I. Background A. Statutory and Legal Background

The Fair Labor Standards Act (“FLSA” or “Act”) requires all covered employers to pay nonexempt employees at least the federal minimum wage for every hour worked in a non-overtime workweek. 1 In an overtime workweek, for all hours worked in excess of 40 in a workweek, covered employers must pay a nonexempt employee at least one and one-half times the employee's regular rate. 2 The FLSA also requires covered employers to make, keep, and preserve certain records regarding employees. 3

The FLSA's minimum wage and overtime pay requirements apply only to employees. 4 Section 3(e) generally defines “employee” to mean “any individual employed by an employer.”  5 Section 3(d) of the Act defines “employer” to “include[ ] any person acting directly or indirectly in the interest of an employer in relation to an employee.”  6 Section 3(g) defines “employ” to “include[ ] to suffer or permit to work.”  7

The Supreme Court, in interpreting these definitions, has stated that “[a] broader or more comprehensive coverage of employees within the stated categories would be difficult to frame,” and that “the term `employee' had been given `the broadest definition that has ever been included in any one act.' ”  8 The Supreme Court has further stated that the “striking breadth” of the FLSA's definition of “employ”—“to suffer or permit to work”—“stretches the meaning of `employee' to cover some parties who might not qualify as such under a strict application of traditional agency law principles.”  9 Thus, the FLSA expressly rejects the common law standard for determining whether a worker is an employee. 10

Though the FLSA's definition of employee is broader than the common law definition, the Supreme Court has also recognized that the Act was “not intended to stamp all persons as employees.”  11 The Supreme Court has acknowledged that even a broad definition of employee “does not mean that all who render service to an industry are employees.”  12 One category of workers that has been recognized as being outside the FLSA's broad definition of “employees” is “independent contractors.”  13 Courts have thus recognized a need to delineate between employees, who fall under the protections of the FLSA, and independent contractors, who do not.

The Supreme Court has repeatedly emphasized that the test for whether an individual is an employee under the FLSA is one of “economic reality.”  14 Under this test, the “technical concepts” used to label a worker as an employee or independent contractor do not drive the analysis, but rather it is the economic realities of the relationship between the worker and the employer that is determinative. 15

In United States v. Silk, 331 U.S. 704, 712 (1947), an early case applying an economic realities test under the Social Security Act, the Supreme Court acknowledged that “[p]robably it is quite impossible to extract from the statute a rule of thumb” regarding the limits of the employment relationship. 16 The Court suggested that federal agencies and courts “will find that degrees of control, opportunities for profit or loss, investment in facilities, permanency of relation and skill required in the claimed independent operation are important for decision.”  17 The Court cautioned that no single factor is controlling and that the list is not exhaustive. 18 The Court went on to note that the workers in that case were “from one standpoint an integral part of the businesses” of the employer, supporting a conclusion that some of the workers in that case were employees. 19

The same day that the Supreme Court issued its decision in Silk, it also issued Rutherford Food Corp. v. McComb, 331 U.S. 722 (1947), in which it affirmed a circuit court decision that analyzed an FLSA employment relationship based on its economic realities. 20 The Court rejected an approach based on “isolated factors” and again considered “the circumstances of the whole activity.”  21 The Court considered several of the factors that it listed in Silk as they related to meat boners on a slaughterhouse's production line, ultimately determining that the boners were employees. 22 The Court noted, among other things, that the boners did a specialty job on the production line, had no business organization that could shift to a different slaughter-house, and were best characterized as “part of the integrated unit of production under such circumstances that the workers performing the task were employees of the establishment.”  23

Since Silk and Rutherford Food, federal courts of appeals have applied the economic realities test to distinguish independent contractors from employees who are entitled to the FLSA's protections. Recognizing that the common law concept of “employee” had been rejected for FLSA purposes, courts of appeals followed the Supreme Court's instruction that “`employees are those who as a matter of economic realities are dependent upon the business to which they render service.' ”  24

All of the courts of appeals have followed the economic realities test, and nearly all of them analyze the economic realities of an employment relationship using the factors identified in Silk. 25 No court of appeals considers any factor or combination of factors to universally predominate over the others in every case. 26 For example, the Ninth Circuit has explained that some of the factors “which may be useful in distinguishing employees from independent contractors for purposes of social legislation such as the FLSA” are: (1) The degree of the employer's right to control the manner in which the work is to be performed; (2) the worker's opportunity for profit or loss depending upon his or her managerial skill; (3) the worker's investment in equipment or materials required for his or her task, or employment of helpers; (4) whether the service rendered requires a special skill; (5) the degree of permanence of the working relationship; and (6) whether the service rendered is an integral part of the employer's business. 27 The Ninth Circuit repeated the Supreme Court's instruction that no individual factor is conclusive and that the ultimate determination depends upon the circumstances of the whole activity. 28

Some courts of appeals have applied the factors with some variations. For example, the Fifth Circuit typically does not list the “integral” factor as one of the considerations that guides the analysis. 29 Nevertheless, the Fifth Circuit—recognizing that the listed factors are not exhaustive—has considered the extent to which a worker's function is integral to a business as part of its economic realities analysis. 30 The Second Circuit varies in that it treats the employee's opportunity for profit or loss and the employee's investment as a single factor, but it still uses the same considerations as the other circuits to inform its economic realities analysis. 31

In sum, since the 1940s, federal courts have consistently analyzed the question of employee status under the FLSA by examining the economic realities of the employment relationship to determine whether the worker is dependent on the employer for work or is in business for him or herself. 32 In doing so, courts have looked to the six factors first articulated in Silk as useful guideposts while acknowledging that those factors are not exhaustive and should not be applied mechanically. 33

Since at least 1954, the Wage and Hour Division (WHD) has applied variations of this multifactor analysis when considering whether a worker is an employee under the FLSA or an independent contractor. 34 In a guidance document issued in 1964, WHD stated, “The Supreme Court has made it clear that an employee, as distinguished from a person who is engaged in a business of his own, is one who as a matter of economic reality follows the usual path of an employee and is dependent on the business which he serves.”  35 Like the courts, WHD has consistently applied a multifactor economic realities analysis when determining whether a worker is an employee under the FLSA or an independent contractor. 36

On February 15, 2021, the TCR Event Management of St. Michaels, MD, notified the Coast Guard that it will be conducting the Maryland Freedom Swim from 7 a.m. to 9:30 a.m. on May 16, 2021. The open water swim consists of approximately 200 participants competing on a designated 1.75-mile linear course. The course starts at the beach of Bill Burton Fishing Pier State Park at Trappe, MD, proceeds across the Choptank River along and between the fishing piers and the Senator Frederick C. Malkus, Jr. Memorial (US-50) Bridge, and finishes at the beach of the Dorchester County Visitors Center at Cambridge, MD. In response, on March 18, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; Choptank River, Between Trappe and Cambridge, MD” (86 FR 14714). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this swim event. During the comment period that ended April 19, 2021, we received no comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Due to the date of the event, it would be impracticable to make the regulation effective 30 days after publication in the Federal Register . Delaying the effective date date of this rule would be impracticable and contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the “Maryland Freedom Swim” event.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port Maryland-National Capital Region (COTP) has determined that potential hazards associated with the swim event will be a safety concern for anyone intending to operate in or near the swim area. The purpose of this rule is to protect event participants, non-participants, and transiting vessels before, during, and after the scheduled event.

As noted above, we received no comments on our NPRM published March 18, 2021. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a special local regulation to be enforced from 6 a.m. to 10:30 a.m. on May 16, 2021. The regulated area will cover all navigable waters of the Choptank River, from shoreline to shoreline, within an area bounded on the east by a line drawn from latitude 38°35′14.2″ N, longitude 076°02′33.0″ W, thence south to latitude 38°34′08.3″ N, longitude 076°03′36.2″ W, and bounded on the west by a line drawn from latitude 38°35′32.7″ N, longitude 076°02′58.3″ W, thence south to latitude 38°34′24.7″ N, longitude 076°04′01.3″ W, located at Cambridge, MD. The duration of the special local regulations and size of the regulated area are intended to ensure the safety of life on these navigable waters before, during, and after the open water swim event, scheduled from 7 a.m. until 9:30 a.m. on May 16, 2021.

Except for participants and vessels already at berth, a vessel or person will be required to get permission from the COTP or Event PATCOM before entering the regulated area. Vessel operators can request permission to enter and transit through the regulated area by contacting the Event PATCOM on VHF-FM channel 16. Vessel traffic will be able to safely transit the regulated area once the Event PATCOM deems it safe to do so. A person or vessel not registered with the event sponsor as a participant or assigned as official patrols will be considered a non-participant. Official Patrols are any vessel assigned or approved by the Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

If permission is granted by the COTP or Event PATCOM, a person or vessel will be allowed to enter the regulated area or pass directly through the regulated area as instructed. Vessels will be required to operate at a safe speed that minimizes wake while within the regulated area. Official patrol vessels will direct non-participants while within the regulated area.

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

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

This regulatory action determination is based on the size, duration and location of the regulated area. Vessel traffic will be able to safely transit around this regulated area, which would impact a small designated area of the Choptank River for 4 1/2 hours. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule will allow vessels to seek permission to enter the regulated area, and vessel traffic will be able to safely transit the regulated area once the Event PATCOM deems it safe to do so.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States. The temporary regulated area will be in effect for eight hours. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Memorandum for the Record supporting this determination is available in the docket where indicated under ADDRESSES .

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA, which would include the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20 (or 40 CFR 725.920 for the MCAN substance), any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0777, is available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Due to the public health emergency, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances which were the subject of PMNs P-17-382, P-18-41, P-18-70, P-18-100, P-18-102, P-18-116, P-18-136, P-18-137, P-18-219, P-18-224, P-18-225, P-18-233, P-18-279, and of MCAN J-18-41. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Previously, in the Federal Register of July 31, 2019 (84 FR 37199) (FRL-9994-62), EPA proposed SNURs for these chemical substances. EPA will address the other proposed SNURs in a subsequent Federal Register document. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including the public comments received on the proposed rules that are described in Unit IV.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III.A.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

During its review of the chemical substances that are the subjects of these SNURs and as further discussed in Unit VI., EPA identified potential risk concerns associated with other circumstances of use that, while not intended or reasonably foreseen, may occur in the future. EPA is designating those other circumstances of use as significant new uses.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

EPA received public comments from two identifying entities on the proposed rule. The Agency's responses are presented in the Response to Public Comments document that is available in the docket for this rule. EPA did not make changes to any of the proposed rules as a result of these comments. Separately, EPA made changes to the SNUR proposed at 40 CFR 725.1079 for the microorganism which was the subject of MCAN J-18-41. This SNUR, as proposed, included references to 40 CFR part 721. These have been changed to refer instead to the equivalent provisions in 40 CFR part 725, concerning reporting requirements and review processes for microorganisms. The effect of the SNUR has not been altered by these changes.

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E, for several chemicals that were the subject of PMNs, and in 40 CFR part 725 for one chemical substance that is a microorganism (MCAN J-18-41). In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:

• PMN or MCAN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the SNUR.

• Potentially useful information.

• CFR citation proposed to be assigned in the regulatory text section. This final rule makes the final assignment to set the CFR citation for the chemical.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

The chemical substances that are the subjects of these SNURs received “not likely to present an unreasonable risk” determinations under TSCA section 5(a)(3)(C) based on EPA's review of the intended, known, and reasonably foreseen conditions of use. However, EPA has identified other circumstances that, should they occur in the future, even if not reasonably foreseen, may present risk concerns. Specifically, EPA has determined that deviations from the protective measures identified in the PMN submissions could result in changes in the type or form of exposure to the chemical substances, increased exposures to the chemical substances, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. These SNURs identify as a significant new use manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protective measures identified in the submissions. As a result, those significant new uses cannot occur without first going through a separate, subsequent EPA review and determination process associated with a SNUN.

EPA is issuing these SNURs because the Agency wants:

• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.

When the chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, the identities of many of the chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

EPA designated July 31, 2019 (the date of FR publication of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under section 5 allowing manufacture or processing to proceed.

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40. According to 40 CFR 725.900, persons submitting an MCAN for a significant new use of a microorganism must comply with the same notification requirements and EPA regulatory procedures as persons submitting an MCAN for a new microorganism, including submission of test data on health and environmental effects as described in 40 CFR 725.160. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket for this rulemaking.

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

This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

According to the PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR part 9, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice and comment.

Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR does not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use”. Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action does not have federalism implications because it is not expected to have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

This action is subject to the CRA (5 U.S.C. 801 et seq. ), and EPA will submit a rule report containing this rule and other required information 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).

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

HHS invited interested parties to participate in a proposed rulemaking published on February 14, 2020 (85 FR 8521) by submitting written views, opinions, recommendations, and data. HHS received 12 submissions from 11 commenters, including unaffiliated individuals, professional societies, trade associations, a labor union, and a law firm. No submissions were received regarding the proposed Paperwork Reduction Act information collection.

Within the February 14, 2020 rulemaking, HHS published a “Proposed Data Collection Submitted for Public Comment and Recommendations” to obtain comments from the public and affected agencies. HHS did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, email omb@cdc.gov. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

The Federal Mine Safety and Health Act of 1977 (Pub. L. 91-173, 30 U.S.C. 801 et seq. ) (Mine Act), authorizes the HHS Secretary (Secretary) to work with coal mine operators to make available to coal miners the opportunity to have regular and routine chest radiographs (X-rays) in order to detect coal workers' pneumoconiosis ( i.e., black lung) and prevent its progression in individual miners. The Mine Act grants the Secretary general authority to issue regulations as is deemed appropriate to carry out provisions of the Act and authorizes the Coal Workers' Health Surveillance Program (Program), within the NIOSH Respiratory Health Division, to detect pneumoconiosis and prevent its progression in individual miners and to provide information to NIOSH for the evaluation of temporal and geographic trends in pneumoconiosis. The Mine Act also authorizes the Secretary to establish specifications for the reading of radiographs and to pay for autopsies submitted to the Program.

The NIOSH Respiratory Health Division uses coal miner autopsies to study important issues affecting coal miners, such as evaluating the cause of rapidly progressive and severe pneumoconiosis by assessing its pathology and determining the lung content of mineral particles relative to what was seen in the past. Also, autopsies are sometimes requested after mine disasters. With this final rule, regulatory language promulgated over 45 years ago is updated to reflect the contemporary costs associated with autopsies. HHS anticipates that increasing the compensation rate will make it economically feasible for pathologists to conduct autopsies of coal miners, thereby allowing the NIOSH Respiratory Health Division to better study pneumoconiosis in contemporary coal miners and to perform public health investigations more thoroughly, especially in the aftermath of mine disasters.

Of the 12 submissions to the docket for this activity, only one addressed the autopsy payment provisions. The commenter agreed that the proposed increase in payment for pathologists who provide autopsies to the NIOSH Coal Workers' Health Surveillance Program is “essential to assure that autopsies can and will be conducted when indicated,” and should be incorporated.

To promote administrative efficiency and ensure program integrity, HHS amends 42 CFR part 37 by updating existing regulatory text in §§ 37.202 through 37.204 to allow NIOSH, on a discretionary basis as needed for public health purposes, to better compensate pathologists who perform autopsies on coal miners. Existing text in § 37.202(a) is revised to clarify that pathologists must secure prior authorization for payment from NIOSH and provide proof that legal consent to conduct an autopsy on a coal miner was either obtained or not required, as in the case of a forensic autopsy. New language in § 37.202(a)(2)(i) and (ii) clarifies the types of chest radiographic images accepted by the Program.

New language in § 37.202(b) specifies that pathologists will be compensated in accordance with their ordinary, usual, or customary fees or at amounts agreed upon through negotiation with NIOSH. NIOSH may survey other board-certified pathologists who provide the same services in the same geographic area to inform payment amounts. Existing language in paragraph (b) is revised to clarify that NIOSH will provide additional payment for the submission of chest radiographs of the autopsy subject made within 5 years of the miner's death. Compensation for chest radiographs is offered to the pathologist because NIOSH has found that asking families or estates to provide radiographs is often cumbersome, difficult, and emotionally painful.

Language in § 37.202(c) states that NIOSH will not pay a pathologist for their services if that pathologist has already received payment from another party. The text is revised to clarify that the prohibition on double payment is extended to the pathologist's employer, the organization in which the pathologist practices, or another entity receiving payment on behalf of or for services provided by the pathologist.

Section 37.203 is revised to update the reference for standard autopsy procedures. Although no public comments addressed § 37.203, NIOSH has added language to paragraph (b)(7) to clarify that the three microscopic slides required for each autopsy must be accompanied by three blocks of tissue that correspond to those slides. The slides and tissue blocks must correspond so that NIOSH can make additional slides if needed.

Finally, new language in § 37.204(a) details the new requirement that the pathologist obtain written authorization from the NIOSH Respiratory Health Division prior to completion of the autopsy. Language specifying how claims for payment should be submitted to NIOSH is reorganized. New language is added to § 37.204(b)(1) to clarify that the claim for payment must include a statement that the pathologist or the pathologist's employer, the organization in which the pathologist practices, or another entity receiving payment on behalf of or for services provided by the pathologist has not been paid for performing the specific autopsy by another party.

In § 37.201(b), the definition of Miner is revised to remove the word “underground,” to clarify that the autopsy provisions pertain to all coal miners. Section 37.201(d) is also revised to update the definition of NIOSH, clarifying that the name of the NIOSH division responsible for administering the Coal Workers' Health Surveillance Program is now the Respiratory Health Division.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This final rule has been determined not to be a “significant regulatory action” under section 3(f) of E.O. 12866. The revisions finalized in this notice allow NIOSH to compensate pathologists at a contemporary rate for autopsies submitted to the Coal Workers' Health Surveillance Program.

The revisions to Part 37 do not impose significant costs on the public and will benefit coal miners and coal mine operators. Allowing the NIOSH Respiratory Health Division to better compensate pathologists for autopsies submitted to the Program would also enhance NIOSH's ability to study pneumoconiosis in coal miners.

The costs to the Federal government of administering these revisions would be minor and infrequent. In addition to the administrative costs, NIOSH estimates that over a 5-year period, it might fund up to 20 autopsies, costing NIOSH approximately $60,000.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. HHS certifies that this final rule has “no significant economic impact upon a substantial number of small entities” within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain Office of Management and Budget (OMB) approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. In accordance with section 3507(d) of the PRA, HHS has determined that the PRA does apply to information collection and recordkeeping requirements included in this rule. OMB has already approved the information collection and recordkeeping requirements under OMB Control Number 0920-0020, National Coal Workers' Health Surveillance Program (CWHSP) (expiration date 9/30/2021). HHS has determined that the amendments in this final rulemaking will not impact the existing collection of data but would add one new item to the approval: The pathologist prior authorization request. To request more information or to obtain a copy of the data collection plan and instrument send an email to omb@cdc.gov.

Comments are invited on the following: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents; and (e) information collection costs. Written comments must be received within 30 days of the publication of this notice. The addition of additional paperwork requirements resulting from this final rule will increase the burden associated with the following provision:

Section 37.204 Procedure for obtaining payment. This section establishes that a pathologist who wants to submit an autopsy to the Coal Workers' Health Surveillance Program must first obtain written authorization from the NIOSH Respiratory Health Division. HHS expects an average of about four requests for prior authorization annually. HHS estimates that each request for prior authorization will take no more than 15 minutes to complete, averaging about one hour annually over a period of years.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), HHS will report the promulgation of this rule to Congress prior to its effective date.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq. ) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this final rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million by State, local, or Tribal governments in the aggregate, or by the private sector.

This final rule has been drafted and reviewed in accordance with Executive Order 12988 and will not unduly burden the Federal court system. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

HHS has reviewed this final rule in accordance with Executive Order 13132 regarding federalism and has determined that it does not have “federalism implications.” The rule does 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.”

In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this final rule on children. HHS has determined that the rule will have no environmental health and safety effect on children.

In accordance with Executive Order 13211, HHS has evaluated the effects of this final rule on energy supply, distribution, or use, and has determined that the rule will not have a significant adverse effect.

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal government administers or enforces. HHS has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR part 37 as follows:

This is a synopsis of the Commission's Report and Order, MB Docket No. 21-61; RM-11885; DA 21-477, adopted April 26, 2021, and released April 26, 2021. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

The proposed rule was published at 86 FR 12163 on March 2, 2021. Gray filed comments in support of the petition reaffirming its commitment to applying for channel 36. No other comments were received. In support, Gray states that the Commission has recognized that VHF channels have certain propagation characteristics which may cause reception issues for some viewers, and that many of its viewers experience significant difficulty receiving KCBD's signal. Gray also demonstrated that while there is a small terrain limited predicted loss area when comparing the licensed channel 11 and the proposed channel 36 facilities, all but 350 of the persons currently served by KCBD will continue to be well served by at least five other stations, a number which the Commission has recognized as de minimis. The Bureau believes the public interest would be served by the channel substitution because it will result in improved service.

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed 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). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

Purpose and Need for Regulatory Action

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

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

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

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

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

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

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

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth.

The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.

In February 2020, NMFS received a request from the Navy for an LOA to take marine mammals incidental to construction activities including marine structure maintenance, pile replacement, and select waterfront improvements at NAVSTA Norfolk. NMFS reviewed the Navy's application, and the Navy provided an updated version addressing NMFS' questions and comments on May 22, 2020. The application was deemed adequate and complete and published for public review and comment on June 9, 2020 (85 FR 35267). We did not receive substantive comments on the notice of the receipt of the Navy's application. We subsequently published a proposed rule in the Federal Register on December 21, 2020 (85 FR 83001). Comments received during the public comment period on the proposed regulations are addressed in the Comments and Responses section of this final rule.

The Navy plans to conduct construction activities at NAVSTA Norfolk and nearby facilities off the lower Chesapeake Bay. Among other activities, the planned project will include both vibratory pile driving and removal, and impact pile driving. The use of both vibratory and impact pile driving is expected to produce underwater sound at levels that have the potential to result in harassment of marine mammals. The Navy requested authorization to take a small number of five species of marine mammals by Level B harassment only. Neither the Navy nor NMFS expect serious injury or mortality to result from this activity. The regulations are valid for five years (2021-2026).

The Navy is proposing to conduct construction activities at NAVSTA Norfolk on the Naval Station, and at nearby facilities off the lower Chesapeake Bay. The Navy's planned activities include pile replacement at the Morale, Welfare and Recreation Marina, and installation of two new floating docks at the V-area. Both areas are located on the Naval Station. The Navy also proposes to conduct maintenance/repair activities at the Naval Station and neighboring Defense Fuel Supply Point Craney Island and Lambert's Point Deperming Station (see Figure 1 of the proposed rule; 85 FR 83001; December 21, 2020). The Navy has indicated specific projects where existing needs have been identified, as well as estimates for expected emergent or emergency repairs. The planned project will include both vibratory pile driving and removal, and impact pile driving (hereafter, collectively referred to as “pile driving”) over approximately 574 days over five years (2021-2026), with the greatest amount of work occurring during Year 1 (approximately 208 days). The Navy plans to conduct all work during daylight hours.

A detailed description of the planned construction project is provided in the proposed rule (85 FR 83001; December 21, 2020). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to the proposed rule for the description of the specific activity.

We published a proposed rule in the Federal Register on December 21, 2020 (85 FR 83001). During the 30-day comment period, we received a letter from the Marine Mammal Commission (Commission), and a comment from the general public. Summaries of all substantive comments, and our responses to these comments, are provided here. Please see the comment letter, available online at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-us-navy-construction-naval-station-norfolk-norfolk-virginia, for full detail regarding the comments received.

Comment 1: The Commission recommended that NMFS re-estimate the numbers of Level B harassment takes of harbor seals based on up to 21 rather than 14 seals potentially being taken on the various days of proposed activities.

Response: In the proposed rule, NMFS calculated takes based on haulout data from the CBBT (14 Level B harassment takes per day. See the Estimated Take section of the proposed rule; 85 FR 83001; December 21, 2020). The CBBT is approximately 19 km (kilometers; 12 miles (mi)) from the project site, and the ES haulout is approximately 48 km (30 mi) from the project site. While some seals tagged at ES haulouts entered the Chesapeake Bay (Ampela et al. 2019), even if a seal enters the Chesapeake Bay, it does not necessarily enter the project area. The Level B harassment zones are <50 m for all impact pile driving, and given the shoreline, Level B harassment zones during vibratory pile driving would be truncated in many directions. Additionally, some seals move between the CBBT and ES haulout sites (Jones et al. 2018); therefore, including seals from both haulouts could result in double counting of the same animals. Further, the nearby HRBT project began pile installation in September, and no seals have been sighted during five months of construction under the project's Marine Mammal Monitoring and Mitigation Program. Therefore, the best available information indicates that the take estimate included in the proposed rule is already conservative, and it is not appropriate to increase the take estimate as suggested by the Commission. Therefore, NMFS does not concur with the Commission's recommendation and does not adopt it.

Comment 2: The Commission recommended that NMFS require the Navy to (1) conduct sound source and sound propagation measurements of vibratory and impact installation of at least 10 high-density polyethylene (HDPE), 10 hollow-core fiberglass, and 3 concrete piles using near-field and far-field hydrophones placed mid-water column and (2) include certain specific elements in its hydroacoustic monitoring report.

The Commission also recommended that NMFS require the Navy to increase the sizes of the shut-down zones and Level B harassment zones if the measured data indicate that the model-estimated zones were underestimated.

Response: Since publication of the proposed rule, the Navy has determined that sound source verification (SSV) may not be feasible given budget constraints associated with the individual, small-scale projects planned. Therefore, NMFS did not adopt the Commission's recommendation to require sound source and sound propagation measurements for the number of piles it indicated, and NMFS has removed the SSV requirement from this final rule. However, subject to funding availability, the Navy may conduct a SSV study for pile types other than timber piles (prioritizing composite pile types). As noted in the proposed rule, composite piles may be either HDPE or hollow-core fiberglass; the Navy will not necessarily install both types.

If funding is available for a SSV study, the Navy will develop an acoustic monitoring plan. The acoustic monitoring plan would follow accepted methodologies regarding source level measurements and propagation measurements. NMFS generally agrees with the elements that the Commission has suggested that the Navy report, though the exact reporting requirements would be outlined in an acoustic monitoring plan, which would be available at a later date, and would be reviewed and approved by NMFS prior to implementation.

If the Navy conducts hydroacoustic monitoring, and the results suggest that the Level A or Level B harassment zones were underestimated in this final rule, NMFS will work with the Navy to update the Level A and Level B harassment zone sizes and the associated shutdown zones, as appropriate.

Comment 3: The Commission recommends generally that NMFS require the use of shutdown zones that encompass the extent of the associated Level A harassment zone. Specifically, the Commission recommends that NMFS require the Navy to implement a shutdown zone of 55 m rather than 50 m for low-frequency (LF) cetaceans during impact installation of 24-inch (in) concrete piles.

Response: NMFS does not agree with the Commission's rationale for this recommendation. Generally speaking, given the duration component associated with actual occurrence of Level A harassment take, it is not necessary to require a shutdown zone equivalent to the estimated Level A harassment zone to avoid permanent threshold shift (PTS), i.e., Level A harassment take. Regardless, in this case, the proposed 50 m shutdown zone is essentially equivalent to the estimated 52 m Level A harassment zone. Nevertheless, the Navy has agreed to implement the 55 m shutdown zone recommended by the Commission.

Comment 4: The Commission recommended that NMFS require the Navy to use at least three PSOs to monitor for marine mammals during vibratory pile installation and removal at Pier 3, Pier 12, and Craney Island and four PSOs for Lambert's Point positioned sufficiently in the far field to monitor the largest extents of the respective Level B harassment zones.

Response: NMFS concurs with the Commission's recommendation and has adopted it. This final rule requires the Navy to employ at least three PSOs during vibratory pile driving at Pier 3, Pier 12, and Craney Island, and at least four PSOs during vibratory pile driving at Lambert's Point, though the exact locations are not stipulated. For all other pile driving activities, a minimum of two PSOs will be used, as stated in the proposed rule (85 FR 83001; December 21, 2020).

Comment 5: The Commission recommended that NMFS make available to the public for review and comment all monitoring plans, hydroacoustic and marine mammal-related, contemporaneously with any proposed rule or proposed incidental harassment authorization that NMFS publishes in the Federal Register .

Response: NMFS agrees that it is important to ensure adequate review of monitoring plans, including hydroacoustic and marine mammal-related monitoring plans, before they are implemented by applicants. NMFS will review the Navy's proposed marine mammal monitoring plan prior to the start of construction, and therefore prior to the implementation of the plan. If funding is available for a SSV study, the Navy will develop an acoustic monitoring plan, and NMFS will review and approve the plan prior to its implementation. It is important to provide the objectives of proposed monitoring for review by the public. However, as is the case here, methodological details follow widely accepted practices and, therefore, it is unnecessary to provide these plans for public review. To do so would necessitate development of standalone plans at an earlier stage than is ideal or, in some cases, possible.

While the Navy initially expected to submit a standalone marine mammal monitoring and mitigation plan in association with the application, it has since indicated that it is unable to do so given restrictions on funding allocation between NEPA and associated analyses/consultations such as this MMPA authorization and separate construction project funding. The construction project funding must be used for further development of site/project-specific monitoring plans at a later stage of project development. All monitoring requirements in the Navy's LOA application, this final rule, and any subsequent LOA(s) will be incorporated into the construction contractor's monitoring plan.

Comment 6: The Commission recommended that NMFS include the requirement, which it deems standard, that the Navy conduct pile driving and removal activities during daylight hours only either in section 218.5 of the final rule or in any LOA issued under the final rule.

Response: We do not concur with the Commission's recommendations, or with their underlying justification, and did not adopt them. While the Navy has no intention of conducting pile driving activities at night, it is unnecessary to preclude such activity should the need arise ( e.g., on an emergency basis or to complete driving of a pile begun during daylight hours, should the construction operator deem it necessary to do so). Further, while acknowledging that prescribed mitigation measures for any specific action (and an associated determination that the prescribed measures are sufficient to achieve the least practicable adverse impact on the affected species or stocks and their habitat) are subject to review by the Commission and the public, any determination of what measures constitute “standard” mitigation requirements is NMFS' alone to make. Even in the context of measures that NMFS considers to be “standard” we reserve the flexibility to deviate from such measures, depending on the circumstances of the action. We disagree with the statement that a prohibition on pile driving activity outside of daylight hours would help to ensure that the Navy is effecting the least practicable adverse impact on the affected species, and the Commission does not justify this assertion.

The final rule includes a measure stating that “should environmental conditions deteriorate such that marine mammals within the entire shutdown zone would not be visible ( e.g., fog, heavy rain, night), pile driving and removal must be delayed until observers are confident marine mammals within the shutdown zone could be detected,” though this need not preclude pile driving at night with sufficient illumination.

Comment 7: The Commission recommends that NMFS revise section 218.6(g)(9) in the final rule to require the Navy to report the number of individuals of each species detected within the Level A and B harassment zones, and estimates of the number of marine mammals taken by Level A and B harassment, by species.

In a related comment, the Commission recommended that, for the final rule, NMFS include requirements in section 218.6(g) that the Navy include in its monitoring report (1) the estimated percentages of the Level B harassment zones that were not visible, (2) an extrapolation of the estimated takes by Level B harassment based on the number of observed exposures within the Level B harassment zones and the percentages of the Level B harassment zones that were not visible ( i.e., extrapolated takes), and (3) the total number of Level B harassment takes based on both the observed and extrapolated takes for each species.

Response: We do not fully concur with the Commission's recommendation and do not adopt it as stated. NMFS agrees with the recommendation to require the Navy to report the number of individuals of each species detected within the Level A and Level B harassment zones. Section 218.6(g)(9) in the proposed rule stated that the Navy must report the “number of marine mammals detected within the harassment zones, by species,” which is effectively the same measure as the Commission's recommended “number of individuals of each species detected within the Level A and B harassment zones.” Therefore, NMFS did not modify that measure. NMFS does not agree with the recommendation to require the Navy to report estimates of the numbers of marine mammals taken by Level A and Level B harassment. The Commission does not explain why it believes this requirement is necessary, nor does it provide recommendations for methods of generating such estimates in a manner that would lead to credible results. NMFS does not agree that the basic method described in footnote 22 of the Commission's November 19, 2020 letter should be expected to yield estimates of total take such that readers of the Navy's report should have confidence that the estimates are reasonable representations of what may have actually occurred.

NMFS does agree that the Navy should report the estimated percentage(s) of the Level B harassment zones that were not visible, and has included this requirement in this final rule (See section 218.6(g)(12)). These pieces of information—numbers of individuals of each species detected within the harassment zones and the estimated percentage(s) of the harassment zones that were not visible—may be used to glean an approximate understanding of whether the Navy may have exceeded the amount of take authorized. Although the Commission does not explain its reasoning for offering these recommendations, NMFS recognizes the basic need to understand whether an IHA-holder may have exceeded its authorized take. The need to accomplish this basic function of reporting does not require that NMFS require applicants to use methods we do not have confidence in to generate estimates of “total take” that cannot be considered reliable.

Comment 8: The Commission recommended that NMFS reinforce that the Navy must keep a running tally of the total Level B harassment takes, both observed and extrapolated, for each species consistent with section 218.5(a)(10) of the final rule.

Response: The LOA will indicate the number of takes authorized for each species. We agree that the Navy must ensure they do not exceed authorized takes, but do not concur with the Commission's repeated recommendations regarding the need for NMFS to dictate how an applicant does so, including by requiring an applicant to maintain a “running tally” of takes. Regardless of the Commission's substitution of the word “reinforce” for the word “ensure,” as compared with its prior recommendations for other actions, compliance with the terms of an issued LOA remains the responsibility of the LOA-holder.

As noted by the Commission in its informal comments on the proposed rule, Table 13 in the proposed rule mistakenly indicated an estimate of 20 Level B harassment takes of harbor porpoise over the five-year duration of this rule. NMFS corrected this take estimate to reflect 24 takes over the five-year period, as described in the Estimated Take section of this final rule. NMFS has also adjusted the harbor seal take estimate in this final rule to reflect estimated take of 13.6 harbor seals per day, rather than 14 harbor seals per day included in the proposed rule, also described further in the Estimated Take section.

Regarding mitigation, this final rule requires the Navy to establish a 55 m shutdown zone for LF cetaceans during impact driving of 24-in concrete piles, rather than 50 m included in the proposed rule.

Regarding monitoring, the proposed rule stated that the Navy would conduct SSV for composite piles; however, this final rule does not include a requirement for the Navy to conduct SSV. Please see the Acoustic Monitoring section for additional information. This final rule requires the Navy to employ at least three PSOs during vibratory pile driving at Pier 3, Pier 12, and Craney Island, and at least four PSOs during vibratory pile driving at Lambert's Point, though the exact locations have not been determined. For all other pile driving activities, a minimum of two PSOs will be used, as stated in the proposed rule (85 FR 83001; December 21, 2020). This change is reflected in the Monitoring and Reporting section of this final rule and in section 218.6(b).

Regarding reporting, this final rule requires the Navy to report the estimated percentage of the Level B harassment zone that was not visible.

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

Table 1 lists all species or stocks for which take is expected and may be authorized, and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2020). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated, nor will mortality be authorized, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. Atlantic and Gulf of Mexico SARs ( e.g., Hayes et al. 2020). All values presented in Table 1 are the most recent available at the time of publication and are available in the 2019 SARs (Hayes et al. 2020) or the 2020 draft SARS, available at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports.

As indicated above, all five species (with seven managed stocks) in Table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and we may authorize take. While North Atlantic right whales ( Eubalaena glacialis ), minke whales ( Balaenoptera acutorostrata acutorostrata ), and fin whales ( Balaenoptera physalus ) have been documented in the area, the temporal and/or spatial occurrence of these whales is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here.

Based on sighting data and passive acoustic studies, the North Atlantic right whale could occur off Virginia year-round (DoN 2009; Salisbury et al. 2016). They have also been reported seasonally off Virginia during migrations in the spring, fall, and winter (CeTAP 1981, 1982; Niemeyer et al. 2008; Kahn et al. 2009; McLellan 2011b, 2013; Mallette et al. 2016a, 2016b, 2017, 2018a; Palka et al. 2017; Cotter 2019). Right whales are known to frequent the coastal waters of the mouth of the Chesapeake Bay (Knowlton et al. 2002) and the area is a seasonal management area (November 1-April 30) mandating reduced ship speeds out to approximately 20 nautical miles (37 km) for the species; however, the project area is further inside the Bay.

North Atlantic right whales have stranded in Virginia, one each in 2001, 2002, 2004, 2005: Three during winter (February and March) and one in summer (September) (Costidis et al. 2017, 2019). In January 2018, a dead, entangled North Atlantic right whale was observed floating over 60 miles (96.6 km) offshore of Virginia Beach (Costidis et al. 2019). All North Atlantic right whale strandings in Virginia waters have occurred on ocean-facing beaches along Virginia Beach and the barrier islands seaward of the lower Delmarva Peninsula (Costidis et al. 2017). Due to the low occurrence of North Atlantic right whales in the project area, NMFS is not authorizing take of this species.

Fin whales have been sighted off Virginia (Cetacean and Turtle Assessment Program (CeTAP) 1981, 1982; Swingle et al. 1993; DoN 2009; Hyrenbach et al. 2012; Barco 2013; Mallette et al. 2016a, b; Aschettino et al. 2018; Engelhaupt et al. 2017, 2018; Cotter 2019), and in the Chesapeake Bay (Bailey 1948; CeTAP 1981, 1982; Morgan et al. 2002; Barco 2013; Aschettino et al. 2018); however, they are not likely to occur in the project area. Sightings have been documented around the Chesapeake Bay Bridge Tunnel (CBBT) during the winter months (CeTAP 1981, 1982; Barco 2013; Aschettino et al. 2018).

Eleven fin whale strandings have occurred off Virginia from 1988 to 2016 mostly during the winter months of February and March, followed by a few in the spring and summer months (Costidis et al. 2017). Six of the strandings occurred in the Chesapeake Bay (three on eastern shore; three on western shore) with the remaining five occurring on the Atlantic coast (Costidis et al. 2017). Documented strandings near the project area have occurred: February 2012, a dead fin whale washed ashore on Oceanview Beach in Norfolk (Swingle et al. 2013); December 2017, a live fin whale stranded on a shoal in Newport News and died at the site (Swingle et al. 2018); February 2014, a dead fin whale stranded on a sand bar in Pocomoke Sound near Great Fox Island, Accomack (Swingle et al. 2015); and, March 2007, a dead fin whale near Craney Island, in the Elizabeth River, in Norfolk (Barco 2013). Only stranded fin whales have been documented in the project area; no free-swimming fin whales have been observed. Due to the low occurrence of fin whales in the project area, NMFS is not authorizing take of this species.

Minke whales have been sighted off Virginia (CeTAP 1981, 1982; Hyrenbach et al. 2012; Barco 2013; Mallette et al. 2016a, b; McLellan 2017; Engelhaupt et al. 2017, 2018; Cotter 2019), near the CBBT (Aschettino et al. 2018), but sightings in the project area are from strandings (Jensen and Silber 2004; Barco 2013; DoN 2009). In August 1994, a ship strike incident involved a minke whale in Hampton Roads (Jensen and Silber 2004; Barco 2013). It was reported that the animal was struck offshore and was carried inshore on the bow of a ship (DoN 2009). Twelve strandings of minke whales have occurred in Virginia waters from 1988 to 2016 (Costidis et al. 2017). There have been six minke whale stranding from 2017 through 2020 in Virginia waters. Because all known minke whale occurrences in the project area are due to strandings, NMFS is not authorizing take of this species.

A detailed description of the species likely to be affected by the Navy's project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the proposed rule (85 FR 83001; December 21, 2020); since that time, we are not aware of any changes in the status of these species and stocks, except that the Gulf of Maine humpback whale stock has been designated as strategic in the 2020 draft SARs; therefore, detailed descriptions are not provided here. Please refer to the proposed rule for these descriptions (85 FR 83001; December 21, 2020). Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al. 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes ( i.e., LF cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for LF cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. Marine mammal hearing groups and their associated hearing ranges are provided in Table 2.

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

For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Five marine mammal species (three cetacean and two phocid pinniped species) have the reasonable potential to co-occur with the planned construction activities. Please refer to Table 1. Of the cetacean species that may be present, one is classified as a LF cetacean ( i.e., humpback whale) one is classified as a mid-frequency cetacean ( i.e., bottlenose dolphin), and one is classified as a high-frequency cetacean ( i.e., harbor porpoise).

The effects of underwater noise from the Navy's activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The proposed rule (85 FR 83001; December 21, 2020) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from the Navy's construction activities on marine mammals and their habitat. That information and analysis is incorporated by reference into this final rule and is not repeated here; please refer to the proposed rule (85 FR 83001; December 21, 2020).

The Estimated Take section in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take section, and the Mitigation Measures section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks. We also provided additional description of sound sources in our proposed rule (85 FR 83001; December 21, 2020).

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

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

Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns and potential TTS for individual marine mammals resulting from exposure to pile driving and removal. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures ( i.e., shutdown zones) discussed in detail below in the Mitigation Measures section, Level A harassment is neither anticipated nor will be authorized.

As described previously, mortality is neither anticipated nor will be authorized for this activity. Below we describe how the take is estimated.

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

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

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

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

Level A harassment for non-explosive sources —NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The Navy's planned construction includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.

These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

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

The sound field in the project area is the existing background noise plus additional construction noise from the planned project. Marine mammals are expected to be affected via sound generated by the primary components of the project ( i.e., impact pile driving and vibratory pile driving). The largest calculated Level B harassment zone extends 7.2 km (4.5 mi) from the source (though truncated by land in some directions), with an area of 4.7 km 2 (1.8 mi 2 ), as calculated using geographic information system (GIS) data as determined by the transmission loss modeling.

The Navy contracted the University of Washington, Applied Physics Laboratory (APL) to conduct site-specific acoustic transmission loss modeling for the project. The APL's full report is included in Appendix B of the Navy's application. NMFS independently reviewed and concurred with the modeling in the report, and has adopted the resulting isopleths for the project, as included in Table 5.

In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. We describe how the information provided above is brought together to produce a quantitative take estimate.

Humpback whales occur in the mouth of the Chesapeake Bay and nearshore waters of Virginia during winter and spring months. Most detections during shipboard surveys were of one or two juveniles per sighting. Although two individuals were detected in the vicinity of MPU project activities, there is no evidence that they linger for multiple days. Because no density estimates are available for the species in this area, the Navy estimated one take for every 60 days of pile driving. However, given the potential group size of two, as indicated by the sightings referenced above, NMFS has estimated that two humpback whales may be taken by Level B harassment for every 60 days of pile driving. Therefore, given the number of project days expected in each year (Table 4), NMFS may authorize a total of 24 takes by Level B harassment of humpback whale over the five-year authorization, with no more than eight takes by Level B harassment in one year.

The largest Level A harassment zone for low-frequency cetaceans extends approximately 52 m from the source during impact pile driving of 24-in concrete piles at the MWR Marina (Table 5). For most activities, the Level A harassment zone is less than 20 m. The Navy is planning to implement a 55-m shutdown zone for humpback whales during impact pile driving of 24-in concrete piles, and shutdown zones that include the entire Level A harassment isopleth for all activities, as indicated in Table 11. Therefore, the Navy did not request, and NMFS will not authorize Level A harassment take of humpback whale.

The expected number of bottlenose dolphins in the project area was estimated using inshore seasonal densities provided in Engelhaupt et al. (2016) from vessel line-transect surveys near NAVSTA Norfolk and adjacent areas near Virginia Beach, Virginia, from August 2012 through August 2015 (Engelhaupt et al. 2016). To calculate Level B harassment takes of bottlenose dolphin, NMFS used the Chesapeake Bay density of 1.38 dolphins/km 2 (Engelhaupt et al. 2016). This density includes sightings inshore of the Chesapeake Bay from NAVSTA Norfolk west to the Thimble Shoals Bridge, and is the most representative density for the project area. NMFS conservatively multiplied the density of 1.38 dolphins/km 2 by the largest Level B harassment zone for each project location (Table 7) and then by the proportional number of estimated pile driving days at each location for each year (Table 6). For example, to calculate Level B harassment takes associated with work at Pier 3 in 2021, NMFS multiplied the density (1.38 dolphins/km 2 ) by largest Level B harassment zone for Pier 3 (10.3 km 2 ) by the proportional number of pile driving days at Pier 3 in 2021 (24.6) for a total of 350 Level B harassment takes at Pier 3 in 2021. Therefore, NMFS may authorize 7,566 takes by Level B harassment of bottlenose dolphin across all five years, with no more than 2,742 in one year.

Atlantic highly migratory species (HMS) fisheries, including BFT fisheries, are managed under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ). The 2006 Consolidated Atlantic HMS Fishery Management Plan (FMP) and its amendments are implemented by regulations at 50 CFR part 635. Section 635.27 divides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Atlantic HMS FMP and its amendments. NMFS is required under the MSA to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

Under § 635.28(a)(1), NMFS publishes a closure notice with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on or after the effective date and time of a closure notice for that category, for the remainder of the fishing year, until the opening of the relevant subsequent quota period or until such date as specified.

The 2021 BFT fishing year, which is managed on a calendar-year basis and subject to an annual calendar-year quota, began January 1, 2021. The Angling category season opened January 1, 2021, and continues through December 31, 2021. The current Angling category quota is 232.4 metric tons (mt), of which 5.3 mt is allocated for the harvest of large medium and giant (trophy) BFT by vessels fishing under the Angling category quota, with 1.8 mt allocated for each of the following areas: North of 39°18' N. lat. (off Great Egg Inlet, NJ); south of 39°18' N. lat. and outside the Gulf of Mexico (the “southern area”); and in the Gulf of Mexico. Per § 635.27(a)(2)(iii), the Gulf of Mexico region includes all waters of the U.S. exclusive economic zone (EEZ) west and north of the boundary stipulated at § 600.105(c). Trophy BFT measure 73 inches (185 cm) curved fork length or greater.

Based on reported landings from the NMFS Automated Catch Reporting System, NMFS has determined that the codified Angling category Gulf of Mexico trophy BFT subquota of 1.8 mt has been reached and exceeded and that a closure of the Gulf of Mexico incidental trophy BFT fishery is warranted. Therefore, retaining, possessing, or landing large medium or giant BFT in the Gulf of Mexico by persons aboard HMS Angling category and the HMS Charter/Headboat permitted vessels (when fishing recreationally) must cease at 11:30 p.m. local time on May 4, 2021. This closure will remain effective through December 31, 2021. This action is intended to prevent further overharvest of the Angling category Gulf of Mexico incidental trophy BFT subquota, and is taken consistent with the regulations at § 635.28(a)(1). NMFS previously closed the 2021 trophy BFT fishery in the southern area on March 1, 2021 (86 FR 12548, March 4, 2021).

If needed, subsequent Angling category adjustments will be published in the Federal Register . Information regarding the Angling category fishery for Atlantic tunas, including daily retention limits for BFT measuring 27 inches (68.5 cm) to less than 73 inches and any further Angling category adjustments, is available at hmspermits.noaa.gov or by calling (978) 281-9260. HMS Angling category and HMS Charter/Headboat permit holders may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure.

HMS Angling category and HMS Charter/Headboat permitted vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is consistent with regulations at 50 CFR part 635, which were issued pursuant to section 304(c) of the Magnuson-Stevens Act and the Atlantic Tunas Convention Act, and is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons: The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. The closure of the Angling category Gulf of Mexico incidental trophy fishery is necessary to prevent any further overharvest of the Gulf of Mexico incidental trophy subquota. NMFS provides notification of closures by publishing the notice in the Federal Register , emailing individuals who have subscribed to the Atlantic HMS News electronic newsletter, and updating the information posted on the Atlantic Tunas Information Line and on hmspermits.noaa.gov.

These fisheries are currently underway, and delaying this action would be contrary to the public interest as it could result in excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the Gulf of Mexico incidental trophy BFT fishery before additional landings of these sizes of BFT occur. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission jointly manage summer flounder. The Council and Commission's Summer Flounder Management Board meet jointly each year to recommend recreational management measures for summer flounder.

In this final rule, NMFS is implementing conservation equivalency to manage the 2021 summer flounder recreational fishery, as proposed on April 6, 2021 (86 FR 17764). The approval of conservation equivalency means that we are waiving Federal summer flounder recreational measures in Federal waters for all federally permitted summer flounder party/charter vessels, regardless of where they fish. States, through the Commission, are collectively implementing measures designed to constrain landings to the 2021 recreational harvest limit. Vessels fishing in Federal waters and Federal party/charter vessels are subject to the regulations in the state they land. These measures are consistent with the recommendations of the Council and the Commission. Additional information on the development of these measures is provided in the proposed rule and not repeated here.

Conservation equivalency, as established by Framework Adjustment 2 (66 FR 36208; July 11, 2001), allows each state to establish its own recreational management measures (possession limits, fish size, and fishing seasons) to achieve its state harvest limit established by the Commission from the coastwide recreational harvest limit, as long as the combined effect of all of the states' management measures achieves the same level of conservation as Federal coastwide measures. Framework Adjustment 6 (71 FR 42315; July 26, 2006) allows states to form regions for conservation equivalency in order to minimize differences in regulations for anglers fishing in adjacent waters.

Similar to the 2016-2020 program, the 2021 management program adopted by the Commission divides the recreational fishery into six management regions: (1) Massachusetts; (2) Rhode Island; (3) Connecticut-New York; (4) New Jersey; (5) Delaware-Virginia; and (6) North Carolina. Each state within a region must implement identical or equivalent measures (fish size, bag limit, and fishing season length), and the combination of those measures must be sufficient to achieve, but not exceed, the recreational harvest limit.

Based on the Commission's recommendation, we find that the 2021 recreational fishing measures required to be implemented in state waters are, collectively, the conservation equivalent of the season, fish size, and possession limit prescribed in 50 CFR 648.104(b), 648.105, and 648.106(a). According to § 648.107(a)(1), vessels subject to the recreational fishing measures are not subject to Federal measures, and instead are subject to the recreational fishing measures implemented by the state in which they land. Section 648.107(a) is amended through this final rule to recognize state-implemented measures as the conservation equivalent of the Federal coastwide recreational management measures for 2021.

In addition, this action reaffirms the default coastwide measures (a 19-inch (48.3-cm) minimum size, four-fish possession limit, and May 15 through September 15 open fishing season), that becomes effective January 1, 2022, upon the expiration of the 2021 conservation equivalency program.

There are no changes from the proposed rule.

NMFS received seven comments on the proposed rule, none of which were directly related to the proposed measures. Four comments were related to state-specific measures and offered concerns over the minimum fish sizes and a perceived lack of recognition of changing fish distribution. Two comments relayed concerns about commercial fishing regulations and general complaints over the management of summer flounder. One commenter discussed a number of ongoing management actions that may impact the future management of the recreational summer flounder fishery. Although there may be future changes to recreational summer flounder management, at this time we are required to either approve conservation equivalency, as this final rule does, or implement coastwide measures. None of these commenters suggested the adoption of coastwide measures or the imposition of the precautionary default measures, which would be alternatives to the conservational equivalent approach of the proposed rule. All comments received were outside the scope of this action. No changes to the final rule are made based on the submitted comments.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Assistant Administrator has determined that this final rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay of effectiveness period for this rule, to ensure that the final management measures are in place as soon as possible.

The Federal coastwide regulatory measures for recreational summer flounder fishing that were codified last year (85 FR 36802; June 18, 2020) remain in effect until the decision to waive Federal measures for 2021 is made effective by this final rule. Many states have already implemented their conservationally equivalent 2021 measures; a delay in implementing the measures of this rule will increase confusion on what measures are in place in Federal waters. Inconsistencies between the states' measures and the Federal measures could lead to potential confusion and misunderstanding of the applicable regulations and could increase the likelihood of noncompliant landings. Additionally, the Federal measures currently in place are more restrictive than many of the measures in state waters, unnecessarily disadvantaging federally-permitted vessels, which are subject to these more restrictive measures until this final rule is effective.

An adjustment period is not needed for regulated entities to comply with this rule. Recreational and charter/party operators will not need new equipment or otherwise need to expend time or money to comply with these management measures. Rather, complying with this final rule simply requires adhering to the published state management measures for summer flounder while the recreational and charter/party operators are engaged in fishing activities.

For these reasons, the Assistant Administrator finds good cause to waive the 30-day delay of effectiveness period and to implement this rule upon filing for public inspection in the Federal Register .

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. A final regulatory flexibility analysis is not required and none has been prepared.

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

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: