is no statutory authority under section 112 of the CAA to exempt sources in a listed source category from NESHAP requirements simply because those sources may be subject to similar requirements through other statutes. In removing these exemptions, the EPA will be meeting its statutory obligations to establish and apply MACT standards for all affected source emissions of HAP at these major sources in the site remediation source category.

With respect to commenters' contention that nothing has changed since the 2003 promulgation of the NESHAP, we note that the basis for removing the exemption is to bring this NESHAP in line with the statutory requirement of CAA section 112 to regulate all affected sources of HAP in a listed source category. Case law since the 2003 promulgation of the NESHAP has only strengthened and confirmed that this is a correct understanding of the plain language of the statute. E.g., Sierra Club v. EPA, 479 F.3d 875, 878 (D.C. Cir. 2007) (confirming the holding in National Lime Association v. EPA, 233 F.3d 625, 633-34 (D.C. Cir. 2000)).

With respect to commenters' contention that EPA did not, in its 2016 proposal, explain why the agency's original conclusion that a RCRA or CERCLA-managed site remediation is the “functional equivalent” of the site remediation standard was incorrect, EPA disagrees that such an explanation is necessary, because the CAA does not authorize exemptions on this basis in the first place. Nonetheless, as the EPA explained in the May 2016 proposal, the site remediation activities conducted under the authority of CERCLA and RCRA are similar to site remediation activities that were not exempt from the Site Remediation NESHAP, and the requirements of the Site Remediation NESHAP are appropriate for and achievable by all site remediation activities.

Comment: Several commenters stated that the Site Remediation NESHAP amendments should not apply retroactively to existing RCRA and CERCLA site remediations. Two commenters added that if it were to apply to any of these sites, it should be only to remediation projects that are not yet fully developed. In the alternative, these commenters suggested that compliance with CERCLA or RCRA corrective action requirements should be deemed as compliance with the Site Remediation NESHAP. Other commenters suggested that where remediation plans under CERCLA or RCRA have already been approved and the plans include air emission control requirements, the EPA should view these as acceptable work practice and control standards. These commenters stated that this would also alleviate any potential conflicts between the Site Remediation NESHAP and the approved remediation plan under CERCLA or RCRA. One commenter also added that the evaluations of the hazards associated with the remediation activity required under CERCLA are more inclusive and protective than the Site Remediation NESHAP requirements. Several commenters stated that a grandfathering provision should be put in place to ensure the sites currently conducting an approved CERCLA or RCRA remediation at the time of the adoption of the final rule can continue to clean up with no delays. One commenter noted that there is precedent for this in NESHAPs, such as the Pharmaceutical NESHAP, which grandfathered existing process vents that were controlled by 93 percent or greater prior to the NESHAP proposal date.

A commenter added that removal of the exemption would eliminate the EPA's current site-specific discretion to determine whether application of the Site Remediation NESHAP is relevant and appropriate for a site. The commenter noted that the reason many sites are addressed under CERCLA is because they are large and complex, and applying the Site Remediation NESHAP may not be consistent with the methods that would otherwise be used to perform the remediation. The commenter also added that even if an alternative work practice were approved, this could either delay the remediation or force additional administrative activities to occur under the CAA. The commenter also remarked that under CERCLA, only the substantive requirements of other laws are considered potentially relevant and appropriate, but not the administrative requirements, such as reporting and recordkeeping. The commenter asked that the EPA consider creating subcategories that would exempt certain large-scale remediation activities, such as cleanups of large volumes of soil, sludge, or sediment, as the Site Remediation NESHAP may interfere with the use of the remedial technologies that would otherwise be selected under the National Contingency Plan.

Response: The EPA disagrees that existing site remediations should not be subject to the Site Remediation NESHAP. Section 112 of the CAA requires that the EPA issue regulations addressing both new and existing sources. See, e.g., CAA sections 112(a), (d), and (i). Removing the exemptions is not retroactive rulemaking. Retroactivity refers to requirements “extending in scope or effect to matters that have occurred in the past.” Black's Law Dictionary 1318 (7th Ed. 1999). The EPA is not applying the removal of the exemptions retroactively but rather prospectively. The requirements of the NESHAP will apply going forward at both new and existing site remediation sources. As authorized under CAA section 112(i)(3), the compliance date for existing sources is 18 months after the effective date of this final rule. In line with how other source categories are regulated, this will provide time for existing site remediations (existing as of May 13, 2016) that become newly subject to the NESHAP through the removal of the CERCLA and RCRA exemptions to comply with the requirements of the Site Remediation NESHAP in accordance with the governing cleanup program's statutory and regulatory requirements. During this time period, the owners or operators of the site remediation affected source will be able to evaluate the need for additional emissions control in accordance with the governing cleanup program and put those controls in place by the compliance date. The commenters have supplied no information with reasonable specificity that this time period for compliance, or the NESHAP's requirements themselves, will unduly delay cleanup activities.

The commenters' requests to consider compliance with CERCLA or RCRA sufficient for compliance with CAA requirements is effectively a request to simply continue the exemptions. As explained above, Congress directed EPA, under CAA section 112, to establish emission standards for listed source categories under the procedures and criteria of that section of the Act and did not provide for EPA to defer that standard-setting process to other statutory programs.

We are not reopening our 2003 determinations regarding MACT for the Site Remediation NESHAP. Under the reasoning and analysis of the original 2003 promulgation of 40 CFR part 63, subpart GGGGG, the EPA's MACT findings were equally valid for the CERCLA and RCRA sources that the EPA exempted. 3 However, we reviewed the comments to determine whether a basis existed to revisit these determinations with respect to the CERCLA and RCRA sources, and we find that commenters have not provided information to the agency that would warrant reopening these determinations.

In particular, commenters have not supplied sufficient information to establish why “grandfathering” a particular emission standard is appropriate, even if “grandfathering” may have been used in the one example cited by commenter. The requirements of the NESHAP have been applicable to non-exempt new and existing site remediation sources since the original NESHAP was promulgated, and the EPA is not aware of any existing sources facing difficulty with compliance with the requirements of the NESHAP, nor have commenters supplied such information.

Nor have the commenters supplied information or examples demonstrating that compliance with the requirements of the NESHAP is incompatible or will interfere with the implementation of ongoing CERCLA or RCRA remediation activities at the formerly exempt sites. In general, the Site Remediation NESHAP does not prescribe remediation strategies, technology, or equipment, but rather establishes emissions limits and in some cases work practice standards that apply depending on the kinds of strategies selected for the remediation ( e.g., if process vents are used, then requirements applicable to process vents apply, if tanks are used, then requirements applicable to tanks apply, etc.). As the EPA indicated at proposal, and as commenters have generally affirmed, the EPA believes that, for the most part, the standards established in the NESHAP are already being met at CERCLA and RCRA overseen cleanups, and thus the emissions control requirements of the NESHAP should not be unreasonably costly or onerous to meet.

Further, the process and sources of information used in adopting the original standards confirm that there is no need to reopen our category-wide MACT determinations. To select a MACT emissions limitation (or work practice standard) for each affected source, in the original promulgation of the NESHAP, we looked at the types of air emission controls required under national air emission standards for sources similar to those sources that potentially may be associated with site remediations. These air emission standards are MACT for other source categories, particularly the Off-site Waste and Recovery Operations (OSWRO) NESHAP under 40 CFR part 63, subpart DD, and the air emission standards for RCRA hazardous waste treatment, storage, and disposal facilities under subparts AA, BB, and CC in 40 CFR parts 264 and 265 (RCRA Air Rules). The control levels established by the emission limitations and work practices we promulgated are widely implemented at existing sources subject to these similar rules, thus demonstrating that the control levels are technically achievable. See 68 FR 58174.

Thus, these control requirements and action levels already existed in either the RCRA Air Rules or the OSWRO NESHAP, or both. Given that these existing rules specify control requirements for sources similar to those comprising the affected source group for the Site Remediation NESHAP, and that sources already regulated by these existing standards also will likely manage and/or treat remediation material regulated by the Site Remediation NESHAP, we continue to believe that the requirements of subpart GGGGG represent achievable industry practice for remediation activities including at the formerly exempt RCRA and CERCLA sites.

Further, as commenters acknowledge, CERCLA cleanups should be designed to meet the substantive environmental requirements of other statutes in accordance with compliance with Applicable or Relevant and Appropriate Requirements (ARARs) under CERCLA section 121(d). The programmatic requirements of CERCLA require the consideration of virtually any Federal standard as an ARAR, including the Site Remediation NESHAP. In other words, substantive requirements of the Site Remediation NESHAP are expected to be considered as potential ARARs. 4 Furthermore, the substantive provisions may also have been considered relevant and appropriate requirements under CERCLA on a site-specific basis since the promulgation of the regulations in 2003.

Finally, the EPA notes that decisions on compliance with ARARs are made within the CERCLA regulatory framework rather than the Clean Air Act, and as a result, the EPA will not address those issues in this action. For example, CERCLA authorizes waivers from applicable environmental regulations in certain situations. Two examples of potential waivers authorized in the statute are when compliance with a substantive Federal requirement that may be an ARAR may result in greater risk to human health and the environment or where other alternatives will achieve equivalent performance. CERCLA section 121(d)(4). In any event, CERCLA remediations must assure protection of human health and the environment. While the EPA anticipates that waiver circumstances should be rare in meeting the requirements of the Site Remediation NESHAP, nonetheless, such flexibility is available on an as-needed basis through the provisions of CERCLA rather than the CAA.

For the reasons discussed above and in the preamble for the proposed rule and our response to comments document available in the docket, we are removing the CERCLA and RCRA exemptions from the Site Remediation NESHAP.

In the May 13, 2016, proposal on reconsideration, the EPA proposed to remove the criterion in 40 CFR 63.7881(a)(2) that an affected site remediation is only subject to the NESHAP if it is co-located with a facility that is a major source already subject to regulation under at least one other NESHAP in 40 CFR part 63. This rule change was proposed to further effectuate the removal of the exemptions so that any formerly exempt CERCLA or RCRA site remediations that are themselves major sources of HAP, without regard for co-location with a major source, should be subject to the rule. 81 FR 29824. This proposed amendment would have the effect of making any site remediations with emissions in excess of major source thresholds subject to the Site Remediation NESHAP for the first time, and would affect all site remediations, not only those falling under the CERCLA or RCRA exemptions.

Based on our review of the public comments, as discussed below, the EPA is not finalizing this proposed rule amendment in this action.

The EPA received several comments in opposition to the removal of the co-location requirement. Key comments and our response include the following:

Comment: Two commenters expressed concern that with the removal of the criteria that a remediation be co-located with a major source facility for HAP, an oil or chemical spill with emissions over the major source thresholds set out in CAA section 112(a)(1) would be subject to the rule, even if the spill occurred in a remote, inaccessible, or potentially expansive location, such as remote Alaska. The commenters urged the EPA to keep the co-location condition or provide an exemption for remediation as a result of a spill response. One commenter added that without the co-location condition, applicability will likely extend to small sources that were not considered in the original rulemaking.

Response: We have concluded that it is not appropriate to finalize the proposed rule amendment to remove the co-location criterion, and we are retaining that provision of the NESHAP. Based on the available information regarding the amount of HAP emitted from site remediations, remediation facilities that are not co-located with major sources are not major sources of HAP— i.e., the Agency has no data to suggest that site remediation affected sources that are not already co-located with a major source themselves emit greater than 10 tons per year of any single HAP or 25 tons per year of all HAPs. 5 The effect of removing the co-location criterion would be to require applicability determinations in many situations where it would be extremely difficult to substantiate whether the applicability thresholds are met or not, and yet it would be unlikely that such thresholds are met. As commenters observe, such circumstances could arise in emergency scenarios where there is an overriding imperative to address immediate threats to human health or the environment. At such source locations ( e.g., in the field or along transportation corridors), neither the “source” itself ( e.g., the site of a spill that is being remediated), or its “owner or operator,” may have any experience with CAA compliance, including the necessary permitting requirements, the data for making CAA applicability determinations, or requirements for monitoring, recordkeeping, and reporting. They may not even possess requisite ownership interests in such sites to be able to effectively implement such requirements. The onset of Site Remediation NESHAP compliance obligations in these circumstances—even if limited to making an applicability determination based on the level of emissions that could occur from site remediation activities—could inhibit or delay responders from taking necessary, immediate steps to protect human health and the environment. Therefore, because there are no data suggesting that there are site remediations that are themselves major sources of HAP, and to avoid the potential that rendering applicability determinations could inhibit site remediations in a variety of unusual or emergency circumstances, the EPA is retaining the applicability condition that site remediations be co-located with a facility that is a major source regulated by at least one other NESHAP. 6

As the EPA is not finalizing the proposed amendment to remove the co-location condition, remote sites not co-located at a stationary source of HAP regulated by another NESHAP will not be regulated through this action. However, we note that if and when a site remediation is performed as a result of a spill, it will be necessary to bring personnel and remediation equipment to the area, and those responding to such circumstances can be expected to implement situation-appropriate measures to protect air quality under relevant emergency response actions, as provided for under CERCLA, Clean Water Act section 311, and other relevant remediation and emergency response statutes at the state and Federal levels.

The EPA proposed several compliance dates in the May 13, 2016, proposed notice of reconsideration. We proposed to make the recordkeeping and reporting requirements specified in 40 CFR 63.7950 through 63.7953 and 63.7955 applicable to new and existing affected sources conducting site remediations under CERCLA or RCRA on the effective date of the final amendments removing the CERCLA and RCRA exemptions, which is the date of publication of this final rule in the Federal Register .

For existing affected sources ( e.g., existing as of May 13, 2016), we proposed a compliance date for the rule's other requirements for site remediations conducted under the authorities of CERCLA or RCRA of 18 months from the effective date of the final amendments removing the CERCLA and RCRA exemptions.

For new affected sources, we proposed a compliance date for the rule's requirements for site remediations conducted under the authorities of CERCLA or RCRA of the effective date of the final amendments removing the CERCLA and RCRA exemptions or upon initial startup, whichever is later.

Based on our review of the public comments, as discussed below, the EPA is finalizing this action with one change to the proposed compliance dates for existing affected sources. For existing affected sources, the compliance date for all the site remediation NESHAP requirements, including the recordkeeping and reporting requirements specified in 40 CFR 63.7950 through 63.7953 and 63.7955, is 18 months from the effective date of the final amendments removing the CERCLA and RCRA exemptions. This date is June 24, 2024. For new affected sources, the compliance date for all the site remediation NESHAP requirements is the effective date of the final amendments removing the CERCLA and RCRA exemptions or upon initial startup, whichever is later. CAA section 112(d)(10), (i)(1).

The EPA received several comments regarding these compliance timeframes. These comments are summarized below along with our responses.

Comment: Several commenters stated that a compliance date 18 months after the final rule is promulgated may be appropriate for facilities that do not require additional emission controls but claimed that additional time will be needed for facilities that require additional emission controls. Several other commenters stated that 18 months is not enough time to comply with the rule, and potentially not enough time to even determine whether sources are exempt from the rule. These commenters suggest 3 years be given for compliance with the rule amendments. One commenter also suggested that the EPA incorporate into the compliance date the time needed to modify existing RCRA permits or CERCLA records of decision (RODs) to reflect new control devices, time for getting an air construction permit, and time for approval of alternative test methods. This commenter suggested a compliance date of 5 years after the promulgation of the standards. One commenter noted concerns about the compliance date for new sources, which may start up soon after promulgation of the amendments. The commenter recommends that new sources be provided 3 years from the amendment affected date or until initial startup, whichever is later, to comply.

Response: We have concluded that 18 months after the effective date of this action is sufficient time for existing sources to come into compliance. We consider 18 months a reasonable estimate for the work to be done. We also note that commenters have not supplied reasonably specific information that 18 months is not practicable, and the EPA is obligated to require compliance with these requirements as expeditiously as practicable. CAA section 112(i)(3). Further, the EPA does not have discretion under the statute to provide 5 years for existing sources to come into compliance as suggested by one commenter. See id (requiring compliance no later than 3 years after the effective date).

As the EPA indicated at proposal, and as commenters have generally affirmed, for the most part, the emissions standards established in the NESHAP are already being met at cleanups overseen under CERCLA and RCRA, and thus additional emissions controls are unnecessary in most cases. To comply with the NESHAP, we anticipate that some facilities may need to install pressure relief device monitors, which entails identifying affected pressure release devices and installing monitors that are capable of alerting a facility operator of a pressure release device actuation. When these requirements were added to the Site Remediation NESHAP in 2020 (85 FR 41680), the compliance date selected for existing sources was 18 months, to allow site remediation facility owners and operators to research equipment and vendors, and to purchase, install, test, and properly operate any necessary equipment. The EPA considers that providing more than 18 months now for existing facilities operating under the authority of RCRA or CERCLA to comply would be excessive compared to the compliance period provided for other existing facilities and relative to the actual work involved. We also anticipate that some existing facilities may need to revise their leak detection and repair (LDAR) programs to use the leak definitions included in 40 CFR part 63, subpart UU, for valves and pumps. A compliance time of 18 months is adequate for existing facility owners or operators to modify their existing LDAR programs to comply with these standards for pumps and valves. When the requirement to comply with 40 CFR part 63, subpart UU, was added to the Site Remediation NESHAP in 2020 (85 FR 41680) for the leak definitions for valves and pumps rather than the leak definitions of 40 CFR part 63, subpart TT, we provided a one-year compliance date for these requirements for existing facilities. However, to simplify compliance, in this action we have provided one date ( i.e., 18 months after promulgation) by which existing facilities must meet all requirements.

In order to avoid any confusion and unnecessary burden regarding the onset of compliance requirements under the NESHAP for formerly exempt existing sources ( e.g., existing by May 13, 2016), we are not finalizing our proposal that existing sources comply by the effective date of the final rule with the recordkeeping and reporting requirements of 40 CFR 63.7950 through 63.7953 and 63.7955. While we generally believe such requirements could be complied with relatively quickly, the content of many of these requirements relates to information regarding compliance with emissions limitations, work practice standards, or other requirements that would not begin until 18 months after the effective date of this action. E.g., 40 CFR 63.7951(a)(1) (first compliance report not due until the onset of compliance obligations according to the schedule established in 40 CFR 63.7883). The Agency has determined that it would make sense in this case to simply align the onset of all requirements of subpart GGGGG for existing sources under a single compliance schedule. Thus, for existing sources, the compliance date for all requirements of the NESHAP will be 18 months from the effective date of this rule.

Affected sources that commenced construction or reconstruction after May 13, 2016 (the date we proposed to remove the exemptions), are “new sources” for purposes of section 112 and must comply immediately upon the effective date of this final rule or on initial startup, whichever is later. This is consistent with the CAA, and the EPA does not have discretion to alter this requirement. CAA section 112(a)(4), 112(d)(10), and 112(i)(1).

To the extent any source-specific circumstances may exist warranting potential relief from compliance timing as authorized by the statute, source owners or operators are encouraged to review the mechanisms for obtaining such relief that are available under subpart A of part 63. 40 CFR 63.6. For example, 40 CFR 63.6(i) allows the Administrator to grant extensions of compliance with emission standards under certain specified circumstances.

For purposes of complying with the Initial Notification requirements of 40 CFR 63.9(b)(2), the EPA is not finalizing any changes to the language of 40 CFR 63.7950 in this action. However, with respect to both new and existing affected sources formerly covered by the CERCLA and RCRA exemptions being removed in this action, the Agency interprets the phrase “120 calendar days after the source becomes subject to this subpart” as used in paragraphs (b) and (c) of § 63.7950 as referring to the date 120 calendar days after the publication of this document in the Federal Register .

Finally, we note that when and how records of decision at CERCLA Superfund sites may be reopened, amended, or modified is a matter to be addressed within the Superfund program itself rather than in this CAA action.

We are, therefore, finalizing a compliance date of 18 months from the effective date of these final amendments for existing sources and on the effective date or upon initial startup, whichever is later, for new sources that become subject to the Site Remediation NESHAP as a result of the removal of the CERCLA and RCRA exemptions.

We estimate 74 facilities will become subject to the Site Remediation NESHAP as a result of the removal of the CERCLA and RCRA exemptions. Based on available information from the RCRA and CERCLA programs, 31 of these 74 facilities are expected to be subject to only a limited set of the rule requirements under 40 CFR 63.7881(c)(1). Due to the low annual quantity of HAP contained in the remediation material excavated, extracted, pumped, or otherwise removed during the site remediations conducted at these facilities, they would likely only be required under the Site Remediation NESHAP to prepare and maintain written documentation to support the determination that the total annual quantity of the HAP contained in the remediation material excavated, extracted, pumped, or otherwise removed at the facility is less than 1 megagram per year. For the remaining 43 facilities, we anticipate each facility will have an annual quantity of HAP in the removed remediation material of 1 megagram or more. For these facilities, we expect that the facilities already generally meet the emission control and work practice requirements of the Site Remediation NESHAP. As discussed in further detail below, we anticipate certain formerly exempt facilities will incur some limited costs to comply with current SSM provisions in the NESHAP following the RTR rulemaking, 85 FR 41691-96, and the updating of leak detection and repair requirements under CAA section 112(d)(6), 85 FR 41690-91. These impacts are estimated below.

The 2020 RTR rulemaking for the site remediation source category made three substantive changes to the standards. We modified the threshold for detection of leaks for valves and pumps within the existing LDAR program. We also added a requirement to monitor certain pressure release devices (PRDs). 7 While current RCRA standards in subpart BB (40 CFR 264.1050) include LDAR, the leak threshold for valves and pumps in light liquid service are 10,000 ppm. In the 2020 RTR for site remediation, the NESHAP's thresholds were revised to 500 ppm for valves, 1,000 ppm for pumps upon inspection, and 2,000 ppm to make a repair. These changes pursuant to the technology review could require additional actions from affected sources to comply with the Site Remediation NESHAP. However, the decision to remove the CERCLA and RCRA exemptions is not dependent on or affected by the cost of compliance with these changes. We stated in the 2016 proposal that we did not anticipate significant costs of compliance for sources affected by removal of the exemptions. We continue to find this to be the case; however, given that the NESHAP was modified in the interim, we have updated our impact analysis to reflect these changes in the NESHAP, which may result in slightly greater environmental benefits due to removing the exemptions, and some slightly higher compliance costs, as summarized in section IV.C. 8

Of the 43 facilities that we anticipate will have an annual quantity of HAP in the removed remediation material of 1 megagram or more, we anticipate that 30 will have no applicable emission control requirements or work practice standards because the waste is shipped offsite for treatment and no controls or work practice requirements would be applicable prior to treatment. For these 30 facilities, we anticipate the only new requirements for the Site Remediation NESHAP will be the initial and ongoing recordkeeping and reporting obligations required by 40 CFR 63.7936 and 63.7950 through 63.7952. These sections describe the recordkeeping and reporting activities required for transferring the remediation material off-site to another facility; the initial notification and on-going notification requirements; the ongoing semi-annual compliance reporting requirements; and recordkeeping requirements for continuous monitoring, planned routine maintenance, and for units that are exempt from control requirements under §§ 63.7885(c) and/or 63.7886(d).

The remaining 13 facilities are anticipated to have on-site remediation activities for which the emission control requirements of the NESHAP will apply. While we anticipate that most of these emission control activities are already being conducted under existing requirements through RCRA or CERCLA, the PRD and revised LDAR requirements ( e.g., new leak detection and repair thresholds for valves and pumps) will also apply, as well as the recordkeeping and reporting activities described above.

Finally, as explained in the following section, while the EPA generally expects that existing, formerly exempt site remediations are already meeting the substantive emissions control requirements of the NESHAP (with the possible exception of the revisions to the NESHAP promulgated in the 2020 RTR rulemaking), there is at least some anecdotal evidence from comments that this may not be the case in all circumstances. As explained in greater detail in the response to comments document, to the extent this situation exists, it could mean the compliance costs of this action are proportionately greater than we estimate; however, such circumstances do not obviate any prior determinations of cost-effectiveness with respect to this NESHAP. Indeed, such circumstances would only strengthen the basis for removing the exemptions to ensure that the emissions reduction benefits of this NESHAP are achieved.

While new site remediations are likely to be conducted under the authority of CERCLA or RCRA in the future, we are currently not aware of any such new site remediation affected sources that are expected to be constructed.

The potential scope of this action's impacts on affected entities is discussed in greater detail in the memorandum, “National Impacts Associated with the Final Amendments to Remove the Exemption for Facilities Performing Site Remediations under CERCLA or RCRA in the NESHAP for Site Remediation,” which is available in the rulemaking docket (Docket ID No. EPA-HQ-OAR-2002-0021).

We estimate that the application of the change in the LDAR leak thresholds to the formerly exempt sources will result in a HAP emissions reduction of 2 tons per year. As explained in the memo “Leak Detection and Repair Program Impacts for Site Remediation RCRA and CERCLA Facilities” the lower leak threshold has the potential to reduce emissions by requiring repair of smaller leaks.

A second change made in the 2020 rule included a requirement to perform additional monitoring of PRD actuations that will also apply to formerly exempt sources. The PRD monitoring leads to emission reductions by immediately alerting operators to the actuation of a PRD, which is typically caused by a malfunction. Due to their nature, the frequency or duration of malfunctions cannot be predicted, so estimation of future emissions reductions is not possible. As such, no additional emissions reductions due to the addition of PRD monitoring are included in our assessment of air quality impacts.

For the remainder of the Site Remediation NESHAP requirements, we estimate the potential for a small amount of HAP emission reductions from the removal of the CERCLA and RCRA exemptions. We expect that most facilities newly becoming subject to the rule will either be subject to a limited set of the emissions control requirements of the rule due to the low amount of HAP contained in the remediation material handled, will already meet the emissions control requirements of the rule, or will not have any applicable emissions control requirements for the specific remediation activities and material handled. We received comments that some sources subject to RCRA or CERCLA requirements would be required to add or supplement controls if the applicability of the NESHAP was changed. The EPA acknowledges that such a situation could arise and only strengthens the basis for removing the exemptions to ensure that the emissions reduction benefits of this NESHAP are achieved. The commenters did not provide information to allow us to make a reliable estimate of how often this may occur, or the cost or amount of emission reductions that could result from applicable requirements and controls. It is also possible that with further examination of the NESHAP and the existing emissions controls at their facility(s), a commenter could determine that no further emission control is necessary. Another possibility is that certain requirements that should have been in place will now be imposed, and the corresponding emissions reductions will now be realized, further strengthening the basis for removing these exemptions. Thus, the EPA acknowledges that there may be HAP emissions reductions as a result of the remainder of the Site Remediation NESHAP requirements, but we have not quantified the potential reductions beyond the 2 tons per year from LDAR reductions, due to a lack of information to substantiate or quantify the potential reductions. Therefore, while unquantified, we consider there is a potential for an unquantified amount of HAP emission reductions to result from this action.

We anticipate that 13 of the 74 affected facilities will implement additional emissions control measures to meet the LDAR and PRD requirements of the Site Remediation NESHAP at a total estimated capital cost of $79,000 and a total annual cost of $21,000 for all 13 facilities. We have estimated the nationwide annual compliance costs, including the LDAR and PRD requirements for these facilities as well as the reporting and recordkeeping requirements for all 74 affected facilities to be approximately $2.7 million.

The EPA conducted economic impact analyses for this final rule, as detailed in the memorandum, “Economic Impact Analysis for Site Remediation NESHAP Amendments: Final Report,” which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2002-0021). The economic impacts of the rule are calculated as the percentage of total annualized costs incurred by each affected ultimate parent owner relative to their revenues. This ratio provides a measure of the direct economic impact to ultimate parent owners of facilities while presuming no impact on consumers. We estimate that none of the ultimate parent owners affected by this proposal will incur total annualized costs of 0.1 percent or greater of their revenues. Thus, these economic impacts are low for affected companies and the industries impacted by this rule, and there will not be substantial impacts on the market. The costs of the rule are not expected to result in a significant market impact, regardless of whether they are passed on to the purchaser or absorbed by the firms.

The final standards are projected to achieve 2 tons of reductions in HAP through the applicability of lower leak detection and repair thresholds. In addition, we anticipate some unquantified amount of HAP emissions reduction at some formerly exempt site remediations as a result of additional monitoring of PRDs. In addition, any future remediation activities initiated at the formerly exempt existing site remediations or site remediations constructed in the future will include the required levels of HAP emissions control. To the extent facilities newly subject to the NESHAP must revise their CAA monitoring, recordkeeping and reporting, we anticipate improved data and information with respect to air emissions at these facilities. We have not quantified the monetary benefits associated with the amendments; however, the avoided emissions will result in improvements in air quality and reduced negative health effects associated with exposure to air pollution from these emissions.

Executive Order 12898 directs the EPA to identify the populations of concern who are most likely to experience unequal burdens from environmental harms; specifically, minority populations (people of color and/or Indigenous peoples) and low-income populations (59 FR 7629, February 16, 1994). Additionally, Executive Order 13985 is intended to advance racial equity and support underserved communities through Federal Government actions (86 FR 7009, January 25, 2021). The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.” In recognizing that people of color and low-income populations often bear an unequal burden of environmental harms and risks, the EPA continues to consider ways of protecting them from adverse public health and environmental effects of air pollution. Consistent with EPA's commitment to integrating EJ in the Agency's actions, and following the directives set forth in multiple Executive Orders, the Agency has carefully considered the impacts of this action on communities with EJ concerns.

To examine the potential for any EJ concerns that might be associated with site remediation facilities that are affected by removing these exemptions, we performed a demographic analysis, which is an assessment of individual demographic groups of the populations living within 5 kilometers (km) and 50 km of the facilities. The EPA then compared the data from this analysis to the national average for each of the demographic groups.

The results show that for populations within 5 km of the 74 existing facilities, the following demographic groups were above the national average: African American (15 percent versus 12 percent nationally), Hispanic/Latino (21 percent versus 19 percent nationally), Other/Multiracial (16 percent versus 8 percent nationally), people living below the poverty level (16 percent versus 13 percent nationally), over 25 without a high school diploma (14 percent versus 12 percent nationally) and linguistic isolation (7 percent versus 5 percent nationally).

The results show that for populations within 50 km of the 74 existing facilities, the following demographic groups were above the national average: African American (15 percent versus 12 percent nationally), Hispanic/Latino (21 percent versus 19 percent nationally), Other/Multiracial (12 percent versus 8 percent nationally), over 25 without a high school diploma (13 percent versus 12 percent nationally) and linguistic isolation (7 percent versus 5 percent nationally). The average percentage of the population living within 50km of the 74 facilities that is living below the poverty level is equal to the national average (13 percent). However, we note that half of the facilities (34 facilities) have populations within 50km that are above the national average for poverty.

A summary of the proximity demographic assessment performed is included as Table 2. The methodology and the results of the demographic analysis are presented in a technical report, “Analysis of Demographic Factors for Populations Living Near Site Remediation Facilities,” available in the docket for this action (Docket ID EPA-HQ-OAR-2002-0021).

The EPA investigated the risk for exempt sources in parallel to the risk assessment for the affected sources of the category (Docket ID No. EPA-HQ-OAR-2018- 0833). The maximum individual risk for cancer was 4-in-1 million for actual emissions and for maximum allowable emissions. The hazard indices for noncancer risks were well below 1 (0.3 for actual and maximum allowable emissions). The regulatory changes to this NESHAP (subpart GGGGG) discussed in section III.A of this action will further the effort to improve human health impacts for populations in these demographic groups.

Among the 13 facilities for which we anticipate this action will result in a reduction of HAP emissions, the area within 5km of at least seven of the facilities exceeds the national average for at least one racial/ethnicity demographic, the area within 5km of at least six facilities exceeds the national average for “People Living Below the Poverty Level”, and the area within 5km of at least five facilities exceeds the national average for “Greater than or equal to 25 years of age without a High School Diploma.” The changes will provide additional health protection for all populations, including for people of color, low-income, and indigenous communities living near these sources.

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel legal and policy issues. Any changes made in response to OMB recommendations have been documented in the docket.

The information collection activities in this rule have been submitted for approval to OMB under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2062.10. OMB Control Number 2060-0534. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them. To check whether the ICR for this action is approved, please consult Reginfo.gov at https://www.reginfo.gov/public/do/PRASearch, and search using OMB Control Number 2060-0534. OMB typically reviews ICR packages within sixty days of a final notice.

The information requirements are based on notification, recordkeeping, and reporting requirements in the NESHAP General Provisions (40 CFR part 63, subpart A), which are mandatory for all operators subject to national emission standards. These recordkeeping and reporting requirements are specifically authorized by section 114 of the CAA (42 U.S.C. 7414). All information submitted to the EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to agency policies set forth in 40 CFR part 2, subpart B.

Respondents/affected entities: Unlike a specific industry sector or type of business, the respondents potentially affected by this ICR cannot be easily or definitively identified. Potentially, the Site Remediation NESHAP may be applicable to any type of business or facility at which a site remediation is conducted to clean up media contaminated with organic HAP when the remediation activities are performed, the authority under which the remediation activities are performed, and the magnitude of the HAP in the remediation material meets the applicability criteria specified in the rule. A site remediation that is subject to this rule potentially may be conducted at any type of privately-owned or government-owned facility at which contamination has occurred due to past events or current activities at the facility. For site remediation performed at sites where the facility has been abandoned and there is no owner, a government agency takes responsibility for the cleanup.

Respondent's obligation to respond: Mandatory (42 U.S.C. 7414).

Estimated number of respondents: 104 total for the source category, of which 74 are estimated to become respondents as a result of this final action.

Frequency of response: Semiannual.

Total estimated burden: 42,945 total hours (per year) for the source category, of which 24,068 hours are estimated as a result of this final action. Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $3.1 million total (per year) for the source category, of which approximately $2.7 million is estimated as a result of this final action. This includes $250,000 total annualized capital or operation and maintenance costs for the source category, of which $146,000 is estimated as a result of this final action.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The final amendments to the Site Remediation NESHAP are estimated to affect 74 facilities. Of these 74 facilities, 19 are owned by the Federal Government, which is not a small entity. The remaining 55 facilities are owned by 46 firms, and the Agency has determined that one of these can be classified as a small entity using the Small Business Administration size standards for their respective industries. The small entity subject to the requirements of this action is a small business. The Agency has determined that one small business may experience an impact of less than 0.1% of revenues in one year. Details of this analysis are presented in the memorandum, “Economic Impact Analysis for Site Remediation NESHAP Amendments: Final Report,” which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2002-0021).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. While this action creates an enforceable duty on the private sector, the cost does not exceed $100 million or more.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. Because the proposed rule amendments would result in reduced emissions of HAP and reduced risk to anyone exposed, the EPA believes that the proposed rule amendments would provide additional protection to children. More information on the source category's risk can be found in section IV of the preamble published on September 13, 2019 (84 FR 46138). The complete risk analysis results and the details concerning its development are presented in the memorandum entitled “Residual Risk Assessment for the Site Remediation Source Category in Support of the 2019 Risk and Technology Review Proposed Rule,” available in the docket (Docket ID No. EPA-HQ-OAR-2018- 0833).

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Additional technological controls are not anticipated due to this action and no increased energy use is expected.

This rulemaking does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations (people of color and/or Indigenous peoples) and low-income populations as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The results of our demographic analysis show that the percentages of people of color, low-income populations and/or indigenous peoples who live within 5 km of the 74 existing facilities are slightly (2 or 3 percent) or moderately higher (8 percent) than the national average: African American (15 percent versus 12 percent nationally), Hispanic/Latino (21 percent versus 19 percent nationally), Other/Multiracial (16 percent versus 8 percent nationally), people living below the poverty level (16 percent versus 13 percent nationally), over 25 without a high school diploma (14 percent versus 12 percent nationally) and linguistic isolation (7 percent versus 5 percent nationally). The small level of emission reductions is unlikely to affect the risk borne by these populations in a measurable amount. The reductions of 2 tons of HAP per year plus an unquantifiable amount due to the remainder of the NESHAP provisions discussed in section IV.B are not enough to be reliably quantified with respect to risk or impact. While the quantity of HAP reductions is small, directionally the final amendments increase the level of protection provided to human health and the environment by regulating site remediations previously exempt from the Site Remediation NESHAP.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons stated in the preamble, the Environmental Protection Agency amends title 40, chapter I, of the Code of Federal Regulations (CFR) 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 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/ title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0189 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 February 21, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0189, by one of the following methods:

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

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

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

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

In the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-11-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11661) by the USDA Animal and Plant Health Inspection Service, 4700 River Road, Unit 149, Riverdale, MD 20737. The petition requested that 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of iron oxide (Fe 3 O 4 ) (CAS Reg. No. 1317-61-9) when used as an inert ingredient (colorant) in pesticide formulations at no more than 2,000 parts per million (ppm) (0.2% by weight) in the final formulation applied to animals. That document referenced a summary of the petition prepared by the USDA Animal and Plant Health Inspection Service, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. When making a safety determination for an exemption for the requirement of a tolerance, FFDCA section 408(c)(2)(B) directs EPA to consider the considerations in section 408(b)(2)(C) and (D). 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. . . .” Section 408(b)(2)(D) lists other factors for EPA consideration making safety determinations, e.g., the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances, among others.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 iron oxide (Fe 3 O 4 ) including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with iron oxide (Fe 3 O 4 ) follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by iron oxide (Fe 3 O 4 ) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The toxicological database of iron oxide (Fe 3 O 4 ) is supported by data regarding iron oxide red and iron oxide yellow. EPA has determined that it is appropriate to bridge iron oxide red and iron oxide yellow data to assess iron oxide (Fe 3 O 4 ) due to similarities in structure, and similarities among the available human health toxicity data of these substances.

Iron oxide (Fe 3 O 4 ) exhibits low levels of acute toxicity via the oral and inhalation routes of exposure and is anticipated to have low acute dermal toxicity. It is not a skin or eye irritant nor a skin sensitizer. No adverse effects were reported in the 90-day study in rats. No evidence of neurotoxicity was observed in the neurotoxicity screening performed in the 90-day oral rat study, and no evidence of immunotoxicity was seen in the available studies. No adverse reproduction or developmental effects were reported in the available reproduction and developmental toxicity study summaries in rats. Furthermore, concern for carcinogenicity is low, based on negative results in a mutagenicity study, and the lack of structural alerts for mutagenicity or carcinogenicity.

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

The hazard profile of iron oxide (Fe 3 O 4 ) is adequately defined. Overall, iron oxide (Fe 3 O 4 ) is of low acute, subchronic, and developmental toxicity. No systemic toxicity is observed up to 1,000 mg/kg/day. Since signs of toxicity were not observed, no toxicological endpoints of concern or PODs were identified. Therefore, a qualitative risk assessment for iron oxide (Fe 3 O 4 ) can be performed.

1. Dietary exposure from food and feed uses and drinking water. In evaluating dietary exposure to iron oxide (Fe 3 O 4 ), EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from iron oxide (Fe 3 O 4 ) in food as follows:

Dietary exposure to iron oxide (Fe 3 O 4 ) may occur from consuming game treated with pesticide formulations (baits) containing this inert ingredient and from non-pesticidal uses (food additive uses and inactive ingredient uses in FDA-approved drugs). Exposure to iron oxide (Fe 3 O 4 ) via drinking water is expected to be negligible, based on the limited use pattern (baits). However, no toxicological endpoints of concern were selected, and therefore, a quantitative dietary exposure assessment for iron oxide (Fe 3 O 4 ) was not conducted.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

No residential exposure is anticipated from the proposed uses for iron oxide (Fe 3 O 4 ) in pesticide formulation applied to animals. Iron oxide (Fe 3 O 4 ) may be present in current pesticide and non-pesticide products that may be used in and around the home. However, a quantitative residential exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

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

Based on the lack of toxicity in the available database, EPA has not found iron oxide (Fe 3 O 4 ) to share a common mechanism of toxicity with any other substances, and iron oxide (Fe 3 O 4 ) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that iron oxide (Fe 3 O 4 ) does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

Based on an assessment of available data for iron oxide (Fe 3 O 4 ), EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. Because there are no threshold effects associated with iron oxide (Fe 3 O 4 ), EPA conducted a qualitative assessment. As part of that assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Because no toxicological endpoints of concern were identified, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to iron oxide (Fe 3 O 4 ) residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of iron oxide (Fe 3 O 4 ) in or on any food commodities. EPA is establishing a limitation on the amount of iron oxide (Fe 3 O 4 ) that may be used in pesticide formulations applied to animals. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 0.2% iron oxide (Fe 3 O 4 ) in the final pesticide formulation.

Therefore, an exemption from the requirement of a tolerance is established in 40 CFR 180.930 for residues of iron oxide (Fe 3 O 4 ) (CAS Reg. No. 1317-61-9) when used as an inert ingredient (colorant) in pesticide formulations at no more than 0.2% by weight of the final formulation applied to animals.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption 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:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0301 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 February 21, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0301, by one of the following methods:

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

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

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

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

In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-6), 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 (PP2F8006) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.213 be amended by establishing tolerances for residues of the herbicide simazine, in or on citrus fruits (crop group 10), pome fruits (crop group 11), stone fruits (crop group 12), and tree nuts (crop group 14, except almond hull) at 0.05, 0.03, 0.1, and 0.07 parts per million (ppm), respectively, and amending the tolerance for residues in or on almond hulls to 3 ppm. In addition, the petition requested the removal of tolerances for apple, hazelnut, peach, pecan, plum, and walnut at 0.20 ppm, and for almond, cherry, grapefruit, lemon, macadamia nut, orange, and pear at 0.25 ppm, upon establishment of the new tolerances. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA determined that the residue data for the citrus fruit crop group support a tolerance level of 0.04 ppm, not 0.05 ppm as proposed by the registrant, and a level of 0.05 ppm not 0.07 ppm is being established for crop group 14-12. The reasons for these changes are explained in Unit IV.C.

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Simazine is a chlorotriazine herbicide that is similar in structure to atrazine and propazine. These chlorotriazine herbicides, along with their common chlorinated metabolites, have been determined by the EPA to share a common neuroendocrine mechanism of toxicity and constitute the triazine common mechanism group (CMG). Because of the similar structures and metabolites among these three pesticides, they are also assumed to be of equal potency for neuroendocrine effects. Therefore, the more robust toxicological database for atrazine has been used to characterize neuroendocrine toxicity, and for endpoint selection, for all of these compounds. The neuroendocrine endpoint chosen for these chemicals is attenuation of the luteinizing hormone (LH) surge after 4 days of exposure, the most sensitive effect which protects for other downstream adverse endocrine related toxicological effects and potential effects on non-endocrine systems.

EPA has concluded that the available data do not identify a unique quantitative susceptibility in the developing organism. None of the available studies with atrazine evaluating rats exposed during gestation, lactation, or in the peri-pubertal periods have shown effects at doses lower than those eliciting the LH surge attenuation in adult female rats after 4 days of exposure. Additionally, the POD, based upon attenuation of the LH surge, is protective against adverse reproductive/developmental outcomes such as delays in onset of puberty, disruption of ovarian cyclicity and inhibition of prolactin release. For other potential adverse outcomes, the effects occurred at dose levels approximately one order of magnitude or higher than the no observed adverse effect level (NOAEL)/lowest observed adverse effect level (LOAEL) for LH surge attenuation. As simazine has been classified as “Not likely to be carcinogenic to humans,” cancer risk is not a concern and a quantitative cancer risk assessment was not conducted.

In addition to the chlorotriazine metabolites, simazine also has an analogous series of metabolites, known as the hydroxy metabolites, in which the chlorine is replaced by a hydroxy moiety. While the hydroxy metabolites are all considered to be of equal toxicity to each other, these compounds exhibit different toxicological properties than the chlorinated metabolites, and risk estimates are therefore quantified separately using an endpoint and POD based on hydroxyatrazine. The available data indicate that the kidney is the primary target organ for hydroxysimazine and its metabolites.

There is no evidence for increased susceptibility in the young following in utero exposure or carcinogenicity in the available data for hydroxysimazine and its metabolites.

A complete discussion of the toxicological profile for simazine and specific information on the studies received and the nature of the adverse effects caused by simazine as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document titled Simazine. “Human Health Risk Assessment for Registration Review and to Support the Registration of Proposed Uses on Citrus Fruit (Crop Group 10-10), Pome Fruit (Crop Group 11-10), Stone Fruit (Crop Group 12-12), Tree Nuts (Crop Group 14-12), and Tolerance Amendment for Almond Hulls” in docket ID number EPA-HQ-OPP-2013-0251.

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

The toxicological endpoints for simazine used for human risk assessment and an explanation for how the Agency calculated those PODs can be found in the Simazine Human Health Risk Assessment, sections 4.6-4.84, 5.4.2.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to simazine, EPA considered exposure under the petitioned-for tolerances as well as all existing simazine tolerances in 40 CFR 180.213. EPA assessed dietary exposures from simazine and its chlorinated metabolites separately from exposures to hydroxysimazine and the hydroxylated metabolites due to the different toxicities observed for the compounds. The assessments of residues of these substances in food were conducted as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for simazine and its chlorinated metabolites but not for hydroxysimazine and the hydroxylated metabolites.

In estimating acute dietary exposure to residues of simazine and its chlorinated metabolites, EPA used 2003-2008 food consumption information from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to anticipated residue levels in food, the acute assessment was refined using field trial data, default processing factors, and assumed that 100% of the proposed and registered commodities were treated.

ii. Four-day/Chronic exposure. Typically, chronic exposure is assessed, but for simazine and its chlorinated metabolites a four-day exposure duration is appropriate since the toxicological effect (attenuation of the LH surge) occurs after four days of exposure and is protective of exposures of longer durations. In conducting the four-day dietary exposure assessment, EPA used the food consumption data from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to anticipated residue levels in food, four-day dietary assessments were partially refined using field trial studies, default processing factors, and assumed that 100% of the proposed and registered commodities were treated.

In conducting the chronic dietary exposure assessment for hydroxysimazine and its hydroxylated metabolites, EPA used the food consumption data from USDA's NHANES/WWEIA. As to anticipated residue levels in food, the chronic dietary assessment for hydroxysimazine and its hydroxylated metabolites was refined using residue levels from metabolism studies, default processing factors, and average percent crop treated data.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that neither simazine nor hydroxysimazine poses a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

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

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

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

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

• Condition c: Data are available on pesticide use and food consumption in a particular area, 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.

The acute and four-day steady state dietary assessment for simazine assumed 100% crop treated for all registered and requested crops. The chronic (background) assessments for simazine and its chlorinated metabolites and for hydroxysimazine and its hydroxylated metabolites incorporated average percent crop treated estimates as follows: almond: 10%; apple: 10%; avocado: 5%; blueberry: 15%; caneberry: 45%; cherry: 5%; field corn: 5%; sweet corn: 2.5%; grapefruit: 20%; grape: 25%; hazelnut: 35%; lemon: 10%; nectarine: 5%; olive: 15%; orange: 25%; peach: 15%; pear: 10%; pecan: 5%; plums/prunes: 2.5%; strawberry: 5%; tangerine: 5%; and walnut: 20%. 100% CT was assumed for the remaining commodities.

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

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

2. Dietary exposure from drinking water. Extensive and robust surface and groundwater monitoring data are available for triazines (including simazine) and were included in the drinking water assessment. The Agency also used screening-level water exposure models in the dietary exposure analysis and risk assessment for simazine in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of simazine. Estimated drinking water concentrations (EDWCs) are based on total triazine residues, which include atrazine, propazine, and simazine, and all the related metabolites, and are not just based on simazine and its chlorinated and hydroxylated metabolites, these EDWCs may be considered high-end estimates for the simazine risk assessment. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment.

Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the surface water concentration calculator (SWCC), and FQPA Index Reservoir Screening Tool (FIRST) modeling, the EDWCs of simazine are estimated to be 265-610 parts per billion (ppb) for surface water and 92.6-100 ppb for groundwater for acute exposure; 265-585 ppb for surface water and 92.6-100 ppb for groundwater for the 4-day exposures; and 76-104 ppb for surface water and 5.11-7.33 ppb for groundwater for chronic exposures for non-cancer assessments.

A drinking water level of comparison (DWLOC) approach to aggregate risk was used to calculate the amount of exposure available in the total `risk cup' for drinking water after accounting for any exposures from food and/or residential use. The DWLOCs are then compared to the EDWCs. If the DWLOCs are greater than the EDWCs, there is no aggregate risk of concern. The use of a DWLOC approach facilitates determining aggregate risks when there are multiple EDWCs or when there are potential aggregate risk estimates of concern. Water ingestion rates are included in the acute and chronic DWLOC calculations. These values vary with population subgroup, the duration time of interest, and the exposure percentile applicable for regulation. These values were determined directly from the NHANES/WWEIA water consumption data, making use of the appropriate exposure durations and percentiles. For the simazine 4-day aggregate assessments, the DWLOC approach used a reciprocal MOE calculation method since the target MOEs (level of concern based on the total uncertainty factor) are the same for all relevant sources of exposure. For the four-day assessment, water consumption is accounted for in the PBPK model when deriving the drinking water PODs and is not included in the DWLOC calculation. Infants and children were assumed to consume water 6 times a day, with a total consumption volume of 0.688557 liters per day (L/day). Youths and female adults were assumed to consume water 4 times a day, with a total consumption volume of 1.71062 L/day.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Simazine is currently registered for the following uses that could result in residential exposures: residential turf. There are no residential handler combined (dermal + inhalation) risk estimates of concern for simazine.

There is potential for short-term post-application exposure for individuals as a result of being in an environment that has been previously treated with simazine. There were post-application dermal risk estimates of concern for adults and children 1 to <2 years old and combined (dermal + incidental oral) risk estimates of concern for children 1 to <2 years old (LOC = 30) from high contact activities on treated turf. These scenarios are considered worst-case and are protective of all other exposure scenarios.

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

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

Simazine is a chlorotriazine herbicide. A cumulative risk assessment with the chlorotriazines atrazine, simazine, propazine, and their common metabolites is available at https://www.regulations.gov, Docket ID EPA-HQ-OPP-2013-0266.

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

2. Prenatal and postnatal sensitivity. For simazine and its chlorinated metabolites, there was no increased quantitative or qualitative susceptibility in any of the guideline studies on atrazine in the rat, and there was no increased quantitative susceptibility in the rabbit study. Although there was increased qualitative susceptibility in the atrazine rabbit study, increased resorptions (deaths) at a dose level that resulted in decreased body-weight gain and clinical signs in the maternal animal the observed effects occur at higher doses than the benchmark dose lower confidence limit (BMDL) of 2.42 mg/kg/day used to assess risk. The BMDL of 2.42 mg/kg/day is protective of developmental effects in the rabbit.

For hydroxysimazine, there was no evidence of increased qualitative or quantitative susceptibility in the available toxicological data on this metabolite including a developmental rat study and female and male pubertal assays.

3. Conclusion. For simazine and its chlorinated metabolites, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X based on lack of increased sensitivity for infants and children. That decision is based on the following findings:

i. The toxicity database for the chlorotriazines (including simazine) and their metabolites is considered complete.

ii. Chlorotriazines have an established neuroendocrine mode of action and LH attenuation is the most sensitive endpoint identified in the database. LH attenuation is protective of potential health outcomes associated with chlorotriazines.

iii. There was no increased quantitative or qualitative susceptibility in any of the guideline studies on atrazine in the rat, and there was no increased quantitative susceptibility in the rabbit study. Although there was increased qualitative susceptibility in the atrazine rabbit study, the observed effects occur at higher doses than the benchmark dose lower confidence limit (BMDL) of 2.42 mg/kg/day used to assess risk. The BMDL of 2.42 mg/kg/day is protective of developmental effects in the rabbit.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to simazine in drinking water. These assessments will not underestimate the exposure and risks posed by simazine.

For hydroxysimazine, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X based on lack of increased sensitivity for infants and children. That decision is based on the following findings:

i. The toxicity database for hydroxysimazine is complete for a metabolite.

ii. Hydroxysimazine does not have a neuroendocrine mode of action as the parent chlorotriazines.

iii. There was no evidence of increased qualitative or quantitative susceptibility in the available toxicological data on this metabolite including a developmental rat study and female and male pubertal assays.

iv. There are no residual uncertainties identified in the exposure databases.

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

1. Acute risk. Simazine and its chlorinated metabolites. The acute aggregate assessment considers food and water exposures. The acute DWLOC for females 13 to 49 years old is 5,500 ppb. The acute DWLOC is greater than the acute EDWCs for total chlorotriazines TCTs in surface water or ground water (EDWC range = 100-610 ppb); there is no acute aggregate risk of concern.

No toxicological effects attributable to a single dose were identified for hydroxysimazine; therefore, an acute endpoint has not been identified and no risk is expected from this exposure scenario.

2. Four-day/Chronic risk. Simazine and its chlorinated metabolites. The four-day aggregate risk assessments are protective for short-term, intermediate-term, and chronic aggregate risks since the POD and endpoint used for the four-day assessment are the most sensitive for any duration, and are, therefore, protective of longer durations of exposure. The calculated four-day DWLOCs are all greater than the 4-day EDWCs for TCTs in surface water or ground water; there are no four-day aggregate risks of concern.

The chronic aggregate risk assessment for the hydroxysimazine considers food and water exposures. No residential exposures to the hydroxysimazine metabolite are expected from the simazine uses. The lowest chronic DWLOC for hydroxysimazine is for all infants (<1 year old) at 1300 ppb. The chronic DWLOCs are greater than the chronic EDWCs for total hydroxytriazines (THTs) in surface water or ground water (EDWC range = 7.33-76 ppb); there is no chronic aggregate risk of concern.

3. Aggregate cancer risk for U.S. population. Simazine has been classified as “Not likely to be carcinogenic to humans.” Hydroxysimazine is also not likely to pose cancer risks based on the lack of cancer effects seen in available studies.

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

Adequate enforcement methodology (LC-MS/MS) is available to enforce the tolerance expression.

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

The Codex has not established MRLs for simazine.

The submitted residue data support a tolerance level of 0.04 ppm for the citrus fruit crop group. The petitioner's proposed tolerance level of 0.05 ppm was based on using the maximum combined residue level of 0.038 ppm (one grapefruit sample) in the Organisation for Economic Co-operation and Development (OECD) tolerance calculation procedures. EPA's approach to tolerance calculations uses the average field trial value of 0.034 ppm, which warrants a tolerance of level of 0.04 ppm instead. Also, although the proposed tolerance level of 0.07 ppm for crop group 14-12 is supported by OECD tolerance calculations, EPA is establishing the tolerance at 0.05 ppm to harmonize with the Canadian MRL. Due to the conservatisms in the OECD calculator, the tolerance level of 0.05 ppm will be sufficient to cover residues of simazine in or on food resulting from legal applications of the pesticide.

In this Final Rule, EPA is reducing the existing tolerances for the commodities of almond from 0.25 to 0.05 ppm as part of nut, tree, group 14-12; apple from 0.2 to 0.03 ppm as part of fruit, pome, group 11-10; cherry from 0.25 to 0.1 ppm as part of fruit, stone, group 12-12; grapefruit, lemon, and orange from 0.25 to 0.04 ppm as part of fruit, citrus, group 10-10; hazelnut, nut, macadamia, pecan, and walnut from 0.2 to 0.05 ppm as part of nut, tree, group 14-12; peach and plum from 0.2 to 0.1 ppm as part of fruit, stone, group 12-12; and pear from 0.25 to 0.03 as part of fruit, pome, group 11-10. The Agency is reducing these tolerances because available residue data demonstrates that the new tolerances are sufficient to cover residues on these commodities.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the WTO of this revision in order to satisfy its obligation. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing tolerances to allow those tolerances to remain in effect for a period of six months after the effective date of this final rule, in order to address this requirement. After the six-month period expires, residues of simazine on grapefruit, lemon, and orange cannot exceed the citrus fruits (crop group 10-10) tolerance of 0.04 ppm; apple and pear cannot exceed the pome fruits (crop group 11-10) tolerance of 0.03 ppm; cherry, peach, and plum cannot exceed the stone fruits (crop group 12-12) tolerance of 0.1 ppm; and almond, hazelnut, nut, macadamia, pecan, and walnut cannot exceed the tree nuts (crop group 14-12) tolerance of 0.05 ppm.

This reduction in tolerance levels is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. The new tolerance levels are supported by available residue data.

Therefore, tolerances are established for residues of simazine in or on Fruit, citrus, group 10-10, Fruit, pome, group 11-10, Fruit, stone, group 12-12, and Nut, tree, group 14-12 at 0.04 ppm, 0.03 ppm, 0.10 ppm, and 0.05 ppm, respectively, and the tolerance for Almond, hulls is amended to 3 ppm.

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

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

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

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

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

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

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, the EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. The EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund section”) and one of sites that are owned or operated by other Federal agencies (the “Federal Facilities section”). With respect to sites in the Federal Facilities section, these sites are generally being addressed by other federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each Federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the HRS, which the EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening tool to evaluate the relative potential of uncontrolled hazardous substances, pollutants or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), the EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. On January 9, 2017 (82 FR 2760), a subsurface intrusion component was added to the HRS to enable the EPA to consider human exposure to hazardous substances or pollutants and contaminants that enter regularly occupied structures through subsurface intrusion when evaluating sites for the NPL. The current HRS evaluates four pathways: ground water, surface water, soil exposure and subsurface intrusion, and air. As a matter of agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL. (2) Each state may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each state as the greatest danger to public health, welfare or the environment among known facilities in the state. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2). (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

• The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

• The EPA determines that the release poses a significant threat to public health.

• The EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

The EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with a permanent remedy, taken instead of or in addition to removal actions” (40 CFR 300.5).) However, under 40 CFR 300.425(b)(2), placing a site on the NPL “does not imply that monies will be expended.” The EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so. Indeed, the precise nature and extent of the site are typically not known at the time of listing.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. However, the NPL site is not necessarily coextensive with the boundaries of the installation or plant, and the boundaries of the installation or plant are not necessarily the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location where that contamination has come to be located, or from where that contamination came.

In other words, while geographic terms are often used to designate the site ( e.g., the “Jones Co. Plant site”) in terms of the property owned by a particular party, the site, properly understood, is not limited to that property ( e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property ( e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to, nor confined by, the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. In addition, the site name is merely used to help identify the geographic location of the contamination; and is not meant to constitute any determination of liability at a site. For example, the name “Jones Co. plant site,” does not imply that the Jones Company is responsible for the contamination located on the plant site.

EPA regulations provide that the remedial investigation (“RI”) “is a process undertaken . . . to determine the nature and extent of the problem presented by the release” as more information is developed on site contamination, and which is generally performed in an interactive fashion with the feasibility study (“FS”) (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, the HRS inquiry focuses on an evaluation of the threat posed and therefore the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted previously, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, it can submit supporting information to the agency at any time after it receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

The EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that the EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii) The remedial investigation has shown the release poses no significant threat to public health or the environment and taking of remedial measures is not appropriate.

In November 1995, the EPA initiated a policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and made available for productive use.

The EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) the EPA has determined that the response action should be limited to measures that do not involve construction ( e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For more information on the CCL, see the EPA's internet site at https://www.epa.gov/superfund/construction-completions-national-priorities-list-npl-sites-number.

The Sitewide Ready for Anticipated Use measure represents important Superfund accomplishments, and the measure reflects the high priority the EPA places on considering anticipated future land use as part of the remedy selection process. See Guidance for Implementing the Sitewide Ready-for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies to final and deleted sites where construction is complete, all cleanup goals have been achieved, and all institutional or other controls are in place. The EPA has been successful on many occasions in carrying out remedial actions that ensure protectiveness of human health and the environment for current and future land uses, in a manner that allows contaminated properties to be restored to environmental and economic vitality. For further information, please go to https://www.epa.gov/superfund/about-superfund-cleanup-process#reuse.

In order to maintain close coordination with states and tribes in the NPL listing decision process, the EPA's policy is to determine the position of the states and tribes regarding sites that the EPA is considering for listing. This consultation process is outlined in two memoranda that can be found at the following website: https://www.epa.gov/superfund/statetribal-correspondence-concerning-npl-site-listing.

The EPA has improved the transparency of the process by which state and tribal input is solicited. The EPA is using the Web and where appropriate more structured state and tribal correspondence that: (1) Explains the concerns at the site and the EPA's rationale for proceeding; (2) requests an explanation of how the state intends to address the site if placement on the NPL is not favored; and (3) emphasizes the transparent nature of the process by informing states that information on their responses will be publicly available.

A model letter and correspondence between the EPA and states and tribes where applicable, is available on the EPA's website at https://www.epa.gov/superfund/statetribal-correspondence-concerning-npl-site-listing.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at the EPA headquarters and in the EPA regional offices.

An electronic version of the public docket is available through https://www.regulations.gov (see table below for docket identification numbers). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facilities identified in section II.D.

The headquarters docket for this rule contains the HRS score sheets, the documentation record describing the information used to compute the score, a list of documents referenced in the documentation record for each site and any other information used to support the NPL listing of the site. These documents are also available online at https://www.regulations.gov.

The EPA regional dockets contain all the information in the headquarters docket, plus the actual reference documents containing the data principally relied upon by the EPA in calculating or evaluating the HRS score. These reference documents are available only in the regional dockets.

You may view the documents that support this rule online at https://www.regulations.gov or by contacting the EPA HQ docket or appropriate regional docket. The hours of operation for the headquarters docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays. Please contact the individual regional dockets for hours. For addresses for the headquarters and regional dockets, see ADDRESSES section in the beginning portion of this preamble.

You may obtain a current list of NPL sites via the internet at https://www.epa.gov/superfund/national-priorities-list-npl-sites-site-name.

This final rule adds the following two sites to the NPL, all to the General Superfund section. Both of these sites are being added to the NPL based on an HRS score of 28.50 or above.

The EPA reviewed all comments received on the sites in this rule and responded to all relevant comments. The EPA is adding two sites to the NPL in this final rule. The Hercules Inc site in Hattiesburg, MS, was proposed for addition to the NPL on March 18, 2022 (87 FR 15349). The PCE—Carriage Cleaners site was proposed for addition to the NPL on September 9, 2022 (87 FR 55342).

Comments on the Hercules Inc site have been addressed in a response to comment support document available in the public docket concurrently with this rule. To view public comments on this site, as well as EPA's response, please refer to the support document available at https://www.regulations.gov.

The EPA received no comments in the docket for the PCE—Carriage Cleaners site. The EPA received three comments in the East Basin Road Groundwater docket that expressed support for sites in the September 9, 2022 proposed rule, including the PCE—Carriage Cleaners site.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA. This rule does not contain any information collection requirements that require approval of the OMB.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of hazardous substances depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector. Listing a site on the NPL does not itself impose any costs. Listing does not mean that the EPA necessarily will undertake remedial action. Nor does listing require any action by a private party, state, local or tribal governments or determine liability for response costs. Costs that arise out of site responses result from future site-specific decisions regarding what actions to take, not directly from the act of placing a site on the NPL.

This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. Listing a site on the NPL does not impose any costs on a tribe or require a tribe to take remedial action. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because this action itself is procedural in nature (adds sites to a list) and does not, in and of itself, provide protection from environmental health and safety risks. Separate future regulatory actions are required for mitigation of environmental health and safety risks.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. As discussed in section I.C. of the preamble to this action, the NPL is a list of national priorities. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance as it does not assign liability to any party. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation. Under 5 U.S.C. 801(b)(1), a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802. Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983), and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996), cast the validity of the legislative veto into question, the EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, the EPA will publish a document of clarification in the Federal Register .

For the reasons set out in the preamble, title 40, chapter I, part 300, of the Code of Federal Regulations is amended as follows:

This summary of the 3.45 GHz Clearinghouse Order in WT Docket No. 19-348, DA 22-1188, adopted and released November 10, 2022. The full text of the 3.45 GHz Clearinghouse Order, including all Appendices, is available for public inspection at the following internet address: https://docs.fcc.gov/public/attachments/DA-22-1188A1.pdf. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to FCC504@fcc.gov or calling the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice) or 202-418-0432 (TTY).

The Regulatory Flexibility Act of 1980, as amended (RFA), requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” 5 U.S.C. 605(b). Accordingly, the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) concerning the possible impact of the rule changes contained in the 3.45 GHz Band Second Report and Order (R&O) (86 FR 17920, April 7, 2021) on small entities. As required by the RFA, an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Further Notice of Proposed Rulemaking ( FNPRM ) released in October 2020 in this proceeding (85 FR 66888, October 21, 2020). The Commission sought written public comment on the proposals in the FNPRM, including comments on the IRFA. No comments were filed addressing the IRFA. This FRFA conforms to the RFA. The Commission will send a copy of the 3.45 GHz Clearinghouse Order, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration.

This document contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, it contains new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will send a copy of the 3.45 GHz Clearinghouse Order (Order) to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

With this final action, the Wireless Telecommunications Bureau (Bureau) identifies four entities that will form a search committee to select a Reimbursement Clearinghouse (Clearinghouse) to oversee the reimbursement of relocation expenses for certain secondary, non-Federal radiolocation licensees in the 3.45-3.55 GHz band (3.45 GHz band). These entities are NBCUniversal, Nexstar Broadcasting (Nexstar), CTIA, and the Competitive Carriers Association (CCA). In addition, the Bureau adopts certain requirements regarding the Clearinghouse search committee process and the operation of the Clearinghouse. These requirements support the prevention of waste, fraud, and abuse in the handling of reimbursement funds and will protect confidential information.

In the 3.45 GHz Band Second R&O, the Commission adopted rules to make 100 megahertz of mid-band spectrum available for flexible use throughout the contiguous United States. To facilitate this goal, the Commission previously had determined that secondary, non-Federal radiolocation licensees in the band would be relocated to the 2.9-3.0 GHz band. In the 3.45 GHz Band Second R&O, the Commission further determined that secondary, non-Federal radiolocation authorizations would sunset 180 days after new 3.45 GHz Service licenses are granted in the band. Because these licenses were granted on May 4, 2022, the non-Federal radiolocation authorizations sunset on October 31, 2022. In addition, the Commission in the 3.45 GHz Band Second R&O required “new flexible-use licensees in the 3.45 GHz Service to reimburse secondary, non-federal radiolocation licensees for reasonable costs related to the relocation of those operations to the 2.9-3.0 GHz band, including the costs of a relocation clearinghouse's administration of the reimbursement.” 36 FCC Rcd 5987, 6042, para 155 (2021), 86 FR 60775 . Specifically, each new 3.45 GHz Service licensee will be responsible for reimbursement of a pro rata share of reasonable relocation costs of non-Federal radiolocation operations.

The Commission in the 3.45 GHz Band Second R&O delegated authority to the Bureau, working in coordination with the Office of the Managing Director, to develop and implement a clearinghouse selection process similar to the process used in the 3.7 GHz proceeding. The Commission's delegation also included the authority to seek notice and comment on the parameters of additional considerations that should inform the creation and administration of the cost-sharing plan to help implement the Commission's decision and, if necessary for the purposes of the more limited relocation in the 3.45 GHz Service, to adjust the procedures adopted in the 3.7 GHz proceeding to tailor them to the relocation in the 3.45 GHz proceeding. As in the 3.7 GHz proceeding, the Commission in the 3.45 GHz Band Second R&O provided for the creation of a neutral, independent clearinghouse to oversee the collection and distribution of relocation reimbursement payments from new 3.45 GHz Service licensees to non-Federal secondary radiolocation incumbents. Unlike in the 3.7 GHz context, however, in the 3.45 GHz proceeding, the Commission did not identify the specific industry stakeholders who would compose the search committee to select the Clearinghouse.

On August 20, 2021, the Bureau released a Public Notice ( Search Committee Public Notice ) seeking comment on the selection process for, and operation of, the Clearinghouse. Comments and replies were due on September 30, 2021, and October 12, 2021, respectively (86 FR 51335, September 15, 2021). The Bureau received comments from Nexstar, NBCUniversal, and CTIA; a reply from the Wireless Infrastructure Association (WIA); and a subsequent ex parte letter from CCA.

As noted above, the Commission delegated authority to the Bureau to implement a clearinghouse selection process similar to the process used in the 3.7 GHz band transition. In the 3.7 GHz proceeding, the Commission determined that the clearinghouse search committee would be composed of nine members appointed by nine entities that the Commission found, collectively, reasonably represented the interests of the stakeholders in the 3.7 GHz band transition. These entities represented incumbents in the band (space station operators—three entities, and earth station operators—three entities) as well as prospective flexible-use licensees (three entities). The Commission determined that the range of entities it had chosen would fairly represent the broad interests of the relevant stakeholders in the 3.7 GHz band transition. Since the clearinghouse search committee was not similarly identified in the 3.45 GHz Band Second R&O, the Bureau sought comment on the optimal number of members and which appropriate industry stakeholders should be included on the search committee for the 3.45 GHz band transition.

NBCUniversal and Nexstar, the two secondary, non-Federal incumbents in the 3.45 GHz band, both seek representation on the search committee. Due to the difference between the use and size of their operations, NBCUniversal and Nexstar favor each company having its own seat, rather than a shared incumbent representative. Similarly, CTIA volunteered to represent traditional wireless providers on the search committee. CTIA also acknowledged the need for another representative to advocate for new entrants in the band that would not be covered by its own membership. WIA likewise supported representation for both small- and large-market new entrants, in addition to incumbents, suggesting two seats for the incumbents and two for new entrants to represent small and large auction winners. Although CCA did not initially file comments in this portion of the proceeding, CCA has since indicated an interest in serving on the search committee to represent the small-market segment of new entrants.

The Bureau finds that equal representation of both interest groups present in the instant transition—incumbent radiolocation systems and new-entrant flexible-use licensees—is both consistent with the 3.7 GHz band transition and will ensure a fair and transparent Clearinghouse selection process in this proceeding. Specifically, each interest group will have two seats: two incumbent seats to represent NBCUniversal's and Nexstar's differing business models, and two new-entrant seats to represent both small- and large-market flexible-use licensees.

First, the Bureau finds that equal representation of both interest groups is consistent with the approach used in the 3.7 GHz band proceeding. There, the search committee was comprised of nine members representing three distinct interest groups: incumbent space station operators, incumbent earth station operators, and prospective flexible-use licensees. Each interest group received three representatives on the search committee, which included seats for smaller and larger interests within each interest group segment. The corollary of the 3.7 GHz band approach here is thus equal representation of the two interest groups in the 3.45 GHz transition: non-Federal radiolocation incumbents and new entrants, with two seats on each side. The Bureau agrees with WIA that new entrants are a diverse group that would be best served by representatives for both smaller and larger new entrants.

Second, the Bureau finds that equal representation will foster compromise. By having equal representation from both interest groups on the search committee, no one group can act unilaterally in the selection process, ensuring that the resulting Clearinghouse fairly facilitates the transition process. WTB agreed with WIA that having equal representation for both interest groups on the search committee will provide “confidence that the clearinghouse selected remains impartial and will seek an equitable outcome for all the parties involved in the relocation.”

While this approach deviates from our proposal in the Search Committee Public Notice to have an odd number of members on the search committee, the Bureau sought comment on the optimal number of members to include on the search committee. Further, the Bureau specifically recognized that the 3.45 GHz relocation would be less complex than that in the 3.7 GHz band, and suggested that a smaller committee might be more efficient. The Bureau finds that a search committee comprised of four members, two incumbent representatives and two new entrant representatives, will accurately reflect the interests present in the 3.45 GHz band, is responsive to suggestions raised by commenters, and is well-positioned to facilitate compromise. In the event that equal representation leads to deadlock despite our instruction to proceed by consensus, the search committee shall inform the Bureau and the Bureau may then consider additional measures, including resolution by majority vote or appointment of an additional search committee member. The Bureau shall act on such request within 30 days, and the search process shall continue consistent with this final action and the Commission's rules.

The Bureau disagrees with Nexstar that the approach most consistent with the 3.7 GHz band process would be to have two-thirds of the search committee seats here represented by incumbent interests. While two-thirds of the 3.7 GHz band search committee was comprised of incumbents, the incumbent space station operators and earth station operators represent distinct industry segments. For example, in the 3.7 GHz band space station operators provide downlink signals to various types of earth stations, and the earth station operators in turn deliver programming to television and radio broadcasters and telephone and data services to consumers. Each incumbent group was given its own equal representation on the 3.7 GHz band search committee to reflect the differences in their interests with respect to the transition process. The Bureau applies the same logic here, and thus have designated equal representation of both the incumbent and new entrant interest groups in the 3.45 GHz band.

As discussed above, the Bureau finds that here the appropriate implementation of equal representation is two search committee seats for the incumbents and two for the new entrants. Specifically, the Bureau finds that the four-member Clearinghouse search committee will be comprised of representatives from NBCUniversal, Nexstar, CTIA, and CCA. As proposed in the Search Committee Public Notice, each entity shall nominate one individual to serve on the search committee. WIA, the commenter to most directly address this issue, supports this process, and states that such representation will promote confidence that the selected clearinghouse will be fair to all parties in the transition.

NBCUniversal and Nexstar, both of which volunteered to be on the search committee, will represent their own respective interests as secondary incumbent radiolocation service users. The Bureau finds that CTIA and CCA together will best represent the interests of new entrants given their diverse memberships. CTIA, which also volunteered to be on the search committee, will represent the larger- new entrant interests to the band. CCA indicated an interest in serving on the search committee and will represent the interests of smaller and rural entities.

The Bureau finds that CCA is best positioned to serve as the second new-entrant representative on the search committee. The Bureau agrees with WIA that the new entrants' interests are diverse and that it is important to have the interests of smaller and rural providers represented on the search committee. CCA notes that its members include “small, rural carriers serving fewer than 5,000 customers” and also indicates that some of its members are license winners in the 3.45 GHz band. Thus, the Bureau finds that CCA is well-situated to represent the smaller and rural new entrants in the band.

In the 3.7 GHz proceeding, the Commission directed the search committee to proceed by consensus, but noted that if a vote on the selection of a clearinghouse was required, it would be by a majority vote. Likewise here, as proposed in the Search Committee Public Notice, the Bureau directs the search committee to proceed by consensus. In the event of deadlock, however, the Bureau directs the search committee to notify the Bureau. As noted above, in the event of deadlock under the current composition, the search committee shall inform the Bureau and the Bureau may then consider additional measures to resolve the deadlock. Further, the Bureau shall act on such request within 30 days of the search committee's request, and the search process shall continue consistent with the Commission's rules.

The Bureau requires each search committee member to certify that they have reviewed and understand the Commission's rules and requirements contained in this final action and the 3.45 GHz Band Second R&O. Such certifications must be filed in the docket of this proceeding prior to the first meeting of the selection committee, but no later than January 5, 2023. In the event that a new search committee member is added, its certification must be filed in the docket of this proceeding no later than 30 days after the Bureau releases a Public Notice identifying the new search committee member.

The search committee must meet no later than January 5, 2023. In addition, by March 6, 2023, the search committee must release and file with the Bureau a Request for Proposal (RFP), or similar solicitation for Clearinghouse applications. Such solicitation must explain in detail the selection criteria for the position of Clearinghouse and must be consistent with the qualifications, roles, and duties of the Clearinghouse as set forth in the Commission's rules and this final action. Entities responding to the RFP must describe how they will comply with these criteria and rules adopted by the Commission. The search committee should ensure that the Clearinghouse meets the relevant best practices and standards in its operation to ensure an effective and efficient transition.

Thus, at a minimum, the search committee's solicitation for the Clearinghouse must include the following requirements to: (1) engage in strategic planning and adopt goals and metrics to evaluate its performance; (2) adopt internal controls for its operations; (3) use enterprise risk management practices; and (4) use best practices to protect against improper payments and to prevent fraud, waste, and abuse in its handling of funds. In addition, the Clearinghouse must be required to create written procedures for its operations, using the Government Accountability Office's (GAO) Green Book to serve as a guide in satisfying such requirements.

CTIA asks that the selected Clearinghouse be required to enter into contracts with stakeholders— i.e., with incumbents and new entrants. CTIA explains that “contracts between new 3.45 GHz Service licensees and the Clearinghouse help ensure that the Clearinghouse's management of clearing funds has appropriate oversight.” CTIA notes, however, that requiring contracts between the Clearinghouse and all stakeholders may stall the reimbursement process if some parties are hold outs because they lack the incentives to undertake the cost of negotiating a contract, which could significantly exceed their reimbursement liability. Instead, CTIA maintains that “appropriate oversight of the Clearinghouse can be assured by confirming that licensees covering some reasonable proportion of the total relocation liability have negotiated contracts with the Clearinghouse.” In addition, CTIA proposes that “the Clearinghouse should be required to contract with any licensee that so desires on terms and conditions that are materially the same as those negotiated by other licensees.”

The Bureau believe this proposal has merit and will require such contracts here. Thus, the Bureau requires the Clearinghouse to enter into contracts with both incumbents and sufficient licensees that hold the majority of 3.45 GHz Service licenses. The Bureau notes that while contracts were not required in the 3.7 GHz band context, that framework “expected” that contracts would be entered into between the selected Clearinghouse and the stakeholders. Accordingly, the Bureau finds that it is both consistent with past precedent and appropriate here to require the Clearinghouse to enter into contracts with the two incumbents and a sufficient number of new entrant licensees holding the majority of 3.45 Service licenses.

In addition, the Clearinghouse must enter into a contract with any licensee that so requests on terms and conditions that are materially the same as those negotiated by other licensees. To this end, the Bureau requires the search committee to include a requirement in its RFP or other similar solicitation document that the selected Clearinghouse will be required to enter into contracts with stakeholders based on and consistent with the Commission's rules and this final agency action, the terms of the RFP, and the applicant's responses to the RFP, as described herein. Further, as part of its response to the RFP, the Clearinghouse selectee must affirmatively represent that it will enter into such contracts with two incumbents and a sufficient number of new entrant licensees holding the majority of 3.45 Service licenses.

The Bureau notes that CTIA also asks that such contracts “be on based on commercially reasonable terms for fiduciaries acting in the capacity of the 3.45 GHz Clearinghouse” and that the Clearinghouse recognize “that it owes fiduciary duties to both incumbents and new entrants.” The Bureau believes that requiring contracts between the Clearinghouse and licensee stakeholders has merit in the context of this proceeding, and such contractual relationships and obligations will provide appropriate safeguards. Thus, the Bureau does not need to reach a decision on CTIA's request for imposing a fiduciary duty.

The search committee's solicitation shall also require that the Clearinghouse adopt robust privacy and data security best practices in its operations, given that it will receive and process information critical to ensuring a successful and expeditious transition. The Clearinghouse shall therefore also comply with, on an ongoing basis, all applicable laws and Federal Government guidance on privacy and information security requirements such as relevant provisions in the Federal Information Security Management Act (FISMA), National Institute of Standards and Technology (NIST) publications, and Office of Management and Budget guidance. The Clearinghouse must hire a third-party firm to independently audit and verify, on an annual basis, the Clearinghouse's compliance with privacy and information security requirements and to provide recommendations based on any audit findings; to correct any negative audit findings and adopt any additional practices suggested by the auditor; and to report the results to the Bureau annually beginning April 1, 2024.

The Bureau will issue a Public Notice notifying the public that the search committee has published criteria for the selection of the Clearinghouse. The Public Notice will announce a closing date of April 2, 2023 for submission of responses to the RFP.

The search committee shall notify the Bureau of its tentative choice for the Clearinghouse by May 2, 2023. This notification shall: (1) be contingent on the selectee's agreement to enter into contracts with incumbent and new, flexible-use licensee stakeholders prior to finalization of the selection; (2) fully disclose any actual or potential organizational or personal conflicts of interest or appearance of such conflict of interest of the Clearinghouse or its officers, directors, employees, and/or contractors; and (3) set out in detail the salary and benefits associated with each position. The Clearinghouse shall have an ongoing obligation to update this information as soon as possible after any relevant changes are made.

Once the search committee has notified the Bureau of its tentative selection, the selectee must negotiate one or more contracts with stakeholder licensees. Specifically, by July 3, 2023, the selectee must submit negotiated and executed contracts to the search committee. The contracts should be consistent with the requirements of this final agency action and the Commission's rules, the RFP, and the selectee's RFP responses. Such contracts should address issues such as any limitations on liability, audits, and any such other commercially reasonable terms as may be expected to be included in contracts of this nature. After submission of contracts to the search committee, the search committee must review the contracts for compliance with the Commission's rules, the RFP, and the selectee's proposal by August 1, 2023. If the search committee determines contracts are in compliance, the search committee will notify the Bureau that it has finalized the selection of the Clearinghouse and will submit copies of the selectee's RFP response and contracts in the docket. The Bureau acknowledges that requiring contracts for all 3.45 GHz Service licensees to be executed prior to the finalization of the Clearinghouse selectee may unduly delay the selection process. Thus, if the search committee has determined that the submitted contracts are in compliance and such contracts have been submitted for both incumbents and sufficient licensees that hold the majority of 3.45 GHz Service licenses, the search committee may submit the Clearinghouse selectee for final confirmation by the Bureau.

After receipt of the search committee's notification of its final selection, the Bureau will issue a Public Notice announcing the entity selected and inviting public comment on whether the selectee satisfies the criteria set out in this final agency action and in the Commission's rules. Following the comment period and submission of the RFP response and contracts in the docket, the Bureau will issue a determination as to whether the criteria for the Clearinghouse either have or have not been satisfied. Should the Bureau be unable to find the criteria have been satisfied, the selection process will start over and the search committee will submit a new proposed entity. The search committee shall remain in place at least until the Bureau issues its determination confirming the selection of the Clearinghouse.

In the event that: (1) the Clearinghouse selectee has not reached agreement with the two incumbent radiolocation service licensees and sufficient licensees that hold the majority of 3.45 GHz Service licenses; (2) the Bureau determines that the submitted contracts do not comply with the relevant requirements; or (3) the Bureau determines that the Clearinghouse selectee has otherwise not satisfied the selection criteria, the Bureau may in its discretion elect to give the parties 30 days to cure such noncompliance or instruct the search committee to reconvene and select a new Clearinghouse candidate, thus restarting the above process.

Consistent with the terms of this final agency action and the Commission's rules, the Clearinghouse selection process must comply with the following deadlines:

• January 5, 2023, or prior to first meeting: search committee members must file certifications in WT Docket No. 19-348.

• January 5, 2023: the search committee must meet.

• March 6, 2023: the search committee must prepare and submit the RFP to the Bureau.

• April 3, 2023: deadline for applicants to submit responses to the RFP.

• May 2, 2023: the search committee must notify the Bureau of its tentative Clearinghouse selectee.

• July 3, 2023: the Clearinghouse selectee must enter into contracts with incumbents and new entrants and submit such contracts to the search committee. For good cause shown, the search committee may request one brief extension of this deadline.

• August 1, 2023: the search committee must review contracts and notify the Bureau whether or not the contracts are approved and whether or not the Clearinghouse selection is finalized, subject to the Bureau determination that the selection criteria have been satisfied.

Consistent with the delegation of authority in the 3.45 GHz Band Second R&O and the Commission's rules, the Bureau herein sets forth the duties of the Clearinghouse. As in other spectrum band transition processes, the Bureau finds that an independent clearinghouse that oversees the reimbursement process for the 3.45 GHz band transition in a “fair, and transparent manner will best serve the public interest.” To that end, below the Bureau establishes procedures to prevent waste, fraud, and abuse in connection with relocation reimbursement disbursements.

Collection of reimbursement requests and supporting documentation. The Clearinghouse will be responsible for collecting from the two incumbent radiolocation operators a showing of their relocation costs for the transition as well as a demonstration of the reasonableness of those costs. The Clearinghouse will determine in the first instance whether costs submitted for reimbursement are reasonable. Parties seeking reimbursement for actual costs must submit to the Clearinghouse a claim for reimbursement, complete with sufficient documentation to justify the amount. The Clearinghouse shall review reimbursement requests to determine whether the costs are reasonable and to ensure they comply with the requirements adopted in the 3.45 GHz Band Second R&O. The Clearinghouse shall give parties the opportunity to supplement any reimbursement claims that the Clearinghouse deems deficient.

Incumbents seeking reimbursement for their actual costs shall provide justification for those costs. The Clearinghouse shall specify a procedure for the submission of relocation cost documentation. Entities must document their actual expenses and shall submit such documentation pursuant to the procedures specified by the Clearinghouse at any time after those expenses have been incurred. The Clearinghouse may conduct audits of entities that receive reimbursements. Incumbents receiving reimbursements must make available all relevant documentation upon request from the Clearinghouse.

To determine the reasonableness of reimbursement requests, the Clearinghouse may consider the submission and supporting documentation and any relevant comparable reimbursement submissions. If the Clearinghouse determines that the amount sought for reimbursement is impermissible or unreasonable, it shall notify the party of any amount that it deems eligible for reimbursement. Approved, adjusted, or denied claims shall be simultaneously invoiced to the relevant claimant and the 3.45 Service licensees, allowing 30 days for review. To the extent that either a claimant or an 3.45 Service licensee wishes to dispute a final Clearinghouse decision, it may do so by providing written notice to the Bureau in the above-captioned docket within 30 days of invoice issuance. The Bureau shall resolve any such dispute. To the extent necessary, the Bureau may establish supplemental procedures for the resolution of any disputes that may arise during the transition. Once the 30-day invoice review period has run and absent any dispute, the Clearinghouse shall disburse approved claims from the reimbursement fund.

Apportionment of Costs Among 3.45 GHz Service Licensees. The Clearinghouse shall apportion costs among 3.45 GHz Service licensees and distribute payments to incumbent radiolocation licensees pursuant to the cost allocation structure established in the 3.45 GHz Band Second R&O and the Commission's rules. Specifically, each 3.45 GHz Service licensee that is granted an initial license (not a renewal) “must pay a pro rata portion to reimburse the costs incurred by authorized non-federal, secondary radiolocation licensees for relocating from the 3.3-3.55 GHz band.” These costs shall include “the cost of a clearinghouse's administration of the reimbursement, which the radiolocation licensees will pay initially and include in their reimbursable costs.” The Clearinghouse shall determine a licensee's pro rata share of relocation costs by dividing the total actual costs of the incumbents' relocation (as approved by the Clearinghouse), “by the total number of 3.45 GHz Service licenses granted, multiplied by the number of such licenses [a] Licensee will hold.” Forty-five days after the Clearinghouse has entered into contracts with incumbents and new licensees, the Clearinghouse shall calculate the share of each 3.45 Service licensee based upon the reimbursement documentation received from the incumbents. The initial share shall incorporate any relocation-related costs incurred prior to the issuance of new flexible-use licenses (May 4, 2022) as well as from the time of issuance until the time of calculation. 3.45 GHz Service licensees shall pay their share of the initial relocation payments into a reimbursement fund, administered by the Clearinghouse, within 30 days of receiving an invoice or other written notification of the calculation of their initial share. The Clearinghouse shall draw from the reimbursement fund to pay approved, invoiced claims that are not subject to a dispute before the Bureau.

Going forward, the Clearinghouse shall calculate the 3.45 GHz Service licensees' share of relocation costs at least every six months, with the discretion to calculate the share on a more frequent basis as needed, and provide each licensee with the amount it owes no more than 30 days after each period that it calculates the licensees' share of relocation costs. Within 30 days of receiving the invoice or other written notification of the calculation of its share, each 3.45 GHz Service licensee shall pay its share of costs into the reimbursement fund. The Clearinghouse shall draw from the reimbursement fund to pay approved reimbursement claims. The Clearinghouse shall pay approved claims 30 days after invoice submission to the relevant claimant and 3.45 GHz Service licensees for their review so long as: (1) funding is available; and (2) there is no dispute regarding the underlying Clearinghouse decision before the Bureau. If the reimbursement fund does not have sufficient funds to pay approved claims before a six-month replenishment, the Clearinghouse shall provide 3.45 GHz Service licensees with 30 days' notice of the additional shares each must contribute. Any interest arising from the reimbursement fund shall be used to defray the costs of the transition for all 3.45 GHz Service licensees on a pro rata basis. At the end of the transition, the Clearinghouse shall return any unused amounts to the 3.45 GHz Service licensees according to their pro rata shares.

If a 3.45 GHz Service license is relinquished to the Commission prior to all relocation cost reimbursements being paid, the remaining payments will be distributed among the remaining 3.45 GHz Service licensees. If a new license is issued for the previously relinquished rights prior to final transition payments becoming due, the new 3.45 GHz Service licensee will be responsible for the same pro rata share of relocation costs as the initial 3.45 GHz Service licensee on a going forward basis from the new license grant date. If a 3.45 GHz Service licensee assigns its rights through the secondary market, the new 3.45 GHz Service licensee will be obligated to fulfill all outstanding and future transition payment obligations associated with the license.

3.45 GHz Service licensees will, collectively, pay for the services of the Clearinghouse and staff. The Clearinghouse shall include and itemize its own reasonable costs in the cost estimates it uses to collect reimbursement fund payments from 3.45 GHz Service licensees. To ensure the Clearinghouse's costs are reasonable, the Clearinghouse shall provide to the Office of the Managing Director and the Wireless Telecommunications Bureau, by April 1 of each year beginning in 2024, an audited statement of funds expended to date, including salaries and expenses of the Clearinghouse. It shall also provide additional financial information as requested by the Office or Bureau to satisfy the Commission's oversight responsibilities and/or agency-specific and government-wide reporting obligations.

Dispute Resolution. As in the 3.7 GHz transition and consistent with our rules, the Clearinghouse here will serve in an administrative role and in a function similar to a special master in a judicial proceeding. In contrast with the 3.7 GHz Band R&O (85 FR 64062, October 9, 2020), which enabled the Clearinghouse to mediate any cost disputes or refer the parties to alternative dispute resolution fora, here the Commission directed that any disputes arising from Clearinghouse decisions shall be decided by the Bureau. The Bureau reiterates that to the extent that either a claimant or a 3.45 Service licensee wishes to dispute a final Clearinghouse decision, it may do so by providing written notice to the Bureau in the above-captioned docket within 30 days of invoice issuance. To the extent that a 3.45 Service licensee wishes to dispute the calculation of its pro rata contributions to the reimbursement fund, or any transition-related payment obligation other than a reimbursement claim invoice, it may do so by providing written notice to the Bureau in the above-captioned docket within 30 days of invoice issuance or other written notification of its payment obligation. To the extent necessary, the Bureau may establish supplemental procedures for the resolution of any disputes that may arise during the transition.

Reports to the Bureau. The Clearinghouse shall provide certain information and reports to the Commission to facilitate our oversight of the transition. Each quarter, the Clearinghouse shall submit progress reports to the Bureau that detail the status of reimbursement funds available, the payments issued, and the amounts collected from licensees. The first such report must be filed no later than April 1, 2024. The reports must account for all funds spent, including the Clearinghouse's own expenses (including salaries and fees paid to law firms, accounting firms, and other consultants). The Clearinghouse shall provide to the Wireless Telecommunications Bureau and the Office of the Managing Director additional information upon request.

No later than 18 months after the release of this final agency action, the Clearinghouse must issue a special, audited report identifying any issues that have not already been referred to the Commission as well as what actions, if any, need to be taken for the Clearinghouse to complete its obligations (including the estimated costs and time frame for completing that work).

Bureau Oversight. To ensure the timely and efficient transition of the band, the Bureau will provide the Clearinghouse with any needed clarifications or interpretations of the Commission's rules or orders issued by the Commission or Bureau. As noted above, the Bureau and the Office of the Managing Director may request any documentation from the Clearinghouse necessary to provide guidance or carry out oversight.

The Bureau will issue a Public Notice upon receipt of a request of the Clearinghouse to wind down and suspend operations. If no material issues are raised within 15 days of the release of said Public Notice, the Bureau may grant the Clearinghouse's request to suspend operations on a specific date. 3.45 GHz Service licensees must pay all transition costs incurred and invoiced prior to the date set forth in the Public Notice.

In the 3.7 GHz Band R&O, the Commission stated that the Clearinghouse should operate “pursuant to Commission rules and oversight, to mitigate financial disputes among stakeholders, and to distribute payments in a timely manner.” 35 FCC Rcd 2343, 2446, para. 255 (2020). In addition, the Commission concluded that it needed to “establish measures to prevent waste, fraud, and abuse with respect to reimbursement disbursements” and that the Clearinghouse should adopt “robust privacy and data security best practices in its operations.” Id. para. 277. The Bureau agrees that such measures are likewise appropriate as part of the 3.45 GHz transition.

CTIA proposes a series of “appropriate safeguards” to protect all involved stakeholders and “ensure the integrity of the process.” Given the Commission's directive in this proceeding to develop and implement a Clearinghouse selection process similar to the process used in the 3.7 GHz proceeding, the Bureau concludes those safeguards proposed by CTIA, which are consistent with the processes articulated in the 3.7 GHz Band R&O, should be adopted here. Thus, the Clearinghouse here must:

• Process claims consistent with the 3.45 GHz Band Second R&O, and any clarifications issued by the Commission or the Bureau;

• Operate in a fair and transparent manner;

• Adopt a process for protecting confidential information;

• Hold deposits to minimize the risk of loss, ( e.g., all funds collected for reimbursement must be placed in a reputable financial institution and may only be invested in U.S. Treasury bonds); and

• Specify timing for the reimbursement process.

In addition, consistent with the need to prevent waste, fraud, and abuse in its handling of reimbursement funds, all Clearinghouse accounting related to such funds is subject to an annual audit to be performed by an independent third party selected by the Clearinghouse. The Clearinghouse shall report to the FCC all evidence and/or allegations of suspected fraud, waste, or abuse related to the 3.45 GHz relocation program, along with an initial assessment of their credibility and substantiality. Further, the Clearinghouse shall establish procedures enabling outside parties to report allegations of fraud, waste, or abuse to the RPC, and maintain a log of all such allegations that it receives. Parties seeking to report claims of fraud, waste, and abuse directly to the FCC may do so either by phone (202-418-1940) or electronically ( 345clearinghouse@fcc.gov ).

To the extent that any adjustments to the Clearinghouse process or administration are necessary going forward, the Commission delegated authority to the Bureau to make such necessary modifications. Should the Clearinghouse violate or otherwise fail to comply with the Commission's rules, the Clearinghouse's authority to operate may be terminated and, subject to the delegated authority discussed above, the selection of a new clearinghouse may be initiated.

CTIA requests that certain rules relating to the operation of the Clearinghouse be waived in order to allow reimbursement payments directly from 3.45 GHz Service licensees to incumbent radiolocation service operators and to permit the Bureau to determine allowable costs for reimbursement as an initial matter. If granted, CTIA's requests would strip the Clearinghouse of its core functions—determining reasonable reimbursement costs, billing and collecting reimbursement funds from new entrants, and disbursing payments to incumbents—and would reduce the Clearinghouse's role to essentially an accounting function. The Bureau finds that CTIA's requests are not for waivers but rather appear to seek rule changes. As such, they are essentially untimely requests to reconsider decisions made by the Commission in the 3.45 GHz Band Second R&O and are beyond the scope of the authority delegated to the Bureau in establishing procedures to select and administer a Clearinghouse. The Bureau therefore dismisses CTIA's requests.

Accordingly, it is ordered that, pursuant to sections 2, 4(i), 5(c), 157, 301, 303, 307, 308, 309, of the Communications Act of 1934, as amended, as well as the Commercial Spectrum Enhancement Act, Public Law 108-494, 118 Stat. 3986 (Dec. 23, 2004) as amended, and the MOBILE NOW Act, Public Law 115-141, 132 Stat. 1098, Div. P, Title VI, sec. 603 (Mar. 23, 2018), 47 U.S.C. 152, 154(i), 155(c), 157, 301, 303, 307, 308, 309, 309(j)(3)(B), 309(j)(4)(D), 923(g), 928, 1502, by the Beat China by Harnessing Important, National Airwaves for 5G Act of 2020, Public Law 116-260, Division FF, Title IX, Sec. 905, and by the authority delegated in paragraph 163 of the 3.45 GHz Second R&O, the Order is hereby adopted .

It is further ordered, that, pursuant to the authority delegated in §§ 0.131 and 0.331 of the Commission's rules, 47 CFR 0.131, 0.331, CTIA's Waiver Requests are denied .

It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the Order, including the Supplemental Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

It is further ordered that the Order shall be effective 30 days after publication in the Federal Register .

This final rule is organized as follows:

To view any documents mentioned as being available in the docket, go to https://www.regulations.gov/docket/FMCSA-2022-0128/document and choose the document to review. To view comments, click this final rule, then click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations at U.S. Department of Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.

This final rule updates an incorporation by reference found at 49 CFR 385.4(b)(1) and referenced at § 385.415(b). The provision at § 385.4(b)(1) currently references the April 1, 2021, edition of CVSA's handbook titled “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” The CVSA handbook contains inspection procedures and OOSC for inspections of shipments of transuranic waste and highway route-controlled quantities of radioactive material. The OOSC, while not regulations, provide enforcement personnel nationwide, including FMCSA's State partners, with uniform enforcement tolerances for inspections. The material is available, and will continue to be available, for inspection at the FMCSA, Office of Safety, 1200 New Jersey Avenue SE, Washington, DC 20590 (Attention: Chief, Compliance Division) at (202) 366-1812. The document may be purchased from the Commercial Vehicle Safety Alliance, 99 M Street SE, Suite 1025, Washington, DC 20003, (202) 998-1002, cvsahq@cvsa.org.

Fourteen updates distinguish the April 1, 2022, handbook edition from the 2021 edition. The updates are all described in detail in the September 7, 2022, notice of proposed rulemaking (NPRM) for this rule (87 FR at 48141). The incorporation by reference of the 2022 edition does not impose new regulatory requirements.

Congress has enacted several statutory provisions to ensure the safe transportation of hazardous materials in interstate commerce. Specifically, in provisions codified at 49 U.S.C. 5105(d), relating to inspections of motor vehicles carrying certain hazardous material, and 49 U.S.C. 5109, relating to motor carrier safety permits, the Secretary of Transportation is required to promulgate regulations as part of a comprehensive safety program on hazardous materials safety permits. The FMCSA Administrator has been delegated authority under 49 CFR 1.87(d)(2) to carry out the rulemaking functions vested in the Secretary of Transportation. Consistent with that authority, FMCSA has promulgated regulations under 49 CFR part 385, subpart E to address the congressional mandate on hazardous materials safety permits. Those regulations are the underlying provisions to which the material incorporated by reference discussed in this final rule is applicable.

In 1986, the U.S. Department of Energy and CVSA entered into a cooperative agreement to develop a higher level of inspection procedures, out-of-service (OOS) conditions and/or criteria, an inspection decal, and a training and certification program for inspectors to conduct inspections on shipments of transuranic waste and highway route-controlled quantities of radioactive material. Thereafter, CVSA developed the North American Standard Level VI Inspection Program for Transuranic Waste and Highway Route Controlled Quantities of Radioactive Material. This inspection program for select radiological shipments includes inspection procedures, enhancements to the North American Standard Level I Inspection, radiological surveys, CVSA Level VI decal requirements, and the “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” As of January 1, 2005, all vehicles and carriers transporting highway route-controlled quantities of radioactive material must pass the North American Standard Level VI Inspection prior to the shipment being allowed to travel in the United States. All CMVs transporting highway route-controlled quantities of radioactive material shipments into the United States must also pass the North American Standard Level VI Inspection either at the shipment's point of origin or when the shipment enters the United States.

Section 385.415 of title 49, Code of Federal Regulations, prescribes operational requirements for motor carriers transporting hazardous materials for which a hazardous materials safety permit is required. Section 385.415(b) requires that motor carriers ensure a pre-trip inspection is performed on each motor vehicle to be used to transport a highway route-controlled quantity of a Class 7 (radioactive) material, in accordance with the requirements of CVSA's handbook titled “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.”

Covid-19 affected the number of roadside inspections for Level I-Level VI primarily during 2020 and 2021. In 2018-2019 approximately 3.5 million Level I-Level VI inspections were performed annually, as compared to 2020-2021 where approximately 2.7 million Level I-Level VI inspections were performed annually. Across all years, nearly 96 percent of these inspections in each year were Level I, Level II, and Level III inspections. During 2018-2019 an average of 1,010 Level VI inspections were performed annually which dropped to an average of 600 annually during 2020-2021 due to Covid-19. On an annual basis Level VI inspections comprise only 0.02 percent of all inspections and, on average, OOS violations were cited in only 6 Level VI inspections annually (0.6 percent). In comparison, on average, OOS violations were cited in 26 percent of all Level I, 25 percent of all Level II, and 6 percent of all Level III inspections annually across 2018-2021 irrespective of Covid-19. As these statistics demonstrate, OOS violations are cited in a far lower percentage of Level VI inspections than Level I, II, and III inspections, due largely to the enhanced oversight and inspection of these vehicles because of the sensitive nature of the cargo being transported.

The changes to the 2022 edition of the CVSA handbook are intended to ensure clarity in the presentation of the OOS conditions and are generally editorial or ministerial. As discussed below, FMCSA does not expect the changes made in the 2022 edition of the CVSA handbook to affect the number of OOS violations cited during Level VI inspections.

FMCSA published a NPRM on August 8, 2022 (87 FR 48141). Whereas the incorporation by reference found at 49 CFR 385.4 and referenced at 49 CFR 385.415(b) references the April 1, 2021, edition of CVSA's “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route-Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403,” the NPRM proposed to incorporate by reference the April 1, 2022, edition. Fourteen updates distinguish the April 1, 2022, edition from the 2021 edition. Each of the changes was described and discussed in detail in the NPRM. Generally, the changes serve to clarify or provide additional guidance to inspectors regarding uniform implementation and application of the out-of-service criteria, and none is expected to affect the number of out-of-service violations cited during Level VI inspections. The incorporation by reference of the 2022 edition does not change what constitutes a violation of FMCSA regulations.

FMCSA solicited comments concerning the NPRM for 30 days ending September 7, 2022. By that date, one comment was received from CVSA, which commended FMCSA for publishing the NPRM and encouraged FMCSA to finalize the rule and update the incorporation by reference.

FMCSA makes an additional revision to 49 CFR 385.4(b) in this final rule to update the address for CVSA. This change is non-substantive and ensures that the incorporation by reference information in § 385.4 is accurate and up-to-date.

Paragraph (a) of § 385.4 is amended to conform with Office of Federal Register requirements for incorporation by reference paragraphs in regulatory text. The introductory text to paragraph (b) is amended by updating the address for CVSA. Paragraph (b)(1) is amended by replacing the reference to the April 1, 2021, edition date with a reference to the new edition date of April 1, 2022.

FMCSA has considered the impact of this final rule under E.O. 12866 (58 FR 51735, Oct. 4, 1993), Regulatory Planning and Review, E.O. 13563 (76 FR 3821, Jan. 21, 2011), Improving Regulation and Regulatory Review, and DOT's regulatory policies and procedures. The Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB) determined that this final rule is not a significant regulatory action under section 3(f) of E.O. 12866, as supplemented by E.O. 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. Accordingly, OMB has not reviewed it under that E.O.

The final rule updates an incorporation by reference from the April 1, 2021, edition to the April 1, 2022, edition of CVSA's handbook titled “North American Standard Out-of-Service Criteria and Level VI Inspection Procedures and Out-of-Service Criteria for Commercial Highway Vehicles Transporting Transuranics and Highway Route Controlled Quantities of Radioactive Materials as defined in 49 CFR part 173.403.” FMCSA reviewed its MCMIS data on inspections performed from 2018 to 2021 and does not expect the handbook updates to have any effect on the number of OOS violations cited during Level VI inspections. Therefore, the final rule's impact would be de minimis.

This rule is not a major rule as defined under the Congressional Review Act (5 U.S.C. 801-808). 1

The Regulatory Flexibility Act (5 U.S.C. 601, et seq .) (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term small entities comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000 (5 U.S.C. 601(6)). Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities, and mandates that agencies strive to lessen any adverse effects on these businesses. None of the updates from the 2022 edition impose new requirements or make substantive changes to the FMCSRs.

When an Agency issues a rulemaking proposal, the RFA requires the Agency to “prepare and make available an initial regulatory flexibility analysis” that will describe the impact of the proposed rule on small entities (5 U.S.C. 603(a)). Section 605 of the RFA allows an agency to certify a rule, instead of preparing an analysis, if the final rule is not expected to impact a substantial number of small entities. FMCSA received no comments in response to the NPRM that would cause the Agency to reconsider the initial determination that this rulemaking is not expected to impact a substantial number of small entities. This final rule updates an incorporation by reference found at § 385.4(b)(1) and referenced at § 385.415(b), and incorporates by reference the April 1, 2022, edition of the CVSA handbook. The changes to the 2022 edition of the CVSA handbook from the 2021 edition are intended to ensure clarity in the presentation of the OOS conditions and are generally editorial or ministerial. As noted above, FMCSA does not expect the changes made in the 2022 edition of the CVSA handbook to affect the number of OOS violations cited during Level VI inspections in the United States. Accordingly, I certify that this final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, 2 FMCSA wants to assist small entities in understanding this rulemaking so they can better evaluate its effects on themselves and participate in the rulemaking initiative. If the final rule affects your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman (Office of the National Ombudsman, see https://www.sba.gov/about-sba/oversight-advocacy/office-national-ombudsman ) and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) requires Federal agencies to assess the effects of their discretionary regulatory actions. The Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $178 million (which is the value equivalent of $100 million in 1995, adjusted for inflation to 2021 levels) or more in any 1 year. Though this rulemaking would not result in such an expenditure, and the analytical requirements of UMRA do not apply as a result, the Agency discusses the effects of this rule elsewhere in this preamble.

This rulemaking contains no new information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under section 1(a) of E.O. 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

FMCSA has determined that this rulemaking does not have substantial direct costs on or for States, nor does it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rulemaking does not have sufficient federalism implications to warrant the preparation of a Federalism Impact Statement.

The Consolidated Appropriations Act, 2005, 3 requires the Agency to assess the privacy impact of a regulation that will affect the privacy of individuals. This rulemaking does not require the collection of personally identifiable information.

This rule does not have Tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

FMCSA analyzed this rule pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321, et seq. ) and determined this action is categorically excluded from further analysis and documentation in an environmental assessment or environmental impact statement under FMCSA Order 5610.1 (69 FR 9680), Appendix 2, paragraph 6(b). This Categorical Exclusion (CE) covers minor revisions to regulations. The requirements in this rulemaking are covered by this CE.

In consideration of the foregoing, FMCSA amends 49 CFR chapter III, part 385, as set forth below:

Why we need to publish a rule. Under section 4(a)(3) of the Act, if we determine that a species is an endangered or threatened species, we must designate critical habitat to the maximum extent prudent and determinable. We published a final rule to list the Florida bristle fern as an endangered species on October 6, 2015 (80 FR 60440). Designations of critical habitat can be completed only by issuing a rule through the Administrative Procedure Act rulemaking process.

What this document does. This rule finalizes a designation of critical habitat for the Florida bristle fern ( Trichomanes punctatum ssp. floridanum ) consisting of 10 units comprising approximately 1,698 ha (4,195 ac) in Miami-Dade and Sumter Counties, Florida.

The basis for our action. Section 4(a)(3) of the Act requires the Secretary of the Interior (Secretary) to designate critical habitat concurrent with listing to the maximum extent prudent and determinable. Section 3(5)(A) of the Act defines critical habitat as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protections; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination by the Secretary that such areas are essential for the conservation of the species. Section 4(b)(2) of the Act states that the Secretary must make the designation of critical habitat on the basis of the best available scientific data and after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if she determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless she determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species.

Economic analysis. In accordance with section 4(b)(2) of the Act, we prepared an economic analysis of the impacts of designating critical habitat for the Florida bristle fern. We published the announcement of, and solicited public comments on, the draft economic analysis (DEA; 85 FR 10371, February 24, 2020). Because we received no comments on the DEA, we adopted the DEA as a final version. The final economic analysis (IEc 2020, entire) is available at https://www.regulations.gov under Docket No. FWS-R4-ES-2019-0068.

Peer review and public comment. In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of actions under the Act, we sought the expert opinions of independent specialists with scientific expertise that included familiarity with the species, the geographic regions in which the species occurs, and conservation biology principles. The purpose of peer review is to ensure that our designation is based on scientifically sound data and analyses. We invited these peer reviewers to comment on our specific assumptions and conclusions in the critical habitat proposal during the public comment period for the February 24, 2020, proposed rule. We received responses from two peer reviewers on our technical assumptions and analysis, and on whether or not we used the best scientific data available. These peer reviewers generally concurred with our methods and conclusions, and they provided additional information, clarifications, and suggestions to improve this final rule. Information we received from peer review is incorporated into this final designation of critical habitat. We also considered all comments and information we received from the public during the comment period for the proposed designation of critical habitat for the Florida bristle fern and the associated DEA (85 FR 10371; February 24, 2020).

On November 9, 2009, the Florida bristle fern was first recognized as a candidate for possible future listing (74 FR 57804). On October 9, 2014, we proposed to list the Florida bristle fern as an endangered species (79 FR 61136). On October 6, 2015, we finalized the listing for the subspecies as an endangered species (80 FR 60440). On February 24, 2020, we proposed to designate critical habitat for the Florida bristle fern (85 FR 10371). Please refer to the October 9, 2014 (79 FR 61136), proposed listing rule for a more detailed description of Federal actions regarding the Florida bristle fern.

This final rule incorporates changes to our proposed rule (85 FR 10371; February 24, 2020) based on the comments and information we received. As a result, the final designation of critical habitat reflects the following changes from the February 24, 2020, proposed rule (85 FR 10371):

1. We revised Matheson Hammock (SF 1) to include additional areas as critical habitat. This unit was originally proposed as 16 ha (39 ac) and now consists of approximately 22 ha (55 ac), which is an increase of approximately 41 percent for this unoccupied unit.

2. We revised Snapper Creek (SF 2) to include additional areas as critical habitat. This unit was originally proposed as 3 ha (8 ac) and now consists of approximately 6 ha (15 ac), which is an increase of approximately 88 percent for this unoccupied unit.

3. We added Charles Deering Estate Hammock as a new unoccupied critical habitat unit (SF 3). This unit consists of approximately 43 ha (106 ac), which is an increase of approximately 3 percent of the total proposed critical habitat acreage.

4. We revised Castellow and Ross Hammocks (proposed SF 3; now SF 4) to include additional areas as critical habitat. This unit was originally proposed as 38 ha (93 ac) and now consists of approximately 56 ha (139 ac), which is an increase of approximately 48 percent for this occupied unit.

5. We revised the unit number for Silver Palm Hammock (proposed SF 4; now SF 5).

6. We revised Hattie Bauer Hammock (proposed SF 5; now SF 6) to include additional areas as critical habitat. This unit was originally proposed as 3 ha (8 ac) and now consists of approximately 6 ha (16 ac), which is an increase of approximately 100 percent for this occupied unit.

7. We revised Fuchs and Meissner Hammocks (proposed SF 6; now SF 7) to remove 1.6 ha (4 ac) that do not contain the essential physical or biological features for the Florida bristle fern and to include an additional 0.4 ha (1 ac) as critical habitat. This unit now consists of approximately 10 ha (25 ac), which is a decrease of approximately 8 percent of the proposed area for this occupied unit.

8. We revised the unit number for Royal Palm Hammock (proposed SF 7; now SF 8), and we updated the acreage for this unit. The proposed rule reported the size of the unit as 60 ha (148 ac); in this rule, we update the size of the unit to 61 ha (150 ac). The change is due to using updated parcel data from Miami-Dade County (2021 data versus 2017 data).

9. We updated the coordinates or plot points from which the maps were generated. The information is available at https://www.regulations.gov under Docket No. FWS-R4-ES-2019-0068, at https://www.fws.gov/office/florida-ecological-services/library, and from the Florida Ecological Services Field Office, Vero Beach.

10. Under Physical or Biological Features Essential to the Conservation of the Species in this rule:

• We corrected the critical habitat unit name and occupancy status where a long-term microclimate study occurred at Deering's Cutler Slough from Deering Snapper Creek to Charles Deering Estate Hammock.

• We changed “underground” to “horizontal” when describing rhizomal stem growth.

• In the description of nonnative, invasive plants that impact Florida bristle fern, we replaced love vine ( Cassytha filiformis ) with the most common aroid vines in the Miami-Dade County critical habitat units (golden pothos ( Epipremnum pinnatum cv. aureum ) and arrowhead vine ( Syngonium podophyllum )).

• We added that invasive vines have become an increasing threat to hammocks in south Florida and can result in canopy collapse during hurricanes or other high wind events.

11. Under Special Management Considerations or Protection in this rule:

• We described the competitive interaction between native bryophytes and Florida bristle fern.

• We added language to describe that most of the critical habitat units are open to public access and that Florida bristle fern may be at risk of collection, damage from people climbing on them, and impacts to microclimate due to installation and improvements of trails.

• We added language discussing the potential short- to mid-term benefits of sea level rise to the fern through lifting a freshwater lens into previously drained areas or areas experiencing a lowered water table, which may restore or preserve a favorable microclimate for the subspecies.

12. We added the potential presence of gametophytes, the cryptic reproductive stage of the fern, at historically occupied areas to our reasoning for designating unoccupied critical habitat units in this rule.

13. In the description of each critical habitat unit in this rule, we removed language suggesting prescribed burning as an appropriate management tool for Florida bristle fern conservation.

Our proposed rule to designate critical habitat for the Florida bristle fern (85 FR 10371; February 24, 2020) opened a 60-day comment period on the proposed action and associated DEA, ending April 24, 2020. We requested that all interested parties submit written comments and 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 Miami Herald and Orlando Sentinel on March 4, 2020. During the comment period, we received two comment letters from peer reviewers directly addressing the proposed critical habitat designation and nine public comments. We did not receive any requests for a public hearing, and we did not receive any comments on the DEA. A majority of the comments supported the designation; none opposed the designation; and the letters from the peer reviewers included suggestions on how we could refine or improve the designation. We received some comments outside the scope of the designation (including information on recovery strategies) and, although we noted these comments, we only respond to comments herein that were within the scope of our action to designate critical habitat. All substantive information provided to us during the comment period has been incorporated directly into this final rule or is addressed below.

(1) Comment: Both peer reviewers suggested adding the following areas in Miami-Dade County to the critical habitat designation: Monkey Jungle (also known as Cox Hammock), Smathers Four Fillies Farm (contiguous to and formerly part of Snapper Creek Hammock), the Charles Deering Estate Hammock (also known as Addison Hammock), and Timms Hammock (within Camp Owaissa Bauer). The reviewers noted that these areas contain one or more of the physical or biological features defined in the proposed critical habitat rule and that Monkey Jungle, Smathers Four Fillies Farm, and the Charles Deering Estate Hammock contained documented historical records of the Florida bristle fern. Timms Hammock (within Camp Owaissa Bauer) was not known to have historical records but was noted to have excellent habitat for the Florida bristle fern and is close to another occupied unit (Hattie Bauer Hammock).

Our Response: All these areas, with the exception of Smathers Four Fillies Farm, were included in the request for information in the proposed critical habitat rule. We asked for information regarding their occupancy status and habitat suitability, whether physical or biological features essential to the conservation of the subspecies are present, and whether they should be included in the designation and why. After re-examining historical records, meeting with land managers, and re-analyzing GIS data, we added Smathers Four Fillies Farm and Charles Deering Estate Hammock to the critical habitat designation as described in Summary of Changes from the Proposed Rule, above, because we have determined they are essential to the conservation of the species and meet the regulatory criteria. Below, we describe our response for not including Monkey Jungle and Timms Hammock to the critical habitat designation.

Monkey Jungle —The documented occurrence from Monkey Jungle (in 1989 by A. Cressler; Cressler 1991, entire) was unconfirmed due to no collections or voucher records. Monkey Jungle is privately owned, and researchers have not been permitted access to survey the entire area for Florida bristle fern (Adimey 2013, pers. comm.; van der Heiden 2013a, pers. comm.; Possley 2021, pers. comm.), so occupancy by the fern is unknown, although it was not found in the areas that were surveyed. Even though this area may have one or more of the physical or biological features essential to the conservation of the Florida bristle fern, the area has a high number of invasive plant species (Adimey 2013, pers. comm.; Possley 2020, pers. comm.), disturbance due to development and management of the park, and potential herbivory by monkeys (Adimey 2013, pers. comm.). Based on these factors, it is unlikely that this area was occupied by the Florida bristle fern at the time of listing or that it is essential for the conservation of the subspecies. Therefore, we are not adding Monkey Jungle as unoccupied critical habitat to the critical habitat designation.

Timms Hammock/Camp Owaissa Bauer —Timms Hammock is located within Camp Owaissa Bauer, which is owned and managed by Miami-Dade County. Even though this area contains some or all of the physical or biological features essential to the conservation of the Florida bristle fern, it does not contain historical or known extant populations of Florida bristle fern nor is it contiguous to currently or historically occupied areas. Because our methodology for determining which unoccupied areas were essential for the conservation of the species excludes areas that do not have historical records, regardless of habitat suitability (see Criteria Used to Identify Critical Habitat, below), Timms Hammock/Camp Owaissa Bauer does not meet the statutory requirement that unoccupied critical habitat be essential for the conservation of the species and is not included in the critical habitat designation.

(2) Comment: One peer reviewer suggested expanding the size of five units in Miami-Dade County (Matheson Hammock, Snapper Creek, Castellow and Ross Hammocks, Hattie Bauer Hammock, and Fuchs and Meissner Hammocks) to include contiguous pieces of hammock that seemed to be excluded despite meeting all habitat criteria. The reviewer noted that many of these parcels are under active forest management by public and private entities (private through a property tax incentive program and/or a local regulatory requirement). All parcels that meet forest and substrate characteristics and that are contiguous to the proposed critical habitat units were considered by the reviewer to provide habitat critical to the survival of Florida bristle fern.

Our Response: To clarify which parcels the reviewer was suggesting adding to the units, we held several discussions with the peer reviewer and the landowners or managers of each parcel to get more information about the suitability of each parcel. We only considered adding parcels to proposed units that met the criteria for designating occupied or unoccupied critical habitat units (see Criteria Used to Identify Critical Habitat, below). After re-examining historical records, meeting with land managers, and re-analyzing GIS data, we added contiguous hammock parcels to Unit SF 1 (Matheson Hammock), Unit SF 2 (Snapper Creek), Unit SF 3 (now SF 4; Castellow and Ross Hammocks), Unit SF 5 (now SF 6; Hattie Bauer Hammock), and Unit SF 6 (now SF 7; Fuchs and Meissner Hammocks) as described in Summary of Changes from the Proposed Rule, above, because we have determined they meet the statutory and regulatory criteria for critical habitat.

(3) Comment: One peer reviewer suggested adding the following areas to the critical habitat designation: Camp Redlands, Bill Sadowski Park, Whispering Pines Hammock, Black Creek Forest, Harden Hammock, Silver Palm Groves, Camp Owaissa Bauer, Lucille Hammock, Loveland Hammock, and Holiday Hammock in Miami-Dade County. The reviewer noted that these areas contain one or more of the physical or biological features essential to the conservation of Florida bristle fern as defined in the proposed critical habitat rule. The reviewer analyzed relative elevation, presence of limestone outcroppings, presence of surrogate ferns ( Asplenium verecundum and Tectaria fimbriata ), canopy cover, and hydrology connection when suggesting areas to add to the critical habitat designation. The reviewer noted that identifying rare fern presence as a surrogate for habitat appropriateness was similar to how the proposed listing considered potential habitat in central Florida.

Our Response: While these areas contain one or more of the physical or biological features essential to the conservation of the Florida bristle fern, they do not contain historical or known extant populations of Florida bristle fern nor are they contiguous to currently or historically occupied areas. Also, the proposed rule did not consider rare fern presence as a surrogate for habitat appropriateness when designating critical habitat units in central or south Florida. Because our methodology for designating unoccupied critical habitat excludes any areas that do not have historical records, regardless of habitat suitability (see Criteria Used to Identify Critical Habitat, below), these areas do not meet our criteria for determining that unoccupied areas are essential for the conservation of Florida bristle fern and are not included in the final critical habitat designation.

Section 4(b)(5)(A)(ii) of the Act requires the Service to give actual notice of any designation of lands that are considered to be critical habitat to the appropriate agency of each State in which the species is believed to occur and invite each such agency to comment on the proposed regulation. Section 4(i) of the Act states that the Secretary shall submit to the State agency a written justification for her failure to adopt regulations consistent with the agency's comments or petition. We did not receive any written comments from the State of Florida on the proposed critical habitat designation for the Florida bristle fern.

(4) Comment: One commenter urged the Service to add more clear reasoning behind our decision for each unoccupied area included.

Our Response: We have added language to the rule to provide more clarity for each unoccupied area. This information further supports including currently unoccupied, but historically occupied, areas to the critical habitat designation. Further information about our rationale for why unoccupied critical habitat is needed for the subspecies can be found in Areas Outside the Geographic Area Occupied at the Time of Listing, below. In addition, information is provided in each unit description below with the rationale for each unit.

Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for threatened and endangered species. In 2019, jointly with the National Marine Fisheries Service, the Service issued final rules that revised the regulations in 50 CFR parts 17 and 424 regarding how we add, remove, and reclassify threatened and endangered species and the criteria for designating listed species' critical habitat (84 FR 45020 and 84 FR 44752; August 27, 2019). At the same time the Service also issued final regulations that, for species listed as threatened species after September 26, 2019, eliminated the Service's general protective regulations automatically applying to threatened species the prohibitions that section 9 of the Act applies to endangered species (collectively, the 2019 regulations).

As with the proposed rule, we are applying the 2019 regulations for this final rule because the 2019 regulations are the governing law just as they were when we completed the proposed rule. Although there was a period in the interim—between July 5, 2022, and September 21, 2022—when the 2019 regulations became vacated and the pre-2019 regulations therefore governed, the 2019 regulations are now in effect and govern listing and critical habitat decisions ( see Center for Biological Diversity v. Haaland, No. 4:19-cv-05206-JST, Doc. 168 (N.D. Cal. July 5, 2022) ( CBD v. Haaland ) (vacating the 2019 regulations and thereby reinstating the pre-2019 regulations)); In re: Cattlemen's Ass'n, No. 22-70194 (9th Cir. Sept. 21, 2022) (staying the district court's order vacating the 2019 regulations until the district court resolved a pending motion to amend the order); Center for Biological Diversity v. Haaland, No. 4:19-cv-5206-JST, Doc. Nos. 197, 198 (N.D. Cal. Nov. 16, 2022) (granting plaintiffs' motion to amend July 5, 2022 order and granting government's motion for remand without vacatur).

Critical habitat is defined in section 3 of the Act as:

(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features

(a) Essential to the conservation of the species, and

(b) Which may require special management considerations or protection; and

(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as an area that may generally be delineated around species' occurrences, as determined by the Secretary ( i.e., range). Such areas may include those areas used throughout all or part of the species' life cycle, even if not used on a regular basis ( e.g., migratory corridors, seasonal habitats, and habitats used periodically, but not solely by vagrant individuals).

Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.

Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the Federal agency would be required to consult with the Service under section 7(a)(2) of the Act. However, even if the Service were to conclude that the proposed activity would result in destruction or adverse modification of the critical habitat, the Federal action agency and the landowner are not required to abandon the proposed activity, or to restore or recover the species; instead, they must implement “reasonable and prudent alternatives” to avoid destruction or adverse modification of critical habitat.

Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific and commercial data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat).

Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. The implementing regulations at 50 CFR 424.12(b)(2) further delineate unoccupied critical habitat by setting out three specific parameters: (1) when designating critical habitat, the Secretary will first evaluate areas occupied by the species; (2) the Secretary will only consider unoccupied areas to be essential where a critical habitat designation limited to geographical areas occupied by the species would be inadequate to ensure the conservation of the species; and (3) for an unoccupied area to be considered essential, the Secretary must determine that there is a reasonable certainty both that the area will contribute to the conservation of the species and that the area contains one or more of those physical or biological features essential to the conservation of the species.

Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.

When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. Additional information sources may include any generalized conservation strategy, criteria, or outline that may have been developed for the species; the recovery plan for the species; articles in peer-reviewed journals; conservation plans developed by States and counties; scientific status surveys and studies; biological assessments; other unpublished materials; or experts' opinions or personal knowledge.

Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act; (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species; and (3) the prohibitions found in section 9 of the Act. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of this species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of these planning efforts calls for a different outcome.

In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12(b), in determining which areas we will designate as critical habitat from within the geographical area occupied by the species at the time of listing, we consider the physical or biological features that are essential to the conservation of the species and that may require special management considerations or protection. The regulations at 50 CFR 424.02 define “physical or biological features essential to the conservation of the species” as the features that occur in specific areas and that are essential to support the life-history needs of the species, including, but not limited to, water characteristics, soil type, geological features, sites, prey, vegetation, symbiotic species, or other features. A feature may be a single habitat characteristic or a more complex combination of habitat characteristics. Features may include habitat characteristics that support ephemeral or dynamic habitat conditions. Features may also be expressed in terms relating to principles of conservation biology, such as patch size, distribution distances, and connectivity. For example, physical features essential to the conservation of the species might include gravel of a particular size required for spawning, alkaline soil for seed germination, protective cover for migration, or susceptibility to flooding or fire that maintains necessary early-successional habitat characteristics. Biological features might include prey species, forage grasses, specific kinds or ages of trees for roosting or nesting, symbiotic fungi, or a particular level of nonnative species consistent with conservation needs of the listed species. The features may also be combinations of habitat characteristics and may encompass the relationship between characteristics or the necessary amount of a characteristic essential to support the life history of the species.

In considering whether features are essential to the conservation of the species, we may consider an appropriate quality, quantity, and spatial and temporal arrangement of habitat characteristics in the context of the life-history needs, condition, and status of the species. These characteristics include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing (or development) of offspring; and habitats that are protected from disturbance.

Florida bristle fern occurs exclusively in upland hardwood forest hammock habitats that support the climate (stable humidity and temperature), hydrology, canopy cover, and limestone substrates necessary for the subspecies to persist, grow, and reproduce. Upland hardwood forests consist of a mosaic of natural hammock and hardwood communities primarily characterized as mesic, hydric, and rockland hammocks, or intermixed hammock strands, with associated transitional wetland matrix/hydric and upland communities (Florida Natural Areas Inventory [Inventory] 2010, pp. 16-28). The hammock habitats occur within and as part of larger matrices of hydric or pine rockland communities (Inventory 2010, pp. 16-28). Detailed descriptions of these natural communities can be found in Natural Communities of Florida (Inventory 2010, pp. 16-28) and in the final listing rule for Florida bristle fern (80 FR 60440; October 6, 2015). Natural communities include both wetland and upland communities having intact vegetation ( i.e., not cleared).

The current range of Florida bristle fern includes two metapopulations, one in south Florida (Miami-Dade County) and one in central Florida (Sumter County). The south Florida metapopulation is currently composed of four known populations, and the central Florida metapopulation is composed of two known populations. The south Florida populations of Florida bristle fern occur in communities characterized by primarily rockland hammock or closed tropical hardwood hammocks occurring within a larger matrix of pine rockland on the Miami Rock Ridge. In central Florida, the populations of the subspecies occur in predominantly mesic hammocks situated in a mosaic of hydric hammock and mixed wetland hardwoods. These internal or inter-mixed strands of hammock within the forested communities are characterized by fairly dense to extremely dense canopy cover, which prevents drastic changes in temperature and humidity and the desiccation of the fern from direct sunlight and drying winds.

The matrix of landscapes associated with the hammocks or the intermixed strands of these communities support the suitable conditions necessary for the growth and reproduction of Florida bristle fern. Suitable habitat quality and size are necessary to ensure the maintenance of the microclimate conditions (stable temperature, high humidity, moisture, canopy shade, and shelter) essential to the subspecies' survival and conservation. These combined factors establish the fern's microclimate: (a) The level of protection/exposure the fern experiences given its location in a solution hole (a limestone solution feature; in the Miami Rock Ridge, they consist of steep-sided pits, varying in size, formed by dissolution of subsurface limestone followed by a collapse above (Snyder et al. 1990, p. 236)) or on an exposed boulder; (b) the quality of the solution hole or exposed boulder substrate; and (c) the amount of canopy cover. The surrounding vegetation is a key component in producing and supporting this microclimate. There are differences in vegetation and substrate characteristics between the two geographically distant metapopulations that can account for differences in the amount of habitat needed to support the fern. For example, Florida bristle fern in south Florida occurs in a tropical climate and attaches to the interior walls of well-protected and insulated solution holes. By comparison, in central Florida, Florida bristle fern occurs in a more temperate climate and is found more exposed by attaching to a substrate that is above the surface. The size and quality of the intact habitat surrounding the exposed substrate can play a greater role in providing and supporting the stable, shaded, and wind-protected microclimate conditions the fern needs. Therefore, the microclimate conditions (stable temperature, high humidity, canopy shade, and shelter) have the potential to be maintained (and the plant is able to persist) within smaller areas in south Florida than those needed to support the microclimate conditions in central Florida. For both metapopulations, intact upland hardwood forest and associated hammock habitat is an essential feature to the conservation of this subspecies, and sufficient habitat is needed to ensure the maintenance of the fern's microclimate and life processes (growth, dispersal).

Therefore, we identify upland hardwood forest hammock habitats of sufficient quality and size to sustain the necessary microclimate and life processes for Florida bristle fern to be a physical or biological feature essential to the conservation of this subspecies.

Florida bristle fern is generally epipetric (grows on rocks) or epiphytic (grows non-parasitically upon another plant). In combination with the habitat characteristics discussed above, the subspecies requires exposed limestone substrate to provide suitable growing conditions for anchoring, nutrients, pH, and proper drainage (van der Heiden 2016, p. 1). Florida bristle fern prefers substrate having exposed oolitic (composed of minute, rounded concretions resembling fish eggs) limestone or limestone solution features (solution holes) filled with a thin layer of highly organic soil and standing water for part or all of the year. The limestone substrate occurs primarily as solution holes in south Florida and exposed limestone boulders in central Florida.

In south Florida, Florida bristle fern is currently found growing in rocky outcrops of rockland hammocks, in oolitic limestone solution holes, and, occasionally, on tree roots in limestone-surrounded areas (Nauman 1986, p. 181; Possley 2013a, pers. comm.). These rockland habitats are outcrops primarily composed of marine limestone representing the distinct geological formation of the Miami Rock Ridge, a feature that encompasses a broad area from Miami to Homestead, Florida, and narrows westward through the Long Pine Key area of Everglades National Park (Snyder et al. 1990, pp. 233-234). The limestone solution holes are considered specialized habitat within these hammock areas that host Florida bristle fern (Snyder et al. 1990, p. 247). The solution-hole features that dominate the rock surface in the Miami Rock Ridge are steep-sided pits formed by dissolution of subsurface limestone followed by the eventual collapse of the surface above (Snyder et al. 1990, p. 236). The limestone solution holes often have complex internal topography and vary in size and depth, from shallow holes a few centimeters deep to those that are several meters in size and up to several meters deep (Snyder et al. 1990, p. 238; Kobza et al. 2004, p. 154). The bottoms of most solution holes are filled with organic soils, while deeper solution holes penetrate the water table and have (at least historically) standing water for part of the year (Snyder et al. 1990, pp. 236-237; Rehage et al. 2014, pp. S160-S161). A direct relationship has been found between the length of time a solution hole contains water (hydroperiod length) and the habitat quality (vegetative cover) of the solution hole (Rehage et al. 2014, p. S161).

Oolitic limestone occurs in south Florida (and other locations in the world), but it does not occur in central Florida. In central Florida, Florida bristle fern resides on limestone substrate in high-humidity hammocks (van der Heiden 2013a, pers. comm.; van der Heiden 2016, p. 1). In the mesic hammocks on the Jumper Creek Tract of the Withlacoochee State Forest, the subspecies has been observed growing on exposed limestone rocks as small as 0.1 meters (m) (0.3 feet (ft)) tall as well as on larger boulders with tall, horizontal faces, and occurs alongside numerous other plant species, including rare State-listed species ( e.g., hemlock spleenwort ( Asplenium cristatum ) and widespread polypody ( Pecluma dispersa )) (van der Heiden 2013b, pers. comm.; van der Heiden and Johnson 2014, pp. 7-8). Rock outcrops may also provide suitable substrate where the underlying Ocala limestone (a geologic formation of exposed limestone near Ocala, Florida) is near the surface.

Therefore, based on the information above, we identify exposed substrate derived from oolitic limestone, Ocala limestone, or exposed limestone boulders, which provide anchoring and nutritional requirements, to be a physical or biological feature essential to the conservation of Florida bristle fern.

Florida bristle fern is considered strongly hygrophilous ( i.e., growing or adapted to damp or wet conditions) and is generally perceived as restricted to constantly humid microhabitat (Krömer and Kessler 2006, p. 57; Proctor 2012, pp. 1024-1025). Features that allow for proper ecosystem functionality and a suitable microhabitat required for the growth and reproduction of the subspecies include a canopy cover of suitable density ( i.e., average canopy closure more than 75 percent) and humidity and moisture of sufficient levels and stability (on average, above approximately 90 percent relative humidity) (van der Heiden and Johnson 2014, p. 8; Possley 2015, pers. comm.; van der Heiden 2016, p. 18).

The relationship between moist habitats and the Hymenophyllaceae Family of ferns (filmy ferns), to which the Trichomanes species belongs, has been long observed and documented (Shreve 1911, pp. 187, 189; Proctor 2003, entire; Proctor 2012, p. 1024). In a tropical rain forest system, the diversity and number of filmy fern species is shown to have a direct relation to the air moisture (relative humidity) (Gehrig-Downie et al. 2012; pp. 40-42). While not in the same fern Family as the Florida bristle fern, a study of the rare temperate woodland fern, Braun's hollyfern ( Polystichum braunii ), found air humidity to be a key factor in species health, with stronger plant productivity occurring in higher humidity levels (Schwerbrock and Leuschner 2016, p. 5). Although a minimum suitable humidity level, or threshold, for Florida bristle fern has not been quantified for either metapopulation of the subspecies, information from field studies indicates conditions of high and stable relative humidity are essential to the subspecies. Minor drops in ambient humidity may limit reproduction of the subspecies and can negatively impact overall health of the existing metapopulations, as well as inhibit the growth of new plants, impacting long-term viability (Possley 2013b, pers. comm.; van der Heiden 2013a, pers. comm.). This relationship was observed in Sumter County, where small drops (approximately 1 to 2 percent) in relative humidity associated with colder weather resulted in observed declines in the health of some clusters of Florida bristle fern within the local population (van der Heiden and Johnson 2014, p. 9).

The average relative humidity for hammocks in Sumter County remained near 95 percent for the duration of a September-November 2013 study (van der Heiden and Johnson 2014, pp. 8-9). Further, the minimum and maximum monthly average relative humidity from September 2013 to March 2015 for the two central Florida hammocks supporting Florida bristle fern were 88 and 99 percent and 89 and 100 percent, respectively (van der Heiden 2016, p. 18). The lowest monthly average relative humidity in each of the hammocks was 65 and 69 percent, respectively. In comparison, the minimum and maximum monthly average relative humidity documented outside of the hammock (from June 2014 to March 2015) was 68 and 93 percent, respectively, with a low monthly relative humidity of 51 percent. In summary, similar and consistently high average humidity values occurred between and within the two hammocks supporting the subspecies, and consistently higher relative humidity values were recorded in the hammocks compared to outside the hammocks.

Likewise, in south Florida, 8 years of data-log monitoring of Deering's Cutler Slough (the location of a known extirpated population, Charles Deering Estate Hammock, of Florida bristle fern) recorded an average of 90 percent relative humidity occurring within a solution hole compared to the 84 percent average relative humidity documented in the slough outside of the solution hole during the same time period (Possley et al. 2009, pp. 4-6; Possley 2015, pers. comm.).

The hammock environments are high or slightly elevated grounds that do not regularly flood but are dependent on a high water table to keep humidity levels high (Inventory 2010, pp. 19-28). The subspecies is affected by humidity at two spatial scales: the larger hammock community-scale and the smaller substrate (boulder/solution hole) microclimate-scale (van der Heiden and Johnson 2014, pp. 9-10). Moisture (precipitation and low evaporation) and humidity levels are likely factors limiting the occurrence of Florida bristle fern (Shreve 1911, p. 189; Proctor 2003, p. 726; Gehrig-Downie et al. 2012, p. 40). The high humidity levels discussed above and stable temperatures, moisture, and shading (cover) are all features considered essential to the subspecies and produced by the combination of:

(1) Solution hole or boulder microclimate;

(2) Organic, moisture-retaining soils (high soil moisture conditions);

(3) Hydrology of the surrounding or adjacent wetlands; and

(4) Protective shelter of the surrounding habitat minimizing effects from drying winds and/solar radiation.

Solution holes provide the limestone substrate and produce the necessary humid and moist microclimate needed by the subspecies in south Florida. In central Florida, the fern occurs in the more northerly portion of the hammocks and northern aspect of the limestone boulders, obtaining greater shading and moist conditions compared to the sunnier and drier south-facing portions of the hammocks and sides of boulders (van der Heiden and Johnson 2014, pp. 7, 31). Variances within hammocks, such as slight structural differences or proximity to water, also play an important part in where suitable microhabitat occurs in the hammock habitats. Intact hydrology and the connectivity of substrates to surface water and streams may play a role in spore and vegetative fragment dispersal for the subspecies (we provide more detail about this below, under Sites for Reproduction, Germination, and Spore Production and Dispersal ). Soils associated with the hammock ecosystems consist of sands mixed with organic matter, which produce better drained soils than soils of surrounding or adjacent wetland communities. Soils in habitats of extant Florida bristle fern populations in south Florida consist of an uneven layer of highly organic soil and moderately well-drained, sandy, and very shallow soils (classified as Matecumbe muck). Soils in habitats of the central Florida metapopulation are predominantly sand and Okeelanta muck (80 FR 60440; October 6, 2015). For both metapopulations, a relatively high soil-moisture content and high humidity are maintained by dense litter accumulation, ground cover, and heavy shade produced by the dense canopy (Service 1999, pp. 3-99).

In addition, the protected hammock habitats are slightly higher in elevation than the surrounding habitat, which combined with the limestone substrate, leaf litter, and sandy soils, create a hydrology that differs from lower elevation habitats. It is this combination of hammock ecosystem characteristics ( i.e., closed canopy, limestone substrate, humid climate, higher elevation) occurring in hardwood forested upland communities as described earlier that are essential to the conservation of the subspecies.

Therefore, based on the information above, we identify a constantly humid microhabitat climate consisting of dense canopy cover, moisture, stable high temperature, and stable monthly average relative humidity of 90 percent or higher, with intact hydrology within hammocks and the surrounding and adjacent wetland communities, to be a physical or biological feature essential to the conservation of Florida bristle fern.

Florida bristle fern occurs exclusively in hardwood hammock habitats having dense canopy, which provides shade necessary to support suitable microhabitat for the subspecies to persist, grow, and reproduce. In south Florida (Miami-Dade County), the extant populations of Florida bristle fern occur in communities classified as rockland hammocks on the Miami Rock Ridge. In central Florida (Sumter County), the extant populations of the subspecies occur in mesic hammocks, often situated in a mosaic of natural communities including hydric hammock and mixed wetland hardwoods.

The dense canopies of the hammock systems (including rockland and mesic hammocks) contribute to maintaining suitable temperature and humidity levels within this microclimate. The dense canopies found in these habitats minimize temperature fluctuations by reducing soil warming during the day and heat loss at night, thereby helping to prevent frost damage to hammock interiors (Inventory 2010, p. 25). In areas with greater temperature variations, as in central Florida, these benefits afforded by the dense canopy of both the mesic hammock and surrounding habitat combined are important to maintaining suitable conditions for Florida bristle fern. The rounded canopy profile of hammocks helps maintain mesic (moist) conditions by deflecting winds, thereby limiting desiccation (extreme dryness) during dry periods and reducing interior storm damage (Inventory 2010, p. 25). Changes in the canopy can impact humidity and evaporation rates, as well as the amount of light available to the understory. Both known extant metapopulations of Florida bristle fern live in dense canopy habitat, with shady conditions, which may be obligatory due to the poikilohydric ( i.e., possess no mechanism to prevent desiccation) nature of some fern species including the Florida bristle fern (Krömer and Kessler 2006, p. 57).

While the proper amount of canopy is critical to the persistence of Florida bristle fern, the lower limit of acceptable canopy density has yet to be quantified for either metapopulation. Field observations in south Florida have found clusters of Florida bristle fern desiccated when the immediate canopy above plants was destroyed or substantially reduced, allowing high amounts of light into the understory (Possley 2019, entire); however, over the course of many months, these clusters eventually recovered. In addition, this dense, closed canopy may serve as a shield for Florida bristle fern to inhibit the growth of other plant species on the same part of an inhabited rock area (van der Heiden and Johnson 2014, p. 9). In central Florida, the average canopy closure where Florida bristle fern occurs has been estimated to be more than 75 percent (van der Heiden and Johnson 2014, p. 9). Although there are several occurrences in these mesic hammocks where sunlight can be observed through the canopy, generally the habitat is shaded throughout the year, with the lowest canopy cover recorded at 64 percent in December (van der Heiden and Johnson 2014, pp. 8, 20). This information was obtained from a study of short duration (September-December 2013), and it is likely that percent canopy cover and consequently shading would be greater in summer months when foliage is densest (van der Heiden and Johnson 2014, p. 8).

Surrounding habitat that minimizes the effects from drying winds and solar radiation and provides a stable and protective shelter is necessary for this fern to survive. A suitable habitat size and quality is necessary to provide a functioning canopy cover that maintains the microclimate conditions (humidity, moisture, temperature, and shade) essential to the conservation of the subspecies. Field observations of Florida bristle fern in central Florida found more robust and healthy ferns in an interior hammock with approximately 300 m (985 ft) of surrounding habitat between it and cleared pastureland. This was compared to ferns in a hammock that had only 100 m (328 ft) of surrounding habitat separating it from the edge of cleared pasture. The ferns located nearer the edge ( i.e., approximately within 100 m (328 ft)) of the adjacent cleared pasture had visible signs of stress, and these ferns appeared desiccated and had fewer reproductive bristles than the ferns in the hammock and with 300 m (985 ft) of surrounding vegetation (van der Heiden 2016, p. 3). These observations are consistent with findings that documented edge effects on ferns up to 200 m (656 ft) into the forest (Hylander et al. 2013, pp. 559-560). Edge effects included loss of individual plants, loss of percent canopy cover, and increased temperature, sunlight, and wind on the microclimate (Hylander et al. 2013, pp. 559-560; Silva and Schmitt 2015, pp. 227-228). There are no similar studies for the fern in Miami-Dade County, though it is assumed their occurrence in solution holes provides some protection from the edge effects of the hammock habitat.

Therefore, based on the information above, we identify dense canopy cover of surrounding native vegetation (at least 300 m (985 ft) as measured from the edge of and surrounding the boulder substrate for central Florida) that consists of the upland hardwood forest hammock habitats and provides shade, shelter, and moisture to be a physical or biological feature essential to the conservation of Florida bristle fern.

Growth and reproduction of Florida bristle fern can occur through spore dispersal, rhizome (horizontal stem) growth, and clonal vegetative fragments (80 FR 60440; October 6, 2015). The habitats identified above provide plant communities, which require a self-maintaining closed canopy and climate-controlled interior, an adequate space for the rhizomal growth, dispersal of seeds, sporophyte and gametophyte survival, and recruitment of plant fragments.

While specific information on spore dispersal distances is largely unknown for this subspecies, the microclimate is found to be essential for spore germination and survival. Dispersal of spores, gametophytes, and vegetative fragments may take place via water-based methods, animals, and, to a lesser extent, wind-driven opportunities. In the Hymenophyllaceae Family of ferns, spores lack the capacity to withstand desiccation, are not known to be dispersed long distance through the wind, and depend upon the moist microclimate for growth and survival (Mohammad Rosli 2014, p. 21).

In terms of protecting the subspecies' genetic components, a recent study of Florida bristle fern chloroplast DNA found little genetic differentiation between the two metapopulations, which can indicate that both metapopulations are recently established from a single source or that there is a favoring of a genetic sequence (Hughes 2015, entire). Lower genetic variation in a population produces a lower effective population (the number of individuals that can undergo cross-fertilization). In such small populations, such as with Florida bristle fern, any loss of individuals may also be a loss of genetic information and a reduction of subspecies fitness (Fernando et al. 2015, pp. 32-34). Therefore, ensuring space for reproduction, germination, spore production, and dispersal of the subspecies helps ensure the conservation of genetic information and subspecies fitness.

Adequate space and the maintenance of the stable microclimate habitat support clonal growth as well as the reproductive stages of Florida bristle fern. The rare American hart's tongue fern ( Asplenium scolopendrium var. americanum ) is a species like the Florida bristle fern that relies on the specific microclimate conditions of high humidity, moisture, and shelter. In a study of the American hart's tongue fern, the presence of these microclimate habitat conditions determined the success of the fern's life-history processes (growth, reproduction, and spore production) (Fernando et al. 2015, p. 33).

Interior condition of the hammock microclimate ( e.g., humidity, temperature) are influenced by the hammock's own canopy and hydrology and the vegetative structure and hydrology of the surrounding habitat. For example, in south Florida, the pre-settlement landscape of the rockland hammocks on the Miami Rock Ridge occurred as “small islands” in a sea of pine rockland and seasonally flooded prairies, or transverse glades (shallow channels through the Miami Rock Ridge that had wet prairie vegetation and moved water out of the Everglades Basin toward the coast). It has been estimated that originally more than 500 hammocks occurred in this area, ranging in size from 0.1 ha (0.2 ac) to over 40 ha (100 ac) (Craighead 1972, p. 153). The vast majority of these hammocks have been destroyed, and those that remain are significantly reduced in size. In addition, the habitats surrounding the remaining rockland hammocks have been drastically altered or destroyed, primarily through urban and agricultural development, and, in many cases, no longer function as effective or efficient buffers to protect rockland hammocks from the impacts of changes in temperature and humidity, or extreme weather or natural stochastic events ( e.g., frost, high winds, and hurricanes/tropical storms). This fragmentation and distance between hammocks can hinder water-based dispersal and the recruitment of new plants and gametophytes. Fragmentation may reduce the stable, protected microclimate conditions and the survivability of spores within that microclimate. Thus, the hammock microhabitat supporting the subspecies must be of a suitable minimum size with sufficiently dense canopy, substrate, and understory vegetation within a hammock's interior, and there must also be intact surrounding habitat of sufficient amount, distribution, and space to support appropriate growing conditions for Florida bristle fern across its range.

The central Florida metapopulation of Florida bristle fern occurs in two mesic hammocks, which exist as part of a wetland matrix of hydric hammock, mixed wetland hardwoods, cypress/tupelo floodplain swamp, and freshwater marsh. The surrounding existing suitable habitat and substrate are essential to providing space for growth, reproduction, and dispersal of the existing populations.

Therefore, we identify the habitats described as physical or biological features above that also provide suitable microhabitat conditions, hydrology, and connectivity that can support the subspecies' growth, distribution, and population expansion (including rhizomal growth, spore dispersal, and sporophyte and gametophyte growth and survival) to be a physical or biological feature essential to the conservation of Florida bristle fern.

Florida bristle fern can be outcompeted by other native, as well as nonnative, invasive species. Nonnative plants and native weeds, including a few of the most common invasive plants such as golden pothos ( Epipremnum pinnatum cv. aureum ), arrowhead vine ( Syngonium podophyllum ), Brazilian pepper ( Schinus terebinthifolius ), and Burma reed ( Neyraudia reynaudiana ), compete with Florida bristle fern for space, light, water, and nutrients; limit the subspecies' growth and abundance; and can make habitat conditions unsuitable for the subspecies. Nonnative plant species have affected hammock habitats where Florida bristle fern occurs, and as identified in the final listing rule (80 FR 60440; October 6, 2015), are considered one of the threats to the subspecies (Snyder et al. 1990, p. 273; Gann et al. 2002, pp. 552-554; Inventory 2010, pp. 22, 26). Invasive vines such as golden pothos, arrowhead vine, Philodendron spp., and Monstera spp., have become an increasing threat to hammocks in south Florida and can result in canopy collapse during hurricanes or other high wind events (Duncan 2020, pers. comm.). Nonnative plants can outcompete and displace Florida bristle fern in solution holes, and can blanket existing occurrences, blocking out all light and smothering the fern (Possley 2013c, pers. comm.). Native bryophytes, especially leafy liverworts such as Neckeropsis undulata, also compete with Florida bristle fern and gain the advantage in higher light levels (Possley 2019, pp. 3-4). In addition to the negative impacts of nonnative and native invasive plants, feral hogs can impact substrate and vegetation (directly) and habitat suitability (indirectly). Rooting from hogs can destroy existing habitat by displacing smaller rocks where the subspecies grows and potentially damage or eliminate a cluster of the fern (Werner 2013, pers. comm.). In the Withlacoochee State Forest, damaged areas from feral hogs are also more susceptible to invasion from nonnative plant species (Werner 2013, pers. comm.).

Therefore, based on the information above, we identify a plant community of predominantly native vegetation that is minimally disturbed or free from human-related disturbance, with either no competitive nonnative, invasive plant species, or such species in quantities low enough to have minimal effect on Florida bristle fern, to be a physical or biological feature essential to the conservation of Florida bristle fern.

We derive the specific physical or biological features essential to Florida bristle fern conservation from studies of the species' habitat, ecology, and life history as described above, in the final listing rule (80 FR 60440; October 6, 2015), and the proposed critical habitat rule (85 FR 10371; February 24, 2020). We have determined that the following physical or biological features are essential to Florida bristle fern conservation:

(1) Upland hardwood forest hammock habitats of sufficient quality and size to sustain the necessary microclimate and life processes for Florida bristle fern.

(2) Exposed substrate derived from oolitic limestone, Ocala limestone, or exposed limestone boulders, which provide anchoring and nutritional requirements.

(3) Constantly humid microhabitat consisting of dense canopy cover, moisture, stable high temperature, and stable monthly average humidity of 90 percent or higher, with intact hydrology within hammocks and the surrounding and adjacent wetland communities.

(4) Dense canopy cover of surrounding native vegetation that consists of the upland hardwood forest hammock habitats and provides shade, shelter, and moisture.

(5) Suitable microhabitat conditions, hydrology, and connectivity that can support Florida bristle fern's growth, distribution, and population expansion (including rhizomal growth, spore dispersal, and sporophyte and gametophyte growth and survival).

(6) Plant community of predominantly native vegetation that is minimally disturbed or free from human-related disturbance, with either no competitive nonnative, invasive plant species, or such species in quantities low enough to have minimal effect on Florida bristle fern.

When designating critical habitat, we assess whether the specific areas within the geographical area occupied by the species at the time of listing contain features which are essential to the conservation of the species and which may require special management considerations or protection. The features essential to the conservation of Florida bristle fern may require special management considerations or protections to reduce threats related to habitat modification and destruction primarily due to development, agricultural conversion, hydrologic alteration, nonnative and invasive species, public use, and sea level rise. For more information on threats to Florida bristle fern, please refer to the final listing rule (80 FR 60440; October 6, 2015).

The four known populations of the south Florida metapopulation occur on County-managed conservation lands at Castellow Hammock, Hattie Bauer Hammock, Fuchs Hammock, and Meissner Hammock. However, these areas are still vulnerable to the effects of activities in the surrounding areas, including agricultural clearing and hydrologic alterations. In addition, these areas are vulnerable to threats from nonnative, invasive species, especially if current control efforts are discontinued or decreased. The small amount of rockland hammock or mixed rockland/mesic hammock is vulnerable to impacts related to urban and agricultural development, including hydrologic alterations, and threats by nonnative, invasive species (especially as such areas are often not actively managed for nonnative species). Also, these areas are open to public access, and Florida bristle fern may be at risk of collection, damage from people climbing on them, and impacts to microclimate due to installation and improvements of trails (Duncan 2020, pers. comm.). We expect these hammock communities in south Florida to be further degraded due to sea level rise and the increase in the number of flood events, which would fully or partially inundate some rockland hammocks along the coast and in the southern portion of Miami-Dade County and in Everglades National Park. In the short to mid-term, sea level rise may benefit the fern by lifting a freshwater lens into previously drained areas or areas experiencing a lowered water table, which may restore or preserve a favorable microclimate for the subspecies (Duncan 2020, pers. comm.). Over the long term, however, sea level rise is expected to increase the salinity of the water table and soils, resulting in vegetation shifts across the Miami Rock Ridge.

The two known populations of the central Florida metapopulation both occur on State-owned land in the Jumper Creek Tract of the Withlacoochee State Forest. Land clearing and hydrological alterations on private lands adjacent to the Jumper Creek Tract continue to be threats to the subspecies' populations and habitat. In addition, while the Withlacoochee State Forest is generally considered public conservation land, it is managed by the Florida Forest Service and is subject to logging in certain areas. Logging is less likely to occur on the Jumper Creek Tract due to the existing matrix of hammocks and pinelands (versus a predominantly pineland community). This area is also subject to impacts from nonnative, invasive species, although forest management on the Jumper Creek Tract currently includes nonnative plant control. Moisture and humidity levels of the fern habitat are also dependent upon the hydrology of the surrounding or adjacent wetlands. Alterations in the natural hydrologic regime within the hammock and these adjacent habitats affect these physical or biological features. Draining, ditching, and excessive pumping of groundwater can lower the water table in hammocks, causing reduced moisture and humidity levels. In such cases, mesic hammocks, for example, may undergo shifts in species composition toward xeric hammock composition. These impacts to hammock systems may ultimately reduce or eliminate suitable habitat for the subspecies. A lowered water table or dewatering of hammocks can also render the habitat vulnerable to catastrophic fire.

Special management considerations and protections that will address these threats include increased coordination and conservation of the subspecies and its habitat (including preventing impacts to hammock hydrology, canopy cover, microclimate, and substrate) on Federal lands and, with the cooperation of State, County, and private landowners, on non-Federal lands. Habitat restoration and management efforts (including nonnative plant treatments) of high-priority sites will be emphasized. At this time, the subspecies does not occur on Federal lands for either metapopulation, but reintroduction is being explored for Royal Palm Hammock in Everglades National Park in south Florida.

As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b), we review available information pertaining to the habitat requirements of the species and identify specific areas within the geographical area occupied by the species at the time of listing and any specific areas outside the geographical area occupied by the species to be considered for designation as critical habitat.

The current distribution of Florida bristle fern is reduced from its historical distribution to a level where it is in danger of extinction. We anticipate that recovery will require continued protection of existing populations and habitat, as well as establishing sites that more closely approximate its historical distribution, in order to ensure there are adequate numbers of Florida bristle fern in stable populations and that these populations occur over a wide geographic area within both metapopulations. This strategy will help to ensure that catastrophic events, such as fire, cannot simultaneously affect all known populations. Rangewide recovery considerations, such as maintaining existing genetic diversity and striving for representation of all major portions of the subspecies' historical range, were considered in formulating this critical habitat designation.

The amount and distribution of the designated critical habitat are designed to provide:

(1) The processes that maintain the physical or biological features that are essential to the conservation of the subspecies;

(2) Sufficient quality and size of habitat to support the persistence of the physical or biological features for the subspecies (hammock microclimate, humidity, temperature, substrate, canopy cover, native plant community);

(3) Habitat to expand the distribution of Florida bristle fern into historically occupied areas;

(4) Space to increase the size of each population to a level where the threats of genetic, demographic, and normal environmental uncertainties are diminished; and

(5) Additional space to improve the ability of the subspecies to withstand local or regional-level environmental fluctuations or catastrophes.

For Florida bristle fern, we are designating critical habitat in areas within the geographical area occupied by the subspecies at the time of listing. For those areas, we determined that they were of suitable habitat within the known historical range, with current occurrence records, contain one or more of the physical or biological features essential to the conservation of the subspecies, and require special management considerations or protection. We are also designating specific areas outside the geographical area occupied by the subspecies at the time of listing because we have determined that a designation limited to occupied areas would be inadequate to ensure the conservation of the subspecies. For those unoccupied areas, we have determined that it is reasonably certain that the unoccupied areas will contribute to the conservation of the subspecies and that the areas contain one or more of the physical or biological features that are essential to the conservation of the subspecies.

To determine the general extent, location, and boundaries of the designated critical habitat, we used the following sources of information:

(1) Historical and current records of Florida bristle fern occurrence and distribution found in publications, reports, personal communications, and associated voucher specimens housed at museums and private collections;

(2) Florida Fish and Wildlife Commission (Commission), Inventory, Institute for Regional Conservation (Institute), and Fairchild geographic information system (GIS) data showing the location and extent of documented occurrences of Florida bristle fern;

(3) Reports and databases prepared by the Institute and Fairchild;

(4) ESRI ArcGIS online basemap aerial imagery (December 2010) and historical aerial imagery (1938 for Miami-Dade County; 1941 for Sumter County); and

(5) GIS data depicting land cover (Commission and Inventory Cooperative Land Cover Map, version 3.3) within Miami-Dade and Sumter Counties, and the location and habitat boundaries of rockland hammocks in Miami-Dade County (Institute et al. 2005; Institute 2009; Miami-Dade County Information Technology Department 2021; Florida Geographic Data Library 2017; Commission and Inventory 2020; Sumter County 2019).

The presence of the physical or biological features was determined using the above sources of information as well as site visits by biologists and botanists (Possley 2019, entire) through field surveys, habitat mapping, and substrate mapping by the Institute (van der Heiden and Johnson 2014, entire; Possley 2015, pers. comm.; van der Heiden 2016, entire), and follow-up discussions with Miami-Dade County, Fairchild staff, and private landowners.

The occupied critical habitat units were delineated around the documented extant populations and the existing physical or biological features that require special management considerations or protection. We have determined that all currently known occupied habitat for Florida bristle fern was also occupied by the subspecies at the time of listing, and that these areas contain the physical or biological features essential to the conservation of the subspecies and which may require special management considerations or protection. We are designating these areas as occupied habitat.

Occupied habitat, which for the south Florida metapopulation occurs in rockland hammock habitat, was identified based on available occurrence data for Florida bristle fern. Rockland hammock boundaries were delineated using the Institute's 2009 rockland hammock GIS layer. Based on our assessment of rockland hammocks on the Miami Rock Ridge (see above, under Sites for Reproduction, Germination, and Spore Production and Dispersal ), we included all of the remaining rockland hammocks currently occupied by Florida bristle fern within the critical habitat assessment. Next, we grouped rockland hammocks, where appropriate, to form units. Rockland hammocks in close proximity to one another provide connectivity and allow spore dispersal (water-based, animal, or wind-driven dispersal) from occupied to adjacent habitat, which is important for establishing new clusters of plants to increase population resiliency and subspecies redundancy. In addition, based on the Act's implementing regulations (50 CFR 424.12(d)), when habitats are in close proximity to one another, an inclusive area may be designated. Although the population historically observed in Ross Hammock has been reported as extirpated, we combined Ross Hammock with Castellow Hammock into a single occupied unit (unit South Florida 4 [SF 4]) because: (1) The subspecies is exceedingly hard to find even by species experts and, therefore, may be present even though it has been reported as extirpated; (2) gametophytes, the very cryptic reproductive stage of the fern, are not recognizable in the field and could still be present on site even if the sporophytes, the recognizable plant form, have been extirpated; (3) there is the likelihood that spores could travel between occupied and adjacent habitat, particularly during high-water events; and (4) habitat directly adjacent to known occurrences ( e.g., separated only by a road) can also be occupied if habitat conditions are suitable. Three occupied units (Castellow and Ross, Hattie Bauer, and Fuchs and Meissner hammocks) totaling 73 ha (180 ac) are designated as critical habitat for the south Florida metapopulation.

For the central Florida populations, habitat was identified as the intersection of mesic, hydric, and elevated hydric hammocks that contain boulder substrate (van der Heiden 2016, p. 3).

On the Jumper Creek Tract, known extant populations of Florida bristle fern occur in two small mesic hammocks located within and supported by a matrix of hydric hammock and mixed wetland hardwood communities. The mesic hammocks are approximately 0.18 ha (0.44 ac) and 0.11 ha (0.28 ac) in size and difficult to differentiate from the surrounding forested vegetation. Our evaluation of occurrence data for this metapopulation also included historical observations of the Florida bristle fern south of the Jumper Creek Tract where the subspecies was formerly known to occur near Battle Slough (near the existing town of Wahoo) and located in close proximity to the extant populations. In this area, habitat types include mixed wetland hardwoods surrounded by freshwater marsh, cypress/tupelo, and mixed hardwood-coniferous forest. Using the information mentioned above on current and historical occurrences and habitat type and applying the data for suitable substrate (boulders), we delineated a contiguous unit of occupied habitat for Florida bristle fern.

As discussed in Physical or Biological Features Essential to the Conservation of the Species, above, suitable hammock micro-conditions in this landscape (specifically the high humidity, stable temperatures, moisture, and shade) required by Florida bristle fern are supported by the surrounding vegetation, which minimizes drastic changes in temperature or humidity at the microclimate scale. Generally, forest edges receive more light, are prone to greater desiccation, and have a reduced biodiversity compared to the forest interiors. Pronounced edge effects from adjacent land clearing and fragmentation, such as with agricultural lands, reduce the quality of forested habitat and detrimentally affect the interior microclimate.

To most accurately represent suitable habitat for Florida bristle fern within these central Florida communities and ensure the persistence of the necessary microclimate, we consider natural communities within 300 m (985 ft) as measured from the edge of and surrounding the boulder substrate (equivalent to 9.3 ha (23 ac)) to be habitat essential to the conservation of the subspecies (van der Heiden 2014, pers. comm.; van der Heiden 2016, p. 3) in protecting the habitat from edge effects. The suitable habitat communities and the distribution of exposed limestone substrate (boulder) in these communities were delineated with the use of ground survey and satellite imagery data (van der Heiden and Johnson 2014, pp. 6-7; van der Heiden 2016, p. 3). Site-level data of vegetative communities produced from aerial photography (Commission and Inventory 2020) and feedback from species experts and local biologists on habitat and substrate occurrence in this area were also used.

Thus, using the best available data, one occupied unit totaling 742 ha (1,834 ac) is designated as critical habitat for the central Florida metapopulation. This critical habitat designation consists of a contiguous unit within and adjacent to Jumper Creek Tract of intact vegetation ( i.e., not cleared) in mesic or hydric hammocks and mixed wetland hardwood communities having exposed limestone substrate (boulders), which have, at minimum, a 300-m (985-ft) radius of surrounding intact vegetation.

To consider for designation areas not occupied by the subspecies at the time of listing, we must determine that these areas are essential for the conservation of Florida bristle fern. In south Florida, occupied critical habitat for the subspecies is within a relatively small amount of highly fragmented habitat and occupied patches are generally isolated from one another within the landscape. In addition, the extent of the geographic area in south Florida (Miami-Dade County) that is currently occupied by the plant is substantially (nearly 80 percent) smaller than its historical range. In central Florida, the two known existing populations are in very close proximity and also in a much smaller area than the known historical range. Because of this fragmentation and loss of range, both metapopulations have lower resiliency under these current conditions compared to historical occurrences, and, therefore, the subspecies' adaptive capacity (representation) and redundancy has been reduced.

Based on these factors in relation to the threats to Florida bristle fern, we have determined that designation of unoccupied areas are needed to conserve the species; thus, additional habitat is essential to provide a sufficient amount of habitat (total area and number of patches) and connectivity for the long-term conservation of the plant. Therefore, we have identified and are designating as critical habitat specific areas outside the geographical area occupied by the subspecies at the time of listing that are essential for the conservation of the subspecies. This will ensure enough sites and individuals exist for each metapopulation of Florida bristle fern to recover. We used habitat and historical occurrence data and the physical or biological features described earlier to identify unoccupied habitat essential for the conservation of the Florida bristle fern. As discussed in more detail below, the unoccupied areas we selected are essential for the conservation of the subspecies because they:

(1) Consist of a documented historical, but now extirpated, occurrence of the subspecies;

(2) Could still have Florida bristle fern gametophytes on site;

(3) Provide areas of sufficient size to support ecosystem processes;

(4) Provide suitable habitat (that contains some or all of the physical or biological features essential to the conservation of the subspecies) that allow for growth and expansion; and

(5) Occur in the known historical range of the subspecies.

These unoccupied areas provide sufficient space for growth and reproduction for the subspecies within the historical range and will provide ecological diversity so that the subspecies has the ability to evolve and adapt over time (representation) and ensure that the subspecies has an adequate level of redundancy to guard against future catastrophic events. These areas also represent the areas within the historical range with the best potential for recovery of the subspecies due to their current conditions, provide habitat and space to support spore dispersal and new growth, and are likely suitable for reintroductions. Also, the areas with historical occurrences of Florida bristle fern have a high likelihood of gametophyte presence, the very cryptic reproductive stage of the fern (Possley 2020, pers. comm.), that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). For these reasons, we have reasonable certainty that the unoccupied areas will contribute to the conservation of the species.

The existing suitable habitat for the south Florida metapopulation consists of a patchwork of small parcels. Therefore, we must ensure the integrity of the solution hole and canopy cover, which is responsible for maintaining the stable damp, humid, and shaded microclimate identified as a physical or biological feature for the subspecies.

Using the Institute's 2009 rockland hammock GIS layer, the Commission and Inventory's Cooperative Land Cover site-level data for rockland hammocks, the Institute et al.' s 2015 Natural Forest Community GIS layer for hammocks, and site visit information from Service staff biologists and botanists from Fairchild and Miami-Dade County, we evaluated all unoccupied sites within rockland hammock habitats, including mixed rockland/mesic hammock and rockland hammock with connecting mixed wetland hardwood habitat, in Miami-Dade County. Specifically, we reviewed available historical aerial photography of 20 rockland hammocks historically occupied, but now unoccupied, by the subspecies. Ten additional potential sites were visited by Service staff. Also, specific information provided by Miami-Dade County and Fairchild on four additional areas was reviewed. A site was considered in the evaluation for unoccupied critical habitat if it is within the historical range of the subspecies and:

(1) Holds a documented historical occurrence;

(2) Contains one or more of the physical or biological features essential to the conservation of the subspecies;

(3) Provides viable habitat for introductions or could be restored to support Florida bristle fern;

(4) Occurs at the edge of the range and provides areas that would allow for growth and expansion; or

(5) Occurs near an occupied site (for potential recruitment).

Each site will, in conjunction with occupied areas of designated critical habitat, support the conservation of the subspecies. Based on our review, we identified four unoccupied rockland hammock units on the Miami Rock Ridge outside of Everglades National Park (see table 1, below). These four units represent the units with documented, but now extirpated, historical occurrences with intact rockland hammock within the historical range of the subspecies outside of the Everglades National Park. Within the Everglades National Park, we identified a fifth unit, the Royal Palm Hammock, for inclusion in the designated critical habitat. This hammock was also historically occupied by the subspecies but was not occupied at the time of listing. The resulting five unoccupied designated units consist of 136 ha (335 ac) and are considered essential for the conservation of Florida bristle fern because they protect habitat needed to recover the subspecies and reestablish wild populations within the known historical range of the subspecies in Miami-Dade County. The unoccupied units each contain one or more of the physical or biological features essential to the conservation of the subspecies and are likely to provide for the conservation of the subspecies. The majority of four of the unoccupied units are on lands managed by Miami-Dade County, and the fifth unoccupied unit is on land managed by Everglades National Park.

For the central Florida metapopulation, criteria for determining unoccupied critical habitat included units that:

(1) Hold a documented historical occurrence;

(2) Contain one or more of the physical or biological features essential to the conservation of the subspecies;

(3) Provide space for growth and recovery (to add resiliency to a small population);

(4) Provide viable habitat for introductions; and

(5) Provide connectivity across the range of the subspecies.

Unoccupied habitat was delineated based on documented historical occurrences, existing suitable habitat (as defined by the physical or biological features), and evaluation of the habitat and substrate delineation mapping (van der Heiden 2016, pp. 5-7) with data obtained through field surveys and satellite mapping. The one unoccupied unit designated as critical habitat consists of approximately 747 ha (1,846 ac) (see table 1, below). It consists of documented historically occupied (now extirpated) habitat with suitable wetland and upland communities having intact vegetation ( i.e., not cleared) and hammocks and exposed limestone boulders with at least a 300-m (985-ft) radius or greater of surrounding native vegetation (van der Heiden 2014, pers. comm.; van der Heiden 2016, p. 3). Its size was based on the conditions necessary to maintain the physical or biological features essential to the conservation of the subspecies. It is considered essential for the conservation of Florida bristle fern because it protects habitat needed to recover the subspecies and reestablish wild populations within the known historical range of the subspecies in Sumter County. The unoccupied unit contains one or more of the physical or biological features essential to the conservation of the subspecies and is likely to provide for the conservation of the subspecies.

When determining critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack the physical or biological features necessary for Florida bristle fern. The scale of the maps we prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed lands. Any such lands inadvertently left inside critical habitat boundaries shown on the maps of this rule have been excluded by text in the rule and are not included for designation as critical habitat. Therefore, a Federal action involving these lands would not trigger section 7 consultation under the Act with respect to critical habitat and the requirement of no adverse modification unless the specific action would affect the physical or biological features in the adjacent critical habitat.

The critical habitat designation is defined by the map or maps, as modified by any accompanying regulatory text, presented at the end of this document under Regulation Promulgation. We include more detailed information on the boundaries of the critical habitat designation in the discussion of individual units below. We will make the coordinates or plot points or both on which each map is based available to the public at https://www.regulations.gov under Docket No. FWS-R4-ES-2019-0068, at https://www.fws.gov/office/florida-ecological-services/library, and at the Florida Ecological Services Field Office, Vero Beach (see FOR FURTHER INFORMATION CONTACT , above).

We are designating approximately 1,698 ha (4,195 ac) in 10 units in Miami-Dade and Sumter Counties, Florida, as critical habitat for Florida bristle fern. The designated critical habitat consists of units identified for the south and central Florida metapopulations and are delineated in (1) south Florida by rockland/tropical hammocks of Miami-Dade County (208 ha (515 ac)); and (2) central Florida by Withlacoochee State Forest, Jumper Creek Tract, and adjacent lands in Sumter County (1,489 ha (3,680 ac)). Four of the units are currently occupied by the subspecies and contain those physical or biological features essential to the conservation of the subspecies but may require special management considerations or protection. Six of the units are currently unoccupied by the subspecies but are essential for the conservation of the subspecies. Table 1 shows the name, occupancy, area, and land ownership of each unit within the critical habitat designation for Florida bristle fern. Land ownership within the entire designated critical habitat consists of Federal (4 percent), State (91 percent), County (3 percent), and private (2 percent) ownership.

We present brief descriptions of all units, and reasons why they meet the definition of critical habitat for Florida bristle fern, below.

The designated critical habitat for the south Florida metapopulation is composed of eight units (SF 1-SF 8) consisting of approximately 208 ha (515 ac) located between South Miami and eastern Everglades National Park in central and southern Miami-Dade County, Florida.

We identified this area as essential for the conservation of the Florida bristle fern. SF 1 consists of approximately 22 ha (55 ac) of habitat in Matheson Hammock in and around Matheson Hammock Park in Miami-Dade County, Florida. This unit is composed of 20.6 ha (51.1 ac) of County-owned land that is primarily managed cooperatively by Miami-Dade County's Environmentally Endangered Lands (EEL) program and Natural Areas Management (NAM) division. The remaining 1.5 ha (3.7 ac) are privately owned and managed by the landowners through the EEL Covenant Program and/or are protected from development through Miami-Dade County's designation as Natural Forest Communities. Matheson Hammock is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains some or all of the physical or biological features essential to the conservation of the subspecies. Unit SF 1 possesses those characteristics as described by the first identified physical or biological feature (upland hardwood forest hammock habitats of sufficient quality and size to sustain the necessary microclimate and life processes for Florida bristle fern) and the second identified physical or biological feature (exposed substrate derived from oolitic limestone, Ocala limestone, or exposed limestone boulders, which provide anchoring and nutritional requirements). The third through sixth identified physical or biological features are degraded in this unit, but with appropriate management and restoration actions (such as removal of invasive plant species), these physical or biological features can be restored. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Miami-Dade County. Re-establishing a population in this unit would increase redundancy in the South Florida metapopulation. It would also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and methods for restoring habitat and reintroducing the subspecies are being developed for this unit. As stated previously, the majority of this unit is composed of County-owned land and primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The EEL program's focus is on the “protection and conservation of endangered lands,” and these EEL areas are managed for restoration and conservation through actions such as invasive plant removal. In addition, State and County partners have shown interest in reintroduction efforts for the Florida bristle fern in this area. The privately owned portions of this unit are either enrolled in the County's EEL Covenant Program, a 10-year commitment to restore and manage the property as a natural area in exchange for tax incentives, or designated as a Natural Forest Community under Miami-Dade County's Code of Ordinances (chapter 24, article IV, division 2, section 24-49.2), which limits development of rockland hammocks to no more than 10 percent of the site.

We identified this area as essential for the conservation of the subspecies. SF 2 consists of approximately 6 ha (15 ac) of habitat in Snapper Creek Hammock adjacent to R. Hardy Matheson Preserve in Miami-Dade County, Florida. This unit consists of 3.2 ha (8 ac) of State-owned land that is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division and 2.6 ha (7 ac) of University of Miami-owned land that is managed in cooperation with Fairchild. Snapper Creek is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains some or all of the physical or biological features essential to the conservation of the subspecies. Unit SF 2 possesses those characteristics as described by the first identified physical or biological feature (upland hardwood forest hammock habitats of sufficient quality and size to sustain the necessary microclimate and life processes for Florida bristle fern) and the second identified physical or biological feature (exposed substrate derived from oolitic limestone, Ocala limestone, or exposed limestone boulders, which provide anchoring and nutritional requirements). The third through sixth identified physical or biological features are degraded in this unit, but with appropriate management and restoration actions (such as removal of invasive plant species), these physical or biological features can be restored. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Miami-Dade County. Re-establishing a population in this unit would increase the subspecies' redundancy in the South Florida metapopulation. It will also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and methods for restoring habitat and reintroducing the subspecies are being developed for this unit. As stated previously, this unit is composed of State-owned land that is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division and University of Miami-owned land that is cooperatively managed with Fairchild. The EEL program's focus is on the “protection and conservation of endangered lands,” and these EEL areas are managed for restoration and conservation through actions such as invasive plant removal. In addition, State, County, and private partners have shown interest in reintroduction efforts for the Florida bristle fern in this area.

We identified this area as essential for the conservation of the Florida bristle fern. SF 3 consists of approximately 43 ha (106 ac) of habitat in the Charles Deering Estate in Miami-Dade County, Florida. This unit is composed of State-owned land that is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. Charles Deering Estate Hammock is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains all of the physical or biological features essential to the conservation of the subspecies. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Miami-Dade County. Re-establishing a population in this unit would increase the subspecies' redundancy in the South Florida metapopulation. It will also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and methods for reintroducing the subspecies are being developed for this unit. As stated previously, this unit is composed entirely of State-owned land and is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The EEL program's focus is on the “protection and conservation of endangered lands,” and these EEL areas are managed for restoration and conservation through actions such as invasive plant removal. In addition, State and County partners have shown interest in reintroduction efforts for the Florida bristle fern in this area.

SF 4 consists of approximately 56 ha (139 ac) of habitat in Castellow and Ross Hammocks in and around Castellow Hammock Preserve in Miami-Dade County, Florida. This unit consists of 17.5 ha (43.3 ac) of State-owned and 25.6 ha (63.4 ac) of County-owned lands that are primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The remaining 13 ha (32.3 ac) are privately owned and managed by the landowners through the EEL Covenant Program and/or are protected from development through Miami-Dade County's designation as Natural Forest Communities. This unit is occupied by the subspecies and contains some or all of the physical or biological features essential to its conservation.

Special management considerations or protection may be required to address threats of commercial, residential, or agricultural development; hydrological alterations; competition with nonnative species; human use and recreation; and sea level rise. In some cases, these threats are being addressed or coordinated with our partners and landowners to implement needed actions. Such actions include removal of invasive species, review of County development plans, and review of projects considering land use changes.

We identified this area as essential for the conservation of the subspecies. SF 5 consists of approximately 4 ha (10 ac) of habitat in Silver Palm Hammock in Miami-Dade County, Florida. This unit consists of State-owned land that is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. Silver Palm Hammock is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains some or all of the physical or biological features essential to the conservation of the subspecies. Unit SF 5 possesses those characteristics as described by the first identified physical or biological feature (upland hardwood forest hammock habitats of sufficient quality and size to sustain the necessary microclimate and life processes for Florida bristle fern); the second identified physical or biological feature (exposed substrate derived from oolitic limestone, Ocala limestone, or exposed limestone boulders, which provide anchoring and nutritional requirements); the third identified physical or biological feature (constantly humid microhabitat consisting of dense canopy cover, moisture, stable high temperature, and stable monthly average humidity of 90 percent or higher, with intact hydrology within hammocks and the surrounding and adjacent wetland communities); the fourth identified physical or biological feature (dense canopy cover of surrounding native vegetation that consists of the upland hardwood forest hammock habitats and provides shade, shelter, and moisture); and the fifth identified physical or biological feature (suitable microhabitat conditions, hydrology, and connectivity that can support Florida bristle fern's growth, distribution, and population expansion (including rhizomal growth, spore dispersal, and sporophyte and gametophyte growth and survival)). The sixth identified physical or biological feature is degraded in this unit, but with appropriate management and restoration actions (such as removal of invasive plant species), this feature can be restored. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Miami-Dade County. Re-establishing a population in this unit would increase the subspecies' redundancy in the South Florida metapopulation. It will also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and methods for restoring habitat are being developed for this unit. As stated previously, this unit is entirely composed of State-owned land and is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The EEL program's focus is on the “protection and conservation of endangered lands,” and these EEL areas are managed for restoration and conservation through actions such as invasive plant removal. In addition, State and County partners have shown interest in reintroduction efforts for the Florida bristle fern in this area.

SF 6 consists of approximately 6 ha (16 ac) of habitat in Hattie Bauer Hammock in and around Hattie Bauer Hammock Preserve in Miami-Dade County, Florida. This unit consists of 4 ha (10 ac) of County-owned land that is primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The remaining 2 ha (6 ac) are privately owned and managed by the landowners through the EEL Covenant Program and/or are protected from development through Miami-Dade County's designation as Natural Forest Communities. This unit is occupied by the subspecies and contains some or all of the physical or biological features essential to its conservation.

Special management considerations or protection may be required to address threats of commercial, residential, or agricultural development; hydrological alterations; competition with nonnative species; human use and recreation; and sea level rise. In some cases, these threats are being addressed or coordinated with our partners and landowners to implement needed actions. Such actions include removal of invasive species, review of County development plans, and review of projects considering land use changes.

SF 7 consists of approximately 10 ha (25 ac) of habitat in Fuchs and Meissner Hammocks in and around Fuchs and Meissner Hammock Preserves in Miami-Dade County, Florida. This unit consists of 2 ha (5 ac) of State-owned and 7.6 ha (19 ac) of County-owned lands that are primarily managed cooperatively by Miami-Dade County's EEL program and NAM division. The remaining 0.4 ha (1 ac) are privately owned and managed by the landowners through the EEL Covenant Program and/or are protected from development through Miami-Dade County's designation as Natural Forest Communities. This unit is occupied by the subspecies and contains some or all of the physical or biological features essential to its conservation.

Special management considerations or protection may be required to address threats of commercial, residential, or agricultural development; hydrological alterations; competition with nonnative species; human use and recreation; and sea level rise. In some cases, these threats are being addressed or coordinated with our partners and landowners to implement needed actions. Such actions include removal of invasive species, review of County development plans, and review of projects considering land use changes.

We identified this area as essential for the conservation of the subspecies. SF 8 consists of approximately 61 ha (150 ac) of habitat in Royal Palm Hammock in Everglades National Park, which is federally owned land, in Miami-Dade County, Florida. Royal Palm Hammock is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains all of the physical or biological features essential to the conservation of the subspecies. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Miami-Dade County. Re-establishing a population in this unit would increase the subspecies' redundancy in the South Florida metapopulation. It will also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and habitat maintenance in this unit is ongoing. This unit is entirely composed of federally owned Everglades National Park land, and the National Park Service has responsibilities under section 7(a)(1) of the Act to carry out programs for the conservation of federally listed endangered and threatened species. The Everglades National Park General Management Plan (Plan), approved in 2015, prior to the published final listing rule for Florida bristle fern, guides the National Park Service's management of Everglades National Park, including conservation of endangered and threatened species. The 2015 Plan identifies the Florida bristle fern as extirpated from Everglades National Park (Royal Palm Hammock), and, therefore, specific conservation measures were not discussed for the subspecies (National Park Service 2015, p. 226). However, Everglades National Park continues to conduct nonnative plant species control in Royal Palm Hammock, which helps maintain the physical or biological features essential to the conservation of the Florida bristle fern.

The designated critical habitat for the central Florida metapopulation is composed of two units (CF 1 and CF 2) consisting of approximately 1,489 ha (3,680 ac) located within and adjacent to the Jumper Creek Tract of the Withlacoochee State Forest in Sumter County, Florida.

CF 1 consists of approximately 742 ha (1,834 ac) of habitat in Sumter County, Florida. This unit consists of 726 ha (1,795 ac) of State-owned land within the Jumper Creek Tract of the Withlacoochee State Forest and 16 ha (39 ac) of privately owned land directly adjacent to the two locations where Florida bristle fern is currently observed. The State-owned land is managed by the Florida Forest Service. This unit is occupied by the subspecies and contains all of the physical or biological features essential to its conservation.

Special management considerations or protection may be required to address threats of residential and agricultural development, land clearing, logging, cattle grazing, hydrological alteration, competition with nonnative species, human use and recreation, and impacts related to climate change. In some cases, these threats are being addressed or coordinated with our partners and landowners to implement needed actions.

We identified this area as essential for the conservation of the subspecies. CF 2 consists of approximately 747 ha (1,846 ac) of habitat on State-owned land within the Jumper Creek Tract of the Withlacoochee State Forest, Sumter County, Florida. This is within the historical range of Florida bristle fern but was not occupied by the subspecies at the time of listing.

Although it is currently considered unoccupied, Florida bristle fern was documented here in the past (80 FR 60440; October 6, 2015), and it is possible that the site still contains the fern's gametophytes (the very cryptic reproductive stage of the fern) (Possley 2020, pers. comm.) that could develop into sporophytes (the recognizable mature plant) under the proper conditions (80 FR 60440; October 6, 2015). Also, this unit contains all of the physical or biological features essential to the conservation of the subspecies. Based upon the presence of key habitat needs and the conditions of the site, this unit constitutes habitat for the Florida bristle fern.

This unit will serve to protect habitat needed to recover the subspecies and reestablish wild populations within the historical range in Sumter County. Re-establishing at least one historical population in this unit would increase the subspecies' redundancy in the Central Florida metapopulation. It will also provide habitat for recolonization in the case of stochastic events (such as hurricanes), should other areas of suitable habitat be destroyed, or should Florida bristle fern be extirpated from one of its currently occupied locations. This unit is essential for the conservation of the subspecies because it will provide habitat for range expansion in known historical habitat that is necessary to increase viability of the subspecies by increasing its resiliency, redundancy, and representation.

We are reasonably certain that this unit will contribute to the conservation of the subspecies because the need for conservation efforts is recognized and is being discussed by our conservation partners, and habitat maintenance in this unit is ongoing. This unit is entirely composed of State-owned land that is part of the Withlacoochee State Forest. The Ten-Year Resource Management Plan for the Withlacoochee State Forest (Management Plan), approved in 2015, prior to the published final listing rule for Florida bristle fern, guides the Florida Forest Service's management, including protection of endangered and threatened species found on the Withlacoochee State Forest. The Management Plan lists the Florida bristle fern as occurring in the Forest, but specific conservation measures are not discussed for the subspecies. However, the Withlacoochee State Forest conducts nonnative species control (Florida Department of Agriculture and Consumer Services 2015, p. 34), which helps maintain the physical or biological features essential to the conservation of Florida bristle fern. The Florida Forest Service has shown interest in reintroduction efforts for Florida bristle fern in this area.

Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they fund, authorize, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species.

We published a final rule revising the definition of destruction or adverse modification on August 27, 2019 (84 FR 44976). Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species.

If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. Examples of actions that are subject to the section 7 consultation process are actions on State, Tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251 et seq. ) or a permit from the Service under section 10 of the Act) or that involve some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation Administration, or the Federal Emergency Management Agency). Federal agency actions within the subspecies' habitat that may require consultation include management and any other landscape-altering activities on Federal lands administered by the Service, Army National Guard, U.S. Forest Service, and National Park Service; issuance of section 404 Clean Water Act permits by the U.S. Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration. Federal actions not affecting listed species or critical habitat, and actions on State, Tribal, local, or private lands that are not federally funded, authorized, or carried out by a Federal agency, do not require section 7 consultation.

Compliance with the requirements of section 7(a)(2) is documented through our issuance of:

(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or

(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.

When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:

(1) Can be implemented in a manner consistent with the intended purpose of the action,

(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,

(3) Are economically and technologically feasible, and

(4) Would, in the Service Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.

Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.

Regulations at 50 CFR 402.16 set forth requirements for Federal agencies to reinitiate formal consultation on previously reviewed actions. These requirements apply when the Federal agency has retained discretionary involvement or control over the action (or the agency's discretionary involvement or control is authorized by law) and, subsequent to the previous consultation: (1) if the amount or extent of taking specified in the incidental take statement is exceeded; (2) if new information reveals effects of the action that may affect listed species or critical habitat in a manner or to an extent not previously considered; (3) if the identified action is subsequently modified in a manner that causes an effect to the listed species or critical habitat that was not considered in the biological opinion; or (4) if a new species is listed or critical habitat designated that may be affected by the identified action.

In such situations, Federal agencies sometimes may need to request reinitiation of consultation with us, but the regulations also specify some exceptions to the requirement to reinitiate consultation on specific land management plans after subsequently listing a new species or designating new critical habitat. See the regulations for a description of those exceptions.

The key factor related to the destruction or adverse modification determination is whether implementation of the proposed Federal action directly or indirectly alters the designated critical habitat in a way that appreciably diminishes the value of the critical habitat as a whole for the conservation of the listed species. As discussed above, the role of critical habitat is to support physical or biological features essential to the conservation of a listed species and provide for the conservation of the species.

Section 4(b)(8) of the Act requires us to briefly evaluate and describe, in any proposed or final regulation that designates critical habitat, activities involving a Federal action that may violate section 7(a)(2) of the Act by destroying or adversely modifying such designation, or that may be affected by such designation.

Activities that we may, during a consultation under section 7(a)(2) of the Act, consider likely to destroy or adversely modify critical habitat include, but are not limited to:

(1) Actions that would significantly alter native vegetation structure or composition within the upland hardwood forest hammock habitat consisting of rockland or closed tropical hardwood hammock (south Florida) or mesic, hydric, or intermixed hammock strands (central Florida) ecosystems as defined as a physical or biological feature essential to the conservation of the Florida bristle fern in the designated critical habitat. Such activities could include, but are not limited to, land conversion or clearing related to residential, commercial, agricultural, or recreational development, including associated infrastructure; logging; introduction of nonnative plant species; or improper fire management. These activities could result in loss, modification, and fragmentation of rockland/mesic hammock habitat, thereby eliminating or reducing the habitat necessary for the growth and reproduction of the subspecies.

(2) Actions that would significantly alter microhabitat for Florida bristle fern within the rockland or closed tropical hardwood hammock (in south Florida) or mesic, hydric, or intermixed hammock strands (in central Florida) ecosystems, including significant alterations to the substrate within the rockland/mesic-hydric hammocks or to the canopy or hydrology within the rockland/mesic-hydric hammocks or surrounding upland hardwood forest vegetation as identified as a physical or biological feature essential to the conservation of the Florida bristle fern in the designated critical habitat. Such activities could include, but are not limited to, residential, commercial, agricultural, or recreational development, including associated infrastructure; land conversion or clearing; logging; introduction of nonnative species, including invasive plants or feral hogs; ground or surface water withdrawals; and ditching. These activities could result in changes to temperature, humidity, light, and existing water levels, thereby eliminating or reducing the microhabitat necessary for the growth and reproduction of the subspecies.

(3) Actions that would significantly alter the hydrology of the upland forested hammock ecosystems as defined as a physical or biological feature essential to the conservation of the Florida bristle fern in the designated critical habitat, including significant alterations to the hydrology of surrounding wetland habitat and the underlying water table. Such activities could include, but are not limited to, regional drainage efforts, ground or surface water withdrawals, and ditching. These activities could result in changes to existing water levels and humidity levels within the hammocks, thereby eliminating or reducing the habitat necessary for the growth and reproduction of the subspecies.

Section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that the Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense (DoD), or designated for its use, that are subject to an integrated natural resources management plan (INRMP) prepared under section 101 of the Sikes Act Improvement Act of 1997 (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation. There are no DoD lands with a completed INRMP within the final critical habitat designation.

Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if she determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless she determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making the determination to exclude a particular area, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor.

The first sentence in section 4(b)(2) of the Act requires that we take into consideration the economic, national security, or other relevant impacts of designating any particular area as critical habitat. We describe below the process that we undertook for taking into consideration each category of impacts and our analyses of the relevant impacts.

On December 18, 2020, we published a final rule in the Federal Register (85 FR 82376) revising portions of our regulations pertaining to exclusions of critical habitat. These final regulations became effective on January 19, 2021, and applied to critical habitat rules for which a proposed rule was published after January 19, 2021. Consequently, these new regulations do not apply to this final rule because the rule proposing critical habitat for Florida bristle fern published on February 24, 2020. In addition, this regulation was rescinded (87 FR 43433; July 21, 2022) and no longer applies to any designations of critical habitat. Therefore, for this final rule designating critical habitat for the Florida bristle fern, we apply the regulations at 424.19 and the 2016 Joint Policy on 4(b)(2) exclusions (81 FR 7226; February 11, 2016).

Section 4(b)(2) of the Act and its implementing regulations require that we consider the economic impact that may result from a designation of critical habitat. In order to consider economic impacts, we prepared an incremental effects memorandum (IEM) and screening analysis which, together with our narrative and interpretation of effects, we consider our economic analysis of the critical habitat designation and related factors (IEc 2020, entire). The analysis, dated January 30, 2020, was made available for public review from February 24, 2020, through April 24, 2020 (85 FR 10371). The economic analysis addressed probable economic impacts of critical habitat designation for Florida bristle fern. Following the close of the comment period, we reviewed and evaluated all information submitted during the comment period that may pertain to our consideration of the probable incremental economic impacts of this critical habitat designation. Additional information relevant to the probable incremental economic impacts of critical habitat designation for the Florida bristle fern is summarized below and available in the screening analysis for the species (IEc 2020, entire), available at https://www.regulations.gov under Docket No. FWS-R4-ES-2019-0068 or by contacting the Florida Ecological Services Field Office, Vero Beach (see ADDRESSES ).

We did not receive any public comments on the DEA. Based on peer review comments and changes that we made to the critical habitat units (see Summary of Changes from the Proposed Rule, above), the IEM was revised to reflect the areas added to the final critical habitat designation. Due to the small amount of area added to the final critical habitat designation, it was determined that the screening analysis did not need to be revised.

In our evaluation of the probable incremental economic impacts that may result from the designation of critical habitat for Florida bristle fern, first we identified, in the IEM dated April 2021, probable incremental economic impacts associated with the following categories of activities: (1) Commercial or residential development; (2) roadway and bridge construction; (3) utility-related activities; (4) agriculture, including land clearing; (5) grazing; (6) groundwater pumping; (7) surface water withdrawals and diversions; (8) forest management; (9) fire management; (10) conservation and restoration activities, including nonnative species control; and (11) recreation. Additionally, we considered whether the activities have any Federal involvement. Critical habitat designation generally will not affect activities that do not have any Federal involvement; under the Act, designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies. In areas where Florida bristle fern is present, Federal agencies already are required to consult with the Service under section 7 of the Act on activities they fund, permit, or implement that may affect the subspecies. When this final critical habitat designation rule becomes effective, consultations to avoid the destruction or adverse modification of critical habitat will be incorporated into the existing consultation process.

In our IEM, we attempted to clarify the distinction between the effects that will result from the subspecies being listed and those attributable to the critical habitat designation ( i.e., the difference between the jeopardy and adverse modification standards) for Florida bristle fern. The following considerations helped to inform our evaluation: (1) The essential physical or biological features identified for critical habitat are the same features essential for the life requisites of the subspecies, and (2) any actions that would result in sufficient harm or harassment to constitute jeopardy to Florida bristle fern would also likely adversely affect the essential physical or biological features of critical habitat. The IEM outlines our rationale concerning this limited distinction between baseline conservation efforts and incremental impacts of the designation of critical habitat for this subspecies. This evaluation of the incremental effects has been used as the basis to evaluate the probable incremental economic impacts of this designation.

The final critical habitat designation for Florida bristle fern totals approximately 1,698 ha (4,195 ac) in Miami-Dade and Sumter Counties, Florida, and includes both occupied and unoccupied units. Within the occupied units, any actions that may affect critical habitat would also affect the subspecies, and it is unlikely that any additional conservation efforts would be recommended to address the adverse modification standard over and above those recommended as necessary to avoid jeopardizing the continued existence of Florida bristle fern. Therefore, the economic impacts of implementing the rule through section 7 of the Act will most likely be limited to additional administrative effort to consider adverse modification.

Within the unoccupied units, incremental section 7 costs will include both the administrative costs of consultation and the costs of developing and implementing conservation measures needed to avoid adverse modification of critical habitat. Therefore, this analysis focuses on the likely impacts to activities occurring in unoccupied units of the final critical habitat designation. This analysis considers the potential need to consult on development, transportation, and other activities authorized, undertaken, or funded by Federal agencies within unoccupied habitat. The total annual incremental section 7 costs associated with the designation were estimated to be $210,000 in 2019 dollars (IEC 2020, p. 12). The increase in size of the unoccupied units from the proposed to the final critical habitat designation is minor (52 ha (129 ac)) and is not anticipated to significantly increase the annual incremental section 7 costs associated with the designation. Accordingly, we conclude that these costs will not reach the threshold of “significant” under E.O. 12866.

We considered the economic impacts of the critical habitat designation. The Secretary is not exercising her discretion to exclude any areas from this designation of critical habitat for the Florida bristle fern based on economic impacts.

In preparing this rule, we have determined that the lands within the final designation of critical habitat for the Florida bristle fern are not owned or managed by the DoD or Department of Homeland Security, and, therefore, we anticipate no impact on national security or homeland security. We did not receive any additional information during the public comment period for the proposed designation regarding impacts of the designation on national security or homeland security that would support excluding any specific areas from the final critical habitat designation under authority of section 4(b)(2) and our implementing regulations at 50 CFR 424.19. Consequently, the Secretary is not exercising her discretion to exclude any areas from the final designation based on impacts on national security.

Under section 4(b)(2) of the Act, we consider any other relevant impacts, in addition to economic impacts and impacts on national security as discussed above. We consider a number of factors, including whether there are permitted conservation plans covering the species in the area such as habitat conservation plans (HCPs), safe harbor agreements, or candidate conservation agreements with assurances, or whether there are non-permitted conservation agreements and partnerships that would be encouraged by designation of, or exclusion from, critical habitat. In addition, we look at the existence of Tribal conservation plans and partnerships and consider the government-to-government relationship of the United States with Tribal entities. We also consider any social impacts that might occur because of the designation.

In preparing this final rule, we have determined that there are currently no HCPs or other management plans for Florida bristle fern, and the designation does not include any Tribal lands or trust resources. We anticipate no impact on Tribal lands, partnerships, HCPs, or permitted or non-permitted plans or agreements from this critical habitat designation. We did not receive any additional information during the public comment period for the proposed rule regarding other relevant impacts to support excluding any specific areas from the final critical habitat designation under authority of section 4(b)(2) and our implementing regulations at 50 CFR 424.19. Accordingly, the Secretary is not exercising her discretion to exclude any areas from the final designation based on other relevant impacts.

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

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

Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA; 5 U.S.C. 801 et seq. ), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine whether potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

Under the RFA, as amended, and as understood in light of recent court decisions, Federal agencies are required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself; in other words, the RFA does not require agencies to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried out by the agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7, only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, it is our position that only Federal action agencies will be directly regulated by this designation. There is no requirement under the RFA to evaluate the potential impacts to entities not directly regulated. Moreover, Federal agencies are not small entities.

During the development of this final rule, we reviewed and evaluated all information submitted during the comment period that may pertain to our consideration of the probable incremental economic impacts of this critical habitat designation. Based on this information, we affirm our certification that this final critical habitat designation will not have a significant economic impact on a substantial number of small entities, and a regulatory flexibility analysis is not required.

Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. OMB has provided guidance for implementing this E.O. that outlines nine outcomes that may constitute “a significant adverse effect” when compared to not taking the regulatory action under consideration. Our economic analysis finds that none of these criteria is relevant to this analysis. Thus, based on information in the economic analysis, energy-related impacts associated with Florida bristle fern conservation activities within critical habitat are not expected. As such, the designation of critical habitat is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), we make the following findings:

(1) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”

The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.

(2) We do not believe that this rule will significantly or uniquely affect small governments because it will not produce a Federal mandate of $100 million or greater in any year; that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The economic analysis concludes that incremental impacts may primarily occur due to administrative costs of section 7 consultations for development and transportation projects, and for other activities primarily related to land and facility management, cultural resource, research, and conservation activities in Everglades National Park; however, these are not expected to significantly affect small governments. Incremental impacts stemming from various species conservation and development control activities are expected to be borne by the Federal Government, State of Florida, and Miami-Dade County, which are not considered small governments. Consequently, we do not believe that the critical habitat designation will significantly or uniquely affect small government entities. As such, a Small Government Agency Plan is not required.

In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for Florida bristle fern in a takings implications assessment. The Act does not authorize us to regulate private actions on private lands or confiscate private property as a result of critical habitat designation. Designation of critical habitat does not affect land ownership, or establish any closures, or restrictions on use of or access to the designated areas. Furthermore, the designation of critical habitat does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. However, Federal agencies are prohibited from carrying out, funding, or authorizing actions that would destroy or adversely modify critical habitat. A takings implications assessment has been completed and concludes that this designation of critical habitat for Florida bristle fern does not pose significant takings implications for lands within or affected by the designation.

In accordance with E.O. 13132 (Federalism), this rule does not have significant Federalism effects. A federalism summary impact statement is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of this critical habitat designation with, the appropriate State resource agencies in Florida. We did not receive comments from the State of Florida. From a federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the rule does not have substantial direct effects either on the States, or on the relationship between the national government and the States, or on the distribution of powers and responsibilities among the various levels of government. The designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the subspecies are more clearly defined, and the physical or biological features of the habitat necessary to the conservation of the subspecies are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist State and local governments in long-range planning because they no longer have to wait for case-by-case section 7 consultations to occur.

Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) will be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.

In accordance with Executive Order 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. We are designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the subspecies, this rule identifies the physical or biological features essential to the conservation of the subspecies. The designated areas of critical habitat are presented on maps, and the rule provides several options for the interested public to obtain more detailed location information, if desired.

This rule does not contain information collection requirements, and a submission to the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) is not required. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses pursuant to the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) in connection with designating critical habitat under the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This position was upheld by the U.S. Court of Appeals for the Ninth Circuit ( Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. 1995), cert. denied 516 U.S. 1042 (1996)).

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. As discussed above (see Exclusions Based on Other Relevant Impacts ), we have determined that no Tribal lands will be affected by this designation.

A complete list of references cited in this rule is available on the internet at https://www.regulations.gov under Docket No. FWS-R4-ES-2019-0068 and upon request from the Florida Ecological Services Field Office, Vero Beach (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the U.S. Fish and Wildlife Service, Florida Ecological Services Field Office

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