The subject of the public hearing is the notice of proposed rulemaking (REG-120653-22) that was published in the Federal Register on Thursday, March 23, 2023, (88 FR 17451).

The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit an outline of the topics to be discussed and the time to be devoted to each topic by July 7, 2023.

A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing, and via the Federal eRulemaking Portal ( www.Regulations.gov ) under the title of Supporting & Related Material. If no outline of the topics to be discussed at the hearing is received by July 7, 2023, the public hearing will be cancelled. If the public hearing is cancelled, a notice of cancellation of the public hearing will be published in the Federal Register .

Individuals who want to testify in person at the public hearing must send an email to publichearings@irs.gov to have your name added to the building access list. The subject line of the email must contain the regulation number REG-120653-22 and the language TESTIFY In Person. For example, the subject line may say: Request to TESTIFY In Person at Hearing for REG-120653-22.

Individuals who want to testify by telephone at the public hearing must send an email to publichearings@irs.gov to receive the telephone number and access code for the hearing. The subject line of the email must contain the regulation number REG-120653-22 and the language TESTIFY Telephonically. For example, the subject line may say: Request to TESTIFY Telephonically at Hearing for REG-120653-22.

Individuals who want to attend the public hearing in person without testifying must also send an email to publichearings@irs.gov to have your name added to the building access list. The subject line of the email must contain the regulation number REG-120653-22 and the language ATTEND In Person. For example, the subject line may say: Request to ATTEND Hearing In Person for REG-120653-22. Requests to attend the public hearing must be received by 5:00 p.m. EST by Monday, July 24, 2023.

Individuals who want to attend the public hearing by telephone without testifying must also send an email to publichearings@irs.gov to receive the telephone number and access code for the hearing. The subject line of the email must contain the regulation number REG-120653-22 and the language ATTEND Hearing Telephonically. For example, the subject line may say: Request to ATTEND Hearing Telephonically for REG-120653-22. Requests to attend the public hearing must be received by 5 p.m. EST by Monday, July 24, 2023.

Hearings will be made accessible to people with disabilities. To request special assistance during a hearing please contact the Publications and Regulations Branch of the Office of Associate Chief Counsel (Procedure and Administration) by sending an email to publichearings@irs.gov (preferred) or by telephone at (202) 317-6901 (not a toll-free number) by Friday, July 21, 2023. Any questions regarding speaking at or attending a public hearing may also be emailed to publichearings@irs.gov.

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

On January 18, 2022, 1 EPA partially approved and partially disapproved Ohio's SO 2 plan for the Muskingum River area submitted on April 3, 2015, and October 13, 2015, and supplemented on June 23, 2020. EPA's January 18, 2022, final rule provided an explanation of the applicable provisions in the CAA and the measures and limitations identified in Ohio's attainment plan to satisfy these provisions. EPA approved the base year emissions inventory and affirmed that the new source review requirements for the area had previously been met. In addition to an attainment demonstration, the January 18, 2022, final rule addressed the requirements for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures (RACM) and reasonably available control technology (RACT), enforceable emission limitations and control measures, base-year and projection-year emission inventories, and contingency measures.

Ohio's June 23, 2020, submittal was based on, among other things, an agreement that the Globe facility would purchase a tract of property to the north that was modeled to be impacted by SO 2 emissions from the facility. Globe decided not to purchase the land as anticipated by the attainment plan. As the attainment demonstration relied on the inclusion of this property within Globe's fenceline, failure to obtain the land rendered the attainment demonstration invalid, and EPA disapproved Ohio's attainment demonstration for the Muskingum River SO 2 nonattainment area. This disapproval started sanctions clocks for this area under CAA section 179(a)-(b), including a requirement for 2-for-1 offsets for any major new sources or major modifications 18 months after the effective date of this action, and highway funding sanctions 6 months thereafter, as well as initiated an obligation for EPA to promulgate a Federal Implementation Plan within 24 months, under CAA section 110(c).

Ohio submitted a supplement to the attainment demonstration on June 24, 2022, to substitute new measures in lieu of the land acquisition. The supplement identifies a modification to the Shop 1 baghouse at the Globe facility that added a vertical release exhaust point at the roof monitor. Ohio also modified the air quality modeling analysis to include the use of site-specific meteorological data instead of National Weather Service data collected 20 miles off-site.

On July 28, 2022, in accordance with Ohio's June 23, 2020, DFFOs, Globe submitted the final report for validation testing conducted on January 11 and 13, 2022. This testing was required to verify the accuracy of the mass balance calculations used to determine compliance with the SO 2 emissions limits. EPA and Ohio EPA agree that the validation testing did verify the accuracy of the mass balance calculations, but the flows measured during the validation testing were different from those used in the air quality modeling that serves as the basis for the attainment demonstration. In addition, during the testing a damper blade was stuck in the open position. While neither affected the mass balance nor the validation testing results, the flow and temperature measurements and the amount of dilution air added after the measurement point may have been affected, which raised questions about the appropriateness of certain modeling parameters used in the source characterization and modeling.

As a result, Ohio submitted additional supplemental information on May 23, 2023, including revised DFFOs for Globe that supersede the June 23, 2020, DFFOs. The new DFFOs retain the SO 2 emission limits set forth in the previous DFFOs but require additional testing within one year of the effective date of the DFFOs to verify the source characterization parameters used in the air quality modeling, including the flow and temperature measurements and the amount of dilution air added after the measurement point. The new DFFOs also require: submittal of a testing protocol to be approved by Ohio EPA in consultation with EPA; continuous monitoring of the damper position and installation of a sensor to detect and record when the damper is not fully closed; automated alarms if the damper is open longer than fifteen minutes; daily visual checks of the damper; reporting of malfunctions; prompt action to respond to any alarms, malfunctions, or inspections which indicate that the damper may be open outside of normally intended operations. The new DFFOs also require associated recordkeeping and reporting. If the values measured in the source characterization testing are determined by Ohio EPA to be sufficiently different from the values used in the current modeling, such that it would be reasonably expected that updated modeling may no longer demonstrate attainment of the standard, the DFFOs require that Globe submit a revised attainment demonstration with updated modeling demonstrating attainment using updated parameters. In that event, Globe will be required to submit an updated modeling protocol, which will be reviewed and approved by Ohio EPA in consultation with EPA.

The 2023 DFFOs will remain in effect until requirements demonstrating attainment of the standard (including procedures for determining compliance) are incorporated into Ohio Administrative Code Chapter 3745-18, the rules are approved into Ohio's SIP, and the requirements are incorporated into the facility's title V operating permit.

EPA is proposing to approve Ohio's SIP attainment plan submission for the Muskingum River SO 2 nonattainment area, which the state previously submitted to EPA on April 3, 2015, October 13, 2015, and June 23, 2020, and supplemented on June 24, 2022, July 28, 2022, and May 23, 2023. This SO 2 attainment plan included Ohio's attainment demonstration for this area. The attainment plan also addressed requirements for emission inventories, RACT/RACM, RFP, and contingency measures. Ohio has previously addressed requirements regarding nonattainment area new source review. Because Ohio's submission provides an appropriate testing requirement to confirm the modeling, EPA has determined that Ohio's SO 2 attainment plan for the Muskingum River SO 2 nonattainment area meets the applicable requirements of CAA sections 110, 172, 191, and 192.

A key element of Ohio's attainment plan is Ohio's revised DFFOs issued to Globe on May 23, 2023. Among other requirements, Ohio's DFFOs retain SO 2 emission limits for Globe set forth in the 2020 DFFOs as a matrix of limits based on 26 separate operating scenarios at the two baghouses, where each of the 26 scenarios was modeled to demonstrate attainment and maintenance of the SO 2 standard. As part of this proposed approval of Ohio's attainment plan for this area, EPA would approve Ohio's May 23, 2023, DFFOs for the Globe facility into the SIP. These DFFOs supersede the previous 2020 DFFOs, retain the SO 2 limits and other requirements set forth in the 2020 DFFOs, and require additional testing, monitoring, and confirmation of certain flow parameters for verification of source modeling characterization. EPA finds that these requirements are sufficient for the required attainment plan demonstration.

By this action, EPA is proposing to codify its approval of both Ohio's May 23, 2023, DFFOs and Ohio's attainment plan for the Muskingum River SO 2 nonattainment area.

In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Ohio's DFFOs issued to Globe Metallurgical, effective May 23, 2023, discussed in section II. of this preamble. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);

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

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

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

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

• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

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

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

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

Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

Ohio EPA did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.

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 those listed in TSCA section 5(a)(2) (see Unit II.A.). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA further provides that such manufacturing (including import) or processing may not commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). EPA has long interpreted the statutory term “significant new use” to include the resumption of a use that had ceased prior to promulgation of the proposed SNUR, for example see, April 25, 2019 (84 FR 17345) (FRL-9991-33)); March 8, 2016 (81 FR 20535 (FRL-9943-83)); December 29, 2014 (79 FR 77891 (FRL-9915-60)) and October 22, 2013 (78 FR 62443 (FRL-9397-1)), and EPA will not determine that a use is a “significant new use” if information reasonably available to the Agency, including that received during the period for public comment, establishes that the use is ongoing at the time the proposed rule is published in the Federal Register .

EPA is proposing SNURs for the following three flame retardants undergoing TSCA section 6 risk evaluations:

• Tris(2-chloroethyl) phosphate (TCEP), CASRN 115-96-8 (Ref. 1);

• 4,4′-(1-methylethylidene)bis[2, 6-dibromophenol], also known as “tetrabromobisphenol A,” (TBBPA), CASRN 79-94-7 (Ref. 2); and

• Triphenyl phosphate (TPP), CASRN 115-86-6 (Ref. 3).

The proposed significant new uses are manufacture (including import) or processing for any use, with the exception that the conditions of use that EPA expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses (Refs. 1, 2, and 3). The conditions of use that EPA identified for the TSCA section 6 risk evaluations include all manufacture, processing, and use the Agency believes to be ongoing, as well as legacy uses and associated disposal, in the United States based on reasonably available information. The proposed significant new uses include manufacture and processing for uses that have ceased; manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States. EPA will consider any information received during the period for public comment suggesting that particular uses had commenced in the United States and not ceased prior to publication date of this notice of proposed rulemaking.

EPA is not proposing to make inapplicable the general exemptions from SNUR notice requirements that are described in 40 CFR 721.45. These include, for example, exemptions from notification requirements for persons manufacturing or processing the chemical substance only as an impurity or certain byproduct, and persons importing or processing the chemical substance as part of an article. (See also the request for comment in Unit II.D.).

EPA is requesting public comment on all aspects of this proposal and specifically on the Agency's description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency, if any (see details discussed in Unit III.). Please note that the Agency has listed the exempted conditions of use from the significant new use proposed designation as these conditions of use appear in the risk evaluation scope documents, including both manufacturing and processing for specific uses and the uses themselves in the same list of exceptions. EPA is interested in comments on how these conditions of use are presented as exemptions from the significant new use.

The Agency is proposing these SNURs to ensure that EPA receives timely advanced notice of any future manufacturing (including importing) or processing of the chemical substances subject to these proposed SNURs for uses identified as significant new uses that may produce changes in human and environmental exposures, and to ensure that an appropriate determination (relevant to the risks associated with such manufacturing (including importing), processing, distribution in commerce, use and disposal) has been issued prior to the commencement of such manufacturing (including importing) or processing. The proposed SNURs are necessary to ensure that manufacturing (including import) or processing for significant new uses cannot proceed until EPA has responded to the planned new use circumstances by taking the required actions under TSCA sections 5(e) or 5(f) in the event that EPA determines under section 5(a)(3) that: (1) The significant new use presents an unreasonable risk under the conditions of use (without consideration of costs or other nonrisk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) identified as relevant by EPA); (2) The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use; (3) In the absence of sufficient information, the manufacturing (including importing), processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities, may present an unreasonable risk (without consideration of costs or other nonrisk factors, and including an unreasonable risk to a PESS identified as relevant by EPA); or (4) There is substantial production and sufficient potential for environmental release or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)). In order for manufacturing (including importing) or processing for the significant new use to proceed after EPA has made one of these four determinations, EPA must take actions under TSCA sections 5(e) or 5(f) to protect health and the environment. However, EPA may also determine that the significant new use is not likely to present an unreasonable risk under TSCA section 5(a)(3)(C), after which manufacturing (including importing) or processing for the significant new use may proceed.

EPA is separately conducting risk evaluations for the chemical substances subject to this proposed rule under their respective conditions of use, pursuant to TSCA section 6(b)(4)(A) (15 U.S.C. 2605(b)(4)(A)). The term “conditions of use” is defined in TSCA section 3(4) to mean the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. Through scoping and subsequent information gathering activity for the risk evaluations, EPA identified conditions of use to consider in the TSCA section 6 risk evaluations for these chemical substances. The conditions of use identified by EPA for the TSCA section 6 risk evaluations are listed for each chemical substance in Unit III.D. These conditions of use include (but are not limited to) all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. EPA is not proposing to designate these conditions of use as significant new uses.

Additionally, as part of the information gathering activity associated with the risk evaluations for these chemical substances, EPA identified certain prior uses that have ceased, as well as industrial, commercial, or consumer conditions of use that are ongoing but for which manufacturing (including import) and processing have ceased. EPA is proposing to determine that manufacture and processing for these two categories of uses are no longer ongoing. These uses are also listed for each chemical substance in Unit III.D. Manufacture (including import) and processing of these chemical substances for these uses, as well as for any other potential use of these chemical substances not identified as a condition of use for the TSCA section 6 risk evaluations, are within the scope of this proposed SNUR.

The rationale and objectives for this proposed SNUR are further explained in Unit II.B.

1. General applicability.

You may be potentially affected by this action if you manufacture (including import), process, or distribute in commerce chemical substances and mixtures. 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.

• Textile manufacturing (NAICS code 313).

• Fabric coating mills (NAICS code 313320).

• All other leather good and allied product manufacturing (NAICS code 316998).

• All other miscellaneous wood product manufacturing (NAICS code 321999).

• Paper bag and coated treated paper manufacturing (NAICS code 322220).

• Coated and laminated paper manufacturing (NAICS code 322222).

• All other converted paper product manufacturing (NAICS code 322299).

• Other basic inorganic chemical manufacturing (NAICS code 325180).

• Alkalies and chlorine manufacturing (NAICS code 325181).

• All other basic inorganic chemical manufacturing (NAICS code 325188).

• All other basic organic chemical manufacturing (NAICS code 325199).

• Plastics material and resin manufacturing (NAICS code 325211).

• Artificial and synthetic fibers and filaments manufacturing (NAICS code 325220).

• Noncellulosic organic fiber manufacturing (NAICS code 325222).

• Paint and coating manufacturing (NAICS code 325510).

• Adhesive manufacturing (NAICS code 325520).

• Custom compounding of purchased resins (NAICS code 325991).

• Photographic film, paper, plate, and chemical manufacturing (NAICS code 325992).

• All other miscellaneous chemical product and preparation manufacturing (NAICS code 325998).

• Plastics and rubber products manufacturing (NAICS code 326).

• Unlaminated plastics film and sheet (except packaging) manufacturing (NAICS code 326113).

• Laminated plastics plate, sheet (except packaging), and shape manufacturing (NAICS code 326130).

• Polystyrene foam product manufacturing (NAICS code 326140).

• Urethane and other foam product (except polystyrene) manufacturing ((NAICS code 326150).

• All other plastics product manufacturing (NAICS code 326199).

• Other concrete product manufacturing (NAICS code 327390).

• Other industrial machinery manufacturing (NAICS code 333249).

• Computer and electronic product manufacturing (NAICS code 334).

• Bare printed circuit board manufacturing (NAICS code 334412).

• Semiconductor and related device manufacturing (NAICS code 334413).

• Electronic connector manufacturing (NAICS code 334417).

• Other electronic component manufacturing (NAICS code 334419).

• Current-carrying wiring device manufacturing (NAICS code 335931).

• Carbon and graphite product manufacturing (NAICS code 335991).

• Automobile manufacturing (NAICS code 336111).

• Other motor vehicle parts manufacturing (NAICS code 336390).

• All other motor vehicle parts manufacturing (NAICS code 336399).

• Aerospace product and parts manufacturing (NAICS code 336400).

• Aircraft manufacturing (NAICS code 336411).

• Other aircraft parts and auxiliary equipment manufacturing (NAICS code 336413).

• Furniture and related product manufacturing (NAICS code 337).

• Gasket, packing, and sealing device manufacturing (NAICS code 339991).

• Other chemical and allied products merchant wholesalers (NAICS code 424690).

• All other pipeline transportation (NAICS code 486990).

• Testing laboratories and services (NAICS code 541380).

• Hazardous waste treatment and disposal (NAICS code 562211).

• Solid waste landfill (NAICS code 562212).

• Other nonhazardous waste treatment and disposal (NAICS code 562219).

• Materials recovery facilities (NAICS code 562920).

• All other miscellaneous waste management services (NAICS code 562998).

• National security (NAICS code 928110).

2. Applicability to importers and exporters.

This action may also affect certain entities through pre-existing import, including import certification, and export notification rules under TSCA. Chemical importers are subject to the import provision of TSCA section 13 (15 U.S.C. 2612), which requires that the Secretary of the Treasury “refuse entry into the customs territory of the United States” of any substance, mixture, or article containing a chemical substance or mixture that fails to comply with any rule issued under TSCA or that “is offered for entry in violation” of TSCA or certain rules or orders issued under TSCA, including rules issued under TSCA section 5. Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are also subject to TSCA section 13 import certification requirements and the corresponding regulations promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28). Chemical importers of the chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.

In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after July 24, 2023 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.

EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers (including importers) and processors of the chemical substances included in this proposed rule. This analysis (Ref. 4), which is available in the docket, is briefly summarized here.

1. Estimated costs for SNUN submissions.

In the event that a SNUN is submitted, costs are an estimated $26,894 per SNUN submission for large business submitters and $11,204 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $19,020 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $3,300 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission of SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in this proposed SNUR. Additionally, these estimates reflect the costs and fees as they are known at the time this rulemaking.

2. Estimated costs for export notifications.

EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D, which require exporters to notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by the proposed SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $66.

1. Submitting CBI. Do not submit this information to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the instructions at https:// www.epa.gov/dockets and clearly mark the part or all the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets. EPA welcomes comment on all aspects of this proposed rule. In providing comments on an identified condition of use or a use that EPA proposes to determine is a significant new use for the chemical substances subject to this rule, please provide sufficient information for EPA to substantiate any assertions of an ongoing use for the specific chemical substance(s). EPA has identified in this notice the conditions of use that it plans to consider in the TSCA section 6 risk evaluation. It also has sought to identify uses that the information available to EPA demonstrates have been discontinued in the United States in Unit III. These lists are intended to provide examples and may not be exhaustive. Please note requests for comment related to specific aspects of this proposed rule in sections that follow (see Units III.B. (impurities and byproducts) and IV. (regulatory alternatives considered)).

1. Determination factors.

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 addition to the factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

2. Scientific standards, evidence, and available information.

EPA has used reasonably available information, as well as technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science, as applicable. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2).

The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Units III.D. and V. and in the references cited throughout the preamble of this proposed rule. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.

3. Determination for these chemical substances.

To determine what would constitute a significant new use of TCEP, TBBPA and TPP, EPA considered relevant information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2). If any entity were to commence a new use, including to resume a use of TCEP, TBBPA, and TPP that had been phased out, that use could both change the type and form and increase the magnitude and duration of human and environmental exposure to the substances, and thus EPA believes such uses should be identified as significant new uses. Based on consideration of the statutory factors discussed herein, EPA is proposing to determine that the following uses constitute significant new uses: manufacturing (including importing) or processing of TCEP, TBBPA, and TPP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses, as discussed in Unit III.D.

1. Rationale.

Under TSCA, no person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a risk determination itself, only a notification requirement for “significant new uses,” so that the Agency has the opportunity to review the SNUN for the significant new use and make a TSCA section 5(a)(3) risk determination.

Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. If a person decides to begin manufacturing (including importing) or processing any of these chemicals for the use, the submission of the SNUN to EPA allows the Agency to evaluate the conditions of use.

EPA has identified the potential for adverse environmental and health effects from the conditions of use of TCEP, TBBPA, and TPP based on data and information sources already described in the proposed designation of TCEP, TBBPA, and TPP as high priority substances for TSCA section 6 risk evaluation and the final scopes of the risk evaluations for TCEP, TBBPA, and TPP (Refs. 1, 2, and 3). EPA will evaluate risk under TSCA section 6 from the conditions of use of TCEP, TBBPA, and TPP.

As discussed in this unit and Unit III.D., based on an extensive review of reasonably available information, EPA is proposing to determine that significant new uses of TCEP, TBBPA, and TPP are manufacture (including import) or processing for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluations include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. The proposed significant new uses include manufacture and processing for uses that have ceased; manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States. Among other things, EPA has identified certain uses of TCEP, TBBPA, and TPP that have ceased as well as industrial, commercial, or consumer conditions of use that are ongoing but for which manufacturing (including import) or processing have ceased. In the absence of a SNUR, the manufacturing (including importing) or processing of TCEP, TBBPA, and TPP for the significant new uses proposed in this rule could begin at any time, without prior notice to EPA under section 5 and without providing EPA an opportunity to review and address potential risks associated with the new use. EPA is concerned that commencement of manufacturing (including importing) or processing TCEP, TBBPA, and TPP for the proposed significant new uses, could significantly increase the volume of manufacturing (including importing) and processing of these chemicals, as well as the magnitude and duration of exposure to humans and the environment over that which would otherwise exist currently, particularly to the potentially exposed or susceptible subpopulations identified by EPA in the final scopes for risk evaluation or during risk evaluation. Given the concerns associated with the conditions of use as described in Unit III.D., EPA believes that notification and EPA's required review are warranted for these chemicals prior to the commencement of a significant new use.

2. Objectives.

Based on the considerations discussed in Unit III.D., EPA wants to achieve the following objectives with regard to the significant new use(s) designated in this proposed rule:

• EPA would receive notice of any person's intent to manufacture (including import) or process the chemical substances for the described significant new use before that activity begins.

• EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing (including importing) or processing the chemical substances for the described significant new use.

• EPA would be able to either determine that the significant new use is not likely to present an unreasonable risk of injury, or to take such regulatory action as is associated with any other determination under TSCA section 5, before the manufacture or processing for the significant new use could commence.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to SNURs, recordkeeping requirements, and exemptions to reporting requirements, among other things.

Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of Premanufacture Notices (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), (h)(2), (h)(3), and (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 under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the significant new use of the chemical substance 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 finding.

The general exemptions from SNUR notice requirements that are described in 40 CFR 721.45 apply to these proposed SNURs.

EPA is requesting public comment on the alternative of making inapplicable the article exemption at 40 CFR 721.45(f). Under this alternative, the import and processing of articles containing TCEP, TBBPA, and TPP would not be exempt from significant new use notification requirements. As EPA collects and reviews information about the importing or processing of TCEP, TBBPA, and TPP as part of articles and the potential exposure to these chemical substances through articles, EPA may consider whether to make inapplicable the articles exemption at 40 CFR 721.45(f).

EPA also seeks comment on the potential impact of making inapplicable the articles exemption on firms that plan to import or process articles containing TCEP, TBBPA, and TPP, because, while not required by the proposed SNUR, these parties may take additional steps to determine whether TCEP, TBBPA, and TPP are part of the articles that they are considering for importing or processing.

Any use that EPA determines, in the final rule, was ongoing as of the date of publication of this proposal and did not cease prior to issuance of the final rule, will not be designated as a significant new use in the final rule.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376 (FRL-3658-5)), EPA has decided that the intent of the TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use after publication of the proposed rule but before the effective date of the final rule. Uses arising after the publication of the proposed rule are distinguished from uses that are identified in the final rule as having been ongoing on the date of publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are identified as ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.

Any person who begins commercial manufacturing (including importing) or processing of the chemical substances for a use that is designated as a significant new use in the final rule would 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 wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied.

1. SNUN submissions.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 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 721.25 and 40 CFR 720.40. E-PMN software is available electronically at https://www.epa.gov/chemicals-under-tsca.

EPA recommends that SNUN submitters consult with the Agency if, for instance, the chemical substance is also subject to a rule, order, or consent agreement under TSCA section 4. Prior to submitting a SNUN, submitters should consider what information may be useful in evaluating a SNUN. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.

2. Development and submission of information with the SNUN.

EPA recognizes that TSCA section 5 does not usually require developing new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is otherwise required to submit information for a chemical substance subject to the SNUR pursuant to a rule, TSCA 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 TSCA section 4 test rule, order, or consent agreement covering the chemical substance, persons are required to submit only information in their possession or control and to describe any other information known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters include information that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture (including import), processing, distribution in commerce, use, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific information it believes may be useful in evaluating a significant new use.

Submitting a SNUN that does not include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. 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 listed in Unit III. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information 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 substance.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

The proposed SNURs would apply to manufacturing (including import) or processing for certain uses of TCEP, TBBPA, and TPP as described in this unit.

As explained in Unit II.D. EPA proposes to base its determination on whether a use is an ongoing use, as opposed to a new use, on information available to the agency (including information received during the public comment period) on whether the use was ongoing as of June 22, 2023. This is referred to as the cutoff date for determining whether a use is ongoing.

In accordance with the impurity exemption at 40 CFR 721.45(d), the proposed SNURs would not apply to persons who manufacture (including import) or process TCEP, TBBPA, or TPP only as an impurity. EPA is not proposing to lift the impurities exemption for these SNURs. EPA is requesting public comment on any ongoing manufacturing (including import) or processing of TCEP, TBBPA, or TPP as an impurity.

There is no broad exemption for byproducts in EPA's general SNUR regulations at 40 CFR 721.45. Rather, EPA has only exempted byproducts from SNUR notification requirements in the limited circumstances where the person manufactures (including imports) or processes the substance only as a byproduct which is used only by public or private organizations that (1) burn it as a fuel; (2) dispose of it as a waste, including in a landfill or for enriching soil; or (3) extract component chemical substances from it for commercial purposes. See 40 CFR 721.45(e). Therefore, without a broader exemption in the proposed regulatory text of the SNURs, any other manufacturing (including importing) or processing of TCEP, TBBPA, or TPP as a byproduct that does not fall within a proposed exemption from the significant new use designations would be a significant new use subject to reporting requirements.

EPA is aware of ongoing activities that produce TBBPA and TPP as byproducts and continues to research such occurrences. EPA is requesting public comment on any ongoing manufacturing (including import) or processing of TCEP, TBBPA, or TPP as a byproduct that may not fall within the scope of the byproduct exemption at 40 CFR 721.45(e) and whether to include a broader exemption for manufacturing (including import) or processing as a byproduct in the final SNUR for these chemicals.

1. Chemical specific information.

For each chemical substance, EPA provides the following information in Unit III.D.:

• Chemical name and Chemical Abstracts Service Registry Number (CASRN);

• Uses EPA proposes to determine are significant new uses;

• Conditions of use and production volumes;

• Potential environmental and health effects; and

• Potential routes and sources of exposure.

2. Background.

a. Conditions of use and production volumes.

In the draft scopes of the risk evaluations under TSCA section 6 for these chemicals, EPA identified and described the categories and subcategories of conditions of use that EPA expects to consider in the TSCA risk evaluations based on information reported to EPA through the Chemical Data Reporting (CDR) and Toxics Release Inventory (TRI) reporting, published literature, public comments and consultation with stakeholders for both uses currently in production and uses for which production may have ceased. EPA revised the conditions of use in the final scope of each risk evaluation based on additional information and public comments (Refs. 1, 2, and 3). TCEP, TBBPA, and TPP have conditions of use based on research conducted by the Agency that identified circumstances under which these chemical substances are intended, known or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.

In conducting additional research on the conditions of use described in this proposed rule, EPA assembled information from the CDR and TRI programs, including production volumes and uses of TCEP, TBBPA, and TPP. Using this information EPA identified and described the categories and subcategories of conditions of use for the following lifecycle stages: manufacturing (including import); processing; distribution in commerce; industrial, commercial and consumer use; and disposal. EPA also consulted a variety of other sources to identify uses of TCEP, TBBPA, and TPP, including published literature, company websites, government and commercial trade databases and publications. To identify formulated products, including articles, EPA searched for safety data sheets (SDS) using internet searches, EPA Chemical and Product Categories (CPCat) data, and other resources in which SDSs could be found. SDSs were cross-checked with company websites to ensure that each product's SDS was current. In addition, EPA considered communications with companies, industry groups and public comments to supplement EPA's understanding of the conditions of use information. Production volume is based on data reported to EPA during the 2020 CDR submission period for calendar years 2016-2019 and described here as a range to protect production volumes that were claimed as CBI.

Finally, the Agency provides lists of identified conditions of use and uses proposed to be determined are significant new uses. In these lists, EPA specifies where such uses are among industrial, commercial, or consumer categories based on information in the final scopes for each chemical (Refs. 1, 2, and 3). In instances where such uses would include all three categories, EPA only lists the identified conditions of use and uses proposed to be determined as significant new uses.

b. Potential effects and routes of exposure.

As previously mentioned, certain phrasings of text and headings used in the proposed SNURs is identical to that used in the scope documents for each chemical. For example, comparable headings in the scope documents identify “Hazards (Effects),” “Environmental Hazards,” and “Human Health Hazards.” In this unit, the Agency is retaining traditional headings used in SNURs and will discuss such “effects” and “hazards” using text transferred from the scope documents.

1. Tris(2-chloroethyl) phosphate (TCEP), CASRN 115-96-8.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TCEP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing, as well as legacy uses and associated disposal, in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TCEP have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

• Domestic manufacturing for any use;

• Manufacturing (including import) for use in building and construction materials (insulation);

• Processing for use in building and construction materials (insulation);

• Manufacturing (including import) for use in wood and engineered wood products (wood resin composites);

• Processing for use in wood and engineered wood products (wood resin composites);

• Manufacturing (including import) for use in fabric and textile products;

• Processing for use in fabric and textile products;

• Manufacturing (including import) for use in foam seating and bedding products, except for foam used in aerospace equipment and products;

• Processing for use in foam seating and bedding products, except for foam used in aerospace equipment and products;

• Processing for incorporation into formulation, mixture, or reaction products, except for industrial and commercial use in polymers used in aerospace equipment and products; and

• Processing for incorporation into article, except for industrial or commercial use in articles used in aerospace equipment and products.

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TCEP that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TCEP. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TCEP is imported into the United States and processed for commercial use in paints and coatings, which may be present in unoccupied spaces of consumer homes, and for industrial or commercial use in polymers for use in aerospace equipment and products (Ref. 1). In addition, TCEP is imported for commercial use as a laboratory chemical (Ref. 1). Historically, TCEP was incorporated into building and construction materials, such as roofing insulation and wood resin composites (Ref. 1). Some of these products may still be present in consumers' homes and in commercial infrastructure and, therefore, are still listed among the commercial and consumer conditions of use EPA has identified for risk evaluation (Ref. 1). Data reported to EPA during the 2020 CDR submission period indicate there is no reported production volume of 25,000 lbs. or more of TCEP domestically manufactured or imported into the United States. Because data reported to EPA during the 2016 CDR submission period indicated that TCEP was being imported, EPA concluded it is reasonably foreseen that TCEP continues to be imported below CDR production volume thresholds.

EPA has identified conditions of use of TCEP that are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document (Ref. 1), with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TCEP and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TCEP that EPA has identified are:

• Import for commercial use as a laboratory chemical;

• Import for commercial use in paints and coatings;

• Import for industrial or commercial use in polymers used in aerospace equipment and products;

• Import for industrial or commercial use in articles used in aerospace equipment and products;

• Processing for commercial use in paints and coatings;

• Processing for industrial or commercial use in polymers used in aerospace equipment and products;

• Processing for industrial or commercial use in articles used in aerospace equipment and products;

• Recycling of articles;

• Distribution in commerce;

• Commercial use as a laboratory chemical;

• Industrial or commercial use in aerospace equipment and products;

• Commercial use in fabric and textile products;

• Consumer use in fabric and textile products;

• Commercial use in building and construction materials (insulation);

• Consumer use in building and construction materials (insulation);

• Commercial use in foam seating and bedding products;

• Consumer use in foam seating and bedding products;

• Commercial use in wood and engineered wood products (wood resin composites);

• Consumer use in wood and engineered wood products (wood resin composites);

• Commercial use in paints and coatings;

• Consumer use in paints and coatings; and

• Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified environmental hazard effects for aquatic and terrestrial organisms, and also identified the following potential human health effects associated with TCEP: acute, repeated dose, genetic, reproductive, developmental, toxicokinetic, cancer, and neurological effects (Ref. 1). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cardiovascular, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculoskeletal, nutritional and metabolic, ocular and sensory, renal, respiratory, skin and connective tissue, absorption, distribution, metabolism and excretion (ADME), and physiological based pharmacokinetic modeling and simulation (Ref. 1). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TCEP Final Scope (Ref. 1).

d. Potential routes and sources of exposure.

As previously mentioned, certain phrasings of text and headings in this unit are identical to that used in the scope documents for each chemical. In this unit, the Agency notes that certain discussions of environmental and general population exposures may list similar routes and sources of exposure; however, instead of modifying or synthesizing such discussions, the Agency is using text transferred from the scope documents. In addition, new or resumed uses would present potential routes and sources of exposure that could create concerns and, therefore, necessitate EPA review.

i. Environmental exposures.

The manufacturing (including import), processing, distribution, use and disposal of TCEP can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) via surface water, sediment, soil and ambient air. Environmental exposures to biota are informed by releases into the environment, overall persistence, degradation, bioaccumulation and partitioning across different media (Ref. 1). Concentrations of chemical substances in biota provide evidence of exposure (Ref. 1). TCEP has been identified in surface water, ground water and sediment, fish samples, seabird samples, and herring gull eggs (Ref. 1).

ii. Occupational exposures.

There is a potential for occupational exposure under various conditions of use of TCEP (Ref. 1). There is potential exposure from the processing of the chemical as it is incorporated into formulations and products and release from article components during their manufacture and industrial/commercial use, including handling and disposal of waste during manufacturing, processing (including recycling), and use (Ref. 1).

iii. Consumer exposures.

TCEP was previously incorporated into consumer products that may still be used, specifically fabric, textile, and leather products, and foam seating and bedding products, as well as building/construction materials including roofing insulation and wood and engineered wood products (Ref. 1). The main exposure routes for these uses where consumers interact with products and articles containing TCEP are dermal, inhalation, and dust ingestion, including children's mouthing of articles ( e.g., plastics, textiles, wood products) containing TCEP (Ref. 1).

iv. General population exposures.

Releases of TCEP from certain conditions of use, such as import, processing or disposal activities, may result in general population exposures (Ref. 1).

2. 4,4′-(1-methylethylidene)bis[2, 6-dibromophenol] (TBBPA), CASRN 79-94-7.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TBBPA for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TBBPA have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

• Manufacturing (including import) for use in batteries ( e.g., adhesive in lead-acid battery casing and in lithium-ion batteries);

• Processing for use in batteries ( e.g., adhesive in lead-acid battery casing and in lithium-ion batteries);

• Manufacturing (including import) for use in fabric, leather, and textile products ( e.g., carpets, office furniture); and

• Processing for use in fabric, leather, and textile products ( e.g., carpets, office furniture).

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TBBPA that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TBBPA. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TBBPA is manufactured (including imported) in the United States (Ref. 2). The chemical is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture or reaction products; and incorporated into articles (Ref. 2). Processing also includes the recycling of TBBPA and TBBPA-containing products (Ref. 2). The predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products ( e.g., printed circuit boards and semiconductor packages) and as an additive flame retardant in electrical and electronic products ( e.g., plastic enclosures) (Ref. 2). The epoxy resin containing TBBPA can also be used in adhesives, laminate for aviation and automobile interiors and building/construction materials (Ref. 2). Data reported to EPA during the 2020 CDR submission period indicate the reported production volume is between 20 million and 100 million pounds per year (Ref. 2).

EPA has identified conditions of use of TBBPA (Ref. 2), which are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document, with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TBBPA and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TBBPA that EPA has identified are:

• Domestic manufacturing;

• Import;

• Processing for use in adhesive manufacturing;

• Processing for use in plastic material and resin manufacturing;

• Processing for use in chemical product and preparation manufacturing;

• Processing for use in electrical equipment, appliance and component manufacturing;

• Processing for use in plastics product manufacturing;

• Processing for use in computer and electronic product manufacturing;

• Processing for use in electrical and electronic products;

• Processing for use in printed circuit boards and semiconductor packages;

• Processing for use in interior material for transportation equipment;

• Processing for use in plastic electronic enclosures;

• Recycling of electronic products;

• Distribution in commerce;

• Industrial or commercial use in electrical and electronic products;

• Consumer use in electrical and electronic products;

• Industrial or commercial use in prepreg material for automotive and aviation interiors;

• Industrial or commercial use in building and construction materials;

• Industrial or commercial use in fabric, textile and leather products ( e.g., carpets, office furniture);

• Consumer use in fabric, textile and leather products ( e.g., carpets, office furniture);

• Industrial or commercial use as a laboratory chemical;

• Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified environmental hazard effects from TBBPA for aquatic and terrestrial organisms, and also identified the following potential human health effects: immunological, neurological, carcinogenic, and developmental (Ref. 2). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cardiovascular, endocrine, gastrointestinal, hematological, hepatic, mortality, nutritional and metabolic ocular and sensory, renal, reproductive, respiratory, skin and connective tissue, and ADME (Ref. 2). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TBBPA Final Scope (Ref. 2).

d. Potential routes and sources of exposure.

As previously mentioned, certain phrasings of text and headings in this unit are identical to that used in the scope documents for each chemical. In this unit, the Agency notes that certain discussions of environmental and general population exposures may list similar routes and sources of exposure; however, instead of modifying or synthesizing such discussions, the Agency is using text transferred from the scope documents. In addition, new or resumed uses would present potential routes and sources of exposure that could create concerns and, therefore, necessitate EPA review.

i. Environmental exposures.

The manufacturing, processing, distribution, use and disposal of TBBPA can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) (Ref. 2). Environmental exposures to biota are informed by releases into the environment, overall persistence, degradation and bioaccumulation within the environment and partitioning across different media (Ref. 2). Concentrations of chemical substances in biota provide evidence of exposure (Ref. 2).

ii. Occupational exposures.

Releases of TBBPA from certain conditions of use, such as manufacturing, processing, industrial/commercial uses, and disposal may result in occupational exposures (Ref. 2). Examples of occupational activities associated with the conditions of use identified for TBBPA include, but are not limited to: unloading and transferring TBBPA to and from storage containers to process vessels during manufacturing; processing and use; handling and disposing of waste containing TBBPA during manufacturing, processing (including recycling), and use; cleaning and maintaining equipment during manufacturing, processing (including recycling), and use; sampling chemicals, formulations or products containing TBBPA for quality control during manufacturing, processing (including recycling), and use; and performing other work activities in or near areas where TBBPA is used (Ref. 2).

EPA anticipates inhalation of dust and other respirable particles as an exposure pathway during the manufacture and processing of various articles containing TBBPA ( e.g., particulate generated during handling of plastic resins, finishing operations associated with the manufacture and finishing of plastics and plastic articles and incorporation of plastics and other article components into finished products) (Ref. 2). Dermal exposures for workers are possible during conditions of use (Ref. 2).

iii. Consumer exposures.

According to CDR reports, TBBPA appears to be used in consumer products used in indoor environments, specifically fabric, textile, and leather products, electrical and electronic products (including in the plastic enclosures), children's products, and building/construction materials (Ref. 2). Several of these products have the potential to be mouthed by children (Ref. 2). In addition, handling TBBPA-containing materials during disposal can lead to consumer and bystander exposures (Ref. 2). The main exposure routes where consumers interact with products and articles containing TBBPA are dermal, inhalation and dust ingestion, including children's mouthing of articles ( e.g., electronics, plastics, textiles) containing TBBPA (Ref. 2).

iv. General population exposures.

Releases of TBBPA from certain conditions of use, such as manufacturing, processing or disposal, may result in general population exposures (Ref. 2). TBBPA has been found in drinking water, ground water, ambient air, indoor air, fish, human breast milk and dust and soil (Ref. 2).

3. Triphenyl phosphate (TPP), CASRN 115-86-6.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TPP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and uses that the information available to the Agency demonstrates to be ongoing in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TPP have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

• Manufacturing (including import) for use in photographic applications; and

• Processing for use in photographic applications.

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TPP that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TPP. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TPP is manufactured (including imported) in the United States (Ref. 3). The chemical is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles (Ref. 3). Several commercial uses were identified, mainly in plastic and rubber products, and in paints and coatings (Ref. 3). Other uses reported include use in lubricants and greases. Consumer uses were reported in foam seating and bedding products (Ref. 3). Data reported to EPA during the 2020 CDR submission period indicate the reported production volume is between 1 million and 10 million pounds per year (Ref. 3).

EPA has identified conditions of use of TPP (Ref. 3), which are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document, with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TPP and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TPP that EPA has identified are:

• Domestic manufacturing;

• Import (including repackaging);

• Processing for use in plastics material and resin manufacturing;

• Processing for use in plastic product manufacturing;

• Processing for use in computer and electronic product manufacturing;

• Processing for use in rubber product manufacturing;

• Processing for use in textiles, apparel, and leather manufacturing;

• Processing for use in furniture and related product manufacturing;

• Processing for use in paint and coating manufacturing;

• Processing for use in all other chemical product and preparation manufacturing;

• Processing for use in adhesives, sealants, lubricants, and greases;

• Processing for use in operational fluids, maintenance fluids and semisolids, reactive fluids, and solids used in aerospace industry;

• Processing for use in turbine engine oils in aviation;

• Processing for use in turbine engine oils in non-aviation industries;

• Processing for use in furniture and related product manufacturing;

• Recycling;

• Distribution in commerce;

• Industrial or commercial use in paints and coatings;

• Industrial or commercial use in plastic and rubber products;

• Consumer use in plastic and rubber products;

• Industrial or commercial use as a laboratory chemical;

• Industrial or commercial use in lubricants and greases;

• Consumer use in lubricants and greases;

• Industrial or commercial use in operational fluids, maintenance fluids and semisolids, reactive fluids, and solids used in aerospace industry;

• Industrial or commercial use in turbine engine oils used in aviation;

• Industrial or commercial use in turbine engine oils used in non-aviation industries;

• Industrial or commercial use in electrical and electronic products;

• Consumer use in electrical and electronic products;

• Industrial or commercial use in foam seating and bedding products;

• Consumer use in foam seating and bedding products;

• Industrial or commercial use in furniture and furnishings;

• Industrial or commercial use in building and construction materials; and

• Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified potential environmental hazard effects from TPP for aquatic and terrestrial organisms, and also identified the following potential human health effects and related information: developmental, irritation, corrosion, and repeated dose (Ref. 3). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cancer, cardiovascular, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal, reproductive, skin and connective tissue, and ADME (Ref. 3). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TPP Final Scope (Ref. 3).

d. Potential routes and sources of exposure.

As previously mentioned, certain phrasings of text and headings in this unit are identical to that used in the scope documents for each chemical. In this unit, the Agency notes that certain discussions of environmental and general population exposures may list similar routes and sources of exposure; however, instead of modifying or synthesizing such discussions, the Agency is using text transferred from the scope documents. In addition, new or resumed uses would present potential routes and sources of exposure that could create concerns and, therefore, necessitate EPA review.

i. Environmental exposures.

The manufacturing, processing, distribution, use and disposal of TPP can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) (Ref. 3). TPP was detected in wastewater effluent, landfill leachate, sediment, soil, ambient air, as well as in fish (including shellfish) and dolphins (Ref. 3).

ii. Occupational exposures.

There is a potential for occupational exposure under the various conditions of use (manufacturing (including import), processing, industrial/commercial uses, and disposal) (Ref. 3). Also, there are potential exposures from the processing of TPP as it is incorporated into formulations and products (Ref. 3). There is also potential for exposure from additive flame retardants due to release from article components during their manufacture and industrial/commercial use (Ref. 3).

EPA anticipates inhalation of mist, dust, and other respirable particles as an occupational exposure pathway during the manufacture, processing, and commercial/industrial use of various products containing TPP ( e.g., particulate generated during manufacture and handling of foam and plastics and incorporation of foam and plastics into finished products, and mist generated during application to textiles and application of paints and coatings) (Ref. 3). For the oral route, workers and occupational non-users may inadvertently ingest inhaled particles that deposit in the upper respiratory tract or may transfer chemicals from their hands to their mouths (Ref. 3). Also, there is potential dermal exposure from contact with solids during packaging and repackaging operations at manufacturing and import sites when TPP is handled as a dry powder (Ref. 3). EPA also anticipates dermal exposure to liquid if TPP is formulated with liquid chemical and handled as a liquid (Ref. 3).

iii. Consumer exposures.

TPP is used in consumer products used in indoor environments, including foam seating and bedding products, and plastic and rubber products (Ref. 3). TPP use has also been reported in electrical and electronic products (Ref. 3). Several of these products have the potential to be mouthed by children. In addition, handling during the disposal of TPP-containing materials can lead to consumer and bystander exposures (Ref. 3). The main exposure routes for these uses where consumers interact with products and articles containing TPP are dermal, inhalation, and dust ingestion, including children's mouthing of articles ( e.g., textiles, wood products and plastics) containing TPP (Ref. 3). Therefore, potential sources and pathways of exposure to consumers include oral, dermal and inhalation; for bystanders, only the inhalation route may result from the conditions of use of TPP (Ref. 3).

iv. General population exposures.

Releases of TPP from certain conditions of use, such as manufacturing, processing, or disposal activities, may result in general population exposures (Ref. 3). TPP was detected in surface water, ground water, soil, ambient air, indoor air, indoor dust, as well as in fish (including shellfish) (Ref. 3).

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

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

This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to a requirement for Executive Order 12866 review.

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing SNUR regulations under OMB Control No. 2070-0038 (EPA ICR No. 1188.13). If an entity were to submit a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for export notifications is less than 1.5 hours per notification. In both cases, if the firm submitting either a SNUN or export notification is already registered in CDX, the burden would be lower than the presented estimates.

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 the 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.

Consistent with the PRA, EPA is interested in comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden or improving the automated collection techniques.

I certify this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are potential future manufacturers (defined by statute to include importers), processors, and exporters of one or more subject chemical substances for a significant new use designated in the proposed SNURs. 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, the Agency has determined 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. 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 10 in federal fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in FY2021, and 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 $19,020 to $3,330. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $11,204 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed 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.

This action does not contain any unfunded mandates as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. 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 proposed rule would 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 as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have 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.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes. This action will not significantly nor uniquely affect the communities of tribal governments, nor would it involve or impose any requirements that affect Indian tribes.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045. Since this is not a “covered regulatory action,” Executive Order 13045 does not apply, and since this action does not address human health concerns, EPA's policy on Children's Health also does not apply to this SNUR. However, the EPA Policy on Children's Health will apply to the consideration of the SNUNs submitted to EPA in response to a SNUR.

Although this action does not concern an environmental health or safety risk, the designation of certain uses of the subject chemicals as significant new uses ensures the Agency has an opportunity to review and address potential risks associated with such uses before an entity begins commencing any manufacture (including import) or processing of the chemical substance for that use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. Such a review will assess whether the use identified in the SNUN may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the chemical substances subject to the SNUR. As discussed previously, EPA is concerned about the potential for adverse health effects from the conditions of use of TCEP, TBBPA, and TPP for children and will evaluate the risk under TSCA section 6.

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

This rulemaking does not involve any technical standards under the NTTAA section 12(d) (15 U.S.C. 272 note).

Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or indigenous peoples) and low-income populations.

EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or indigenous peoples. The SNURs do not address any human health or environmental risks or affect the level of protection provided to human health or the environment. Although this action does not concern human health or environmental conditions, the designation of certain uses as significant new uses subject to this proposed SNUR ensures the Agency has an opportunity to review and address potential risks associated with such uses. As noted previously, EPA is concerned about the potential for adverse health effects from the conditions of use of TCEP, TBBPA, and TPP and will evaluate those conditions of use under TSCA section 6, including health effects associated with those conditions of use affecting potentially exposed or susceptible subpopulations that may be at greater risk of adverse health effects due to biological susceptibility based on factors such as race/ethnicity, life stage, lifestyle factors, and nutrition status. The SNUR would require the submission of a SNUN before the manufacture (including import) or processing for the significant new use can commence. EPA would then review the SNUN submission to assess whether the use identified in the SNUN may present unreasonable risk to health or the environment and take appropriate action to prevent unreasonable risk from the chemical substances subject to the SNUR. Furthermore, information submitted under TSCA can also be used by others to identify potential problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment and may make more information available to the public and interested communities that they can use to better assess potential exposures and risks to minority, low-income or indigenous populations, or tribes. For example, EPA provides public access to the information EPA receives and develops about chemical substances regulated under TSCA via ChemView ( https://chemview.epa.gov/chemview ).

Therefore, for the reasons set forth in the preamble, it is proposed that 40 CFR chapter I be amended as follows:

The Privacy Act of 1974, 5 U.S.C. 522a, governs how the Federal Government collects, maintains, and uses personally identifiable information in systems of record. The Privacy Act requires that federal agencies publish in the Federal Register a system of records notice (SORN) that identifies purpose of data collection, the routine use of its disclosures, and how individuals may get access to their own records and contest it.

The Inspector General Act of 1978, 5 U.S.C. 401-424; 5 U.S.C. App. 3, allows the U.S. AbilityOne Commission/OIG to maintain the system to fulfill its mission. The U.S. AbilityOne Commission OIG is responsible for conducting and supervising independent and objective audits, inspections, and investigations of the programs and operations of the Committee. OIG promotes economy, efficiency, and effectiveness within the U.S. AbilityOne Commission/OIG and prevents and detects fraud, waste, and abuse in its programs and operations. OIG's Office of Investigations investigates allegations of criminal, civil, and administrative misconduct involving U.S. AbilityOne Commission employees, contractors, grantees, and Departmental programs and activities. This includes investigating for violations of criminal laws by entities regulated by U.S. AbilityOne Commission, regardless of whether they receive Federal funds. These investigations can result in criminal prosecutions, fines, civil monetary penalties, and administrative sanctions.

The investigative and law enforcement nature of the system of records makes it necessary for the system to be exempt from the notice and access requirements. The Privacy Act contains general and specific exemptions for law enforcement purposes that grant these exemptions. The general exemption, 5 U.S.C. 552a(j)(2), allows exemptions for system of records that are “maintained by an agency or component thereof which performs as its principal function any activity pertaining to the enforcement of criminal laws, including police efforts to prevent, control, or reduce crime or to apprehend criminals, and the activities of prosecutors, courts, correctional, probation, pardon, or parole authorities, and which consists of (A) information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release, and parole and probation status; (B) information compiled for the purpose of a criminal investigation, including reports of informants and investigators, and associated with an identifiable individual; or (C) reports identifiable to an individual compiled at any stage of the process of enforcement of the criminal laws from arrest or indictment through release from supervision.” Similarly the specific exemption in 5 U.S.C. 552a(k)(2) allows exemptions for systems of records for “investigatory material compiled for law enforcement purposes, other than material within the scope of subsection (j)(2) of this section: Provided, however, That if any individual is denied any right, privilege, or benefit that he would otherwise be entitled by Federal law, or for which he would otherwise be eligible, as a result of the maintenance of such material, such material shall be provided to such individual, except to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence, or, prior to the effective date of this section, under an implied promise that the identity of the source would be held in confidence.” The data collected by the AbilityOne/OIG-001 Case Management System falls under these categories and for this reason, we are proposing to add 41 CFR 51-9.6.

For reasons stated in the preamble, the Committee proposes to amend 41 CFR part 51-9 as follows:

The purposes of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. (the Act)), are to provide a means to conserve the ecosystems upon which listed species depend, develop a program for the conservation of listed species, and achieve the purposes of certain treaties and conventions. Moreover, it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species and use its authorities to further the purposes of the Act (16 U.S.C. 1531(c)(1)). This proposed rulemaking action pertains primarily to sections 4 and 9 of the Act.

Section 9 of the Act provides a specific list of prohibitions for endangered species but does not provide these same prohibitions to threatened species. Instead, section 4(d) of the Act requires that the Secretary issue regulations necessary and advisable to provide for the conservation of threatened species; these are referred to as “4(d) rules.” Congress delegated the authority to the Secretary to determine what protections would meet this standard for a given species. Early in the administration of the Act, the Service promulgated “blanket rules,” two sets of protective regulations that generally applied to threatened species of wildlife and plants, at 50 CFR 17.31 and 17.71, respectively. These regulations extended the majority of the protections (all of the prohibitions that apply to endangered species under section 9 and additional exceptions to the prohibitions) ( e.g., 50 CFR 17.31(a) and 17.71(a) (2018)) to threatened species, unless we issued an alternative rule under section 4(d) of the Act for a particular species ( i.e., a species-specific rule). For species with a species-specific rule, that rule contained all of the protective regulations for that species.

On August 27, 2019, we issued a final rule that revised 50 CFR 17.31 and 17.71 (84 FR 44753; hereinafter, “the 2019 4(d) rule”) and ended the blanket rule option for application of section 9 prohibitions to species newly listed as threatened after the effective date of those regulatory revisions (September 26, 2019). The blanket rule protections continued to apply to threatened species that were listed prior to September 26, 2019, without an associated species-specific rule. Under the 2019 4(d) rule, the only way to apply protections to a species newly listed as threatened is for us to issue a species-specific rule setting out the protective regulations that are appropriate for that species.

On January 20, 2021, the President issued Executive Order 13990 (86 FR 7037, January 25, 2021; hereinafter referred to as “the E.O.”), which required all agencies to review agency actions issued between January 20, 2017, and January 20, 2021, to determine consistency with the purposes articulated in section 1 of the E.O. Pursuant to the direction in the E.O., we reviewed our 2019 4(d) rule to assess whether to keep it in place or to revise any aspects. Our review included evaluating the benefits or drawbacks of the regulations, the necessity of the regulations, their consistency with applicable case law, and other factors. Based on our evaluation, and for reasons discussed in more detail below, we propose to revise our regulations at 50 CFR 17.31 and 17.71 to reinstate the “blanket rules” that apply many of the section 9 protections to newly listed threatened species and update other provisions. This proposed revision would not require any previously finalized species-specific rules issued since September 2019 to be reevaluated on the basis of the final decision. However, under this proposal any wildlife or plant species that the Service listed as threatened prior to September 26, 2019, and protected with the previous “blanket rules,” would have the revised prohibitions and exceptions outlined under 50 CFR 17.31(a) or 17.71(a), respectively, for any future actions after the finalization of this rule. Applying the revised prohibitions and exceptions would make only two changes to the protections for those previously listed threatened species. First, it would add federally recognized Tribes to the entities authorized to aid, salvage, or dispose of threatened species. Second, it would update our endangered plant regulations at 50 CFR 17.61(c)(1) to match amendments to the Act that Congress enacted in 1988. These updates would also apply to threatened plants protected under the “blanket rule.” The Secretaries of the Interior and Commerce share responsibilities for implementing most of the provisions of the Act. Generally, marine species and some anadromous (sea-run) species are under the jurisdiction of the Secretary of Commerce, and all other species are under the jurisdiction of the Secretary of the Interior. Authority to administer the Act has been delegated by the Secretary of the Interior to the Director of the U.S. Fish and Wildlife Service (“the Service”) and by the Secretary of Commerce to the Assistant Administrator for the National Marine Fisheries Service (NMFS). The Service and NMFS (jointly “the Services”) each have separate regulations for implementation of section 4(d) protective regulations for species within their respective jurisdictions. When we amended our section 4(d) regulations in 2019, those amendments affected only species under Service jurisdiction. This proposal, if finalized, would have the same result.

The 2019 4(d) rule, along with other revisions to the Act's regulations finalized in 2019 (revisions to 50 CFR parts 402 and 424), were subject to litigation in the United States District Court for the Northern District of California. On July 5, 2022, the court issued a decision vacating the 2019 4(d) rule without reaching the merits of the case. On September 21, 2022, the United States Court of Appeals for the Ninth Circuit temporarily stayed the effect of the July 5th decision pending the District Court's resolution of motions seeking to alter or amend that decision. On October 14, 2022, the Services notified the District Court that we anticipated proceeding with a rulemaking process to revise the 2019 4(d) rule. Subsequently, on November 14 and 16, 2022, the District Court issued orders remanding the 2019 4(d) rule to the Services without vacating it, as the Services had asked the Court to do. Accordingly, the Service has developed this proposal to amend our regulations at 50 CFR part 17.

This proposed rule is one of three proposed rules publishing in today's Federal Register that propose changes to the regulations that implement the Act. Two of these proposed rules are joint between the Services, and this document is specific to the Service.

We propose revisions to the regulations in 50 CFR part 17, subparts C, D, F, and G, with minor administrative revisions to subpart A. Our proposal would reinstate the general application of the “blanket rule” option for protecting newly listed threatened species pursuant to section 4(d) of the Act, with the continued option to craft species-specific rules. Reinstating the “blanket rule” option and other proposed regulation revisions would only result in minor changes to protections for currently listed threatened species, whether those species received 4(d) protections from the prior versions of the “blanket rules” or from a species-specific rule. Species that were protected under prior versions of the “blanket rules” or under species- specific rules that refer to any of the sections we propose revising would receive the updated protections for any actions occurring after finalization of this proposed rule. As stated above, applying the revised prohibitions and exceptions would make only two changes to the protections for those previously listed threatened species. First, it would add federally recognized Tribes to the entities authorized to aid, salvage, or dispose of threatened species. Second, it would update our endangered plant regulations at 50 CFR 17.61(c)(1) to match amendments to the Act that Congress enacted in 1988. These updates would also apply to threatened plants protected under a “blanket rule.” Finally, we propose minor changes to clarify, without changing the scope or intent of, the existing regulations at 50 CFR 17.21 and 17.61 for endangered species, as well as technical corrections such as revising the use of the phrase “special rule” to “species-specific rule” in several locations ( e.g., 50 CFR 17.8, 17.40).

The primary proposed revisions are to 50 CFR 17.31 and 17.71; the proposed revisions would reinstate the general application of the “blanket rule” options for protecting newly listed threatened wildlife and plant species, respectively, pursuant to section 4(d) of the Act. As mentioned above, the Service had “blanket rules” for wildlife and plants between the 1970s and September 2019, at which time we revised the pertinent regulations to no longer apply to newly listed threatened species. For those species listed prior to September 26, 2019, we also had the option to issue species-specific rules, which we did approximately 25 percent of the time. This proposal would retain the continued option to promulgate species-specific rules. Also as stated above, applying the revised prohibitions and exceptions would make only two changes to the protections for those previously listed threatened species. First, it would add federally recognized Tribes to the entities authorized to aid, salvage, or dispose of threatened species. Second, it would update our endangered plant regulations at 50 CFR 17.61(c)(1) to match amendments to the Act that Congress enacted in 1988. These updates would also apply to threatened plants protected under a “blanket rule.” On August 27, 2019, we issued a rule to revise 50 CFR 17.31 and 17.71 such that species listed or reclassified as threatened species after the effective date of those revisions would no longer be afforded protective regulations unless we promulgated a species-specific rule (84 FR 44753). Between that rule's effective date in September 2019 and early May 2023, we listed or reclassified 35 threatened species (27 wildlife and 8 plant species) and finalized associated species-specific rules for each of those species. During that time, there were no newly listed threatened species for which time elapsed between listing and putting in place protective regulations because we finalized species-specific rules concurrently with each final classification action. The vast majority of species-specific rules included the prohibitions afforded to endangered species along with commonly provided exceptions to those prohibitions ( e.g., exceptions for activities pertaining to defense of life; salvage and recovery actions by employees of the Service, NMFS, and State natural resource agencies; law enforcement possession). All rules for wildlife species also included tailored exceptions to take prohibitions that allow for take (1) with minimal anticipated negative effects to the species or (2) that was unavoidable and associated with activities that would result in overall beneficial effects to the species. Five rules for plant species included similar regulatory language as language included in prior blanket rules. Three other rules for plant species included additional exceptions.

For every newly listed threatened species, we will determine what section 4(d) protections are appropriate. We anticipate that for some species we will determine that a species-specific rule would be appropriate while for other species we will determine that “blanket rule” protections are appropriate. In the latter instances, we conclude for two primary reasons that it would be preferable to apply section 9 prohibitions similar to our longstanding “blanket rules” that were available prior to the 2019 4(d) rule.

The first reason is biological: We want to prevent declines in the species' status, and section 4(d) provides that the Secretary shall promulgate regulations that are necessary and advisable to provide for the conservation of the species. Although threatened species are not currently in danger of extinction like endangered species, we have determined those species are likely to become in danger of extinction in the foreseeable future and we have an opportunity to try to prevent that from happening. In furtherance of the conservation purposes of the Act identified in section 2(b), Congress put in place the section 9 prohibitions as an immediate way after listing endangered species to help prevent further declines in the species' status. The plain language of section 4(d) indicates that the Secretary may by regulation prohibit acts under section 9, and we have concluded that applying those prohibitions in the “blanket rules” upon the listing of threatened species will similarly help prevent further declines of the species and further the conservation purposes of the Act.

The section 9 prohibitions make it illegal for any person subject to the jurisdiction of the United States to engage in the following actions:

• With respect to endangered wildlife—take such a species within the United States or on the high seas; or possess, sell, deliver, carry, transport, or ship any such species that has been taken illegally;

• With respect to endangered plants—remove and reduce to possession, or maliciously damage or destroy, any such plants from areas under Federal jurisdiction; or remove, cut, dig up, or damage or destroy such plants on any other area in knowing violation of any State law or regulation in the course of violating any State criminal trespass law; or

• With respect to endangered fish or wildlife or plants—import or export any such species; deliver, receive, carry, transport, or ship any such species in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any such species (sections 9(a)(1) and 9(a)(2) of the Act; 50 CFR 17.21 and 17.61).

Another aspect of our biological reason to apply section 9 prohibitions similar to our longstanding “blanket rules” is that, for newly listed species, we often lack a complete understanding of the causes of a species' decline, and taking a precautionary approach to applying protections would proactively address potentially unknown threats. In addition, the initial listing of a species may bring new attention to the species, and that attention may increase the risk of collection or sale. Therefore, we determined that this approach of applying section 9 prohibitions to threatened species under the “blanket rules” assists our goal of putting in place protections that will both prevent the species from becoming endangered and promote the recovery of species. As we learn more about a given species and the reasons for its decline over time, we have the option to establish or revise species-specific rules accordingly.

The second reason for applying the section 9 prohibitions for endangered species to threatened species under a “blanket rule” is a practical reason. For purposes of implementation and enforcement, it is easier to explain and comprehend threatened species protections if they are modeled after the section 9 prohibitions—with which agency staff and the public are widely familiar. Therefore, rather than craft similar, but slightly different prohibitions for threatened species, we refer directly to endangered species regulations at 50 CFR 17.21 and 17.61, where appropriate, in our “blanket rules” as well as most species-specific rules.

While we propose to include the statutory section 9 prohibitions for threatened species in the “blanket rules,” we also propose to include certain specific exceptions to those prohibitions. These specific exceptions were available in “blanket rules” prior to the 2019 4(d) rule, and we have no reason not to reinstate them. These include existing exceptions for endangered species ( e.g., any person may take endangered wildlife in defense of their own life or the lives of others; Federal and State law enforcement officers may possess, deliver, carry, transport, or ship any endangered wildlife taken in violation of the Act as necessary in performing their official duties; certain individuals can take wildlife to aid, salvage, or dispose of threatened species). We also propose to reinstate the exceptions for employees or agents of the Service, NMFS, or a State conservation agency operating a conservation program in accordance with section 6(c) of the Act to take threatened species. We also recognize that we need to maintain our ability to tailor take prohibitions or other protections to what is necessary and advisable for a given species. As stated in our 2019 4(d) rule, we have found significant conservation benefits from developing and implementing species-specific rules, such as (1) facilitating implementation of beneficial conservation actions and (2) reducing or otherwise tailoring permitting requirements for prohibited actions ( e.g., take) under circumstances that are considered inconsequential to the conservation of the species, which can also make better use of our limited personnel and fiscal resources and reduce regulatory burden. In some cases, we anticipate that we will continue to propose and finalize species-specific rules. However, in other situations, we may find that the suite of protections and exceptions outlined in this proposed rule for threatened species is appropriate. Given this desire to maintain flexibility to do what is best to conserve threatened species, our current preferred approach is to again make the “blanket rule” option available to apply to newly listed threatened species unless we develop and publish species-specific rules.

The proposed revisions to 50 CFR 17.31(a) and 17.71(a) in the rule portion of this document include all protections and exceptions for threatened wildlife and plant species and an explanation that these provisions apply unless we develop a species-specific rule for that species. When we find that the suite of protections and exceptions at proposed §§ 17.31(a) or 17.71(a) is appropriate for a given species, we would state so in the preamble of the proposed and final rule listing a species as threatened, and we would not develop any additional regulatory text that would appear as a species-specific rule ( e.g., at 50 CFR 17.40 through 17.48). This approach would result in less confusion, less duplication of regulatory text in the Code of Federal Regulations, a lower risk of error in transposing regulatory text, and reduced administrative costs associated with developing and publishing a rule in the Federal Register and Code of Federal Regulations.

The statute does not require us to make a finding that our decision to apply, or not to apply, specific section 9 prohibitions to a threatened species is necessary and advisable to provide for the conservation of the species ( In re: Polar Bear Endangered Species Act Listing and 4(d) Rule Litigation, 818 F. Supp. 2d 214, 228 (D.D.C. 2011) (citing Sweet Home Chapter of Cmtys. for a Great Or. v. Babbitt, 1 F.3d 1, 8 (D.C. Cir. 1993), rev'd on other grounds, 515 U.S. 687 (1995)). Nevertheless, to be as transparent as possible, we explain below why applying our regulatory text at proposed §§ 17.31(a) and 17.71(a) is, as a whole, necessary and advisable to provide for the conservation of threatened species unless a species-specific rule is developed (see the section below titled Necessary and Advisable Determination ). Similarly, in circumstances in which we develop a species-specific rule, we will explain why the species-specific rule, as a whole, satisfies the requirement in section 4(d) of the Act to issue regulations deemed necessary and advisable to provide for the conservation of that species. Further, when we develop species-specific rules, the explanation must stand on its own based on the information that we have on that particular species and our understanding of its threats; therefore, for newly listed threatened species, we will not compare or contrast the protections at §§ 17.31(a) or 17.71(a) with any of the individual proposed species-specific protective regulations. If this proposal is finalized, the final regulations will not require the reevaluation of any prior species-specific rules or prior use of §§ 17.31(a) or 17.71(a) for species without species-specific rules. All of the proposed relevant regulatory changes, if finalized, would apply to future actions that may impact threatened species.

In our August 27, 2019, final rule revising the “blanket rules” (84 FR 44753), we explained that going forward we would promulgate species-specific rules for particular species, which is the process NMFS uses. As discussed above, we have reconsidered that approach during our review of our 2019 4(d) rule in accordance with E.O. 13990. We now find our prior approach of having the option of the “blanket rule” is preferable. We recognize that after reinstatement of the general application of the “blanket rule” option with the continued option to craft species-specific rules, our approach to implementing section 4(d) of the Act will again differ from NMFS' approach. However, many efficiencies can be gained through invoking the “blanket rules” as opposed to promulgating species-specific rules in all instances, and this is particularly important based upon the sheer number of species we have listed as threatened species as compared to NMFS. Given that our agencies applied these different approaches for over 40 years, and we do not have any evidence to suggest there was confusion resulting from this difference, we do not find a risk of increased confusion of reverting to these differing approaches.

In addition, having an approach that differs from NMFS' approach does not mean that either one is unreasonable. Each agency makes policy choices that best further the purposes of the Act for the species within its jurisdiction. As we have stated before ( i.e., 87 FR 43433, July 21, 2022), in some situations it may make sense for the Service and NMFS to apply their own regulations for implementing the Act. We conclude that this is one of those situations.

We propose revisions to 50 CFR 17.31 and 17.71 to extend to federally recognized Tribes the ability currently afforded to the Service and other Federal and State agencies to aid, salvage, or dispose of threatened species. The longstanding policy of the Department of the Interior (DOI) has been to carry out responsibilities under the Act and other statutes in harmony with the Federal trust responsibility to Tribes and to strive to ensure that Indian Tribes do not bear a disproportionate burden for the conservation of listed species (DOI S.O. 3206 1997). Because of the unique government-to-government relationship between Indian Tribes and the United States, DOI prioritizes effective working relationships and mutual partnerships to promote the conservation of sensitive species (including candidates, species proposed for listing, and listed species) and the health of ecosystems upon which they depend. The proposed changes to the threatened species protective regulations are a recognition that Tribes are governmental sovereigns with inherent powers to make and enforce laws, administer justice, and manage and control their natural resources. Further, S.O. 3206 envisioned that, when the Service exercises regulatory authority for threatened species under section 4(d) of the Act, we would strive to avoid or minimize effects on Tribal management or economic development, or the exercise of reserved Indian fishing, hunting, gathering, or other rights, to the maximum extent allowed by law.

In addition to the DOI-specific guidance on coordination with the Tribes, a number of recent memoranda and Executive orders describe the commitment of the U.S. Government to strengthening the relationship between the Federal Government and Tribal Nations and to advance equity for Indigenous people, including Native Americans, Alaska Natives, Native Hawaiians, and Indigenous peoples of the U.S. Territories. These include the Memorandum on Tribal Consultation and Strengthening Nation-to-Nation Relationships (86 FR 7491, Jan. 29, 2021); Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (86 FR 7009, Jan. 25, 2021); Executive Order 14031: Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders (86 FR 29675, June 3, 2021); and Memorandum on Indigenous Traditional Ecological Knowledge and Federal Decision Making (Nov. 15, 2021). The commitments described in these recent Executive orders and memoranda include ensuring that Federal agencies conduct regular, meaningful, and robust consultation with Tribal officials in the development of Federal research, policies, and decisions, especially decisions that may affect Tribal Nations and the people they represent. Specifically, the November 15, 2021, memorandum on Indigenous knowledge states that Tribes and Indigenous peoples have unique knowledge and information that should be recognized in the Federal decision-making process. The proposed revisions to the threatened species regulations recognize the merit of allowing any employee or agent of a federally recognized Tribe, who is designated by the Tribe for such purpose, to be able to aid injured or diseased wildlife or plants or dispose of dead individuals without permits. We consider the failure to extend this exception to federally recognized Tribes in the past to be an error of omission rather than commission and that, consistent with various Executive orders, Secretary's orders, and memoranda, we are now proposing to extend this exception to Tribes in recognition of their authority and expertise in managing natural resources on Tribal lands.

In addition to the proposed revisions above, we are also proposing revisions in 50 CFR 17.21, 17.31, 17.61, and 17.71. These proposed changes are intended to improve readability, increase consistency among sections, provide alignment with the Act, and correct other inaccuracies.

We propose updating our endangered plant regulations at 50 CFR 17.61(c)(1) to match amendments to the Act that Congress enacted in 1988 (16 U.S.C. 1538(a)(2)(B); Act section 9(a)(2)(B), Pub. L. 100-478 (Oct. 7, 1988)). The House Report at the time concluded that the amendments were necessary because, without them, “anyone [could] pick, dig up, cut or destroy an endangered plant with impunity” unless it was committed on an area under Federal jurisdiction and removed from that area (H. Rept. No. 100-467 (Dec. 7, 1987)). To ensure that the regulations conform to the statutory language regarding prohibitions for endangered plants, we are proposing to add a provision that also makes it unlawful to: (a) “maliciously damage or destroy” an endangered plant species on an area under Federal jurisdiction; or (b) “remove, cut, dig up, or damage or destroy” an endangered plant species on any area that is not under Federal jurisdiction in knowing violation of a State law or regulation or in the course of violating a State criminal trespass law.

We also propose language at §§ 17.31(c) and 17.71(c) to make it clear that the provisions that allow the Service to issue permits for certain activities that are otherwise prohibited (§§ 17.32 and 17.72), as well as the provisions that provide exceptions for certain individuals to aid, salvage, or dispose of threatened species and to take threatened species in the course of carrying out conservation programs for listed species (§§ 17.31(b) and 17.71(b)), always apply to threatened species, unless specifically prohibited in a species-specific rule. We have always intended for these provisions to apply to threatened species as appropriate and did not intend to require every species-specific rule to spell out these provisions. We anticipate these provisions would generally be similar or identical for most species, so applying these provisions unless a species-specific rule provides otherwise would likely avoid substantial duplication.

We also propose modifications to these sections to state clearly that the species-specific rule will include all applicable prohibitions and “any additional” exceptions to highlight that these exceptions always apply unless otherwise specified. We propose similar revisions at § 17.72 to clearly state that the permitting provisions for threatened plant species apply unless expressly prohibited in a species-specific rule. This provision was already clear at § 17.32 for threatened species of wildlife; therefore, this proposed change would align our approach for plants with the provision for wildlife.

We also propose minor edits ( e.g., to correct errors in citations and addresses) in 50 CFR 17.21, 17.31, 17.61, and 17.71. For example, we propose to update prohibitions and exceptions regarding take of federally listed migratory birds to align the 50 CFR part 17 regulations with changes previously made at 50 CFR part 21. We also propose edits to clarify that take of a threatened species is excepted for the Service and NMFS independent of the section 6 provision. To provide greater clarity and specificity, we also propose replacing the phrase “special rule” with “species-specific rule” in several locations in 50 CFR part 17.

Section 4(d) provides two separate authorities. First, the Secretary “shall” issue whatever regulations they deem necessary and advisable for the conservation of any threatened species. Second, the Secretary “may” choose to prohibit for a threatened species any of the activities that section 9 prohibits for endangered species.

The first sentence has two components: a requirement (to issue regulations for threatened species, if there are any that meet the standard) and a standard (that the regulations be necessary and advisable to provide for the conservation of the species). Thus, we must determine what regulations, if any, are necessary and advisable to provide for the conservation of the species, and if so, promulgate them. We interpret the statutory language (“necessary and advisable to provide for the conservation of the species”) to focus the standard for 4(d) rules on providing for the conservation of the species. Therefore, within that context we have interpreted the “necessary and advisable” language to establish a single standard, and we do not attempt to evaluate or make independent findings as to whether a 4(d) rule is separately “necessary” and “advisable.” This interpretation was upheld by the court in In re Polar Bear Endangered Species Act Listing and §  4(d) Rule Litigation, 818 F. Supp. 2d 214, 234 (D.D.C. 2011) (referring to “Congress's broad delegation of authority to the Secretary to determine what measures are necessary and advisable to provide for the conservation of threatened species”). If this proposal is finalized, for threatened species that use the blanket rules found at 50 CFR 17.31(a) and 17.71(a), we will not make necessary and advisable determinations for the use of those blanket rules in future proposed or final listing rules. Rather, we explain here why use of the blanket rules is necessary and advisable to provide for the conservation of threatened species unless we have issued a species-specific rule for a given species (for species-specific rules, we will continue to include the rationale for why as a whole it is necessary and advisable to provide for the conservation of the species that is the subject of the rule, as has been our past practice).

The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act provides a specific list of prohibitions for endangered species under section 9, but the Act does not provide these same prohibitions to threatened species. Therefore, when we conduct a rulemaking action to list a species as threatened, we recognize that the species is likely within the foreseeable future to become at risk of extinction, and we will either promulgate a species-specific rule to establish regulations to provide for the conservation of the species or the species will be afforded protections under the “blanket rules” at §§ 17.31(a) or 17.71(a), as was the case for species listed prior to September 26, 2019.

The second source of authority in section 4(d) states that the Secretary may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1), in the case of fish or wildlife, or 9(a)(2), in the case of plants. The use of the word “may,” along with the absence of any specific standards, in the second sentence grants us particularly broad discretion to put in place for threatened species any of the prohibitions that section 9 contains for endangered wildlife and plants. These prohibitions make it illegal for any person subject to the jurisdiction of the United States to engage in the following actions:

• With respect to endangered wildlife—take such a species within the United States or on the high seas; or possess, sell, deliver, carry, transport, or ship any such species that has been taken illegally;

• With respect to endangered plants—remove and reduce to possession, or maliciously damage or destroy, any such plants from areas under Federal jurisdiction; or remove, cut, dig up, or damage or destroy such plants on any other area in knowing violation of any State law or regulation in the course of violating any State criminal trespass law; or

• With respect to endangered fish or wildlife or plants—import or export any such species; deliver, receive, carry, transport, or ship any such species in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any such species (sections 9(a)(1) and 9(a)(2) of the Act; 50 CFR 17.21 and 17.61).

The statute does not require us to make a finding that our decision to apply, or not to apply, specific section 9 prohibitions to a threatened species is necessary and advisable to provide for the conservation of the species. However, we think it is most transparent if in this proposed rule we describe our rationale for why the regulatory texts that we are proposing at §§ 17.31(a) and 17.71(a) (“blanket rules”) are, as a whole, necessary and advisable to provide for the conservation of threatened species.

For all the reasons we described in this and the previous sections above, we propose to find, even though we are not required to do so, that the blanket rules are necessary and advisable to apply to a threatened species unless we issue a species-specific rule for that species. Section 4(d) of the Act indicates that the Secretary may by regulation prohibit acts under section 9, and we have concluded that applying those prohibitions immediately upon the listing of threatened species in many circumstances will similarly help prevent further declines of the species and further the conservation purposes of the Act. In addition, we often lack a complete understanding of the cause of a species' decline, and affording a threatened species protections that are similar to the protections for an endangered species follows basic conservation principles to attempt to prevent further declines of the species. We have also found that it is easier to explain and comprehend most species' protective regulations for purposes of implementation and enforcement if they are modeled after the section 9 prohibitions—with which agency staff and the public are widely familiar. Providing all of the common exceptions to threatened species afforded protections under a “blanket rule” also helps to conserve the species by incentivizing conservation through reducing unneeded permitting ( e.g., to allow take associated with aiding injured wildlife).

Pursuant to section 10(j) of the Act, members of experimental populations are generally treated as threatened species; and pursuant to 50 CFR 17.81, experimental populations are designated through population-specific regulations found in §§ 17.84 through 17.86. Under our existing practice, each population-specific regulation contains all of the applicable prohibitions, along with any exceptions to prohibitions, for that experimental population. All of the relevant changes associated with this proposed rulemaking would similarly change existing species-specific rules for experimental populations that include references to 50 CFR 17.21, 17.31, 17.61, or 17.71.

In addition to the proposed regulatory revisions described above, we are also considering including an additional provision in §§ 17.31(b) and 17.71(b) that would extend exceptions to the prohibitions to certain individuals from federally recognized Tribes for take associated with conservation-related activities. These exceptions to prohibitions for threatened species are already afforded to employees or agents of the Service, NMFS, States, and other agencies. Adding this exception to the general prohibitions for threatened species may be appropriate and would better align with our longstanding policy because it would demonstrate DOI and Service recognition of federally recognized Tribes as discussed above (see the section above titled New Exceptions for Tribes ). This potential change would recognize the management efforts and expertise, including Indigenous Knowledge, that federally recognized Tribes bring to conservation of threatened species.

Therefore, we are soliciting comments on the following additional text that we are considering for inclusion in § 17.31(b): “Notwithstanding § 17.21(c)(1) and unless otherwise specified, any employee or agent of the Service or NMFS, of a federally recognized Tribe's natural resource agency undertaking conservation activities in accordance with an approved cooperative agreement with the Service that covers that threatened species of wildlife, or of a State conservation agency that is operating a conservation program pursuant to the terms of an approved cooperative agreement with the Service that covers the threatened species of wildlife in accordance with section 6(c) of the Act, who is designated by their agency for such purposes, may, when acting in the course of their official duties, take those species.”

We are also soliciting comments on the following additional text that we are considering for inclusion in § 17.71(b): “Notwithstanding § 17.61(c)(1) and unless otherwise specified, any employee or agent of the Service, of a federally recognized Tribe's natural resource agency undertaking conservation activities in accordance with an approved cooperative agreement with the Service that covers the threatened species of plant, or of a State conservation agency that is operating a conservation program pursuant to the terms of an approved cooperative agreement that covers the threatened species of plant with the Service in accordance with section 6(c) of the Act, who is designated by that agency for such purposes, may, when acting in the course of official duties, remove and reduce to possession from areas under Federal jurisdiction those species.”

These potential regulatory changes would allow Tribes to conduct conservation-related activities without a permit under the Act but would not remove any requirements for Tribes to receive any other applicable authorizations from the appropriate Federal land manager ( e.g., U.S. Forest Service special-use permits) or permits from a State natural resource agency for situations in which the activity occurs outside of lands owned and managed by the Tribe. In addition, if we finalize regulations with the exceptions set forth above, nothing would require Tribes to change their past practices for compliance with the Act.

We request information and comments from Tribes and other members of the public on the following issues:

• The current regulatory burden to federally recognized Tribes to apply for and receive permits for conservation actions for threatened species and the extent to which extending this exception to federally recognized Tribes would alleviate that burden.

• Whether federally recognized Tribes would view this type of exception as helpful or desirable.

• Whether the inclusion of this exception in “blanket rules” is consistent with the conservation purposes of the Act.

• Whether we should require cooperative agreements with federally recognized Tribes to provide the exception for conservation-related activities and how we should determine the scope of such exceptions.

• Whether the phrase “employee or agent” of a Tribe's “natural resource agency” is the best way to describe the organizational or functional role of individuals who would be designated by a federally recognized Tribe for conservation purposes.

• Whether this change that we are considering would have a significant effect on the human environment.

Based upon the comments we receive, we may finalize the language exactly as written above, we may finalize a revised version of the language under consideration, or we may decide not to finalize this provision.

We are seeking comments from all interested parties on the specific revisions we are proposing or considering, including on whether reinstating the “blanket rules” as a whole with the additional exception we are considering for federally recognized Tribes, is necessary and advisable to provide for the conservation of threatened species, as well as on any of our analyses or preliminary conclusions in the Required Determinations section of this document. We will consider all relevant information prior to issuing a final rule. Depending on the comments received, we may change the proposed regulations based upon those comments.

You may submit your comments concerning this proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES . Comments sent by any other method, to any other address or individual, may not be considered. Comments must be submitted to https://www.regulations.gov before 11:59 p.m. (eastern time) on the date specified in DATES . We will not consider hand-delivered comments that we do not receive by, or mailed comments that are not postmarked by, the date specified in DATES .

Comments and materials we receive will be posted and available for public inspection on https://www.regulations.gov. This generally means that we will post any personal information you provide us. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

Regulatory Planning and Review—Executive Orders 12866, E.O. 13563, and 14094

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this proposed rule is significant.

Executive Order 14094 amends E.O. 12866 and reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and be consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements. This proposed rule is consistent with E.O. 13563, including with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

We are proposing revisions to portions of the implementing regulations at 50 CFR part 17. The preamble to this proposed rule details how the regulatory changes we are proposing will improve the implementation of the Act.

The proposed revisions to 50 CFR 17.31 and 17.71 reinstate the general application of the “blanket rule” option for protecting newly listed threatened wildlife and plant species, respectively, pursuant to section 4(d) of the Act. The proposal retains the continued option to promulgate species-specific rules.

When we removed the “blanket rule” options in 2019, we compiled certain historical data regarding the numbers of threatened wildlife and plant species that the Service listed and the number of species-specific rules that we had adopted each year between 1997 and 2018 (the analysis timeframe) in an effort to describe for OMB and the public the potential effects of those regulations (on https://www.regulations.gov, see Supporting Document No. FWS-HQ-ES-2018-0007-69539 of Docket No. FWS-HQ-ES-2018-0007).

If we reinstate the “blanket rules,” we anticipate that in some cases we will continue to propose and finalize species-specific rules that are designed to meet the specific conservation needs of species. However, in other situations, we may find that the standard suite of protections and exceptions for threatened species in the blanket rule is appropriate. Because the blanket rule option had been available for over 40 years prior to the 2019 4(d) rule, we do not anticipate any material effects to the process or outcomes as a result of this proposed change. However, because protections and exceptions for threatened species are so highly fact-specific, it is not possible to specify future benefits or costs stemming from the proposed revisions. The updates we are proposing to the endangered plant regulations at 50 CFR 17.61(c)(1) to match amendments to the Act that Congress enacted in 1988 (16 U.S.C. 1538(a)(2)(B); Act section 9(a)(2)(B), Public Law 100-478 (Oct. 7, 1988)) and other minor edits, also referred to as technical corrections ( e.g., in 50 CFR 17.8, 17.21, 17.31, 17.61, and 17.71) will improve readability, increase consistency among sections, provide alignment with the Act, and correct other inaccuracies and will not materially change the protections provided to threatened or endangered species or their effects on any potentially regulated entities.

We are also proposing revisions to 50 CFR 17.31 and 17.71 to extend to federally recognized Tribes the exceptions to prohibitions for threatened species that the regulations currently provide to the Service and other Federal and State agencies to aid, salvage, or dispose of threatened species. These proposed revisions would reduce the regulatory burden or potential legal risks on Tribes associated with conducting these activities. There may also be cost savings for the Service for reduced permit application processing. We cannot specify the extent to which there may be reduced costs to Tribes associated with permit applications or risk of law enforcement action, as we cannot predict which species may be listed as threatened species, and of those species, which may occur in areas in which federally recognized Tribes may conduct these actions.

The proposed revisions would further the effectiveness of the Service's program to carry out the statutory mandates for conserving threatened species. There are no identifiable quantifiable effects from the proposed rule. There may be reduced administrative costs for federally recognized Tribes or the Service associated with a potential reduction in permitting. We do not anticipate any material effects such that the rule would have an annual effect that would reach or exceed $200 million or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or that person's designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that, if adopted as proposed, this proposed rule would not have a significant economic impact on a substantial number of small entities. The following discussion explains our rationale.

This rulemaking proposes to revise the Service's regulations protecting endangered and threatened species under the Act. The changes in this proposed rule are instructive regulations and do not directly affect small entities.

Since the only potential entities directly affected by this proposed regulation change are not small entities, including any small businesses, small organizations, or small governments, we certify that, if adopted as proposed, this rule would not have a significant economic effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ): (a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this proposed rule would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A small government agency plan is not required. As explained above, small governments would not be affected because the proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or Tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or Tribal governments.

In accordance with E.O. 12630, this proposed rule would not have significant takings implications. This proposed rule would not directly affect private property, nor would it cause a physical or regulatory taking. It would not result in a physical taking because it would not effectively compel a property owner to suffer a physical invasion of property. Further, the proposed rule would not result in a regulatory taking because it would not deny all economically beneficial or productive use of the land or aquatic resources and it would substantially advance a legitimate government interest (conservation and recovery of endangered species and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with E.O. 13132, we have considered whether this proposed rule would have significant federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to the Service's protective regulations for endangered and threatened species promulgated under the Act and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of E.O. 12988. This proposed rule would revise the Service's regulations for protecting species pursuant to the Act.

In accordance with E.O. 13175, “Consultation and Coordination with Indian Tribal Governments,” and the Department of the Interior's manual at 512 DM 2, we are considering possible effects of this proposed rule on federally recognized Indian Tribes. The Service has reached a preliminary conclusion that the changes to these implementing regulations do not directly affect specific species or Tribal lands. This proposed rule would revise regulations for protecting endangered and threatened species pursuant to the Act. The only provision in these proposed regulations that could appear to have an effect on Tribes is the exception to aid, salvage, or dispose of threatened species. However, the inclusion of this exception does not require any Tribe to do anything or change their management practices. Further, we are not changing the relationship between the Service and Tribes. The proposed provision simply provides a new mechanism for compliance with the Act. These proposed regulations would not have substantial direct effects 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.

We are considering the possible effects of this proposed rule on federally recognized Indian Tribes. We will continue to collaborate with Tribes on issues related to federally listed species and their habitats and work with them as we implement the provisions of the Act. See Secretaries' Order 3206, “American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act” (June 5, 1997).

This proposed rule does not contain any new collection of information that requires approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (45 U.S.C. 3501 et seq. ). OMB has previously approved the information collection requirements associated with permitting and reporting requirements and assigned OMB Control Number 1018-0094 (expires 01/31/2024). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We are analyzing this proposed rule in accordance with the criteria of the NEPA (42 U.S.C. 4321 et seq. ), the Department of the Interior regulations on Implementation of the National Environmental Policy Act (43 CFR 46.10-46.450), and the Department of the Interior Manual (516 DM 8). We invite the public to comment on the extent to which this proposed rule may have a significant impact on the human environment or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment that would require further analysis under NEPA. We will complete our analysis, in compliance with NEPA, before finalizing these proposed regulations.

In developing this proposed rule, the Service is acting in our unique statutory role as administrator of the Act and is engaged in a legal exercise of interpreting the standards of the Act. The Service's promulgation of interpretive rules that govern our implementation of the Act is not an action that is in itself subject to the Act's provisions, including section 7(a)(2). The Service has a historical practice of issuing our general implementing regulations under the Act without undertaking section 7 consultation. Given the plain language, structure, and purposes of the Act, we find that Congress never intended to place a consultation obligation on the Service's promulgation of implementing regulations under the Act. In contrast to actions in which we have acted principally as an “action agency” in implementing the Act to propose or take a specific action ( e.g., issuance of section 10 permits and actions under statutory authorities other than the Act), here, the Service is carrying out an action that is at the very core of our unique statutory role as administrator—promulgating general implementing regulations interpreting the terms and standards of the statute.

As stated above, some of the proposed regulatory changes would result in minor changes to protections for currently listed threatened species that were protected under prior versions of the “blanket rules” or under a species-specific rule. To the extent that section 7 may apply to any of these proposed changes, we will undertake any section 7 analysis as appropriate before finalizing these changes.

Executive Order 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. The proposed revised regulations are not expected to affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no statement of energy effects is required.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you believe that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you believe are unclearly written, identify any sections or sentences that you believe are too long, and identify the sections where you believe lists or tables would be useful.

We issue this rule under the authority of the Endangered Species Act, as amended (16 U.S.C. 1531 et seq. ).

Accordingly, we hereby propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

The purposes of the Endangered Species Act of 1973, as amended (“ESA” or “Act”; 16 U.S.C. 1531 et seq. ) are to provide a means to conserve the ecosystems upon which listed species depend, to develop a program for the conservation of listed species, and to achieve the purposes of certain treaties and conventions. Moreover, the Act states that it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species and use its authorities in furtherance of the purposes of the Act. The Secretaries of the Interior and Commerce share responsibilities for implementing most of the provisions of the Act. Generally, marine species and some anadromous (sea-run) species are under the jurisdiction of the Secretary of Commerce, and all other species are under the jurisdiction of the Secretary of the Interior. Authority to administer the Act has been delegated by the Secretary of the Interior to the Director of the U.S. Fish and Wildlife Service (FWS) and by the Secretary of Commerce to the Assistant Administrator for the National Marine Fisheries Service (NMFS). References in this document to “the Services” mean FWS and NMFS.

Title 50, part 402, of the Code of Federal Regulations establishes the procedural regulations governing interagency cooperation under section 7 of the Act, which requires Federal agencies, in consultation with and with the assistance of the Secretaries of the Interior and Commerce, to insure that any action authorized, funded, or carried out by such agencies is not likely to jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of critical habitat of such species. In 2019, the Services issued a final rule that revised several aspects of the regulations to clarify and improve the consultation process (84 FR 44976, August 27, 2019; hereafter referred to as “the 2019 rule”). Those revised regulations became effective October 28, 2019 (84 FR 50333).

Executive Order 13990 (“Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis”), issued January 20, 2021, directed all departments and agencies immediately to review agency actions taken between January 20, 2017, and January 20, 2021, and, as appropriate and consistent with applicable law, consider suspending, revising, or rescinding agency actions that conflict with important national objectives, including promoting and protecting our public health and the environment, and to immediately commence work to confront the climate crisis. A “Fact Sheet” that accompanied E.O. 13990 identified a non-exhaustive list of particular regulations requiring such a review and included the 2019 rule (see www.whitehouse.gov/briefing-room/statementsreleases/2021/01/20/fact-sheet-list-of-agency-actions-for-review/ ). In response to E.O. 13990 and in light of recent litigation over the 2019 rule, the Services have reviewed the 2019 rule, evaluated the specific regulatory revisions promulgated through that process, and now propose to make revisions to the regulations at 50 CFR part 402, as discussed in detail below.

The 2019 rule, along with other revisions to the ESA regulations finalized in 2019, were subject to litigation in the United States District Court for the Northern District of California. On July 5, 2022, the court issued a decision vacating the 2019 rule, while remanding the rule to the Services without reaching the merits of the case. On September 21, 2022, the United States Court of Appeals for the Ninth Circuit temporarily stayed the effect of the July 5th decision pending the District Court's resolution of motions seeking to alter or amend that decision. On October 14, 2022, the Services notified the District Court that we anticipated proceeding with a rulemaking process to revise the 2019 rule. Subsequently, on November 14 and 16, 2022, the District Court issued orders remanding the 2019 regulations to the Services without vacating them, as the Services had asked the Court to do. Accordingly, the Services have developed the following proposal to amend some aspects of the 2019 rule.

Our review of the 2019 rule indicated that, while most of the changes finalized in that rule met the intent of clarifying and improving the consultation process, certain revisions would be beneficial to further improve and clarify interagency consultation, while continuing to provide for the conservation of listed species.

This proposed rule is one of three proposed rules publishing in today's Federal Register that propose changes to the regulations that implement the ESA. Two of these proposed rules, including this one, are joint between the Services, and one proposed rule is specific to the FWS.

In proposing the specific changes to the regulations and setting out the accompanying explanatory discussion in this preamble, the Services are proposing standards that, if finalized, would apply prospectively. Thus, nothing would require that any previous consultations under section 7(a)(2) of the Act be reevaluated on the basis of these proposed revisions, in the event they are finalized.

In the 2019 rule, we revised the definition of “effects of the action” at 50 CFR 402.02. The 2019 definition revised the prior definition that had been in place since 1986 in six main respects.

First, we collapsed the various concepts of direct and indirect effects, and the effects of interrelated and interdependent actions, into a first sentence that indicates effects of the action are all consequences to the listed species and critical habitat caused by the proposed action. The first sentence of the revised definition stated that these consequences include “the effects of other activities that are caused by the proposed action.” It included a distinction between the word “action,” which referred to the action proposed to be authorized, funded, or carried out, in whole or in part, by the Federal agency and brought in for consultation with the Services, and “activity” or “activities,” which referred to those activities that are caused by the proposed action but are not part of the proposed action. Under the pre-2019 definition, these activities would have been considered under either “indirect effects” or “interrelated” or “interdependent” activities. The Services' intent with the first sentence of the 2019 definition was for consultations to focus on identifying the full range of the effects rather than on categorizing them (84 FR 44976-44977, August 27, 2019; 83 FR 35178 at 35183, July 25, 2018).

Second, we adopted an explicit two-part test to determine when a consequence is caused by the proposed action. A consequence (an effect or an activity and its effects) is caused by the proposed action if it would not occur but for the proposed action, and it is reasonably certain to occur. Both of these concepts (“but-for” causation and “reasonably certain to occur”) have long been part of the Services' query into identifying the effects of the action. By making them explicit and applicable to all aspects of the causation standard, the Services' goal was to describe a transparent standard that simplified the definition of “effects of the action,” while still maintaining the scope of the assessment required to ensure a complete analysis of the effects of proposed actions.

Third, the Services removed the definition of “environmental baseline” from the definition of “effects of the action” and established it as its own stand-alone definition. Fourth, the Services moved the instruction that the effects of the proposed action shall be added to the environmental baseline into the regulations guiding the Services' responsibilities in formal consultation in § 402.14(g). Fifth, consistent with the prior definition of “indirect effects,” the Services included a third sentence in the “effects of the action” definition to serve as a reminder that the effects of the action may occur throughout the action area and on an ongoing, or even delayed, timeframe after completion of the action. And, finally, the Services added a parenthetical reference to § 402.17, a new section that further defined the concept of “reasonably certain to occur.”

While the 2019 changes to the definition of “effects of the action” have largely provided the clarity to the consultation process that the Services intended by articulating in more detail the standards that had been used for many decades in implementing section 7 of the Act, some revisions to the definition of “effects of the action” are warranted to align with other changes we are proposing. As described in more detail below, we propose to remove § 402.17 from the regulations, and, therefore, we propose a conforming change to remove the parenthetical reference to that section in the “effects of the action” definition. Due to our intent to maintain the scope of the analysis of effects of the action, we propose to move the phrase “but that are not part of the action” from § 402.17 to the end of the first sentence of the definition of “effects of the action” in § 402.02. The modified definition is set forth below in the proposed regulatory text section of this document.

As discussed above, the reference to “activities” in the first sentence of the 2019 “effects of the action” definition is to those activities that are caused by, but that are not part of, the proposed action. Because this concept is important, we are proposing to retain the concept by adding the text to the definition of the “effects of the action.” As the Services explained in 2019, the proposed action receives a presumption that it will occur ( e.g., 84 FR 44976 at 44979, August 27, 2019). For this reason, it would not be appropriate to apply the two-part causation test to the proposed action itself, especially the concept of reasonably certain to occur. However, activities that may be caused by the proposed action, but that are not part of the proposed action, are subject to the two-part causation test.

We are proposing minor, clarifying edits to the definition of “environmental baseline.” In 2019, we removed the definition of environmental baseline from the definition of “effects of the action” and established it as its own stand-alone definition at 50 CFR 402.02. At that time, we also added a third sentence to the definition that stated that the consequences to listed species or designated critical habitat from ongoing agency activities or existing agency facilities that are not within the agency's discretion to modify are part of the environmental baseline. The purpose of the third sentence was to codify the Services' past practice and explain aspects of the environmental baseline and effects of the action definitions that had caused confusion in the past, particularly with regard to impacts from a Federal action agency's ongoing activities or existing facilities that are not within that Federal agency's discretion to modify. We are proposing three changes to this sentence.

The first change we are proposing is to replace the term “consequences” with the word “impacts” at the start of the third sentence of the definition of “environmental baseline.” While we consider “consequences,” “impacts,” and “effects” to be equivalent terms, we propose this modification to be consistent with the language in the previous sentence. Because ongoing agency activities or existing agency facilities that are not within the agency's discretion to modify belong in the baseline and not the proposed action, we propose to consistently use the term “impacts” throughout the definition for items that belong in the environmental baseline while retaining the use of the term “consequences” in the first sentence for effects that are caused by the proposed action and not included in the environmental baseline.

The second and third changes we are proposing are to revise the third sentence of the definition of “environmental baseline” to remove the term “ongoing” and add the term “Federal” in two locations. These changes are intended to emphasize the central question of the Federal agency's discretion over their own activities and facilities in determining what is properly categorized as falling within the environmental baseline. Further, the use of the term “ongoing” has resulted in misinterpretation and distracted from the intended focus on Federal agency discretion.

The Services' 2019 revised definition did not articulate as clearly as it could have that the action agency's discretion to modify the activity or facility is the determining factor when deciding which impacts of an action agency's activity or facility should be included in the environmental baseline, as opposed to the effects of the action. We did not sufficiently emphasize that when the Services referred to an “agency” in that third sentence, we were referring to the Federal agency taking the action that is subject to the ESA section 7 consultation. Here, when we refer to an “agency,” “action agency,” or “Federal agency,” it is in reference to the Federal agency that has proposed the action undergoing section 7 consultation. Consistent with § 402.03, the obligation of a Federal agency to consult on a Federal action pursuant to section 7 and the requirements of the part 402 regulations apply to all actions in which there is discretionary Federal involvement or control. Therefore, those components of Federal activities or Federal facilities that are not within the discretionary control of the Federal agency are not subject to the requirement to consult, and as a result, the impacts of those non-discretionary activities and facilities to listed species and critical habitat are not a consequence of a proposed discretionary Federal action.

Although we are proposing to further modify the 2019 rule's definition of “environmental baseline” for clarity, the practice of the Services and our application of the definition in consultations will not change. Thus, the information and examples provided in the 2019 rule's preamble (84 FR 44976 at 44978-44979, August 27, 2019) remain relevant. As discussed in the 2019 rule's preamble, the Services' practice of including in the baseline the impacts from Federal agency activities or existing Federal agency facilities that are not within the Federal agency's discretion to modify is supported by the Supreme Court's conclusion in National Ass'n of Home Builders v. Defenders of Wildlife, 551 U.S. 644, 667-71 (U.S. 2007) (“Home Builders”). In that case, the Court held that it was reasonable for the Services to narrow the application of section 7 to a Federal agency's discretionary actions because “(t)he regulation's focus on `discretionary' actions accords with the commonsense conclusion that, when an agency is required to do something by statute, it simply lacks the power to `insure' that such action will not jeopardize endangered species.” Id. It follows, then, that when a Federal agency has authority for managing or operating an existing facility, but lacks discretion to remove or fundamentally alter the physical structure of the facility, the impacts from the physical presence of the facility on the landscape to listed species and critical habitat are appropriately placed in the environmental baseline and are not considered an effect of the action under consultation.

To illustrate the interplay between a Federal agency's non-discretionary facility and its discretionary operations, consider an example where, prior to the passage of the ESA, Congress authorized a Federal agency to construct and operate a dam and provided the Federal agency with discretion to operate the dam for various purposes including fish and wildlife management but provided the Federal agency with no discretion to remove or fundamentally alter the structure of the dam in the future. If a species was subsequently listed after the passage of the ESA, the Federal agency would have a duty to consult on their continued discretionary operations of the dam, but the existence of the dam itself and its future impacts to the listed species would be considered part of the environmental baseline (along with the past and present impacts of dam operations up to the time of consultation). If the existence of this dam kills 100 individuals of the listed species per year, consultations on the discretionary operations of the dam would consider the consequences of the discretionary operations in addition to the baseline loss of 100 individuals per year, every year, for the duration of the consultation analysis. Further, future consequences of the entire discretionary operation would be evaluated as effects of the proposed action even if the proposed action does not contemplate changes to some aspects of past discretionary practices or operations. For example, the Federal agency may propose to continue the operations of the dam's flow regime with no changes from past practices, or with only minor changes. Regardless of their “ongoing” nature, all of the consequences of the proposed discretionary operations of the structure are “effects of the action.” Thus, deletion of the term “ongoing” from the original third sentence remedies a misperception that anything that was a continuation of past and present discretionary practice or operation would be in the environmental baseline.

Similarly, the addition of the word “Federal” to agency activities or existing facilities in the third sentence emphasizes that the question of discretion for purposes of defining what is in the environmental baseline versus the effects of a proposed action is relevant to the Federal agency's own facilities and activities but not those of third parties. Thus, in the example above, if the Federal agency's discretionary operations of the dam result in recreational activities by third parties using the reservoir created behind the dam, then the future consequences of those activities caused by the proposed action would be considered effects of the action (not environmental baseline) even though the Federal agency may lack the discretion to control or regulate the recreational activities.

When questions arise as to whether the impacts from a particular Federal agency activity or facility are treated as part of the environmental baseline, the Services will work closely with the Federal agency to understand the scope of the Federal agency's authorities and discretion. As with other aspects of a package to initiate consultation, the Services often confer with the Federal agency to seek clarification on or additional support for the Federal agency's description of their governing authorities and scope of their discretion. When initiating consultation and in these discussions, we would expect the Federal agency to clearly identify and describe with sufficient detail the governing authorities that may constrain their discretion over some or all of the Federal agency activity or facility at issue. Absent unusual circumstances, the Services anticipate we would likely defer to the Federal action agency's interpretation of their authorities.

In the 2019 rule, we removed the term “formal” from the heading and text of § 402.16 to acknowledge that the requirement to reinitiate consultation applies to all section 7(a)(2) consultations (84 FR 44976 at 44980, August 27, 2019). We are proposing one change to the text of § 402.16(a) to clarify the responsibilities of the Federal agency and the Services regarding the requirement to reinitiate consultation.

The current text at § 402.16(a) states that reinitiation of consultation is required and shall be requested by the Federal agency or by the Service, where discretionary Federal involvement or control over the action has been retained or is authorized by law. We now propose to delete the words “or by the Service.”

The Services are aware that the wording of § 402.16(a) has often been misunderstood or misinterpreted in regard to whether the Federal action agency or the Services have the obligation to request reinitiation of consultation when one or more of the triggers has been met. In the 2019 rule, we stated clearly in the preamble that the Services do not have the authority to require reinitiation of a consultation when the requirements for reinitiation have been met. We explained that reference to the Service in that section does not impose an affirmative obligation on the Service to reinitiate consultation if the criteria have been met. Rather, this reference has always been interpreted by the Services to allow us to recommend reinitiation of consultation to the relevant Federal action agency if we have information that indicates reinitiation is warranted. It is ultimately the responsibility of the Federal action agency to request reinitiation of consultation with the relevant Service when warranted. See 84 FR 44976 at 44980, August 27, 2019.

The Services' attempt in the preamble of the 2019 rule to clarify the action agency's duty to reinitiate has not been sufficient to resolve this issue. See, e.g., Center for Biological Diversity v. U.S. Forest Service, CV-20-00020-TUC-DCB, 2020 WL 6710944 (D. Ariz. Nov. 16, 2020) (interpreting the language of the regulation to require that FWS had a duty to reinitiate consultation). As a result, we are proposing to remove the reference to the Service in § 402.16(a) to conform to our longstanding practice and understanding of the limits of our authority under the Act. Under the statutory scheme of section 7 of the ESA, the Services lack the authority to require either the initiation of consultation or reinitiation of a completed consultation. See 51 FR 19926 at 19956, June 3, 1986 (consulting agencies lack the authority to require Federal agencies to reinitiate consultation if they choose not to do so). The legislative history of the ESA similarly reflects that it is the action agency that bears any duty to reinitiate consultation. See H.R. Rep. No. 97-567, at 27 (1982) (“if the specified impact on the species is exceeded, the Committee expects that the Federal [action] agency or permittee or licensee will immediately reinitiate consultation”). Similarly, the Services' Consultation Handbook recognizes that the Services cannot “require Federal agencies to reinitiate consultation if they choose not to do so.” Consultation Handbook (FWS and NMFS, March 1998) at 2-11.

To attempt to reinitiate consultation unilaterally without a request for reinitiation and cooperation from the action agency is contrary to the fundamental nature of the consultation process under section 7—a provision that Congress entitled “interagency cooperation.” The responsibility and obligation to reinitiate that consultation lies with the Federal agency that retains discretionary involvement or control over its action. Our proposed alteration does not prevent the Services from notifying the Federal agency if we conclude that circumstances appear to warrant a reinitiation of consultation or engaging in a conversation with the Federal agency over that issue.

In the 2019 rule, we added a new section, § 402.17, “Other provisions,” which was intended to clarify several aspects of the process of determining whether an activity or consequence is reasonably certain to occur.

Within this new section, paragraph (a) pertained to activities that are reasonably certain to occur, in order to clarify the application of the “reasonably certain to occur” standard to activities included in the definitions of “effects of the action” and “cumulative effects” in § 402.02. This new provision applied only to activities caused by, but not part of, the proposed action captured in the definition of “effects of the action” and future non-Federal activities under “cumulative effects.” Consistent with the ESA, existing regulations, and agency practice, we noted that the reasonable certainty standard does not apply to whether aspects of the proposed action itself will be implemented, but again, only to the analysis of the effects caused by the action to the listed species and critical habitat. (See 83 FR 35178 at 35189, July 25, 2018; also 84 FR 44976 at 44977-44978, August 27, 2019.)

In the 2019 rule, we also added § 402.17(b) pertaining to consequences caused by the proposed action to emphasize other considerations when reviewing whether a consequence is not reasonably certain to occur. Similar to the provisions of § 402.17(a), § 402.17(b)(1) through (b)(3) identified a list of factors that could be relevant to this inquiry. We explained that those factors were not exhaustive, new, or more stringent factors than what we have used in the past to determine if a consequence would or would not occur (84 FR 44976 at 44981, August 27, 2019). They were not meant to imply that time, distance, or multiple steps inherently make a consequence not reasonably certain to occur, but that these are relevant considerations. See id.

We also explained that each consultation will have its own set of evaluations and will depend on the underlying factors unique to that consultation. We used the following example in the 2019 rule: A Federal agency is consulting on the permitting of installation of an outfall pipe. A secondary, connecting pipe owned by a third party is to be installed and would not occur “but for” the proposed outfall pipe, and existing plans for the connecting pipe make it reasonably certain to occur (84 FR 44976 at 44981, August 27, 2019). Under our 2019 definition for “effects of the action,” any consequences to listed species or critical habitat caused by the secondary pipe would be considered to fall within the effects of the agency action. However, we also recognized that there are situations, such as when consequences are so remote in time or location or are only reached following a lengthy causal chain of events, that the consequences would not be considered reasonably certain to occur.

In both § 402.17(a) and (b), we also added a sentence intended to describe the nature of the information needed to determine that either an activity (paragraph (a)) or a consequence (paragraph (b)) is reasonably certain to occur. This sentence required the conclusion of reasonably certain to occur to be based on clear and substantial information, using the best scientific and commercial data available.

By adding this sentence, we explained that we did not intend to change the statutory requirement that determinations under the Act are made based on the best scientific and commercial data available. Rather, by clear and substantial information, we explained that the conclusion of reasonably certain to occur must be based on solid information and provide a firm basis for such conclusion (84 FR 44976 at 44981, August 27, 2019). Lastly, we added § 402.17(c) to reinforce that both the action agency and the Services must consider the framework provided by § 402.17(a) and (b).

Since the final rule was published in August 2019, the Services have noted several areas of potential confusion as to the intent and structure of § 402.17. Because of these concerns, we propose to remove section § 402.17 in its entirety.

Specifically, one point of potential confusion and structural complexity was that the language of § 402.17 included additional elements in the definition of “effects of the action” found in § 402.02. However, the definition in § 402.02 should be self-contained and complete on its own terms without the need to reference additional sections of the regulations. As described further below, we will address factors relevant for determining if a consequence is reasonably certain to occur in the more appropriate forum of a guidance document.

Second, another point of potential confusion centered around our introduction of the phrase “clear and substantial information” in § 402.17 to determine if an activity or consequence is reasonably certain to occur. This phrase has inadvertently created the misperception that it represents an additional, or different, standard upon which to base a conclusion as to whether an activity is reasonably certain to occur. That was not our intent. The standard regarding the information upon which to base such determinations, as noted in the phrase following “clear and substantial information,” is the statutory requirement of “using the best scientific and commercial data available.” The “clear and substantial information” standard was intended to indicate that any rationale regarding activities or consequences that are reasonably certain to occur needed to be solidly based on the “best scientific and commercial data available.” However, the addition of the “clear and substantial information” requirement did not have the desired effect and, on reconsideration, we also find that it may be in tension with the statutory standard.

Although we did not intend for the language in the 2019 rule to require a certain amount of numerical data or to provide a guarantee that a consequence was reasonably certain to occur (84 FR 44976 at 44993, August 27, 2019), the preambular language that also described this standard as requiring a “degree of certitude” ( e.g., p. 44981) could contribute to confusion over application of this terminology. Rather than promoting consistency in application of how we determine the scope of effects of the action, this language instead creates confusion. In addition to the information standard supplied by the ESA itself, the standards for rational agency decision-making under the Administrative Procedure Act (5 U.S.C. 551 et seq. ) also apply and give courts the jurisdiction to review the Services' final agency actions on the basis of the relevant administrative record. Accordingly, by removing this section, we would not be changing the applicable standards for determining whether consequences may result from an agency action undergoing consultation but instead would be removing language that could otherwise contribute to inconsistent application of these standards.

Third, we propose to capture the point in § 402.17(a) that the “reasonably certain to occur” standard does not apply to the proposed action itself, but instead to activities that are caused by the proposed action, by the addition of the phrase “but that are not part of the action” directly to the definition of “effects of the action” in § 402.02, as discussed above.

Fourth, the provisions set forth in § 402.17(a)(1) through (a)(3) were an attempt to identify non-exclusive factors that could be examined to determine whether an activity is reasonably certain to occur. This language repeated elements that were similar to those mentioned in the preamble to the 1986 final rule on interagency cooperation (51 FR 19926 at 19933, June 3, 1986) and the Services' 1998 Consultation Handbook (Handbook at 4-32). The text at § 402.17(b) similarly described a non-exclusive list of factors to determine when a consequence may not be reasonably certain to occur. These are relevant considerations. However, on reconsideration, we find that this information would be better suited for discussion in a guidance document rather than regulations because these factors do not necessarily apply in all cases, and further explanation is needed on when and how these factors may be appropriately considered. We expect to address and expand on these factors in updates to the Services' Consultation Handbook. Additional explanation as to the appropriate application of the “reasonably certain to occur” standard may also be found in the preamble to the Services' 2015 ESA rulemaking in which the Services expressly adopted “reasonably certain to occur” as the standard for determining when incidental take is anticipated to occur (80 FR 26832 at 26837, May 11, 2015).

Because § 402.17(c) speaks directly to application of both § 402.17(a) and (b), we propose to eliminate paragraph (c) as well. Therefore, we are proposing to remove the entire section from the regulations in part 402.

The previously articulated bases for § 402.17 will be addressed by alternative means either through these proposed regulatory text revisions or future guidance. This proposed regulatory revision simplifies the regulations and eliminates the need for any reader to consult multiple sections of the regulations to discern what is considered an “effect of the action.”

In addition to the regulatory changes proposed in response to our review of the 2019 rule, we are also proposing changes to other aspects of part 402 that were not addressed in 2019. To change the Services' implementation of the ESA so that it better reflects congressional intent and better serves the conservation goals of the ESA, we are proposing amendments to the regulatory provisions relating to the scope of reasonable and prudent measures (RPMs) in an incidental take statement (ITS). Minimizing impacts of incidental take on the species through the use of offsetting measures can result in improved conservation outcomes for species incidentally taken due to proposed actions and may reduce the accumulation of adverse impacts, sometimes referred to as “death by a thousand cuts.” In addition, by allowing the Services to specify offsets outside the action area as RPMs, conservation efforts can be focused where they will be most beneficial to the species. For example, in some circumstances, offsetting measures applied outside the action area would more effectively minimize the impact of the proposed action to the subject species.

RPMs authorized under ESA section 7(b)(4) are issued by the Services to minimize impacts to species from incidental take reasonably certain to occur from a Federal action analyzed in an ESA section 7 biological opinion. The Services have previously taken the position that RPMs  1 should be confined to only those measures that avoid or reduce incidental take and that occur inside the “action area” (which the ESA regulations define as “all areas to be affected directly or indirectly by the Federal action,” 50 CFR 402.02). For example, the Services' 1998 Consultation Handbook states:

Thus, under this position taken in the Consultation Handbook, RPMs may not consist of measures that offset impacts from the taking of individuals through activities other than avoiding or reducing the level of incidental take. In addition, RPMs must occur within the action area.

With the benefit of having conducted a careful review of the Act's text, the purposes and policies of the ESA, and the 1982 ESA legislative history, the Services propose revisions to the regulations to reflect a change in the Services' interpretation of the Act's provisions relating to RPMs. Under these proposed regulatory revisions, the Services would clarify that, after considering measures that avoid or reduce incidental take within the action area, the Services may consider for inclusion as RPMs measures that offset any remaining impacts of incidental take that cannot be avoided. For example, in instances where the impact to the species occurs as the result of habitat modifications or destruction within the action area and cannot be minimized within the project site or action area, offsetting measures could include restoring or protecting suitable habitat for the affected species ( e.g., via a species conservation bank, conservation easement with endowment, in lieu fee program, restoration program, etc.).

Such offsetting measures are not an alternative to RPMs that reduce or avoid incidental take, but rather are additional measures to address the residual impacts to the species that remain after measures to avoid and, therefore, reduce incidental take are applied. These additional measures do not modify the action subject to consultation and may occur inside or outside of the action area. As a shorthand, the preamble will sometimes refer to “offsetting measures” or “offsets” as measures that address the remaining impacts of incidental take that cannot be avoided.

To illustrate how offsetting measures may be applied under this proposal, assume a Federal agency consults on its issuance of a permit for a transmission line. The Service determines in a biological opinion the proposed action is not likely to jeopardize federally listed species. The project, as proposed, was designed to minimize impacts to the species, and incidental take would be kept to a minimum. When developing the incidental take statement, the Service then considers whether any RPMs could be applied within the action area to avoid and further reduce incidental take levels. Then, the Service considers whether any offsetting measures to minimize the remaining impacts to the species from incidental take could be applied, giving preference to offsets that can be applied within the action area. This offset would not be limited to the action area, and as mentioned previously, the offset could include the Federal agency or applicant restoring or protecting suitable habitat for the affected species though a conservation bank.

As further explained below, the Services have significant discretion to specify offsetting measures as RPMs and offsets would not be required in every case. Their use would also be subject to several limitations. As with all RPMs, they would be limited by the existing “minor change rule” in 50 CFR 402.14(i)(2). Offsetting measures would be considered for inclusion only in a sequence in which the Services first considered appropriate measures within the action area and may be included as RPMs for minimizing any remaining impacts that cannot otherwise be avoided. In addition, measures offsetting any remaining impacts of incidental take that cannot be avoided must be commensurate with the scale of the impact.

ESA section 7(b)(4) provides the requirements for issuance of an ITS. If, after consultation, the Secretary concludes that the agency action will not violate section 7(a)(2) of the Act ( i.e., will not jeopardize the continued existence of a listed species or result in the destruction or adverse modification of critical habitat), but incidental take of the listed species is anticipated, 2 the Secretary must provide the agency with a written statement that includes certain components. The written statement must specify the impact of such incidental taking on the species and specify those reasonable and prudent measures that the Secretary considers necessary or appropriate to minimize such impact (16 U.S.C. 1536(b)(4)). ESA section 7(o) further provides that taking in compliance with the terms and conditions of the ITS is then exempt from the taking prohibitions of ESA section 9 (16 U.S.C. 1536(o)).

None of these provisions indicate the specific types of RPMs that may be used to minimize impacts of incidental take, nor do they require RPMs to occur within the action area. By referring to measures the Services deem “necessary or appropriate,” the Act provides the Services with substantial discretion to identify RPMs, and the Act plainly states that RPMs minimize the impacts of incidental take, not minimize incidental take itself. Thus, contrary to the position taken in the Consultation Handbook, RPMs are not limited to measures that avoid or reduce levels of incidental take. Moreover, nothing in the ESA indicates that RPMs are to be carried out in the action area.

The proposed clarification would include a preferred order for RPMs. The Services would first consider and apply measures within the action area to minimize the impact of incidental take, including, as appropriate, measures to reduce or avoid incidental take of individuals. The Services may then consider measures within the action area that use offsets to further minimize any of the remaining impacts of incidental take. After fully considering these measures within the action area, the Services may then consider additional measures outside the action area that use offsets of take to further minimize any remaining impacts of incidental take. This approach allows the Services to implement our respective mitigation policies more effectively, as both policies are predicated on a mitigation hierarchy approach of avoiding impacts, and then addressing any remaining impacts that cannot be avoided.

Under this proposal, RPMs would still need to be “reasonable and prudent” and, therefore, must be measures that are within the authority and discretion of the action agency or applicants to carry out. See Consultation Handbook at 4-53. In addition, such measures would remain subject to the longstanding regulatory requirement that these measures “cannot alter the basic design, location, scope, duration, or timing of the action and may involve only minor changes.” See 50 CFR 402.14(i)(2).

Moreover, the measures would need to be appropriately scaled. In addition to the limitations of the minor change rule, the scale of the take caused by the action would provide an upper limit on the scale of any offsetting measures. The discretion to “minimize” the impacts on the species means that the measures in any case would not be more than necessary or appropriate to offset the impacts of taking of the species in the action area that had not already been addressed through avoidance measures. As always, the Services must determine the extent of RPMs that are “necessary or appropriate.”

This proposed change is compatible with other mitigation policies and guidance, including the Services' respective mitigation policies and the mitigation sequencing approach reflected in the Council on Environmental Quality's regulations implementing the National Environmental Policy Act (42 U.S.C. 4321 et seq. ). In fact, an additional reason for proposing this change is that it would allow the Services to adhere more effectively to the preferred sequence in the development of mitigation that aims to avoid impacts to the species first, and then potentially minimize residual impact to the species through offsets. Moreover, clarifying that RPMs are not restricted to the action area and may include offsets provides greater flexibility in meeting the statutory objective of minimizing the impact of take, which could be particularly helpful when incidental take cannot be avoided. In addition, if finalized, this change in our approach to RPMs would not affect the existing ability of action agencies to incorporate mitigative measures voluntarily as part of the proposed action being evaluated under ESA section 7(a)(2).

None of this is meant to imply that the Services must require offsetting measures inside or outside the action area, only that they have discretion to do so. In proposing specific changes to the regulations and setting forth the justification for these changes in this preamble, the Services are proposing revisions that, if finalized, would apply prospectively. Thus, nothing would require that any previous consultations under section 7(a)(2) of the Act be reevaluated on the basis of these proposed revisions, in the event they are finalized.

These proposed revisions would not alter the way that the impacts of incidental taking are currently specified in an ITS. Under current regulations, the impact of incidental taking is expressed in terms of “amount or extent” of such taking. See 50 CFR 402.14(i). Amount or extent may be expressed by specifying the number of individuals taken, or through an appropriate surrogate ( e.g., similarly affected species or habitat or ecological conditions). Id. Nor do the Services propose to change the requirement for reinitiation of consultation any time “the amount or extent of taking specified in the incidental take statement is exceeded.” 50 CFR 402.16(a). All that would change is a recognition that the ESA does not prohibit RPMs outside the action area and that such measures may, where necessary or appropriate, include minimization of the impacts of the taking on the species through offsets.

Based upon the above discussion, we are proposing the following:

The current definition of “reasonable and prudent measures” provides that reasonable and prudent measures refer to those actions that the Director believes necessary or appropriate to minimize the impacts, i.e., amount or extent, of incidental take.

In our proposed revisions, we would revise the definition to adhere more closely to the statute. We would do so by replacing the term “believes” with “considers.” In addition, we would replace the clause “impacts, i.e., amount or extent, of incidental take” with “impact of the incidental take on the species.” This proposed change would more closely track the statutory language at section 7(b)(4); further, regulatory language in 50 CFR 402.14 already provides that the impact on the species is to be specified in terms of the amount or extent of incidental take caused by the action.

We propose revising § 402.14(i)(1)(i) and (ii) to reflect our interpretation that RPMs are not limited solely to reducing incidental take and may occur outside of the action area. In addition, a new paragraph at (i)(3) is proposed to clarify that offsets within or outside the action area can be required to minimize the impact of incidental taking on the species. This proposed regulation specifies the sequence in which such measures will be considered, giving priority to measures that avoid or reduce incidental take, followed by consideration of measures that offset the remaining impacts of incidental take that cannot be avoided.

We are seeking comments from all interested parties on the proposed revisions to 50 CFR part 402, as well as on any of our analyses or preliminary conclusions in the Required Determinations section of this document. While comments on all aspects of this proposed rule are solicited, we particularly note that the public is invited to comment on revisions to the regulations in 50 CFR 402.02 and 402.14 regarding the scope of RPMs in incidental take statements, given that this was a topic not raised in the 2019 rule revisions. We will also accept public comment on all aspects of the 2019 rule, including whether any of those provisions should be rescinded in their entirety (restoring the prior regulatory provision) or revised in a different way. All relevant information will be considered prior to making a final determination regarding the regulations for interagency cooperation. Depending on the comments received, we may change the proposed regulations based upon those comments.

You may submit your comments concerning this proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES . Comments sent by any other method, to any other address or individual, may not be considered.

Comments and materials we receive will be posted and available for public inspection on https://www.regulations.gov. This generally means that we will post any personal information you provide us. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this proposed rule is significant.

Executive Order 14094 amends E.O. 12866 and reaffirms the principles of E.O. 12866 and E.O 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and be consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements. This proposed rule is consistent with E.O. 13563, including the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

We are proposing revisions to the Services' implementing regulations at 50 CFR 402. Specifically, the Services are proposing changes to implementing regulations at: (1) § 402.02, definitions; (2) § 402.16, reinitiation of consultation; (3) § 402.17, other provisions; and (4) § 402.14(i)(1), formal consultation. The preamble to this proposed rule explains in detail why we anticipate that the regulatory changes we are proposing will improve the implementation of the Act.

When we made changes to §§ 402.02, 402.16, and 402.17 in 2019, we compiled historical data for a variety of metrics associated with the consultation process in an effort to describe for OMB and the public the effects of those regulations (on https://www.regulations.gov, see Supporting Document No. FWS-HQ-ES-2018-0009-64309 of Docket No. FWS-HQ-ES-2018-0009; Docket No. 180207140-8140-01). We presented various metrics related to the regulation revisions, as well as historical data supporting the metrics.

For the 2019 regulations, we concluded that because those revisions served to clarify rather than alter the standards for consultation under section 7(a)(2) of the Act, the 2019 regulation revisions were substantially unlikely to affect our determinations as to whether proposed Federal actions are likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat.

As with the 2019 regulations, the revisions we are now proposing, as described above, are intended to provide transparency and clarity and align more closely with the statute—not only to the public and stakeholders, but also to the Services' staff in the implementation of the Act. As a result, we do not anticipate any substantial change in our determinations as to whether or not proposed actions are likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat.

Similarly, although the proposed revisions to the regulatory provisions relating to RPMs are amendments not considered in the 2019 rulemaking, this change, if finalized, would align the regulations with the plain language of the statute. This change would not affect most consultations under section 7(a)(2) of the Act. This is because most consultations are completed informally, and this change would only apply to formal consultations that require an ITS containing RPMs. Even among formal consultations that require an ITS containing RPMs, some of these consultations will be able to address impacts of incidental take through measures that avoid or reduce incidental take within the action area, and the change would not apply to those consultations. As explained in the preamble language above, the use of offsetting measures in RPMs would not be required in every consultation. As with all RPMs, these offsetting measures must be commensurate with the scale of the impact, subject to the existing “minor change rule,” be reasonable and prudent, and be necessary or appropriate to minimize the impact of the incidental taking on the species. Lastly, several different action agencies in various locations throughout the country readily include offsetting measures as part of their project descriptions. This practice of including offsets as part of the proposed action being evaluated in a consultation is not uncommon. The Services may find that offsets included in the proposed action adequately minimize impacts of incidental take, thus obviating the need to specify additional offsets as RPMs. Examples of these types of consultations that incorporate offsetting measures into the proposed action include programmatic consultations, certain consultations regarding transportation projects, and Army Corps of Engineers Clean Water Act section 404 permit projects.

It is not possible to know how many formal consultations will include offsetting measures as RPMs due to the tremendous variation in Federal actions subject to formal consultation, the specific impacts from these actions, and the affected species that may be analyzed. Although we cannot predict the costs of the RPM proposal due to these variable factors associated with formal consultations, any costs would be constrained by the statutory and regulatory requirements that RPMs are “reasonable and prudent,” commensurate with the residual impacts of incidental take caused by the proposed action, and subject to the “minor change rule.” Similarly, while we cannot quantify the benefits from this proposal, some of the benefits include further minimization of the impacts of incidental take caused by the proposed action, which, in turn, further mitigates some of the environmental “costs” associated with that action. In allowing for residual impacts to be addressed, the proposal may also reduce the accumulation of adverse impacts to the species that is often referred to as “death by a thousand cuts.” Sources of offsetting measures, such as conservation banks and in-lieu fee programs, have proven in other analogous contexts to be a cost-effective means of mitigating environmental impacts and may have the potential to enhance mitigative measures directed at the loss of endangered and threatened species when they are applied strategically. See, e.g., U.S. Fish and Wildlife Service Mitigation Policy and Endangered Species Act Compensatory Mitigation Policy, Appendix 1, 501 FW 3 (May 15, 2023) or NOAA Mitigation Policy for Trust Resources, NOA 216-123 (July 22, 2022).

These changes provide transparency, clarity, and more closely comport with the text of the ESA. We, therefore, do not anticipate any material effects such that the rule would have an annual effect that would reach or exceed $200 million or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his or her designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that these proposed regulations would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

This proposed rule would revise and clarify existing requirements for Federal agencies, including the Services, under section 7 of the ESA. Federal agencies would be the only entities directly affected by this proposed rule, and they are not considered to be small entities under SBA's size standards. No other entities would be directly affected by this proposed rule.

This proposed rule, if made final, would be applied in determining whether a Federal agency has insured, in consultation with the Services, that any action it would authorize, fund, or carry out is not likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. This proposed rule will not affect our determinations as to whether proposed actions are likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. The proposed rule would serve to provide clarity to the standards with which we will evaluate agency actions pursuant to section 7 of the ESA. Therefore, we certify that, if adopted as proposed, this rule would not have a significant economic effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this proposed rule would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A small government agency plan is not required. As explained above, small governments would not be affected because the proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or Tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no additional management or protection requirements on State, local, or Tribal governments.

In accordance with E.O. 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered species and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with E.O. 13132, we have considered whether this proposed rule would have significant federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to improving and clarifying the interagency consultation processes under the ESA and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of E.O. 12988. This proposed rule would clarify the interagency consultation processes under the ESA.

In accordance with E.O. 13175 “Consultation and Coordination with Indian Tribal Governments,” the Department of the Interior's manual at 512 DM 2, and the Department of Commerce (DOC) “Tribal Consultation and Coordination Policy” (May 21, 2013), DOC Departmental Administrative Order (DAO) 218-8, and NOAA Administrative Order (NAO) 218-8 (April 2012), we are considering possible effects of this proposed rule on federally recognized Indian Tribes and Alaska Native Corporations. This proposed rule is general in nature and does not directly affect any specific Tribal lands, treaty rights, or Tribal trust resources. Therefore, we preliminarily conclude that this proposed rule does not have “tribal implications” under section 1(a) of E.O. 13175. Thus, formal government-to-government consultation is not required by E.O. 13175 and related policies of the Departments of Commerce and the Interior. We will continue to collaborate and coordinate with Tribes and Alaska Native Corporations on issues related to federally listed species and their habitats. See Joint Secretaries' Order 3206 (“American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act,” June 5, 1997) and Joint Secretaries' Order 3225 (“Endangered Species Act and Subsistence Uses in Alaska (Supplement to Secretarial Order 3206”)).

This proposed rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (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 unless it displays a currently valid OMB control number.

We are analyzing this proposed regulation in accordance with the criteria of NEPA, the Department of the Interior regulations on implementation of NEPA (43 CFR 46.10-46.450), the Department of the Interior Manual (516 DM 8), the NOAA Administrative Order 216-6A, and the companion manual, “Policy and Procedures for Compliance with the National Environmental Policy Act and Related Authorities,” which became effective January 13, 2017. We invite the public to comment on the extent to which this proposed rule may have a significant impact on the human environment or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment. We will complete our analysis, in compliance with NEPA, before finalizing these proposed regulations.

In developing this proposed rule, the Services are acting in their unique statutory role as administrators of the Act and are engaged in a legal exercise of interpreting the standards of the Act. The Services' promulgation of interpretive rules that govern their implementation of the Act is not an action that is in itself subject to the Act's provisions, including section 7(a)(2). The Services have a historical practice of issuing their general implementing regulations under the ESA without undertaking section 7 consultation. Given the plain language, structure, and purposes of the ESA, we find that Congress never intended to place a consultation obligation on the Services' promulgation of implementing regulations under the Act. In contrast to actions in which we have acted principally as an “action agency” in implementing the Act to propose or take a specific action ( e.g., issuance of section 10 permits and actions under statutory authorities other than the ESA), here, the Services are carrying out an action that is at the very core of their unique statutory role as administrators—promulgating general implementing regulations interpreting the terms and standards of the statute.

E.O. 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. The proposed revised regulations are not expected to affect energy supplies, distribution, and use. Therefore, this action is a not a significant energy action, and no statement of energy effects is required.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

We issue this proposed rule under the authority of the Endangered Species Act, as amended (16 U.S.C. 1531 et seq. ).

Accordingly, we propose to amend subparts A and B of part 402, subchapter A of chapter IV, title 50 of the Code of Federal Regulations, as set forth below:

The Secretaries of the Interior and Commerce (the “Secretaries”) share responsibilities for implementing most of the provisions of the Endangered Species Act, as amended (hereafter referred to as “ESA or the Act;” 16 U.S.C. 1531 et seq. ), and authority to administer the Act has been delegated by the respective Secretaries to the Director of FWS and the Assistant Administrator for NMFS. Together, the Services have promulgated regulations that interpret aspects of the listing and critical habitat designation provisions of section 4 of the Act. These joint regulations, which are codified in the Code of Federal Regulations at 50 CFR part 424, were most recently revised in 2019 (84 FR 45020, August 27, 2019; hereafter, “the 2019 rule”). Those revised regulations became effective September 26, 2019.

Executive Order 13990, “Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis,” issued January 20, 2021, directed all departments and agencies to immediately review agency actions taken between January 20, 2017, and January 20, 2021, and, as appropriate and consistent with applicable law, consider suspending, revising, or rescinding agency actions that conflict with important national objectives, including promoting and protecting our public health and the environment, and to immediately commence work to confront the climate crisis. A “Fact Sheet” that accompanied E.O. 13990 provided a non-exhaustive list of particular regulations requiring such a review and included the 2019 rule (see www.whitehouse.gov/briefing-room/statementsreleases/2021/01/20/fact-sheet-list-of-agency-actions-for-review/ ). In response to E.O. 13990 and in light of recent litigation over the 2019 rule, the Services have reviewed the 2019 rule, evaluated the specific regulatory revisions promulgated through that process, and now propose to make revisions to the regulations at 50 CFR part 424 as discussed in detail below.

The 2019 rule, along with other revisions to the ESA regulations finalized in 2019, were subject to litigation in the United States District Court for the Northern District of California. On July 5, 2022, the court issued a decision vacating the 2019 rule, without reaching the merits of the case. On September 21, 2022, the United States Court of Appeals for the Ninth Circuit temporarily stayed the effect of the July 5th decision pending the District Court's resolution of motions seeking to alter or amend that decision. On October 14, 2022, the Services notified the District Court that we anticipated proceeding with a rulemaking process to revise the 2019 rule. Subsequently, on November 14 and 16, 2022, the District Court issued orders remanding the 2019 regulations to the Services without vacating them, as the Services had asked the Court to do. Accordingly, the Services have developed the following proposal to amend some aspects of the 2019 rule.

This proposed rule is one of three proposed rules publishing in today's Federal Register that propose changes to the regulations that implement the ESA. Two of these proposed rules, including this one, are joint between the Services, and one proposed rule is specific to FWS.

Section 2 of the Act states that the purposes of the Act include providing a means to conserve the ecosystems upon which endangered and threatened species depend, developing a program for the conservation of listed species, and achieving the purposes of certain treaties and conventions (16 U.S.C. 1531(b)). Section 2 of the Act also makes explicit that it is the policy of Congress that all Federal agencies and departments seek to conserve threatened and endangered species and use their authorities to further the purposes of the Act (16 U.S.C. 1531(c)).

To determine whether listing a species is warranted, the Act requires that the Services conduct a review of the status of the species and consider any efforts being made by any State or foreign nation (or subdivision thereof) to protect the species. The Act also requires that determinations of whether a species meets the definition of an endangered or threatened species be based solely on the best scientific and commercial data available (16 U.S.C. 1533(b)(1)(A)).

When a species warrants listing, the Act requires the Services to designate critical habitat concurrent with the listing rule to the maximum extent prudent and determinable, or within 1 year following listing if critical habitat was not initially determinable. Critical habitat is defined in section 3 of the Act as: (1) the specific areas within the geographical area occupied by the species at the time it is listed on which are found those physical and biological features that are essential to the conservation of the species and that may require special management considerations or protections; and (2) specific areas outside the geographic area occupied by the species at the time it is listed upon a determination by the Secretary that such areas are essential for the conservation of the species (16 U.S.C. 1532(5)). The Act sets forth a two-part definition for critical habitat based on whether the species occupies an area or does not occupy an area at the time of listing. For simplicity, throughout this document we will refer to the former type as “occupied” critical habitat and the latter type as “unoccupied” critical habitat.

In passing the Act, Congress viewed habitat loss as a significant factor contributing to species endangerment, and the “present or threatened destruction, modification, or curtailment” of a species' habitat or range is specifically listed in section 4(a)(1) of the Act as the first of the factors that may underlie a determination that a species meets the definition of an endangered or threatened species. The designation of critical habitat is a regulatory tool designed to further the conservation of a listed species, i.e., to help bring the threatened or endangered species to the point at which protection under the Act is no longer necessary. More broadly, designation of critical habitat also implicitly serves as a tool for meeting one of the Act's stated purposes: Providing a means for conserving the ecosystems upon which endangered and threatened species depend. Once critical habitat is designated, Federal agencies must ensure that any actions they authorize, fund, or carry out are not likely to result in destruction or adverse modification of the critical habitat (16 U.S.C. 1536(a)(2)).

Following a review of the specific regulatory revisions made in the 2019 rule, the Services propose to revise several of those same regulatory provisions of 50 CFR part 424, as detailed below. The specific changes to the regulations proposed herein are intended to be prospective standards only. If finalized, these regulations would apply to classification and critical habitat rules finalized after the effective date of this rule and would not apply retroactively to classification and critical habitat rules finalized prior to the effective date of this rule. Nothing in these proposed revisions to the regulations is intended to require (at such time as this rule becomes final) that any prior final listing, delisting, or reclassification determinations or previously completed critical habitat designations be reevaluated on the basis of any final regulations.

We are proposing to restore the phrase “without reference to possible economic or other impacts of such determination” to the end of 50 CFR 424.11(b) to clarify and affirm that, consistent with the plain language of the statute, the economic impacts and any other impacts that might flow from a listing decision must not be taken into account when making listing, reclassification, and delisting (collectively, classification) determinations. In 2019, when we removed this phrase, we reasoned that it was not necessary because neither the Act nor the legislative history indicates that Congress intended to completely prohibit the Services from compiling economic information about potential listings, and because there may be circumstances in which referencing economic or other impacts would be informative to the public. Based on our subsequent review of the 2019 rule, the language of the Act, and the legislative history, we find that this change was not the most reasonable interpretation and created the problematic impression that the Services would begin to compile information regarding the economic impacts of classification determinations and that the Services might actually take such information into account directly or indirectly when making classification determinations, which would run afoul of the Act's mandate. When evaluating a species' classification status, the Services cannot take into account potential economic impacts that could stem from the classification decision, such as costs associated with prohibitions on commercial harvest or interstate sale of that species, or other impacts, such as potential restrictions on land management.

The Act states that determinations under section 4(a)(1) are to be made solely on the basis of the best scientific and commercial data available. Congress added this requirement through amendments to the Act in 1982 (Pub. L. 97-304, Oct. 13, 1982). The legislative history for the 1982 amendments describes the purposes of the amendments using the following language (emphases added): “to ensure that [listing and delisting] decisions . . . are based solely upon biological criteria,” Conf. Rep. (H.R.) No. 97-835 (1982) (“Conf. Rep.”), at 19; “to prevent non-biological considerations from affecting [listing and delisting] decisions,” id.; and “economic considerations have no relevance to [listing and delisting] determinations,” id. at 20. The legislative history of the Act is clear that the phrase “commercial data” is intended only to allow for consideration of “trade data,” ” was “not intended, in any way, to authorize the use of economic considerations in the process of listing a species.” See H.R. Rep. 97-657 (H.R. Rep. No. 567, 97th Cong., 2nd Sess. 1982, 1982 U.S.C.C.A.N. 2807, 1982 WL 25083) at 20. Similarly, clarifying that the Services cannot take into account potential economic impacts stemming from classification when making such determinations does not preclude the Services from evaluating economic data and information relevant to understanding the threats to the species that must be assessed under the statutory factors. In passing the Act, Congress declared that untempered economic growth and development had rendered species extinct (16 U.S.C. 1531(a)(1)) and instructed the Services to assess whether species are threatened by habitat destruction and other human-made threats (16 U.S.C. 1533(a)(1)(A)-(E)).

The removal of this phrase from the regulations, as well as certain statements made by the Services in the preamble accompanying its removal (see 83 FR 35193 at 35194-95, July 25, 2018), caused confusion regarding the Services' intentions with respect to the collection, presentation, and consideration of economic impact information stemming from the classification of species. The Services never intended, as a matter of general or routine practice, to compile, analyze, or present information pertaining to the economic impacts of species classification. However, as a result of removing this phrase, some stakeholders expected us to do just that and provided comments to that end. Restoring this phrase to the regulations would address this confusion and remove this expectation.

Furthermore, even the appearance of an intention to consider economic impact information could undermine the Services' classification determinations. Any suggestion by the Services that they could ignore the clear statutory sideboards in reaching their classification determinations could appear to taint an otherwise appropriate, science-based listing determination and could lead to needless and time-consuming litigation to determine whether any economic impact considerations were improperly taken into account—litigation that would do nothing to further the conservation of species. We find that the previous regulatory language is most consistent with the intent of Congress and provides an important guardrail for the scientific integrity of classification determinations; therefore, we are proposing to restore this language to the regulations.

We propose to revise § 424.11(d), which describes the Services' framework for interpreting and implementing the term “foreseeable future” in the Act's definition of “threatened species” (16 U.S.C. 1532(20)). The interpretation in the 2019 rule's framework, consistent with the Services' longstanding practice, was based on a 2009 opinion from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion”), that provides guidance on addressing the concept of the foreseeable future within the context of determining the status of species. Following promulgation of the 2019 regulations, the language in the final rule created confusion regarding the way in which the Services interpret and implement this term. We now find it is appropriate to revise this regulatory provision to explain more clearly the concept of the foreseeable future as it is used in the Act's definition of a “threatened species” and to align the regulatory language more closely to that of the M-Opinion as discussed below. As noted below, however, we are also considering whether rescission of the provision at § 424.11(d) may be more appropriate than revising the regulatory framework.

The “foreseeable future” concept in the Act's definition of “threatened species” sets the temporal structure that guides the Services in evaluating the best available scientific information when determining whether the species meets the substantive standard set out in the Act's definition of a threatened species. The second sentence in the “foreseeable future” paragraph we added to the regulations in 2019 ( i.e., “reasonably determine that both the future threats and the species' responses to those threats are likely”) created confusion, because it seemed to suggest the Services were adopting a novel requirement to conduct an independent analysis of the status of the species, rather than simply articulating how we determine the appropriate timeframe over which to conduct that analysis. The statutory reference to the “foreseeable future” simply sets the time period within which to make the substantive determination about the status of the species ( i.e., whether the species is likely to become an endangered species, within the foreseeable future, 16 U.S.C. 1532(20).

Therefore, we are proposing to delete the current second sentence and replace it with the following new sentence: “The term foreseeable future extends as far into the future as the Services can reasonably rely on information about the threats to the species and the species' responses to those threats.” This proposed language more clearly explains the appropriate role of the foreseeable future concept in listing determinations and is also consistent with the M-Opinion that has guided the Services since 2009 in interpreting this statutory term.

Under the M-Opinion, the extent of the foreseeable future depends on our ability to reasonably rely on information to anticipate the future. The M-Opinion describes a forecast or prediction into the foreseeable future as something that a reasonable person would rely on in making predictions about their own future (M-37021, at 8). Consistent with the best available information standard, we do not need to have absolute certainty about the information we use; rather, we need to have a reasonable degree of confidence in the prediction. Under the revisions we are proposing, the Services would continue to avoid speculation and ensure that the data, information, analysis, and conclusions we rely upon are rationally articulated and fully supported.

While we propose specific revisions to § 424.11(d), the Services are also considering whether this paragraph should be rescinded in its entirety. Prior to the addition of this provision to the regulations in 2019, both Services had been relying on M-Opinion 37021 to construe the phrase “foreseeable future” and would continue to do so even in the absence of the regulatory framework regarding the foreseeable future. Maintaining an interpretation of this statutory phrase in the regulations is of limited utility to the Services, as well as potentially confusing to the public, if that regulatory provision is susceptible to being read or understood as inconsistent with the M-Opinion, which provides a more thorough and detailed examination and explanation of how this statutory phrase is interpreted. While the M-Opinion standing alone does not have the force of law and is not binding on NMFS, both Services nonetheless continue to find it is a reasonable interpretation of the statute and intend to continue relying on it to support their listing decisions. In the absence of a regulatory framework regarding the foreseeable future, the Services would still be required to document and explain in their listing determinations how the best available data support decisions with respect to species' status over the foreseeable future.

We propose to make several revisions to § 424.11(e) to better clarify the procedure and standards that the Services will apply when making delisting decisions. (These provisions were previously included at § 424.11(d).) First, we propose to revise the opening sentence of this section by replacing the phrase “shall delist a species if” with “it is appropriate to delist a species if.” While this proposed revision does not substantively change the meaning, standards, or procedure for delisting, we find this change would remove the potential for confusion or concerns that the Services can or will take immediate action to delist a species upon completion of a status review without following notice-and-comment rulemaking procedures, or that the outcome of such a rulemaking is predetermined in any way. The fundamental question under the Act for listing, delisting, or reclassification is whether the species meets the definition of an “endangered species” or “threatened species” because of any of the factors in section 4(a)(1) of the Act, which is the standard we have retained in our regulations. As required by the Act, the Services intend to continue to base delisting determinations on the best available scientific and commercial data and to delist species through a rulemaking process that allows for peer review, a proposed delisting rule open to public comment, and a final rule that responds to and incorporates comments as appropriate. Furthermore, the word “shall” in these regulations is not necessary for requiring or ensuring that the Services abide by the Act's standards, which apply to all delisting decisions and cannot be supplanted by regulation.

The current regulations in § 424.11(e) list three circumstances in which it is appropriate to delist a species: the species is extinct, the species does not meet the definition of a threatened or endangered species, and the listed entity does not meet the definition of a species. These three general categories of circumstances have been in the Services' joint regulations for decades ( e.g., see 45 FR 13010 at 13022, February 27, 1980). Revisions to the wording of these circumstances were made in 2019 to achieve three main goals: to simplify and streamline what was considered unnecessary and potentially confusing regulatory text, to eliminate the possibility of misinterpreting the categories of circumstances as actual criteria for delisting, and to clarify that the standards applicable to listing and delisting determinations are the same. As part of those revisions, we removed the word “recovery” from the list of reasons for delisting at what was then § 424.11(d)(2)) and changed the wording of the circumstance indicating that a species warrants delisting if it does not meet the definition of a threatened or endangered species. Specifically, this circumstance, as currently specified in 50 CFR 424.11(e)(2)), was revised in 2019 to indicate that a species would be delisted if it does not meet the definition of an endangered species or a threatened species and that, in making such a determination, the Services would apply the same factors and standards as when making listing and reclassification determinations.

As we explained in the 2019 rule and the associated proposed rule, in making this revision, our intention was to clarify that the standard for whether a species merits protection under the Act should be applied consistently, regardless of whether the context is potential listing, reclassification, or delisting; and to remove the misperception that delisting decisions are contingent upon the satisfaction of a recovery plan for that species ( e.g., 84 FR 45020 at 45036, August 27, 2019). This revision and the removal of the word “recovery” were the focus of many public comments. Commenters expressed concerns that the Services would begin to delist species before they are recovered and asserted that these revisions could circumvent recovery plans and improperly make section 4(f) of the Act meaningless (84 FR 45020 at 45035, August 27, 2019). As we explained in the 2019 rule, we disagreed that the Services would begin to delist species before they are recovered and indicated that we would continue to develop and use recovery plans to guide recovery of listed species consistent with the Act. We also explained that the revisions in no way would diminish the Services' goal of recovering threatened and endangered species.

Although we do not agree that any of the outcomes expressed in comments received in 2019 would come to pass under the regulations as revised in 2019, after reconsidering these regulations we find that it is appropriate and preferable to include “recovered” in the delisting regulations as an express, important example of when a species should be delisted. Therefore, we propose to insert the phrase “the species is recovered” at the beginning of this particular provision. Specifically, we are proposing to revise 50 CFR 424.11(e)(2) to read as follows: The species is recovered or otherwise does not meet the definition of a threatened or endangered species. In making such a determination, the Secretary shall consider the factors and apply the standards set forth in paragraph (c) [of § 424.11] regarding listing and reclassification.

We find that inclusion of the word “recovered,” and thus the concept of recovery, in the delisting regulations acknowledges one of the principal goals of the Act and of the Services. Using the term “recovered” in our regulations maintains a clear linkage between this primary goal and one of the circumstances in which the Services would delist a species. Because this section of the regulations still clearly indicates that the Secretary must consider the factors and standards of section 4 of the Act when evaluating species for delisting, the revision we now propose does not alter, in any way, the set of circumstances in which delisting is appropriate, or the standards or process for doing so. As courts have made clear, satisfying a recovery plan is one, but not the exclusive, possible pathway by which a species may reach the point of no longer requiring the protections of the Act ( Friends of Blackwater v. Salazar, 691 F.3d 428 (D.C. Cir. 2012)).

We note that we are not proposing to remove the phrase “does not meet the definition of a threatened or endangered species,” which was added to § 424.11(e) in 2019. We are retaining this phrase because the Act requires that species added to or retained on the lists of threatened and endangered species meet the definition of either a “threatened species” or an “endangered species.” We are also retaining this phrase because recovery is not the only reason that a species may not meet the definition of a threatened or endangered species. For example, additional data may become available after a species has been listed that reveal that another species that was previously classified as taxonomically distinct is actually part of the listed entity. In this hypothetical example, the additional data could potentially lead to a finding that the particular listed species does not meet the definitions of either “threatened species” or “endangered species” and should therefore be delisted.

Lastly, we propose to remove the word “same” from both instances where it occurs in the sentence stating that we must “consider the same factors and apply the same standards” when determining whether a species is recovered or no longer warrants listing as when listing or reclassifying a species. As already stated, while delisting determinations must review the species' status and consider the factors listed in section 4(a)(1) of the Act using the best scientific and commercial data available, we propose to remove the word “same” to eliminate any possible, though unintended, confusion that the analysis is limited to those same, specific factors or threats that initially led us to list that particular species. For example, a particular threat or combination of threats, such as overfishing and inadequate harvest regulations, may have caused a species' initial decline and endangerment, but those threats may have subsequently been controlled, and other threats, such as habitat modification and disease, may have since arisen. A status review conducted to determine whether a species warrants delisting must consider not just the same factors that led to the initial listing, but also any relevant factors that affect the biological status of the species. Thus, while the set of factors identified in section 4(a)(1) of the Act and the standards outlined in section 4(b)(2) of the Act apply in the context of listing, delisting, and reclassification decisions, the particular circumstances and facts may differ.

In addition to the substantive revisions discussed above, we are also proposing one administrative revision to § 424.11(a) to correct a cross-reference. The citation to “§ 424.02(k)” is wrong as § 424.02 does not include a paragraph (k) or any designated paragraphs. Therefore, we are proposing to replace the reference to “§ 424.02(k)” with a reference to “§ 424.02.”

We propose to revise § 424.12(a)(1), which provides a non-exhaustive list of circumstances in which the Services may find it is not prudent to designate critical habitat. Specifically, we propose to remove the second half of § 424.12(a)(ii), which states that designation of critical habitat would not be prudent if threats to the species' habitat stem solely from causes that cannot be addressed through management actions resulting from consultations under section 7(a)(2) of the Act. This was a newly identified circumstance adopted through the 2019 rule. In adding this language, our stated intent was to identify a circumstance in which designation of critical habitat may not contribute to the conservation of the species. As explained in the preamble to the 2019 rule, scenarios in which such a circumstance might arise include when the listed species is experiencing adverse impacts solely from climate-driven threats such as melting glaciers, sea-level rise, or reduced snowpack and no other habitat-related threats (84 FR 45020 at 45042, August 27, 2019).

Following our review of this language in light of the goals laid out in E.O. 13990, we find that this clause requires that the Services presuppose the scope and outcomes of future section 7 consultations under the Act and suggests that the only conservation benefits of a critical habitat designation are through the section 7 process, a presumption not supported by the language of the Act or court decisions (see, e.g., Natural Res. Def. Council v. U.S. Dep't of the Interior , 113 F.3d 1121, 1126 (9th Cir. 1997) (rejecting FWS's argument that, in order for there to be a benefit from designation, the majority of land use activities in critical habitat would have to be subject to section 7 consultation); Conservation Council for Haw. v. Babbitt, 2 F. Supp. 2d 1280, 1286 (D. Haw. 1998) (reasoning that even though consultation requirements apply only to Federal activities, Congress did not exclude private lands from the designation of critical habitats in part because “the designation of the critical habitat provides greater information [than listing alone] to the public and state and local government by informing not only that the species is endangered or threatened but also what area is essential to the conservation of the species.”)). This language has also been interpreted by the public as potentially allowing the Services to regularly decline to designate critical habitat for species threatened by climate change, which was not our intent.

For these reasons, and to clarify that the Services intend to continue to consider anticipated climate-change impacts in the context of critical habitat designations, we are now proposing to remove this language. While the Act provides some limited flexibility to find that the designation of critical habitat should not be undertaken for particular species, as we described in the preamble to the 2019 rule, not-prudent determinations are rare, and we anticipate they will continue to be rare.

We also propose to delete § 424.12(a)(1)(v), which is the last circumstance set forth in § 424.12(a)(1), and states that the Secretary otherwise determines critical habitat would not be prudent based on the best scientific data available. Setting this text out separately within the list of circumstances in which the Secretary could potentially make a not-prudent determination inadvertently gave the appearance that the Services might overstep their authority under the Act by issuing “not prudent” determinations for any number of unspecified reasons that may be inconsistent with the purposes of the Act. As this was not our intention, we are proposing to remove the circumstance set out in § 424.12(a)(1)(v). However, we cannot foresee all possible circumstances in which critical habitat may not be prudent, and the statute does not identify the circumstances in which a designation is “not prudent.” Rather, the statute delegates to the Secretary the authority to make a determination that critical habitat is not prudent, subject to the requirements that the determination is based on the best available scientific data and so long as the determination is not inconsistent with the conservation purposes of the Act. Therefore, we propose to retain in the regulations a recognition that the Secretary may make not-prudent determinations in cases that do not fit within the remaining circumstances set forth in § 424.12(a)(1)(i)-(iv) by inserting a clause into the opening sentence of this section to indicate that the list of identified circumstances is not intended to be exhaustive.

We propose to make several revisions to § 424.12(b)(2) to address the designation of specific areas as unoccupied critical habitat (specific areas outside the geographical area occupied by the species at the time the species is listed under the Act). As we discuss further below, the changes we now propose would remove requirements for designating unoccupied critical habitat that are not mandated by the language or structure of the Act and, in the view of the Services, would better fulfill the Secretaries' authority to further the conservation purposes of the Act. As part of these revisions, we also propose to make a series of wording changes to improve readability and organization of this section of the regulations.

The regulations governing the designation of unoccupied critical habitat have been amended twice within recent years, once through a 2016 rule (81 FR 7414, February 11, 2016) and then through the 2019 rule that we are now revisiting (84 FR 45020, August 27, 2019). In both the 2016 and 2019 rules, the Services addressed the concept of prioritizing or sequencing how occupied and unoccupied areas should be considered when developing a critical habitat designation. In the 2019 rule, we revised the criteria for designating unoccupied critical habitat to explicitly require a two-step process that prioritizes the designation of occupied areas over unoccupied areas by adding the following sentence: The Secretary will only consider unoccupied areas to be essential where a critical habitat designation limited to geographical areas occupied would be inadequate to ensure the conservation of the species (84 FR 45020 at 45053, August 27, 2019). A similar prioritization step was removed from the implementing regulations in 2016, because, at that time, we determined that it was an unnecessary and unintentionally limiting requirement (81 FR 7414 at 7434, February 11, 2016). The revisions made in 2016 instead allowed for simultaneous consideration of occupied and unoccupied habitat according to the definition of “critical habitat” in the Act. In justifying the adoption of new regulatory requirements for designating unoccupied areas in 2019, which included a two-step prioritization process, we explained that we were responding to concerns that the Services would inappropriately designate overly expansive areas of unoccupied critical habitat (83 FR 35193 at 35197-98, July 25, 2018), and that a two-step approach would help further Congress' intent to place increased importance on habitat within the geographical area occupied by the species (84 FR 45020 at 45043, August 27, 2019).

We now propose to address this issue anew by revising § 424.12(b)(2) to set out a clear and logical approach for identifying unoccupied critical habitat that, as we discuss below, better fulfills the statutory objectives regarding critical habitat. Specifically, our proposed, revised version of § 424.12(b)(2) is as follows: After first evaluating areas occupied by the species, the Secretary will identify, at a scale determined by the Secretary to be appropriate, specific areas outside the geographical area occupied by the species at the time of listing that the Secretary determines are essential for the conservation of the species. Such a determination must be based on the best scientific data available.

This proposal would insert text stating “after identifying areas occupied by the species at the time of listing” to the first sentence and delete the second sentence of the current regulation stating that the Secretary will first identify areas occupied by the species. As is clear from the text, under this proposed change the Services would continue to identify and consider areas that are occupied by the species before evaluating areas that are unoccupied by the species. We find that this approach is the most logical way to begin a critical habitat analysis and has consistently been the practice of the Services regardless of which regulations have been in place.

However, we also propose to remove the sentence that was added in 2019 stating that the Secretary “will only consider” unoccupied areas to be essential where a critical habitat designation limited to occupied areas would be inadequate to ensure the conservation of the species. Deletion of this sentence from the current regulation would remove the requirement that the Secretary exhaust all occupied areas before considering whether any unoccupied areas may be essential for conservation of the particular species. Neither the Act nor the legislative history creates a requirement to exhaust occupied areas before considering designation of unoccupied areas; therefore, this is an area where the statutory framework contains a gap that the Services may fill with a reasonable interpretation as we are presenting here.

In the preamble to the 2019 rule, we presented certain legislative history to support the approach in that final rule, but those sources do not unequivocally support the approach that was ultimately adopted. For example, although we stated in 2019 that Congress intended to place increased importance on habitat within the geographical area occupied by the species (84 FR 45020 at 45043, August 27, 2019), it is not clear that that was the best interpretation of the intent of Congress from the H.R. Rep. 95-1804, which we cited. Moreover, the Act does not require that occupied habitat be found inadequate for conservation before unoccupied habitat can be designated. Rather the Act requires that the Services identify areas that meet the definition of critical habitat—occupied and unoccupied—based on the best available data, and then consider economic, national security, and other relevant impacts of designating any particular area. The 1978 House Report, for example, expressed the House Committee's belief that “the Secretary should be exceedingly circumspect in the designation of critical habitat outside of the presently occupied area of the species” (H.R. 96-1625, at 25 (1978)), but it does not require determining that a designation limited to occupied critical habitat is inadequate before allowing any consideration of unoccupied areas.

More importantly, the “inadequacy” requirement added in 2019 could undermine the Secretaries' duty to designate areas that otherwise meet the definition of critical habitat and are essential to support the conservation of the species. Under the proposed revisions, we would no longer need to determine that a designation limited to occupied areas is “inadequate to ensure the conservation of the species” before we could even consider designating unoccupied habitat. In short, the proposed revision removes unnecessary constraints to the Secretaries' duty to consider designation of unoccupied areas where such areas are essential for the species' conservation and, in our view, better aligns the regulations with the statutory definition of “critical habitat.” Furthermore, under the proposed revision, we would still be required to provide a rational explanation of why any unoccupied areas are essential for the conservation of the species. Because the identification of areas that are essential for the conservation of a species is a scientific and fact-specific inquiry, we continue to recognize that the exercise of this authority requires a reasoned explanation in the supporting administrative record for a particular designation of why any areas that are not occupied by the species are essential for its conservation.

In § 424.12(b)(2), we also propose to strike the last sentence, which states that for an unoccupied area to be considered essential, the Secretary must determine, with reasonable certainty, both that the area will contribute to the conservation of the species and that it contains one or more of the physical or biological features essential to the conservation of the species. After reconsidering this particular sentence, which was added to the regulations in 2019, we find that these additional criteria for determining whether an area is “essential” impose standards for designating unoccupied critical habitat that go beyond, and could potentially conflict with, the science-based determination required by the statute and the Act's mandate to designate critical habitat to the maximum extent prudent and determinable based on the best scientific data available (see 16 U.S.C. 1533(a)(3)(A), 1533(b)). The Act requires that critical habitat be designated on the basis of the best scientific data available and, based on those data, whether and what specific unoccupied areas are essential for the conservation of the species.

Imposing a “reasonable certainty” standard is also unnecessary in light of the best available data standard of the Act, because this standard already inherently contains an obligation for the Services not to base their decisions on information that is merely potential or speculative. Moreover, the statutory best scientific data available standard has not previously been interpreted to require a specific level of certainty, such as the “high degree” level articulated in the 2019 final rule preamble (84 FR 45020 at 45022, August 27, 2019). Imposing a specific standard of certainty therefore could potentially result in the Services excluding from consideration the best available data merely because it was deemed not to be sufficiently certain. All of the Services' critical habitat designations must comply with both the Act's “best scientific data available” standard as well as the standards for rational agency decision-making.

Courts have held that the Act's “best scientific data available” standard, which also applies (with slight differences not relevant here) to listing decisions and biological opinions under section 7, does not require that the information relied upon by the Services be perfect or free from uncertainty. (See, e.g., Oceana, Inc. v. Ross, 321 F. Supp. 3d 128, 142 (D.D.C. 2018) (“the plain language of the provision requires NMFS only to use the best data available, not the best data possible ”) (emphases in original); Alaska Oil & Gas Ass'n v. Jewell, 815 F.3d 544, 555 (9th Cir. 2016) (noting that the Act's best-data-available requirement does not require perfection in the data but only precludes basing decisions on speculation or surmise) (citations omitted).

In short, the Act “accepts agency decisions in the face of uncertainty” where the Services have used the best data available. Arizona Cattle Growers' Ass'n v. Salazar, 606 F.3d 1160, 1164 (9th Cir. 2010) (citations omitted); see also In re Polar Bear Endangered Species Act Listing & 4(d) Rule Litigation, 794 F. Supp. 2d 65, 106 (D.D.C. 2011) (“It is well-settled in the D.C. Circuit that FWS is entitled—and, indeed, required—to rely upon the best available science, even if that science is uncertain or even `quite inconclusive.' ”) (citation omitted), aff'd, 709 F.3d 1 (D.C. Cir. 2013); Oceana, Inc. v. Evans, 384 F. Supp. 2d 203, 219 (D.D.C.) (“Time and again courts have upheld agency action based on the `best available ' science, recognizing that some degree of speculation and uncertainty is inherent in agency decision-making, even in the precautionary context of the ESA.”) (emphasis in original), order clarified, 389 F. Supp. 2d 4 (D.D.C. 2005).

In proposing to delete the last sentence of § 424.12(b)(2), we would also remove the requirement for unoccupied areas to contain (with reasonable certainty) one or more of the physical or biological features essential to the conservation of the species (“essential features”). Congress expressly defined occupied critical habitat and unoccupied critical habitat separately, mentioning essential features only in connection with occupied critical habitat (see 16 U.S.C. 1532(5)(A)(i)). Further, with respect to unoccupied habitat, the Act requires a determination that designated areas are essential for the conservation of the species (see 16 U.S.C. 1532(5)(A)(ii)). However, in 2019, we interpreted the legislative history as supporting a conclusion that unoccupied critical habitat must contain one or more essential feature(s). In particular, in the 2019 rule preamble, we pointed to a statement in the 1978 House Committee report and asserted that the Services' 1978 regulatory definition of “critical habitat” could conceivably lead to the designation of virtually all of the habitat of a listed species as its critical habitat (H.R. Rep. No. 95-1625, at 25 (1978)), and we implied that this statement, among others, reflected an intention on the part of Congress that unoccupied critical habitat be defined more narrowly than as areas contemplated for species expansion. See 84 FR 45020 at 45022, August 27, 2019 (citing H.R. Rep. No. 95-1625 pp. 18, 25 (1978); S. Rep. No. 95-874, at 9-10 (1978)).

In reviewing the discussion presented in the 2019 rule and the legislative history related to the 1978 amendments to the Act, we now find that the 2019 rule preamble created unnecessary tension with the statutory text as adopted (see 16 U.S.C. 1532(5)(A); 84 FR 45020 at 45022, August 27, 2019 (describing portions of 1978 House and Senate Reports reacting to the Services' 1978 regulatory definition of “critical habitat”)). While we relied on those excerpts from legislative history regarding earlier draft statutory language as illuminating the meaning of “unoccupied critical habitat,” the actual text of the Act does not carry over the requirements for occupied critical habitat into the definition of unoccupied critical habitat. The best evidence of congressional intent is well understood to be reflected in the text of a statute itself (see, e.g., Sutherland Statutes and Statutory Construction, volume 2A, section 45:5 (7th ed.) (“Judicial opinions overwhelmingly emphasize the legislature's words as the most reliable source of legislative intent, particularly when a statute is `unambiguous.' ”) (internal citations omitted)), and the statutory definition of “critical habitat” clearly establishes different criteria for occupied and unoccupied critical habitat (see 16 U.S.C. 1532(5)(A)). By confounding the criteria for defining occupied and unoccupied critical habitat, we eroded the statutory distinction between those two types of areas and made the standards for designating those areas more similar than what the Act plainly indicates.

We acknowledge, as discussed in the preamble to the 2019 rule, that a number of court decisions have addressed the relationship between the standards for designation for unoccupied critical habitat and those for occupied critical habitat. The revised § 424.12(b)(2) we now propose would be consistent with the cases referenced in the 2019 preamble ( Home Builders Ass'n v. U.S. Fish & Wildlife Serv., 616 F.3d 983, 990 (9th Cir. 2010) (“Essential conservation is the standard for unoccupied habitat . . . and is a more demanding standard than that of occupied critical habitat.”); Cape Hatteras Access Pres. All. v. U.S. Dep't of the Interior, 344 F. Supp. 2d 108, 119 (D.D.C. 2004) (“it is not enough that the area's features be essential to conservation, the area itself must be essential”)). These decisions do not add any limitations to the designation of unoccupied critical habitat that do not appear in the Act itself. Our proposal best conforms to the statutory standard for designating unoccupied critical habitat by reiterating the requirement that the Secretary must determine any unoccupied areas identified for designation are essential to the species' conservation.

The preamble of the 2019 rule also pointed to the decision in Weyerhaeuser Co. v. U.S. FWS, 139 S. Ct. 361 (2018), as justification for adding the requirement that at least one essential feature be present in order for unoccupied areas to qualify for designation as critical habitat. In Weyerhaeuser, the Court held that an area is eligible for designation as critical habitat under the Act only if it is habitat for that species. The Weyerhaeuser decision, however, does not resolve the specific issue of how to define “habitat” against the backdrop of the two prongs of the statutory definition of “critical habitat.” To avoid the potential for rendering any part of the statutory language surplusage, we find that our implementing regulations must clearly accord independent meaning to each prong. Therefore, we no longer find that importing language from the statutory definition of “occupied” critical habitat (regarding essential features) into the requirements for defining “unoccupied” critical habitat is the best way to resolve this issue. We now find that requiring reasonable certainty that one or more essential features are present in an area is an unnecessary and, ultimately, an incomplete substitute for the full science-based and species-specific inquiry into whether an area qualifies as habitat. As we articulated in the recent final rule rescinding the regulatory definition of the term “habitat,” we recognize the importance of the Supreme Court's ruling in Weyerhaeuser and will ensure that the administrative record for each designation documents how the designated areas are in fact habitat for the particular species at issue, using the best available scientific data and explaining the needs of that species (87 FR 37757, June 24, 2022).

In the 2019 rule preamble, we also acknowledged that the Services had not previously taken the position that unoccupied critical habitat must contain essential features (see 84 FR 45023, August 27, 2019). As a practical matter, many areas of unoccupied habitat that are included in a critical habitat designation will contain one or more habitat features essential to the conservation of the species. However, the plain language of the Act does not require this to be the case, and we no longer consider the best reading of the Act to require that unoccupied areas contain “one or more of those physical or biological features essential to the conservation of the species” for the area itself to be essential for that species' conservation. The revisions we are now proposing would bring the Services' interpretation in line with this better reading of the statute.

In addition, we note that neither the two-step prioritization process for designating unoccupied critical habitat nor the requirement for “reasonable certainty” for conservation or presence of essential features is necessary to achieve the purported goal of avoiding overly expansive designations. The Act sufficiently guards against this outcome by requiring the Secretary to explain why any unoccupied areas are essential for the conservation of the species and by providing in section 3 that the Secretary will generally not designate all areas that can be occupied by the species (16 U.S.C. 1532(5)(C)).

We also propose to make a series of more minor revisions to § 424.12(b)(2) that collectively would streamline the text and improve clarity and readability. Specifically, we propose to make the regulatory language of § 424.12(b)(2) consistent with, and parallel to, the regulatory language of the preceding paragraph (§ 424.12(b)(1)) by replacing the existing phrase “will designate as critical habitat” with the words “will identify, at a scale determined by the Secretary to be appropriate, specific areas. . . .” This proposed revision would also describe the process of designating critical habitat in a more logical way, because identifying specific areas that may qualify as unoccupied critical habitat must occur before any designation of those areas; even after identifying specific areas that qualify as critical habitat, the Services must complete subsequent, required steps ( e.g., consideration of impacts as outlined in 50 CFR 424.19) before designating those areas as critical habitat.

We also propose to make a minor clarifying amendment to the first sentence of § 424.12(b)(2) by inserting the phrase “at the time of listing” to avoid potential ambiguity and align the characterization of unoccupied areas with the statutory definition of “critical habitat.” While this additional language does not alter the meaning or intent of the first sentence of § 424.12(b)(2), the proposed language would improve the clarity of the regulatory text. In the first sentence, we also propose to simplify the regulatory text by replacing the existing phrase “only upon a determination that such areas” with “that the Secretary determines.” The current phrase is unnecessary, as the Act already clearly establishes through the section 3 definition of “critical habitat” that the designation of unoccupied areas must be based upon a determination that those areas are essential for the conservation of the species (see 16 U.S.C. 1532(5)(a)(ii)).

Lastly, we propose to add a sentence to the end of § 424.12(b)(2) that reiterates the statutory requirement to identify unoccupied critical habitat using the best scientific data available. This additional proposed sentence serves to emphasize the statutory requirement that the determination of whether a specific area is essential for the conservation of the species must be driven by the best available data.

In conclusion, we have reconsidered the 2019 rule and now find that the interpretation of unoccupied critical habitat adopted in 2019 is not the best one for the multiple reasons outlined here. In view of the Act's framework and conservation purposes, as well as the “best scientific data available” standard (16 U.S.C. 1533(b)(2)) and the requirement to designate critical habitat “to the maximum extent prudent and determinable” (16 U.S.C. 1533(a)(3)(A)), we find that it is most appropriate for the Services to make all the required determinations on the basis of the best available science and the particular record for the action at hand, consistent with the generally applicable legal standards. By deleting the multiple, additional requirements for designating unoccupied critical habitat that were added in 2019, we would restore the implementation of section 3(5)(A) of the Act so as to better reflect the statutory language and the legislative history.

We are seeking comments from all interested parties on the proposed revisions to 50 CFR part 424, as well as on any of our analyses or conclusions in the Required Determinations section of this document. We will also accept public comment on all aspects of the 2019 rule, including whether any of those provisions should be rescinded in their entirety (restoring the prior regulatory provision) or revised in a different way. All relevant information will be considered prior to making a final determination regarding the regulations for listing endangered and threatened species and designating critical habitat. Depending on the comments received, we may change the proposed regulations based upon those comments. You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES . Comments sent by any other method, to any other address or individual, may not be considered.

Comments and materials we receive will be posted and available for public inspection on https://www.regulations.gov. This generally means that we will post any personal information you provide us. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this proposed rule is significant.

Executive Order 14094 amends E.O. 12866 and reaffirms the principles of E.O. 12866 and E.O 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and be consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements. This proposed rule is consistent with E.O. 13563 and in particular with the requirement of retrospective analysis of existing rules designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

We are proposing revisions to the Services' implementing regulations at 50 CFR 424.11 and 424.12. Specifically, the Services are proposing changes to implementing regulations at: (1) § 424.11(b), the factors for listing, delisting, or reclassifying species; (2) § 424.11(d), the foreseeable future framework; (3) § 424.11(e), the standards for delisting; (4) § 424.12(a), criteria for not prudent determinations for critical habitat; and (5) § 424.12(b)(2), the criteria for designation of unoccupied critical habitat. The preamble to this proposed rule explains in detail why we anticipate that the regulatory changes we are proposing will improve the implementation of the Act.

When we made changes to these same sections in 2019, we compiled historical data on the occurrence of specific metrics of listing and critical habitat determinations by the Services in an effort to describe for OMB and the public the potential scale of any effects of those regulations (on https://www.regulations.gov, see Supporting Document No. FWS-HQ-ES-2018-0006-0002 of Docket No. FWS-HQ-ES-2018-0006; Docket No. 180202112-8112-01). We presented various metrics related to the regulation revisions, as well as historical data supporting the metrics.

For the 2019 regulations, we concluded—with respect to the provisions related to listing, reclassification, and delisting of species—that, because those revisions served to clarify rather than alter the standards for classifying species, the 2019 regulation revisions would not change the average number of species classification ( i.e., listing, reclassification, delisting) outcomes per year. With respect to the critical habitat provisions, we concluded that, because the outcomes of critical habitat determinations are highly fact-based, it was not possible to forecast reliably whether more or fewer not-prudent determinations or designations of unoccupied critical habitat would be made each year if the 2019 regulation revisions were finalized.

The revisions we are now proposing to the listing, delisting, and reclassification provisions as described above are intended to align more closely with the statute and to provide transparency and clarity—not only to the public and stakeholders, but also to the Services' staff in the implementation of the Act. As a result, we do not anticipate any change in the rate or frequency or particular classification outcomes due to the proposed regulation. Similarly, the proposed revisions to the provisions related to the Secretaries' duty to designate critical habitat are intended to align the regulations with the Act, and—because the outcomes of critical habitat analyses are so highly fact-specific and it is not possible to forecast how many related circumstances will arise—any future benefit or cost stemming from these revisions is currently unknowable.

These changes provide transparency and clarity, and there are no identifiable, quantifiable effects from the proposed rule. Further, we do not anticipate any material effects such that the rule would have an annual effect that would reach or exceed $200 million or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or that person's designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that these proposed regulations would not have a significant economic impact on a substantial number of small entities. The following discussion explains our rationale.

This proposed rule would revise and clarify requirements for NMFS and FWS in classifying species and designating critical habitat under the Act and do not directly affect small entities. NMFS and FWS are the only entities that would be directly affected by this proposed rule because we are the only entities that list species or designate critical habitat. No external entities, including any small businesses, small organizations, or small governments, will experience any direct economic impacts from this proposed rule. Therefore, we certify that, if adopted as proposed, this rule would not have a significant economic effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this proposed rule would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A small government agency plan is not required. As explained above, small governments would not be affected because the proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or Tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or Tribal governments.

In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered species and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to factors for listing, delisting, or reclassifying species and designation of critical habitat under the Endangered Species Act and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This proposed rule would not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify factors for listing, delisting, or reclassifying species and designation of critical habitat under the Endangered Species Act.

In accordance with Executive Order 13175 “Consultation and Coordination with Indian Tribal Governments,” the Department of the Interior's manual at 512 DM 2, and the Department of Commerce (DOC) “Tribal Consultation and Coordination Policy” (May 21, 2013), DOC Departmental Administrative Order (DAO) 218-8, and NOAA Administrative Order (NAO) 218-8 (April 2012), we considered possible effects of this proposed rule on federally recognized Indian Tribes. This proposed rule is general in nature and does not directly affect any specific Tribal lands, treaty rights, or Tribal trust resources. Therefore, we preliminarily conclude that this proposed rule does not have “tribal implications” under section 1(a) of E.O. 13175. Thus, formal government-to-government consultation is not required by E.O. 13175 and related policies of the Departments of Commerce and the Interior. We will continue to collaborate with Tribes on issues related to federally listed species and their habitats. See Joint Secretaries' Order 3206 (“American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act,” June 5, 1997).

This proposed rule does not contain any new collection of information that requires approval by the OMB under the Paperwork Reduction Act of 1995 (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 unless it displays a currently valid OMB control number.

We are analyzing this proposed regulation in accordance with the criteria of NEPA, the Department of the Interior regulations on implementation of NEPA (43 CFR 46.10-46.450), the Department of the Interior Manual (516 DM 8), the NOAA Administrative Order 216-6A, and the companion manual, “Policy and Procedures for Compliance with the National Environmental Policy Act and Related Authorities,” which became effective January 13, 2017. We invite the public to comment on the extent to which these proposed regulations may have a significant impact on the human environment or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment. We will complete our analysis, in compliance with NEPA, before finalizing this proposed rule.

In developing this proposed rule, the Services are acting in their unique statutory role as administrators of the Act and are engaged in a legal exercise of interpreting the standards of the Act. The Services' promulgation of interpretive rules that govern their implementation of the Act is not an action that is in itself subject to the Act's provisions, including section 7(a)(2). The Services have a historical practice of issuing their general implementing regulations under the ESA without undertaking section 7 consultation. Given the plain language, structure, and purposes of the ESA, we find that Congress never intended to place a consultation obligation on the Services' promulgation of implementing regulations under the Act. In contrast to actions in which we have acted principally as an “action agency” in implementing the Act to propose or take a specific action ( e.g., issuance of section 10 permits and actions under statutory authorities other than the ESA), here, the Services are carrying out an action that is at the very core of their unique statutory role as administrators—promulgating general implementing regulations interpreting the terms and standards of the statute.

Executive Order 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. The proposed revised regulations are not expected to affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no statement of energy effects is required.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you believe that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

We issue this proposed rule under the authority of the Endangered Species Act, as amended (16 U.S.C. 1531 et seq. ).

For the reasons set out in the preamble, we hereby propose to amend part 424, subchapter A of chapter IV, title 50 of the Code of Federal Regulations, as set forth below:

The revisions read as follows: