On February 2, 2021, the United States Department of Energy (“DOE”) postponed the effective date of its final rule establishing procedures for the issuance of DOE guidance documents, published in the Federal Register on January 6, 2021 (86 FR 451), until March 21, 2021 (86 FR 7799, February 2, 2021). The January 6, 2021, rule implemented Executive Order 13891 (84 FR 55235), which the President revoked on January 20, 2021, in Executive Order 13992 (86 FR 7049). Executive Order 13992 directed the Director of the Office of Management and Budget and the heads of agencies to promptly take steps to rescind any rules, regulations, guidelines, or policies, or portions thereof, implementing or enforcing Executive Order 13891, among other Executive orders, as appropriate and consistent with applicable law, including the Administrative Procedure Act, 5 U.S.C. 551 et seq. DOE's delay of the effective date of its January 6, 2021, guidance rule was necessary to give DOE officials the opportunity to promptly take steps to rescind the rule as directed by Executive Order 13992. DOE also sought comment on any further delay of the effective date, including the impacts of such delay, as well as comment on the legal, factual, or policy issues raised by the rule. DOE received no comments on these issues.

DOE intends to publish a separate notice of proposed rulemaking in the future to withdraw the January 6, 2021, guidance rule. Further delay of the effective date of the guidance rule is necessary to allow DOE to consider comments on the proposed withdrawal and further review its regulations in light of Executive Order 13992 before the rule goes into effect. Accordingly, DOE delays the effective date of 10 CFR part 1061 to June 17, 2021.

To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, DOE's implementation of this action without opportunity for public comment, effective immediately upon publication in the Federal Register , is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3). Pursuant to 5 U.S.C. 553(b)(B), DOE has determined that good cause exists to forego the requirement to provide prior notice and an opportunity for public comment thereon for this rule as such procedures would be impracticable, unnecessary or contrary to the public interest. As an initial matter, DOE provided an opportunity for comment related to the earlier extension of the effective date, and no comments were submitted. Further, DOE has tentatively concluded that, if it goes into effect, the January 6, 2021 final rule will hinder DOE in providing timely guidance in furtherance of DOE's statutory duties. The final rule will in particular hinder DOE's ability to address the economic recovery and climate change challenges enumerated in Executive Order 13992. As discussed in the Executive Order, agencies must have flexibility to timely and effectively address these challenges. The procedures of 10 CFR part 1061 are not required by the Administrative Procedure Act (5 U.S.C. 551 et seq. ), and they limit the regulatory tools available to DOE to address the challenges listed in Executive Order 13992. Part 1061 deprives DOE of flexibility in determining when and how best to issue guidance based on particular facts and circumstances, and restricts DOE's ability to provide timely guidance on which the public can confidently rely.

In addition, DOE's stated purpose in issuing part 1061 was to promote transparency and public involvement in the development and amendment of DOE guidance documents. DOE notes, however, that its procedures for public transparency and involvement in the development of agency guidance documents will remain unchanged by withdrawal of part 1061. DOE guidance documents will continue to be available on DOE's website. DOE will also continue its practice, as appropriate, of soliciting stakeholder input on guidance documents of significant stakeholder and public interest. Additionally, stakeholders may still petition DOE at any time to issue, withdraw or revise DOE guidance documents, or inquire about DOE guidance documents, by emailing petitions or inquiries to Guidance@hq.doe.gov. The benefits of binding DOE to the procedures of part 1061 therefore appear outweighed by the need for DOE to have the ability to issue guidance timely and effectively to address the challenges listed in the Executive Order, and otherwise to meet its statutory duties. Moreover, DOE notes that guidance, whether issued under part 1061 or otherwise, is non-binding, and does not have the force and effect of law.

As a result, seeking public comment on this delay is unnecessary and contrary to the public interest. For these same reasons DOE finds good cause to waive the 30-day delay in effective date provided for in 5 U.S.C. 553(d).

This document of the Department of Energy was signed on March 13, 2021, by John T. Lucas, Acting General Counsel, Office of the General Counsel, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Section 1031(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) provides that the Bureau of Consumer Financial Protection (Bureau) may use its authorities, among other things, to prevent a covered person or service provider from committing or engaging in an unfair, deceptive, or abusive act or practice under Federal law in connection with any transaction with a consumer for a consumer financial product or service, or the offering of a consumer financial product or service. 1 Section 1031(d) of the Dodd-Frank Act sets forth standards for when the Bureau may declare that an act or practice is abusive for purposes of the Dodd-Frank Act.

On January 24, 2020, the Bureau announced a policy statement entitled “Statement of Policy Regarding Prohibition on Abusive Acts or Practices” (Policy Statement), which provided a framework for the Bureau's exercise of its supervisory and enforcement authority to address abusive acts or practices. 2 Specifically, the Policy Statement provided that the Bureau intended to apply the following three principles during its supervision and enforcement work. First, the Bureau stated that it intended to focus on citing conduct as abusive in supervision or challenging conduct as abusive in enforcement if the Bureau concluded that the harms to consumers from the conduct outweighed its benefits to consumers. 3 Second, the Bureau stated that it would generally avoid challenging conduct as abusive that relied on all or nearly all of the same facts that the Bureau alleged are unfair or deceptive. 4 The Bureau stated that where it nevertheless decided to include an alleged abusiveness violation, the Bureau intended to plead such claims in a manner designed to clearly demonstrate the nexus between the cited facts and the Bureau's legal analysis of the claim. The Bureau stated that, in its supervision activity, the Bureau similarly intended to provide more clarity as to the specific factual basis for determining that a covered person had violated the abusiveness standard. 5 Third, the Bureau stated that it generally did not intend to seek certain types of monetary relief for abusiveness violations where the covered person was making a good-faith effort to comply with the abusiveness standard. 6

The Bureau asserted that the Policy Statement was necessary to address the uncertainty of the abusiveness standard based on the Bureau's conclusions that such uncertainty was “not beneficial,” presented “significant challenges” to businesses, imposed “substantial costs, including impeding innovation,” and may cause consumers to “lose the benefits of improved products or services and lower prices.”  7 As the Policy Statement referenced, some panelists at the Bureau's June 2019 Symposium on Abusive Acts or Practices urged the Bureau to resolve the abusiveness standard's uncertainty for these and other reasons, 8 while others expressed the view that the statutory definition of abusiveness is sufficiently clear and that no evidence supported the claims that the uncertainty had affected business practices, including chilling innovation. 9

Based on its review of, and experience in applying, the Policy Statement, however, the Bureau has concluded that the principles set forth in the Policy Statement do not actually deliver clarity to regulated entities. In fact, the Policy Statement's intended principles, including “making a good-faith effort to comply with the abusiveness standard,” themselves afford the Bureau considerable discretion in its application and add uncertainty to market participants. Additionally, the Bureau's further consideration of and experience under the Policy Statement have led it to conclude that the intended principles have the effect of hampering certainty over time. Not asserting abusiveness claims solely because of their overlap with unfair or deceptive conduct or based on the other intended principles articulated in the Policy Statement has the effect of slowing the Bureau's ability to clarify the statutory abusiveness standard by articulating abusiveness claims as well as through the ensuing issuance of judicial and administrative decisions. It is thus counterproductive to the purpose of the original Policy Statement.

The Policy Statement also provided that the Bureau intended to focus on citing conduct as abusive in supervision and challenging conduct as abusive in enforcement if the Bureau concluded that the harms to consumers from the conduct outweighed its benefits to consumers. This principle was intended to “ensure[ ] that the Bureau is committed to using its scarce resources to address conduct that harms consumers” and to ensure consistency across supervisory and enforcement matters. 10 The Bureau has concluded, however, that there is no basis to treat application of the abusiveness standard differently from the normal considerations that guide the Bureau's general use of its enforcement and supervisory discretion. The Bureau also did not find this principle helpful in practice.

Moreover, based on its review of, and experience in applying, the Policy Statement, the Bureau has concluded that the principles set forth in the Policy Statement have the opposite effect on preventing harm. One of the Bureau's statutory objectives is “ensuring that, with respect to consumer financial products and services . . . consumers are protected from unfair, deceptive, or abusive acts and practices and from discrimination.”  11 Declining to apply the full scope of the statutory standard pursuant to the policy has a negative effect on the Bureau's ability to achieve its statutory objective of protecting consumers from abusive practices. In particular, the policy of declining to seek certain types of monetary relief for abusive acts or practices—specifically civil money penalties and disgorgement—is contrary to the Bureau's current priority of achieving general deterrence through penalties and other monetary remedies and of compensating victims for harm caused by violations of the Federal consumer financial laws through the Bureau's Civil Penalty Fund. Likewise, adhering to a policy that disfavors citing or alleging conduct as abusive when that conduct is also unfair or deceptive is contrary to the Bureau's current priority of maximizing the Bureau's ability to successfully resolve its contested litigation, as it does not allow the Bureau to assert alternative legal causes of action in a judicial action or administrative proceeding. The Bureau's statutory purpose includes “ensuring . . . that markets for consumer financial products and services are fair, transparent, and competitive.”  12 Declining to cite or penalize conduct as abusive based on the articulated principles in the Policy Statement may also skew the consumer financial marketplace, to the detriment of market participants who do not act abusively. The Bureau will, of course, continue to engage in typical prosecutorial discretion as appropriate and can use that discretion to marshal its resources effectively.

The Policy Statement was not required under the abusiveness standard set forth in the Dodd-Frank Act. The statutory standard for what the Bureau has authority to declare an “abusive act or practice” is set forth in section 1031(d) of the Dodd-Frank Act. The Policy Statement stated an intent to refrain from applying the abusiveness standard even when permitted by law. Had Congress intended to limit the Bureau's authority to apply the full scope of the abusiveness standard, it could have prescribed a narrower abusiveness prohibition, but it did not. As the Policy Statement itself acknowledged, courts have consistently found that section 1031(d) provides sufficient notice for due process purposes. 13 Moreover, because the Policy Statement did not create binding legal obligations on the Bureau or create or confer any substantive rights on external parties, it did not create any reasonable reliance interests for industry participants. Thus, rescinding the Policy Statement is consistent with the Bureau's statutory authority.

The Bureau has determined that it should exercise the full scope of its supervisory and enforcement authority to identify and remediate abusive acts or practices. On reconsideration, the Bureau has concluded the Policy Statement's effectiveness in accomplishing its stated purposes does not justify its potential to harm consumers and the marketplace. For these reasons, the Bureau is rescinding the Policy Statement and instead, in its discretion, intends to exercise its supervisory and enforcement authority consistent with the Dodd-Frank Act and with the full authority afforded by Congress consistent with the statutory purpose and objectives of the Bureau.

The statutory standard for what the Bureau has authority to declare an “abusive act or practice” is set forth in section 1031(d) of the Dodd-Frank Act. Specifically, section 1031(d) states that the Bureau shall have no authority under this section to declare an act or practice abusive in connection with the provision of a consumer financial product or service, unless the act or practice—(1) materially interferes with the ability of a consumer to understand a term or condition of a consumer financial product or service; or (2) takes unreasonable advantage of—(A) a lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service; (B) the inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service; or (C) the reasonable reliance by the consumer on a covered person to act in the interests of the consumer. 14 To demonstrate a violation of section 1031(d), the Bureau therefore must satisfy the specific elements of sections 1031(d)(1), 1031(d)(2)(A), 1031(d)(2)(B), or 1031(d)(2)(C). When the Bureau alleges an abusiveness violation, the Bureau intends to satisfy these elements.

Regulatory Requirements: The Policy Statement constituted a general statement of policy exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act (APA). 15 It was intended to provide information regarding the Bureau's general plans to exercise its supervisory and enforcement discretion and did not impose any legal requirements on external parties, nor did it create or confer any substantive rights on external parties that could be enforceable in any administrative or civil proceeding. The rescission of this policy statement likewise is a general statement of policy exempt from the notice and comment rulemaking requirements of the APA. It is intended to provide information regarding the Bureau's general plans to exercise its supervision and enforcement discretion and does not impose any legal requirements on external parties or create or confer any substantive rights on external parties that could be enforceable in any administrative or civil proceedings. Because no notice of proposed rulemaking was originally required in issuing the Policy Statement, and is not required in issuing this rescission, the Regulatory Flexibility Act also does not require an initial or final regulatory flexibility analysis for this rescission. The Bureau has also determined that the rescission of the Policy Statement does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act.

Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., the Bureau will submit a report containing the rescission of the Policy Statement and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to its applicability date. The Office of Information and Regulatory Affairs has designated the rescission of the Policy Statement as not a “major rule” as defined by 5 U.S.C. 804(2).

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and finds that, for the same reason, good cause exists for adopting these special conditions upon publication in the Federal Register .

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On September 27, 2019, Lufthansa Technik applied for a supplemental type certificate for installation of large, non-structural glass in the passenger cabin in the Boeing Model 787-8 airplane. The Boeing Model 787-8 is a twin-engine, transport category airplane, with capacity for 381 passengers, and a maximum takeoff weight of 476,000 pounds.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Lufthansa Technik must show that the Boeing Model 787-8 airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. TC No. T00021SE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 787-8 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 787-8 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Boeing Model 787-8 airplane will incorporate the following novel or unusual design features:

Lufthansa Technik is proposing to install large non-structural glass items in Model 787-8 airplanes. Possible installations of large non-structural glass items include, but are not limited to, the following items:

• Glass partitions.

• Glass floor installations.

• Glass attached to the ceiling.

• Glass parts integrated in the stairway.

• Wall or Door mounted mirrors and glass panels.

• Mirrors as part of a door blow out panel.

• Glass plate installed in a doorframe.

• Washstand with glass-panel.

The installation of these glass items in the passenger compartment, which can be occupied during taxi, take-off and landing (TT&L), is a novel or unusual design feature with respect to the installed material. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design features.

The use of glass results in trade-offs between the one unique characteristic of glass—its capability for undistorted or controlled light transmittance, or transparency—and the negative aspects of the material. Glass, in its basic form as annealed, untreated sheet, plate, or float glass, when compared to metals, is extremely notch-sensitive, has a low fracture resistance, has a low modulus of elasticity, and can be highly variable in its properties. While reasonably strong, it is nonetheless not a desirable material for traditional airplane applications because it is heavy (about the same density as aluminum), and when it fails, it breaks into extremely sharp fragments that have the potential for injury, and which have been known to be lethal. Thus, the use of glass traditionally was limited to windshields, and instrument or display transparencies. The regulations in § 25.775 only address, and likewise only recognize, the unique use of glass in windshield or window applications where no other material will serve. This regulation does address the adverse properties of glass, but pilots occasionally are injured from shattered glass windshields.

The FAA divides other uses of glass in the passenger cabin into four groups. These groups were created to address the practical and functional uses of glass. The four groups are as follows:

The first group is glass items installed in rooms or areas in the cabin that are not occupied during TT&L, and a person does not have to enter or pass through the room or area to get to any emergency exit.

The second group is glass integrated into a functional device the operation of which is dependent upon the characteristics of glass, such as instrument or indicator protective transparencies, or monitor screens such as liquid crystal displays or plasma displays. This group may be installed in any area in the cabin regardless of occupancy during TT&L. Acceptable means of compliance for these items may depend on the size and specific location of the device containing the glass.

The third group is small glass items installed in occupied rooms or areas during TT&L, or rooms or areas that a person does not have to enter or pass through to get to any emergency exit. The FAA defines a small glass item as less than 8.8 lbs (4 kg) in mass.

The fourth group is large glass items, the subject of these special conditions, installed in occupied rooms or areas during TT&L, or rooms or areas that a person must enter or pass through to get to any emergency exit. A large glass item is defined as 8.8 lbs (4 kg) or greater in mass. Groups of glass items that collectively weigh 4 kg or more would also be included. The mass is based on the amount of glass that becomes hazardous in high inertial loads.

The glass items in groups one, two, and three are restricted to applications where the potential for injury is either highly localized, such as flight-instrument faces, or the location is such that injury due to failure of the glass is unlikely, for example mirrors in lavatories, because these installations necessitate the use of glass. These glass items typically are addressed in a method-of-compliance issue paper for each project based on existing part 25 regulations, or in established policy. These issue papers identify specific tests that could include abuse loading and ball-impact testing. In addition, these items are subject to the inertia loads contained in § 25.561, and maximum positive-differential pressure for items like video monitors to meet § 25.789.

The items in group four are much larger and heavier than previously approved, and raise additional safety concerns. These large, heavy glass panels, primarily installed as architectural features, were not envisioned in the regulations. The unique aspects of glass, with the potential to become highly injurious or lethal objects during emergency landing, minor crash conditions, or in flight, warrant a unique approach to certification that addresses the characteristics of glass that prevented its use in the past. These special conditions were developed to ensure that airplanes with large glass features in passenger cabins provide the same level of safety as airplanes using traditional, lightweight materials. The FAA reiterates this intention in the text of the special conditions by qualifying their use for group four glass items.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Boeing Model 787-8 airplane. Should Lufthansa Technik apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. T00021SE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 787-8 airplanes, as modified by Lufthansa Technik.

For large glass items (a single item, or a collective group of glass items, that weigh 4 kg or more in mass) installed in passenger-occupied rooms or areas during taxi, takeoff, and landing, or installed in rooms or areas that occupants must enter or pass through to access any emergency exit, the glass installations on the Lufthansa Model 787-8 airplane must meet the following conditions:

1. Material Fragmentation—The applicant must use tempered or otherwise treated glass to ensure that, when fractured, the glass breaks into small pieces with relatively dull edges. The glass component installation must retain all glass fragments to minimize the danger from flying glass shards or pieces. The applicant must demonstrate this characteristic by impact and puncture testing, and testing to failure. The applicant may conduct this test with or without any glass coating that may be used in the design.

2. Strength—In addition to meeting the load requirements for all flight and landing loads, including any of the applicable emergency-landing conditions in subparts C & D of 14 CFR part 25, the glass components that are located such that they are not protected from contact with cabin occupants must not fail due to abusive loading, such as impact from occupants stumbling into, leaning against, sitting on, or performing other intentional or unintentional forceful contact with the glass component. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

3. Retention—The glass component, as installed in the airplane, must not come free of its restraint or mounting system in the event of an emergency landing, considering both the directional loading and resulting rebound conditions. The applicant must assess the effect of design details such as geometric discontinuities or surface finish, including but not limited to embossing and etching.

4. Instruction for Continued Airworthiness—The instructions for continued airworthiness must reflect the method used to fasten the panel to the cabin interior, and must ensure the reliability of the methods used ( e.g., life limit of adhesives, or clamp connection). The applicant must define any inspection methods and intervals based upon adhesion data from the manufacturer of the adhesive, or upon actual adhesion-test data, if necessary.

On March 24, 2020, DHS published notice of its decision to temporarily limit the travel of individuals from Canada into the United States at land ports of entry along the United States-Canada border to “essential travel,” as further defined in that document. 1 The document described the developing circumstances regarding the COVID-19 pandemic and stated that, given the outbreak and continued transmission and spread of the virus associated with COVID-19 within the United States and globally, DHS had determined that the risk of continued transmission and spread of the virus associated with COVID-19 between the United States and Canada posed a “specific threat to human life or national interests.” DHS later published a series of notifications continuing such limitations on travel until 11:59 p.m. EDT on March 21, 2021. 2

DHS continues to monitor and respond to the COVID-19 pandemic. As of the week of March 7, 2021, there have been over 116.1 million confirmed cases globally, with over 2.5 million confirmed deaths. 3 There have been over 29.2 million confirmed and probable cases within the United States, 4 over 881,000 confirmed cases in Canada, 5 and over 2.1 million confirmed cases in Mexico. 6

Given the outbreak and continued transmission and spread of COVID-19 within the United States and globally, the Secretary has determined that the risk of continued transmission and spread of the virus associated with COVID-19 between the United States and Canada poses an ongoing “specific threat to human life or national interests.”

U.S. and Canadian officials have mutually determined that non-essential travel between the United States and Canada poses additional risk of transmission and spread of the virus associated with COVID-19 and places the populace of both nations at increased risk of contracting the virus associated with COVID-19. Moreover, given the sustained human-to-human transmission of the virus, returning to previous levels of travel between the two nations places the personnel staffing land ports of entry between the United States and Canada, as well as the individuals traveling through these ports of entry, at increased risk of exposure to the virus associated with COVID-19. Accordingly, and consistent with the authority granted in 19 U.S.C. 1318(b)(1)(C) and (b)(2), 7 I have determined that land ports of entry along the U.S.-Canada border will continue to suspend normal operations and will only allow processing for entry into the United States of those travelers engaged in “essential travel,” as defined below. Given the definition of “essential travel” below, this temporary alteration in land ports of entry operations should not interrupt legitimate trade between the two nations or disrupt critical supply chains that ensure food, fuel, medicine, and other critical materials reach individuals on both sides of the border.

For purposes of the temporary alteration in certain designated ports of entry operations authorized under 19 U.S.C. 1318(b)(1)(C) and (b)(2), travel through the land ports of entry and ferry terminals along the United States-Canada border shall be limited to “essential travel,” which includes, but is not limited to—

• U.S. citizens and lawful permanent residents returning to the United States;

• Individuals traveling for medical purposes ( e.g., to receive medical treatment in the United States);

• Individuals traveling to attend educational institutions;

• Individuals traveling to work in the United States ( e.g., individuals working in the farming or agriculture industry who must travel between the United States and Canada in furtherance of such work);

• Individuals traveling for emergency response and public health purposes ( e.g., government officials or emergency responders entering the United States to support federal, state, local, tribal, or territorial government efforts to respond to COVID-19 or other emergencies);

• Individuals engaged in lawful cross-border trade ( e.g., truck drivers supporting the movement of cargo between the United States and Canada);

• Individuals engaged in official government travel or diplomatic travel;

• Members of the U.S. Armed Forces, and the spouses and children of members of the U.S. Armed Forces, returning to the United States; and

• Individuals engaged in military-related travel or operations.

The following travel does not fall within the definition of “essential travel” for purposes of this Notification—

• Individuals traveling for tourism purposes ( e.g., sightseeing, recreation, gambling, or attending cultural events).

At this time, this Notification does not apply to air, freight rail, or sea travel between the United States and Canada, but does apply to passenger rail, passenger ferry travel, and pleasure boat travel between the United States and Canada. These restrictions are temporary in nature and shall remain in effect until 11:59 p.m. EDT on April 21, 2021. This Notification may be amended or rescinded prior to that time, based on circumstances associated with the specific threat. 8

The Commissioner of U.S. Customs and Border Protection (CBP) is hereby directed to prepare and distribute appropriate guidance to CBP personnel on the continued implementation of the temporary measures set forth in this Notification. The CBP Commissioner may determine that other forms of travel, such as travel in furtherance of economic stability or social order, constitute “essential travel” under this Notification. Further, the CBP Commissioner may, on an individualized basis and for humanitarian reasons or for other purposes in the national interest, permit the processing of travelers to the United States not engaged in “essential travel.”

On March 24, 2020, DHS published notice of its decision to temporarily limit the travel of individuals from Mexico into the United States at land ports of entry along the United States-Mexico border to “essential travel,” as further defined in that document. 1 The document described the developing circumstances regarding the COVID-19 pandemic and stated that, given the outbreak and continued transmission and spread of the virus associated with COVID-19 within the United States and globally, DHS had determined that the risk of continued transmission and spread of the virus associated with COVID-19 between the United States and Mexico posed a “specific threat to human life or national interests.” DHS later published a series of notifications continuing such limitations on travel until 11:59 p.m. EDT on March 21, 2021. 2

DHS continues to monitor and respond to the COVID-19 pandemic. As of the week of March 7, 2021, there have been over 116.1 million confirmed cases globally, with over 2.5 million confirmed deaths. 3 There have been over 29.2 million confirmed and probable cases within the United States, 4 over 881,000 confirmed cases in Canada, 5 and over 2.1 million confirmed cases in Mexico. 6

Given the outbreak and continued transmission and spread of COVID-19 within the United States and globally, the Secretary has determined that the risk of continued transmission and spread of the virus associated with COVID-19 between the United States and Mexico poses an ongoing “specific threat to human life or national interests.”

U.S. and Mexican officials have mutually determined that non-essential travel between the United States and Mexico poses additional risk of transmission and spread of the virus associated with COVID-19 and places the populace of both nations at increased risk of contracting the virus associated with COVID-19. Moreover, given the sustained human-to-human transmission of the virus, returning to previous levels of travel between the two nations places the personnel staffing land ports of entry between the United States and Mexico, as well as the individuals traveling through these ports of entry, at increased risk of exposure to the virus associated with COVID-19. Accordingly, and consistent with the authority granted in 19 U.S.C. 1318(b)(1)(C) and (b)(2), 7 I have determined that land ports of entry along the U.S.-Mexico border will continue to suspend normal operations and will only allow processing for entry into the United States of those travelers engaged in “essential travel,” as defined below. Given the definition of “essential travel” below, this temporary alteration in land ports of entry operations should not interrupt legitimate trade between the two nations or disrupt critical supply chains that ensure food, fuel, medicine, and other critical materials reach individuals on both sides of the border.

For purposes of the temporary alteration in certain designated ports of entry operations authorized under 19 U.S.C. 1318(b)(1)(C) and (b)(2), travel through the land ports of entry and ferry terminals along the United States-Mexico border shall be limited to “essential travel,” which includes, but is not limited to—

• U.S. citizens and lawful permanent residents returning to the United States;

• Individuals traveling for medical purposes ( e.g., to receive medical treatment in the United States);

• Individuals traveling to attend educational institutions;

• Individuals traveling to work in the United States ( e.g., individuals working in the farming or agriculture industry who must travel between the United States and Mexico in furtherance of such work);

• Individuals traveling for emergency response and public health purposes ( e.g., government officials or emergency responders entering the United States to support federal, state, local, tribal, or territorial government efforts to respond to COVID-19 or other emergencies);

• Individuals engaged in lawful cross-border trade ( e.g., truck drivers supporting the movement of cargo between the United States and Mexico);

• Individuals engaged in official government travel or diplomatic travel;

• Members of the U.S. Armed Forces, and the spouses and children of members of the U.S. Armed Forces, returning to the United States; and

• Individuals engaged in military-related travel or operations.

The following travel does not fall within the definition of “essential travel” for purposes of this Notification—

• Individuals traveling for tourism purposes ( e.g., sightseeing, recreation, gambling, or attending cultural events).

At this time, this Notification does not apply to air, freight rail, or sea travel between the United States and Mexico, but does apply to passenger rail, passenger ferry travel, and pleasure boat travel between the United States and Mexico. These restrictions are temporary in nature and shall remain in effect until 11:59 p.m. EDT on April 21, 2021. This Notification may be amended or rescinded prior to that time, based on circumstances associated with the specific threat. 8

The Commissioner of U.S. Customs and Border Protection (CBP) is hereby directed to prepare and distribute appropriate guidance to CBP personnel on the continued implementation of the temporary measures set forth in this Notification. The CBP Commissioner may determine that other forms of travel, such as travel in furtherance of economic stability or social order, constitute “essential travel” under this Notification. Further, the CBP Commissioner may, on an individualized basis and for humanitarian reasons or for other purposes in the national interest, permit the processing of travelers to the United States not engaged in “essential travel.”

I. Approvals

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

Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-437 for OSNURIA (betamethasone acetate, florfenicol, terbinafine) Otic Gel to Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.

Pharmasone LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-690 for ZOASHIELD 25% (zoalene Type A medicated article) to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.

Also, Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the 39 NADAs and 17 ANADAs listed below to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140:

Following these changes of sponsorship, neither Bayer HealthCare LLC nor Pharmasone LLC are the sponsor of an approved application. Accordingly, they will be removed from the list of sponsors of approved applications in 21 CFR 510.600(c). As provided in the regulatory text, the animal drug regulations are amended to reflect these changes of sponsorship.

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

• 21 CFR 520.905a is amended to reflect the approved conditions of use for fenbendazole suspension in laying hens.

• 21 CFR 522.1182 is amended to reflect the 2016 change of sponsorship of an injectable ferric hydroxide product in young piglets.

• 21 CFR 522.1193 is amended to reflect the approved withdrawal period for a clorsulon injectable solution product.

• 21 CFR 522.1696a is amended to reflect an associated limitation for a penicillin G benzathine and penicillin G procaine injectable suspension product.

• 21 CFR 522.1890 is amended to reflect the current format for titling regulations for injectable dosage form new animal drugs.

• Entries in parts 556 and 558 (21 CFR parts 556 and 558) for a coumaphos Type A medicated article are being added. These sections were withdrawn in error (85 FR 18114, April 1, 2020).

• Part 558 is amended to reflect current naming and organization for specifications and application sponsors.

• 21 CFR 558.261 is amended to reflect an approved incorporation level of florfenicol in medicated feed for fish.

• 21 CFR 558.311 for lasalocid in medicated feed is amended to reflect a current tabular organization by species.

• 21 CFR 558.355 is amended to provide accurate cross references for approved uses to special considerations and label statements for monensin medicated feeds.

• 21 CFR 558.450 is amended to add two indications for use of oxytetracycline in medicated feed for fish that were removed during the recent codification of a supplemental approval (84 FR 12491 at 12502, April 2, 2019).

• Part 558 is amended by removing 21 CFR 558.465, which is redundant with 21 CFR 558.464. The cross reference for poloxalene in part 556 is amended to reflect this action.

• Part 558 is amended by adding 21 CFR 558.470 to reflect the approved conditions of use of a polyoxyethylene medicated feed block, which previously had been removed from 21 CFR part 520 without being added to part 558.

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

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

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

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

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On September 18, 2020,  1 EPA proposed to partially approve and partially disapprove a revision to the Michigan SIP submitted on May 31, 2016, supplemented on June 30, 2016. EPA proposed to take the following actions:

(1) EPA proposed to disapprove Michigan Administrative Code (MAC) 336.1430 (“Rule 430”) because the Michigan Court of Claims invalidated Rule 430 on October 4, 2017. Therefore, there is no enforceable rule remaining at the state level for EPA to incorporate into the SIP.

(2) EPA proposed to disapprove the Detroit SO 2 attainment plan pursuant to 172(c) and 192(a), because it relied on Rule 430 to demonstrate attainment, which can no longer be relied on as an enforceable mechanism.

(3) Because of the lack of enforceable measures from Rule 430, the remaining control strategies can no longer be assessed as a part of a complete attainment demonstration. Instead, EPA proposed to approve two permits as SIP strengthening, Carmeuse Lime's Permit to Install 193-14A and DTE Energy—Trenton Channel's Permit to Install 125-11C. SIP strengthening is appropriate for limits that improve air quality but do not meet a specific CAA requirement.

(4) EPA proposed to disapprove the DTE River Rouge permit, Permit to Install 40-08H, because it was recently superseded by a new permit to install, not included in the SIP package, that corrected an error in the long-term averaging calculation for the superseded permit.

(5) EPA proposed to approve the 2012 baseline inventory as meeting the requirements of CAA section 172(c)(3) and (4) for the Detroit SO 2 NAA.

(6) EPA proposed to affirm that the new source review requirements for the area have been met because Michigan has a fully approved NNSR Program. 2

(7) Because the Detroit plan is missing enforceable measures for some major sources of SO 2 and is therefore not able to demonstrate attainment, EPA proposed to disapprove the following:

EPA's action to disapprove portions of the Detroit attainment plan will start new sanctions clocks under CAA section 179(a)-(b) which can be stopped only if the conditions of EPA's regulations at 40 CFR 52.31  3 are met. Only a full SIP approval or EPA's promulgation of a Federal implementation plan (FIP) under CAA section 110(c)(1) can stop FIP clocks, so this action does not have any effect on the FIP clock that started April 18, 2016. 4

The proposed action described above had a public comment period that closed October 19, 2020, and then by request, was reopened until November 16, 2020. This action received 21 supportive comments, nine comments not directly relevant to the rulemaking, and a joint comment letter from Sierra Club and Earth Justice that was partially adverse. This joint comment letter is summarized below along with EPA's responses.

Comment: The commenters contend that the state's modeling contains several flaws and the modeling methodology should be explicitly disapproved. The commenters went on to point out several elements with which they took issue in the modeling. The commenters additionally provided their own modeling demonstration showing further reductions needed from several sources in the area.

Response: The state's modeling is part of the attainment demonstration which is being disapproved as part of this action. Because the attainment demonstration is not approvable due to enforceability issues, it is not necessary for EPA to determine whether or not the modeling supports attainment, when the modeling relies on limits that no longer exist. However, EPA has taken note of the modeling concerns in this comment letter and will include them for consideration during the continued attainment planning efforts for this area.

Comment: The commenters pointed out that the reason for the invalidation of Rule 430 was because Michigan does not have authority to impose facility-specific limits. The commenters contend that EPA should consider whether a SIP-call under CAA section 110(k)(5) is needed due to Michigan appearing to not meet the requirement of section 110(a)(2)(E)(i) to have adequate authority to carry out its implementation plan. EPA should also move forward with a FIP if the state lacks proper authority.

Response: Although prohibitions on adoption of individual facility limits in state rules is not uncommon, in this situation it resulted in some of the State's submitted SIP limits being invalidated under state law, which precludes approval of the attainment demonstration and of those limits. EPA expects now that Michigan will draft future rules to avoid this prohibition which resulted in invalid limits and make necessary efforts to properly implement the NAAQS. Additionally, EPA is actively working on continued attainment planning efforts for this area, and the result of this SIP disapproval action will be to impose CAA section 179 sanctions if the State does not take necessary steps to correct the deficiencies giving rise to the disapproval. Consequently, in this final action EPA is not prepared to exercise its discretion to issue a CAA section 110(k)(5) SIP Call to Michigan regarding this issue, and notes that the State is already obligated to remedy the deficiencies that would be addressed by any additional SIP Call under section 110(k)(5), which, if issued, would occur under its own separate notice and comment process. In addition, in this final action EPA is not able to additionally promulgate a FIP under CAA section 110(c), as that requires its own notice and comment rulemaking process pursuant to CAA section 307(d). Consequently, this final action to partially approve and partially disapprove the submitted SIP does not include any final action under section 110(k)(5) regarding whether to issue a SIP Call, or under section 110(c) to promulgate a FIP.

Comment: The commenters recommended that EPA not approve the Trenton Channel permit as SIP strengthening because the limit is above the plant's actual current emissions and, therefore, does not immediately improve air quality. Additionally, the commenters contend that if included, the limits should undergo a robust analysis on how the 30-day average is appropriate to meet the one-hour standard.

Response: EPA disagrees with both points. The permit's inclusion into the SIP does improve air quality because it restricts the facility's potential to emit at higher levels in the future compared to currently allowable levels, even if the facility is not currently emitting at the permit's levels or the even higher levels allowed under the current SIP. Additionally, the 30-day average does not need to be evaluated as to whether it is sufficient to provide attainment under the one-hour NAAQS, because the permit is not currently being approved as part of a strategy to meet that standard. However, if the permit is relied on in future attainment planning efforts, a robust analysis of the 30-day averaging limit (and any other limits relied upon in such a future demonstration) will be provided. In this action, EPA makes no final judgment on whether the 30-day limit combined with other future possible limits will provide for NAAQS attainment.

Comment: The commenters stated that EPA should not approve the 2012 base year inventory because it does not meet the CAA section 172(c)(3) requirements of being “comprehensive, accurate, [and] current”. The commenters attempted to demonstrate this by showing emission increases at two sources when comparing 2012 to 2018 annual emissions.

Response: During the attainment planning and eventual redesignation process, three different inventories are considered and approved: Base year, attainment year, and future maintenance year. This action is only approving the base year inventory. Base year inventories are a nonattainment year upon which all future attainment work is based. Regarding the commenters' claim that the 2012 inventory is out of date, when Michigan began their attainment planning, 2012 was the most current year with available emissions data. EPA would not expect a base year inventory to be amended because time has passed since the submittal date. The 2018 data would not have been available until 2019 at the earliest, which was three years after the state's submittal. EPA disagrees with the commenters' second issue, that the 2012 inventory is inaccurate. The commenters' examples of 2018 emissions are from the Michigan Air Emissions Reporting System (MAERS), publicly available annual emissions data for all major sources in Michigan. The commenters compared the emissions increase at two sources between 2012 and 2018 to show inaccuracy in the base year inventory. EPA disagrees that this data proves inaccuracies, but rather demonstrates the variability of emissions over time, generally due to economic factors, i.e. increased affordability of natural gas lowering emissions and increased manufacturing due to economic demands increasing emissions. When comparing all the sources in the inventory from 2012 to 2018, total emissions have decreased by 82 percent, shown in Table 1 below as tons per year (tpy) of SO 2 emissions.

Emissions inventories are always likely to vary year to year, but that does not deem a previous year's inventory inaccurate. As an example, Dearborn Industrial Generation (DIG), one of the sources pointed out by the commenters as increasing emissions between 2012 and 2018, varies greatly year to year. Looking at data over the most recent 15 years in MAERS, 2003 to 2018, DIG had a lowest value of 364.61 tpy in 2009 and a highest value of 1,038.72 tpy in 2016, showing that the 2012 and 2018 years are both in the middle of the normal annual fluctuations. The eventual action to approve or disapprove an attainment year inventory will consider changes in emissions levels during the attainment planning period, including the differences pointed out in the comment between 2012 and 2018, and additional reductions needed to bring the area into attainment. However, the eventual development of an attainment year inventory will not change the factual basis of the base year inventory. The attainment planning process will account for these possible fluctuations by focusing on potential to emit rather than the actual inventories of any given year. Therefore, EPA believes 2012 is appropriate for a base year inventory, and that the submitted 2012 base year inventory is approvable for its purposes of charactering what emissions were in that base year.

Comment: The commenters pointed to the language from EPA's proposed approval stating, “EPA modeling demonstrates that attainment at violating receptors can be achieved when the emission limits in the DTE Trenton Channel Permit are analyzed together with those contained in a recently issued permit for the DTE River Rouge facility (Permit to Install 40-08I)” and contended that EPA should not finalize a finding that revisions to the DTE Trenton Channel and River Rouge permits would be enough to achieve attainment.

Response: EPA is not finalizing a finding that revisions to the DTE Trenton Channel and River Rouge permits would be enough to achieve attainment of the one-hour standard. Such a final determination could be made only upon approval of the state's attainment plan or as part of EPA's promulgation of a FIP. EPA meant this discussion to explain the reasoning for DTE River Rouge alone to obtain a new permit in response to a calculation error found in both the River Rouge and Trenton Channel 30-day averaging limits. EPA is clarifying that these changes alone do not prejudge whether these or any other measures will or will not result in attainment for the entire Detroit area.

Comment: The commenters are supportive of the disapproval of the RACT/RACM, RFP, and contingency measure elements and recommended EPA finalize as expeditiously as possible. The commenters additionally supplied recommendations for next steps in replacing the disapproved portions of this plan.

Response: In addition to the modeling recommendations, EPA will also consider the “next steps” recommendations in this letter as a part of the ongoing attainment planning efforts.

EPA is finalizing the following actions as proposed: EPA is approving the base year inventory and affirming that the new source review requirements for the area have been met. EPA is also approving the DTE Trenton Channel and Carmeuse Lime permits as SIP strengthening. EPA is proposing to disapprove the attainment demonstration, as well as the requirement for meeting RFP toward attainment of the NAAQS, RACM/RACT, contingency measures, the invalidated Rule 430 related to U.S. Steel, and the superseded 2016 permit related to DTE River Rouge. This disapproval will start new sanctions clocks for this area under CAA section 179(a)-(b).

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Michigan Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 5

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 18, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

On November 9, 2020, the EPA issued a final rule titled “Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; California; South Coast Moderate Area Plan and Reclassification as Serious Nonattainment for the 2012 PM 2.5 NAAQS.”  1 That publication inadvertently omitted from the description of the Riverside County portion of the designated area, language indicating that the lands of the Santa Rosa Band of Cahuilla Mission Indians and Pechanga Band of Luiseno Mission Indians of the Pechanga Reservation are excluded from that portion of the Los Angeles-South Coast Air Basin nonattainment area for the 2012 PM 2.5 NAAQS. This action corrects the omission and revises the entry as intended in the November 9, 2020 final rule.

The EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this action are unnecessary because the underlying rule for which this correcting amendment has been prepared was already subject to a 30-day comment period, and this action merely corrects an error in the rule text. Further, this action is consistent with the purpose and rationale of the final rule, which is corrected herein. Because this action does not change the EPA's analyses or overall actions, no purpose would be served by additional public notice and comment. Consequently, additional public notice and comment are unnecessary.

The EPA also finds that there is good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date of less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. This action merely corrects an error in a previous rulemaking. For these reasons, the EPA finds good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action.

This action:

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

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

• Is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Is not subject to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4);

• Does not impose a significant intergovernmental mandate or significantly or uniquely affect small governments, as described in sections 203 and 204 of the UMRA;

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

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

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

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this error correction action does not involve technical standards; and

• Does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994).

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

In issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order.

The Congressional Review Act (CRA) (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the Agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, the EPA has made such a good cause finding, including the reasons therefore, and established an effective date of March 19, 2021. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This correction to 40 CFR part 81 for California is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons stated in the preamble, the EPA corrects Part 81, Chapter I, Title 40 of the Code of Federal Regulations by making the following correcting amendments:

This final rule is organized as follows:

Entities such as industrial facilities, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to fresh waters of the United States under the State of Oregon's jurisdiction could be affected by this rule because Federal WQS promulgated by EPA in this rule will be the applicable WQS for fresh waters in Oregon for CWA purposes after the effective date of this rule. These WQS are the minimum standards which must be used in such CWA regulatory programs as National Pollutant Discharge Elimination System (NPDES) permitting  1 and identifying impaired waters under CWA Section 303(d). Categories and entities that could potentially be affected by this rule include the following:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could ultimately be affected by this action. Any parties or entities who depend upon or contribute to the water quality of Oregon's fresh waters could be affected by this rule. To determine whether your facility or activities could be affected by this action, you should carefully examine this rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

EPA carefully considered the public comments and feedback received from interested parties on the proposal published in the Federal Register at 84 FR 18454 on May 1, 2019. EPA provided a 45-day public comment period and held two public hearings on June 11 and June 12, 2019, to provide clarification on the contents of the proposed rulemaking and to accept verbal public comments.

A total of eight organizations and individuals submitted comments either to the docket or during the public hearings on a range of issues prior to the close of the public comment period on June 17, 2019. Some comments addressed issues beyond the scope of this rule. Brief summaries of specific comments and EPA's responses are provided in this action. For a full accounting of the comments and the Agency's responses, see EPA's Response to Comments document in the official public docket for this rule.

CWA Section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS for state waters subject to CWA jurisdiction. CWA Section 303(c)(2)(A) provides that WQS shall consist of designated uses of the waters and water quality criteria based on those uses. EPA's implementing regulations at 40 CFR 131.11(a)(1) provide that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use [and] [f]or waters with multiple use designations, the criteria shall support the most sensitive use.” In addition, 40 CFR 131.10(b) provides that “[i]n designating uses of a water body and the appropriate criteria for those uses, the [s]tate shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.”

States review applicable WQS at least once every three years and, if appropriate, revise or adopt new WQS (CWA Section 303(c)(1); 40 CFR 131.20). Any new or revised WQS must be submitted to EPA for review and approval or disapproval (CWA Sections 303(c)(2)(A) and (c)(3); 40 CFR 131.20 and 131.21). If EPA disapproves a state's new or revised WQS as not consistent with CWA requirements, the state has 90 days to adopt a revised WQS that adopts the changes specified by EPA to meet CWA requirements. If the state fails to do so, EPA must promptly propose and then, within 90 days, promulgate such WQS unless the state has adopted a revised or new WQS that EPA determines to be consistent with CWA requirements (CWA Sections 303(c)(3) and (c)(4)).

Under CWA Section 304(a), EPA periodically publishes national criteria recommendations for states to consider when adopting water quality criteria for particular pollutants to meet the CWA Section 101(a)(2) goal. When EPA has published recommended criteria, states should establish numeric water quality criteria based on the Agency's CWA Section 304(a) recommended criteria, CWA Section 304(a) recommended criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). Water quality criteria must protect the designated use and be based on sound scientific rationale. For waters with multiple use designations, the criteria shall support the most sensitive use (40 CFR 131.11(a)(1)).

As explained in the preamble of the proposed rulemaking, EPA disapproved the State's freshwater aluminum criteria in 2013 because the State had not supplied a scientific rationale for the pH range under which the State's criteria would apply, which differed from the applicable pH range specified in EPA's 1998 national CWA Section 304(a) recommended criteria for aluminum (84 FR 18456-57, May 1, 2019) that existed at that time but have since been updated.

Under the terms of a consent decree (as amended) to resolve litigation in Northwest Environmental Advocates v. U.S. EPA, 3:15-cv-00663-BR (D. Or. 2015), EPA is required, no later than six months after the date on which the National Marine Fisheries Service (also known as National Oceanic and Atmospheric Administration (NOAA) Fisheries) issues its Biological Opinion on the aluminum criteria previously proposed by EPA, to either approve aluminum criteria to protect aquatic life in fresh waters submitted by Oregon or sign a notice for publication in the Federal Register to finalize the aluminum criteria EPA proposed for Oregon. NOAA Fisheries transmitted its Biological Opinion to EPA on July 1, 2020. Since Oregon has not yet adopted freshwater aluminum criteria to meet CWA requirements, EPA is promulgating freshwater aluminum criteria for Oregon waters in accordance with CWA Sections 303(c)(3) and (c)(4).

Under the Agency's CWA Section 304(a) authority, EPA develops national recommended criteria and methodologies to protect aquatic life and human health for specific pollutants and pollutant parameters. EPA invites public comment on draft recommended criteria and methodologies and seeks scientific expert review before EPA finalizes them as formal national water quality criteria recommendations for states to consider when developing and adopting applicable water quality criteria. EPA's Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (referred to as the “Aquatic Life Guidelines”)  2 describe the systematic way in which EPA establishes concentrations for a pollutant in water that will support the aquatic life designated use.

Numeric criteria derived using EPA's Aquatic Life Guidelines are expressed as acute and chronic values representing short-term and long-term exposures, respectively. The combination of a criterion maximum concentration (CMC), typically expressed as a one-hour average value, and a criterion continuous concentration (CCC), typically specified as a four-day average value, protects aquatic life from acute and chronic toxicity, respectively. Neither value is to be exceeded more than once in three years. An exceedance occurs when the average concentration over the duration of the averaging period is above the CMC or the CCC. EPA based its maximum exceedance frequency recommendation of once every three years on the ability of aquatic ecosystems to recover from the exceedances.

The Aquatic Life Guidelines recommend reliance on toxicity test data from a minimum of eight taxa of aquatic organisms in order to derive criteria. These taxa are intended to be representative of a wide spectrum of aquatic life, such that the representative taxa serve as surrogates for untested species. Therefore, the representative test organism species do not need to be present in the water(s) where the criteria will apply. A state is not precluded from relying on toxicity data using resident species to develop site-specific criteria to apply at a localized site. In developing site-specific criteria, EPA recommends that the state maintain similar broad taxonomic representation in calculating the site-specific criteria to ensure protection of the most sensitive species at the site. If a state chooses to carry out the “deletion of data” portion of the species re-calculation process, the state should consider how to demonstrate that the species included in the derivation of EPA's national recommended criteria are not present and would not serve as surrogates for other species that occur at the site. 3

EPA's 2018 national CWA Section 304(a) recommended freshwater aquatic life criteria for aluminum (Final Aquatic Life Ambient Water Quality Criteria for Aluminum 2018, EPA 822-R-18-001, as cited in the Federal Register at 83 FR 65663, December 21, 2018), referred to in this action as the “2018 national recommended criteria,” were developed following the Aquatic Life Guidelines. These recommended criteria update and replace EPA's 1988 national CWA Section 304(a) recommended freshwater aquatic life criteria for aluminum. The 2018 national recommended criteria apply to fresh waters and include a calculator that takes into account three water chemistry characteristics that affect aluminum toxicity. The 2018 national recommended criteria reflect the latest scientific knowledge and understanding of the interaction between water chemistry and aluminum toxicity, and represent a scientifically defensible method upon which EPA is basing this CWA action to establish WQS for fresh waters in Oregon (83 FR 65663, December 21, 2018).

The 2018 national recommended criteria are based upon Multiple Linear Regression (MLR) models for fish and invertebrate species that use site-specific pH, dissolved organic carbon (DOC), and total hardness inputs to quantify the effects of these water chemistry parameters on the toxicity of aluminum to aquatic organisms. The MLR models normalize the available toxicity data to accurately reflect the effects of the site-specific water chemistry (pH, DOC, total hardness) on the toxicity of aluminum to tested species. The normalized toxicity test data are then used in a criteria calculator to generate criteria for specific ambient water chemistry conditions. The numeric outputs of the 2018 national recommended criteria calculator for a given set of conditions vary depending on the site-specific pH, DOC, and total hardness entered into the calculator. The calculator outputs (CMC and CCC) for a given set of input conditions are numeric values that would be protective for that set of input conditions ( i.e., water-chemistry-condition-specific CMC and CCC outputs).

Users of the 2018 national recommended criteria can generate criteria magnitude values in two ways: (1) Use the lookup tables provided in the criteria document to find the numeric aluminum CMC and CCC most closely corresponding to the local conditions for pH, DOC, and total hardness; or (2) use the provided Aluminum Criteria Calculator V2.0 Excel spreadsheet to enter the pH, DOC, and total hardness conditions at a specific site to calculate the numeric aluminum CMC and CCC corresponding to the local input conditions.

In its 2018 national recommended criteria, EPA expressed the aluminum criteria as “total recoverable” metal concentrations. The primary reason for the expression of the criteria as total recoverable aluminum concentrations is because the laboratory toxicity tests used in the effects assessment in the development of the aluminum criteria reported the aluminum concentrations as total recoverable aluminum. The use of total aluminum concentrations is justified for laboratory toxicity test data where the total aluminum concentration is in either a dissolved monomeric form or precipitated forms ( e.g., aluminum hydroxides) of aluminum. The laboratory dilution waters in tests used for EPA's criteria development did not contain suspended solids, clays, or particulate matter where aluminum could be bound. However, total recoverable aluminum concentrations measured in natural waters may overestimate the potential risks of toxicity to aquatic organisms if suspended solids, clays, or particulate matter to which aluminum may be bound are present, because total recoverable methods measure bioavailable and non-bioavailable forms of aluminum.

As discussed in Section 2.6.2 of EPA's 2018 national recommended criteria document, the different forms of aluminum vary in toxicity. The criteria document discusses differences between aluminum toxicity in a controlled laboratory setting and the toxicity of aluminum in natural waters that contain suspended particles, clays, and aluminosilicate minerals not present in lab waters. Dissolved and particulate ( e.g., aluminum hydroxides) aluminum, as well as small sized colloids containing aluminum, exhibit toxic effects on aquatic life depending on the pH, DOC, and total hardness of the waters. Total recoverable aluminum methods determine the total concentration of monomeric (both organic and inorganic) forms of aluminum, polymeric and colloidal forms, as well as particulate forms and aluminum sorbed to clays present in a sample. Total recoverable methods use a strong acid (pH <2) digestion step to prepare the sample for measurement. In contrast, methods to determine dissolved concentrations of aluminum involve filtering test samples prior to digestion, which excludes particulate forms of aluminum from the test sample. Methods to determine dissolved concentrations of aluminum, therefore, may underestimate the toxicity of the aluminum in a sample if the particulate forms including aluminum hydroxide precipitates that contribute to toxicity are not measured. In conclusion, dissolved aluminum measurements are not appropriate for comparison to the aluminum criteria that EPA is promulgating for Oregon. EPA acknowledges, as several commenters noted during the comment periods for both EPA's 2017 draft national CWA Section 304(a) recommended criteria for aluminum and EPA's proposed criteria for Oregon, that not all forms of aluminum that may be present in ambient waters are biologically available or “bioavailable” to aquatic species. Bioavailable aluminum (or the bioavailable fraction of aluminum) is defined as the amount of aluminum that is available to cause a biological response in an aquatic organism. The best measures of bioavailability involve interactions of aluminum with a membrane ( e.g., aluminum binding to proteins of gill membranes), diffusion through the cell membrane, and flocculation of precipitated aluminum on the gill. Bioavailable aluminum is the toxicologically relevant fraction of aluminum which results from a combination of dissolved and precipitated aluminum, in contrast to mineralized (non-toxic) forms of aluminum. 4 The non-bioavailable fraction of aluminum includes large suspended particles, clays, and aluminosilicate minerals.

EPA's 2018 national recommended criteria document (Section 2.6.2 from pp. 22-25) explains the science behind this understanding of aluminum chemistry and toxicity in more detail. There is also relevant discussion of aluminum chemistry (Section 2.2 from pp. 7-10) and mode of action and toxicity (Section 2.3 from pp. 10-16) that help explain the factors affecting bioavailability and toxicity.

EPA is promulgating aluminum criteria for Oregon that incorporate by reference the calculation of CMC and CCC freshwater aluminum criteria values for a site using the 2018 national recommended criteria. 5 Doing so means that the CMC and CCC freshwater aluminum criteria values for a site shall be calculated using the 2018 Aluminum Criteria Calculator V.2.0 ( Aluminum Criteria Calculator V.2.0.xlsx ) or a calculator in R or other software package using the same 1985 Guidelines calculation procedure and underlying model equations as in the Aluminum Criteria Calculator V.2.0 Excel spreadsheet, as established in the 2018 national recommended criteria. Consistent with the 2018 national recommended criteria, the final water quality criteria for aluminum in Oregon fresh waters are expressed as the CMC as a one-hour average total recoverable aluminum concentration (in µg/L) and the CCC as a four-day average total recoverable aluminum concentration (in µg/L). The CMC and CCC are not to be exceeded more than once every three years.

EPA is promulgating multiple footnotes to the criteria statement to provide clarification on the criteria's intended application, and highlights two in this paragraph. The first footnote specifies that to apply the aluminum criteria for CWA purposes, criteria values based on ambient water chemistry conditions must protect the water body over the full range of water chemistry conditions, including during conditions when aluminum is most toxic. The second footnote states that (1) these criteria are based on aluminum toxicity studies where aluminum was analyzed using total recoverable analytical methods; (2) Oregon may utilize total recoverable analytical methods to implement the criteria; (3) for characterizing ambient waters, Oregon may also utilize, as scientifically appropriate and as allowable by State and Federal regulations, analytical methods that measure the bioavailable fraction of aluminum, as described above, ( e.g., utilizing a less aggressive initial acid digestion, such as to a pH of approximately 4 or lower, that includes the measurement of amorphous aluminum hydroxide yet minimizes the measurement of mineralized forms of aluminum such as aluminum silicates associated with suspended sediment particles or clays); and (4) Oregon shall use measurements of total recoverable aluminum where required by Federal regulations.

Commenters were generally supportive of EPA's proposal to base its promulgation for Oregon on EPA's 2018 national recommended criteria for aluminum. EPA acknowledged in the preamble to the proposal that the Agency may consider future modifications to the criteria if warranted based on, among other things, further public input, tribal consultation, new data, or evaluations of listed species completed during Endangered Species Act (ESA) consultation, or the results of ESA consultation. On February 13, 2020 and July 1, 2020, EPA completed consultation with the U.S. Fish and Wildlife Service (USFWS) and NOAA Fisheries, respectively. After evaluating potential effects of the Agency's action on federally-listed species during ESA Section 7(a)(2) consultation with USFWS and NOAA Fisheries, in addition to consideration of comments received during the public comment period associated with the proposed rulemaking, EPA is promulgating aluminum criteria consistent with the 2018 national recommended criteria.

The 2018 national recommended criteria represent the latest scientific knowledge on aluminum speciation, bioavailability, and toxicity, and provide predictable and repeatable outcomes. Consistent with the Aquatic Life Guidelines, the 2018 national recommended criteria protect aquatic life for acute effects (survival and immobility), as well as chronic effects (survival, growth, and reproduction) at a level of 20% chronic Effects Concentration (EC20) for the 95th percentile of sensitive genera. The docket for the 2018 national recommended criteria document contains detailed information on the science underlying that recommendation (Docket ID: EPA-HQ-OW-2017-0260).

As mentioned above, commenters pointed out that, as EPA had acknowledged in its 2018 national recommended criteria document, the current test methods for total recoverable aluminum may, in some waters, overestimate the amount of aluminum that will be toxic to aquatic life in ambient waters in Oregon. Commenters suggested that in order to better approximate the toxic fraction of aluminum, EPA should allow use of an emerging analytical method that measures bioavailable aluminum by using an initial digestion at pH 4. Commenters urged use of such an analytical method to characterize aluminum concentrations in ambient waters, particularly in waters with high levels of total suspended solids suggesting the presence of colloidal, particulate, and clay-bound aluminum. Some commenters requested that the final criteria for Oregon be expressed as “bioavailable or total recoverable” aluminum to confirm availability for use of an alternative analytical method.

EPA acknowledges in the final rule that the promulgated criteria are based on aluminum toxicity laboratory studies where aluminum was analyzed using total recoverable analytical methods. However, EPA also acknowledges that under natural conditions not all of these forms of aluminum would be biologically available to aquatic species. All of the approved total recoverable methods require that samples be preserved in the field by acidifying to pH <2 and digested in the laboratory with strong acid solution that dissolves the monomeric and polymeric forms of aluminum, in addition to colloidal, particulate, and clay-bound aluminum. Over the last three decades, the scientific consensus has been that the total recoverable method for aluminum potentially overestimates the biologically available fraction and that a method that better addresses concerns with including aluminum bound to particulate matter would be useful ( e.g., He and Ziemkiewics 2016; Ryan et al. 2019). 6

In an attempt to address concerns with measuring total recoverable aluminum concentrations, researchers recently investigated new analytical methods to measure biologically available forms of aluminum (Rodriguez et al. 2019). 7 This approach does not digest the sample at pH of −0.05 to +0.7 but rather to pH 4 to better measure only the bioavailable fraction of aluminum. Rodriguez et al. reported that sodium acetate buffer is added to the sample to reach the desired pH, followed by sample agitation for a specified period of time, and finally 0.45-µm sample filtration. The sample is then acidified with nitric acid before inductively coupled plasma-optical emission spectrometry analysis. These authors provided data that led them to conclude that their proposed method is better able to discriminate chronic toxicity effects attributable to bioavailable aluminum from mineralized nontoxic forms of aluminum compared with existing methods using total or total recoverable aluminum.

EPA expects that an analytical method that uses a less aggressive initial acid digestion that liberates bioavailable forms of aluminum (including amorphous aluminum hydroxide), yet minimizes dissolution of mineralized forms of aluminum such as aluminosilicates associated with suspended sediment particles and clays (referred to as a bioavailable analytical method), will better estimate the bioavailable fraction of aluminum in ambient waters. EPA is not prescribing use of any specific method and looks to further research and method standardization efforts to identify best practices.

For the reasons articulated above, EPA is including the option for Oregon to use a bioavailable analytical method for characterizing aluminum concentrations in ambient waters, except where measurements of total recoverable aluminum are required by Federal regulations ( e.g., NPDES permit limits for aluminum and compliance reports, by regulation at 40 CFR 122.45, 40 CFR 122.44, and 40 CFR 122.48, must be expressed as “total recoverable aluminum” and measured using analytical methods approved at 40 CFR part 136). Doing so, particularly when testing ambient samples expected to contain significant amounts of colloidal, particulate, and clay-bound aluminum, will better approximate the fraction of aluminum that is “available” to aquatic life in Oregon waters. The footnote in the criteria statement that speaks to Oregon's use of a bioavailable analytical method specifies that such a method may utilize “a less aggressive initial acid digestion, such as to a pH of approximately 4 or lower, that includes the measurement of amorphous aluminum hydroxide yet minimizes the measurement of mineralized forms of aluminum such as aluminum silicates associated with suspended sediment particles or clays.” Oregon may use such methods “as scientifically appropriate and as allowable by State and [F]ederal regulations.” For more discussion on analytical methods considerations, refer to Section C. Implementation of Final Freshwater Acute and Chronic Aluminum Criteria in Oregon of this preamble.

In addition to addressing comments pertaining to the use of analytical methods described above, EPA also addressed separate and unrelated comments regarding language included in the proposed criteria table. In the proposed rulemaking, the proposed criteria table included the following text: “Calculator outputs shall be used to calculate criteria values for a site that protect aquatic life throughout the site under the full range of ambient conditions, including when aluminum is most toxic given the spatial and temporal variability of the water chemistry at the site.” Commenters requested that the text be moved out of the criteria table because they suggested that it referred to implementation of the criteria and that the criteria regulation should only contain a reference to the 2018 national recommended criteria for aluminum. In response, the final rule removes the proposed text from the criteria table and instead includes a modification of EPA's statement as a footnote to the criteria table. The Agency is using Oregon's adopted water quality criteria for the copper Biotic Ligand Model (BLM) as its guide, specifically Endnote N, Subpart 3(a), which states that Oregon “will apply the BLM criteria for Clean Water Act purposes to protect the water body during the most bioavailable or toxic conditions.”  8

Commenters also requested that EPA edit the above-referenced statement to avoid the implication that a static set of criteria values must be calculated for each site for CWA implementation purposes. EPA affirms that the State need not calculate static criteria values for each site and has revised the statement to provide that for CWA purposes, criteria values based on ambient water chemistry conditions must protect the water body over the full range of water chemistry conditions, including during conditions when aluminum is most toxic. The intention of the statement is to reflect that site-specific pH, DOC, and total hardness conditions vary both spatially and temporally and that the State must apply the criteria in a manner that ensures protection over the full range of variability.

The State may ensure protection over the full range of water chemistry conditions in different ways for different CWA implementation purposes. For example, for NPDES permitting, the permit protects the water body during critical conditions and therefore under other foreseeable conditions. The State could use multiple outputs of the calculator to generate a static set of criteria values that would be protective for the range of ambient conditions at a site, and use these to calculate a water quality-based effluent limit (WQBEL) for an NPDES permit for a water body. For assessment, the State could concurrently measure the aluminum concentration and the input parameters at the site. The calculator would generate instantaneous criteria values against which the concurrently collected aluminum monitoring data would be compared.

Regarding the topic of default criteria values, Oregon will need to use ambient water chemistry data ( i.e., paired pH, DOC, total hardness) as inputs to the calculator in order to determine protective aluminum criteria values when implementing the criteria, unless the State provides protective default values. To ensure that all subject waters will be protected by the aluminum criteria, EPA recommends the State have either protective default input values for DOC, default criteria magnitude values, or procedures for how to calculate criteria values for waters for which there are insufficient data to adequately characterize site-specific conditions in the water body. EPA recommends that pH values be directly measured rather than estimated, given the variability of pH in the environment and the sensitivity of criteria calculations to differences in pH. EPA solicited comment in the preamble to the proposed rulemaking on whether it should promulgate default criteria values for aluminum to ensure protection of the aquatic life designated use when available data are insufficient to characterize a site. EPA agrees with comments that while default values may be needed in some situations, it is preferable to collect the needed ambient data and use the calculator to calculate criteria values. Commenters supported the use of default ecoregional criteria values for situations when data for more than one input parameter are unavailable, but requested that the final rule not include promulgation of default criteria values. In consideration of these comments, EPA has elected not to finalize default criteria procedures or values in this rule.

Although Oregon is not required to identify default input parameters or default criteria values for aluminum, the State is required to protect the designated uses of the waterbodies within its jurisdiction. As described in more detail below, EPA has elected to provide the procedures for developing default criteria values and default DOC inputs in the docket to this rulemaking. These procedures are available to Oregon to use at the State's discretion, in the event the State does not yet have sufficient site-specific ambient data upon which to rely for a particular location. EPA expects that the State will provide publicly available default procedures or values so that the public and implementing entities will be aware of how all of the State's fresh waters subject to the rule will be protected by the criteria when available data are insufficient to characterize a site.

Per commenters' suggestions, this final preamble briefly describes a suggested procedure for calculating default ecoregional criteria, but does not include a table of pre-calculated values. Comments supported the option of “ecoregional criteria default values” based on the 10th percentile of the distribution of calculator outputs calculated within an ecoregion, which is similar to the approach that EPA suggested in the preamble to the proposal and described in a technical analysis included in the docket (“Analysis of the Protectiveness of Default Ecoregional Al Criteria Values” Docket ID: EPA-HQ-OW-2016-0694-0114). In this procedure, EPA calculated ecoregional default aluminum criteria values based on publicly available data from each of Oregon's Level III Ecoregions. 9 To calculate ecoregional default criteria values, (1) EPA identified paired measurements of the three calculator input parameters where available, and (2) where paired measurements of the three calculator input parameters were unavailable, EPA identified paired ambient data measurements for available input parameters along with estimated DOC and/or total hardness estimated from measured Total Organic Carbon (TOC) and specific conductivity, respectively as needed. EPA then calculated the 10th percentile CMC and CCC (and other percentiles) for each ecoregion from the distributions of calculator outputs. Finally, depending on the ecoregion and data censoring method, EPA selected the 5th or 10th percentile as a statistic that represents a lower bound of spatially and temporally variable conditions that will be protective in the majority (>90%) of cases. This procedure is available for the State to use to generate default criteria values for areas for which the Aluminum Criteria Calculator v.2.0 will be used and there are insufficient site-specific ambient data. The State may also use another scientifically defensible procedure to generate default criteria values.

In addition to soliciting comment on including default ecoregional criteria, EPA also solicited comment on whether the final rule should include default DOC input values. Among the input parameters, ambient DOC data are the least likely to be available out of the three input parameters. DOC influences aluminum toxicity unidirectionally. Higher levels of DOC provide more mitigation of aluminum toxicity. For water bodies for which sufficient pH and total hardness data are available, but sufficient DOC data are not available, Oregon may develop default DOC input values to use with ambient pH and total hardness data, as an alternative to using default criteria values. Comments supported the use of default DOC inputs when DOC input parameter data are unavailable. Commenters requested the final rule afford the State the discretion to develop its own DOC defaults, including a comment requesting that the State be able to use its own DOC default inputs from its copper BLM criteria rule. 10 EPA has elected not to finalize default DOC inputs for this aluminum rule so that the State may use its discretion to develop or apply its own.

Per commenters' suggestions, EPA briefly describes a possible procedure for calculating default DOC input values. One such approach would be to mirror the approach EPA described in the preamble to the proposed rulemaking, which also is described in technical support materials associated with EPA's proposed rulemaking and included in the docket to this rulemaking (“Analysis of the Protectiveness of Default DOC Options” Docket ID: EPA-HQ-OW-2016-0694-0116). In that analysis, EPA analyzed the State's DOC default procedures for its copper water quality standard and found that in most of the ecoregions, the default values those procedures would generate would be protective as default inputs for aluminum as well, with some exceptions and considerations. EPA derived its suggested default DOC input values as the 15th or 20th percentile of the distribution of data from a compilation of high quality data available for Oregon's georegions (aggregated ecoregions with similar water quality characteristics). Depending on the ecoregion and the data censoring method, EPA selected the 5th, 15th, or 20th percentiles as low-end percentiles of georegional DOC concentrations that represent a lower bound of spatially and temporally variable conditions that will be protective in the majority of cases. EPA encourages the State to continue refining its DOC default input procedures to ensure the calculated aluminum criteria values will be protective for all of Oregon's fresh waters subject to this rule.

EPA understands that states have certain flexibilities under 40 CFR part 131 regarding how each implements water quality standards, such as today's freshwater aluminum criteria for Oregon. To support the State, the proposed rulemaking identified a range of acceptable approaches for the State and the commenting public to consider. The State may elect to utilize one or more of the approaches or to implement the final aluminum criteria in other ways that are consistent with 40 CFR part 131.

For CWA implementation purposes, the State will need to identify one or more outputs from the calculator or a value derived from a scientifically defensible percentile of the distribution of the output values as the magnitude(s) of the criteria, to be applied together with duration and frequency, to protect the water body under the range of water chemistry conditions at a site. In practice, EPA expects the State to collect sufficient data to characterize the most toxic conditions at a site. The State could collect samples for the input parameters concurrently or as close to the same time as possible while representing the same environmental condition, and could use default values if appropriate where data are unavailable or insufficient to capture the variability in conditions. The ways by which the State may evaluate sufficiency are described in more detail below.

The proposal preamble described three example approaches that the State could use to calculate criteria values when multiple calculator outputs, representing different ambient conditions over time, are available ( i.e., how to reconcile multiple calculator outputs). EPA agrees with commenters' suggestions that further development and implementation of these approaches should be left to the State's discretion, and that the term used to identify one or more protective values, “reconcile,” was not appropriate to describe how the State should manage multiple calculator outputs. The appropriate approach for each circumstance will depend primarily on data availability and on the programmatic purposes for which criteria values are being calculated. For purposes which require forecasting a protective loading allocation under varying ambient conditions, for example, the State could calculate a single set of numeric criteria values (CMC and CCC) by choosing the lowest output or a low percentile of the outputs of multiple calculator runs, or use conservative default values.

Oregon should ensure that sufficiently representative data are collected for the calculator's input parameters (pH, DOC, and total hardness) to have confidence that the most toxic conditions are adequately characterized. To accomplish this, Oregon may evaluate the input parameter data and resultant criteria values that are calculated over time for different flows and seasons through the use of appropriate statistical methods, such as Monte Carlo  11 simulation. One consideration when defining a site to which to apply criteria for aluminum is whether the concentration of metals are generally consistent throughout the area. As the size of a site increases, the spatial and temporal variability is likely to increase; thus, more water samples may be required to adequately characterize the entire site. Implementation materials that outline the State's approaches will help provide transparency for the public and predictable, repeatable outcomes. Additional transparency and public accountability will be achieved if Oregon makes publicly available each site's ambient water chemistry data, including the inputs used in the aluminum criteria value calculations, resultant criteria values, and the geographic extent of the site.

Similarly, NPDES permit effluent limits that are derived from the aluminum criteria calculator should be sufficiently explained in Fact Sheets or Statements of Basis. This includes providing an explanation of how the aluminum criteria values were calculated; the input data or summary of input data and source of data; and how criteria values were used to determine whether the discharge would cause or have the reasonable potential to cause or contribute to an excursion above the aluminum criteria, and if so, how the values were used to derive WQBELs for aluminum. The State's assessment methodology and any TMDLs developed for waters impaired for aluminum criteria developed using the calculator should also be adequately explained for transparency and public accountability in TMDL documents and Integrated Reports, as appropriate.

Substantial changes in a water body's ambient input parameter concentrations will likely affect aluminum toxicity at that site. In addition, as a robust, site-specific dataset is developed with regular monitoring, criteria values previously calculated by the State can be updated to more accurately reflect site conditions. The State may wish to revisit calculated aluminum criteria values periodically (for example, with each CWA Section 303(d) listing cycle or WQS triennial review) or when changes in water chemistry are evident or suspected at a site and as additional monitoring data become available. This will ensure that the criteria values used for implementing CWA programs accurately reflect the toxicity of aluminum and remain protective of the aquatic life designated uses including when aluminum is most toxic.

As discussed earlier, the forms of aluminum introduced into the laboratory toxicity tests upon which EPA relied for criteria development do not include suspended solids or clays where aluminum may be bound. Aluminum bound in suspended solids or clays would be extracted when using total recoverable methods that have a strong acid (pH <2) digestion step, but these forms of aluminum would not be biologically available to aquatic species in ambient waters. Empirical laboratory chronic (7-day) testing with Ceriodaphnia dubia investigating survival and reproduction endpoints indicates that total recoverable (pH −0.05 to +0.7 digestion) and bioavailable measurements of aluminum in lab waters are essentially equal up to approximately 1 mg/L of aluminum. 12 Studies are currently being conducted at Oregon State University with test solutions with greater than 1 mg/L of aluminum to better understand the relationship between the total recoverable and bioavailable analytical methods at concentrations above 1 mg/L. Initial studies indicate there is little variability between total recoverable and bioavailable aluminum above 1 mg/L in lab waters because the laboratory waters do not include clays or suspended solids.

It is not necessary to apply a conversion or translation factor to compare field measurements using a bioavailable method against the promulgated aluminum total recoverable criteria. This is because both bioavailable and total recoverable analytical methods quantify the toxic fraction of aluminum equivalently in laboratory test waters given that standard toxicity test waters do not include suspended solids or clays per test protocols. For NPDES compliance monitoring and reporting, total recoverable measurements for metals are required. By comparison, for ambient water measurements, analytical methods that measure bioavailable aluminum should provide more accurate quantification of the toxic fraction of aluminum. EPA has included a footnote to the final criteria statement specifically noting that for characterizing ambient waters, Oregon may utilize, as scientifically appropriate and as allowable by State and Federal regulations, analytical methods that measure the bioavailable fraction of aluminum. The State's use of such a method would need to comply with other requirements in the State's own program, for example, any applicable Quality Assurance/Quality Control requirements. For assessment and listing purposes, ambient field measurements analyzed using a bioavailable analytical method may be compared directly to the criteria because both represent the toxic fraction of aluminum.

EPA recognizes that in some circumstances, assessing waters using the total recoverable analytical method could result in the listing of some waters ( i.e., those with high amounts of total suspended solids) as impaired even though the elevated aluminum measurements could be largely attributed to non-bioavailable forms of aluminum. EPA's existing regulations do not require use of analytical test methods promulgated at 40 CFR part 136 in the implementation of CWA Section 303 programs, including assessment and listing of waters, nor in the determination of the need for a WQBEL. However, EPA's regulations require that states assemble and evaluate all existing and readily available water quality-related data and information for use in developing their CWA Section 303(d) lists. 40 CFR 130.7(b)(5). The requirement to assemble and evaluate all data and information for assessment and listing purposes includes situations where only total recoverable aluminum data and information are available. However, in those circumstances, the State is not required to rely on that data for listing purposes as long as it provides a technical, science-based rationale for not using the data and information. 40 CFR 130.7(b)(6)(iii). This technical, science-based rationale documenting the State's consideration of existing and readily available data and information is referenced in the additional footnote language to the criteria statement, which speaks to Oregon's ability to use analytical methods that measure the bioavailable fraction of aluminum for characterizing ambient waters “as scientifically appropriate.” For example, the State may be able to demonstrate that total recoverable aluminum samples are not representative of water quality conditions because non-toxic, non-bioavailable forms of aluminum are leading to an exceedance above the criterion. When data and information are available for both total recoverable and bioavailable aluminum, the State must evaluate all of it, but need not rely on all of it for assessment and listing purposes. Applicable regulations do not prohibit the State from assigning more weight to data and information about bioavailable aluminum than total recoverable aluminum for assessment and listing purposes.

For developing TMDLs and load allocations, field measurements analyzed using a bioavailable method also may be used as the basis for identifying allocations for TMDLs, both wasteload allocations (WLA) for point sources and load allocations (LA) for nonpoint sources. For implementing a WLA, the associated WQBEL must be assessed for NPDES compliance purposes using total recoverable methods just as would be the case for other NPDES applications consistent with permitting regulations (NPDES permit limits for aluminum and compliance reports, by regulation at 40 CFR 122.44, 40 CFR 122.45, and 40 CFR 122.48, must be expressed as “total recoverable aluminum” and measured using analytical methods approved at 40 CFR part 136). For implementing a LA, a bioavailable analytical method could be used to measure nonpoint source contributions because significant solids with colloid and clay-bound aluminum could be present (He and Ziemkiewics 2016; Ryan et al. 2019), 13 and should not contribute to the measured aluminum for comparison to a LA.

The contexts where use of an EPA approved method is required are: (1) Applications for NPDES permits, specifically, measurements of effluents, (2) reports required from dischargers, and (3) certifications issued by states under CWA Section 401. 40 CFR 136.1(a). NPDES permit limits for metals must be expressed as “total recoverable” metals with the exception of circumstances that would not apply for the aluminum criteria in this rule. 40 CFR 122.45(c).

The regulatory text incorporates an EPA document by reference, specifically, EPA's Final Aquatic Life Ambient Water Quality Criteria for Aluminum—2018, December 2018 (EPA-822-R-18-001). The 2018 national recommended criteria document is an update to the 1988 recommended aluminum aquatic life ambient water quality criteria, in accordance with the provisions of CWA Section 304(a) directing EPA to revise criteria from time to time to reflect the latest scientific knowledge. The criteria for aluminum that protect aquatic life in fresh water depend on a site's water chemistry parameters. Using those inputs, users can enter a site's pH, DOC, and total hardness into the aluminum criteria calculator or use the lookup tables in the criteria document's appendix. Incorporating this document by reference will allow the State to access all of the underlying information and data EPA used to develop the 2018 national recommended criteria for aluminum. With access to this information, the State will have the flexibility to create its own version of the calculator built upon the underlying peer-reviewed models. EPA has made, and will continue to make, this document publicly available electronically through www.regulations.gov at the docket associated with this rulemaking and at www.epa.gov/wqc/aquatic-life-criteria-aluminum.

To ensure that the final criteria for aluminum are applied appropriately to protect Oregon's aquatic life uses, EPA recommends Oregon use critical low flow values consistent with longstanding EPA guidance  14 when calculating the available dilution for the purposes of determining the need for and establishing WQBELs in NPDES permits. Dilution is one of the primary mechanisms by which the concentrations of contaminants in effluent discharges are reduced following their introduction into a receiving water. During a low flow event, there is less water available for dilution, resulting in higher instream pollutant concentrations. If criteria are implemented using inappropriate critical low flow values ( i.e., flow values that are too high), the resulting ambient concentrations could exceed criteria values when low flows occur. 15

EPA notes that in ambient settings, critical low flow conditions used for NPDES permit limit derivation purposes may not always correspond with conditions of highest aluminum bioavailability and toxicity. EPA's NPDES Permit Writers' Manual describes the importance of characterizing effluent and receiving water critical conditions, because if a discharge is controlled so that it does not cause water quality criteria to be exceeded in the receiving water under critical conditions, then water quality criteria should be attained under all other conditions. 16

EPA's March 1991 Technical Support Document for Water Quality-based Toxics Control recommends two methods for calculating acceptable critical low flow values: The traditional hydrologically-based method developed by the USGS and a biologically based method developed by EPA. 17 The hydrologically-based critical low flow value is determined statistically, using probability and extreme values, while the biologically-based critical low flow is determined empirically using the specific duration and frequency associated with the criterion. For the acute and chronic aluminum criteria, EPA recommends the following critical low flow values, except where modeling demonstrates that the most significant critical conditions occur at other than low flow:

The final criteria must be attained at the point of discharge unless Oregon authorizes a mixing zone. Where Oregon authorizes a mixing zone, the criteria would apply at the locations allowed by the mixing zone ( i.e., the CMC would apply at the defined boundary of the acute mixing zone and the CCC would apply at the defined boundary of the chronic mixing zone). 19 20

Section 7(a)(2) of the ESA requires that each Federal agency ensure that any action authorized, funded, or carried out by such Agency is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. For this rule, EPA transmitted a Biological Evaluation to NOAA Fisheries Service and USFWS on September 20, 2019. NOAA Fisheries responded on October 18, 2019, that EPA's Biological Evaluation was insufficient to initiate formal consultation. EPA submitted a revised Biological Evaluation to NOAA Fisheries on January 2, 2020. On February 13, 2020, EPA received a final Biological Opinion from USFWS that determined that EPA's proposed action is likely to adversely affect, but will not jeopardize the continued existence of bull trout and will not destroy or adversely modify its designated critical habitat. USFWS also concluded that the proposed action may affect, but is not likely to adversely affect, eight other federally-listed species and is not likely to destroy or adversely modify the critical habitat for the other species that were included in the consultation. On July 1, 2020, EPA received a final Biological Opinion from NOAA Fisheries that determined that EPA's proposed action is likely to adversely affect, but will not jeopardize the continued existence of 18 listed species and will not destroy or adversely modify designated critical habitat for the species that were included in the consultation. The receipt of the NOAA Biological Opinion concludes the consultation for this rule under ESA Section 7(a)(2). Documents associated with ESA consultation are available in the docket associated with this rule (Docket ID: EPA-HQ-OW-2016-0694).

Under the CWA, Congress gave states and authorized tribes primary responsibility for developing and adopting WQS for their navigable waters (CWA Sections 303(a) through (c)). Although EPA is finalizing aluminum aquatic life criteria for Oregon's fresh waters subject to this rule on the basis of having disapproved Oregon's 2004 criteria in February 2013, Oregon retains the option to adopt and submit to the Agency acute and chronic aluminum criteria for the State's fresh waters consistent with CWA Section 303(c) and the Agency's implementing regulation at 40 CFR part 131. Indeed, EPA encourages Oregon to do so expeditiously. The Agency would approve the State's criteria if the criteria meet the requirements of CWA Section 303(c) and implementing regulation at 40 CFR part 131. If EPA's federally promulgated criteria are more stringent or prescriptive than the State's criteria, EPA's federally promulgated criteria are and will be the applicable water quality standard for purposes of the CWA until the Agency withdraws those federally promulgated standards (40 CFR 131.21(c)). EPA would expeditiously undertake such a rulemaking to withdraw the Federal criteria if and when Oregon adopts, and the Agency approves, corresponding criteria that meet the requirements of CWA Section 303(c) and implementing regulation at 40 CFR part 131. After such a withdrawal of EPA's federally promulgated criteria, the State's EPA-approved criteria would become the applicable criteria for CWA purposes (40 CFR 131.21(c)).

The Federal WQS regulation at 40 CFR part 131 provides several tools that Oregon has available to use at its discretion when implementing or deciding how to implement these aquatic life criteria, once effective. Among other things, EPA's WQS regulation: (1) Specifies how states and authorized tribes establish, modify, or remove designated uses (40 CFR 131.10); (2) specifies the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions (40 CFR 131.11); (3) authorizes and provides regulatory guidelines for states and authorized tribes to adopt WQS variances that provide time to achieve the applicable WQS (40 CFR 131.14); and (4) allows states and authorized tribes to authorize the use of compliance schedules in NPDES permits to meet WQBELs derived from the applicable WQS (40 CFR 131.15). Each of these approaches is discussed in more detail in the next sections. Whichever approach a state pursues, however, all NPDES permits would need to comply with EPA's regulations at 40 CFR 122.44(d)(1)(i).

EPA's final aluminum criteria apply to fresh waters in Oregon where the protection of fish and aquatic life is a designated use (see Oregon Administrative Rules at Chapter 340 Division 41). The Federal regulation at 40 CFR 131.10(g) provides requirements for establishing, modifying, and removing designated uses when attaining the use is not feasible for one of the six factors in the regulation. If Oregon removes designated uses such that no fish or aquatic life uses apply to any particular water body affected by this rule and adopts the highest attainable use, 21 the State must also adopt criteria to protect the newly designated highest attainable use consistent with 40 CFR 131.11. It is possible that criteria other than the federally promulgated criteria would protect the highest attainable use. If EPA finds removal or modification of the designated use and the adoption of the highest attainable use and criteria to protect that use to be consistent with CWA Section 303(c) and the implementing regulation at 40 CFR part 131, the Agency would approve the revised WQS. EPA would then undertake a rulemaking to withdraw the corresponding Federal WQS for the relevant water(s).

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

EPA's regulations at 40 CFR 122.47 and 131.15 address how permitting authorities can use schedules for compliance with a limit in the NPDES permit if the discharger needs additional time to undertake actions like facility upgrades or operation changes to meet a WQBEL based on the applicable WQS. EPA's regulation at 40 CFR 122.47 allows a permitting authority to include a compliance schedule in the NPDES permit, when appropriate and where authorized by the state, in order to provide a discharger with additional time to meet a WQBEL implementing applicable WQS. EPA's regulation at 40 CFR 131.15 requires that a state that intends to allow the use of NPDES permit compliance schedules adopt specific provisions authorizing their use and obtain EPA approval under CWA Section 303(c) to ensure that a decision to allow a permit compliance schedule is transparent and allows for public input (80 FR 51022, August 21, 2015). EPA already has approved Oregon's State law provision authorizing the use of permit compliance schedules (see OAR 340-041-0061), consistent with 40 CFR 131.15. Oregon's compliance schedule authorizing provision is not affected by this rule. Oregon is authorized to grant permit compliance schedules, as appropriate, based on the Federal water quality criteria for aluminum in Oregon, as long as such permit compliance schedules are consistent with EPA's permitting regulation at 40 CFR 122.47.

To best inform the public of the potential impacts of this rule, EPA evaluated the potential costs associated with State implementation of the Agency's aluminum criteria based on available information. This analysis is documented in Economic Analysis for the Final Rule: Federal Aluminum Aquatic Life Criteria Applicable to Oregon, which can be found in the record for this rule. For this analysis, EPA assumed that Oregon fully implements its existing narrative water quality criteria for aluminum ( i.e., “baseline criteria”) and estimated the incremental impacts for compliance with the aluminum criteria in this rule. For point source costs, EPA assumed any NPDES-permitted facility that discharges aluminum would have reasonable potential and would be subject to effluent limits and would incur compliance costs if it chose to continue discharging. EPA also evaluated nonpoint sources that contribute aluminum loadings to waters that would be considered impaired for aluminum under the final criteria, which may incur incremental costs for additional best management practices (BMPs). The total cost annualized of this final rule would range from $1.2 million to $8.0 million at a 3% discount rate, and $1.2 million to $8.1 million at a 7% discount rate, for the first 10 years. See Economic Analysis for the Final Rule: Federal Aluminum Aquatic Life Criteria Applicable to Oregon for a detailed summary of the information and assumptions EPA relied on to estimate potential costs for the final rule.

Additional information about these statutes and Executive orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is a significant regulatory action and was submitted to the Office of Management and Budget (OMB) for review. Any changes made during OMB's review have been documented in the docket. EPA prepared an analysis of the potential costs to NPDES dischargers associated with State implementation of the aluminum criteria in this rule. This analysis, Economic Analysis for the Final Rule: Federal Aluminum Aquatic Life Criteria Applicable to Oregon, is summarized in section VIII of the preamble and is available in the docket.

This action is considered an Executive Order 13771 regulatory action. Details on the estimated costs of this final rule can be found in EPA's analysis of the potential costs and benefits associated with this action.

This action does not impose any new information-collection burden under the Paperwork Reduction Act. This action does not directly contain any information collection, reporting, or record-keeping requirements. OMB has previously approved the information collection requirements contained in the existing regulations 40 CFR part 131 and has assigned OMB control number 2040-0049.

The Agency certifies that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act. This action will not impose any requirements on small entities. The EPA-promulgated WQS are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters except in compliance with a NPDES permit. CWA Section 301(b)(1)(C)  22 and EPA's implementing regulations at 40 CFR 122.44(d)(1) and 122.44(d)(1)(vii)(A) provide that all NPDES permits shall include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, EPA's promulgation of WQS establishes WQS that the State implements through the NPDES permit process. While the State has discretion in developing discharge limits, as needed to meet the WQS, those limits, per regulations at 40 CFR 122.44(d)(1)(i), “must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Director determines are or may be discharged at a level that will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard, including [s]tate narrative criteria for water quality.” As a result of this action, the State of Oregon will need to ensure that permits it issues include any limitations on discharges necessary to comply with the WQS established in the final rule. In doing so, the State will have a number of choices associated with permit writing. Oregon's implementation of the rule may ultimately result in new or revised permit conditions for some dischargers. EPA is unaware of any current permit holders or other entities that would be required to obtain new permits or update existing permits as a result of this action, including small entities. EPA's action, by itself, does not impose any requirements on small entities; that is, the requirements are not self-implementing.

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

This action does not have federalism implications. EPA believes, however, that this action may be of significant interest to state governments. Consistent with EPA's policy to promote communications between EPA and state and local governemnts, EPA consulted with Oregon early in the process of developing this rulemaking to permit them to have meaningful and timely input into its development. EPA discussed with Oregon the Agency's development of the Federal rulemaking and clarified early in the process that if and when the State decided to develop and establish its own aluminum standards, EPA would assist the State in its process. During these discussions, EPA explained the scientific basis for the aluminum criteria to protect aquatic life for fresh waters in Oregon; the Agency's consideration of comments received during the public comment period associated with this rulemaking; and the overall timing of the Federal rulemaking effort. EPA took these discussions with the State into account during the drafting of this rule.

This action does not have tribal implications as specified in Executive Order 13175. This rule does not impose substantial direct compliance costs on federally recognized tribal governments, nor does it substantially affect the relationship between the Federal Government and tribes, or the distribution of power and responsibilities between the Federal Government and tribes. Thus, Executive Order 13175 does not apply to this action.

Consistent with EPA Policy on Consultation and Coordination with Indian Tribes, the Agency offered government to government consultation to potentially affected tribes during the development of this action. EPA sent letters to tribal leaders of potentially affected tribes in the Pacific Northwest offering government-to-government consultation on the proposed aluminum rule for fresh waters in Oregon. EPA held two conference calls (June 4 and June 13, 2019) with the interested tribal water quality staff to explain the Agency's proposed action and timeline. No tribes requested formal government-to-government consultation on this rulemaking. EPA has continued to apprise the tribes of the status of its final action.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This rule does not involve technical standards.

EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The freshwater criteria for aluminum in Oregon will support the health and abundance of aquatic life in Oregon, and will therefore benefit all communities that rely on Oregon's ecosystems.

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

This document of the Environmental Protection Agency was signed on December 30, 2020, by Andrew Wheeler, Administrator, pursuant to the Third Amended Consent Decree in Northwest Environmental Advocates v. EPA, No. 15-cv-0663-BR (D. Ore., Mar. 16, 2020). That rulemaking document with the original signature and date is maintained by EPA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned EPA Official re-signs the document for publication, as an official document of the Environmental Protection Agency. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set forth in the preamble, EPA amends 40 CFR part 131 as follows:

This supplementary information is organized as follows:

Submit your written comments, identified by Docket ID No. EPA-HQ-OW-2020-0595, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from the docket. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Contact EPA if you want to submit CBI; see FOR INFORMATION CONTACT section of this document. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.

EPA published this rule without a prior proposed rule. The Agency views this action as noncontroversial and anticipates no adverse comment. However, in the “Proposed Rules” section of the Federal Register , EPA is publishing a separate document that serves as the proposed rule if the Agency receives adverse comment on this direct final rule. The Agency will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If EPA receives adverse comment, the Agency will publish a timely withdrawal in the Federal Register , informing the public that this direct final rule will not take effect. The Agency will then consider and address all public comments in any subsequent final rule based on the proposed rule.

This table is intended to be a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. If you have questions regarding the applicability of this action to a particular entity, consult the persons listed in the preceding FOR FURTHER INFORMATION CONTACT section.

EPA approves Michigan's UIC Program primacy application for Class II injection wells located within the State, as required by rule under the SDWA, to prevent underground injection activities that endanger underground sources of drinking water. Accordingly, the Agency codifies Michigan's program in the Code of Federal Regulations (CFR) at 40 CFR part 147, under the authority of the SDWA, Section 1425, 42 U.S.C. 300h-4. Michigan applied to EPA under Section 1425 of the SDWA for primacy for all Class II injection wells within the State except those in Indian country.

The Agency's approval is based on a legal and technical review of Michigan's primacy application. The review included an evaluation of Michigan's requirements for permitting, compliance evaluation, and enforcement and of the programmatic structures and legal authority needed to ensure the protection of underground sources of drinking water (USDWs) in coordination with EPA. Through this process the Agency determined that the State's program is effective. EPA will continue to oversee Michigan's administration of the SDWA Class II UIC program. As part of EPA's oversight responsibility, EPA will require Michigan to submit semi-annual reports of non-compliance and annual UIC performance reports pursuant to 40 CFR 144.8. The Memorandum of Agreement between EPA and Michigan, signed by the EPA Region 5 Regional Administrator on October 13, 2020, makes available to EPA any information obtained or used by Michigan's Class II UIC program, without restriction. The Agency continues to administer the UIC program for Class I, III, VI, V, and VI, injection wells in the State and for all wells in Indian country.

The State published a notification in the Michigan Register announcing their UIC Class II regulations and requesting comment on February 15, 2018. Public comment was accepted through March 16, 2018, and a public hearing on the State's regulations and its intent to apply for primacy was held on February 28, 2018. Both oral and written comments received for the hearing were generally supportive of the State pursuing primacy for the UIC Class II injection well program.

On April 15, 2020, the Agency published a notification of Michigan's complete application in the Federal Register (80 FR 69629) and posted a similar announcement on the EPA Region 5 website. The document established a public comment period of 60 days and a public hearing on May 27, 2020. The May 27, 2020 public hearing was held virtually due to restrictions on meetings imposed by the State of Michigan related to COVID-19 and to protect public health. EPA had also directly contacted federally recognized tribes in the State of Michigan to provide a separate opportunity for consultation on the Michigan Class II UIC primacy application. A tribal consultation call was held on April 14, 2020.

EPA received a total of 40 public comments in the electronic docket, by paper mail, and during the virtual hearing. Thirty-seven of the comments contained general expressions of support for Michigan's application. One letter submitted was from a tribal government, offering comments and requesting specific information; these comments and request were addressed through the tribal consultation process. One electronic docket statement was determined to be out of scope of this action as it expressed a general desire for Michigan to adopt a clean energy statute. One speaker at the virtual hearing asked several questions about Michigan's program. The speaker did not make a comment or statement about the application.

Through a March 9, 2020 written letter, EPA invited interested tribes to consult regarding the Agency's review of the State's request for program approval, in accordance with EPA Policy for Consultation and Coordination with Indian Tribes (May 4, 2011). EPA held a telephone conference with interested tribes on April 14, 2020. Additionally, EPA received written comments from two tribes. EPA communicated the concerns raised in these comments via email to the Michigan Department of Environment, Great Lakes, and Energy (EGLE) on July 23, 2020. In response, EGLE sent a letter dated August 6, 2020, in which the Department committed to consult and coordinate with tribes regarding permit applications for wells adjacent to Indian country (defined in accordance with 18 U.S.C. 1151) and within the ceded territory where tribes hold off-reservation treaty rights. Detailed documents covering the comments submitted to EPA through the public comment process and the tribal consultation, as well as the Agency's responses and steps taken can be viewed in the docket.

In this action, EPA is approving Michigan's Class II UIC program; whereby the State will assume primacy for regulating Class II injection wells in the State, except within Indian country. Michigan's statutes and supporting documentation are publicly available in EPA's Docket No. EPA-HQ-OW-2020-0595. This action amends 40 CFR part 147 and incorporates by reference EPA-approved state statutes and regulations. EPA will continue to administer the UIC program for all other well classes in Michigan and all well classes within Indian country.

The provisions of Michigan's statutes and regulations that contain standards, requirements, and procedures applicable to owners or operators of UIC Class II wells are incorporated by reference into 40 CFR 147.1150 by this rule. Any provisions incorporated by reference, as well as all permit conditions or permit denials issued pursuant to such provisions, will be enforceable by EPA pursuant to the SDWA Section 1423 and 40 CFR 147.1(e).

In order to better serve the public, EPA is reformatting the codification of “EPA-Approved State of Michigan Safe Drinking Water Act § 1425 Underground Injection Control (UIC) Program Statutes and Regulations for Class II wells.” Instead of codifying the Michigan statutes and regulations as separate paragraphs, EPA is now incorporating by reference a compilation that contains EPA-approved Michigan statutes and regulations for Class II wells. This compilation is incorporated by reference into 40 CFR 147.1150 and is available at https://www.regulations.gov in the docket for this rule. EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and in hard copy at the EPA Region 5 office (see the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). A complete list of the Michigan statutes and regulations contained in the compilation, titled “EPA-Approved State of Michigan Safe Drinking Water Act § 1425 Underground Injection Control (UIC) Program Statutes and Regulations for Class II wells,” dated November 24, 2020, is codified as Table 1 to paragraph (a) in that section.

Additional information about these statutes and Executive orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is exempt from review by the Office of Management and Budget (OMB) because OMB has determined that the approval of primacy for the UIC program is not a significant regulatory action.

This action does not impose any new information collection burden under the PRA. EPA determined that there is no need for an Information Collection Request under the PRA because this direct final rule does not impose any new Federal reporting or recordkeeping requirements. Reporting or recordkeeping requirements will be based on Michigan's UIC Regulations, and Michigan is not subject to the PRA. However, OMB has previously approved the information collection activities contained in the existing UIC regulations and for Section 1425 states under the provisions of the PRA, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-0042.

The Agency certifies that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. This action would not impose any new requirements on small entities. It simply approves and codifies Michigan's Class II UIC program, which meets the same effectiveness standard under SDWA Section 1425 for regulating a Class II UIC well program. EPA has therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector. EPA's approval of Michigan's primacy application will not constitute a Federal mandate because there is no requirement that a state establish UIC regulatory programs and because the program is a state, rather than a Federal program.

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

This action does not have tribal implications as specified in Executive Order 13175 as explained in Section V.B. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in Section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it approves a state program.

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

This rulemaking does not involve technical standards.

EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish either a new environmental health or a new safety standard. This action is providing Michigan with primacy under the SDWA for the Class II UIC program, pursuant to which Michigan will be implementing and enforcing a state regulatory program that is as effective as the existing federal program.

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

For the reasons set out in the preamble, EPA amends 40 CFR part 147 as follows:

This is a summary of the Commission's Erratum, FCC 20-65, published June 18, 2020 (85 FR 36786). This is the first set of corrections.

Because this change is editorial and non-substantive, we find good cause to conclude that notice and comment are unnecessary for its adoption. Because this rule change does not require notice and comment, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., does not apply. See id. section 601(2).

This Erratum does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198; see 44 U.S.C. 3506(c)(4).

The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of the Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

Accordingly, it is ordered that, effective on the date of publication of this Erratum in the Federal Register , 47 CFR 73.3580(e)(2) of the rules is amended , as set forth herein, pursuant to the authority contained in sections 4(i) and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), and in sections 553(b)(3)(B) and 553(d)(3) of the Administrative Procedure Act, 5 U.S.C 553(b)(3)(B), 553(d)(3).

Accordingly, 47 CFR part 73 is corrected by making the following correcting amendments:

NMFS manages U.S. groundfish fisheries of the GOA under the GOA FMP. The North Pacific Fishery Management Council (Council) prepared, and the Secretary of Commerce (Secretary) approved, the GOA FMP under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the GOA FMP appear at 50 CFR parts 600 and 679. The Rockfish Program is implemented by the GOA FMP and regulations at 50 CFR parts 600 and 679.

On January 29, 2021, the Council received a request from Rockfish Program participants to consider emergency action under section 305(c) of the Magnuson-Stevens Act to modify the fishing season start date for the Rockfish Program in 2021. On February 10, 2021, the Council recommended that NMFS implement an emergency rule to modify the fishing season start date for fishing vessels participating in a rockfish cooperative as part of the Rockfish Program from May 1, 2021 to April 1, 2021 to address the negative economic and social impacts on harvesters and processors participating in the Rockfish Program and the community of Kodiak, Alaska due to the Coronavirus (COVID-19) pandemic.

The following sections describe the Rockfish Program, the existing dates of the fishing season, the emergency rule, and justification for emergency action.

This section provides a brief overview of the Rockfish Program and additional detail is available in Section 2 of the Analysis (see ADDRESSES ).

The Rockfish Program is a limited access privilege program (LAPP) developed to enhance resource conservation and improve economic efficiency in the Central Gulf of Alaska (CGOA) rockfish fisheries. The Rockfish Program was implemented by Amendment 88 to the GOA FMP (76 FR 81247, December 27, 2011), and reauthorized under Amendment 111 to the GOA FMP on March 31, 2020 (86 FR 11895, March 1, 2021). For more information about the background and history of this program, see the preamble to the final rule for Amendment 111 (86 FR 11895, March 1, 2021).

Generally, the Rockfish Program (1) assigns quota share (QS) and cooperative quota (CQ) to participants for primary and secondary species, (2) allows a participant holding an license limitation program (LLP) license with rockfish QS to form a rockfish cooperative with other persons, (3) allows holders of catcher/processor LLP licenses to opt-out of rockfish cooperatives for a given year, (4) establishes a limited access fishery for participants who do not participate in a fishery cooperative for a given year, (5) includes an entry level longline fishery for persons who do not hold rockfish QS, (6) establishes constraints, commonly known as sideboard limits, for other non-Rockfish Program fisheries that apply to vessels and LLP licenses eligible to participate in the Rockfish Program, and (7) includes monitoring and enforcement provisions.

As summarized in Sections 2 and 4.2 of the Analysis (see ADDRESSES ), one of the overall goals of the Rockfish Program is to provide greater security to harvesters through the formation of rockfish cooperatives. Fishing under cooperative management resulted in a slower-paced fishery that allows a harvester to choose when to fish. The Rockfish Program also provided greater stability for processors by spreading out production over a longer period. Overall, the Rockfish Program provides greater benefits to shoreside processors, catcher/processors, CGOA fishermen, and communities than were realized under the previous LLP management scheme.

Amendment 111 to the FMP and the implementing final rule (86 FR 11895, March 1, 2021) reauthorized the Rockfish Program, removed the Rockfish Program sunset date of December 31, 2021 and addressed a variety of administrative and management issues associated with the existing Rockfish Program. For more detail on the changes made by Amendment 111 to the FMP, see the preambles to the proposed rule (85 FR 55243, September 4, 2020) and final rule (86 FR 11895, March 1, 2021).

Fishing by cooperative participants, specifically fishing vessels, under the Rockfish Program is currently authorized from 1200 hours, A.l.t., May 1 through 1200 hours, A.l.t., November 15 each year. With implementation of the Rockfish Program, the Central GOA rockfish fishery has changed from an approximate 3-week race to fish starting at the beginning of July, to a fishery that primarily occurs in May and June, with smaller harvest amounts occurring until November. Prior to the implementation of the Rockfish Program, the Gulf of Alaska rockfish fisheries opened on July 1 for fishing vessels using trawl gear.

As summarized in Section 3 of the Analysis (see ADDRESSES ), the Rockfish Program was developed to slow the race for fish, minimize bycatch and associated mortalities, provide for improved conservation of habitat, and address the social and economic concerns that have arisen under the original management system. The longer fishing season established under the Rockfish Program provides participants access to markets (including a possible fresh market) that were historically impossible to access because of the short duration and timing of the previous open access fishing season. In addition, by slowing the race for fish, Rockfish Program participants could focus on improving the quality of their landings, increasing fishery value and reducing overall Prohibited Species Catch (PSC).

The lengthened fishing season under the Rockfish Program, enables cooperative members to consolidate their rockfish allocations and realize operational efficiencies.

As summarized in Section 3.6 of the Analysis, the start and end dates for the current fishing season under the Rockfish Program were set based on considerations of bycatch of other species, rockfish reproduction, and processor activity. The pre-Rockfish Program July season start date for the rockfish trawl fishery was intended to reduce halibut PSC.

Under the Rockfish Program, an earlier start date was implemented because PSC limits are effectively managed by participating cooperatives. Bycatch of non-PSC species has been minimally impacted by the extended Rockfish Program season. The overall level of halibut, chinook and chum salmon PSC in the Rockfish Program remains low due to the PSC avoidance measures implemented by cooperative managers that include various reporting requirements and bycatch standards that have been proven to reduce PSC under the extended season.

In establishing existing Rockfish Program season start date, the Council and NMFS considered the timing of rockfish reproduction. The proposed April 1 season start date for this emergency rule is within the range of season start dates analyzed in the implementation of Rockfish Program. Section 3.6 of the Analysis prepared for this emergency rule notes that modifying the opening season start date to April 1 would not create a biological concern but that the most conservative management approach would be to maintain the season start date at May 1 to marginally reduce any potential fishery impacts on rockfish reproduction and improve operational efficiency by staggering the opening of this fishery relative to other fisheries.

The season closing date of November 15 was selected to allow for fishing activity to be distributed over the course of the year where value could be maximized and efficiencies improved. An earlier or later end date was not given a large amount of consideration as November 15 corresponds closely with when processors and plants are generally closing for the fishing year.

This emergency rule modifies the season start date from May 1, 2021 to April 1, 2021 for fishing vessel members of a cooperative under the Rockfish Program in the 2021 fishing year. This emergency rule is intended to provide flexibility for vessel operators and shoreside processors that receive deliveries from harvesters in a cooperative by establishing a longer timeframe in which they would be able to harvest the quota. This emergency rule adds regulations at § 679.80(a)(3)(iii) to modify the season start date to begin on April 1 at 1200 hours Alaska local time for the 2021 fishing year. This emergency rule temporarily suspends regulations at § 679.80(a)(3)(ii) that authorize fishing vessels that are members of rockfish cooperatives to commence fishing on May 1 at 1200 hours Alaska local time for the 2021 fishing year. The season end date of November 15 at 1200 hours Alaska local time remains unchanged. This emergency rule does not modify any other aspect of the Rockfish Program. Modifying the season start date to April 1 would only affect the 2021 fishing year. In subsequent years, the season start date would return to May 1.

This emergency action does not impose additional restrictions on the fishery, but would alleviate limitations on the fishery. This emergency rule does not increase the amount of fish available to harvest, increase the risk of overharvest, or otherwise modify conservation measures. This emergency rule is needed to allow for the complete and efficient harvest of the rockfish fishery and to temporarily alleviate unforeseen economic and social consequences due to the recent and unforeseen limitations on the rockfish fishery. This emergency rule does not modify existing requirements on the types of vessels and gear that could be used, monitoring requirements, record keeping regulations, or other aspects of the Rockfish Program.

Section 305(c) of the Magnuson-Stevens Act authorizes the Secretary to promulgate regulations to address an emergency. Under that section, a Council may request that the Secretary promulgate emergency regulations. NMFS's Policy Guidelines for the Use of Emergency Rules require that an emergency must exist and that NMFS have an administrative record justifying emergency regulatory action and demonstrating compliance with the Magnuson-Stevens Act and the National Standards (see NMFS Procedure 01-101-07 (March 31, 2008) and 62 FR 44421; August 21, 1997). Emergency rulemaking is intended for circumstances that are “extremely urgent,” where “substantial harm to or disruption of the . . . fishery . . . would be caused in the time it would take to follow standard rulemaking procedures (62 FR 44421-01).”

Under NMFS' Policy Guidelines for the Use of Emergency Rules, the phrase “an emergency exists involving any fishery” is defined as a situation that meets the following three criteria:

1. Results from recent, unforeseen events or recently discovered circumstances;

2. Presents serious conservation or management problems in the fishery; and

3. Can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rule making process.

The following sections describe why the Council and NMFS determined that modifying the season start date to April 1 for the 2021 fishing year meets these criteria.

Two recent and recently discovered circumstances have limited the ability of vessels to harvest and process groundfish in the port of Kodiak in 2021. Rockfish Program catcher vessels and the shoreside processors the vessels deliver to are located only in the port of Kodiak. First, beginning in early 2021, the groundfish fleet operating out of Kodiak has discovered that there are no longer economically viable markets for a variety of flatfish species, including species such as arrowtooth flounder. For several decades, these markets have been essential to harvesters and processors operating out of Kodiak. This lack of economically viable markets has created an unforeseen lack of harvesting and deliveries to processors operating out of Kodiak in the month of April. The U.S. government has recognized the impact of limited seafood markets and included flatfish fisheries prosecuted in Alaska in the Seafood Trade Relief Program (STRP), which provides payments to eligible commercial fishermen of seafood commodities that have been impacted by trade actions of foreign governments resulting in the loss of exports (85 FR 56572). In addition to flatfish, Kodiak processors and harvesters are heavily dependent on the salmon and rockfish fisheries. Rockfish landings at Kodiak processors occur in May and June, after flatfish in April, and are followed by summer salmon landings.

Second, COVID-19 outbreaks in January and February 2021 in three large processors in the communities of Akutan and Unalaska, shut down fishing and processing operations in those communities for several weeks, creating widespread disruptions during the fishing season and broad economic impacts. Throughout 2020, processing facilities in Alaska were able to operate effectively with limited long-term disruption to processing activities. While Kodiak processors have not seen widespread COVID-19 outbreaks, the mitigation measures there mirrored those of the three large processors in the communities of Akutan and Unalaska. The closure of processing facilities in Alaska in early 2021 was not anticipated based on largely successful mitigation of COVID-19 in 2020. Even with strict mitigation measures in place, these outbreaks raise concern of future outbreaks across processing facilities in Alaska. Given the continued risk of COVID-19 transmission and outbreaks, and lack of widespread vaccinations, fishery participants anticipate there may be additional processor shutdowns throughout 2021.

For Kodiak processors, an earlier start date for the Rockfish Program will help alleviate the operational disruption and economic impact from the lack of a flatfish market in April and will help ensure adequate processing capacity to fully prosecute the rockfish program fisheries throughout the 2021 fishing season. Due to these limitations, and the recent, unforeseen circumstances, an emergency action is required to move the start date of the 2021 Rockfish Program fishery to April 1.

Recent, unforeseen, and ongoing COVID-19 outbreaks in processing plants across Alaska present serious management problems in the Rockfish Program. If the season start is not moved to April 1, 2021, there is a risk that the rockfish season may conflict with the summer salmon fisheries, causing seafood businesses to choose between one revenue source or another, particularly if a COVID outbreak occurs in Kodiak and reduces processing capacity for several weeks. This presents a serious management problem for the fishery.

Additionally, moving the season start date to April 1, 2021 will help processors continue to employ fishermen and plant personnel throughout April, a month that is typically busy with flatfish but will have an anticipated gap in 2021 due to the lack of a flatfish market. By permitting fishing and processing operations through the month of April, this emergency rule would result in a decrease in travel to and from the port of Kodiak, Alaska, thereby reducing the health risks to essential seafood workers and residents.

NMFS and the Council have determined that the emergency situation created by the lack of a flatfish market and the continued risk of COVID-19 outbreaks across processing and fishing operations can be addressed by emergency regulations. Opening the rockfish season one month earlier does not create conservation and management concerns because the earlier start date was analyzed during the development of the Rockfish Program and is consistent with the overall goals of the Rockfish Program to provide additional harvest flexibility to cooperative participants.

To address the emergency in a timely manner, NMFS must implement an emergency rule that waives the notice-and-comment rulemaking period. The benefits of waiving notice-and-comment rulemaking will serve the industry and public by allowing an additional month for fishery participants to harvest rockfish. Any delay that results in implementing this rulemaking may impact the ability for the fishery to start earlier. Section 4 of the Analysis (see ADDRESSES ) describes the potential additional harvest opportunities for the rockfish participants in greater detail.

Without the waiver of notice-and-comment rulemaking, the Rockfish Program cooperative participants will not have sufficient time for operational planning before the requested April 1, 2021 season opening date. Without sufficient notice of the season opening date, fish processors participating in the Rockfish Program may not have enough time to staff their facilities and coordinate fishing activities for an earlier season.

The Council could not recommend and NMFS could not implement an earlier season start date through the conventional notice-and-comment rulemaking process before the regular 2021 Rockfish Program begins on May 1. Typically, the process of Council analysis and rulemaking takes at least one-year to implement. In this case, NMFS received the request for regulatory change on February 10, 2021, and the next regularly scheduled Council meeting begins April 5, 2021. Given that the Rockfish Program starts on May 1, 2021, this rule starts the season a month earlier, and the time required for Council action and notice-and-comment rulemaking, this process could not be accomplished before the earlier start date of April 1, 2021.

As discussed further below, emergency-based fishery regulations that waive prior notice and comment and a 30-day delay in effectiveness period must be consistent with the requirements of the Administrative Procedure Act (APA).

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) of the APA to waive prior notice and the opportunity for public comment because it would be impracticable and contrary to the public interest. The benefits of waiving notice-and-comment rulemaking will serve the industry and public by allowing an additional month for fishery participants to harvest rockfish. Any delay that results in implementing this rulemaking may impact the ability for the fishery to start earlier. This emergency rule would modify the season start date for members of a rockfish cooperative as part of the Central Gulf of Alaska Rockfish Program (Rockfish Program) for the 2021 fishing year. This emergency rule is intended to provide flexibility to Rockfish Program participants by moving the season start date from May 1, 2021 to April 1, 2021. This emergency rule does not modify other provisions of the Rockfish Program.

This emergency rule is in response to the recent and unforeseen impacts that have prompted a limited shoreside market for flatfish as a result of the unforeseen lack of economically viable groundfish markets and the continued impacts of the COVID-19 pandemic and associated health concerns on the members of rockfish cooperatives. The lack of the flatfish market, comprising species such as arrowtooth flounder, have created a processing gap for the month of April in Kodiak. Modifying the season start to one month earlier will provide additional flexibility to Rockfish Program participants to mitigate negative economic and social impacts to harvesters and processors and the community of Kodiak, Alaska. Without the increased flexibility of an earlier season start date, if a COVID outbreak occurs resulting in the reduction of processing capacity for several weeks, the rockfish season may conflict with the summer salmon fisheries, causing harvesters and processors to choose between revenue sources. It is likely that a significant portion of the harvest could be forgone. The associated loss in harvesting and processing revenues would likely impact the harvesters, crew, and communities that are active in the Rockfish Program.

Industry participants notified the Council and NMFS on January 29, 2021, of the continued safety and health concerns of the ongoing pandemic and seafood tariffs may impact Rockfish Program participants for the 2021 fishing year. The Council and NMFS had no way of foreseeing the impact on fishery operations.

Finally, the time required for notice-and-comment rulemaking would not provide relief from the forgone harvests because it would not provide sufficient time before the proposed season start date. The Rockfish Program season start date is May 1 and there is not enough time to follow the standard rulemaking process prescribed by the Magnuson-Stevens Act and required by the APA. NMFS has no other way than this emergency rule to amend the season start date in time to restore forgone fishing opportunities for 2021. Allowing for a longer time to harvest rockfish quota will provide immediate social and economic benefits that outweigh the value of the deliberative notice-and-comment rulemaking process.

Similarly, for the reasons above that support the need to implement this emergency rule in a timely manner, the Assistant Administrator for Fisheries finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness provision of the APA and make the emergency rule effective immediately upon publication in the Federal Register . As stated above, NMFS anticipates that this emergency rule will allow for additional flexibility to Rockfish Program participants to harvest and process the quota over a longer timeframe and should prevent prolonged economic losses from the potential forgone harvests.

This action is being taken pursuant to the emergency provision of the Magnuson-Stevens Act and is exempt from Office of Management and Budget (OMB) review.

This emergency rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is not subject to the requirement to provide prior notice and opportunity for public comment pursuant to 5 U.S.C. 553 or any other law. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

This emergency rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, 50 CFR part 679 is amended as follows: