On November 5, 2021 (86 FR 61047), the NRC published a direct final rule amending its regulations in part 72 of title 10 of the Code of Federal Regulations to revise the TN Americas LLC, TN-32 Dry Storage Cask listing in the “List of approved spent fuel storage casks” to renew, for an additional 40 years, the initial certificate and Amendment No. 1 of Certificate of Compliance No. 1021. The renewal of the initial certificate and Amendment No. 1 of Certificate of Compliance No. 1021 revises the certificate of compliance's conditions and technical specifications to address aging management activities related to the structures, systems, and components of the dry storage system to ensure that these will maintain their intended functions during the period of extended storage operations. In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on January 19, 2022. The NRC did not receive any comments on the direct final rule. Therefore, the direct final rule will become effective as scheduled.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0243, dated November 5, 2020 (EASA AD 2020-0243) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition on RRD Trent 1000-AE3, Trent 1000-CE3, Trent 1000-D3, Trent 1000-G3, Trent 1000-H3, Trent 1000-J3, Trent 1000-K3, Trent 1000-L3, Trent 1000-M3, Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3, and Trent 1000-R3 model turbofan engines.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all RRD Trent 1000-AE3, Trent 1000-CE3, Trent 1000-D3, Trent 1000-G3, Trent 1000-H3, Trent 1000-J3, Trent 1000-K3, Trent 1000-L3, Trent 1000-M3, Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3, and Trent 1000-R3 model turbofan engines. The NPRM published in the Federal Register on August 25, 2021 (86 FR 47417). The NPRM was prompted by the manufacturer revising the engine TLM life limits of certain critical rotating parts and DAC data files. In the NPRM, the FAA proposed to require the operator to revise the ALS of their existing approved AMP by incorporating the revised tasks of the applicable TLM for each affected model turbofan engine, as specified in an EASA AD. The FAA is issuing this AD to address the unsafe condition on these products. See the MCAI for additional background information.

The FAA received comments from one commenter, The Boeing Company (Boeing). Boeing supported the NPRM without change.

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

The FAA reviewed EASA AD 2020-0243. EASA AD 2020-0243 specifies revising the approved AMP by incorporating the limitations, tasks, and associated thresholds and intervals described in the TLM. 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 .

The FAA reviewed Chapter 05-10 of Rolls-Royce (RR) Trent 1000 TLM T-TRENT-10RRT, dated August 1, 2020. RR Trent 1000 TLM T-TRENT-10RRT, Chapter 05-10, identifies the reduced life limits of certain critical rotating parts.

The FAA also reviewed Chapter 05-20 of RR Trent 1000 TLM T-TRENT-10RRT, dated August 1, 2020. RR Trent 1000 TLM T-TRENT-10RRT, Chapter 05-20, identifies the critical rotating part inspection thresholds and intervals.

The FAA estimates that this AD affects 4 engines installed on airplanes of U.S. registry.

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 2019-01-08, Amendment 39-19547 (84 FR 4318, February 15, 2019) (AD 2019-01-08). AD 2019-01-08 applied to certain The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes. The NPRM published in the Federal Register on June 25, 2021 (86 FR 33574). The NPRM was prompted by a report that showed a non-compliance exists on some in-service galley attendant seat fitting installations, and a determination that additional airplanes are subject to the unsafe condition. In the NPRM, the FAA proposed to continue to require modifications for galley mounted attendant seat fittings and expand the applicability to include additional airplanes. The FAA is issuing this AD to address non-compliant flight attendant seats, which could fail in a high-G crash and result in potential injury to flight attendants and consequent inability of the flight attendants to assist with passenger evacuation in a timely manner.

The FAA received comments from Boeing and United Airlines, 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. 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 Special Attention Service Bulletin 777-25-0649, Revision 2, dated October 8, 2020. This service information specifies procedures for modifying galley mounted attendant seat fittings. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 50 airplanes of U.S. registry. 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 by adding an AD that would apply to certain Brantly Helicopters Industries U.S.A. Co., Ltd., Model 305 helicopters and Brantly International, Inc., Model B-2, B-2A, and B-2B helicopters. The NPRM published in the Federal Register on July 30, 2021 (86 FR 40967). The NPRM was prompted by a report of a crack in T/R hub part number (P/N) 2951. In the NPRM, the FAA proposed to require repetitively cleaning, and using a 10X or higher power magnifying glass, inspecting the areas where each T/R blade attaching arm extends from the T/R hub for a crack, corrosion, and pitting, and depending on the results, removing the T/R hub from service. This NPRM also proposed to require repetitively cleaning and dye penetrant inspecting the radius at the shoulder of each T/R hub spindle for a crack and pitting, and depending on the results, removing the T/R hub from service.

This condition, if not addressed, could result in loss of T/R control and subsequent loss of control of the helicopter. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from one individual. The commenter supports the proposal but recommended the FAA acquire sufficient data regarding the unsafe condition and investigate to determine if this unsafe condition exists on the T/R hub of other helicopters. The following presents the comments received on the NPRM and the FAA's response to each comment.

The individual recommended that prior to implementing the proposed rule, the FAA ensure adequate data has been acquired and proceed if the frequency of incident is proven to be material.

Prior to issuing the NPRM, the FAA reviewed the report and associated data for a crack in the T/R hub. In accordance with FAA Order 8110.107A Monitor Safety/Analyze Data, the FAA has determined that an unsafe condition exists that supports AD action.

The individual stated that the FAA should investigate whether issues exist in the T/R hub of other model helicopters.

No data has been provided to substantiate the individual's comment; however, available data for this unsafe condition is limited to T/R hub P/N 161-1 and 2951, which are only approved for installation on Brantly Helicopters Industries U.S.A. Co., Ltd., Model 305 helicopters and Brantly International, Inc., Model B-2, B-2A, and B-2B helicopters.

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 a minor editorial change to paragraph (e) of this AD, this AD is adopted as proposed in the NPRM. This change will not increase the economic burden on any operator.

The FAA reviewed Brantly Helicopter Service Letter No. 102, dated July 11, 1974 (SL 102). SL 102 specifies repetitively cleaning and inspecting the areas where each T/R blade attaching arm extends from the T/R hub for a crack. SL 102 also specifies repetitively cleaning and dye penetrant inspecting the radius at the shoulder of each T/R hub spindle for a crack. If there is a crack, SL 102 specifies replacing the part and reporting any cracks to Brantly Operators, Inc.

SL 102 applies to all Brantly helicopters, whereas this AD applies to helicopters with T/R hub P/N 2591 or 161-1 installed. This AD requires using a 10X or higher power magnifying glass when inspecting the area where the T/R blade attaching arm extends from the T/R hub for a crack, corrosion, and pitting, whereas SL 102 does not specify using a magnifying glass and only specifies inspecting for a crack in that area. This AD requires dye penetrant inspecting the radius at the shoulder of each T/R spindle for a crack and pitting, whereas SL 102 only specifies dye penetrant inspecting for a crack in those areas. SL102 specifies reporting any cracks to Brantly Operators, Inc., whereas this AD does not require reporting any information.

The FAA estimates that this AD affects 57 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this AD.

Cleaning and inspecting the T/R hub with a magnifying glass takes about 1 work-hour for an estimated cost of $85 per helicopter and $4,845 for the U.S. fleet, per inspection cycle. Cleaning and dye penetrant inspecting the T/R hub takes about 2 work-hours for an estimated cost of $170 per helicopter and $9,690 for the U.S. fleet, per inspection cycle. If required, replacing a T/R hub takes about 0.5 work-hour and parts cost about $500 for an estimated cost of $543 per replacement.

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:

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0244, dated November 5, 2020 (EASA AD 2020-0244) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all RRD Trent 7000-72 and Trent 7000-72C model turbofan engines.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all RRD Trent 7000-72 and Trent 7000-72C model turbofan engines. The NPRM published in the Federal Register on August 12, 2021 (86 FR 44316). The NPRM was prompted by the manufacturer revising the engine TLM life limits of certain critical rotating parts and updating certain maintenance tasks. In the NPRM, the FAA proposed to require accomplishing the actions specified in EASA AD 2020-0244, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and the EASA AD.” The FAA is issuing this AD to address the unsafe condition on these products. See the MCAI for additional background information.

The FAA received comments from three commenters. The commenters were Air Line Pilots Association, International, The Boeing Company, and Delta Air Lines, Inc. (DAL). The following presents the comments received on the NPRM and the FAA's response to each comment.

DAL requested that paragraph (h), Exceptions to EASA AD 2020-0244, of the proposed rule, be updated to provide an exception to the definition of the AMP for airplanes operated under FAA regulations. DAL noted that the EASA AD's definition of an AMP is applicable to an airplane operated under European Union regulations.

The FAA agrees and has updated paragraph (h)(1) of this AD.

DAL requested that paragraph (h), Exceptions to EASA AD 2020-0244, of this AD, be updated to provide an exception for the HPT blade visual inspections in the TLM to make the FAA AD consistent with the most recent publication of RR Trent 7000 TLM-T-T7000-1RR (the TLM) and with EASA AD 2021-0169, dated July 19, 2021 (EASA AD 2021-1069). DAL reasoned that EASA AD 2021-0169 incorporates a life limit of 1,000 flight cycles since new on the HPT blade and explicitly cancels the inspection intervals defined in the TLM.

The FAA disagrees with adding this exception to paragraph (h) of this AD. The unsafe condition and corrective actions in EASA AD 2021-0169 are beyond the scope of this AD. The FAA may consider future rulemaking in response to EASA AD 2021-0169.

Air Line Pilots Association, International, and The Boeing Company supported the AD 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, 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 EASA AD 2020-0244. EASA AD 2020-0244 specifies revising the approved AMP by incorporating the limitations, tasks, and associated thresholds and intervals described in the TLM. 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 reviewed Chapter 05-10 of RR Trent 7000 TLM T-T7000-1RR, dated July 10, 2020. RR Trent 7000 TLM T-T7000-1RR, Chapter 05-10, identifies the reduced life limits of certain critical rotating parts.

The FAA also reviewed Chapter 05-20 of RR Trent 7000 TLM T-T7000-1RR, dated July 10, 2020. RR Trent 7000 TLM T-T7000-1RR, Chapter 05-20, identifies the critical rotating part inspection thresholds and intervals.

The FAA estimates that this AD affects 10 engines installed on airplanes of U.S. registry.

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 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:

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers or aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the typed of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

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

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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

Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

Upon request, FDA has classified the nonimplanted nerve stimulator for functional abdominal pain relief as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On October 25, 2018, Innovative Health Solutions, Inc. submitted a request for De Novo classification of the IB-Stim. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on June 7, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 876.5340. 1 We have named the generic type of device nonimplanted nerve stimulator for functional abdominal pain relief, and it is identified as a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

At the time of classification, nonimplanted nerve stimulators for functional abdominal pain relief are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

Upon request, FDA has classified the endoscopic transhepatic venous access needle as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)'s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On November 19, 2018, Cook Ireland Ltd. submitted a request for De Novo classification of the EchoTip® Insight TM Portosystemic Pressure Gradient Measuring System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on November 20, 2019, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.1050. 1 We have named the generic type of device Endoscopic transhepatic venous access needle, and it is identified as a device that is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

At the time of classification, Endoscopic transhepatic venous access needles are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collection of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes actuarial assumptions—including interest assumptions—for valuing benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974 (ERISA). The interest assumptions in the regulation are also published on PBGC's website ( https://www.pbgc.gov ).

PBGC uses the interest assumptions in appendix B to part 4044 (“Interest Rates Used to Value Benefits”) to determine the present value of annuities in an involuntary or distress termination of a single-employer plan under the asset allocation regulation. The assumptions are also used to determine the value of multiemployer plan benefits and certain assets when a plan terminates by mass withdrawal in accordance with PBGC's regulation on Duties of Plan Sponsor Following Mass Withdrawal (29 CFR part 4281).

The first quarter 2022 interest assumptions will be 2.37 percent for the first 20 years following the valuation date and 2.03 percent thereafter. In comparison with the interest assumptions in effect for the fourth quarter of 2021, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.03 percent in the select rate, and a decrease of 0.08 percent in the ultimate rate (the final rate).

PBGC has determined that notice of, and public comment on, this rule are impracticable, unnecessary, and contrary to the public interest. PBGC routinely updates the interest assumptions in appendix B of the asset allocation regulation each quarter so that they are available to value benefits. Accordingly, PBGC finds that the public interest is best served by issuing this rule expeditiously, without an opportunity for notice and comment, and that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication to allow the use of the proper assumptions to estimate the value of plan benefits for plans with valuation dates early in the first quarter of 2022.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

Employee benefit plans, Pension insurance, Pensions.

In consideration of the foregoing, 29 CFR part 4044 is amended as follows:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish the security zone by December 12, 2021 to ensure security of this vessel and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to provide for the security of this vessels.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the transit of the M/V Liberty Pride when loaded with specialized cargo will be a security concern within a 500-yard radius of the vessel. This rule is needed to protect the vessels while they are transiting within Corpus Christi, TX, from December 12 through December 16, 2021.

The Coast Guard is establishing a 500-yard radius temporary moving security zone around M/V Liberty Pride. The zone for the vessel will be enforced from the time the vessel arrives on December 12, 2021, until it enters the Inner Harbor. The duration of the zone is intended to protect the vessels and specialized cargo on board while the vessels are in transit. No vessel or person will be permitted to enter the security zone without obtaining permission from the COTP or a designated representative.

Entry into the security zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Corpus Christi. Persons or vessels desiring to enter or pass through the zone must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate of the enforcement times and dates for the security zone.

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

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

This regulatory action determination is based on the size, duration, and location of the security zone. This rule will impact a small designated area of 500-yards around the vessel during the vessel's transits within the Corpus Christi Ship Channel while loaded with cargo over a five-day period. Moreover, the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a security zone lasting for the duration of time that the M/V LIBERTY PRIDE is within the Corpus Christi Ship Channel. It will prohibit entry within a 500 yard radius of the M/V LIBERTY PRIDE while the vessel is transiting within the Corpus Christi Ship Channel. It is categorically excluded from further review under paragraph L60(c) in Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

Colonial National Historical Park is located along the James and York Rivers and encompasses the historic Jamestown Island, Colonial Parkway, and the Yorktown Battlefield. There are also small, inland parcels of the park located at Greenspring, Gloucester Point, and Fort Story. The park tells the story of the Colonial era from the origins of the occupancy of Jamestown Island in 1607 to the last major battle of the Revolutionary War at Yorktown in 1781. These two sites are connected by the Colonial Parkway, which winds 23 miles through scenic forests, over waterways, along river banks, and under Colonial Williamsburg. Much of the park is surrounded by water and includes an extensive amount of shoreline. All of the waterways in the area are a part of the Captain John Smith Chesapeake National Historic Trail that overlays the entire Chesapeake Bay and a large portion of its navigable tributaries. The park and the national historic trail are both administered by the National Park Service (NPS) and go hand-in-hand in this area of Virginia.

Since the park was established in the 1930s, the NPS has prohibited the launching or landing of watercraft, except in emergency situations. The current prohibition at 36 CFR 7.1(a) states that, except in emergencies, no privately owned vessel shall be launched from land within the park and no privately owned vessel shall be beached or landed on land within the park. Consistent with the 2003 Record of Decision for the Jamestown Project Development Concept Plan, the NPS has been exploring new opportunities for boating within the park. Local partners and members of the community have approached the NPS to discuss funding the construction of potential launch sites to better connect a variety of visitors to the shared history of the area. The NPS and its partners share an interest in establishing access to the James and York Rivers, and thus the Captain John Smith Chesapeake National Historic Trail, for water-based educational and recreational activities.

In order to allow the NPS to pursue these management objectives, this rule removes the special regulation at 36 CFR 7.1(a). Without this park-specific prohibition, the launching and landing of vessels will be governed by NPS general regulations at 36 CFR 3.8(a)(2). This regulation prohibits the launching or recovering ( i.e., retrieval) of a vessel, except at launch sites designated by the Superintendent. Under this general regulation, the Superintendent of a park has the discretion to designate launch and retrieval sites within the park. Under NPS policy, this would only occur if the Superintendent determines that the use of those sites for boating activities is appropriate to the purpose for which the park was established and can be sustained without causing unacceptable impacts. See NPS Management Policies 8.1.1. The Superintendent would provide notice to the public of any such designation using one or more of the methods set forth in 36 CFR 1.7.

This rule also removes the special regulations for the park at 36 CFR 7.1(b). These regulations require a permit for the operation of commercial passenger-carrying motor vehicles within the park and establish a fee structure for obtaining a permit. For each seat carrying a passenger, an annual permit costs $3.50 and a quarterly permit costs $1. One-day permits are available for $1 (up to 5-passenger vehicles) or $3 (over 5 passenger vehicles). 36 CFR 7.1(b)(1) through (4).

The permit requirement is unnecessary because it is redundant with the NPS general regulation at 36 CFR 5.3, which requires a permit, contract, or other written agreement in order to engage in business operations within a park area. The NPS uses commercial use authorizations (CUAs) to authorize commercial passenger-carrying motor vehicles. A CUA is a type of permit that allows an individual, group, company, or other for-profit entity to conduct commercial activities and provide specific visitor services within a unit of the National Park System.

The fee structure in 36 CFR 7.1(b) is over 30 years old. The NPS no longer charges those fees because they would not come close to offsetting the increasing administrative costs of managing commercial passenger-carrying vehicles within the park. Instead, the NPS charges an entrance fee for commercial passenger-carrying vehicles under section 803 of the Federal Lands Recreation Enhancement Act (16 U.S.C. 6802) and CUA fees under 54 U.S.C. 101925.

The NPS published a proposed rule in the Federal Register on October 6, 2020 (85 FR 63062). The NPS accepted public comments on the proposed rule for 60 days via the mail, hand delivery, and the Federal eRulemaking Portal at http://www.regulations.gov. Comments were accepted through December 7, 2020. A total of 73 comments were submitted and reviewed. Many commenters supported the proposed rule and did not raise any issues or suggest any changes. Several commenters supported the potential of launch and retrieval sites to create recreational and educational opportunities in the park and a stronger connection with local communities. Some commenters raised concerns or questions about the proposed rule that the NPS summarizes and responds to below. After considering the public comments and after additional review, the NPS did not make any changes to the rule.

1. Comment: Several commenters asked whether the NPS will evaluate potential impacts to the environment before designating launch and retrieval sites within the park. Commenters raised concerns that increased boating activity would harm wildlife and submerged vegetation, erode shorelines, degrade water quality and introduce aquatic invasive species.

NPS Response: Decisions to construct and designate launch and retrieval sites will be subject to compliance with the National Environmental Policy Act, which means the NPS will evaluate potential impacts to the environment from construction activities and the expected use of the launch and retrieval sites prior to making such decisions. The Superintendent may develop sites and allow the launching and retrieval of vessels only if such activity is appropriate to the purpose for which the park was established and can be sustained without causing unacceptable impacts to the environment.

2. Comment: One commenter stated that the NPS should undergo notice-and-comment rulemaking prior to designating launch and retrieval sites within the park in order to allow interested parties to comment.

NPS Response: NPS general regulations at 36 CFR 3.8(a)(2) provide the Superintendent with discretionary authority to designate launch and retrieval sites within the park. The Superintendent may exercise this discretionary authority at the park level without the need to promulgate special regulations, which would require notice-and-comment rulemaking under the Administrative Procedure Act. Many NPS regulations give the Superintendent similar discretionary authorities to designate areas for visitor use activities. See, for example, regulations allowing the Superintendent to designate: (1) Campsites (36 CFR 2.10); (2) trails, routes and areas for the use of use of horses or pack animals (36 CFR 2.16); and (3) areas for using roller skates, skateboards, roller skis, coasting vehicles, or similar devices (36 CFR 2.20). In contrast to 36 CFR 3.8(a)(2) and regulations that provide similar discretionary authority to Superintendents, other NPS regulations specifically require rulemaking. See, for example, regulations governing the use of: (1) Aircraft (36 CFR 2.17); (2) snowmobiles (36 CFR 2.18); (3) personal watercraft (36 CFR 3.9); and (3) motor vehicles off park roads and parking areas (36 CFR 4.10).

Even though 36 CFR 3.8(a)(2) does not require a special regulation, the NPS will provide interested stakeholders with an opportunity to review and comment on proposed launch sites through the Planning, Environment and Public Comment (PEPC) website ( https://parkplanning.nps.gov/ ). All discretionary actions taken by the Superintendent must be compiled in writing, updated annually, and made available to the public upon request. 36 CFR 1.7(b). This compilation is referred to as the Superintendent's Compendium. The Superintendent will identify designated launch and retrieval sites in the Superintendent's Compendium for the park, which is available on the park's website ( https://www.nps.gov/colo/learn/management/lawsandpolicies.htm ).

3. Comment: Several commenters asked the NPS to clarify the types of vessels that could be allowed to launch and land within the park. Many commenters supported the use of nonmotorized vessels only and suggested that motorized vessels be prohibited in order to preserve the visitor experience on the beaches and the pristine nature and soundscape of the park.

NPS Response: NPS general regulations at 36 CFR 3.8(a)(2) allow the Superintendent to designate launch and retrieval sites for “vessels,” which are defined broadly in 36 CFR 1.4 to mean “every description of watercraft, or other artificial contrivance used, or capable of being used, as a means of transportation on the water.” As a result, the Superintendent will have the discretion to allow motorized vessels to launch and land from designated sites in the park. The Superintendent may limit use to nonmotorized vessels, however, if that is appropriate given the purpose of the park and potential impacts to the environment or other park visitors from motorized vessels. At this time, the NPS does not plan to allow motorized vessels to launch and land from designated sites within the park.

4. Comment: Several commenters suggested specific launch and retrieval sites within the park, including sites along the York River, James River, College Creek, and Mill Creek. Other commenters identified sites that should not be considered due to the potential for adverse visual impacts to the historical character of certain locations within the park, including Jamestown Island and the Yorktown Battlefield. One commenter requested that the NPS select sites that would minimize trail and sidewalk construction.

NPS Response: The NPS will engage with the public prior to site selection to better understand potential impacts to resources and visitors, support for, and controversy associated with a particular location. The NPS will evaluate existing conditions and potential management strategies at potential sites within the park to serve a diversity of visitor needs and enhance the quality of the visitor experience. A decision to develop a site for launch and retrieval facilities will take into account both primary impacts of development (such as noise, air, and water pollution), and secondary impacts (including cumulative effects over time) that recreational use associated with the development may have on park resources and visitor enjoyment. Any launch location will be carefully sited and designed to avoid unacceptable adverse effects on historical sites and aquatic and riparian habitats, and to minimize conflicts between boaters and other visitors who enjoy the park.

5. Comment: Several commenters questioned the cost of constructing launch and retrieval sites. Some commenters stated that the NPS would not be able to justify the cost of building launch sites for motorized vessels due to the availability of nearby marinas that can be used for this purpose outside of the park. One commenter expressed concern that new boating activity could have broader cost implications for the NPS if it leads to increased traffic on the parkway, which the commenter stated is already in need of rehabilitation.

NPS Response: The planning process for selecting launch and retrieval sites will consider the costs of initial construction as well as ongoing maintenance. Local partners and members of the community have approached the NPS to discuss funding the construction of potential launch sites to better connect a variety of visitors to the shared history of the area. The Superintendent is exploring different opportunities for cost-sharing, such as fundraising through a Friends Group or receiving direct support from the local county. This would alleviate the financial burden to the NPS associated with initial construction costs. The Superintendent will not select a site for development if the NPS would not be able to cover these costs in a manner that would maintain the site in good working order. The evaluation of costs will include those associated with the site itself and those associated other park facilities, including roads, that would be impacted by increased visitation caused by the launch and retrieval sites. The NPS will consider the availability of nearby launch and retrieval sites when determining the magnitude of potential benefits to park visitors from the development of sites within the park.

6. Comment: One commenter expressed concern that increased boating activity will lead to commercialization and economic expansion that will negatively impact park values.

NPS Response: This rule will not change the level of commercial activity within the park. Engaging in any business within the park is prohibited except in accordance with the provisions of a permit, contract, or other written agreement. 36 CFR 5.3. This prohibition on commercial activity within the park applies to commercial passenger-carrying vessels, which are not authorized under 36 CFR 3.8(a)(2) without some separate written authorization. At this time, the NPS is not considering any written authorization that would allow commercial passenger-carrying vessels to operate from launch sites within the park.

7. Comment: Several commenters questioned how the NPS will promote boating safety if launch and retrieval sites are designated by the Superintendent. One commenter expressed concern that designating launch and retrieval sites will lead to personal watercraft (PWC) use within the park, which would present a high risk of injury and fatality for park visitors.

NPS Response: The NPS will provide information to park visitors about boating safety if launch and retrieval sites are developed and designated within the park. This information will be provided at launch sites and on the park's website ( www.nps.gov/colo ). Under no circumstances would PWCs be allowed to launch and land from within the boundary of the park. This is prohibited by NPS general regulations at 36 CFR 3.9. PWC use that originates and occurs outside the boundary of the park is not subject to NPS jurisdiction.

8. Comment: Several commenters encouraged the NPS to work with Indian tribes to select launch and retrieval sites and to create an interpretive program associated with boating activities that represents the experience of Virginia Indians in the shared landscape of the park.

NPS Response: The NPS will consult with federally recognized tribes if and when launching and retrieval sites for vessels are proposed for designation. The NPS recognizes that the Pamunkey Tribe may be particularly interested in siting decisions because of the potential for increased water access to the shorelines of Jamestown Island which is a traditional area and has historical significance for the tribe.

9. Comment: Several commenters expressed concern that removing the permit requirement for commercial passenger-carrying motor vehicles would result in less revenue for the NPS and more commercial vehicle use of the parkway, which would harm park resources.

NPS Response: Revenue to the NPS from commercial passenger-carrying vehicles will not be affected by this rule. The fee structure being removed is over 30 years old and is no longer implemented by the NPS because the stated fees would not come close to offsetting the increasing administrative costs of managing commercial passenger-carrying vehicles within the park. In order to offset these costs, the NPS charges an entrance fee for commercial passenger-carrying vehicles under section 803 of the Federal Lands Recreation Enhancement Act (16 U.S.C. 6802) and CUA fees under 54 U.S.C. 101925. The NPS does not expect the rule to change the level of commercial vehicle use of the parkway because the NPS has not used the permit and fee structure in the special regulations for many years.

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

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

This rulemaking will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This certification is based on information contained in the economic analyses found in the report entitled “Cost-Benefit and Regulatory Flexibility Analyses: Regulations for Vessels and Commercial Passenger-Carrying Motor Vehicles at Colonial National Historical Park.” The document may be viewed at www.regulations.gov by searching for “1024-AE39.”

This rulemaking is not a major rule under 5 U.S.C. 804(2), the CRA. This rulemaking:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This rulemaking does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rulemaking does not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

This rulemaking does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, the rulemaking does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This rulemaking only affects use of federally-administered lands and waters. It has no outside effects on other areas. A Federalism summary impact statement is not required.

This rulemaking complies with the requirements of Executive Order 12988. This rulemaking:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rulemaking under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and have determined that tribal consultation is not required because the rule will have no substantial direct effect on federally recognized Indian tribes. During a scheduled formal consultation about park issues with the Chiefs of the Chickahominy, Eastern Chickahominy, Mattaponi, Nansemond, Pamunkey, Rappahannock, and Upper Mattaponi, the NPS briefed them on the proposed change for launching and landing private vessels at the park. All of the Chiefs expressed their support for the rule and the opportunity it would provide for the tribes to expand their interpretative programs to tell Native stories in Native places. The NPS will consult with federally recognized tribes if and when launching and retrieval sites for vessels are designated.

This rulemaking does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS 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.

This rulemaking does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rulemaking is covered by a categorical exclusion. The NPS has determined the rule is categorically excluded under 43 CFR 46.210(i). The environmental effects of removing 36 CFR 7.1(a) are too broad, speculative, or conjectural to lend themselves to meaningful analysis. Decisions to construct and designate launching and retrieval sites will later be subject to the NEPA process, either collectively or case-by-case. The nature of the proposal to remove 36 CFR 7.1(b) is administrative, financial and legal. The NPS has determined the rulemaking does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rulemaking is not a significant energy action under the definition in Executive Order 13211. The rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and the rule has not otherwise been designated by the Administrator of OIRA as a significant energy action. A Statement of Energy Effects in not required.

In consideration of the foregoing, the National Park Service amends 36 CFR part 7 as set forth below:

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(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-2020-0691 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 14, 2022. 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-2020-0691, by one of the following methods:

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

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

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

In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-08) EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8864) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.339 be amended by revising tolerances for residues of the herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid), both free and conjugated, resulting from the direct application of MCPA or its sodium, dimethylamine salts or its 2-ethylhexyl ester in or on the raw agricultural commodities clover, forage at 0.1 parts per million (ppm), and clover, hay at 0.1 ppm. The petitioned-for tolerances are lower than the existing tolerances for these commodities due to the results from clover residue data that were generated by IR-4 which indicated that lower tolerances were appropriate for clover, forage and clover, hay. Previously, no clover-specific data had been generated. That document referenced a summary of the petition, 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 is establishing the tolerances at different levels than petitioned for. Additionally, the tolerance expression is being modified to be consistent with Agency policy. A discussion of these modifications can be found 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 therein, 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 MCPA including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with MCPA follows.

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

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

Toxicological profile. For a discussion of the Toxicological Profile of MCPA, see Unit III.A. of the MCPA tolerance rulemaking published in the Federal Register of April 13, 2021 (86 FR 19145) (FRL-10020-79).

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for MCPA used for human risk assessment, please reference Unit III.B. of the April 13, 2021 rulemaking.

Exposure assessment. The new use on clover does not impact the dietary assessment, because the clover use does not result in a significant increase in dietary exposure. For a description of the approach to and assumptions for the exposure assessment, including with respect to estimated drinking water concentrations, non-occupational exposure, and cumulative exposure, please reference Unit III.C. of the April 13, 2021 rulemaking.

Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X, except for acute dietary (general population, including infants and children) and inhalation scenarios where a 10X safety factor is retained as a lowest-observed-adverse-effect-level (LOAEL) to no-observed-adverse-effect-level (NOAEL) extrapolation factor. See Unit III.D. of the April 13, 2021 rulemaking for a discussion of the Agency's rationale for that determination.

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

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD; they are 29% of the aPAD for all infants less than 1 year old, the group with the highest exposure. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 28% of the cPAD for all infants less than 1 year old, the group with the highest exposure. EPA has concluded the combined short-term food, water, and residential exposures result in aggregate margins of exposure at or above the level of concern of 100 for all scenarios assessed and are not of concern. An intermediate-term adverse effect was identified; however, MCPA is not registered for any use patterns that would result in intermediate-term residential exposure. EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for MCPA, which is below the Agency's level of concern. MCPA is classified as “Not Likely to Be Carcinogenic to Humans”; therefore, EPA does not expect MCPA exposures to pose an aggregate cancer risk.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to MCPA residues. More detailed information on this action can be found in the document titled “MCPA. Human Health Risk Assessment in Support of a Section 3 Registration for Use of MCPA on Clover” in docket ID EPA-HQ-OPP-2020-0691.

For a discussion of the available analytical enforcement method, see Unit IV.A. of the April 13, 2021 rulemaking.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

Currently, there are no Codex MRLs for residues of MCPA in or on clover. Therefore, harmonization is not an issue.

All residues at or below the limit of quantitation (LOQ) equate to a recommended LOQ tolerance level of 0.05 ppm for both clover, forage and clover, hay, as opposed to the tolerances that were proposed (0.1 ppm for both clover, forage and clover, hay). The tolerances include residues of parent (MCPA) and metabolite 2-HMCPA [(4-chloro-2-hydroxymethylphenoxy)acetic acid]. However, MCPA is the only residue of concern for tolerance enforcement purposes. In addition, EPA is modifying the tolerance expression to use the Chemical Abstracts Service (CAS) name for consistency with other tolerance expressions.

Finally, EPA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of MCPA not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compound mentioned in the tolerance expression.

Therefore, tolerances are modified for residues of MCPA in or on Clover, forage from 0.5 ppm to 0.05 ppm, and Clover, hay from 2.0 ppm to 0.05 ppm and the tolerance expression is updated.

This action 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 to 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

Pursuant to the CRA (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 1 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(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-2020-0538 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 14, 2022. 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-2020-0538, by one of the following methods:

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

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

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

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

In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-10016-93), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8849) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 22709-3528. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of mefentrifluconazole in or on banana at 1.5 parts per million (ppm) and coffee at 0.4 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the petitioner, which is available in the docket for this action, docket ID number EPA-HQ-OPP-2020-0538 at, https://www.regulations.gov. One comment from an anonymous citizen was received in response to the notice of filing (NOF). The Agency response is listed in Unit IV.C.

With respect to the subject action, the proposed tolerance levels were not altered, but the commodity definition for coffee was revised. The reason for this change is explained in Unit IV.D.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, 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 mefentrifluconazole, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mefentrifluconazole follows.

In an effort to streamline Federal Register publications, EPA is directing readers to certain sections of Federal Register notices for previous tolerance rulemakings for the same pesticide that contain information that has not changed in the current risk assessment. To that end, on June 28, 2019, EPA published in the Federal Register a final rule establishing a tolerance for residues of mefentrifluconazole in or on many livestock, corn, fruit, grain, nut and vegetable commodities based on the Agency's conclusion that aggregate exposure to mefentrifluconazole is safe for the general population, including infants and children. See 84 FR 30939 (FRL-9994-51). Please refer to the following sections of the aforementioned tolerance rulemaking that contain information that has remained the same under the current risk assessment for this rulemaking: Units III.A (Toxicological Profile); III.B (Toxicological Points of Departure/Levels of Concern); III.C (Exposure Assessment), except as explained in the next paragraph; and III.D (Safety Factor for Infants and Children).

Updates to exposure assessment. The Agency conducted an updated risk assessment to evaluate exposure to residues of mefentrifluconazole on banana and coffee. EPA's acute and chronic dietary (food and drinking water) exposure assessments have been updated to include the additional exposure from use of mefentrifluconazole on banana and coffee. As to residue levels in food, a partially refined chronic dietary exposure and risk assessment was conducted assuming 100 percent crop treated (PCT) and using average field-trial residues for some commodities and tolerance-level residues for other commodities (banana and coffee). There will be no U.S. registrations for use of mefentrifluconazole on banana and coffee, and there is no proposed new residential use. Therefore, EPA's assessments of dietary exposure from drinking water and non-dietary ( i.e., residential) exposure, as well as cancer classification and cumulative effects from substances with a common mechanism of toxicity, have not changed and are described in the June 2019 tolerance rulemaking.

Assessment of aggregate risks. Acute aggregate risk estimates are equal to acute dietary (food and drinking water) risk estimates, which are below the Agency's level of concern of 100% of the acute population adjusted dose (aPAD): The exposure estimate is 5.6% of the aPAD at the 95th percentile of exposure for females 13 to 49 years old, which is the population subgroup with the highest exposure estimate. Chronic aggregate risk estimates are equal to chronic dietary (food and drinking water) risk estimates, which are below the Agency's level of concern of 100% of the chronic population adjusted does (cPAD): The exposure estimate is 82% of the cPAD for children 1 to 2 years old, which is the population subgroup with the highest exposure estimate. Short-term aggregate risk estimates are equal to the total short-term residential post-application dermal exposure estimates plus average dietary exposure estimates. For adults, the most conservative residential exposure estimate is from post-application dermal exposure from golfing activities after applications to golf courses, with a margin of exposure (MOE) above the Agency's level of concern of 100 (MOE = 2600). For children 6 to less than 11 years old, the most highly exposed child subgroup for residential exposure, the most conservative residential exposure estimate is from post-application dermal exposure from golfing activities after applications to golf courses. The dietary exposure for children 6 to 12 years old was used to calculate aggregate exposure as this subgroup is similar to the subgroup children 6 to less than 11 years old. The MOE is above the Agency's level of concern of 100 (MOE = 1900). Children 1 to <2 years old were the highest exposed child subgroup for dietary exposures, which does not match the most highly exposed child subgroup for residential exposure (children 6 to <11 years old). However, the selected residential exposure scenarios for aggregation, adults and children (6 to <11 years old), represent the worst-case risk estimates and are protective of all other life stages and exposure scenarios. Considering both the total short-term residential post-application dermal exposures and average dietary exposures for both adults and children, EPA has concluded the short-term aggregate MOEs are 790 and 620 for adults and children 6 to less than 11 years old, respectively, which are above the level of concern of 100 and therefore are not of concern. Intermediate-term residential exposures are not expected from the residential use of mefentrifluconazole; therefore, intermediate-term aggregate risk is not a concern and quantitative estimates were not calculated. Mefentrifluconazole is classified as “not likely to be carcinogenic to humans”; therefore, a quantitative cancer assessment was not conducted.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to mefentrifluconazole residues. More detailed information on the subject action to establish a tolerance in or on banana and coffee can be found in the document entitled, “Mefentrifluconazole. Human Health Risk Assessment for Petition for the Establishment of Permanent Tolerances for Use on Banana and Coffee without U.S. Registration.” dated 10/20/2021 at https://www.regulations.gov, under docket ID number EPA-HQ-OPP-2020-0538.

The analytical enforcement methodologies found in Unit IV.A. of the final rule published in the Federal Register on June 28, 2019, establishing tolerances for residues of mefentrifluconazole in or on multiple commodities are adequate for banana and coffee. See 84 FR 30939 (FRL-9994-51). The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex 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.

There are currently no Codex or Canadian MRLs established for residues of mefentrifluconazole in banana or coffee; therefore, there are no issues with harmonization.

One anonymous comment to the NOF was submitted insisting that no residues of fluoride, which is a different chemical, should be permitted for bananas and coffee. Even so, no additional information was provided that would support a conclusion that the tolerances requested for mefentrifluconazole are not safe. Although some individuals do not want pesticides to be used on food, the FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action, and the commenter provided no information to support a determination that the tolerance is not safe.

EPA is establishing a tolerance on “coffee, green bean” rather than the requested tolerance on “coffee” to be consistent with the terminology the Agency uses for that commodity.

Therefore, tolerances are established for residues of mefentrifluconazole in or on banana at 1.5 ppm and coffee, green bean, at 0.4 ppm.

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

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

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

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

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

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

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-2020-0421 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 14, 2022. 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-2020-0421, by one of the following methods:

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

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

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

In the Federal Register of April 22, 2021 (86 FR 21317) (FRL-10022-59), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8829) by Nichino America, Inc. 4550 Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide pyflubumide, including its metabolites and degradates, in or on the raw agricultural commodity tea, dried at 70 parts per million (ppm). That document referenced a summary of the petition prepared by Nichino America, Inc., 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 is establishing the tolerance for tea, dried at a different level than requested and is also establishing a tolerance for tea, instant. 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. Neither of these exposures are relevant to this action, however. 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 pyflubumide. EPA's assessment of exposures and risks associated with pyflubumide follows.

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

The toxicological database for pyflubumide is complete for the establishment of a tolerance without U.S. registration. Based on a weight-of-evidence approach and considering all available pyflubumide hazard and exposure information, EPA waived the requirement for a subchronic neurotoxicity (SCN) study, an immunotoxicity study, and a comparative thyroid assay (CTA). The affected target organs following the administration of pyflubumide included the thyroid (rat, mouse, and dog), liver (rat, mouse, rabbit, and dog), kidney (rat and dog), adrenal gland (mouse, rat, and dog), heart (rat and dog), and lung (developing rat).

No evidence of increased qualitative or quantitative susceptibility was seen in the rat and rabbit developmental toxicity studies. Increased quantitative susceptibility was observed in the multigeneration reproduction toxicity study where lung lesions in offspring were observed at a lower dose (6 mg/kg/day) than the dose eliciting parental toxicity (29 mg/kg/day).

There was no evidence of neurotoxicity in the available acute neurotoxicity (ACN) study or throughout the database (subchronic, chronic, and mechanistic studies). The chronic point of departure (POD) (1 mg/kg/day) is protective of effects seen in the multigeneration reproduction toxicity study.

For the acute dietary exposure scenario (females of childbearing age and infants), the point of departure (POD) is based on the increased incidence of lung lesions (alveolar dilatation) from dosing on two consecutive days (post-natal day (PND) 4-5 or PND 6-7) in a mechanistic study that evaluated the occurrence of alveolar dilatation in rat pups by short term oral administration of pyflubumide. Since these lung effects resulted from at most two exposures, this finding was selected to be protective of potential acute lung effects that could occur due to a single day's exposure to pyflubumide during the perinatal period. The increased incidence of lung lesions was observed in rat pups and was not found in maternal rats. Nursing pups may be exposed through the mother's milk which can result in the observed lung effects.

The POD selected for chronic dietary is based on bile duct hyperplasia and decreased triglycerides in both sexes; increased liver weights in females; increased urinary protein, urine volume, increased incidence of kidney urinary casts; and increased incidence of tubular basophilic change in the kidney in males in a one-year chronic rat toxicity study. This POD is protective of all adverse effects observed in the multigeneration reproductive, the chronic dog, the rat carcinogenicity, and the mouse carcinogenicity studies. It is also protective of lung effects observed across studies.

Pyflubumide is classified as: “Suggestive Evidence of Carcinogenic Potential” based on treatment-related hepatocellular adenomas in male mice at a dose level of 176 mg/kg/day. There is no mutagenic concern for pyflubumide. The quantification of risk using a non-linear approach ( i.e., a chronic population adjusted dose) will adequately account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to pyflubumide.

Specific information on the studies received and the nature of the adverse effects caused by pyflubumide 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 “Pyflubumide. Human Health Risk Assessment for a Petition for the Establishment of Permanent Tolerances for Residues on Tea without a U.S. Registration. New Active Ingredient.” hereinafter “Pyflubumide Human Health Risk Assessment” at pages 24-67 in docket ID number EPA-HQ-OPP-2020-0421.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide .

A summary of the toxicological endpoints for pyflubumide used for human risk assessment can be found in the Pyflubumide Human Health Risk Assessment.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyflubumide, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from pyflubumide in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for pyflubumide for only infants (<1 year old). Although no adverse effects were observed for females of childbearing age (13 to 49 years old), risk estimates for females of childbearing age (13 to 49 years old) are provided since there is still the potential for nursing infants to be exposed to pyflubumide from breast milk of mothers who consume treated tea. Thus, the risk estimate for females of childbearing age (13 to 49 years old) is protective for nursing infants. No acute dietary analysis was performed for the general population because an appropriate acute toxicological endpoint was not identified for the general population. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the United States Department of Agriculture (USDA), National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used the Maximum Residue Limit (MRL) calculator to estimate the upper bound limit for combined residues of pyflubumide (parent) and pyflubumide-NH (metabolite) with 100 percent crop treated (PCT) assumptions.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used 2003-2008 food consumption data from the USDA NHANES/WWEIA. As to residue levels in food, EPA used the MRL calculator to estimate the upper bound limit for combined residues of pyflubumide and pyflubumide-NH with 100 PCT assumptions.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Based on the data discussed in Unit III.A., EPA has concluded that a chronic reference dose (cRfD) and chronic population-adjusted dose (cPAD) are protective for all chronic toxicity, including any potential carcinogenicity. Thus, a separate quantitative cancer dietary exposure assessment was not conducted.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pyflubumide. An estimated upper bound limit based on the combined residue levels of pyflubumide and pyflubumide-NH at a 7-day preharvest interval, and 100 PCT, were assumed for all food commodities.

2. Dietary exposure from drinking water. EPA assumes that there is no exposure through drinking water because pyflubumide is not registered for use in the United States. Because residues are not expected in drinking water, dietary risk estimates include exposures from food only.

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). Pyflubumide is not registered for any specific use patterns that would result in residential exposure.

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 considers “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pyflubumide and any other substances. In addition, pyflubumide does not appear to produce a toxic metabolite that is produced by other substances. For the purposes of this action, therefore, EPA has not assumed that pyflubumide has a common mechanism of toxicity with other substances.

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. The margin of safety accounts for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. No evidence of increased qualitative or quantitative susceptibility was seen in the rat and rabbit developmental toxicity studies. However, increased quantitative susceptibility was observed in the offspring of the multigeneration reproduction toxicity study where lung lesions in offspring were observed at a lower dose than the dose eliciting parental toxicity. A mechanistic study found that the increased incidence of lung lesions (alveolar dilatation and hemorrhage), following exposure to pyflubumide, was observed during post-natal exposure without any effects seen during in utero exposure. Although quantitative susceptibility was observed in the multigeneration reproduction study at 6 mg/kg/day, a clear level at which no adverse effects occurred was identified at 1 mg/kg/day. In two mechanistic studies where lung lesions were identified, a clear NOAEL was established. Oral gavage administration of the parent compound (pyflubumide) to rat pups led to the increased incidence of lung lesions at a lower dose (10 mg/kg/day) than the metabolites (50 mg/kg/day) and a clear NOAEL was established at 2 mg/kg/day. In addition, oral gavage administration of the parent (50 mg/kg/day) over a two-day period (post-natal day [PND] 4-5 or PND 6-7), led to the increased incidence of lung (alveolar enlargement) lesions in the pups and a clear NOAEL was established at 10 mg/kg/day. An acute exposure below 10 mg/kg/day is not likely to result in the development of lung lesions. A point of departure was established for both the acute (10 mg/kg/day) and chronic dietary (1 mg/kg/day) exposure scenario which is protective of lung effects observed in the aforementioned studies. The combination of these factors provided a weight of the evidence to support reducing the FQPA safety factor to 1X.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for pyflubumide is complete for evaluating and characterizing toxicity, assessing offspring susceptibility under FQPA, and selecting endpoints for the exposure pathways of concern. The developmental toxicity studies in rats and rabbits, a multigeneration reproduction toxicity study, an acute neurotoxicity study in rats, and mechanistic studies on the incidence of lung lesions in rat pups are available for FQPA consideration.

ii. There is no indication that pyflubumide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. As stated above, no evidence of increased qualitative or quantitative susceptibility was seen in the rat and rabbit developmental toxicity studies. However, increased quantitative susceptibility was observed in the offspring of the multigeneration reproduction toxicity study where lung lesions in offspring were observed at a lower dose than the dose eliciting parental toxicity. The concern for the susceptibility observed in the multigeneration reproductive toxicity study is low, as there is a clear NOAEL established for the offspring effects and the PODs selected for risk assessment are protective of the observed susceptibility.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% PCT and combined residue levels for pyflubumide and pyflubumide-NH at a 7-day preharvest interval. These assessments will not underestimate the exposure and risks posed by pyflubumide.

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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to pyflubumide from food only will utilize 3.5% of the aPAD for females (13 to 49 years old). The acute dietary risk estimate for females (13 to 49 years old) is protective for nursing infants because lactating mothers who consume tea with pyflubumide residues are not expected to have lower exposures than infants who subsequently consume the mother's breast milk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyflubumide from food only will utilize 7.7% of the cPAD for adults (50 to 99 years old), the most highly exposed population subgroup. There are no residential uses for pyflubumide.

3. Short and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because pyflubumide is not registered in the United States, the only exposures will be dietary, from residues in or on imported tea; therefore, no short-term or intermediate-term residential exposure is expected. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for pyflubumide.

4. Aggregate cancer risk for U.S. population. As stated in Unit III.A, EPA has concluded that the chronic reference dose (cRfD) will adequately account for all repeated exposure/chronic toxicity, including carcinogenicity, which could result from exposure to pyflubumide. Based on the lack of chronic risk at regulated levels of exposure, EPA concludes that exposure to pyflubumide will not pose an aggregate cancer risk.

5. 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 pyflubumide residues.

Adequate enforcement methodology (QuEChERS-based high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS), Method A) is available to enforce the tolerance expression.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

The Codex has not yet established a MRL for pyflubumide residues in or on tea, dried or tea, instant. The Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Meeting on Pesticide Residues (JMPR) evaluated toxicology and residue data for apple and tea submitted by Nichino in September 2019. JMPR proposed an MRL level of 80 ppm for tea, dried (Pesticide Residues in Food 2019—Joint FAO/WHO Meeting on Pesticide Residues, pg 1620-1622; https://www.fao.org/3/ca7455en/ca7455en.pdf ). The U.S. tolerance of 80 ppm for residues of pyflubumide in/on tea, dried is harmonized with the MRL proposed by JMPR.

The petition requested tolerances for residues of pyflubumide in or on tea, dried at 70 ppm. EPA is establishing the tolerance for residues of pyflubumide in or on tea, dried at 80 ppm. Two of the submitted field residue trials were conducted at half the label rate. EPA normalized those resulting residues to a 1X rate using proportionality and used the Organization for Economic Co-operation and Development (OECD) MRL calculation procedures, which resulted in a tolerance level of 80 ppm for tea, dried. EPA is also establishing a tolerance for tea, instant, which is another processed commodity of tea, plucked leaves, and EPA has determined that the same tolerance of 80 ppm is appropriate for instant tea.

Therefore, tolerances are established for residues of pyflubumide, including its metabolites and degradates, in or on tea, dried at 80 ppm and tea, instant at 80 ppm.

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

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

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

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

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

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

We received an application from the Navy requesting five-year regulations and authorization to take multiple species of marine mammals. This rule establishes a framework under the authority of the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq. ) to allow for the authorization of take by Level A and Level B harassment incidental to the Navy's construction activities, including impact and vibratory pile driving. Please see Background below for definitions of harassment.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to five years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Mitigation section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart R provide the legal basis for issuing this final rule containing five-year regulations, and for any subsequent LOAs. As directed by this legal authority, this final rule contains mitigation, monitoring, and reporting requirements.

Following is a summary of the major provisions of this final rule regarding Navy construction activities. These measures include:

• Required monitoring of the construction areas to detect the presence of marine mammals before beginning construction activities;

• Shutdown of construction activities under certain circumstances to avoid injury of marine mammals; and

• Soft start for impact pile driving to allow marine mammals the opportunity to leave the area prior to beginning impact pile driving at full power.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361 et seq. ) directs the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made, regulations are issued, and notice is provided to the public.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth.

NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

In July 2020, NMFS received a request from the Navy requesting authorization to take small numbers of seven species of marine mammals incidental to construction activities including bulkhead replacement and repairs at NAVSTA Newport. NMFS reviewed the Navy's application, and the Navy provided responses addressing NMFS' questions and comments on February 22, 2021. The application was deemed adequate and complete and published for public review and comment on May 19, 2021 (86 FR 27069). We did not receive substantive comments on that notice and request for comments and information. We subsequently published a proposed rule in the Federal Register on October 13, 2021 (86 FR 56857). Comments received during the public comment period on the proposed regulations are addressed in the Comments and Responses section of this final rule.

The Navy requested authorization to take a small number of seven species of marine mammals by Level A and B harassment. Neither the Navy nor NMFS expects serious injury or mortality to result from this activity. The regulations are valid for five years (2022-2027).

The Navy plans to replace or repair several sections of deteriorating, unstable, hazardous, and eroding bulkhead, sheet pile, and revetment (approximately 2,730 total linear feet (ft)) along the Coddington Cove waterfront of NAVSTA Newport. Over time, the existing storm sewer systems and bulkheads along the Coddington Cove waterfront have severely degraded due to erosion from under-capacity stormwater system piping and aging infrastructure. This impacts the ability of the installation to minimize shoreline erosion and minimize safety risks from associated upland subsidence, while also maintaining potential berthing space. The Navy plans to conduct necessary work, including impact and vibratory pile driving, to repair and replace bulkheads over five years. The specified activities may occur at any time during the 5-year period of validity of the regulations. The Navy expects pile driving to occur on approximately 222 non-consecutive in-water pile driving days over the five-year duration. Pile driving activities are anticipated to be completed within 4 years. However, because the planned construction is dependent on the allocation of funding, the Navy requested that the LOA be issued for the entire 5-year construction period to ensure flexibility in the project schedule. Table 1 provides the anticipated construction schedule for the planned activities.

The specific sections planned for bulkhead repair and replacement are described in detail in the proposed rule (86 FR 56857; October 13, 2021) and are summarized in Table 2 below.

Since the proposed rule, which contains a detailed description of the planned construction, was published (86 FR 56857; October 13, 2021), no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to the proposed rule for further description of the specific activity.

We published a proposed rule in the Federal Register on October 13, 2021 (86 FR 56857). During the 30-day comment period, we received six comments from private citizens, with five expressing general support for the project and one expressing general opposition to the project.

Sections 3 and 4 of the Navy's application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SARs; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS's website ( https://www.fisheries.noaa.gov/find-species ).

Table 3 lists all species or stocks for which take is expected and planned for authorization, and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2021). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. Atlantic and Gulf of Mexico SARs ( e.g., Hayes et al. 2021). All values presented in Table 3 are the most recent available at the time of publication and are available in the 2020 SARs (Hayes et al. 2021) or the 2021 draft SARS, available at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports.

As indicated above, all seven species in Table 3 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and we have authorized take. Several depleted species of whales occur seasonally in the waters off Rhode Island including Humpback ( Megaptera novaeangliae ), Fin ( Balaenoptera physalus ), Sei ( Balaenoptera borealis ), Sperm ( Physeter macrocephalus ) and North Atlantic Right whales ( Eubaleana glacialis ). These whales are seasonally present in New England waters; however, due to the depths of Narragansett Bay and near shore location of the project area, these listed marine mammals are unlikely to occur. Therefore, no takes were requested and none are anticipated or planned for authorization by NMFS and they are not discussed further.

A detailed description of the species likely to be affected by the Navy's project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the proposed rule (86 FR 56857; October 13, 2021). We are not aware of any changes in the status of these species and stocks since that time. Please refer to the proposed rule for these descriptions (86 FR 56857; October 13, 2021).

Hearing is the most important sensory modality for marine mammals underwater and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al. 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes ( i.e., low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible, thus the lower bound from Southall et al. (2007) is retained. Marine mammal hearing groups and their associated hearing ranges are provided in Table 4.

The pinniped functional hearing group was modified from Southall et al. (2007) on the basis of data indicating that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä et al. 2006; Kastelein et al. 2009; Reichmuth and Holt, 2013).

For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Seven marine mammal species (three cetacean and four phocid pinniped species) have the reasonable potential to co-occur with the planned construction activities. Please refer to Table 3. Of the cetacean species that may be present, two are classified as a mid-frequency cetacean ( i.e., dolphins), and one is classified as a high-frequency cetacean ( i.e., harbor porpoise).

The effects of underwater noise from the Navy's activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the project area. The proposed rule (86 FR 56857; October 13, 2021) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from the Navy's construction activities on marine mammals and their habitat. That information and analysis applies to this final rule and is not repeated here; please refer to the proposed rule (86 FR 56857; October 13, 2021).

The Estimated Take section in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take section, and the Mitigation Measures section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks. We also provided additional description of sound sources in our proposed rule (86 FR 56857; October 13, 2021).

This section provides an estimate of the number of incidental takes authorized, which will inform both NMFS' consideration of small numbers and the negligible impact determination.

Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

Authorized takes would be by Level A and B harassment, in the form of disruption of behavioral patterns and potential TTS and PTS for individual marine mammals resulting from exposure to pile driving and removal. As described previously, no serious injury or mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.

Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available ( e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the take estimate.

NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

Level B Harassment —Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source ( e.g., frequency, predictability, duty cycle), the environment ( e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al. 2007, Ellison et al. 2012). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa (rms) (reference pressure microPascal, root mean square) for continuous ( e.g., vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive ( e.g., seismic airguns) or intermittent ( e.g., scientific sonar) sources.

The Navy's construction includes the use of continuous (vibratory pile driving) and impulsive (impact pile driving) sources, and therefore the level of 120 and 160 dB re 1 μPa (rms) is applicable.

Level A harassment —NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise. The technical guidance identifies the received levels, or thresholds, above which individual marine mammals are predicted to experience changes in their hearing sensitivity for all underwater anthropogenic sound sources, and reflects the best available science on the potential for noise to affect auditory sensitivity. The technical guidance does this by identifying threshholds in the follow manner:

Dividing sound sources into two groups ( i.e., impulsive and non-impulsive) based on their potential to affect hearing sensitivity;

Choosing metrics that best address the impacts of noise on hearing sensitivity, i.e., sound pressure level (peak SPL) and sound exposure level (SEL) (also accounting for duration of exposure); and

Dividing marine mammals into hearing groups and developing auditory weighting functions based on the science supporting the fact that not all marine mammals hear and use sound in the same manner.

These thresholds were developed by compiling and synthesizing the best available science and are provided in Table 5 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at https://www.fisheries.noaa.gov/national/marine-mammal-protection.

The Navy's planned construction includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.

Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels transmission loss coefficient.

Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions, including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log(range)). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log(range)). As is common practice in coastal waters, here we assume practical spreading (4.5 dB reduction in sound level for each doubling of distance). Practical spreading is a compromise that is often used under conditions where water depth increases as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Practical spreading was used to determine sound propagation for this project.

The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. There are sound source level (SSL) measurements available for certain pile types and sizes from the similar environments from other Navy pile driving projects that were evaluated and used as proxy sound source levels to determine reasonable sound source levels likely to result from the pile driving and removal activities (Table 6). Some of the proxy source levels are expected to be conservative, as the values are from larger pile sizes.

For 42-in steel piles, a SSL of 181 dB SEL was used for impact driving and is similar to SSL of 180 dB SEL for 36-in piles in CALTRANS (2015). There are no SSL values for 42-in piles in CALTRANS, the nearest values are for 36-in and 60-in steel pipe piles. For 30-in steel pipe piles, an SSL of 181 dB SEL was used for impact pile driving as a proxy from the Navy's San Diego Bay Acoustic Compendium (NAVFAC SW 2020) (the median value from the greatest sound levels recorded for 30-in steel piles). The SSL used for 30-in steel piles during impact pile driving is also more conservative than the SSL of 177 dB SEL for 30-in steel piles in CALTRANS (2015). For 31.5-in sheet piles, an SSL of 181 dB SEL was used for impact pile driving as a proxy from 30-in steel pipe piles (NAVFAC SW 2020), which is also slightly more conservative than an SSL of 180 dB SEL for 24-in piles in CALTRANS (2015) (no larger sheet piles are described in CALTRANS 2015). During vibratory pile driving of 31.5-in sheet piles, the Navy used an SSL of 163 dB SPL, which is also more conservative than an SSL of 160 dB SPL for 24-in sheet piles in CALTRANS (2015) (no large sheet piles are described in CALTRANS 2015). For 22.5-in Z-shaped steel sheet piles, an SSL of 180 dB SEL was used for impact pile driving and is also equivalent to 24-in sheet piles in CALTRANS (2015). During vibratory pile driving, an SSL of 163 dB SPL is a proxy from NAVFAC Mid-Atlantic (2018) and is also more conservative than 24-in sheet piles in CALTRANS (2015) where the SSL is 160 dB SPL for 24-in sheet piles (no larger sheet piles are described in CALTRANS (2015). For 14-in steel H-piles, an SSL of 158 dB SPL was used from CALTRANS (2015).

In conjunction with the NMFS Technical Guidance (2018), in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, NMFS developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that, because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimation of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools and will qualitatively address the output where appropriate. For stationary sources (such as from impact and vibratory pile driving), the NMFS User Spreadsheet (2020) predicts the closest distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would not incur PTS. Inputs used in the User Spreadsheet (Tables 7 and 8), and the resulting isopleths are reported below (Table 9).

Utilizing the practical spreading model, NMFS determined underwater noise will fall below the behavioral effects threshold of 120 dB rms for marine mammals at the distances shown in Table 10 for vibratory pile driving. With these radial distances, the largest Level B harassment zone calculated was 7,356 m for sheet piles. However, this distance would be truncated due to the presence of intersecting land masses. For calculating the Level B harassment zone for impact driving, the practical spreading loss model was used with a behavioral threshold of 160 dB rms. The maximum radial distance of the Level B harassment zone for impact piling equaled 2,512 m for 30-in piles, 42-in piles and 31.5-in sheet piles. Table 10 below provides all Level B harassment radial distances (m) and ensonified areas (km 2 ) during the Navy's planned activities.

In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. Potential exposures to impact pile and vibratory pile driving noise for each acoustic threshold were estimated using marine mammal density estimates (N) from the Navy Marine Species Density Database NMSDD (Navy 2017) for which data of monthly densities of species were evaluated in terms of minimum, maximum, and average annual densities within Narragansett Bay and multiplied by the zone of influence (ZOI) and the maximum days of pile driving (take estimate = N × ZOI × days of pile driving). The pile type, size, and installation method that produce the largest ZOI were used to estimate exposure of marine mammals to noise impacts. We describe how the information provided above is brought together to produce a quantitative take estimate in the species sections below.

Atlantic white-sided dolphins occur seasonally, occurring primarily along the continental shelf with occasional unconfirmed opportunistic sightings in Narragansett Bay in fall and winter. The most recent observation of a pod of dolphins in Narragansett Bay was in October 2007 (NUWC Division, 2011). Construction activity could occur at any time of year and would be short-term and intermittent. Therefore, the average species density was determined to be appropriate for estimating takes of Atlantic white-sided dolphin. Based on density data for Narragansett Bay (Navy 2017), the average density of Atlantic white-sided dolphin was determined to be 0.003/km 2 . This density was used to estimate abundance of animals that could be present in the area for exposure. Using this information, 1 take was calculated for Years 1, 3, and 4 and 0 takes in Year 2 (Table 11). However, the annual take by Level B harassment for Atlantic white-sided dolphins has been increased to the average group size (16) (NAVSEA NUWC 2017) for Years 1, 3, and 4, because the calculated annual take is below the average group size. Therefore, the Navy requested, and NMFS authorized, 16 takes annually in Years 1, 3, and 4 (0 in Year 2) for a total of 48 takes by Level B harassment of Atlantic white-sided dolphin (Table 11). No takes by Level A harassment of Atlantic white-sided dolphin are anticipated to occur or are authorized. Because this species' regular occurrence is in much deeper waters than the extent of the ZOI (Hayes et al., 2019), expected takes of this species are extremely low.

Common dolphins are the most likely dolphin species to be spotted in Narragansett Bay, and usually occur in late fall or winter (Kenney, 2013). The most recent sighting of a common dolphin recorded in Narragansett Bay was in October of 2016 (Hayes et al., 2019). Construction activity could occur at any time of year and would be short-term and intermittent. Based on density data for Narragansett Bay (NMSDD, Navy, 2017), the average density of common dolphin was determined to be 0.011/km 2 . Using this information, 3 takes by Level B harassment were calculated for Years 1 and 4, 2 takes for Year 2 and 6 takes for Year 3 (Table 12). Because the calculated annual take is below the average group size, the annual take by Level B harassment for common dolphin has been increased to the average group size (28) (NAVSEA NUWC 2017). Therefore, the Navy requested, and NMFS authorized, 28 takes annually (with the exception of Year 2, for which it was doubled to 56 takes as a conservative approach to account for more vibratory and impact pile driving activities that occur during that year in two sections (S366 and Pier 1)) for a total of 140 takes by Level B harassment of common dolphin (Table 12). No takes by Level A harassment of common dolphin are anticipated to occur or are authorized. Because this species' regular occurrence is in much deeper waters than the extent of the ZOI (Hayes et al., 2019), takes of this species are expected to be extremely low.

Harbor porpoise are not common to Narragansett Bay but may occur, especially in winter and spring months (Kinney 2013). Harbor porpoise is the most stranded cetacean in Rhode Island, with a strong seasonal occurrence in the spring. Construction activity could occur at any time of year and would be short-term and intermittent. Therefore, the average species density was determined to be appropriate for estimating takes of harbor porpoise. Based on density data for Narragansett Bay (NMSDD, Navy 2017), the average density of harbor porpoise was determined to be 0.012/km 2 . Using this information, 4 takes by Level B harassment were calculated for Years 1 and 4, 2 takes for Year 2, and 7 takes for Year 3 (Table 13). Because the calculated take in Year 2 was less than the group size, the annual take by Level B harassment for harbor porpoise has been increased to the average group size (3) and multiplied by two for 6 takes (NAVSEA NUWC 2017) as a conservative approach to account for more vibratory and impact pile driving activities that occur during that year in two sections (S366 and Pier 1)). Therefore, the Navy requested, and NMFS authorized, 4 takes in Years 1 and 4, 6 takes in Year 2, and 7 takes in Year 3, and a total of 21 takes by Level B harassment of harbor porpoise (Table 13). Level A harassment could occur during years 1, 3 and 4 (Table 13).

Harbor seals are the most common seal in Narragansett Bay, which is a well-known winter feeding ground for the species (Moll et al., 2017). Seals are commonly observed from late September through April (Moll et. al., 2017; DeAngelis, 2020). Of the 22 known haulouts within Narragansett Bay, The Sisters is the nearest haulout to the project area (0.9 mi). Harbor seals are rarely observed at The Sisters haulout in the early fall (September-October) but consistent numbers are regularly observed in mid-November (0-10 animals). These numbers gradually increase with peak numbers in the upper 40s occurring in March, typically at low tide (DeAngelis, 2020). The NMSDD (Navy, 2017a) models harbor and gray seals as a guild due to the difficulty in distinguishing these species at sea. Harbor seal is expected to be the most common pinniped in Narragansett Bay with year-round occurrence (Kenney and Vigness-Raposa, 2010). Therefore, the maximum species density for the harbor-gray seal guild was determined to be appropriate for estimating takes of harbor seal. Based on density data for Narragansett Bay (Navy, 2017a), the maximum density of seals was determined to be 0.623/km 2 . This density value is for all seals (harbor and gray seals as a guild); therefore, this density value results in some degree of overestimation when applied to harbor seals only. The Navy requested and NMFS authorized a high of 25 takes by Level A harassment and 353 takes by Level B harassment during Year 3, and a low of 13 takes by Level A harassment and 138 takes by Level B harassment during Year 2 (Table 14).

Based on stranding records, gray seals are seasonally present in Rhode Island with the largest populations occurring from February through June with a sharp peak in March and April. The NMSDD (Navy, 2017a) provides combined densities for harbor seal and gray seal (as discussed above). Gray seals are the second most likely seal to be observed in Rhode Island waters, next to harbor seals, and more of an occasional visitor (Kenney, 2020); therefore, the average species density for the harbor-gray seal guild was determined to be appropriate for determining takes of gray seal. Based on density data for Narragansett Bay (Navy, 2017a), the average density of seals was determined to be 0.131/km 2 . This density value is for all seals (harbor and gray seals as a guild); therefore, it results in some degree of overestimation when applied to gray seals only. Calculated takes by Level A harassment and Level B harassment may occur each construction year with up to 5 takes by Level A harassment and 74 takes by Level B harassment during Year 3. Fewer annual takes were calculated for Year 2 and 3 by Level A harassment and 28 takes by Level B (Table 15). Because the calculated annual take is below the average group size, the annual take by Level B harassment for gray seal has been increased to the average group size (50 gray seals) (NAVSEA NUWC 2017) and conservatively doubled for Year 1, 2, and 4, during which years calculated takes were less than group size. Therefore, the Navy requested, and NMFS authorized, 100 takes of gray seals in Years 1, 2 and 4, and 74 takes in Year 3, and a total of 374 takes by Level B harassment of gray seals. A total of 17 takes of gray seals by Level A harassment is also authorized.

Harp seals may be present in the project vicinity January through May. In general, harp seals are much rarer than the harbor seal and gray seal in Narragansett Bay and are rarely observed in the bay (Kenney, 2015). Therefore, the minimum species density was determined to be appropriate for determining takes of harp seal. Based on density data for Narragansett Bay obtained from the NMSDD (Navy 2017), the minimum density of harp seal was determined to be 0.050/km 2 . The Navy requested and NMFS authorized that 2 takes by Level A harassment could occur in Year 3, and 1 take by Level A harassment in Years 1, 2, and 4, for a total of 5 takes (Table 16). Calculated takes by Level B harassment range from 11 to 29 and total 72 takes over the project (Table 16).

Hooded seals may be present in the project vicinity from January through May, although their exact seasonal densities are unknown. In general, hooded seals are much rarer than the harbor seal and gray seal in Narragansett Bay and are rarely observed in the Bay (Kenney, 2005). Based on density data for Narragansett Bay obtained from the NMSDD, the minimum density of hooded seal was determined to be 0.001/km 2 . Hooded seals have the potential to occur but are considered the least likely seal to be present in Narragansett Bay. No Level A (PTS onset) or Level B (behavioral) takes are anticipated during any construction year. However, in order to guard against unauthorized take, the Navy is requesting, and NMFS authorized, 1 Level B (behavioral) take of hooded seal per month of construction when this species may occur (Jan through May) for each construction year for a total of 20 takes by Level B harassment (Table 17). No take by Level A harassment is anticipated to occur or is authorized.

Table 18 below summarizes the authorized take for all the species described above as a percentage of stock abundance.

Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.110. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102 and final 2021 allocations were published on December 21, 2020 (85 FR 82946).

The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan (FMP), as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider three criteria in the evaluation of requests for quota transfers or combinations: The transfer or combinations would not preclude the overall annual quota from being fully harvested; the transfer addresses an unforeseen variation or contingency in the fishery; and the transfer is consistent with the objectives of the FMP and the Magnuson-Stevens Fishery Conservation and Management Act. The Regional Administrator has determined these three criteria have been met for the transfer approved in this notification.

North Carolina is transferring 14,285 lb (6,480 kg) to Virginia through mutual agreement of the states. This transfer was requested to repay landings made by out-of-state permitted vessel under a safe harbor agreement. The revised summer flounder quotas for 2021 are: North Carolina, 2,918,480 lb (1,323,800 lb) and Virginia, 2,374,061 lb (1,076,856 kg).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 648.162(e)(1)(i) through (iii), which was issued pursuant to section 304(b), and is exempted from review under Executive Order 12866.

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

The 2021 TAC of Pacific ocean perch, in the EAI, allocated to vessels participating in the BSAI trawl limited access sector fishery was established as a directed fishing allowance of 742 metric tons by the final 2021 and 2022 harvest specifications for groundfish in the BSAI (86 FR 11449, February 25, 2021).

In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the EAI by vessels participating in the BSAI trawl limited access sector fishery. While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch directed fishery in the EAI for vessels participating in the BSAI trawl limited access sector fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 9, 2021.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.