The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-26-08, Amendment 39-21867 (86 FR 72833, December 23, 2021) (AD 2021-26-08). AD 2021-26-08 applied to Bell Textron Canada Limited Model 206, 206A, 206A-1, 206B, 206B-1, 206L, 206L-1, 206L-3, and 206L-4 helicopters, with nut P/N MS21042L4 or P/N MS21042L5 installed on the TRDS Thomas couplings. AD 2021-26-08 required removing certain nuts from service, installing newly designed nuts, and applying a specific torque and a torque stripe to each newly installed nut. AD 2021-26-08 also required, after the installation of each newly designed nut, inspecting the torque and, depending on the inspection results, either applying a torque stripe or performing further inspections and removing certain parts from service. Finally, AD 2021-26-08 prohibited installing any affected nut on any TRDS Thomas coupling. The FAA issued AD 2021-26-08 to prevent failure or loss of a nut on any TRDS Thomas coupling.

AD 2021-26-08 was prompted by Transport Canada AD CF-2020-15, dated May 13, 2020 (Transport Canada AD CF-2020-15). Transport Canada, which is the aviation authority for Canada, issued Transport Canada AD CF-2020-15 to correct an unsafe condition for Bell Textron Canada Limited Model 206, 206A, 206A-1, 206B, 206B-1, 206L, 206L-1, 206L-3, and 206L-4 helicopters, all serial numbers. Transport Canada AD CF-2020-15 specifies for certain model helicopters, newly designed nuts cannot be installed because Supplemental Type Certificate (STC) SH2750NM and Transport Canada STC SH99-202 install a pulley at the Thomas coupling location causing insufficient clearance. Transport Canada advises, for certain model helicopters with STC SH2750NM or Transport Canada STC SH99-202 installed, different part-numbered nuts may be installed and are now required to be replaced with a new part-numbered nut that is not vulnerable to the unsafe condition.

The NPRM published in the Federal Register on June 30, 2022 (87 FR 39015). The NPRM was prompted by reports of cracked or missing nuts installed on the TRDS Thomas couplings. The NPRM was also prompted by the determination that certain P/Ns and certain torque values in paragraph (g) of AD 2021-26-08 need to be revised. Furthermore, the FAA advises that the 50-70 in lb torque values are only applicable to certain bolts and nuts, and a 150-180 in lb torque value is required for other bolts and nuts that are required to be installed by this AD. The FAA also advises that certain part-numbered nuts that are required to be installed according to AD 2021-26-08 need to be removed from service and replaced due to a certain pulley configuration. The NPRM proposed to require removing certain nuts from service; installing newly designed nuts; applying torque and a torque stripe; and additional corrective actions if necessary. The NPRM also proposed to prohibit installing any affected nut on any TRDS Thomas coupling, as specified in Transport Canada AD CF-2020-15.

The FAA is issuing this AD to prevent failure or loss of a nut on the TRDS Thomas couplings, which if not addressed could result in loss of the tail rotor and subsequent loss of control of the helicopter. See Transport Canada AD CF-2020-15 for additional background information.

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

These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA reviewed the relevant data, considered the 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 helicopters. This AD is adopted as proposed in the NPRM, except the FAA has removed the note to the applicability paragraph and updated the identification of Model 206A-1 helicopters in the applicability paragraph to Model 206A-1 (OH-58A) helicopters to match the FAA type certificate data sheet. None of these changes will increase the economic burden on any operator.

Transport Canada AD CF-2020-15 requires the replacement of certain part-numbered nuts with newly designed nuts at each TRDS Thomas coupling and prohibits installing any affected nut on any TRDS Thomas coupling. The replacement includes applying torque, and a torque stripe.

The FAA reviewed Air Comm Corporation Service Bulletin SB 206EC-092619, Revision NC, dated September 26, 2019, which also specifies procedures for replacing the affected nuts with the newly designed corrosion-resistant nuts, but explains that affected helicopters equipped with Air Comm Corporation air conditioning systems installed under STC SH2750NM use the affected nut to attach a pulley onto the TRDS, which causes clearance issues for the nuts to be installed at the coupling. Therefore, this service bulletin specifies replacing the nut with a lower profile nut.

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

The FAA also reviewed Bell Alert Service Bulletin (ASB) 206-19-136, dated August 27, 2019, for FAA-certificated Model 206, 206A-series, and 206B-series helicopters, and non FAA-certificated Model TH-67 helicopters; and Bell ASB 206L-19-181, dated August 27, 2019, and Revision A, dated August 29, 2019, for Model 206L, 206L-1, 206L-3, and 206L-4 helicopters. This service information specifies procedures for replacing the affected nuts with the newly designed corrosion-resistant nuts. Revision A of Bell ASB 206L-19-181 corrects a typographical error.

Additionally, the FAA reviewed Bell Service Instruction BHT-206-SI-2052, Revision 1, dated October 14, 2010. This service information specifies procedures to upgrade Model 206L-1 and 206L-3 helicopters to allow operations at an increased internal gross weight.

Transport Canada AD CF-2020-15 requires compliance with certain actions within 600 hours air time or within the next 24 months, whichever occurs first, whereas this AD requires compliance within 600 hours time-in-service only. Service information referenced in Transport Canada AD CF-2020-15 specifies if any P/N MS21042L4 nuts are found loose or damaged, reporting the location and providing the information to Bell, whereas this AD requires if any P/N MS21042L4 nuts are found loose or damaged, inspecting each TRDS Thomas coupling, including each bolt, nut, and washer, for any elongated holes, fretting on the fasteners, and damaged fasteners, and depending on the results of the inspection, removing from service each affected part and replacing it with an airworthy part.

The FAA estimates that this AD affects 1,359 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Replacing each affected nut with the newly designed nut and applying torque and a torque stripe takes about 4 work-hours, and parts cost about $75 for an estimated cost of $415 per nut replacement and $563,985 per nut replacement for the U.S. fleet.

In addition, the costs of the actions that are part of the required replacement are as follows:

If required, due to loose or damaged nuts found, inspecting each TRDS Thomas coupling, and each bolt, nut, and washer for elongated holes and fretting on the fasteners takes about 0.5 work-hour for an estimated cost of $43 per inspection.

If required, replacing each TRDS Thomas coupling takes about 4 work-hours, and parts cost about $4,000 for an estimated cost of $4,340 per TRDS Thomas coupling replacement.

If required, replacing a bolt or washer takes a minimal amount of time and parts cost a nominal amount.

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 serial-numbered Piaggio Model P-180 airplanes. The NPRM published in the Federal Register on June 17, 2022 (87 FR 36415). The NPRM was prompted by MCAI originated by the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union. EASA issued EASA AD 2021-0104, dated April 15, 2021 (referred to after this as “the MCAI”), to address the unsafe condition on certain serial-numbered Piaggio Model P.180 airplanes. The MCAI states:

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-0599.

In the NPRM, the FAA proposed to require repetitively inspecting the fuselage skin panels, visually inspecting the entire fuselage inner side skin if necessary, and taking any necessary corrective actions. The FAA is issuing this AD to prevent degradation of the structural integrity of the fuselage. The unsafe condition, if not addressed, could lead to loss of control of the airplane.

The FAA received a comment from one individual commenter. The following presents the comment received on the NPRM and the FAA's response to the comment.

An individual commenter requested the FAA not require a 26-month repetitive inspection as proposed in the NPRM. The commenter stated that all U.S. operators follow the Piaggio P.180 Avanti II Maintenance Manual (MM) inspection program in which these areas are already being inspected every 5 years and 3,600 flight hours. The commenter also asserted that there could be patch repairs for previously inspected and repaired areas, and that, if patch repairs are found with no corrosion in previously inspected areas, no further action should be required. Therefore, the commenter believes implementing the 26-month repetitive inspection is excessive.

The FAA partially agrees. The FAA does not agree that all U.S.-registered airplanes are required to comply with Chapter 5 of the MM, which is where the inspections referenced by the commenter are located. Owners and operators must only comply with the Airworthiness Limitations section of the MM (located in Chapter 4 of this MM), as well as 14 CFR part 43, unless the airplane is operated under 14 CFR part 135 and its operating specifications require it. In addition, if the fuselage panels affected by this AD are replaced as part of the corrective actions required by paragraph (g)(1) of this AD, the repetitive inspections in paragraph (g)(2)(ii) of this AD are not required. Corrosion found outside of the affected fuselage areas of this AD should be repaired; however, these repairs are not mandated by this AD. Only the fuselage areas defined in the referenced service bulletin are affected by this AD. If corrosion is found as a result of the inspections required by this AD, this would show that the primer coating is inadequate to protect the material from corrosion; therefore, the repetitive inspections in this AD are necessary. The EASA, as the state of design, determined that a repetitive inspection interval of not to exceed 660 hours time-in-service (TIS) or 26 months, whichever occurs first, is appropriate. The FAA has no data to dispute this specified criteria concerning the time-in-service or calendar-month inspection interval determination. The FAA does agree that if repairs were previously accomplished on the areas required to be inspected by this AD and no corrosion was found during the inspections required by paragraph (g)(1) of this AD, the repetitive inspections in paragraph (g)(2)(ii) of this AD are not required. The FAA has not changed this final rule as a result of this comment.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comment 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 this product. Except for updating this AD to reflect that the type certificate holder changed from Piaggio Aero Industries S.p.A. to Piaggio Aviation S.p.A and changing the term “fuselage wing skin panel” used in paragraph (g)(1) of the NPRM to “fuselage skin panel,” this AD is adopted as proposed in the NPRM. None of the changes increase the economic burden on any operator.

The FAA reviewed Piaggio SB 80-0405, Revision 0, dated March 15, 2021. This service information specifies procedures for inspecting the fuselage skin panels and inspecting the full inner fuselage skin. It also specifies repairing or replacing any parts where corrosion is found.

The FAA also reviewed Piaggio SB 80-0405, Revision 0, Errata Corrige No. 1, dated March 24, 2021, which addresses discrepancies identified in Piaggio SB 80-0405, Revision 0, dated March 15, 2021.

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 MCAI allows credit for the fuselage inner skin inspection if previously done using Piaggio Aviation S.p.A. Temporary Revision No. 332 to Chapter 53-00-00 of Piaggio P.180 Avanti II MM, and this AD does not. The FAA will consider requests for an alternative method of compliance for this under paragraph (h) of this AD.

The MCAI specifies compliance times of 8 months and 12 months depending on when the P.180 Avanti II MM 3,600-flight-hour or 5-year inspection was accomplished. This AD has a 12-month compliance time for all airplanes because the 3,600-flight-hour and 5-year MM inspections are not required for all U.S. operators by FAA regulation.

The service information specifies contacting Piaggio for certain repair instructions, while this AD requires repair using a method approved by the FAA or EASA.

The FAA estimates that this AD affects 14 airplanes of U.S. registry.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Bell Textron Canada Limited Model 206L, 206L-1, 206L-3, and 206L-4 helicopters with a certain part-numbered M/R blade installed under STC SR02684LA. The NPRM published in the Federal Register on March 24, 2022 (87 FR 16652). The NPRM was prompted by testing by Van Horn Aviation, LLC (Van Horn), which revealed the potential for delamination in M/R blade part number (P/N) 20633000-101. Delaminations were then confirmed by inspection of in-service M/R blades. Testing by Van Horn confirmed that the 90° plies fail in spanwise tension (normal to the fiber direction) at the inboard end of the weight receptacle near M/R blade station 186.0. Delamination then propagates outboard from M/R blade station 186.0 at the interface between the 0° and 90° plies. According to Van Horn, fatigue testing has shown that the delamination initiates almost immediately and progresses slowly in a stable, predictable manner. The delamination has been found to develop first on the lower surface and grow outboard from the inboard end of the weight receptacle and forward of the balance weight pocket. After approximately 4 to 6 inches growth of the delamination on the lower surface, a similar delamination becomes detectable on the M/R blade upper surface. Should the delaminations continue to grow to the point of static overload, the receptacle could depart the M/R blade. In the NPRM, the FAA proposed to require, at specified intervals, removing the affected M/R blade, drawing rectangular inspection areas “Zone 1” and “Zone 2” with a permanent marker, tap inspecting the inspection areas for delamination, marking and measuring the length of any delamination, and depending on the results, removing the M/R blade from service. The NPRM also proposed to require reporting certain information to Van Horn. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from one commenter, Van Horn. The following presents the comments received on the NPRM and the FAA's response to each comment.

Van Horn stated that the M/R blade stations indicated for inspections are incorrect in the proposed AD and requested the FAA revise the required actions to change the M/R blade stations for “Zone 1” and “Zone 2.” However, the measurements Van Horn included in the comment in the AD docket to correct the M/R blade stations for “Zone 1” and “Zone 2” were also incorrect. Van Horn then contacted the FAA to correct these measurements; a record of this ex parte contact is included in the AD docket. For information on locating the docket, see “Examining the AD Docket.” According to Van Horn's revised comments, “Zone 1” described in the NPRM as M/R blade stations 186.0 and 191.0, beginning 1.1 inches from the leading edge of the M/R blade to 4.9 inches from the leading edge of the M/R blade should be revised to M/R blade stations 185.75 and 192.75, or measured from the tip end of the M/R blade between 36.25 inches and 29.25 inches beginning 1.2 inches from the leading edge of the M/R blade to 5.0 inches from the leading edge of the M/R blade. “Zone 2” described in the NPRM as M/R blade stations 186.0 and 191.0 should be revised to M/R blade stations 185.9 and 192.9, or measured from the tip end of the M/R blade between 36.1 inches and 29.1 inches.

The FAA agrees and has revised this AD accordingly.

Van Horn proposed that Note 1 to paragraph (g)(2)(i) cite Van Horn Service Bulletin Notice No. 33000-4R4, dated March 31, 2022 (SB33000-4R4) rather than Van Horn Service Bulletin Notice No. 33000-4R3, dated November 8, 2021 (SB 33000-4R3).

The FAA partially agrees. The FAA appreciates that the latest revision of that service bulletin is SB33000-4R4; however, the portions of that service bulletin that are specified in the proposed AD are identical in SB33000-4R3 and SB33000-4R4. Accordingly, the FAA has made updates throughout the Required Actions paragraph to allow both SB33000-4R3 and SB33000-4R4 in this final rule.

Van Horn proposed edits in Note 1 to paragraph (g)(2)(i) to refer to the Van Horn Instructions for Continued Airworthiness, ICA Manual No. VMM-MR-206L-501, Revision N/C, dated May 24, 2018, for a blade configuration drawing.

The FAA disagrees because it does not provide information that could be helpful for operators to comply with this AD.

Van Horn also requested the FAA revise the list of tap hammers in paragraph (g)(2)(iii) of the proposed AD to add Van Horn Aviation Tap Hammer P/N VHACS0003 to the list of tap hammers.

The FAA agrees and has revised this AD as requested.

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 SB 33000-4R3 and SB 33000-4R4. This service information specifies procedures to identify “Zone 1” and “Zone 2” inspection areas, accomplish repetitive visual and tap inspections of the zones to detect and monitor the growth of any delamination, and depending on the results, remove the M/R blade from service and contact Van Horn. SB 33000-4R3 applies to M/R blade P/N 20633000-101 serial numbers A012 through A104. SB 33000-4R4 expanded the applicability to include M/R blade P/N 20633000-101 with serial numbers A007, A008, and A009; these serial-numbered parts were included in the NPRM's applicability.

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.

This AD requires using certain part-numbered composite tap hammers, whereas SB 33000-4R3 and SB 33000-4R4 do not. SB 33000-4R3 and SB 33000-4R4 specify procedures to visually inspect the M/R blade, whereas this AD does not. If there is any delamination in the upper surface inspection zone (“Zone 1”), this AD requires removing the M/R blade from service, whereas SB 33000-4R3 and SB 33000-4R4 do not specify procedures for this condition.

The FAA considers this AD to be an interim action. The inspection reports that are required by this AD will enable the FAA to obtain better insight into the unsafe condition. If final action is later identified, the FAA might consider further rulemaking.

The FAA estimates that this AD will affect 23 helicopters of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Removing, tap inspecting, and re-installing an M/R blade will take about 4.5 work-hours for an estimated cost of $383 per M/R blade, per inspection cycle and up to $8,809 for the U.S. fleet per M/R blade, per inspection cycle. Replacing an M/R blade will take about 4 work-hours and parts will cost about $71,500 per M/R blade for a total of $71,840 per M/R blade. Reporting information to Van Horn will take about 1 work-hour for an estimated cost of $85 per report.

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

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

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

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

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

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

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would modify the Class E airspace at Colorado Plains Regional Airport, CO, to support IFR operations at the airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for FAA-2022-0711 (87 FR 45723; July 29, 2022) to modify the Class E airspace designated as a surface area, modify the Class E airspace extending upward from 700 feet above the surface, remove the Class E airspace extending upward from 1,200 feet above the surface, and make administrative changes to the Class E legal descriptions. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to publication of the NPRM in the Federal Register , the FAA identified a discrepancy with the proposed Class E2 legal description. The airport name is removed from the description, as it is in the second line of the header and duplication is not necessary.

This document amends FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the “ ADDRESSES ” section of this document. FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending 14 CFR part 71 by modifying the Class E airspace designated as a surface area, modifying the Class E airspace extending upward from 700 feet above the surface, and removing the Class E airspace extending upward from 1,200 feet above the surface at Colorado Plains Regional Airport, CO.

The Class E airspace designated as a surface area is expanded to a 4.6-mile radius around the airport to more appropriately contain circling maneuvers.

Additionally, the Class E airspace extending upward from 700 feet above the surface is expanded to the southeast to contain aircraft conducting procedure turns for the VOR RWY 29 approach, as terrain exists within 1,500 feet of the minimum procedure turn altitude.

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

Finally, this action makes several administrative modifications to the airport's legal descriptions. The airport name in the text header was incorrect in the existing Class E2 and E5 legal descriptions. They now read “Colorado Plains Regional Airport, CO.” The geographic coordinates for the airport are updated to match the FAA's database. Lastly, the navigational aid (NAVAID) used in the existing Class E2 legal description is removed. The NAVAID has been reclassified and is not needed to describe the airspace. Its removal simplifies the airspace description.

Class E2 and E5 airspace designations are published in paragraphs 6002 and 6005, respectively, of FAA Order JO 7400.11G, dated August 19, 2022, and became effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

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

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

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

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

On April 18, 2019, at 84 FR 16205, the Federal Mediation and Conciliation Service (FMCS) published a final rule amending the “Appendix to Part 1404—Arbitration Policy; Schedule of Fees,” which implemented a modest increase in user fees that had remained unchanged for more than eight years. FMCS increased fees to more accurately reflect FMCS' costs of maintaining the Arbitration Roster and the technology to support it, as well as responding to requests for arbitrator panels and biographical data.

After consideration and review, FMCS has concluded that the rule addressing fees is duplicative and currently incorporated in subparts of the rule. Therefore, FMCS is issuing this final rule, which rescinds the rule on the Appendix to Part 1404—Arbitration Policy; Schedule of Fees.

FMCS has determined that this rule is suitable for final rulemaking. The revisions to FMCS' policies and requirements surrounding arbitrators are purely internal matters of agency management, as well as the agency's procedure, and practice. Accordingly, FMCS is not required to engage in a notice and comment process to issue this rule under the Administrative Procedures Act, See U.S.C. 553(a)(2), 553(b)(A). Furthermore, because this rule is procedural rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule not be effective until at least 30 days after publication in the Federal Register is inapplicable. FMCS also finds good cause to provide an immediate effective date for this rule because it imposes no obligations on parties outside the federal government and therefore no advance notice is required to enable employers or other private parties to come into compliance.

For the reasons discussed in the preamble, and under the authority of 29 U.S.C. 172 and the Taft-Hartley Act of 1947, FMCS amends 29 CFR part 1404 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 because it is impracticable to publish a Notice of Proposed Rulemaking because the Coast Guard must establish this safety zone by November 9, 2022, and lacks sufficient time to provide a reasonable comment period and to 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 impracticable because immediate action is needed to protect personnel, vessels, and the marine environment from the potential safety hazards created by the demolition of the railroad bridge.

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 Port Arthur (COTP) has determined that potential hazards associated with demolition of the railroad bridge that crosses Brakes Bayou will be a safety concern for anyone within 200-feet of bridge located in approximate position 30°05′22.3″ N 094°05′53.5″ W (NAD83). For this reason, this rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the bridge is being demolished.

This rule establishes a safety zone from November 9, 2022 through December 9, 2022. The safety zone will cover all navigable waters within 200-feet of vessels and machinery being used by personnel to demolish the railroad bridge that crossed Brakes Bayou in Beaumont, TX. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the bridge is being demolished. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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 limited size and location of the safety zone. This safety zone will impact a small bayou tributary to the Neches River in Beaumont, TX. The bayou above the railroad bridge is approximately 2.2 NM, possess no residences, boat houses or public boat ramps and no commercial docks.

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 safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves safety zone lasting 30 days that will prohibit entry within 200-feet the abandoned railroad bridge that crossed Brakes Bayou in approximate position 30°05′22.3″ N 094°05′53.5″ W (NAD83) during demolition operations. It is categorically excluded from further review under paragraph L60(d) of 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. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

At its November 9, 2022 meeting, the Access Board approved a number of changes to its bylaws, published at 36 CFR 1151. Specifically:

• A new section (to be codified at 36 CFR 1151.3) sets out requirements for Board membership, consistent with section 502 of the Rehabilitation Act (29 U.S.C. 792), and prescribes rules for the designation in writing of federal members and federal liaisons to the Board. Federal members are heads of agencies listed in paragraph (b) of § 1151.3, or their designees, who must be at Level IV of the Executive Schedule or higher. Federal members may include individuals serving in positions on a temporary or acting basis, in accordance with federal law and with agency rules, policies, and practices (paragraph (c)(2)). Federal members and federal liaisons to the Board must be designated in writing (paragraphs (c)(1) and (3)), (which may include designation by electronic mail from a verifiable account), by someone who has authority to make the designation (paragraph (c)(4)). Written designations for members may identify the particular position within the agency, an individual, or both. Previously, the Board bylaws had no requirements concerning designation in writing of federal members or liaisons.

• The language in what was, prior to amendment of the bylaws, § 1151.3(a) (concerning officers), which says that the Board is the governing body of the agency, is now the first sentence in § 1151.2. Additionally, former paragraph (b) (Chair and Vice Chair) and former paragraph (c) (Elections), have been combined and redesignated as paragraphs (a)(1) and (2), former paragraph (d) (Executive Director) is now paragraph (b), and former paragraph (e) (General Counsel) is now paragraph (c).

• Section 1151.5 (previously § 1151.4), entitled “Delegations,” has been revised slightly. The title of paragraph (a) is now “Delegations to the Executive Committee,” since that is more consistent with the overall title of the section and better describes the contents of the paragraph, which describe delegations to, not by, the Executive Committee. A cross-reference to § 1151.7(a), which establishes the Executive Committee is also provided here, since this is the first reference to the Executive Committee in the bylaws.

• Section 1151.6 (previously § 1151.5) makes several changes with respect to Board meetings.

○ Paragraph (a) reduces the number of meetings from six annually to four. One of the meetings may be a public event outside of the Washington, DC area. Such a public event is not, as it previously had been, required each year, but may instead be a regular meeting of the Board.

○ Paragraph (b) says that meetings ordinarily will occur in January, April, July, and October, but does not specify a particular day or week during each month that the meeting must occur. Previously, the bylaws said that regular meetings of the Board would occur on the Wednesday following the second Tuesday of the month. The Chair may reschedule a meeting to the month before or after the month specified in the bylaws.

○ Paragraph (c) which is new, specifies that two meetings will be in-person, with an option for participation remotely, and two meetings may be entirely remote. This paragraph also states that the Board will comply with all applicable laws in the manner in which it conducts meetings, including the obligation to provide reasonable accommodations for Board members, employees, members of the public, and other participants (who might include, for example, individuals making presentations to the Board or a committee). Because of the addition of this paragraph, the lettering of subsequent paragraphs has been adjusted.

○ Paragraph (d) alters the requirement, in former paragraph (c), that the Chair establish the agenda for Board meetings to say that the Chair may consult with the Executive Director as necessary and appropriate. This merely clarifies existing practice.

○ Paragraph (e) provides for notice to the Board and to the public of the dates for each year's Board meetings at least 30 days prior to the January meeting. Notice may be provided on the Access Board's website and/or through any other means by which the public is likely to access it. Notice to members of the public will include language indicating that reasonable accommodation will be provided to enable participation in the meeting by individuals with disabilities, absent undue burden. Although the Board has historically provided reasonable accommodations for Board members, staff, and members of the public, inclusion of this language in the notice promotes the broadest level of participation possible by informing individuals with disabilities who may not be aware of the right to reasonable accommodation, and is consistent with the Board's mission of promoting accessibility and inclusion for people with disabilities.

○ Paragraph (f) says that the Chair will give notice of a meeting's cancelation at least 10 days prior to the meeting where practical, and if the meeting is a public meeting, will give notice to the public of the cancelation at the same time.

○ Paragraph (g) requires reasonable advance notice of a special meeting, as well as the time place and purpose of the meeting. This is consistent with the current bylaws. However, anticipating the possibility that a special meeting could be a public meeting, the amendment provides for notice to the public of the meeting, including language indicating that the Board will provide reasonable accommodation to enable participation, absent undue burden.

○ Paragraph (k)(5) provides five business days for a notational vote. The Chair has discretion to extend the period of time if, at the end of the voting period, there are an insufficient number of votes for the Board to take action. An amendment specifying that notational voting may occur through electronic mail reflects current practice. The bylaws previously provided for notational voting for actions taken between meetings of the Board, but did not describe the manner or form in which it would occur.

○ Paragraph (l), which says that Board members shall be considered present at any meeting in which they participate by teleconference or other equipment that allows all participants to communicate with each other is unchanged from former paragraph (k). Its labeling simply changed when a new paragraph (c) was inserted.

Section 1151.7 (previously 1151.6) makes some changes to requirements related to committees.

○ Paragraph (a)(1) has been revised to make certain duties of the Executive Committee discretionary rather than mandatory. For example, the Executive Committee now may, but is not required to, review and recommend changes to the bylaws prior to submission of proposed amendments to the Board.

○ Paragraph (b)(2) has been revised to require the Board to vote only for the Chair of a subject matter committee. Previously, paragraph (b)(2) said that the Board elects both the Chair and Vice Chair of a subject matter committee; however, this contradicted the language in paragraph (b)(3) immediately following, which said that the Chair of the Board appoints members of standing committees other than the Chair, who is elected by the Board. The revised bylaws resolve the contradiction in favor of the Board voting on the Chair only, since this would simplify the voting process and have no impact on the operation of committees.

○ Paragraph (b)(3) reduces the number of members on a subject matter committee from seven to nine to five to seven). Currently, the Board has four subject matter committees and three special committees, as well as an Executive Committee. The amendment to the bylaws reducing the number of committee members will actually facilitate committee work while limiting the number of committees to which specific Board members need to be assigned.

This final rule implements amendments to the Access Board's bylaws and solely addresses internal matters related to agency management and practices. As such, this rule is exempt from the notice-and-comment process pursuant to the Administrative Procedures Act. See 5 U.S.C. 553(a)(2), 553(b)(3)(A).

This final rule establishes internal rules of agency procedure only. OMB has determined that the rule is not a significant regulatory action within the meaning of Executive Order 12866.

This final rule is not a major rule within the meaning of the Congressional Review Act. See 5 U.S.C. 801 et seq.

The Regulatory Flexibility Act (RFA) requires Federal agencies to analyze regulatory options that may assist in minimizing any significant impact of a rule on small businesses and small governmental jurisdictions. See 5 U.S.C. 604, 605(b). Because this final rule relates solely to agency internal procedures and, moreover, is not subject to notice-and-comment rulemaking, the RFA is inapplicable.

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

This final rule does not specify any new collections of information or recordkeeping requirements that require OMB approval under the Paperwork Reduction Act. See 44 U.S.C. 3501 et seq.

The Unfunded Mandates Reform Act of 1995 (codified at 2 U.S.C. 1531 et seq. ) (“UMRA”) generally requires that Federal agencies assess the effects of their discretionary regulatory actions that may result in the expenditure of $100 million (adjusted for inflation) or more in any one year by the private sector, or by State, local, and tribal governments in the aggregate. Because this final rule is not subject to notice-and-comment rulemaking, UMRA's analytical requirements do not apply. See 2 U.S.C. 1532(a).

For the reasons set forth in the preamble, the Access Board amends 36 CFR part 1151 as follows:

This final rule describes new prices and product features for competitive products, by class of mail, established by the Governors of the United States Postal Service®. New prices are available under Docket Number CP2023-42 on the Postal Regulatory Commission PRC website at http://www.prc.gov, and on the Postal Explorer® website at http://pe.usps.com.

The Postal Service will revise Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), to reflect changes to prices and mailing standards for the following competitive products:

• Priority Mail Express®.

• Priority Mail®.

• First-Class Package Service®.

• Parcel Select®.

• USPS Retail Ground®.

• Extra Services.

• Return Services.

• Mailer Services.

• Recipient Services.

• Other.

Competitive product prices and changes are identified by product as follows:

Overall, Priority Mail Express prices will increase 6.6 percent. Priority Mail Express will continue to offer zoned and Flat Rate, Retail and Commercial pricing.

Retail prices will increase an average of 6.7 percent. The Flat Rate Envelope price will increase to $28.75, the Legal Flat Rate Envelope will increase to $28.95, and the Padded Flat Rate Envelope will increase to $29.45.

Commercial prices will increase an average of 6.0 percent.

The Postal Service is consolidating Priority Mail Express “Commercial Base” and “Commercial Plus” into one “Commercial” price category. Consolidating the “Commercial Base” and “Commercial Plus” price categories will simplify the Priority Mail Express pricing structure. The eligibility standards for Priority Mail Express Commercial will mirror the current “Commercial Base” price category.

Overall, Priority Mail prices will increase 5.5 percent. Priority Mail will continue to offer zoned and Flat Rate, Retail and Commercial pricing.

Retail prices will increase an average of 6.8 percent. The Flat Rate Envelope price will increase to $9.65, the Legal Flat Rate Envelope will increase to $9.95, and the Padded Flat Rate Envelope will increase to $10.40. The Small Flat Rate Box price will increase to $10.20, and the Medium Flat Rate Boxes will increase to $17.10. The Large Flat Rate Box will increase to $22.80 and the APO/FPO/DPO Large Flat Rate Box will increase to $21.20.

Commercial prices will increase an average of 3.6 percent.

The Postal Service is consolidating the Priority Mail “Commercial Base” and “Commercial Plus” price categories into one “Commercial price category. Consolidating the “Commercial Base” and “Commercial Plus” price categories will simplify the Priority Mail pricing structure. The eligibility standards for Priority Mail Commercial will mirror the current “Commercial Base” price category.

The Postal Service is discontinuing the Priority Mail Regional Rate product offering. The decision to discontinue Regional Rate Boxes will simplify the Priority Mail offering.

Overall, First-Class Package Service prices will increase 7.8 percent.

First-Class Package Service—Retail prices will increase 6.9 percent.

First-Class Package Service—Commercial prices will increase 8.0 percent.

The prices for Parcel Select Destination Entry will increase an average of 5.1 percent. Parcel Select Ground will have a 0.0 percent price change, but prices will be updated in zones 1 and 2. The prices for Parcel Select Lightweight® will increase an average of 6.1 percent. The prices for USPS Connect® Local will remain the same.

Overall, USPS Retail Ground prices will increase an average of 6.4 percent.

Adult Signature Required and Adult Signature Restricted Delivery service prices are increasing 6.5 and 6.8 percent respectively. The price for Adult Signature Required will increase to $9.05 and Adult Signature Restricted Delivery will increase to $9.35.

The Postal Service is revising the standards for Parcel Return Service (PRS) to be a competitive product only available through a Negotiated Service Agreement (NSA). As a nonpublished offering, the standards will be removed from the DMM and the prices will be removed from the Price List, Notice 123.

The Postal Service is discontinuing the Certificate of Mailing and Signature Confirmation extra service options for USPS Returns products.

In an effort to provide product simplification, the Postal Service believes it is in the best interest to no longer offer Certificate of Mailing or Signature Confirmation services for USPS Returns products.

The Pickup on Demand® service fee will increase 6.0 percent to $26.50.

The USPS Premium Tracking Service TM prices will remain the same.

The Postal Service is implementing USPS Label Delivery Service TM to provide customers with an option to have their domestic outbound and return mailing labels printed and delivered for a fee per label at a Post Office where available. USPS Label Delivery Service is not available for APO/FPO/DPO addresses. Customers requesting USPS Label Delivery Service will be provided the tracking information for tracking purposes. A customer may request USPS Label Delivery Service at www.usps.com.

USPS Label Delivery Service is available for Retail and Commercial Priority Mail Express and Priority Mail, First-Class Package Service—Retail, First Class Package Service—Commercial, USPS Retail Ground, Parcel Select Ground, Priority Mail Return service, and First-Class Package Return service.

There are no extra services available with labels requested through USPS Label Delivery Service.

For USPS Label Delivery Service, the Postal Service will refund the postage and USPS Label Delivery Service fee if the label is not delivered. The Postal Service will refund the postage only if the label is delivered and not used.

The competitive Post Office Box TM service prices will increase an average of 6.5 percent within the updated price ranges.

Premium Forwarding Service® (PFS®) prices will increase between 6.5 and 6.6 percent depending on the specific price element. The enrollment fee paid at the retail counter for PFS-Residential will increase to $25.45 and the PFS-Residential, PFS-Commercial, and PFS-Local enrollment fee paid online will increase to $23.40 per application. The price of the weekly shipment charge for PFS-Residential and per container charge for PFS-Local will increase to $25.45.

The USPS Package Intercept® fee will increase 6.6 percent to $17.00.

Address Enhancement Service competitive product prices will remain the same.

The small parcel forwarding fee will remain the same at $5.25.

The Postal Service is modifying zone price categories for all applicable Competitive products. This zone modification will redefine the local zone and remove it as a zone price category. The Postal Service will also split zones 1 and 2 into separate price categories. This will result in nine individual zone price categories.

Additionally, the Postal Service is clarifying that the zone 1 price applies to pieces mailed within the same 3 Digit O/D Pairs and pieces mailed with different 3 Digit O/D Pairs whose centroids are up to 50 miles in distance.

The Postal Service provides additional resources to assist customers with this price change for competitive products. These tools include price lists, downloadable price files, and Federal Register Notices, which may be found on the Postal Explorer® website at http://pe.usps.com.

We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

Accordingly, 39 CFR part 111 is amended as follows:

We find that this constitutes good cause under 5 U.S.C. 553(b)(B).

In FR doc. 2018-21150 appearing on page 49297 at 83 FR 49297 in the Federal Register of October 1, 2018, the following correction to the regulatory text is made:

On June 7, 2022, EPA proposed to approve MDEQ's November 17, 2016, SIP revision. See 87 FR 34609. In that notice of proposed rulemaking (NPRM), EPA also proposed to determine that the SIP revision corrects the deficiency with respect to Mississippi that the Agency identified in the June 12, 2015, action titled “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction” (“2015 SSM SIP Action”). See 80 FR 33839 (June 12, 2015). The reasons for the proposed approval and determination are stated in the proposed action (87 FR 34609, June 7, 2022) and will not be restated here. The public comment period for EPA's proposed approval and determination ended on July 7, 2022. EPA received one set of comments in a joint letter submitted by the Sierra Club and the Environmental Integrity Project (hereinafter collectively referred to as the commenter) on this date. The comments are available in the docket for this action.

EPA will not address the comments that express support for the proposed action. Instead, this section of the rulemaking will focus on the portions of the July 7, 2022, letter which did not support the proposed action or which called on EPA to provide advice to the State.

Comment 1: The commenter asserts that Rule 1.10.B(1) is not fully approvable as included in the November 17, 2016, submittal. Specifically, the commenter states that as a standalone provision, paragraph B(1) could be read to impermissibly exempt sources from otherwise applicable SIP emission limits. Paragraph B(1) states, “Startups and shutdowns are part of normal source operation. Emission limitations apply during startups and shutdowns unless source-specific emission limitations or work practice standards for startups and shutdowns are defined by an applicable rule, regulation, or permit.” The commenter goes on to note EPA's past comments on the proposed changes to Rule 1.10.B in 2016 during prehearing review, which stated that EPA was “concerned that this provision appears to provide that an `applicable rule, regulation, or permit' that is not approved into the SIP might contain limitations that apply during startups and shutdowns in lieu of an applicable SIP limit” (emphasis in original).

The commenter points to EPA's analysis in the June 7, 2022, NPRM which states that Rule 1.10.B(1) and B(2) “taken together” sufficiently address the finding of substantial inadequacy in the final 2015 SSM SIP Action, and argues that to ensure Rule 1.10.B(1) is administered correctly, EPA should conditionally approve the SIP revision pursuant to Clean Air Act (CAA) section 110(k)(4), requiring Mississippi to submit, within one year of the effective date of the final conditional approval, a corrective SIP revision. According to the commenter, the corrective revision should either remove Rule 1.10.B(1) or replace the phrase “defined by an applicable rule, regulation, or permit” with “defined by an applicable SIP provision or permit as provided in section 1.10.B(2)(d) below.”

Response 1: EPA disagrees that Rule 1.10.B(1) is not approvable as transmitted in the November 17, 2016, SIP submittal. As MDEQ notes in its SIP revision responding to EPA's September 16, 2016, comment letter, the regulatory language must be read in conjunction with other air program regulations. 1 Specifically, the language at Rule 1.10.B(1) correctly acknowledges that “source specific emission limitations or work practice standards for startups and shutdowns” may be established in applicable rules, regulations, or permits. First, MDEQ has the ability to establish emission limitations via new or revised regulatory requirements at 11 MAC, Part 2, Chapter 1, Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants, or Chapter 11, Regulations for Ambient Air Quality Nonattainment Areas, where MDEQ could consider whether any specific alternative emission limitations (AELs) would be justifiable for startups and/or shutdowns.

Next, MDEQ has the ability to establish emission limits in permits pursuant to its program at 11 MAC, Part 2, Chapter 2, Permit Regulations for the Construction and/or Operation of Air Emissions Equipment, where MDEQ could consider establishing specific AELs for startups and/or shutdowns. Pursuant to Rule 1.10.B(2), alternatives to existing SIP emission limits in any such permits are not effective until MDEQ adopts the alternatives into Rule 1.10.B, MDEQ submits them to EPA for approval and inclusion in the SIP, and EPA approves them into the SIP.

Other possible sources of an “applicable rule [or] regulation” are the New Source Performance Standards (NSPS) at 40 CFR part 60 and the National Emissions Standards for Hazardous Air Pollutants (NESHAP) at 40 CFR part 63, 2 which MDEQ incorporates by reference at 11 MAC, Part 2, Chapter 1, Rule 1.6, New Sources, at 1.6.C and Rule 1.8, Provisions for Hazardous Air Pollutants, at 1.8.A, respectively. Several of the NSPS and NESHAP include AELs that “impose different numerical levels during different modes of source operation or impose emission limitations that are composed of a combination of a numerical limitation during some modes of operation and a specific technological control requirement or work practice requirement during other modes of operation” such as startup and shutdown. See 80 FR 33839, 33889 (June 12, 2015). Rule 1.10.B(1) accurately acknowledges that as to applicable emission limits in general, the limits will apply during startup and shutdown periods unless some applicable rule, regulation or permit specifies different requirements for those periods. EPA interprets this to mean that those other limits cannot replace or relax the SIP emission limit without EPA approval via a SIP revision that meets CAA requirements.

Our interpretation stems from MDEQ's assertion in its SIP revision that the ability to establish AELs during startups and shutdowns does not mean that alternatives to any SIP emission limits can be established via the rules, regulations, or permit requirements without a SIP revision. In response to EPA's comment letter, MDEQ revised its Rule 1.10.B(2) to provide greater clarity that any specific AELs established by rules, regulations, or permits not yet incorporated into the SIP and applicable to startups and/or shutdowns would not replace any existing SIP emission limit for those periods of operation unless and until the AELs were approved into the SIP. Specifically, Rule 1.10.B(2)(d) provides, “Following permit issuance, the emission limitations or work practice standards are considered State-only requirements until they have been adopted into [Rule 1.10] and approved by the EPA into the SIP.” In this way, Rule 1.10.B(2) operates in conjunction with B(1) to explain what must happen in the context of providing alternatives to existing SIP emission limits.

Comment 2: Among factors MDEQ will consider in possibly establishing AELs for periods of startups and/or shutdowns, Rule 1.10.B(2)(a) provides, “The source must demonstrate that it is technically infeasible, considering its specific control strategy, to comply with existing SIP emission limitations during startups and shutdowns.” The commenter argues that the phrase “considering its specific control strategy” creates an “illogical loophole that would allow sources with pollution controls that are outdated, undersized, not well maintained, not operated properly, or otherwise inadequate to claim technical infeasibility based on their controls, even though those sources, if properly designed, operated, and/or maintained, could comply with applicable SIP emission limits.”

The commenter points to EPA's statement in the 2015 SSM SIP Action that “alternative requirements applicable to the source during startup and shutdown should . . . take into account considerations such as . . . the control technology that is feasible during startup and shutdown.” See 80 FR 33839, 33980 (June 12, 2015). The commenter states that EPA should conditionally approve the SIP revision pursuant to CAA section 110(k)(4), requiring Mississippi to submit, within one year of the effective date of the final conditional approval, a corrective SIP submission to remove the phrase “considering its specific control strategy.”

Response 2: EPA disagrees that Rule 1.10.B(2)(a) is not approvable as transmitted in the November 17, 2016, SIP submittal. Consideration of a specific control strategy is consistent with EPA guidance in the 2015 SSM SIP Action. Mississippi's SIP requires that any potential AELs “be narrowly tailored and take into account considerations such as the technological limitations of the specific source category and the control technology that is feasible during startup and shutdown” as recommended by EPA. See 80 FR 33839, 33980. EPA's restatement of the 1999 SSM Guidance in the 2015 SSM SIP Action includes the following two (of seven total) criteria recommended for developing a SIP revision with potential AELs: “(1) The revision is limited to specific, narrowly defined source categories using specific control strategies ( e.g., cogeneration facilities burning natural gas and using selective catalytic reduction); (2) Use of the control strategy for this source category is technically infeasible during startup or shutdown periods.” Id. Mississippi Rule 1.10.B(2) is consistent with these criteria, requiring at B(2)(c) that the AELs must be specific to the source and its particular control strategy, which EPA interprets as the control strategy that corresponds to the relevant narrowly defined source category ( e.g., cogeneration facilities burning natural gas and using selective catalytic reduction), and requiring at B(2)(a) a demonstration that the control strategy is technically infeasible during startup and shutdown periods.

Additionally, EPA does not agree that the language at Rule 1.10.B(2)(a), or EPA's language in the 2015 SSM Action or the 1999 SSM Guidance, would necessarily limit such a demonstration to considering existing controls only. Rule 1.10.B(2)(a) makes no reference to actual installed equipment. This rule requires the source to demonstrate that its strategy for emissions control is not capable of achieving compliance during startup and shutdown, and such demonstration should be made based on an assumption of properly designed and maintained equipment as well as the control strategy's suitability for the narrowly defined source category.

Moreover, EPA and the public will have an opportunity to evaluate any specific AELs, as they will be submitted as source-specific SIP revisions to act as alternatives to SIP emission limits. The record supporting any such AELs would show how the criteria at Rule 1.10.B(2) were satisfied.

Comment 3: The commenter states that EPA should clarify in its rulemaking record that “even for those sources (if any) that truly cannot meet normal limits during startup and shutdown, Rule 1.10.B(2) should in most cases establish alternative numerical limits, rather than allow for work practices.” The commenter references the 2015 SSM Action, 80 FR 33839, 33980, where EPA states: “In cases in which measurement of emissions during startup and/or shutdown is not reasonably feasible, it may be appropriate for an emission limitation to include as a component a control for startup and/or shutdown periods other than a numerically expressed emission limitation.” The commenter asserts that under EPA's guidance, work practice standards are only appropriate during those periods where emissions cannot be measured. The commenter also states that EPA's approval should include the guidance that numerical limits are preferable to work practice standards because they are the “most legally and practicably enforceable SIP requirements,” and cites to the 2015 SSM SIP Action, 80 FR 33839, 33974-75. The commenter goes on to state that for situations in which a work practice is appropriate, EPA should advise that pollution control equipment should be operated while fuel-burning equipment are burning primary fuels or when power plants are generating electricity, and that the SIP should require clean fuels to be burned until the point at which the pollution controls are engaged.

Response 3: EPA does not believe clarification is necessary regarding a preference for numerical emission limits versus work practice standards. In this action, EPA is evaluating the November 17, 2016, SIP revision in light of the 2015 SSM SIP Action. Rule 1.10.B(2) states that, where a source is unable to comply with an existing SIP emission limit, MDEQ will consider establishing “source specific emission limitations or work practice standards for startups and shutdowns” as alternatives to those SIP limits. As outlined in the June 7, 2022, NPRM, Rule 1.10.B(2) goes on to specify criteria that EPA believes to be appropriate in considering establishing either a numerical emission limit or a work practice standard to apply as an AEL. Provisions 1.10.B(2)(a)-(d) are consistent with the guidance criteria EPA has established for setting AELs, as discussed in the same section of the 2015 SSM SIP Action cited by the commenter. 3 4

As EPA notes in the 2015 SSM SIP Action, SIP emission limitations “(i) do not need to be numerical in format; (ii) do not have to apply the same limitation ( e.g., numerical level) at all times; and (iii) may be composed of a combination of numerical limitations, specific technological control requirements and/or work practice requirements, with each component of the emission limitation applicable during a defined mode of source operation.” See 80 FR 33839, 33889. Therefore, if MDEQ establishes AELs comprised of work practice standards in some part, pursuant to Rule 1.10.B(2), the emission limit overall “must be continuous, must meet applicable CAA stringency requirements, and must be legally and practically enforceable.” Id. Moreover, EPA and the public will have an opportunity to evaluate any specific AELs, as they will be submitted as source-specific SIP revisions to act as alternatives to SIP emission limits. At that time, EPA can evaluate the AELs in consideration of the criteria established in the SIP and the guidance referenced above.

Next, in the 2015 SSM SIP Action, EPA noted that “there may be sources for which a numerically expressed emission limitation is the most legally and practically enforceable,” (emphasis added) and that “there are many sources for which a numerically expressed emission limitation will be the most appropriate and will result in the most legally and practically enforceable SIP requirements. However, . . . for some source categories, under some circumstances, it may be appropriate for the SIP emission limitation to include a specific technological control requirement or specific work practice requirement that applies during specified modes of source operation such as startup and shutdown.” See id. at 33974-75. Therefore, EPA disagrees that the approval of the November 17, 2016, SIP revision must include any additional guidance regarding a preference for numerical emission limits versus work practice standards.

Additionally, EPA does not agree with the commenter's conclusion that the 2015 SSM SIP Action and EPA guidance would only find work practice standards appropriate when emissions measurements cannot be made during startup and/or shutdown. While the language referenced by the commenter suggests that work practice standards may be appropriate in cases in which measurement of emissions during startup or shutdown is not reasonably feasible, EPA does not assert that this is the only circumstance in which work practice standards may be utilized as part of a continuous emission limitation. Thus, EPA believes that a work practice standard could be a sufficient AEL in various other circumstances. The 2015 SSM SIP Action notes, for example, regarding sources of sulfur dioxide (SO 2 ), “if the otherwise applicable numerical SO 2 emission limitation in the SIP is not achievable, and the otherwise required SO 2 control measure is not effective during startup and shutdown and/or measurement of emissions during startup and shutdown is not reasonably feasible, then it may be appropriate for that emission limitation to impose a different control measure, such as use of low sulfur coal, applicable during defined periods of startup and shutdown in lieu of a numerically expressed emission limitation.” See 80 FR 33839, 33975.

The 2015 SSM SIP Action goes on to discuss instances of where the Agency has established work practice standards as components of emission limits that are consistent with the definition of “emission limitation” or “emission standard” at CAA section 302(k), such as 40 CFR part 63, subpart UUUUU, National Emission Standards for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating Units, and 40 CFR part 60, subpart Da, Standards of Performance for Electric Utility Steam Generating Units. See id. at 33891. These examples are rules which require use of continuous emission monitoring systems, so measurement during periods of startup and/or shutdown would not necessarily be infeasible, and yet EPA chose to establish work practice standards as components of the emission limits applicable to these sources. For the reasons stated above, EPA believes that Mississippi's November 17, 2016, SIP revision adequately addresses situations for which AELs may need to be established and appropriately notes that the AELs can take the form of a numerical emission limit or some work practice standard.

Finally, regarding potential work practice standards for fuel-burning equipment, EPA does not find it appropriate to speculate on any specific work practice requirements in absence of specific information on the source or source category. However, EPA notes that the Agency indicated regulations and technical materials supporting the NSPS and NESHAP could be helpful in developing emission limits or AELs and that definitions of startup and shutdown and work practices for those periods could be appropriate for incorporation into a SIP. See 80 FR 33839, 33980. Several of the suggestions for fuel-burning equipment made by the commenter are included in the NSPS and NESHAP, indicating that these could be appropriate components of work practice standards. 5 So, although some of the suggestions made by the commenter could be reasonable depending on the specific circumstances, they are not relevant to this action; EPA will address the contents of any proposed work practice standards in the source-specific SIP revisions that Mississippi submits to EPA for approval and incorporation into the SIP.

Comment 4: The commenter states that Rule 1.10.B(2)(c)(iv) requires sources “only to document startup and shutdown events in contemporaneous logs and does not require sources to report to the MDEQ any information to assure that sources are complying with the requirements of the rule.” The commenter asserts that, as written, any work practice standards would not be practically enforceable by MDEQ, EPA, or citizens, and therefore, would not comply with CAA section 110(a)(2)(A). The commenter goes on to recommend that EPA advise Mississippi that if work practices are selected for any sources, that MDEQ should “require the work-practice compliance information from the proposed rule to be reported by sources through, at the least, their quarterly Title V compliance reports.”  6

Response 4: EPA disagrees that it is necessary to advise Mississippi regarding the reporting of work practice compliance information. CAA section 110(a)(2)(C) provides that the SIP shall include a program to provide for the enforcement of the measures described in section 110(a)(2)(A), including a permit program to regulate the construction and modification of stationary sources. Therefore, the permitting process can establish the means by which an emission limitation is enforceable, including recordkeeping and reporting requirements, particularly in the case of source-specific emission limits submitted for inclusion in the SIP. Generally, Rule 1.10.B(2)(d) provides that any source-specific emission limitations or work practice standards intended as an alternative to existing SIP emission limits must be established in a permit issued pursuant to 11 MAC Part 2, Chapter 2, and then submitted to EPA for incorporation into the SIP. MDEQ's Rule 2.2, General Standards Applicable to All Permits, and Rule 2.9, Recordkeeping and Reporting, provide that the permit board in Mississippi has the authority to establish requirements for determining compliance with applicable requirements, including recordkeeping and reporting of necessary monitoring. EPA will review these permit conditions as part of any source-specific SIP revision and evaluate the adequacy of the AELs (including the practicable enforceability of any applicable work practice standards) pursuant to the CAA and EPA guidance.

Additionally, for any major sources, facilities will also be subject to semiannual reporting, which would outline any deviations from permit requirements, and annual certification, pursuant to EPA's title V regulations at 40 CFR part 70 and Mississippi's federally approved title V program at 11 MAC Part 2, Chapter 6, Air Emissions Operating Permit Regulations for Purposes of Title V of the Federal Clean Air Act. 7 These reporting requirements would include the information needed for determining compliance with any applicable source-specific work practices standards, including those that may be approved into the SIP. For example, 11 MAC Part 2, Chapter 2, Rule 6.3(C)(5) provides requirements for a “compliance certification with terms and conditions contained in the permit, including emission limitations, standards, or work practices,” consistent with 40 CFR 70.6(c)(5).

Furthermore, as stated in the NPRM, EPA considers the requirements of Rule 1.10.B(2) to be consistent with the seven criteria EPA has recommended for the development of AELs and that this provision is sufficient to guide the development of specific AELs. In the 2015 SSM SIP Action, EPA recommended that “to be approvable ( i.e., meet CAA requirements)” an AEL should be developed with seven specific criteria, including that it “requires that the owner or operator's actions during startup and shutdown periods are documented by properly signed, contemporaneous operating logs or other relevant evidence.”  8 Mississippi's Rule 1.10.B(2)(c)(iv) fulfills that recommendation by providing that “the source must document all startups and shutdowns using properly signed contemporaneous logs or other relevant evidence.”

Comment 5: The commenter states that EPA should require Mississippi to more narrowly define “startup” and “shutdown” in Rule 1.2, Definitions. The commenter asserts that these definitions are vague and would allow for unlimited periods of startup or shutdown. As an example, the commenter claims that the term “operation,” as used in the definitions of these two terms, is ambiguous. The commenter states that the terms must be specific and narrowly tailored, citing to a section of EPA's 2015 SSM SIP Action that addresses the seven criteria EPA developed in the 1999 SSM Guidance and clarified in the 2015 SSM SIP Action, for approval of alternative emissions limits. The commenter then claims that it is preferable that “startup” be defined as beginning when primary fuel-burning sources start burning their primary fuel, and “shutdown” be defined as beginning when fuel-burning sources stop burning their primary fuel. The commenter closes by stating that CAA section 110(a)(2) would be violated if these definitions are not properly bounded.

Response 5: EPA disagrees that the Agency should require Mississippi to more narrowly define the terms “startup” and “shutdown” in its general definitions rule as part of this rulemaking. First, Rule 1.2, Definitions, is not part of the SIP call in EPA's 2015 SSM Action and is not part of the SIP revision before EPA for consideration in this rulemaking.

Second, Mississippi's definitions of startup and shutdown are consistent with the definitions used in the 2015 SSM SIP Action and are not inconsistent with 40 CFR part 51, which does not define these terms. 9 10 Mississippi's definitions and those used in the 2015 SSM SIP Action are designed to generally convey what these modes of operation consist of and when they begin. As noted in the 2015 SSM Action, it may be appropriate in individual SIP provisions to include a specifically tailored definition to address a particular source category for a particular purpose. However, EPA does not believe that Mississippi's definitions need to be further tailored because emission limits now apply during startup and shutdown periods, and sources must comply with those limits during startup and shutdown periods unless an AEL is approved. Presently, there are no specific AELs approved for periods of startup or shutdown in the SIP, and therefore, there are no current concerns about unlimited periods of startups or shutdowns.

Third, any future AELs will need to adequately define the modes of operation during which the AELs apply. The requirements of Rule 1.10.B(2) are consistent with the seven criteria EPA has recommended for the development of AELs—including the third criteria regarding minimizing the frequency and duration of startup and shutdown modes  11 —and this rule is sufficient to guide the development of specific AELs. Specifically, Rule 1.10.B(2)(c)(i) states: “the source must limit the frequency and duration of startups and shutdowns to the greatest extent practicable.” Thus, MDEQ will establish the necessary requirements specific to the source in the permit or rule, including the boundaries of the startup and shutdown periods during which the AELs will apply. Subsequently, those conditions will be reviewed by EPA and the public through EPA's proposed action to approve or disapprove the source-specific AELs replacing any applicable SIP emission limits for startups and/or shutdowns. EPA will review the contents of any source-specific SIP revision and evaluate the adequacy of the AELs (including the startup and shutdown parameters) pursuant to the CAA and EPA guidance.

Therefore, EPA disagrees that Mississippi must revise its current SIP-approved definitions of “startup” and “shutdown” included in Rule 1.2 and that these definitions are inconsistent with the CAA.

Comment 6: Regarding MDEQ's revised rules at Rule 1.10.B generally, the commenter states that “EPA should advise Mississippi that it should help provide clarity for the public and regulated entities by including notes or parenthetical information in its published regulations about which requirements are state-only and which are SIP-approved.”

Response 6: EPA notes that this action clearly delineates which portions of Rule 1.10 are not approved into the SIP, including notation at 40 CFR 52.1270(c), and will ultimately also be reflected in the compilation of approved Mississippi rules available at EPA's website. 12 Regarding any further notation that MDEQ may elect to include in the portions of the rules which are state-only, EPA has no authority to prescribe such alterations of the text. Therefore, this comment is outside the scope of this action.

EPA is approving Mississippi's November 17, 2016, SIP submission revising Rule 1.10.B, Startups and Shutdowns, and requesting removal of Rule 1.10.A, Upsets, Rule 1.10.B(3), and Rule 1.10.C, Maintenance, from the Mississippi SIP-approved version of Rule 1.10, Provisions for Upsets, Startups, and Shutdowns. EPA has also determined that this SIP revision corrects the deficiency identified in the 2015 SSM SIP Action. Mississippi is retaining Rules 1.10.A and Rule 1.10.B(3) for state law purposes only, with changes to clarify that the upset provisions of Rule 1.10.A apply to enforcement actions by the State (specifically, the Mississippi Commission on Environmental Quality) only and “are not intended to prohibit EPA or third-party enforcement actions.”  13 See 87 FR 34609.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, as discussed in Sections I and II of this preamble, EPA is finalizing the incorporation by reference of 11 Mississippi Administrative Code, Part 2, Chapter 1, Rule 1.10, Provisions for Upsets, Startups, and Shutdowns, state effective December 10, 2016, except for Rule 1.10.A and 1.10.B(3), which MDEQ is not requesting EPA to incorporate into the SIP. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 14

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 17, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

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

This final rule is organized as follows:

Entities that are subject to Clean Water Act (CWA) regulatory programs such as industrial facilities, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to surface waters of the United States under the State of Washington's jurisdiction could be affected by this rulemaking because the Federal water quality standards (WQS) promulgated by EPA are applicable WQS for surface waters in Washington for CWA purposes. Categories and entities that could potentially be affected by this rulemaking include the following:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could be indirectly affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

In developing this final rule, EPA carefully considered the public comments and feedback received from interested parties. EPA provided a 60-day public comment period after publishing the proposed rulemaking in the Federal Register on April 1, 2022. 1 In addition, EPA held two online public hearings on May 24 and 25, 2022, to discuss the contents of the proposed rulemaking and accept verbal public comments.

Over 20 organizations and individuals submitted comments on a range of issues. EPA also received over 300 letters from individuals associated with a mass letter writing campaign. Some comments addressed issues beyond the scope of the rulemaking, and thus EPA did not consider them in finalizing this rule. In this preamble, EPA provides summaries of certain comments received on aspects of the proposal that generated the most commenter interest. For a complete summary of all comments received and EPA's responses, see EPA's Response to Comments document in the official public docket.

CWA section 101(a)(2) establishes as a national goal “water quality which provides for the protection and propagation of fish, shellfish, and wildlife, and recreation in and on the water, wherever attainable.” EPA interprets these CWA section 101(a)(2) goals to include, at a minimum, designated uses providing for the protection of aquatic communities and human health related to consumption of fish and shellfish. 2

Consistent with the CWA, EPA's WQS program assigns to states and authorized tribes the primary authority for adopting WQS. 3 CWA section 303(c)(2)(A) and EPA's implementing regulations at 40 CFR part 131 require, among other things, that a state's WQS specify appropriate designated uses of the waters, and water quality criteria that protect those uses. EPA's regulations at 40 CFR 131.11(a)(1) provide that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use. For waters with multiple use designations, the criteria shall support the most sensitive designated use.”

Under CWA section 304(a), EPA periodically publishes criteria (including HHC) recommendations for states to consider when adopting water quality criteria for particular pollutants to protect CWA section 101(a) goal uses. Where EPA has published recommended criteria, states should establish numeric water quality criteria based on EPA's CWA section 304(a) criteria recommendations, CWA section 304(a) criteria recommendations modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)).

After a state adopts a new or revised WQS, the state must submit it to EPA for review and action in accordance with CWA section 303(c). 4 If EPA determines that a state's new or revised WQS is not consistent with the requirements of the Act, the state has 90 days to submit a modified standard. If the state fails to adopt a revised WQS that EPA approves, CWA section 303(c)(4)(A) requires EPA to propose and promulgate a revised or new standard for the waters involved. In addition, CWA section 303(c)(4)(B) grants the EPA Administrator discretion to determine “that a revised or new standard is necessary to meet the requirements of [the Act].”  5 After making such a determination, known as an Administrator's Determination, 6 the agency must “promptly” propose an appropriate WQS and finalize it within ninety days unless the state adopts an acceptable standard in the interim. 7

EPA's 2000 Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health   8 (2000 Methodology) describes the methods EPA uses when developing national CWA section 304(a) recommended HHC and when promulgating Federal HHC. The 2000 Methodology also serves as guidance to states and authorized tribes for developing their own HHC. EPA's guidance informs, but does not dictate, EPA's implementation of the applicable statutory and regulatory requirements noted above. EPA's 2000 Methodology recommends that HHC be designed to reduce the risk of adverse cancer and non-cancer effects occurring from lifetime exposure to pollutants through the ingestion of drinking water and consumption of fish/shellfish obtained from inland and nearshore waters. Consistent with the 2000 Methodology, EPA's practice is to establish a criterion for both drinking water ingestion and consumption of fish/shellfish from inland and nearshore waters combined and a separate criterion based on ingestion of fish/shellfish from inland and nearshore waters alone. This latter criterion applies in cases where the designated uses of a waterbody include supporting fish/shellfish for human consumption but not drinking water supply sources ( e.g., non-potable estuarine waters).

Consistent with EPA's 2000 Methodology, EPA establishes HHC based on two types of toxicological endpoints: (1) carcinogenicity; and (2) noncancer toxicity ( i.e., all adverse effects other than cancer). Where sufficient data are available, EPA derives criteria using both carcinogenic and non-carcinogenic toxicity endpoints and uses the lower ( i.e., more health-protective) value. EPA calculates HHC for carcinogenic effects using the following input parameters: cancer slope factor (CSF), cancer risk level (CRL), body weight, drinking water intake rate, fish consumption rate (FCR), and a bioaccumulation factor(s). EPA calculates HHC for both non-cancer and nonlinear carcinogenic effects using a reference dose (RfD) and relative source contribution (RSC) in place of a CSF and CRL (the remaining inputs are the same for both toxicology endpoints). The RSC is applied to apportion the RfD among the media and exposure routes of concern for a particular chemical to ensure that an individual's total exposure from all exposure sources does not exceed the RfD. Each of these inputs is discussed in more detail in sections II.B.a through II.B.d of this preamble and in EPA's 2000 Methodology. 9

Consistent with the 2000 Methodology, EPA generally assumes, in the absence of data to indicate otherwise, that carcinogens exhibit linear “non-threshold” dose-responses which means that there are no “safe” or “no-effect” levels. Therefore, EPA calculates HHC for carcinogenic effects as pollutant concentrations corresponding to lifetime increases in the risk of developing cancer. EPA calculates HHC values at a 10 −6 (one in one million) CRL and recommends that states and authorized tribes use CRLs of 10 −6 or 10 −5 (one in one hundred thousand) when deriving HHC for the general population. 10 EPA notes that states and authorized tribes can also choose a more health protective risk level, such as 10 −7 (one in ten million), when deriving HHC.

A dose-response assessment is required to understand the quantitative relationships between exposure to a pollutant and adverse health effects. EPA evaluates dose-response relationships based on the available data from animal toxicity and human epidemiological studies to derive dose-response metrics. For carcinogenic effects, EPA uses an oral CSF to derive the HHC. The oral CSF is an upper bound, approximating a 95 percent confidence limit, on the increased cancer risk from a lifetime oral exposure to a pollutant. For non-carcinogenic effects, EPA uses the reference dose (RfD) to calculate the HHC. A RfD is an estimate of a daily oral exposure of an individual to a substance that is likely to be without an appreciable risk of deleterious effects during a lifetime. A RfD is often derived from a laboratory animal toxicity multi-dose study from which a no-observed-adverse-effect level (NOAEL), lowest-observed-adverse-effect level (LOAEL), or benchmark dose level can be identified. However, human epidemiology studies can also be used to derive a RfD. Uncertainty factors are applied to account for gaps or deficiencies in the available data ( e.g., differences in response among humans) for a chemical. For the majority of EPA's latest (2015) updated national CWA section 304(a) recommended HHC, EPA's Integrated Risk Information System (IRIS)  11 was the source of both cancer and noncancer toxicity values ( i.e., RfD and CSF). 12 For some pollutants, EPA selected risk assessments produced by other EPA program offices ( e.g., Office of Pesticide Programs, Office of Water, Office of Land and Emergency Management), other national and international programs, and state programs.

EPA's exposure assumptions provide an overall level of protection targeted at the high end of the general population, as stated in the 2000 Methodology. EPA selects a combination of high-end and central tendency inputs to the criteria derivation equation and avoids “double counting” of exposures and combining unlikely co-occurrences. Consistent with the 2015 national CWA section 304(a) recommended HHC, EPA uses a default drinking water intake rate of 2.4 liters per day (L/day) and default rate of 22 grams per day (g/day) for consumption of fish and shellfish from inland and nearshore waters, multiplied by pollutant-specific bioaccumulation factors (BAFs) to account for the amount of the pollutant in the edible portions of the ingested species.

EPA's national default drinking water intake rate of 2.4 L/day represents the per capita estimate of combined direct and indirect community water ingestion at the 90th percentile for adults ages 21 and older. 13 EPA's national FCR of 22 g/day represents the 90th percentile consumption rate of fish and shellfish from inland and nearshore waters for the U.S. adult population 21 years of age and older, based on National Health and Nutrient Examination Survey (NHANES) data from 2003 to 2010. 14 15 EPA calculates HHC using a default body weight of 80 kilograms (kg), the average weight of a U.S. adult age 21 and older, based on NHANES data from 1999 to 2006.

Prior to publication of the 2000 Methodology, in which EPA began recommending the use of BAFs to reflect the uptake of a contaminant from all sources by fish and shellfish, 16 EPA relied on bioconcentration factors (BCFs) to estimate chemical accumulation of waterborne chemicals by aquatic organisms. However, BCFs only account for chemical accumulation in aquatic organisms through exposure to chemicals in the water column. In 2000, EPA noted that “there has been a growing body of scientific knowledge that clearly supports the observation that bioaccumulation and biomagnification occur and are important exposure issues to consider for many highly hydrophobic organic compounds and certain organometallics.” For that reason, the 2000 Methodology observed that “[f]or highly persistent and bioaccumulative chemicals that are not easily metabolized, BCFs do not reflect what the science indicates.”  17 Therefore, consistent with the 2000 Methodology EPA uses, when data are available, measured or estimated BAFs, which account for chemical accumulation in aquatic organisms from all potential exposure routes, including, but not limited to, food, sediment, and water. 18 EPA uses separate BAFs for each trophic level to account for potential biomagnification of chemicals in aquatic food webs, as well as physiological differences among organisms that may affect bioaccumulation. 19

EPA derives national default BAFs, in part, as a resource for states and authorized tribes with limited resources for deriving site-specific BAFs. 20 EPA's approach for developing national BAFs represents the long-term average bioaccumulation potential of a pollutant in aquatic organisms that are commonly consumed by humans across the United States. In the 2015 national CWA section 304(a) recommended HHC update, EPA relied on field-measured BAFs and laboratory-measured BCFs available from peer-reviewed, publicly available databases to develop national BAFs for three trophic levels of fish. 21 If this information was not available, EPA selected octanol-water partition coefficients (K ow values) from publicly available, published peer-reviewed sources for use in calculating national BAFs. As an additional line of evidence, EPA reported model-estimated BAFs for every chemical based on the Estimation Program Interface (EPI) Suite to support the field-measured or predicted BAFs. 22

Although EPA uses national default exposure-related input values to calculate national CWA section 304(a) recommended criteria, EPA's methodology notes a preference for the use of local data, when available, to calculate HHC ( e.g., locally derived FCRs, drinking water intake rates and body weights, and waterbody-specific bioaccumulation rates) over national default values. Using local data helps ensure that HHC represent local conditions. 23 EPA also recommends, where sufficient data are available, selecting an FCR that reflects consumption that is not suppressed by fish availability or concerns about the safety of available fish. 24 Deriving criteria using an unsuppressed FCR furthers the restoration goals of the CWA and ensures protection of human health as pollutant levels decrease, fish habitats are restored, and fish availability increases. Moreover, as explained further below, selecting an FCR that reflects unsuppressed fish consumption could be necessary where tribal treaty or other reserved fishing rights apply. In such circumstances, if sufficient data regarding unsuppressed fish consumption levels are unavailable or inconclusive, states should consult with tribes when deciding which fish consumption data should be used in selecting an FCR.

The inclusion of an RSC factor  25 is important for protecting public health. When deriving HHC for non-carcinogens and nonlinear carcinogens, EPA includes an RSC factor to account for sources of exposure other than drinking water and consumption of fish and shellfish from inland and nearshore waters. These other sources of exposure include but are not limited to ocean fish consumption (which is not included in EPA's default national FCR), non-fish food consumption ( e.g., fruits, vegetables, grains, meats, poultry), dermal exposure, and inhalation exposure. Using an RSC ensures that the level of a chemical allowed by a water quality criterion, when combined with other exposure sources, will not result in exposures that exceed the RfD, thus helping to prevent adverse health effects from aggregate exposure to a given chemical over a person's lifetime. EPA's guidance  26 includes an approach for determining an appropriate RSC for a given pollutant ranging in value from 0.2 to 0.8 to ensure that drinking water and fish consumption alone are not apportioned the entirety of the RfD. This approach, known as the Exposure Decision Tree, considers the adequacy of available exposure data, levels of exposure, relevant sources/media of exposure, and regulatory agendas. As explained below in section III.B.d of this preamble, EPA made science-based adjustments to the application of the RSC in this rulemaking to avoid “double counting” exposures.

In 1992, EPA promulgated the National Toxics Rule (NTR) at 40 CFR 131.36, establishing chemical-specific numeric criteria for 85 priority toxic pollutants for 14 states and territories (states), including Washington, that were not in compliance with the requirements of CWA section 303(c)(2)(B). Subsequently, when states covered by the NTR adopted their own criteria for toxic pollutants that were consistent with the CWA and EPA's implementing regulations, EPA amended the NTR to remove those chemical-specific criteria for those states. In 2015, Washington was one of the states that remained covered by the NTR.

On September 14, 2015, the EPA Administrator determined that updated HHC for Washington were “necessary” pursuant to CWA section 303(c)(4)(B). EPA proposed HHC to protect the health of Washington residents, including tribes with treaty-reserved rights to fish. 27 In that proposal, EPA explained that the majority of waters under Washington's jurisdiction are subject to tribal treaty-reserved fishing rights. 28 To give effect to such rights in establishing revised WQS for Washington waters, EPA determined that tribal treaty fishing rights “appropriately must be considered when determining which criteria are necessary to adequately protect Washington's fish and shellfish harvesting designated uses.”  29 Specifically, EPA proposed to consider the tribal populations exercising their legal right to harvest and consume fish and shellfish as the general population for purposes of deriving protective HHC. To this end, EPA proposed HHC based on an FCR of 175 g/day and CRL of 10 −6 to reflect consideration of tribal treaty-reserved rights, as informed by consultation with the tribes and fish consumption surveys of tribal members. 30 In addition to an FCR and CRL calculated to ensure protection of applicable tribal treaty-reserved rights, EPA also utilized other inputs to derive the proposed HHC based on the agency's latest scientific knowledge. Specifically, EPA calculated the proposed HHC using the national trophic level four BAFs and updated chemical-specific RSC values from its June 2015 CWA section 304(a) recommended criteria updates. 31

Before EPA finalized the proposed Federal criteria, the State of Washington adopted HHC following an extensive public process and submitted the updated HHC to EPA for review on August 1, 2016. The updated HHC incorporated some of the new data and information from EPA's June 2015 CWA section 304(a) criteria updates. Washington's HHC were based on the same 175 g/day FCR and 10 −6 CRL that EPA used to derive the proposed Federal HHC, with the exception of the CRL for polychlorinated biphenyls (PCBs). 32 Although Washington used the same FCR and CRL as EPA, Washington used BCFs instead of BAFs and used an RSC of 1. The scientific inputs of BCFs and an RSC of 1 do not reflect the latest scientific knowledge.

On November 15, 2016, EPA partially approved and partially disapproved Washington's HHC. 33 For the criteria that were disapproved, EPA concurrently signed a final rule promulgating the Federal criteria it had proposed in 2015. 34 Like EPA's 2015 proposal, the 2016 final rule articulated EPA's conclusion that it is necessary and appropriate to consider tribal treaty-reserved rights within the framework of the CWA and provided a discussion of the tribal treaties relevant to the State of Washington and applicable case law. 35 The 2016 final rule was informed by public comment that addressed both the proposed criteria and EPA's consideration of tribal treaties, as well as consultation with a number of federally recognized tribes.

EPA's disapproval of Washington's HHC in 2016 was largely predicated on Washington's use of input values that were not reflective of sound scientific rationale. In its letter to the State, EPA explained that the agency “evaluated Washington's criteria values against criteria that EPA determined would be protective of the State's designated uses and scientifically defensible ( e.g., based on appropriate bioaccumulation factors (BAFs) and protective relative source contribution (RSC) values of less than 1).”  36 EPA found that Washington had not demonstrated that the majority of its criteria were based on sound scientific rationale as required by the CWA and EPA's implementing regulations. 37 Specifically for PCBs, EPA found that Washington had not provided adequate support or analysis to justify its use of a chemical-specific CRL (2.3 × 10 −5 ) that was less stringent than the CRL used for all other pollutants, and did not explain how the use of this CRL was protective of the State's designated uses. 38

With respect to the criteria that EPA approved, the agency also explained that “while the EPA carefully considers the scientific defensibility and protectiveness of both the inputs used to derive criteria and the resulting criteria values, it is ultimately on the criteria values that the EPA takes approval or disapproval action under CWA section 303(c).”  39 After evaluating Washington's criteria against criteria using appropriate scientific inputs, EPA determined that certain of Washington's criteria were as or more stringent than scientifically defensible criteria that the EPA determined would be protective of Washington's designated uses. 40 Accordingly, EPA approved those criteria. 41

In a petition dated February 21, 2017, several regulated entities requested that EPA reconsider its November 15, 2016, partial disapproval and repeal its concurrent promulgated Federal criteria. 42 Following the 2017 petition, Washington and several federally recognized tribes with treaty-reserved fishing rights sent letters urging EPA to deny the petition and to leave the federally promulgated HHC in place. 43

Despite objections from the State and several tribes, on May 10, 2019, EPA granted the 2017 industry petition by reversing the agency's prior partial disapproval to an approval of certain HHC (`2019 Reconsidered HHC') and subsequently issuing a final rule withdrawing the federally promulgated criteria. 44 EPA's May 10, 2019 approval concluded that the State's reliance on scientific inputs that were not reflective of the latest science was an appropriate risk-management decision. 45 The withdrawal of the Federal criteria went into effect on June 12, 2020, and as of that date, the HHC submitted by Washington on August 1, 2016 and approved by EPA on May 10, 2019 were in effect for CWA purposes.

On June 6, 2019, the State of Washington filed a complaint challenging the legality of EPA's May 2019 decision to reverse its November 2016 partial disapproval. 46 The Sauk-Suiattle Indian Tribe and Quinault Indian Nation subsequently joined Washington's lawsuit as plaintiff-intervenors. On June 6, 2020, following EPA's withdrawal of the promulgated Federal HHC, another lawsuit was filed by the Makah Indian Tribe, the Pacific Coast Federation of Fishermen's Associations, and environmental groups challenging both EPA's withdrawal of the federally promulgated HHC and its May 10, 2019 decision to reverse the November 2016 partial disapproval. 47 In September 2020, the Plaintiffs in the case filed by the State of Washington amended their complaints to also challenge EPA's rule withdrawing the Federal HHC.

Consistent with Executive Order 13990, 48 in February 2021, EPA sought and was granted an abeyance in both cases to conduct an initial review to determine whether it intended to reconsider the challenged actions. During this initial three-month abeyance, EPA decided to reconsider the challenged actions. Based on its initial review of the agency's prior actions, EPA sought a longer abeyance from the court, expressing substantial concern that Washington's HHC may not be adequately protective and may not be based on sound scientific rationale. On July 6, 2021, the Court granted EPA an abeyance to reconsider its prior actions and to propose protective HHC for Washington and take final action on the proposal within 18 months. EPA proposed protective HHC for Washington on April 1, 2022, 49 and is now finalizing protective HHC for Washington in this final rule.

After consideration of all comments received on EPA's proposed rulemaking, EPA is finalizing Federal criteria that supersede the 2019 Reconsidered HHC for CWA purposes. 50 EPA's final rule does not change or supersede the Federal HHC that EPA promulgated for arsenic, 51 methylmercury, or bis (2-chloro-1-methylethyl) ether in 2016 and that remain in place for CWA purposes, nor Washington's HHC that EPA approved in 2016 and have remained in effect since that time. EPA's final rule also does not change or supersede Washington's HHC for dioxin and thallium that EPA approved in 2019. EPA had previously taken no action on these two pollutants in 2016.

Some commenters asked EPA to quickly take separate prompt action to strengthen dioxin criteria and establish criteria for per- and polyfluoroalkyl substances (PFAS) unless Washington addresses those pollutants itself in a future State rulemaking. As noted in EPA's Response to Comment document in the docket for this rule, such comments are beyond the scope of this rulemaking.

Finally, certain commenters referred to EPA's prior actions related to HHC for arsenic and mercury in Washington. EPA's proposed rulemaking did not address those prior actions, which were based on the administrative record before the agency at that time, nor did EPA solicit comment on those actions. Therefore, such comments are also beyond the scope of this rule.

The HHC in this final rule apply to surface waters under the State of Washington's jurisdiction, and not to waters within Indian country, 52 unless otherwise specified in Federal law.

EPA is finalizing HHC for Washington using the same FCR of 175 g/day, body weight of 80 kg and drinking water intake rate of 2.4 L/day that the agency proposed in its April 1, 2022, proposed rulemaking, 53 which are the same values Washington used in 2016  54 and that EPA used in its 2016 Federal rule. 55 The comments addressing these input values are briefly summarized below.

With respect to the FCR, some commenters asserted that protective HHC should accurately account for the amount of fish people are eating, and that EPA was right to propose HHC using an FCR of 175 g/day. However, the same commenters state that 175 g/day is a compromise rate and is therefore, not conservative because many communities in Washington eat more than 175 g/day, even with suppressed fish stocks. Those commenters assert that 175 g/day is only acceptable if that rate is paired with a CRL of one in one million (10 −6 ) and the most recent science for the other inputs.

Other commenters asserted that 175 g/day is an inappropriate FCR to use to derive HHC in Washington, and/or that it should not be paired with a 10 −6 CRL. These commenters state that lower FCRs, or greater CRLs of one in one hundred thousand (10 −5 ) or one in ten thousand (10 −4 ), would be protective of all consumers in Washington, including tribes. Some commenters characterized 175 g/day as a high-biased estimate of fish consumption that is based on an outdated survey method. Additionally, commenters assert that 175 g/day is too high to use to derive HHC for Washington because it includes consumption of fish that predominantly accumulate pollutants in waters outside of Washington's jurisdiction ( i.e., the open ocean). Commenters state that EPA relies in part on an argument that fish consumption in Washington is suppressed but assert that EPA has not provided scientific evidence of such suppression or guidance on how to account for suppression. These commenters state that there is no evidence of lower fish stocks limiting consumption, and that fish availability should not be a factor in setting HHC since those criteria do not impact fish availability.

EPA reiterates its explanation in the proposed rulemaking that it does not have new data or information suggesting a need to revisit the inputs utilized in the 2016 rule. 56 Thus, EPA is applying the same rationale here as the agency articulated to support its use of those inputs in the 2016 Federal rule. The agency has concluded that it is important to keep these values consistent between the HHC in this rule and the other HHC that this rule will not impact ( i.e., the HHC that Washington adopted and EPA approved in 2016, and the Federal HHC that remain in place for arsenic, methylmercury, or bis (2-chloro-1-methylethyl) ether), because these values are associated with the population that the criteria are intended to protect and are not pollutant-specific. For detailed responses to all comments received, see EPA's Response to Comment document in the docket for this rule.

EPA is finalizing HHC for Washington using the same reference doses and cancer slope factors that the agency proposed in its April 1, 2022, proposed rulemaking, 57 which are the same values Washington used in 2016  58 and that EPA used in its 2016 Federal rule. 59 These are the same toxicity values that EPA uses in its national CWA section 304(a) recommended HHC. While there may be new toxicity information available for certain pollutants that is not yet reflected in EPA's CWA section 304(a) national recommended HHC, such information has not yet been reviewed through EPA's comprehensive CWA section 304(a) criteria development process and therefore is not incorporated into this final rule. 60 See Table 1, columns B1 and B3 of this preamble for a list of EPA's toxicity factors by pollutant.

EPA only received comments on reference doses and cancer slope factors in the context of specific pollutants, namely PCBs and mercury. As noted above, comments on mercury are beyond the scope of this rulemaking. For comments on PCBs, see below and EPA's Response to Comment document in the docket for this rule.

EPA is finalizing HHC for Washington using the same CRL of 10 −6 that the agency proposed in its April 1, 2022, proposed rulemaking for all pollutants, including PCBs. 61 This is the same CRL Washington used in 2016 for all pollutants except for PCBs  62 and that EPA used in its 2016 Federal rule for all pollutants. 63

EPA's selection of a 10 −6 CRL is consistent with EPA's 2000 Methodology, which states that EPA intends to use the 10 −6 level, which reflects an appropriate risk for the general population, when promulgating water quality criteria for states and tribes. 64 Additionally, many of Washington's rivers are in the Columbia River basin, upstream of Oregon's portion of the Columbia River. Oregon's criteria for PCBs and other pollutants are based on an FCR of 175 g/day and a CRL of 10 −6 . EPA's final Federal HHC for Washington using a CRL of 10 −6 along with an FCR of 175 g/day helps ensure that Washington's criteria will provide for the attainment and maintenance of Oregon's downstream WQS as required by 40 CFR 131.10(b).

As noted in EPA's 2016 final rule for Washington, 65 several tribes in Washington have treaty-reserved rights to fish on waters throughout the State. Consistent with those rights, tribal members catch and consume fish for their subsistence. EPA determined that a 10 −6 CRL was appropriate independent of treaty rights, for the reasons explained in this section and EPA's Response to Comment document in the docket for this rule. Nonetheless, EPA's selection of a 10 −6 CRL is protective of tribal members exercising their legal right to harvest and consume fish and shellfish at subsistence levels. 66

Some commenters asserted that EPA's use of a CRL of 10 −6 is consistent with EPA's guidance and national precedent. These commenters agreed with EPA's proposal of HHC for PCBs based on a CRL of 10 −6 paired with an FCR of 175 g/day and asserted that it violates the CWA and civil rights to expose high fish consumers to a higher cancer risk due to PCBs. Commenters stated that EPA did not show why Washington's criteria that it previously disapproved in 2016 were protective in 2019. Finally, commenters asserted that upstream pollution impacts the Spokane Tribe's ability to safely exercise their treaty reserved fishing rights and EPA's proposed PCB criteria are closer to the Tribe's criteria and therefore more likely to provide for downstream protection. Commenters also state that use of a CRL of 10 −6 to derive HHC for Washington addresses the potential for synergistic toxicity from exposure to multiple toxins.

Other commenters asserted that EPA's use of a 10 −6 CRL is inconsistent with EPA's guidance and longstanding policy on acceptable risk levels. These commenters stated that EPA accepts CRLs of 10 −6 or 10 −5 , provided the median FCR for highly exposed populations is protected to a 10 −4 risk level, and pointed to prior EPA actions, including EPA's 2019 approval of HHC in Idaho, 2011 HHC approval in Oregon, and EPA's Clean Water Act national recommended 304(a) criteria that pair a 10 −6 cancer risk level with a general population fish consumption rate rather than an FCR associated with high fish consumers. Some commenters characterized a CRL of 10 −4 as effectively zero risk to a small population such as the tribal population in Washington. Other commenters argued that the CRL is a choice for states to make and that EPA was right to accept Washington's choice of a PCB-specific CRL in 2019 because Washington's 2016 PCB criteria strike a more appropriate balance between cost and human health protection, and EPA's proposed PCB criteria are not scientifically defensible or attainable with currently available technology. Some commenters raised concerns that EPA's proposed criteria are below analytical method quantitation limits and therefore it is not clear how dischargers can comply with the criteria and this could be misleading to the public. Some commenters criticized EPA's cost estimates for the proposed rule, stating that testing methodology may improve, such that dischargers will then be out of compliance with permit limits, and stating that Washington is unlikely to adopt WQS variances to provide dischargers with relief. These commenters asserted that certain dischargers are already being pushed by EPA to use an unapproved PCB test method as the basis to design and install new treatment systems, and that EPA was wrong to assume that PCBs are not likely to be found in the effluent from minor facilities. Some commenters raised concerns that EPA and Washington State allow for the continued release of PCBs into the environment under the Toxic Substances Control Act, tribal and Federal hatchery operations in Washington, and Washington's Model Toxics Control ACT, which in turn puts an unfair burden on dischargers in Washington to meet the proposed HHC for PCBs. Commenters also raised concerns that EPA has not shared the latest science evaluating the toxicity of inadvertently generated PCBs and there is ongoing scientific uncertainty with EPA's proposed PCB criteria that EPA has not sufficiently explained.

As noted above, in this final rule EPA is maintaining its proposed CRL of 10 −6 , which Washington used in 2016 and EPA used in its 2016 Federal rule for all pollutants. With respect to the comments regarding utilizing that same CRL for PCBs, for the reasons that EPA further explained in the proposed rulemaking, the agency has concluded that Washington's PCB HHC are not protective of Washington's designated uses because of Washington's selected chemical-specific CRL, which is not based on a sound scientific rationale. For detailed responses to all comments received, including those which reiterate prior comments that EPA received on its 2015 proposed rulemaking for Washington and previously responded to, such as comments about the intersection of the CWA and the Toxic Substances Control Act with respect to PCBs, see EPA's Response to Comment document in the docket for this rule.

EPA recommends using an RSC for non-carcinogens and nonlinear carcinogens to account for sources of exposure other than drinking water and consumption of inland and nearshore fish and shellfish (see section II.B.d of this preamble). In its 2015 304(a) criteria recommendations, after evaluating information on chemical uses, properties, occurrences, releases to the environment and regulatory restrictions, EPA developed chemical-specific RSCs for non-carcinogens and nonlinear carcinogens ranging from 0.2 (20 percent) to 0.8 (80 percent) following the Exposure Decision Tree approach described in EPA's 2000 Human Health Methodology. 67 68

When EPA promulgated HHC for Washington in 2016, EPA adjusted RSC values using a ratio of the national dataset characterizing all FCRs versus inland and nearshore-only FCRs derived from the NHANES dataset. EPA then applied this ratio to the proportion of the RfD reserved for inland and nearshore fish consumption in the RSC, and used this adjustment to account for double-counted potential exposure to certain chemicals in certain anadromous fish species ( e.g., salmon). This approach involves the following assumptions:

• The pollutant concentrations in anadromous fish are the same as those in inland and nearshore fish; and

• The ratio of all fish to inland and nearshore fish from NHANES data approximates the ratio of inland, nearshore, and anadromous fish to just inland and nearshore fish from Columbia River Inter-Tribal Fish Commission (CRITFC)  69 data (since CRITFC data were used to derive the 175 g/day FCR).

At the 90th percentile rate of consumption, the national adult consumption rate from NHANES data for all fish is 53 g/day and 22 g/day for inland and nearshore-only fish, or a ratio of 2.4. Applying this to an RSC of 0.2 yields 0.48, or 0.5 rounding to a single decimal place. Because the 175 g/day FCR includes some but not all marine species, EPA decided to use this approach to adjust the RSC values. However, EPA only adjusted RSC values to 0.5 for criteria calculations previously using an RSC between 0.2 and 0.5. Criteria derived using an RSC greater than 0.5 remained unchanged. EPA is using these same 2016 RSCs to derive HHC for Washington in this final rule, having no new data or information to support revising RSCs. The inclusion of protective RSCs in the development of HHC is a science-based decision that protects human health by ensuring that a person's exposure to multiple sources of a chemical is accounted for. See Table 1, column B2 of this preamble for a list of EPA's RSCs by pollutant.

Some commenters asserted that use of an RSC of 1 is scientifically indefensible and that returning to EPA's 2016 approach of using an RSC equal to or less than 0.8 will ensure that the HHC consider other potential exposures. Commenters stated that tribes are regularly exposed to toxins through other routes of exposure in addition to fish consumption, such as dermal exposure. Commenters agreed with EPA's statement in the proposed rule that the choice of cancer risk level (CRL) is irrelevant to the choice of RSC since these inputs are for mutually exclusive categories of pollutants (carcinogens vs. non-carcinogens).

Other commenters asserted that the RSC value is a discretionary risk management decision and there is no regulatory requirement to examine multiple exposure routes when developing HHC. Commenters also stated that the criteria are only intended to protect for risks related to surface water exposure, i.e., fish and water. Some commenters asserted that it is arbitrary for EPA to use an RSC less than 1 when the FCR includes all fish. Other commenters pointed to prior EPA actions, including EPA's 2011 HHC approval in Oregon, and EPA's 2013 approval of HHC for the Spokane Tribe, to assert that EPA has approved HHC that rely on an RSC of 1. Finally, some commenters state that EPA's use of RSCs in the drinking water program under the Safe Drinking Water Act (SDWA) is different than using them for WQS since SDWA allows for consideration of cost in setting the final regulatory limits.

As explained in the proposed rulemaking, EPA determined that Washington's use of an RSC value of 1 to derive HHC is not based on sound scientific rationale as it apportioned the entire “safe” dose of certain chemicals to drinking water and fish consumption, ignoring other sources of those chemicals. While EPA acknowledges the comments indicating that it has previously approved WQS where states and authorized tribes utilized an RSC of 1 to develop certain HHC, in those prior actions, EPA only approved HHC that used an RSC of 1 if EPA had not yet updated its own corresponding national recommended 304(a) criteria to reflect chemical-specific RSC values following the Exposure Decision Tree approached described in the 2000 Methodology. Without updated national recommended 304(a) criteria, states and tribes did not yet have the benefit of EPA's thorough review of exposure information that now exists since EPA updated its national HHC recommendations in 2015. Since the 2015 recommended HHC updates, EPA has encouraged all states to consider the latest science reflected in EPA's 2015 HHC recommendations during the triennial review of state WQS and update their HHC to incorporate appropriate RSCs. For detailed responses to all comments received, see EPA's Response to Comment document in the docket for this rule.

Where data are available, EPA uses BAFs to account for the uptake and retention of waterborne chemicals by aquatic organisms from all surrounding media and to ensure that resulting criteria are science-based and protect designated uses for human health. Consistent with the 2016 Federal rule for Washington, 70 EPA is finalizing HHC for Washington by applying the trophic level four BAF from the 2015 CWA section 304(a) recommended HHC updates in conjunction with the 175 g/day FCR. 71

Some commenters asserted that the choice of BCFs versus BAFs is a science-based rather than risk management decision, and that EPA is appropriately following the science in applying BAFs in this rule. These commenters asserted that BCFs undercount the amount of chemicals in fish, and EPA disregarded science and its own guidance when it approved BCF-based HHC in 2019.

Other commenters asserted that Washington's choice to use BCFs rather than BAFs was a sound science policy choice. These commenters asserted that BCFs are based on sound scientific principles and state that EPA has previously approved HHC that rely on BCFs. Commenters asserted that EPA's national recommended BAFs are just guidance, that they overestimate bioaccumulation and therefore lead to overly stringent HHC, and that they are insufficiently explained such that it is not possible to determine if they are appropriate for Washington. Some commenters asserted that both BAFs and BCFs are influenced by the local environment ( e.g., food web structure, water temperature, dissolved carbon) and therefore cannot be based on a single set of assumptions for all waters.

Regarding the comments supporting the use of BCFs, as explained in the proposed rule, the use of BCFs rather than BAFs, where BAF data are available, to calculate the HHC is inconsistent with sound scientific rationale on the bioaccumulation of pollutants. EPA has considered the comments received on its selected BAFs and reiterates its explanation in the proposed rule that it does not have new data or information to support an alternative to its 2016 decision to use the trophic level four BAFs, given that the species commonly consumed in Washington are trophic level four fish ( e.g., salmon). For certain pollutants for which science-based BAFs are not currently available, EPA is finalizing HHC using the BCFs from its updated CWA section 304(a) recommended HHC for those pollutants as the best available scientific information. See Table 1, columns B4 and B5 of this preamble for a list of EPA's bioaccumulation factors by pollutant. For detailed responses to all comments received, see EPA's Response to Comment document in the docket for this rule.

EPA is finalizing 141 HHC for 72 different pollutants (70 organism-only criteria and 71 water-plus-organism criteria) to protect the applicable designated uses of Washington's waters (see Table 1 of this preamble). The final HHC are the same criteria that EPA promulgated in 2016. The water-plus-organism criteria in column C1 of Table 1 of this preamble, are the applicable criteria for any waters that include the Domestic Water use (domestic water supply) defined in Washington's WQS (WAC 173-201A-600). The organism-only criteria in column C2 of Table 1 of this preamble, are the applicable criteria for any waters that do not include the Domestic Water use (domestic water supply) and that Washington defines at WAC 173-201A-600 and 173-201A-610 as the following:

• Fresh waters—Harvesting (fish harvesting), and Recreational Uses;

• Marine waters—Shellfish Harvesting (shellfish—clam, oyster, and mussel—harvesting), Harvesting (salmonid and other fish harvesting, and crustacean and other shellfish—crabs, shrimp, scallops, etc.—harvesting), and Recreational Uses.

Under the CWA, Congress gave states primary responsibility for developing and adopting WQS for their navigable waters (CWA section 303(a)-(c)). Although EPA is finalizing revised HHC for Washington, Washington continues to have the option to adopt and submit to EPA newly revised HHC for the State's waters consistent with CWA section 303(c) and EPA's implementing regulations at 40 CFR part 131. If, subsequent to this final rule, Washington adopts and submits revised HHC, EPA's federally promulgated criteria will remain applicable for purposes of the CWA until EPA withdraws the federally promulgated criteria (40 CFR 131.21(c)). EPA would undertake such a rulemaking to withdraw the Federal criteria if and when Washington adopts and EPA approves corresponding State criteria that meet the requirements of section 303(c) of the CWA and EPA's implementing regulations at 40 CFR part 131.

The Federal WQS regulation at 40 CFR part 131 provides several tools that Washington has available to use at its discretion when implementing or deciding how to implement these HHC. Among other things, EPA's WQS regulation: (1) specifies how states and authorized tribes establish, modify, or remove designated uses (40 CFR 131.10); (2) specifies the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions (40 CFR 131.11); (3) authorizes and provides a regulatory framework for states and authorized tribes to adopt WQS variances where it is not feasible to attain the applicable WQS at that time (40 CFR 131.14); and (4) allows states and authorized tribes to authorize the use of compliance schedules in National Pollutant Discharge Elimination System (NPDES) permits to meet water quality-based effluent limits (WQBELs) derived from the applicable WQS (40 CFR 131.15). Each of these approaches is discussed in more detail in the next sections. Whichever approach a state pursues, however, all NPDES permits would need to comply with EPA's regulations at 40 CFR 122.44(d)(1)(i).

EPA's HHC apply to waters that Washington has designated for the following:

• Fresh waters—Harvesting (fish harvesting), Domestic Water (domestic water supply), and Recreational Uses;

• Marine waters—Shellfish Harvesting (shellfish—clam, oyster, and mussel—harvesting), Harvesting (salmonid and other fish harvesting, and crustacean and other shellfish—crabs, shrimp, scallops, etc.—harvesting), and Recreational Uses (see WAC 173-201A-600 and WAC 173-201A-610).

The Federal regulation at 40 CFR 131.10(g) provides requirements for establishing, modifying, and removing designated uses when attaining the use is not feasible based on one of the six factors specified in the regulation. If Washington removes a use and adopts the highest attainable use, 72 the State must also adopt criteria to protect the newly designated highest attainable use consistent with 40 CFR 131.11. It is possible that criteria other than the federally promulgated criteria would protect the highest attainable use. If EPA found removal or modification of the designated use and the adoption of the highest attainable use and criteria to protect that use to be consistent with CWA section 303(c) and the implementing regulation at 40 CFR part 131, the agency would approve the revised WQS. EPA would then undertake a rulemaking to withdraw the corresponding Federal WQS for the relevant water(s).

Washington's WQS provide authority to apply WQS variances when implementing federally promulgated HHC, as long as such WQS variances are adopted consistent with 40 CFR 131.14 and submitted to EPA for review under CWA section 303(c). The Federal regulation at 40 CFR 131.3(o) defines a WQS variance as a time-limited designated use and criterion, for a specific pollutant or water quality parameter, that reflects the highest attainable condition during the term of the WQS variance. A WQS variance may be appropriate if attaining the use and criterion would not be feasible during the term of the WQS variance because of one of the seven factors specified in 40 CFR 131.14(b)(2)(i)(A). These factors include a situation where NPDES permit limits more stringent than technology-based controls would result in substantial and widespread economic and social impact. WQS variances adopted in accordance with 40 CFR 131.14 (including a public hearing consistent with 40 CFR 25.5) provide a flexible but defined pathway for states and authorized tribes to issue NPDES permits with limits that are based on the highest attainable condition during the term of the WQS variance. This allows dischargers to make water quality improvements when the WQS is not immediately attainable but may be in the future. When adopting a WQS variance, states and authorized tribes specify the interim requirements of the WQS variance by identifying a quantitative expression that reflects the highest attainable condition (HAC) during the term of the WQS variance, establishing the term of the WQS variance, and describing the pollutant control activities expected to occur over the specified term of the WQS variance. WQS variances provide a legal avenue by which NPDES permit limits can be written to comply with the WQS variance rather than the underlying WQS for the term of the WQS variance. If dischargers are still unable to meet the WQBELs derived from the applicable WQS once a WQS variance term is complete, the regulation allows the State to adopt a subsequent WQS variance if it is adopted consistent with 40 CFR 131.14. EPA is finalizing HHC that apply to use designations that Washington has already established. Washington's WQS regulations currently include provisions to use WQS variances when implementing criteria (see WA 173-210A-420), as long as such WQS variances are adopted consistent with 40 CFR 131.14 and approved by EPA. Washington may use the State's EPA-approved WQS variance procedures when adopting such WQS variances.

EPA's regulations at 40 CFR 122.47 and 131.15 address how permitting authorities can use schedules for compliance with a limit in the NPDES permit if the discharger needs additional time to undertake actions like facility upgrades or operation changes to meet a WQBEL based on the applicable WQS. EPA's regulation at 40 CFR 122.47 allows a permitting authority to include a compliance schedule in the NPDES permit, when appropriate and where authorized by the state, to provide a discharger with additional time to meet a WQBEL implementing applicable WQS. EPA's regulation at 40 CFR 131.15 requires that a state that intends to allow the use of NPDES permit compliance schedules adopt specific provisions authorizing their use and obtain EPA approval under CWA section 303(c) to ensure that a decision to allow a permit compliance schedule is transparent and allows for public input. 73 EPA has approved Washington's State law provision authorizing the use of permit compliance schedules (see WAC-173-201A-510(4)), consistent with 40 CFR 131.15. Washington's compliance schedule authorizing provision is not affected by this rule. Washington is authorized to grant permit compliance schedules, as appropriate, based on the Federal HHC in Washington, if such permit compliance schedules are consistent with EPA's permitting regulation at 40 CFR 122.47.

EPA focused its economic analysis on the potential cost impacts to current holders of individual NPDES permits (point sources) and the costs the State of Washington may bear to develop Total Maximum Daily Loads (TMDLs) for waters newly identified as impaired under CWA section 303(d) using the revised WQS. Costs might also arise to holders of general permits  74 should the State modify those permits in some manner as a result of the revised WQS. Costs might also arise to sectors whose operations are nonpoint sources of pollutants through implementation of TMDLs or through other voluntary, incentivized, or State-imposed controls. This rule does not directly regulate nonpoint sources and under the CWA states are responsible for the regulation of nonpoint sources. EPA recognizes that controls for nonpoint sources may be part of future TMDLs, but any such future decisions will be made by the State. Nonpoint sources are intermittent, variable, and occur under hydrologic or climatic conditions associated with precipitation events. Data to model and evaluate the potential cost impacts associated with nonpoint sources were not available and any estimate would be too uncertain to be informative. EPA also did not estimate potential sediment remediation costs for this analysis.

These WQS may serve as a basis for development of NPDES permit limits. Washington has NPDES permitting authority and retains considerable discretion in implementing standards. EPA evaluated the potential costs to NPDES dischargers associated with State implementation of EPA's criteria. This analysis is documented in “Economic Analysis for Restoring Protective Human Health Criteria in Washington,” which can be found in the record for this rule. Any NPDES-permitted facility that discharges pollutants for which the revised HHC are more stringent than the applicable aquatic life criteria (or for which HHC are the only applicable criteria) could potentially incur compliance costs. The types of affected facilities could include industrial facilities and POTWs discharging wastewater to surface waters ( i.e., point sources).

EPA identified 406 point source facilities that could ultimately be affected by this rule. Of these potentially affected facilities, 73 are major dischargers and 333 are minor dischargers. EPA did not include general permit facilities in its analysis because data for such facilities are limited and requirements typically focus on best management practices. Of the potentially affected facilities, EPA evaluated a sample of 18 major facilities. Minor facilities are less likely to incur costs as a result of implementation of the rule because of the reduced potential for significant presence of toxic pollutants in their effluent. EPA did not have effluent data on toxic pollutants to evaluate minor facilities for this analysis. Table 2 summarizes these potentially affected facilities by type and category.

EPA evaluated the two major municipal facilities with design flows greater than 100 mgd and the largest industrial facility, to attempt to capture the facilities with the potential for the largest costs. For the remaining major facilities, EPA evaluated a random sample of facilities to represent discharger type and category. For all sample facilities, EPA evaluated existing baseline permit conditions, reasonable potential to exceed HHC based on the rulemaking, and potential to exceed projected effluent limitations based on the last three years of effluent monitoring data (if available). Only compliance actions and costs that would be needed above the baseline level of controls are attributable to the rulemaking.

EPA assumes that dischargers would pursue the least cost means of compliance with WQBELs. Compliance actions attributable to the rulemaking may include pollution prevention, end-of-pipe treatment, and alternative compliance mechanisms ( e.g., WQS variances). EPA annualizes capital costs, including study ( e.g., WQS variance) and program ( e.g., pollution prevention) costs, over 20 years using discount rates of 3 percent and 7 percent to obtain total annual costs per facility. To obtain an estimate of total costs to point sources, EPA extrapolates the annualized costs for the random sample based on the flow volume for the sample facilities and the flow volume for all facilities.

Based on the results for 18 sample facilities across 10 industrial and municipal categories, 75 EPA did not identify any incremental costs to any major point source discharges of process wastewater from POTWs or industrial facilities attributable to EPA's criteria revisions. This does not mean that EPA anticipates there would be no costs to point sources over time to implement controls or modify processes to meet future permit limits, only that available data do not indicate the immediate need for the facilities evaluated. It would be highly speculative to attempt to estimate potential costs either based on the possibility of measuring pollutant levels at lower levels as a result of future requirements or future technology, or based on changes to facility operations or practices. Should the need to consider advanced treatment or other substantial costs arise in the future, there are mechanisms such as WQS variances in place which may consider cost and feasibility in the application of protective criteria, and alternative permit limits may be derived to avoid excessive costs. EPA will work with the State of Washington and with stakeholders on a continuing basis to assess the possibility of economically significant future costs of compliance. If such costs arise, EPA will provide guidance for applying alternative compliance mechanisms to minimize costs.

One important contributing factor to examining point source costs is the limitations of required analytical methods to measure chemical concentrations in effluents. Nearly half of pollutant parameters addressed in this rule have analytical quantitation limits that are above both the criteria currently in place and EPA's criteria. PCBs are a good example. The current criterion in place is 170 picograms per liter (pg/L) and EPA's criterion is 7 pg/L. However, the State identifies the analytical detection limit for effluent measurement as 65,000 pg/L as the means to evaluate compliance. EPA has completed a multi-laboratory validation of a new analytical method for PCBs (method 1628) that has an average analytical quantitation limit for each PCB congener of approximately 2,000 pg/L, which is a substantial improvement over the current regulatory method, but still well above either the criterion currently in place or EPA's criterion. As a general matter, analytical methods and quantitation limits are subject to change over time. As such, it is important that WQS reflect the necessary level of protection regardless of contemporary limitations of analytical methods.

EPA also evaluated potential administrative costs to the State for developing additional TMDLs under CWA section 303(d) for any waters that are newly identified as impaired as a result of EPA's criteria. Using available ambient monitoring data, EPA compared pollutant concentrations to the baseline and revised criteria, identifying waterbodies that may be incrementally impaired ( i.e., impaired under EPA's criteria but not under the baseline). EPA identified 32 impairments under the baseline criteria and 61 under the revised criteria, resulting in 29 potential incremental impairments. The estimated total annual costs for TMDL development range from $100,000 to $182,000, at a 3 percent discount rate, based on single-cause single-waterbody TMDL development costs. Actual costs may be reduced if the State develops multi-cause or multi-waterbody TMDLs.

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

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

This action does not impose any new information collection burden under the PRA. While actions to implement these WQS could entail additional paperwork burden, this action does not directly contain any information collection, reporting, or record-keeping requirements. OMB has previously approved the information collection activities contained in the existing regulation at 40 CFR part 131 and has assigned OMB control number 2040-0049.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Small entities, such as small businesses or small governmental jurisdictions, are not directly regulated by this rule. EPA-promulgated WQS are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters except in compliance with a NPDES permit. CWA section 301(b)(1)(C) and EPA's implementing regulations at 40 CFR 122.44(d)(1) introductory text and (d)(1)(i) provide that all NPDES permits shall include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, EPA's promulgation of WQS establishes standards that the State implements through the NPDES permit process. While the State has discretion in developing discharge limits, as needed to meet the WQS, those limits, per regulations at 40 CFR 122.44(d)(1)(i), “must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Director determines are or may be discharged at a level that will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard, including [s]tate narrative criteria for water quality.” As a result of this action, the State of Washington will need to ensure that permits it issues include any limitations on discharges necessary to comply with the WQS established in this final rule. In doing so, the State will have a number of choices associated with permit writing. While Washington's implementation of the rule may ultimately result in new or revised permit conditions for some dischargers, including small entities, EPA's action, by itself, does not impose any of these requirements on small entities; that is, these requirements are not self-implementing.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.

Under the technical requirements of Executive Order 13132, the EPA has determined that this rule may not have federalism implications but believes that the consultation requirements of the Executive order have been satisfied in any event. This rule does not alter Washington's considerable discretion in implementing these WQS, nor does it preclude Washington from adopting WQS that EPA concludes meet the requirements of the CWA after promulgation of this final rule.

This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. This rule could affect federally recognized Indian tribes in Washington because the numeric criteria for Washington will apply to waters adjacent to (or upstream or downstream of) the tribal waters. Additionally, there are six federally recognized Indian tribes in the Columbia River Basin located in the States of Oregon and Idaho that this rule could affect because their waters could affect or be affected by the water quality of Washington's downstream or upstream waters.

EPA consulted with tribal governments under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to ensure meaningful and timely input into its development. In August 2021, EPA held coordination and consultation sessions with tribal environmental staff and leadership to share information, hear their views and answer questions on the rulemaking. Representatives from 17 tribes and two tribal consortia participated in two leadership meetings with EPA held in August 2021. Additionally, EPA conducted tribal consultation and coordination activities on the proposed rulemaking from March 29, 2022, through June 3, 2022. During these meetings, the tribes repeatedly asked EPA to reinstate the 2016 Federal HHC for Washington, which EPA is doing in this final rule.

A Summary of EPA's Consultation, Coordination, and Outreach with Federally Recognized Tribes on the Restoration of Protective Human Heath Criteria for Washington is available in the docket for this final rule.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in section II.B of this preamble, in which EPA recommends that HHC be designed to reduce the risk of adverse cancer and non-cancer effects occurring from lifetime exposure to pollutants through the ingestion of drinking water and consumption of fish/shellfish obtained from inland and nearshore waters. EPA's HHC for Washington are similarly based on reducing the chronic health effects occuring from lifetime exposure and therefore are expected to be protective of a person's exposure during both childhood and adult years.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866. This action establishes CWA HHC for waters under the State of Washington's jurisdiction.

This rule does not involve technical standards.

EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or Indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The documentation for this decision is contained below.

EPA defines Environmental Justice (EJ) as the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation and enforcement of environmental laws, regulations and policies. 76 Three Executive orders (E.O. 12898, 77 13985, 78 and 14008  79 ) advance EJ by calling on Federal agencies to identify and address disproportionate impacts on historically underserved, marginalized, and economically disadvantaged people. Additionally, EPA has expressed a commitment to conducting EJ analyses for rulemakings as described in the April 30, 2021, revisions to the Cross-State Air Pollution Rule (CSAPR). 80

EPA believes that this rule is not expected to have disproportionately high and adverse human health or environmental effects on low-income populations, people of color, or tribal populations, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). In its economic impact analysis, EPA only estimates administrative costs to the State of Washington to develop TMDLs and no incremental costs to point source discharges based on available data, as explained above in section IV of this preamble. Therefore, EPA does not anticipate that this rule will impose any additional costs or other negative impacts on tribes or other low income or disadvantaged communities.

Instead, this action identifies and ameliorates disproportionately high and adverse human health effects on tribal communities, people of color and low-income populations in Washington by restoring HHC in Washington that are based on sound scientific rationale and protect high fish consumers.

Many groups in Washington, such as Asian, Pacific Islanders, and subsistence and recreational tribal and non-tribal fishers consume large amounts of fish and shellfish as part of traditionally influenced diets. 81 The 2019 Reconsidered HHC currently expose these high fish consumers to greater risk from toxic pollutants because the criteria do not accurately account for pollutant bioaccumulation into fish and expose fish consumers to a greater risk of cancer from PCB exposure.

Environmental impacts to tribes may be considered under the category of EJ in recognition that tribes may at times be among the disadvantaged communities disproportionately impacted by environmental degradation. Where tribal communities are part of a larger non-tribal community, many of the EJ considerations are very similar to those of other disadvantaged groups. However, there is a very unique set of EJ considerations for tribes, particularly in this context where tribes are exercising their cultural practices and treaty-reserved rights outside of their reservations on state waters.

While the overall impacts to communities with EJ concerns are improved as a result of this rule, by relying on the fish consumption rates based on tribal data, this rule helps ensure that tribal members, in particular, and their treaty-protected activities and resources are protected. 82 Specifically, this rule establishes HHC based on an FCR of 175 g/day reflective of regional tribal FCR survey data  83 to represent and protect higher fish consumers. In conjunction with the FCR, the rule uses a CRL of 10 −6 to derive HHC for all cancer-causing pollutants, including PCBs, a rate which is protective of tribal members exercising their legal right to harvest and consume fish and shellfish at the 175 g/day level.

Central to working with tribes on their environmental issues and opportunities is government to government consultation, which is consistent with Executive Order 13175 (65 FR 67249, November 6, 2000). To ensure that this rule considers the interests and perspective of tribes, EPA engaged with tribes that may be affected by this action to receive meaningful and timely input from tribal officials. See section V.F of this preamble for a summary of tribal consultation.

In addition to Executive Orders 12898 and 13175, and in accordance with Title VI of the Civil Rights Act of 1964, each Federal agency shall ensure that all programs or activities receiving Federal financial assistance that affect human health or the environment do not directly, or through contractual or other arrangements, use criteria, methods, or practices that discriminate on the basis of race, color, or national origin. With that directive in mind, in August 2011 the Environmental Justice Interagency Working Group established a Title VI Committee to address the intersection of agencies' environmental justice efforts with their Title VI enforcement and compliance responsibilities. If Washington receives Federal funds for CWA implementation, they are legally prohibited from discriminating on the basis of race, color or national origin under Title VI when engaging in CWA implementation activities. Additionally, and in compliance with Executive Order 12898, EPA expects that Washington will consider disproportionately high adverse human health and environmental effects on minority and low-income populations when implementing this rule under the CWA.

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

For the reasons set forth in the preamble, EPA amends 40 CFR part 131 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-2021-0387 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 January 17, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0387, 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 October 21, 2021 (86 FR 58239) (FRL-8792-04-OCSPP) and April 28, 2022 (87 FR 25178) (FRL-9410-12-OCSPP), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E8904) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to establish tolerances for residues of the insecticide cyclaniliprole, 3-bromo- N -[2-bromo-4-chloro-6-[[(1-cyclopropylethyl)amino]carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H -pyrazole-5-carboxamide, including its metabolites and degradates, in or on the raw agricultural commodities: Artichoke, globe at 1.5 parts per million (ppm); Pepper/eggplant subgroup 8-10B at 1.5 ppm; Sunflower subgroup 20B at 0.4 ppm; Tomato subgroup 8-10A at 0.6 ppm; Hog, meat at 0.01 ppm; Hog, fat at 0.015 ppm; Hog, meat byproducts at 0.015 ppm; Egg at 0.01 ppm; Poultry, meat at 0.01 ppm; Poultry, fat at 0.015 ppm; and Poultry, meat byproducts at 0.015 ppm. Upon the establishment of the tolerances specified above, IR-4 requested to remove the established tolerance for Vegetable, fruiting, group 8-10 at 0.20 ppm. The documents referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. There were no substantive comments received in response to the notices of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is modifying the commodities for which tolerances are being set.

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

No single or repeated dose study performed by any route of exposure produced an adverse effect following cyclaniliprole exposure at dose levels below, at, or above the limit dose (1,000 milligrams/kilogram/day (mg/kg/day)). Although the oral toxicity studies in dogs were conducted at approximately a third of the limit dose, no adverse effects were seen. While adaptive liver effects were seen in these studies, it is unlikely that cyclaniliprole would produce adverse liver effects if tested at higher doses in dogs as a structurally related chemical, chlorantraniliprole, was tested up to the limit dose in dogs and did not demonstrate adverse liver effects. There is no evidence that cyclaniliprole produces increased susceptibility with prenatal or postnatal exposures. Cyclaniliprole is considered not likely to be carcinogenic based on no increase in treatment-related tumor incidence in carcinogenicity studies in rats and mice and no genotoxicity.

Specific information on the studies received for cyclaniliprole as well as the no-observed-adverse-effect-level (NOAEL) from the toxicity studies can be found at https://www.regulations.gov in document, “Cyclaniliprole: Human Health Risk Assessment for the Proposed New Uses on Globe Artichoke and Sunflower Subgroup 20B and for new Greenhouse Uses (with Amended Tolerances) on Tomato Subgroup 8-10A and Pepper/Eggplant Subgroup 8-10B”, in docket ID number EPA-HQ-OPP-2021-0387.

Based on the review of the available cyclaniliprole toxicological studies, no toxicity endpoints or points of departure were selected for risk assessment. Based on the toxicological profile of cyclaniliprole, EPA has concluded that the FFDCA requirements to retain an additional safety factor for protection of infants and children and to consider cumulative effects do not apply. Section 408(b)(2)(C) requires an additional tenfold margin of safety in the case of threshold risks, which cyclaniliprole does not present. Section 408(b)(2)(D)(v) requires consideration of information concerning cumulative effects of 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 cyclaniliprole and any other substances, and cyclaniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that cyclaniliprole has a common mechanism of toxicity with other substances.

Cyclaniliprole has been grouped with the pyridyl pyrazoles. As part of the ongoing process to review registered pesticides, the Agency intends to apply this framework to determine if the available toxicological data for cyclaniliprole suggests a candidate common mechanism group (CMG) may be established with other pesticides. If a CMG is established, a screening-level toxicology and exposure analysis may be conducted to provide an initial screen for multiple pesticide exposure.

There is a potential for exposure to cyclaniliprole residues via food and drinking water based on existing uses and the proposed uses for cyclaniliprole application directly to growing crops. These applications can also result in cyclaniliprole reaching surface and ground water, both of which can serve as sources of drinking water. There are no existing or proposed uses in residential settings and therefore no anticipated residential exposures, although exposures resulting from spray drift from agricultural applications onto residential areas may occur. However, no quantitative risk assessment was conducted because no toxicity endpoints or points of departure were selected for risk assessment.

Determination of safety. Based on the available data indicating a lack of adverse effects from exposure to cyclaniliprole, 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 cyclaniliprole residues.

Adequate enforcement methodology (liquid chromatography with tandem mass spectrometry (LC-MS/MS)) is available to enforce the tolerance expression for plants and livestock commodities. 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 established MRLs for cyclaniliprole. The tolerance definitions are harmonized between the U.S. and Codex for plant and livestock commodities. There are Codex MRLs established on tomato subgroup 8-10A at 0.08 ppm for most commodities and at 0.1 ppm for tomato and on pepper/eggplant subgroup 8-10B at 0.15 ppm. For peppers (bell/non-bell) and tomatoes, the Agency is not harmonizing with the Codex MRLs because the Codex MRLs are much lower than the U.S. tolerances (0.15 vs 1.5 ppm for pepper subgroup and 0.1 vs 0.7 ppm for tomato subgroup). Harmonization could potentially result in tolerance exceedances in the U.S. and is therefore not possible.

The Agency has revised the tolerance value for tomato subgroup 8-10A from 0.6 ppm to 0.7 ppm because EPA used different residue data to calculate the tolerance. The proposed preharvest interval (PHI) for tomato is 1 day and the petitioner used residue data from a 1-day PHI. The decline trial indicated that residues increased at higher PHIs, so EPA included the highest cyclaniliprole residue at a PHI of 7 days in the tolerance calculation to be conservative.

EPA has determined that tolerances for Hog, meat; Hog, fat; Hog, meat byproducts; Egg; Poultry, meat; Poultry, fat; and Poultry, meat byproducts are not necessary because the calculated dietary burdens for swine and poultry are very low such that there is no reasonable expectation of finite residues in these commodities as a result of eating treated feedstuff (40 CFR 180.6(a)(3)).

Although the lack of toxicity supports a safety finding for an exemption from the requirement of tolerance for all crops, EPA is establishing tolerances for residues resulting from direct applications to certain commodities because the petitioner requested them for international trade purposes. Therefore, tolerances are established for residues of cyclaniliprole in or on Artichoke, globe at 1.5 ppm; Pepper/eggplant subgroup 8-10B at 1.5 ppm; Sunflower subgroup 20B at 0.4 ppm; and Tomato subgroup 10A at 0.7 ppm. Additionally, the tolerance for Vegetable, fruiting, group 8-10 is removed as unnecessary.

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 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 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 1 as follows:

The BLM Northwest Oregon District, Siuslaw Field Office manages the Lower Lake Creek SRMA. This popular recreation site contains unique waterfalls and natural water slide features that draw visitors from throughout the region. Visitors hike along a short trail to Lake Creek and enjoy swimming in natural pools and other in-water recreational activities. The consumption of alcoholic beverages in the SRMA has resulted in increased occurrences of unsafe behavior by visitors, such as wading in fast-moving and shallow sheet water flowing over natural rock formations. This final supplementary rule will ban the possession and consumption of alcoholic beverages in the area and, as a result, return the area to a safer and more family-friendly outdoor recreation opportunity for all members of the public to enjoy.

BLM law enforcement, recreation personnel, local law enforcement, and local search and rescue professionals agree that some visitors' consumption of alcohol has been a major factor in contributing to increased public safety risks at the recreation site. Such public safety issues include an increase in fatal traffic accidents involving travelers driving to and from the recreation area, as well as increased problems associated with litter, sanitation, and noise. This final supplementary rule is needed to ensure a safe recreational setting for all visitors and the local communities of Triangle Lake and Blachly, Oregon.

This final supplementary rule is established under the authority of 43 CFR 8365.1-6, which allows BLM State Directors to establish supplementary rules for “the protection of persons, property, and public lands and resources.” This final supplementary rule prohibits visitors of all ages from consuming, possessing, or furnishing any beverage defined as an alcoholic beverage by Oregon State Law within the boundaries of the Lower Lake Creek SRMA, including, but not limited to, the parking lot, day-use area and surrounding hillside, Lower Lake Creek Falls swimming area, and pathways leading to the swimming area and waterfalls site. Prohibited acts under this provision include the consumption, possession, and furnishing of any alcoholic beverage within motor vehicles, tents, or other structures in the area described herein.

On August 9, 2012, the BLM published a proposed supplementary rule (77 FR 47662) to replace an existing supplementary rule on alcohol use within the Lower Lake Creek SRMA. The existing supplementary rule, adopted in 1997, prohibits “consumption, possession, or furnishing of any alcoholic beverage in violation of Oregon State law.” Because of the way it is written, the existing supplementary rule does not actually ban the consumption, possession, or furnishing of alcohol in the SRMA.

The substance of the “Prohibited Act” in this final supplementary rule, which is the same as the substance of the proposed supplementary rule ( i.e., alcoholic beverages), would prohibit consumption, possession, or furnishing of “any beverage defined as an alcoholic beverage by Oregon State law while on public lands” within the boundaries of the Lower Lake Creek SRMA. In the proposed supplementary rule, the BLM explained that the existing supplementary rule is insufficient to control an increasing population of visitors who consume, possess, or furnish alcohol, and the proposed supplementary rule would put in place an enforceable ban on alcoholic beverages for all visitors, regardless of age.

The BLM received no comments on the proposed supplementary rule. The BLM signed a decision record on the Proposed Rules for public land within the Lower Lake Creek SRMA Environmental Assessment (DOI-BLM-ORWA-E050-2012-0002-EA), which was posted on the BLM's ePlanning website on October 11, 2016. The BLM received two comments during the environmental assessment's (EA) 30-day comment period. These commenters thanked the BLM for moving forward with a ban on alcoholic beverages at the Lower Lake Creek Falls SRMA.

This supplementary rule is not a significant regulatory action and is not subject to review by the Office of Management and Budget under E.O. 12866. This supplementary rule would not have an annual effect of $100 million or more on the economy. It is not intended to affect commercial activity but imposes a rule of conduct on recreational visitors for public safety in a limited area of public lands. This supplementary rule would not adversely affect, in a material way, the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal Governments or communities. This supplementary rule would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This supplementary rule does not materially alter the budgetary effects of entitlements, grants, user fees, or loan programs or the right or obligations of their recipients, nor does it raise novel legal or policy issues; it merely strives to protect public safety.

A ban on alcoholic beverages was analyzed in the EA titled “Proposed Rules for Public Land Within the Lower Lake Creek SRMA” (DOI-BLM-ORWA-E050-2012-0002-EA). This document was subject to a 30-day public comment period. On July 23, 2012, BLM determined that this supplementary rule did not constitute a major Federal action significantly affecting the quality of the human environment under section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. On October 11, 2016, BLM signed a decision record based on the EA, which analyzed a permanent restriction on consuming alcohol. This supplementary rule merely regulates conduct on the BLM lands administered by the Siuslaw Field Office within the boundaries of the Lower Lake Creek Falls SRMA in order to protect public safety. A detailed environmental impact statement under NEPA is not required.

The BLM reviewed and signed a Determination of NEPA Adequacy (DNA) in 2018 (DOI-BLM-ORWA-N030-2017-0005-DNA) after confirming that the EA's analysis is still valid. Circumstances in the SRMA have not changed since then.

The BLM has placed the EA, the decision record, the finding of no significant impact, and the DNA on file in the BLM administrative record at the address specified in the ADDRESSES section.

This final supplementary rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (RFA) of 1980, 5 U.S.C. 601, et seq. Congress enacted the RFA to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule would have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. The supplementary rule does not pertain specifically to commercial, not-for-profit, or governmental entities of any size, but to public consumption of alcoholic beverages on specific public lands.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(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; and

(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 supplementary rule does not impose an unfunded mandate on State, local, or Tribal Governments of more than $100 million per year; nor does it have a significant or unique effect on State, local, or Tribal Governments or the private sector. This supplementary rule does not impose requirements on State, local, or Tribal Governments. A statement containing the information required by the Unfunded Mandates Reform Act, 2 U.S.C. 1531 et seq., is not required.

This supplementary rule does not contain information collection requirements that the Office of Management and Budget must approve under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

This rule does not affect a taking of private property or otherwise have takings implications under E.O. 12630. This supplementary rule is not a Government action capable of interfering with constitutionally protected property rights. This supplementary rule does not address property rights in any form and does not cause the impairment of any private property rights. A takings implication assessment is not required.

Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. This supplementary rule will not have a substantial direct effect on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of Government. A federalism summary impact statement is not required.

This rule complies with the requirements of E.O. 12988. Specifically, the following rule:

(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. We have evaluated this rule under the Department's consultation policy and under the criteria in E.O. 13175 and have determined that it has no substantial direct effects on federally recognized Indian Tribes and that consultation under the Department's Tribal consultation policy is not required.

This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.

The principal author of this supplementary rule is Cheryl Adcock, Field Manager for the Siuslaw Field Office, Oregon/Washington.

For the reasons stated in the preamble, and under authority for supplementary rules at 43 U.S.C. 1740 and 43 CFR 8365.1-6, the BLM Oregon/Washington State Director establishes a supplementary rule for public lands administered by the BLM in Oregon/Washington, to read as follows:

Alcoholic beverage uses the definition set forth in 2017 ORS 471.001(1).

No person may consume, possess, or furnish alcoholic beverages within the boundaries of the Lower Lake Creek Falls SRMA, including, but not limited to, the parking lot, day-use area and surrounding hillside, Lower Lake Creek Falls swimming area, and pathways leading to the swimming area and falls site. Prohibited acts under this provision also include the consumption, possession, and furnishing of any alcoholic beverage within motor vehicles, tents, or other structures.

No persons, agencies, municipalities, or companies are exempt from the supplementary rule unless specifically authorized in writing by the BLM.

Any person who violates this supplementary rule may be tried before a United States magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both. In accordance with 43 CFR 8365.1-7, State or local officials also impose penalties for violations of Oregon law.

This document announces that OMB approved the information collection requirement in § 64.1200(o) on November 3, 2022.

The Commission publishes this document as an announcement of the compliance date of the rule.

If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3.317, 45 L Street NE, Washington, DC 20554. Please include the OMB Control Number, 3060-1303, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

This document also removes § 64.1200(p) of the Commission's rules, which advised that compliance was not required until OMB approval was obtained.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on July 20, 2022, for the information collection requirement contained in the modification to 47 CFR 64.1200(o).

Under 5 CFR 1320.5(b), an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirement in 47 CFR 64.1200(o) is 3060-1306.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Pubulic Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1306.

OMB Approval Date: November 3, 2022.

OMB Expiration Date: November 30, 2025.

Form Number: N/A.

Respondents: Business or other for-profit entities.

Number of Respondents: 6,493 respondents; 77,916 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: On-occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in sections 4(i), 4(j), 201, 202, 217, 227, 227b, 251(e), 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 201, 202, 217, 227, 227b, 251(e), 303(r), 403.

Total Annual Burden: 77,916 hours.

Total Annual Cost: No cost.

Needs and Uses: The notification and request for comments sought to establish a new information collection as it pertains to the Advanced Methods to Target and Eliminate Unlawful Robocalls Sixth Report and Order and Call Authentication Trust Anchor Fifth Report and Order (“Gateway Provider Report and Order”) (87 FR 42916, July 18, 2022). Unwanted and illegal robocalls have long been the Federal Communication Commission's (“Commission”) top source of consumer complaints and one of the Commission's top consumer protection priorities. Foreign-originated robocalls represent a significant portion of illegal robocalls, and gateway providers serve as a critical choke-point for reducing the number of illegal robocalls received by American consumers. In the Gateway Provider Report and Order, the Commission took steps to prevent these foreign-originated illegal robocalls from reaching consumers and to help track these calls back to the source. Along with further extension of the Commission's caller ID authentication requirements and Robocall Mitigation Database filing requirements, the Commission adopted several robocall mitigation requirements, including a requirement for gateway providers to respond to traceback within 24 hours, mandatory blocking requirements, a “know your upstream provider” requirement, and a general mitigation requirement.

Gateway Provider Report and Order, FCC 22-37, paras. 87-91, 47 CFR 64.1200(o).

A provider that serves as a gateway provider for particular calls must, with respect to those calls, block any calls purporting to originate from a number on a reasonable do-not-originate list. A list so limited in scope that it leaves out obvious numbers that could be included with little effort may be deemed unreasonable. The do-not-originate list may include only:

• Numbers for which the subscriber to which the number is assigned has requested that calls purporting to originate from that number be blocked because the number is used for inbound calls only;

• North American Numbering Plan numbers that are not valid;

• Valid North American Numbering Plan Numbers that are not allocated to a provider by the North American Numbering Plan Administrator; and

• Valid North American Numbering Plan numbers that are allocated to a provider by the North American Numbering Plan Administrator, but are unused, so long as the provider blocking the calls is the allocatee of the number and confirms that the number is unused or has obtained verification from the allocatee that the number is unused at the time of blocking.

This document also removes § 64.1200(p) of the Commission's rules, which advised that compliance was not required until OMB approval was obtained.

The Federal Communications Commission amends part 64 of title 47 of the Code of Federal Regulations as follows: