TCCA, which is the aviation authority for Canada, has issued TCCA AD CF-2020-41, issued October 15, 2020 (TCCA AD CF-2020-41) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The NPRM published in the Federal Register on April 16, 2021 (86 FR 20097). The NPRM was prompted by reports of IFESs; investigations are ongoing to determine the root cause. Investigation results indicated that an IFES could be caused by high altitude climbs at higher thrust settings on engines with certain thrust ratings. The NPRM proposed to require amending the existing AFM to incorporate a new limitation and revise certain normal procedures, as specified in TCCA AD CF-2020-41.

The FAA is issuing this AD to provide the flightcrew with information and procedures for operation above 29,000 feet to prevent uncontained failure of an engine during an IFES, which could result in structural damage and reduced structural integrity of the airplane. See the MCAI for additional background information.

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

The FAA received additional comments from one commenter. The following presents the comment received on the NPRM and the FAA's response.

Delta Air Lines Inc. (Delta) asked that the proposed AD also require amending the AFM with Supplement 21 at Issue 016 for Model A220-300 (BD-500-1A11) airplanes. Delta stated that the proposed AD requires amending the AFM with Supplement 21 for only Model A220-100 (BD-500-1A10) airplanes, and should include amending the AFM for both models.

The FAA agrees with the commenter's request. Paragraph (h)(2) of the proposed AD incorrectly identified only the A220-100 AFM. The FAA intended to require the AFM revision based on the applicable AFM for both Model BD-500-1A10 and BD-500-1A11 airplanes, including both the A220-100 and A220-300 AFMs. The FAA has added the AFM amendment for Model A220-300 (Model BD-500-1A11) airplanes to paragraph (h)(2) of this AD.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

The FAA also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

TCCA AD CF-2020-41 specifies procedures for amending the applicable AFM to incorporate a new limitation and revise the normal procedures to limit the engine N1 setting for flights above 29,000 feet.

Airbus Canada Limited Partnership has issued Supplement 21—Operation Above 29000 Feet, of Airbus A220-100 Airplane Flight Manual, Publication BD500-3AB48-22200-00, and Airbus A220-300 Airplane Flight Manual Publication BD500-3AB48-32200-00, both Issue 016, dated October 16, 2020. These supplements specify limitations, information, and procedures for operation above 29,000 feet. These documents are distinct since they apply to different airplane models.

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

The FAA estimates that this AD affects 42 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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

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

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

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

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

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

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

The Entity List (supplement no. 4 to part 744 of the EAR) identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States. The EAR (15 CFR parts 730-774) impose additional license requirements on, and limit the availability of most license exceptions for, exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License Review Policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document adding entities to the Entity List. BIS places entities on the Entity List pursuant to part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

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

This rule implements the decision of the ERC to add thirty-seven entities under forty entries to the Entity List. The thirty-seven entities are added based on § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The entities are located in the People's Republic of China (China), Georgia, Malaysia, and Turkey. Of the forty entries, thirty-four are located in China, three are located in Georgia, one is located in Malaysia, and two are located in Turkey. Three entities are listed under multiple destinations, accounting for the difference between the number of entities and number of entries in this final rule.

The ERC determined to add the Academy of Military Medical Sciences (AMMS) in China and eleven of its research institutes (the Institute of Health Service and Medical Information; the Institute of Radiation and Radiation Medicine; the Institute of Basic Medicine; the Institute of Hygiene and Environmental Medicine; the Institute of Microbiology and Epidemiology; the Institute of Toxicology and Pharmacology; the Institute of Medical Equipment; the Institute of Bioengineering; the Field Blood Transfusion Institute; the Institute of Disease Control and Prevention; and the Military Veterinary Research Institute) to the Entity List under the destination of China based on the body of information that AMMS and its eleven research institutes use biotechnology processes to support Chinese military end uses and end users, to include purported brain-control weaponry. This activity is contrary to U.S. national security and foreign policy interests under § 744.11(b) of the EAR.

The ERC determined to add China Electronics Technology Group Corporation 52nd Research Institute, Shaanxi Reactor Microelectronics Co. Ltd., Shanghai AisinoChip Electronics Co., Ltd., and Hangzhou Hikmicro Sensing Technology Co., Ltd. to the Entity List for their support of China's military modernization. This activity is contrary to national security and foreign policy interests under Section 744.11(b) of the EAR. In addition, the ERC determined to add HMN International, Jiangsu Hengtong Marine Cable Systems, Jiangsu Hengtong Optic-Electric, Shanghai Aoshi Control Technology Co., Ltd., and Zhongtian Technology Submarine Cable to the Entity List for acquiring and attempting to acquire U.S.-origin items in support of military modernization for the People's Liberation Army. This activity is contrary to national security and foreign policy interests under Section 744.11(b) of the EAR.

As determined by the ERC, Wavelet Electronics, Comtel Technology Limited, and HSJ Electronics are being added to the Entity List under the destination of China for actions contrary to the national security or foreign policy interests of the United States. Specifically, these companies have supplied or attempted to supply U.S.-origin items that could provide material support to Iran's advanced conventional weapons and missile programs to entities designated by the U.S. Department of the Treasury's Office of Foreign Assets Control as Specially Designated Nationals (SDN).

The ERC determined to add Aerosun Corporation, Changsha Jingjia Microelectronics Co., Ltd., Fujian Torch Electron Technology Co., Ltd., and Inner Mongolia First Machinery Group Co., Ltd. to the Entity List for their support of China's military modernization. This activity is contrary to national security and foreign policy interests under Section 744.11(b) of the EAR.

The ERC determined to add the following entities to the Entity List for their involvement in activities that are contrary to the national security and/or foreign policy interests of the United States: Hong Kong Cheung Wah Electronics Technology Company Limited, Hyper Systems Union Limited, Shenzhen Rion Technology, and Thundsea Electric Limited, under the destination of China; Gensis Engineering under the destinations of Georgia and Turkey; Integrated Scientific Microwave Technology under the destinations of China and Malaysia; ROV Solutions under the destinations of China and Georgia; SAEROS Safety ERO Company under the destination of Georgia; and Vangurd Tec Makina Sanyi Ithalat under the destination of Turkey. Specifically, these entities are a part of a network used to supply or attempt to supply Iran with U.S-origin items that would ultimately provide material support to Iran's defense industries, in violation of U.S. export controls.

Pursuant to § 744.11(b) of the EAR, the ERC determined that the conduct of the above-described entities raises sufficient concerns that prior review, via the imposition of a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR involving these thirty-seven entities and the possible issuance of license denials or the possible imposition of license conditions on shipments to these entities, will enhance BIS's ability to prevent violations of the EAR or otherwise protect U.S. national security or foreign policy interests.

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

For the reasons described above, this final rule adds the following thirty-seven entities under forty entries to the Entity List and includes, where appropriate, aliases:

• Academy of Military Medical Sciences;

• Academy of Military Medical Sciences, Field Blood Transfusion Institution;

• Academy of Military Medical Sciences, Institute of Basic Medicine;

• Academy of Military Medical Sciences, Institute of Bioengineering;

• Academy of Military Medical Sciences, Institute of Disease Control and Prevention;

• Academy of Military Medical Sciences, Institute of Health Service and Medical Information;

• Academy of Military Medical Sciences, Institute of Hygiene and Environmental Medicine;

• Academy of Military Medical Sciences, Institute of Medical Equipment;

• Academy of Military Medical Sciences, Institute of Microbiology and Epidemiology;

• Academy of Military Medical Sciences, Institute of Radiation and Radiation Medicine;

• Academy of Military Medical Sciences, Institute of Toxicology and Pharmacology;

• Academy of Military Medical Sciences, Military Veterinary Research Institute;

• Aerosun Corporation;

• Changsha Jingjia Microelectronics Co., Ltd.;

• China Electronics Technology Group Corporation 52nd Research Institute;

• Comtel Technology Limited;

• Fujian Torch Electron Technology Co., Ltd.;

• Hangzhou Hikmicro Sensing Technology Co., Ltd.;

• HMN International Co., Ltd.;

• Hong Kong Cheung Wah Electronics Technology Company Limited;

• HSJ Electronics;

• Hyper Systems Union Limited;

• Inner Mongolia First Machinery Group Co., Ltd.;

• Integrated Scientific Microwave Technology;

• Jiangsu Hengtong Marine Cable Systems Co., Ltd.;

• Jiangsu Hengtong Optic-Electric Co., Ltd.;

• ROV Solutions;

• Shaanxi Reactor Microelectronics Co., Ltd.;

• Shanghai Aisinochip Electronics Technology Co., Ltd.;

• Shanghai Aoshi Control Technology Co., Ltd.;

• Shenzhen Rion Technology;

• Thundsea Electric Limited;

• Wavelet Electronics; and

• Zhongtian Technology Submarine Cable Co.

• Gensis Engineering;

• ROV Solutions, and

• SAEROS Safety ERO Company.

• Integrated Scientific Microwave Technology.

• Gensis Engineering; and

• Vangurd Tec Makina Sanyi Ithalat.

The ERC determined to modify one existing entry on the Entity List, Huawei Technologies Co., Ltd. (Huawei), first added to the Entity list under the destination of China on May 2019 (84 FR 22963). Specifically, this rule adds three additional aliases (HMN Technologies, Huahai Zhihui Technology Co., Ltd., and HMN Tech) under one of its affiliated entities: Huawei Marine Networks.

Shipments of items removed from eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export, reexport, or transfer (in-country), on December 17, 2021, pursuant to actual orders for export, reexport, or transfer (in-country) to or within a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR).

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

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and commodity classification, and carries a burden estimate of 29.6 minutes for a manual or electronic submission for a total burden estimate of 31,835 hours. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule.

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

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

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

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

Upon request, FDA has classified the manual percutaneous surgical set assembled in the abdomen as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation.

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

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

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

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

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

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

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

For this device, FDA issued an order on August 26, 2011, finding the Percutaneous Surgical Set with 5mm or 10mm Attachments not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.

On September 21, 2011, FDA received Ethicon Endo-Surgery, Inc.'s request for De Novo classification of the Percutaneous Surgical Set with 5mm or 10mm Attachments. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on April 30, 2012, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 878.4805. 1 We have named the generic type of device manual percutaneous surgical set assembled in the abdomen, and it is identified as a prescription device consisting of a percutaneous surgical set used as a means to penetrate soft tissue to access certain areas of the abdomen. The device's effectors or attachments are provided separately from the percutaneous shaft and are introduced to the site via a traditional conduit such as a trocar. The attachment or effectors are connected to the shaft once the tip of the shaft is inside the abdomen. Once inside the abdomen, the surgical set is used to grasp, hold, and manipulate soft tissues. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in 21 CFR parts 868 through 892.

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

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, manual percutaneous surgical sets assembled in the abdomen are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

This final rule removes 32 CFR part 901, “Appointment to the United States Air Force Academy,” which was originally published on June 26, 1986 (51 FR 23221), and has not since been updated. Part 901 is outdated, contains internal guidance, reiterates statutory law, and is otherwise subject to the military function exemption to rulemaking. Current policy is provided individually to applicants and is contained in Air Force Manual 36-2032, Military Recruiting and Accessions, September 27, 2019 (available at https://static.e-publishing.af.mil/production/1/af_a1/publication/afman36-2032/afman36-2032.pdf ). Accordingly, this part is unnecessary and can be removed from the CFR. It has been determined that publication of this CFR part removal for public comment is impracticable and contrary to the public interest because it is based on removing outdated and unnecessary content. This rule is not significant under Executive Order 12866, Sec 3, “Regulatory Planning and Review.”

The Under Secretary of the Air Force, Ms. Gina Ortiz Jones, having reviewed and approved this document, is delegating the authority to electronically sign this document to Mr. Tommy W. Lee, who is the Air Force Federal Register Liaison Officer, for purposes of publication in the Federal Register .

On December 9, 2021, Skanska-Corman-McLean, Joint Venture, notified the Coast Guard that the company will be setting structural steel sections across the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge. The bridge contractor stated the work required to set structural steel across the channel, originally scheduled to occur in November 2021, and rescheduled to December 2021, is now scheduled to occur from January 3, 2022, through January 15, 2022. The work described by the contractor requires the movement in and anchoring at multiple points of a large crane barge within the federal navigation channel. This crane can accommodate all of the steel to be hoisted and placed, which will streamline the operation by avoiding multiple reloads of steel and reducing the time in the channel by multiple days. This operation will impede vessels requiring the use of the channel. Note, the Coast Guard has previously issued other temporary safety zones at this location for placement of fender ring elements in association with construction of the new bridge (USCG-2021-0127; USCG-2021-0650; and USCG-2021-0745).

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. Construction operations involving large crane heavy lifts at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge must occur within the federal navigation channel. Immediate action is needed to respond to the potential safety hazards associated with bridge construction. Hazards from the construction operations include low-hanging or falling ropes, cables, large piles and cement cast portions, dangerous projectiles, and or other debris. We must establish this safety zone by January 3, 2022, to guard against these hazards.

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 and contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with construction operations at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge to be conducted within the federal navigation channel.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that potential hazards associated with bridge construction starting January 3, 2022, will be a safety concern for anyone within the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge construction site. 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 constructed.

This rule establishes a temporary safety zone from 7 a.m. on January 3, 2022, until 8 p.m. on January 15, 2022. The safety zone will cover all navigable waters of the Potomac River encompassed by a line connecting the following points beginning at 38°21′50.96″ N, 076°59′22.04″ W, thence south to 38°21′43.08″ N, 076°59′20.55″ W, thence west to 38°21′41.00″ N, 076°59′34.90″ W, thence north to 38°21′48.90″ N, 076°59′36.80″ W, and east back to the beginning point, located between Charles County, MD and King George County, VA.

The duration of the zone is intended to protect personnel and the marine environment in these navigable waters while structural steel is being set across the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge.

Except for marine equipment and vessels operated by Skanska-Corman-McLean, Joint Venture, or its subcontractors, no vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Maryland-National Capital Region or a designated representative.

The COTP Maryland-National Capital Region will notify the public that the safety zone will be enforced by all appropriate means to the affected segments of the public, as practicable, in accordance with 33 CFR 165.7(a).

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 size and duration of the safety zone. The temporary safety zone is approximately 450 yards in width and 270 yards in length. We anticipate that there will be no vessels that are unable to conduct business. Excursion vessels and commercial fishing vessels are not impacted by this rulemaking. Excursion vessels do not operate in this area, and commercial fishing vessels are not impacted because of their draft. Some towing vessels may be impacted, but bridge project personnel have been conducting outreach throughout the project in order to coordinate with those vessels. Vessel traffic not required to use the navigation channel will be able to safely transit around the safety zone. Such vessels may be able to transit to the east or the west of the federal navigation channel, as similar vertical clearance and water depth exist under the next bridge span to the east and west. This safety zone will impact a small designated area of the Potomac River for 13 days, but coincides with the non-peak season for recreational boating.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the temporary 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 a temporary safety zone lasting 13 total days that will prohibit entry within a portion of the Potomac River. It is categorically excluded from further review under paragraph L60(a) 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:

The Coast Guard will enforce the safety zone in 33 CFR 165.1198 for the Military Ocean Terminal Concord regulated area from December 17, 2021 from 12:01 a.m., until December 21, 2021, at 11:59 p.m., or as announced via marine local broadcasts. This safety zone is necessary to protect personnel, vessels, and the marine environment from potential explosion within the explosive arc. Our regulation for this safety zone, § 165.1198, specifies the location of the safety zone which encompasses the navigable waters in the area between 500 yards of MOTCO Pier 2 in position 38°03′30″ N, 122°01′14″ W and 3,000 yards of the pier. During the enforcement periods, as reflected in § 165.1198(d), if you are the operator of a vessel in the regulated area you must comply with the instructions of the COTP or the designated on-scene patrol personnel. Vessel operators desiring to anchor or otherwise loiter within the safety zone must contact Sector San Francisco Vessel Traffic Service at 415-556-2760 or VHF Channel 14 to obtain permission.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners, and marine information broadcasts.

The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 24, for the San Francisco New Year's Eve Firework Display from noon on December 31, 2021 through 12:45 a.m. on January 1, 2022. The Coast Guard will enforce a 100-foot safety zone around the two fireworks barges during the loading, standby, transit, and arrival of the fireworks barges from the loading location to the display location and until the start of the fireworks display. On December 31, 2021, the fireworks barges will be loaded with pyrotechnics at Pier 50 in San Francisco, CA from appoximately noon until approximately 6 p.m. The fireworks barges will remain on standby at the loading location until their transit to the display location. From 10:45 p.m. to 11:15 p.m. on December 31, 2021 the loaded fireworks barges will transit from Pier 50 to the launch site near the San Francisco Ferry Plaza in approximate position 37°47′45″ N, 122°23′15″ W (NAD 83), where they will remain until the conclusion of the fireworks display. At approximately 11:59 p.m. on December 31, 2021, 15-minutes prior to the fireworks display, the safety zone will expand to encompass all navigable waters, from surface to bottom, within a circle formed by connecting all points 1,000 feet out from the fireworks barges. The firework barges will be near the San Francisco Ferry Plaza in San Francisco, CA in approximate position 37°47′45″ N, 122°23′15″ W (NAD 83) as set forth in 33 CFR 165.1191, Table 1, Item number 24. The safety zone will be enforced until 12:45 a.m. on January 1, 2022, or as announced via Broadcast Notice to Mariners.

In addition to this notification in the Federal Register , the Coast Guard plans to provide notification of the safety zone and its enforcement period via the Local Notice to Mariners.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM or other Official Patrol, defined as a federal, state, or local law enforcement agency on scene to assist the Coast Guard in enforcing the regulated area. Additionally, each person who receives notice of a lawful order or direction issued by the PATCOM or Official Patrol shall obey the order or direction. The PATCOM or Official Patrol may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

EPA's lead drinking water rules are a critical part of reducing the lead exposure for consumers of tap water in the United States. Lead poses serious health risks to both children and adults. Because lead in drinking water primarily results from leaching of lead from plumbing in homes and from lead service lines (lead pipes connecting homes to the water distribution system), and portions of lead service lines may be owned by the water system or homeowner, the drinking water rules intended to reduce the amount of lead in tap water have been complex and controversial. The latest version of those rules, the Lead and Copper Rule Revisions (LCRR), published in January 2021, is no exception.

In compliance with the Biden Administration executive order to review rules issued in the past Administration, EPA undertook an extensive review of the LCRR and delayed the effective and compliance dates in the rule during the review period. To get comprehensive input, EPA talked with states, tribes, water utilities, as well as people who have been underrepresented in past rule-making efforts. EPA sought input from communities disproportionately impacted by lead in drinking water, especially lower-income people and communities of color, to learn from their experiences. The broad range of thoughtful input EPA received provided valuable insights on ways to improve the LCRR, and more generally, other available tools to address lead in drinking water.

Based upon EPA's evaluation and stakeholder feedback, the agency has concluded that EPA actions to protect the public from lead in drinking water should consider the following policy objectives: Replacing 100 percent of lead service lines (LSLs) is an urgently needed action to protect all Americans from the most significant source of lead in drinking water systems; equitably improving public health protection for those who cannot afford to replace the customer-owned portions of their LSLs; improving the methods to identify and trigger action in communities that are most at risk of elevated drinking water lead levels; and exploring ways to reduce the complexity of the regulations.

To achieve these policy objectives, EPA intends to take the following regulatory and non-regulatory actions: First, EPA intends to propose for public comment a new rule to revise the LCRR to advance the goals described above while balancing stakeholder interests and incorporating required economic, environmental justice, and other analyses. A regulatory framework that addresses these considerations, combined with the other actions described in this document, has the potential to permanently eliminate the most significant source of lead contamination, better target other actions to reduce lead exposure where the highest risks are presented, and provide equitable protections to all Americans. At the same time, because the LCRR provides additional protections relative to the pre-existing rule and contains components (such as the LSL inventory) that supports any future rule, EPA is not further extending the effective date of the LCRR. Therefore, as explained herein, compliance with certain key provisions of the LCRR will not be delayed while the rulemaking is underway.

Because regulatory actions alone may not be adequate to achieve these policy objectives, this document also discusses important non-regulatory actions EPA intends to take, including programs to provide technical assistance and infrastructure funding.

On January 15, 2021, EPA published the “National Primary Drinking Water Regulation: Lead and Copper Rule Revisions” in the Federal Register (86 FR 4198) (LCRR). On January 20, 2021, President Biden issued the “Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.” (86 FR 7037, January 25, 2021) (Executive Order 13990). Section 1 of Executive Order 13990 states that it is “the policy of the Administration to listen to the science, to improve public health and protect our environment, to ensure access to clean air and water . . . , and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.” Executive Order 13990 directs the heads of all Federal agencies to immediately review regulations that may be inconsistent with, or present obstacles to, the policy it establishes. On June 16, 2021, EPA published the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective and Compliance Dates (86 FR 31939), which delayed the LCRR effective date until December 16, 2021, and the compliance date until October 16, 2024. During EPA's review, while the LCRR was delayed, EPA engaged with stakeholders to better understand their thoughts and concerns about the LCRR.

EPA heard significant concerns from many drinking water stakeholders about the LCRR. These concerns included whether the rule will adequately protect public health, the confusion it might create about drinking water safety, and the implementation burden that will be placed on systems and states. Stakeholders also expressed concerns that EPA did not provide adequate opportunities for a public hearing in the development of the LCRR that was published on January 15, 2021 (86 FR 4198), and did not provide a complete or reliable evaluation of the costs and benefits of the proposed LCRR. The delay in the effective date of the LCRR enabled the Agency to engage meaningfully with the public regarding this important public health regulation before it took effect.

Lead exposure is a critical public health issue. Its adverse effects on children and the general population are serious and well known. Lead has acute and chronic impacts on the body. Lead exposure causes damage to the brain and kidneys and may interfere with the production of red blood cells that carry oxygen to all parts of the body. 1 The most susceptible life-stages are the developing fetus, infants, and young children. The Centers for Disease Control and Prevention (CDC) states that “no safe blood lead level in children has been identified.”  2 Because they are growing, children's bodies absorb more lead than adults do, and their brains and nervous systems are more sensitive to its damaging effects. As a result, even low-level lead exposure is of particular concern to children.

The association between lead and adverse cardiovascular effects, renal effects, reproductive effects, immunological effects, neurological effects, and cancer has been documented in the EPA 2013 Integrated Science Assessment for Lead, 3 the U.S. Department of Health and Human Services (HHS) National Toxicology Program (NTP) Monograph on Health Effects of Low-Level Lead, 4 and the Agency for Toxic Substances and Disease Registry (ATSDR) 2020 Toxicological Profile for Lead. 5 EPA's Integrated Risk Information System (IRIS) Chemical Assessment Summary provides additional health effects information on lead.

The environmental justice analysis for the final LCRR found that minority and low-income populations appear to be disproportionately exposed to the risks of lead in drinking water delivered by community water systems. 6 LSLs are typically the primary source of lead in drinking water, 7 meaning their presence is likely a driver of this disproportionate exposure given that these populations tend to live in older housing where LSLs are more likely to have been installed. Because of disparities in the quality of housing, community economic status, and access to medical care, lower-income people are also disproportionately affected by lead from other media. For example, children of color and children in low-income communities are more likely to live in proximity to lead-emitting industries and to live in urban areas, which are more likely to have contaminated soils, contributing to their overall exposure (Leech et al., 2016  8 ). Additionally, non-Hispanic black people are more than twice as likely as non-Hispanic whites to live in moderately or severely substandard housing, which is more likely to present risks from deteriorating lead-based paint (Leech et al., 2016; White et al., 2016). 9 The disparate exposure to all sources of environmental lead experienced by low-income people and communities of color may be exacerbated because of their more limited resources for remediating LSLs, which can be a significant source of lead exposure. In addition, a higher incidence of rental housing in these communities creates an additional barrier to lead service line replacement (LSLR) where the property owner does not consent to full replacement.

EPA reviewed the LCRR in light of the serious stakeholder concerns about it; the adverse health effects of lead; and the potential environmental justice issues associated with lead exposure. For a more detailed explanation of the decision to review the LCRR, see “National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective and Compliance Dates” (86 FR 31939) (June 16, 2021); “National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective and Compliance Dates” (86 FR 14063) (March 12, 2021); and “National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective Date” (86 FR 14003) (March 12, 2021).

EPA hosted a series of virtual engagements from April to August 2021 to obtain public input on the review of the LCRR. EPA also opened a docket, from April 5, 2021 to July 30, 2021, to accept written comments, suggestions, and data from the public. Summaries of these engagements, including summaries of the meetings and written comments, can be found in the docket, EPA-HQ-OW-2021-0255 at https://www.regulations.gov/. Recordings of the public listening sessions and community, tribal, and national stakeholder association roundtables can also be found in the docket. The virtual engagement meetings included two public listening sessions, ten community roundtables, a tribal roundtable, a national stakeholder association roundtable, a national co-regulator meeting, and a meeting with organizations representing elected officials. A diverse group of individuals and associations provided feedback through these meetings and the docket, including people from communities impacted by lead in drinking water, local governments, water utilities, tribal communities, public health organizations, environmental groups, environmental justice organizations, and co-regulators.

EPA specifically sought engagement with communities that have been disproportionately impacted by lead in drinking water, especially lower-income people and communities of color that have been underrepresented in past rule-making efforts. EPA hosted roundtables with individuals and organizations from Pittsburgh, PA; Newark, NJ; Malden, MA; Washington, DC; Newburgh, NY; Benton Harbor and Highland Park, MI; Flint and Detroit, MI; Memphis, TN; Chicago, IL; and Milwaukee, WI. These geographically-focused roundtables included a range of participants including local government entities, community organizations, environmental groups, local public water utilities, and public officials. EPA worked with community representatives to develop meeting agendas that reflected community priorities. Each community roundtable included a presentation by local community members. EPA held a separate roundtable with representatives from tribes and tribal communities. Participants in all roundtables were invited to share diverse perspectives with the agency through verbal discussion and a chat feature. EPA obtained detailed, valuable feedback from these engagements, which often focused on the lived experiences of people impacted by lead in drinking water.

Many commenters, in their statements at virtual engagements and in their written materials provided to the docket, expressed concern that the LCRR would not provide equitable public health protections and would be difficult to implement. Commenters also provided many suggestions beyond the LCRR to reduce drinking water lead exposure.

While commenters provided feedback on all aspects of the LCRR, most comments focused on LSLR, the action level (AL) and trigger level (TL), tap sampling, public education, and sampling for lead in schools and child-care facilities. Each of these topics are discussed in more detail below.

Lead Service Line Replacement: Nearly all commenters expressed support for the goal of full replacement of all the nation's lead service lines. Many commenters raised concerns regarding LSLR and the financial and public health burdens placed on communities. Some participants noted the frequent split ownership of LSLs between water systems and property owners and that the LCRR does not prohibit partial replacements in which the private LSL remains in place if a customer is unwilling or unable to replace the private-side LSL. Partial replacements can cause elevated lead levels due to the physical disturbance associated with the practice as well as the potential for galvanic corrosion with the new portion of the service line. Frequent suggestions included: A regulatory requirement for water systems to proactively replace all LSLs over a defined time period ( e.g., 10-15 years) regardless of drinking water lead levels, a ban on all or certain partial replacements, and increased financial support for LSLR coordinated across Federal agencies. One participant also suggested the use of opportunity zone funds to provide tax incentives for replacement. Some commenters did not support a complete ban on partial LSLR, stating that there are some situations where they are necessary and that risk mitigation steps can reduce lead levels associated with partial replacements while maintaining water service for drinking, basic sanitation, and fire suppression purposes. Many commenters expressed that individual homeowners should not be asked to pay for the replacement of any part of an LSL. Many commenters also expressed the need for equitable distribution of funding for LSLR, noting that low-income people and communities of color are disproportionately served by LSLs and lack the resources to replace them. Commenters expressed the need for state and federal assistance, cautioning that funding LSLR by rate revenue could disproportionately affect low-income households given potential impacts on water rates. Some commenters also discussed potential barriers to private-side replacement, including local or state ordinances that may limit water system access to private property, restrictions on using rate revenue for such projects, or the possibility that customers may decline replacement even when available at no cost to them. Many commenters also observed that renters lack the ability to compel the replacement of the portions of LSLs that are owned by their landlords. Additionally, a few commenters cautioned that only conducting LSLR in conjunction with existing planned infrastructure projects may result in LSLs remaining in communities that have experienced historic disinvestment, particularly communities of color. Several commenters also expressed support for strengthening the LSL inventory requirements, including setting a deadline for identifying service line material and including lead connectors in the definition of a LSL for purposes of the inventory.

Action Level (AL): Most commenters expressed concern that the LCRR did not lower the lead AL. Some requested that EPA reconsider setting a Maximum Contaminant Level (MCL) for lead at 5 parts per billion (ppb) and that the agency reduce the AL ( e.g., 10, 5, or 1 ppb) if an MCL is not set. These commenters stated that the MCL or AL should be lowered to compel more systems to take actions to reduce drinking water lead exposure. Several commenters suggested removing the TL and reducing the AL to 10 ppb, noting that the use of two regulatory values would create confusion and be onerous to implement. These commenters noted that adding a TL that compels similar but different actions for LSLR, corrosion control, and public education creates confusion regarding which actions systems must take. Some commenters noted that the TL and AL also create confusion regarding health risks since neither is a health-based number. Some commenters discussed high childhood blood lead levels in their communities, noting that health impacts occur at levels much lower than the AL. Others did not support reducing the AL from 15 ppb, citing feasibility and the burden on water systems.

Tap Sampling: Many commenters expressed support for requiring first and fifth liter samples in homes served by LSLs and using the samples with the highest levels of lead in 90th percentile calculations. Commenters emphasized the need to prioritize the most at-risk populations in tap sample site selection. Several commenters recommended allowing water systems to maintain existing compliance tap sampling schedules.

Public Education Materials: A common recommendation was that the LCRR should require accessible public education materials and outreach to residents about lead risk. EPA was urged to ensure that public education information is provided in multiple languages and appropriate for people with different reading levels. Many commenters also called for more proactive communication about lead in drinking water and for clarity in general communications from water systems regarding the potential for lead in drinking water. Multiple commenters emphasized the need for public education targeted specifically towards renters. Commenters suggested that regulators and water systems should partner with local trusted messengers and organizations to conduct community outreach. There were also many commenters who expressed concerns with the number of public education and notification requirements. Some recommended streamlining the requirements and reducing certifications to primacy agencies.

Water Testing in Schools and Child-Care Facilities: Some commenters identified the inherent shortcomings of the LCRR's schools and child-care lead testing requirement given the statutory limitations of the Safe Drinking Water Act. Commenters recommended that more coordination between the water system and relevant entities, such as child-care facilities and state or local licensing entities, could improve outcomes. Many commenters recommended expansion of the requirements for water system-conducted lead testing in schools and child-care facilities. These recommendations included requiring sampling all elementary and secondary schools, more frequent sampling at more taps, making results public, and requiring remediation measures or installation of filters. Other commenters expressed concern regarding the ability of schools and child-care facilities to address lead issues given the potential associated financial, technical, and staff burdens. Some commenters also requested that EPA allow previous school and child-care sampling efforts to count towards the LCRR requirement while a few others stated that water systems should not be responsible for sampling in schools and child-care facilities.

Additional Comments: EPA also received comments on other areas of the LCRR, including corrosion control treatment (CCT) related requirements, “find-and-fix” (see below), and small system flexibility. On CCT, commenters requested:

• More flexibility in CCT requirements;

• Additional oversight of CCT decisions;

• Additional water quality parameter (WQP) monitoring; and

• More frequent monitoring after source or treatment changes.

Multiple commenters expressed support for the intention of find-and-fix provisions, which require water systems to follow up with customers where tap sampling was conducted to identify the cause of a lead sample exceeding 15 ppb. Some commenters raised potential implementation challenges for find-and-fix requirements including cases of repeat exceedances and customer inability or unwillingness to address lead in premise plumbing. Commenters supported limiting the flexibility provided by the small system options. Many commenters also requested timely guidance on a range of rule topics, including LSL inventory development, tap sampling site selection, CCT, and find-and-fix.

Most commenters requested that EPA revise the LCRR, citing inadequate health protection. However, some commenters urged EPA to implement the LCRR as finalized, and requested that if the agency makes further revisions that it suspend compliance dates, citing regulatory uncertainty.

Based upon EPA's evaluation and stakeholder feedback, EPA has determined that there is a range of potential regulatory and non-regulatory actions the agency can take to further reduce drinking water lead exposure.

EPA finds that although the LCRR improves public health protection in comparison to the previous version of the rule, there are significant opportunities to further improve upon it to achieve increased protection of communities from lead exposure through drinking water. Specifically, after hearing from stakeholders, including during the engagements that took place over the last nine months, the agency has concluded that regulations and other non-regulatory actions to protect the public, from lead in drinking water, should consider: The urgent need to replace LSLs as quickly as possible to protect all Americans from the most significant source of drinking water lead,; equitably improving public health protection for those who cannot afford to replace the customer-owned portions of their LSLs; and improving the methods to identify and trigger action in communities that are most at risk of elevated drinking water lead levels. A framework including regulatory and nonregulatory actions to address these considerations has the potential to permanently eliminate the most significant sources of drinking water lead contamination, better target other actions to reduce lead exposure to where the highest risks are presented, and provide equitable protections to all Americans. Accordingly, EPA intends to propose for public comment a rulemaking to revise the LCRR as part of its overall strategy to advance these policy goals while balancing stakeholder interests, and incorporating required economic, environmental justice, and other analyses, and to take other steps towards these goals. And, as with any rulemaking, EPA will maintain an open mind and looks forward to receiving comments on its proposed new rule. Each of these considerations is discussed more fully below.

First, our review impressed upon the agency the urgency of fully removing all lead service lines using any and all regulatory and non-regulatory tools available to EPA and its federal partners. Leaving millions of LSLs in place would result in generations of Americans being at risk of significant lead exposure through their drinking water. Where present, LSLs are the most significant source of drinking water lead exposure. 10 These LSLs present a risk of sustained lead exposure through drinking water, which presents a risk of damage to the brains of children and the kidneys and other critical functions of adults. EPA estimates that the LCRR would result in replacements of only approximately five percent of LSLs over a 35-year period. Our review leads the agency to believe that there are opportunities to do significantly more to address this urgent public health risk. EPA plans to seek comment on how revisions to the LCRR could advance the Administration's priority of removing 100 percent of LSLs.

Second, based on EPA's review of the LCRR, the agency believes there are significant potential opportunities to revise the LCRR to ensure that it equitably improves public health protection for all, regardless of their economic status, to avoid exacerbating existing health and economic inequalities. To reach this goal, EPA will explore potential regulatory revisions in combination with financial assistance programs and partnerships targeted to disadvantaged consumers, regardless of whether they are homeowners, in an effort to direct limited community resources towards low-income households that have been historically underserved. Communities such as Newark, New Jersey, and Flint, Michigan have shown that full LSLR can be equitably achieved when there is both a regulatory requirement and a commitment to prioritize funding.

Third, EPA's review of the LCRR leads the agency to conclude that there are opportunities to better identify the communities that are most at risk of elevated drinking water lead levels and explore ways to compel action before consumers have been put at risk, rather than only after a lead action level exceedance. Specifically, EPA is considering potential revisions to the LCRR to expeditiously compel steps to replace lead service lines and ensure that the higher tap sampling result is used for measuring compliance, including levels found in the service line or in plumbing fixtures inside homes. In addition, EPA is considering potential revisions to the LCRR to reduce complexity from the lead action and trigger levels in particular and ensure that the rule is easily understandable and triggers appropriate and feasible corrective actions.

To protect public health and fully and equitably meet the requirements of the Safe Drinking Water Act, the agency intends to propose for comment revisions to the Lead and Copper Rule and to undertake non-regulatory actions. This section describes the potential improvements to the LCRR that EPA plans to explore through a notice and comment rulemaking and additional actions EPA is contemplating to ensure greater public health protection from lead in drinking water.

EPA intends to immediately begin to develop a proposed National Primary Drinking Water Regulation: Lead and Copper Rule Improvements (LCRI) to address the issues identified in the E.O. 13990 review. EPA will follow all Safe Drinking Water Act (SDWA) and other relevant statutory and E.O. requirements in proposing the LCRI and taking final action on the proposal, including all necessary economic and environmental justice analyses and the consideration of alternatives and public comment. EPA intends to take final action on the LCRI proposal prior to the October 16, 2024 compliance date of the existing regulations ( i.e., the LCRR); the implications for compliance and primacy applications under the LCRR are discussed in detail below in Section IV.B. This schedule ensures that as little time as possible is lost before the improved public health protections of the LCRR and the LCRI can be realized in communities across the country.

EPA intends to propose changes to the LCRR to address the main opportunities for improvement identified in our review, as well as consider other potential improvements. These are described below.

First, there is a significant opportunity to improve the LCRR with regard to replacement of LSLs. Under the LCRR, water systems are only required to replace a small percentage of their LSLs and only after their customers are exposed to high lead levels. Water systems serving more than 10,000 people with more than 10 percent of samples above the action level of 0.015 mg/L need only replace 3 percent of their LSLs per year. These systems may stop their LSLR programs in as little as two years if the system meets the action level in four consecutive 6-month monitoring periods. Large systems with 90th percentile lead concentrations above the trigger level of 0.010 mg/L are only required to replace LSLs at a goal rate approved by the state. EPA projected that goal rate would likely be lower than 3 percent (USEPA, 2020). 11 Systems may stop these goal-based LSLR programs in as little as one year if the system meets the trigger level in two consecutive 6-month monitoring periods. Ultimately, most systems would be required to replace only a small portion of the LSLs in their distribution system: EPA projected that only 339,000 to 555,000 LSLs (out of 6.3 to 9.3 million LSLs) would be replaced over the 35-year period of analysis for the rulemaking (USEPA, 2020). This Administration believes it is an urgent priority to eliminate all LSLs to improve the health of our people. President Biden has called for replacement of all LSLs in the nation, which will improve public health while putting Americans to work. 12 To help achieve this goal, the recently enacted Bipartisan Infrastructure Law (BIL) provides $15 billion in funding over the next five years for LSLR.

Given the serious risks of lead exposure through drinking water, replacing all LSLs is an important policy goal. The States of Michigan, Illinois, and New Jersey have recently passed laws requiring all of their water systems to proactively replace lead service lines. These are three of the five states with the highest estimated numbers of LSLs according to a 2016 national survey (Cornwell 2016). 13 Cornwell 2016 reported that the sum of the estimated number of LSLs in these three states is just over one-fourth of the remaining estimated number of LSLs in the country.

EPA is mindful however, that the existing LCRR requirements and action by selected states and federal funding incentives may not be sufficient to achieve 100 percent replacement of LSLs and reduce risks to families living in the homes served by these lines without additional actions. Therefore, EPA intends to propose for comment requirements that, along with other, non-regulatory actions, would result in the replacement of all LSLs as quickly as is feasible. EPA's proposal will fully consider the agency's statutory authority and required analyses, including an economic and environmental justice analysis.

Second, there are important opportunities to ensure that public health is protected equitably. The cost of replacing the customer-portion of an LSL may leave the most vulnerable Americans disproportionately exposed to lead if they cannot afford the expense of replacement. In the Economic Analysis for the final LCRR (USEPA, 2020), EPA estimated that between 21 and 28 percent of the anticipated LSLRs under the LCRR would be customer-initiated replacements. Those are replacements where the system replaces the public portion of an LSL after being notified that a homeowner has replaced the private portion of the service line. The remaining LSLR predicted under the LCRR would be done by systems that exceed the action level or trigger level. To meet the LCRR's mandatory 3 percent replacement or state-approved goal rate, some systems may focus on replacing lines where the customer could pay to replace their portion of the line.

To address both of these issues, EPA intends to propose for comment rule revisions to advance the policy goal to prioritize distributional impacts. For instance, EPA intends to explore how to replace LSLs in a manner that prioritizes historically disadvantaged communities. Through the regulatory development process, EPA will also evaluate options to partner and provide financial assistance and prioritize the removal of LSLs in communities disproportionately impacted by lead in drinking water. EPA is also committing to partnering on a number of non-regulatory actions to address this issue of the cost of LSLR on consumers (see Section IV.C of this document).

The goal of these potential LSLR regulatory improvements and non-regulatory actions is to equitably improve public health protection and remove the most significant source of lead in drinking water.

There are also significant potential opportunities to identify the communities that are most at risk of experiencing elevated levels of lead in drinking water and compel actions sufficient to reduce the health risks in those communities. At sites with LSLs, the LCRR requires a fifth liter sample to be analyzed for lead to better characterize the lead which has been introduced while the water was in contact with the LSL, as opposed to the building premise plumbing. It also requires a first liter sample to be analyzed for copper when copper is also being monitored at those sites. For non-lead LSL sites, a first liter sample is analyzed for both lead and copper. The State of Michigan revised its Lead and Copper Rule in 2018 to require the first and fifth liter samples to be analyzed for lead at sites with LSLs, with the higher of the two results used for the 90th percentile calculation. The Association of State Drinking Water Administrators, in their May 21, 2021 comments, summarized data from the initial round of sampling in Michigan. Using the highest number from the first and fifth liters, 31 systems had an action level exceedance. When just the fifth liter results were used, only 22 systems had an action level exceedance. EPA will explore these and other available data in developing potential revisions to strength compliance tap sampling in the forthcoming LCRI proposal.

In the forthcoming proposed LCRI, EPA also intends to evaluate options for utilities to address lead contamination at lower levels and improve sampling methods to provide better health protection and more effective implementation of the rule. The agency will evaluate options to consolidate and potentially lower the LCRR's action and trigger levels. Stakeholders participating in the virtual engagement identified the action level/trigger level concept as the central regulatory variable that drives system and state action to reduce elevated lead levels in drinking water and many stakeholders commented that the action level should be lower to require more systems to take corrective action to protect public health from the adverse effects of lead. In the forthcoming proposed LCRI, the agency will explore options to address these concerns, including whether to eliminate the trigger level and lower the action level to compel action by water systems sooner to reduce the health risks in more communities. The agency will also evaluate whether the trigger level requirements of the LCRR would still be necessary if improved proactive LSLR and a more aggressive lower action level are adopted.

EPA intends to primarily focus its rulemaking process on proposing approaches aimed at the policy goal of proactive and equitable LSLR, as well as proposals to address compliance tap sampling improvements; re-evaluation of the action and trigger levels; and consideration of prioritizing protections for historically disadvantaged communities. The agency also received stakeholder input suggesting improvements to a number of additional components of the LCRR. EPA will also be considering these suggestions and other options to equitably improve public health protection and improve implementation of the rule to ensure that it prevents adverse health effects of lead to the extent feasible. These additional components may include the LCRR provisions for small system flexibility, school and child-care sampling, risk communication, and corrosion control treatment. EPA will also consider addressing these issues through non-regulatory actions such as the development of implementation tools, guidance, and other federal programs.

The final agency action, National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective and Compliance Dates (published on June 16, 2021 in the Federal Register (86 FR 31939)), delayed the effective date of the LCRR until December 16, 2021 and the compliance date until October 16, 2024. Following the LCRR review, EPA has decided to not delay the effective date any further. At this time, EPA is also not planning to further change the compliance dates for the LCRR. EPA will consider any such changes through its forthcoming rulemaking. While EPA has identified components of the LCRR for potential revision to improve public health protection, the agency has also determined that the LCRR includes advancements that should proceed in order to ensure continued progress toward reducing drinking water lead exposure.

The current compliance deadline for the LCRR is thus October 16, 2024. EPA intends to propose, in the LCRI, revisions to the compliance deadlines only for components of the rule that the agency will propose to significantly revise. At this time, EPA does not expect to propose changes to the requirements for information to be submitted in the initial LSL inventory or the associated October 16, 2024 compliance date. Continued progress to identify LSLs is integral to lead reduction efforts regardless of potential revisions to the rule. The inventory provides critical information on the locations of potentially high drinking water lead exposure within and across public water systems, which will allow for quick action to reduce exposure. By preparing an LSL inventory, water systems will be able to target communication to residents in homes with LSLs about the actions they can take to reduce their lead exposure. Preparing the initial inventory will allow systems to assess the extent of the LSLs within their system, better identify sampling locations, and begin planning for LSLR actions, including applying for state and federal grants and loans. LSL inventories will allow water systems, states, tribes, and the Federal government to determine the prevalence of these lead sources and to target lead risk communication and lead removal programs where they are needed most. With the development of these initial inventories nationwide over the next three years, EPA anticipates that water systems, states and tribes will be prepared to quickly implement the other LCRR requirements, as well as any improvements made through the planned LCRI rulemaking that may be adopted to further reduce drinking water lead levels, and be well-positioned to apply for any available grants or loans for LSLR.

There are two other actions that water systems currently must complete by the LCRR's October 16, 2024 compliance date: the LSLR plan and the tap sampling plan. The LSLR plan would describe the procedure for systems to conduct lead service line replacements in accordance with the LCRR and the tap sampling plan would identify the locations and procedures for systems to conduct tap sampling in accordance with the LCRR. Because EPA intends to propose changes to the LSLR and tap sampling requirements, however, the agency also expects to propose to delay the October 16, 2024 deadline for submitting LSLR and tap sampling plans so that systems can incorporate any potential revisions made through LCRI rulemaking. While EPA expects to complete that rulemaking prior to the 2024 compliance date, EPA recognizes that this announcement of the forthcoming proposal creates some uncertainty for water systems and states regarding the deadline for completion of these plans. EPA plans to continue to engage with states, tribes, water systems, and all other stakeholders as the agency proposes the LCRI and takes final action on the proposal. In those engagements, which include a notice and comment process, EPA will seek input on a number of issues including whether current LCRR deadlines should be changed. As part of those discussions, EPA will consider concerns expressed by some commenters that further delays in compliance dates for some LCRR provisions may delay public health improvements. EPA also intends to seek comment on whether it would be practicable for water systems to implement any of the proposed LCRI requirements earlier than three years from the date of final action on the proposed LCRI, consistent with SDWA section 1412(b)(10).

SDWA section 1413(a)(1) and 40 CFR 142.12(b), require states and tribes with primary enforcement authority (primacy) to submit final requests for approval of primacy program revisions to adopt new or revised EPA regulations two years after promulgation. As noted above, the LCRR is taking effect on December 16, 2021. EPA is not withdrawing the LCRR or further delaying its effective date because, among other reasons, it is critical for states and tribes to begin working with water systems to implement the initial LSL inventory provisions of the LCRR and because some other provisions of the LCRR, which advance protections from lead in drinking water, may not be revised as part of the forthcoming LCRI rulemaking. As explained in the final rule delaying the effective and compliance dates for the LCRR, EPA interprets the primacy revision application deadline in 40 CFR 142.12(b)(1) to be calculated using this publication date, December 17, 2021. As a result, primacy revision applications are due on December 18, 2023. However, a state or tribe may apply for an extension of the deadline for up to two years in accordance with 40 CFR 142.12(b)(2).

As further stated in this document, EPA anticipates completing its LCRI rulemaking prior to October 16, 2024. The forthcoming proposed regulatory changes under the LCRI, if finalized, would also result in states and tribes having to submit a primacy application for that regulation two years after it is promulgated. States and tribes will have greater clarity with respect to the primary enforcement (primacy) application revisions process and relevant timeframes when the LCRI is proposed. Accordingly, states and tribes that are concerned about submitting two successive primacy applications may request an extension of their LCRR primacy application deadline to be able to group the program revisions for the LCRR and LCRI into a single primacy application in accordance with 40 CFR 142.12(b)(2)(i)(C).

EPA's review of the LCRR and information received during the engagements process led the agency to conclude that EPA should take a number of additional actions outside of the SDWA regulatory framework to achieve the agency's policy objectives. These actions include:

• Developing and partnering on plans to ensure the equitable distribution of funds for reducing lead in drinking water;

• Encouraging cabinet level commitments for federal collaboration to address school and child-care lead in drinking water;

• Committing to target oversight and technical assistance for communities impacted by high lead levels;

• Improving risk communication through additional EPA guidance and tool development;

• Supporting water systems in meeting LSL Inventory requirements through the issuance of guidance; and

• Encouraging full LSL replacement and strongly discouraging partial LSL replacement.

Funding is key to a community's ability to accelerate both voluntary and required LSLR programs. EPA collaborates with states and tribes to provide opportunities for below-market interest rate loans and grants through the Drinking Water State Revolving Fund (DWSRF) and the Water Infrastructure Finance and Innovation Act (WIFIA) loan program. To support LSLR programs, special financing terms are available through the DWSRF for disadvantaged communities to help address affordability and the impacts of past disinvestment. EPA will encourage states to use their disadvantaged community programs to their fullest extent to provide subsidies and other assistance to support LSLR in vulnerable communities.

Since 2018, EPA has also developed and implemented three grant programs  14 under the Water Infrastructure Improvements for the Nation (WIIN) Act to fund grants to small and disadvantaged communities. More than $175 million has been provided to date for: developing and maintaining compliance with national primary drinking water regulations (NPDWRs); lead reduction projects; and support for voluntary testing of drinking water in schools and child-care facilities. Funding from these programs can continue to be used to support actions to reduce lead in drinking water in addition to regulatory actions. Specifically, EPA has determined that there are multiple lead reduction activities that these grant programs authorize the use of funds for:

• Developing LSL inventories;

• Replacing full LSLs (including replacing the customer-owned portion of an LSL);

• Installing or improving corrosion control treatment;

• Supporting voluntary lead drinking water testing programs for schools and child-care facilities; and

• Remediating lead in school and child-care drinking water.

EPA learned during the LCRR virtual engagements that many small and historically disadvantaged communities face challenges accessing these EPA funding opportunities. Many lack the capacity to develop competitive funding applications and have not applied for DWSRF loans or other infrastructure grants in the past. EPA will seek opportunities to provide technical assistance to small and disadvantaged communities. The agency will also promote awareness of the availability of these programs to address lead in drinking water, including, for LSL replacement, regardless of ownership of the LSLs. EPA will also highlight case studies from communities that have successfully addressed concerns regarding the use of public funds for private-side LSLR. To the extent possible, expanded, or new funding programs under future legislation will also be directed to similar projects.

States can direct funds available under the American Rescue Plan (ARP) Act to water infrastructure, and specifically lead reduction. States could also use ARP funds to address lead in schools and child-care facilities and to accelerate voluntary LSLR programs.

Through E.O. 14008, President Biden established the Justice 40 initiative—setting a goal that 40 percent of the overall benefits of certain Federal investments flow to disadvantaged communities that have been historically marginalized and overburdened by pollution and underinvestment in housing, transportation, water and wastewater infrastructure, and health care. This initiative is a critical part of the Administration's whole-of-government approach to advancing equity and environmental justice. Two EPA programs central to EPA's goal to accelerate LSLR are pilot programs under the Justice 40 initiative: The DWSRF and the WIIN Reduction in Lead via Drinking Water Exposure Grant. EPA is engaging with stakeholders and exploring opportunities to maximize the benefits of these programs in disadvantaged communities, including their specific application to LSLR projects.

EPA will partner with states, tribes, and other stakeholders to collaborate with disadvantaged communities to build their capacity to better compete for and access water infrastructure funding. EPA will develop tools to share information, improve transparency and accountability. EPA is committed to improving public education and outreach on the availability of funding opportunities and the tools and resources to support accessing these dollars.

One of EPA's priorities is to ensure that entities receiving federal financial assistance from the agency comply with the federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, sex and age, including Title VI of the Civil Rights Act of 1964. Federal civil rights laws protect many of the populations that have been exposed to disproportionate levels of harmful environmental, quality of life, and health impacts from pollution and environmental contamination. These populations are also more likely to be exposed to lead in drinking water. Many states and water systems receive some form of federal funding under the Safe Drinking Water Act and have an affirmative obligation to ensure their actions comply with civil rights laws. States and water systems receiving federal funds have an affirmative obligation to implement effective non-discrimination compliance programs. EPA intends to carefully evaluate the provisions of the rule, including the LSLR provisions, and implementation of EPA financial assistance programs to ensure compliance with these laws.

The recent Bipartisan Infrastructure Law (BIL)  15 provides an additional $11.713 billion in general DWSRF funding and $15 billion specifically targeted to communities for the identification and replacement of LSLs through the DWSRF. Each funding provision is scheduled over the next five years. The BIL authorizes $500 million for the WIIN Reduction in Lead Program over the next five years, emphasizing LSL replacement and corrosion control treatment in disadvantaged communities. BIL also authorizes $200 million for lead testing and remediation in school and child-care drinking water and authorizes $10 million for a new grant program for LSLR in communities with existing inventories. EPA will work with its state and tribal partners, communities, and other stakeholders to identify potentially high impact but underutilized authorities that would allow states and tribes to fund full LSL replacement. The agency will also significantly increase federal, state, and tribal outreach and engagement efforts to communities to support LSLR activities. Additionally, EPA will update funding program guidance to provide examples of best state practices for addressing disproportionate and adverse health and environmental impacts experienced by communities, including communities of color and low-income communities.

Children spend a significant portion of their time at places of learning, so it is critical to reduce lead in drinking water in schools and child-care facilities. This is a challenging problem. EPA's authority to regulate actions by schools and child-care centers that may be necessary to address lead in drinking water is limited. Moreover, due to resource constraints, schools and child-care facilities may choose not to participate in voluntary efforts to sample for lead in drinking water if funding for remediation is not available. Some commenters representing facilities with lead in drinking water indicated they need financial support to address lead. Finally, schools and child-care facilities that serve low-income communities are less likely to have the resources necessary to identify and address lead issues.

EPA currently advances efforts to address lead in schools and child-care facilities through two vehicles: (a) The Memorandum of Understanding on Reducing Lead Levels in Drinking Water in Schools and Child-Care Facilities (MOU), which includes 14 federal and non-federal partners; and (b) funding under grant programs like the Lead Testing in School and Child-care Drinking Water Grant and the Reducing Lead in Drinking Water Grant. While these efforts assist schools and child-care facilities to develop and implement lead testing programs, EPA recognizes the urgency of a more comprehensive federal approach to address this issue.

To address these critical concerns, EPA is pursuing deeper partnerships with a range of Federal agencies to make progress on reducing lead in drinking water from schools and child-care facilities. EPA will explore funding that may be available from Federal agencies that could be used towards remediation of lead in drinking water in these facilities, with a particular focus on communities at risk of multiple forms of lead exposure. Collaboration at the federal level has the potential to further the reduction of lead in drinking water at schools and child-care facilities than could be achieved by reliance on regulatory requirements alone.

While EPA will propose important changes to the regulation of lead in drinking water, it is critical for systems to conduct proper sampling for lead and maintain the water chemistry needed to minimize lead corrosion under existing rules. EPA will collaborate with states to provide oversight of these critical provisions as well as provide assistance to low income and other historically disadvantaged communities experiencing high levels of lead in their drinking water because they are disproportionately served by LSLs. Communities impacted by lead in drinking water participating in the LCRR virtual engagements emphasized the need for financial and technical assistance. In collaboration with our state and tribal coregulators, EPA intends to provide targeted technical assistance to community water systems to reduce lead exposure.

Throughout the LCRR virtual engagements, EPA received feedback that risk communication about lead in drinking water must be improved and that water utilities need support to develop effective communication materials. EPA intends to develop guidance and templates to assist states, tribes, and water systems in the communication of lead risk to householdsand communities. Additionally, EPA intends to propose revisions to the Consumer Confidence Report Rule (40 CFR 141, subpart O) which will include requirements related to providing information on corrosion control efforts and on lead action level exceedances when corrective action is needed.

To further advance the proactive replacement of LSLs, EPA will pursue research to use data analytics and other methods to accelerate and improve the process of identifying LSLs. EPA intends to publish inventory development guidance to assist water systems, states, and tribes by providing best practices, case studies, and templates. The guidance will address issues raised by commenters including the use of statistical models to help determine LSL locations, classification of unknowns, goosenecks, and galvanized plumbing, best practices for service line material verification, inventory form and format, inventory accessibility, tools to support inventory development and data tracking, and how LSL identification may be prioritized. EPA is also updating the Safe Drinking Water Information System, including all relevant components, to support state and tribal data management needs for LSL inventories.

Partial LSLRs can cause short-term elevation of lead concentrations in drinking water and further extend lead health risk from service lines because a portion of the lead line remains in service. EPA strongly discourages water systems from conducting partial LSLR. EPA recommends systems proactively implement full LSLR programs. The agency also expects water systems to effectively inform and engage customers during LSLR and provide outreach and filters to residents with LSLs for six months following replacements. EPA also recommends that LSLR programs prioritize the most vulnerable populations by focusing on schools, child-care facilities, homes where children are living, other locations where children are present, and households of those who historically have been disproportionately exposed to lead from water and other media.

EPA will provide training and guidance on LSLR program development and available methods for replacing LSL as safely and efficiently as possible. EPA also will provide tools, best practices, and case studies for systems to set up voluntary LSLR programs and to implement required ones. The agency will update the document Funding and Technical Resources for Lead Service Line Replacement in Small and Disadvantaged Communities, 16 and promote awareness of funding and financing that can be used for LSLR, including the replacement of the customer-owned portion of the service line. All the agency's communications will describe the risks posed by partial LSLR and mitigation measures to reduce elevated water lead concentrations.

In FR Doc. 2021-25009 (86 FR 64819), the final rule entitled, “Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States” there were technical errors that are identified and corrected in this correcting document. These corrections are applicable as of December 16, 2021.

On page 64819 of the Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States final rule, we inadvertently omitted the delayed effective date of the revised definition of “Best price” at § 447.505(a), which was previously published in the December 31, 2020 Federal Register (85 FR 87000) in instruction 10.a.

On page 64825, we inadvertently included amendatory instruction 3.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. In addition, section 553(d) of the APA mandates a 30-day delay in effective date after issuance or publication of a substantive rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements. Section 553(b)(B) of the APA authorizes an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and includes a statement of the finding and the reasons for it in the rule. Similarly, section 553(d)(3) of the APA allows the agency to avoid the 30-day delay in effective date where good cause is found and the agency includes in the rule a statement of the finding and the reasons for it. In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements.

This document merely corrects technical errors in the Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States final rule. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies that were proposed, subject to notice and comment procedures, and adopted in the Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States final rule. As a result, the corrections made through this correcting document are intended to resolve inadvertent errors so that the rule accurately reflects the policies adopted in the final rule. Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States final rule or delaying the effective date of the corrections would be contrary to the public interest because it is in the public interest to ensure that the rule accurately reflects our policies as of the date they take effect. Further, such procedures would be unnecessary because we are not making any substantive revisions to the final rule, but rather, we are simply correcting the Federal Register document to reflect the effective date for the policies that we previously proposed, received public comment on, and subsequently finalized in the final rule. For these reasons, we believe there is good cause to waive the requirements for notice and comment and delay in effective date.

In FR Doc. 2021-25009 (86 FR 64819), make the following corrections:

On page 64819 in the second column, correct the DATES section to read:

The Treaty between the Government of the United States of America and the Government of Canada concerning Pacific salmon was signed at Ottawa on January 28, 1985, and subsequently was given effect in the United States by the Pacific Salmon Treaty Act (Act) at 16 U.S.C. 3631-3644.

Under authority of the Act, Federal regulations at 50 CFR part 300, subpart F, provide a framework for the implementation of certain regulations of the Commission and inseason orders of the Commission's Panel for U.S. sockeye and pink salmon fisheries in the Fraser River Panel Area.

The regulations close the U.S. portion of the Panel Area to U.S. sockeye and pink salmon tribal and non-tribal commercial fishing unless opened by Panel regulations that are given effect by inseason orders issued by NMFS (50 CFR 300.94(a)(1)). During the fishing season, NMFS may issue inseason orders that establish fishing times and areas consistent with the Commission agreements and regulations of the Panel. Such orders must be consistent with domestic legal obligations and are issued by the Regional Administrator, West Coast Region, NMFS. Official notification of these inseason actions is provided by two telephone hotline numbers described at 50 CFR 300.97(b)(1) and in 84 FR 19729 (May 6, 2019). The inseason orders are published in the Federal Register as soon as practicable after they are issued. Due to the frequency with which inseason orders are issued, publication of individual orders is impractical.

NMFS issued the following inseason orders for U.S. fisheries within Panel Area waters during the 2021 fishing season, consistent with the orders adopted by the Panel. Each of the following inseason actions was effective upon announcement on telephone hotline numbers as specified at 50 CFR 300.97(b)(1) and in 86 FR 26425 (May 16, 2021); those dates and times are listed herein. The times listed are local times, and the areas designated are Puget Sound Management and Catch Reporting Areas as defined in the Washington State Administrative Code at Chapter 220-22.

Areas 4B, 5, and 6C: Open for drift gillnet fishing from 12 p.m. (noon), Saturday, August 21, 2021, through 12 p.m. (noon), Wednesday, August 24, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 7 and 7A: Open to reef net fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m. Monday, August 23, 2021.

Areas 4B, 5, and 6C: Extend for drift gillnet fishing from 12 p.m. (noon), Wednesday, August 25, 2021, through 12 p.m. (noon), Saturday, August 28, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 7 and 7A, excluding the Apex: Open to purse seine fishing, from 5 a.m. to 9 p.m., Friday, August 27, 2021. Sockeye non-retention.

Areas 7 and 7A, excluding the Apex: Open to drift gillnet fishing, from 8 a.m. to 11:59 p.m., Friday, August 27, 2021. Sockeye non-retention.

The Apex is defined as those waters north and west of the Area 7A “Iwersen Dock Line”. The Iwersen Dock Line is the line projected from Iwersen Dock on Point Roberts to the Georgina Point light at the entrance to Active Pass in the Province of British Columbia.

Areas 4B, 5, and 6C: Extend for drift gillnet fishing from 12 p.m. (noon), Saturday, August 28, 2021, through 12 p.m. (noon), Wednesday, September 1, 2021. Release sockeye.

Areas 6, 7, and 7A in the area southerly and easterly of a straight line drawn from Iwersen's dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open for net fishing from 5 a.m., Sunday, August 29, 2021, through 9 a.m., Monday, August 30, 2021. Release sockeye.

Areas 7 and 7A in the area southerly and easterly of a straight line drawn from Iwersen's dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open to purse seine fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m. Tuesday, August 31, 2021.

Areas 7 and 7A in the area southerly and easterly of a straight line drawn from Iwersen's dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open to drift gillnet fishing, with non-retention of sockeye, from 8 a.m. to 11:59 p.m., Tuesday, August 31, 2021.

Area 7: Open to reef net fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m., Tuesday, August 31, 2021.

Areas 4B, 5, and 6C: Extend for drift gillnet fishing from 12 p.m. (noon), Wednesday, September 1, 2021, through 12 p.m. (noon), Saturday, September 4, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 6, 7, and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open for net fishing from 5 a.m., Tuesday, August 31, 2021, through 9 a.m., Thursday, September 2, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 7 and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open to purse seine fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m., Wednesday, September 1, 2021.

Areas 7 and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open to drift gillnet fishing, with non-retention of sockeye, from 8 a.m. to 11:59 p.m., Wednesday, September 1, 2021.

Area 7: Open to reef net fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m., Wednesday, September 1, 2021.

Areas 4B, 5, and 6C: Extend for drift gillnet fishing from 12 p.m. (noon), Saturday, September 4, 2021, through 12 p.m. (noon), Tuesday, September 7, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 6, 7, and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open for net fishing from 5 a.m., Saturday, September 4, 2021, through 9 a.m., Tuesday, September 7, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 4B, 5, and 6C: Open for drift gillnet fishing from 12 p.m. (noon), Wednesday, September 8, 2021, through 12 p.m. (noon), Friday, September 10, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 6, 7, and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open for net fishing from 5 a.m., Wednesday, September 8, 2021, through 9 a.m., Friday, September 10, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 4B, 5, and 6C: Open for drift gillnet fishing from 12 p.m. (noon), Saturday, September 11, 2021, through 12 p.m. (noon), Monday, September 13, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Areas 6, 7, and 7A in the area southerly and easterly of a straight line drawn from the Iwersen Dock on Point Roberts in the State of Washington to the Georgina Point Light at the entrance to Active Pass in the Province of British Columbia: Open for net fishing from 5 a.m., Saturday, September 11, 2021, through 9 a.m., Monday, September 13, 2021. Sockeye non-retention, all efforts must be made to release sockeye alive.

Area 7: Open to reef net fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m., Saturday, September 11, 2021 and 5 a.m. to 9 p.m., Sunday, September 12, 2021.

Area 7: Open to reef net fishing, with non-retention of sockeye, from 5 a.m. to 9 p.m., Tuesday, September 14, 2021, 5 a.m. to 9 p.m., Wednesday, September 15, 2021, 5 a.m. to 9 p.m., Thursday, September 16, 2021, and 5 a.m. to 9 p.m., Friday, September 17, 2021.

Areas 6, 6A, and 7: Relinquish regulatory control effective 11:59 p.m., Saturday, September 18, 2021.

The Assistant Administrator for Fisheries NOAA (AA), finds that good cause exists for the inseason orders to be issued without affording the public prior notice and opportunity for comment under 5 U.S.C. 553(b)(B) as such prior notice and opportunity for comments is impracticable and contrary to the public interest. Prior notice and opportunity for public comment is impracticable because NMFS has insufficient time to allow for prior notice and opportunity for public comment between the time the stock abundance information is available to determine how much fishing can be allowed and the time the fishery must open and close in order to harvest the appropriate amount of fish while they are available.

The AA also finds good cause to waive the 30-day delay in the effective date, required under 5 U.S.C. 553(d)(3), of the inseason orders. A delay in the effective date of the inseason orders would not allow fishers appropriately controlled access to the available fish at that time they are available.

This action is authorized by 50 CFR 300.97, and is exempt from review under Executive Order 12866.

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

The 2021 Pacific ocean perch TAC in the Bering Sea subarea of the BSAI is 10,782 metric tons (mt) as established by the final 2021 and 2022 harvest specifications for groundfish in the BSAI and groundfish reserve release (86 FR 11449, February 25, 2021, and 86 FR 64827, November 19, 2021).

The Regional Administrator has determined that the 2021 TAC for Pacific ocean perch in the Bering Sea subarea of the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 10,712 mt, and is setting aside the remaining 70 mt as bycatch to support other anticipated groundfish fisheries. Consequently, in accordance with § 679.20(d)(1)(iii), NMFS is prohibiting directed fishing for Pacific ocean perch in the Bering Sea subarea of the BSAI. While this closure remains in effect the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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