Background

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2022-01-09, Amendment 39-21897 (87 FR 1666, January 12, 2022) (AD 2022-01-09). AD 2022-01-09 applied to all Stemme AG Model Stemme S 10-VT and Model Stemme S 12 gliders with a freewheel clutch part number (P/N) 12AK with a serial number starting with “12-” installed. AD 2022-01-09 required removing the affected freewheel clutch from service and prohibited installing an affected part on any glider. The FAA issued AD 2022-01-09 to address unintended slipping of the freewheel clutch with overheating (burnishing) of the friction pads inside of the clutch, which if not addressed, could result in a loss of thrust and consequent loss of glider control.

The NPRM published in the Federal Register on November 18, 2022 (87 FR 69220). The NPRM was prompted by EASA AD 2021-0278R1, dated August 11, 2022 (referred to after this as “the MCAI”), issued by EASA, which is the Technical Agent for the Member States of the European Union. The MCAI states that the definition of affected part is amended to exclude certain modified and re-identified freewheel clutches. You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2022-1421.

In the NPRM, the FAA proposed to retain the requirements of AD 2022-01-09 for removing the affected freewheel clutch from service and continue to prohibit the installation of an affected part, and amend the definition of an affected part and clarify the part installation prohibition.

The FAA received a comment from one commenter. An individual supported the NPRM without change.

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comment received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, including correcting a typographical error in the Required Action and Compliance paragraph, this AD is adopted as proposed in the NPRM.

The FAA estimates that this AD affects 63 gliders of U.S. registry.

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

This rule implements the Helping American Victims Affected by Neurological Attacks (HAVANA) Act of 2021, Public Law 117-46, codified in 22 U.S.C. 2680b(i), which (among other things) required Department heads to publish implementing rules. The Department published an IFR on June 30, 2022 (87 FR 38981), which laid out the process for HAVANA Act claimants in a new 22 CFR part 135, and provided that physicians certified by the American Board of Psychiatry and Neurology (ABPN) could certify the Form DS-4316, Eligibility Questionnaire for HAVANA Act Payments. The IFR provided for 30 days of public comment. Based on some of the prevalent comments, the Department published a supplemental IFR on August 9, 2022 (87 FR 48444), which provided that physicians certified by the American Board of Physical Medicine and Rehabilitation (ABPMR) could certify the Form DS-4316. Both the IFR and supplemental IFR were effective August 15, 2022.

Further background is contained in the preamble to the IFR.

The Department received a total of 69 public comments in response to the IFR. Comments provided feedback under nine general categories: clinician criteria; date of injury restriction; imaging/magnetic resonance imaging scan (MRI) studies; “other incident;” length of qualifying medical treatment; payment eligibility criteria; qualifying injury definition; personal experience; and other. Many comments provided input on multiple subjects. Such comments were assigned to multiple categories. All comments are addressed in the aggregate below.

1. Clinician criteria: Thirty comments challenged the clinician certification required to determine a qualifying injury to the brain. They stated that the requirement to be diagnosed by a board-certified neurologist from the American Board of Psychiatry and Neurology (ABPN) was too narrow, and that other certifications and physician specialties should be considered.

As noted above, the Department accepted these comments and submitted a supplementary IFR to modify the provision of the IFR relating to the Board certification of the physician who is required to assess and diagnose an individual's qualifying injury to the brain and complete the Form DS-4316. In addition to the ABPN and the ABPMR, through this final rule, the Department provides that physicians currently certified by the American Osteopathic Board of Neurology and Psychiatry (AOBNP) and the American Osteopathic Board of Physical Medicine and Rehabilitation (AOBPMR) may certify the Form DS-4316. The regulatory text (§ 135.3) and the DS-4316 are being amended accordingly.

2. Date of Injury Restriction: Fifteen comments focused on the date of injury, all expressing a belief that people who were affected by an anomalous health incident (AHI) earlier than January 1, 2016, should be eligible for a payment. The Department is unable to accept this suggestion. The HAVANA Act specifies that payments are for incidents occurring on or after January 1, 2016. The Department may not broaden the eligibility date without an amendment to the HAVANA Act or additional legislative action authorizing additional eligibility timeframes.

3. Imaging/MRI Studies: Nine comments raised objections to what was perceived as a blanket requirement for imaging/MRI studies that supported a diagnosis of “acute injury to the brain.” This perception is not correct. An individual may submit an MRI or other imaging studies to the certified physician to demonstrate an acute injury to the brain, but that is not the only way to demonstrate a qualifying injury under the IFR. The IFR also permits individuals to submit electroencephalogram (EEG) results, physical examination results, or other appropriate testing results to their certified physician for use in their physician's assessment. The Department is adding an “or” between “EEG” and “physical examination” in the definition of “Qualifying injury to the brain” (§ 135.2), between paragraphs (2)(i) and (ii), to clarify the language, and is also amending Question 3 on the Form DS-4316 accordingly.

4. “Other Incident”: Seven comments noted that the language of the HAVANA Act regarding the occurrence of the injury (“in connection with war, insurgency, hostile act, or other incidents designated by the Secretary of State”) was very broad. With regard to “other incidents”, the commenters stated that this language makes the determination subjective and not measurable, and asked how those who would be denied would know that the decision was made using objective criteria. One commenter expressed concern over who would determine that an “attack” had occurred.

The definition of “other incident” in the IFR is: “A new onset of physical manifestations that cannot otherwise be readily explained.” For each request for payment, the Department will review available information on the reported incident, including any investigations that may have been conducted. If the reports and the results of investigations do not provide a credible alternate explanation for the incident, that incident will be recommended for designation by the Secretary of State or their designee. Incidents for which an explanation has been identified will not be recommended for designation.

The list of reported incidents will be administratively controlled and will not be made public in order to ensure privacy for everyone who has reported an AHI. The IFR refers to only those from 2016 to the present because, as defined in the Act, only incidents that occurred on or after January 1, 2016, are eligible for payment. The Department maintains a list of all reported incidents; that list is not time-limited.

In the event of an adverse decision on a request for payment under the HAVANA Act, the Department has established an appeals process by which an individual may request further consideration.

5. Length of Qualifying Medical Treatment: Nine comments provided feedback on the length of qualifying medical treatment criteria. All comments disagreed that 12 months of qualifying medical treatment should be a requirement, with several suggesting that the time period be shorter—for example, three months instead of 12 months. Some proposed that the 12 months of treatment be replaced with other criteria, citing examples such as, receiving prescription medication or therapy for brain injury-related conditions such as migraines, vertigo, vision problems, and hearing loss. Another commenter suggested that the required 12 months of medical treatment be replaced with language that the “demonstrated effect of injury” was expected to last more than 12 months. The same comment expressed concern that covered employees who have been evaluated, but not yet had access to treatment, would not qualify otherwise and are excluded.

Individuals may be eligible for a HAVANA Act payment if they meet one of three criteria under the definition of “qualifying injury to the brain”: (1) an acute injury to the brain, such as, but not limited to, a concussion or penetrating injury, or as a consequence of an event that leads to permanent alterations in brain function as demonstrated by confirming correlative findings on imaging studies (to include computer tomography scan (CT) or MRI) or EEG; or (2) a medical diagnosis of a traumatic brain injury (TBI) that required active medical treatment for 12 months or more; or (3) acute onset of new persistent, debilitating neurologic symptoms as demonstrated by confirming correlative findings on imaging studies (to include CT or MRI), or EEG, or physical exam, or other appropriate testing and that required active medical treatment for 12 months or more.

Of those three criteria, only (2) and (3) require 12 months of treatment, which would demonstrate that the individual suffers from a chronic condition.

Even if a covered individual has not yet received 12-months or more of treatment as outlined in (2) or (3), the covered individual may nevertheless qualify at a later time if treatment lasts for twelve months or more. Such individuals are not excluded but will have to meet the criteria to be eligible for a payment.

6. Payment eligibility criteria: Thirty-three comments discussed various aspects of the payment eligibility criteria. The majority of the comments expressed concern about who was eligible for payments. Another subset of comments questioned how eligibility is to be (or can be) determined without a clear definition or known cause of AHI. An additional comment raised a question about adequate funding for payments under the Act. The Department anticipates that resources will be available to provide payments to those who meet the eligibility criteria. One commenter asked what would happen if the Department underestimated the costs needed to pay all eligible requesters. The Department anticipates that resources will be available to provide payments to those who meet the eligibility criteria.

Fourteen comments stated that the payment eligibility criteria should be expanded, challenged the scope of “covered individuals” defined in the Act, and specifically mentioned unpaid interns and Embassy Science Fellows as examples of persons who should be included. The Department agrees that the payment eligibility criteria should be expanded to include unpaid interns and will consequently insert “students providing volunteer services under 5 U.S.C. 3111” after “Temporary Appointments” in the definition of “covered employee.” The Department believes that Embassy Science Fellows are also covered under the definition of “covered employee”, unless they are an employee of another Federal agency. In the latter case, the employing agency would be responsible for making a determination for payment and making a payment if qualified under that agency's rules. Additionally, the definition of covered employee has no reference to nationality, and employees who are citizens of other countries may qualify if they otherwise meet the criteria for payment.

The State Department drafted the IFR in close coordination with the interagency and National Security Council. As contemplated by Congress, other Federal agencies will need to prepare their own rules for implementation of the HAVANA Act.

Another comment questioned the objective capability of the Department to determine eligibility and award payment and suggested that a neutral outside board do so instead. The Department disagrees. For each request for payment, the Department will rely on the submission from the independent board-certified physician who completed the Form DS-4316, as well as available information on the reported incident, including any investigations that may have been conducted.

One comment stated that bodily injuries caused by AHI should be eligible for payments under the Act. The Department notes that the HAVANA Act of 2021 specifically authorizes payments for qualifying “injuries to the brain,” not “bodily injuries”.

Another comment shared a belief that the Department should make HAVANA Act payments posthumously to family members who had died because of mental health issues, arguing that not enough investigation has been done into the impacts of AHI on mental health illness. The Department notes that the HAVANA Act of 2021 specifically authorizes payments for qualifying “injuries to the brain,” not for mental health illnesses.

Several comments pointed out that there was no definition for or known cause of AHI and asked how it would be possible to determine who would qualify under the HAVANA Act, which they viewed as too broad and susceptible to abuse. Conversely, multiple comments expressed concern that the medical requirements to show an injury to the brain were too stringent. In response, the Department notes that, recognizing that the nature of AHI includes a lack of consensus by the medical and scientific communities, the definition of “qualifying injury to the brain” in the IFR was written to be comprehensive, respect congressional intent, and allow the physician completing the Form DS-4316 to consider appropriate medical information and context.

Two comments proposed alternate/additional payment eligibility criteria under § 135.3, Eligibility for payments by the Department of State, including allowing covered employees who have a Department-approved reasonable accommodation to be eligible for a Base Plus HAVANA Act payment. One comment said that a medical retirement from the Department should be sufficient to qualify for a Base Plus HAVANA Act payment.

In response to these two comments, the Department notes that it developed the eligibility criteria for a Base Plus payment under § 135.3 of the rule to cover individuals who have no employment potential with or without a reasonable accommodation. The Department believes that the four separate options for meeting the criteria in § 135.3(e)(2) represent a fair and consistent approach to determining Base Plus payments. In addition, the Department has added approval for Social Security Insurance (SSI) benefits as one of the eligibility criteria for a Base Plus payment.

7. Qualifying Injury: The Department received 24 comments related to qualifying injury. Several comments noted that the IFR's definition of “qualifying injury to the brain” was not an actual definition, was too broad, and was open to “vast” interpretation. They asked if multiple sclerosis, idiopathic tics, dementia, epilepsy, Parkinson's, and several other medical conditions would qualify as an eligible injury. Other comments pointed out that traditional imagery is not likely to accurately identify changes to the brain, and that other documentation should be accepted or required, including vestibular tests. Likewise, some comments asserted a belief that TBI was a required diagnosis to qualify (which is inaccurate). Others expressed fraud and abuse concerns as taxpayers on the potential monetary scope of payments under the Act. They stated their belief that AHIs were not real and noted that there is no International Classification of Diseases, Tenth Revision (ICD-10), diagnosis code for AHI. Therefore, there would be no way to ensure that prospective recipients had been affected by an AHI, as opposed to other causative factors.

Recognizing that the nature of AHI includes a lack of consensus by the medical and scientific communities, the definition of “qualifying injury to the brain” in the IFR was written to be comprehensive, respect congressional intent, and allow the physician completing the Form DS-4316 to consider appropriate medical information and context. “Acute onset of new persistent, disabling neurologic symptoms as demonstrated by confirming correlative findings on imaging studies (to include CT or MRI), or EEG, or physical exam or other appropriate testing . . .” recognizes that the board-certified physician who completes the Form DS-4316 may exercise their professional judgment as to what elements are relevant. An ICD-10 diagnosis code specifically for AHI is not necessary as payments are for qualifying injuries to the brain, which will have one or more relevant ICD-10 codes.

Another comment specifically focused on children of affected covered employees, who reportedly did not receive evaluation of a possible AHI when their parent(s) were medically evacuated as the result of a suspected AHI. The comment states the writer's belief that dependents of AHI-affected employees should automatically qualify for a HAVANA Act payment without medical documentation, based on their parent(s)' injury. The Department notes that eligibility for a HAVANA Act payment under the IFR requires a currently board-certified physician to make a determination based in part on medical documentation submitted to the physician by the requester, and to complete the Form DS-4316 for each requester. Children of affected covered employees who may not have been evaluated at the time of the parent(s)' medevac may qualify for a payment if they meet the eligibility criteria.

The Department also notes that imagery is one of several means by which requesters can establish eligibility for payment, and that the certifying physician will consider all available medical documentation when assessing the requester's condition. A diagnosis of a TBI is a non-exclusive criterion to potentially demonstrate eligibility under the HAVANA Act, and there are other ways in which an individual may meet the medical requirement, as listed in the definition. Regarding the concern that the injury may have been caused by factors other than an AHI, the physician must certify that they do not “have evidence or otherwise believe that the [requester's] symptoms can be attributed to a pre-existing condition.”

8. Personal Experience: Three comments shared detailed accounts of individual experiences. One comment expressed frustration that the Department of Defense has not implemented its policy or procedures regarding the HAVANA Act. Another comment shared the commenter's experiences related to clinician care for AHI. The third shared the commenter's AHI experience. The Department of State respects and recognizes the service of persons from numerous departments, agencies, and institutions, public and private, who are working or have worked to advance the interests of the United States. The Department's IFR only covers persons who were employed by the State Department and dependents of those persons when the reported AHI occurred. Other U.S. Federal Government agencies will need to complete their own rulemaking process to evaluate payment eligibility.

9. Other: The Department received three comments that provided input on issues that are outside the scope of this rulemaking, including recommendations/comments on compensating employees for lost career growth as a result of an AHI; a belief that the Department must work with the Department of Labor (Federal Employees' Compensation Act (FECA)) on FECA requirements for TBI; and speculation about directed energy weapons. One commenter took the opportunity to address another comment with which they disagreed. The Department also received an email from an individual who felt that the Department's “product” was linking to their family's devices.

The Department has a process to compensate employees for demonstrated lost career growth as a result of an AHI. It was given this authority under previous legislation. The Department also works closely with the Department of Labor on FECA claims filed by its employees, but the Department of Labor sets the requirements for eligibility for FECA benefits.

This rule is being published as a final rule. Because this rule is a matter relating to public benefits, it is exempt from the requirements of 5 U.S.C. 553. See 5 U.S.C. 553(a)(2). Since the rule is exempt from the entirety of section 553 pursuant to section 553(a)(2), the provisions of section 553(d) do not apply and the rule will be in effect upon publication.

The Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) has determined that this rule is not a major rule as defined by 5 U.S.C. 804 for the purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801-808).

This rule will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in any year; and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

The Department of State certifies that this rulemaking will not have an impact on a substantial number of small entities. A regulatory flexibility analysis is not required under the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ).

The Department of State has provided this final rule to OMB for its review. OIRA has designated this rule as “significant” under Executive Order 12866. Potential causes of AHI are being investigated but remain unknown. Given the nature of the incidents, it is difficult to accurately estimate future incidents and numbers of individuals affected. The Department approved/obligated funds for five cases totaling $796,025 by the expiration of Fiscal Year (FY) 2022 on September 30. This is below our previous FY 22 estimate of $1,545,225 primarily because we did not begin accepting requests for payment until 45 days before the end of the fiscal year. For FY 2023, the estimated numbers are up to $7.3 million for 47 people. The Department has also reviewed the rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866 and finds that the benefits of the rule (in providing mechanisms for individuals to obtain compensation for certain injuries) outweigh any costs to the public, which are minimal. The Department of State has also considered this rulemaking in light of Executive Order 13563 and affirms that this regulation is consistent with the guidance therein.

The Department of State has reviewed this rule in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

This rule will not have substantial direct effect on the states, on the relationships between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. Executive Order 12372, regarding intergovernmental consultation on Federal programs and activities, does not apply to this regulation.

This rulemaking is related to an information collection for the Form DS-4316, “Eligibility Questionnaire for HAVANA Act Patients,” OMB Control Number 1405-0250. This collection was approved under an emergency authorization. After OIRA approved the changes, the DS-4316 has been revised in accordance with the supplemental IFR and this final rule. The Department published a 60-day notice on September 9, 2022 (87 FR 55456). No public comments were received. The Department published a 30-day notice on November 21, 2022 (87 FR 70887) and OIRA approved the information collection on January 13, 2023.

Accordingly, for the reasons stated in the preamble, the interim rules adding and amending 22 CFR part 135, which were published on June 30, 2022 (87 FR 38981), and August 9, 2022 (87 FR 48444), are adopted as final with the following changes:

On August 21, 2019 (84 FR 43536), the U.S. Department of Housing and Urban Development published a document implementing the “Demonstration To Assess the National Standards for the Physical Inspection of Real Estate and Associated Protocols.” (“the 2019 document”). Through this demonstration, HUD is collecting, processing, and evaluating physical inspection data and information, and is improving and refining the NSPIRE model. On September 28, 2021 (86 FR 53570), HUD extended this demonstration through October 1, 2021.

During this demonstration, participants have not received an inspection of record, meaning the result of the inspection is provisional and does not result in a traditional score that is recorded in Multifamily Housing's system of record, the Integrated Real Estate Management System (iREMS). Because the demonstration has been running since 2019, demonstration participants have not received an inspection of record for several years, longer than HUD intended when HUD initially established the demonstration. Therefore, HUD seeks to prioritize providing demonstration participants an inspection of record. Through this notification, HUD is informing Multifamily Housing program participants who are currently in this demonstration and have yet to receive an inspection of record since joining the demonstration that between April 1, 2023, and September 30, 2023, HUD intends to conduct an inspection using the NSPIRE standards and scoring and that this inspection will be considered an inspection of record.

Demonstration participants who do not wish to be subject to an NSPIRE inspection of record before October 1, 2023, may choose to opt out of the NSPIRE demonstration by submitting a request via email to NSPIRE-Demo-Opt-Out@hud.gov no later than March 1, 2023. Demonstration participants who opt out of the demonstration will be subject to a UPCS inspection of record.

Additionally, through this notification, HUD is revising the end of this demonstration to align with the NSPIRE final rule. The demonstration will end for Public Housing participants on June 30, 2023, the day before HUD intends to begin inspections under NSPIRE for Public Housing, and the demonstration will end for Multifamily Housing participants on September 30, 2023, one day before the day HUD intends the NSPIRE final rule to take effect for Multifamily Housing. HUD will provide additional notice through Federal Register notice should these dates change.

This Notification provides operating instructions and procedures in connection with activities under a Federal Register document that has previously been subject to a required environmental review. Accordingly, under 24 CFR 50.19(c)(4), this Notification is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321, et seq. )

In 1964, a Code of Professional Conduct for Labor Mediators was drafted by a Federal-State Liaison Committee and approved by the Federal Mediation and Conciliation Service (FMCS) and the Association of Labor Mediation Agencies. On April 13, 1968, at 33 FR 5765, the Federal Mediation and Conciliation Service (FMCS) published a final rule entitled “Code of Professional Conduct for Labor Mediators.” This final rule adopted and codified the Code of Conduct for Labor Mediators. This Code has not been updated in nearly sixty years and no longer reflects the agency's values, scope of services provided by FMCS mediators, or best practices for conflict management and resolution services. Therefore, FMCS is creating a new code of professional conduct and is updating this rule to reference this internal Code of Professional Conduct for FMCS Mediators.

For the reasons set forth in the preamble, and under the authority 29 U.S.C. 172 of the Taft Harley Act of 1947, FMCS propose to amend 29 CFR chapter XII part 1400 as follows:

On December 13, 2022, the Postal Service published a notice of proposed rulemaking (87 FR 76170-76171) to clarify the refund policy for customers who qualified for a Group “E” (free) P.O. Box. The Postal Service did not receive any customer comments.

To ensure uniform treatment of customers who were not provided Group E P.O. Box service, the Postal Service is providing a refund policy if it has been determined that a customer paying for P.O. Box service is entitled to Group E P.O. Box service. A refund of prorated fees may be issued for each full consecutive month preceding the determination, up to a maximum of 24 months. Interest will not be paid on the amount refunded.

The Postal Service is also making a minor revision to the text in subsection 508.4.5.2c for clarity in the standard and in subsection 604.9.0 to establish a link to the P.O. Box fee refund standards in subsection 508.4.6.

We believe the proposed revisions will provide customers with a more efficient mailing experience.

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

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

Accordingly, 39 CFR part 111 is amended as follows:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Office of Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0305 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before March 27, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0305, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-03-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11559) by Valent BioSciences, LLC, 1910 Innovation Way, Suite 100, Libertyville, Il 60048. The petition requested that 40 CFR be amended by establishing an exemption from the requirement of a tolerance for residues of malic acid (CAS Reg. No. 6915-15-7) when used as an inert ingredient (buffering and stabilizing agent) in pesticide formulations applied to growing crops pre-harvest under 40 CFR 180.920. That document referenced a summary of the petition prepared by Valent BioSciences, LLC, the petitioner, which is available in the docket, https://www.regulations.gov. There were no relevant comments received in response to the notice of filing.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. When making a safety determination for an exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B) directs EPA to consider the considerations in section 408(b)(2)(C) and (D). Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Section 408(b)(2)(D) lists other factors for EPA consideration making safety determinations, e.g., the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances, among others.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for malic acid including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with malic acid follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by malic acid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The toxicological database of malic acid is supported by data regarding fumaric acid. EPA has determined that it is appropriate to bridge fumaric acid data to assess malic acid due to fumaric acid being metabolized to malic acid in biological systems.

The available toxicity studies indicate that malic acid has low overall toxicity. Malic acid has low acute toxicity via the oral route, it is anticipated to have low acute inhalation toxicity based on a study with fumaric acid, and it is anticipated to have low acute dermal toxicity, based on its low absorption through human skin. Malic acid is an eye and dermal irritant, but it is not a skin sensitizer.

No adverse effects were reported in a chronic toxicity study in rats or in the chronic toxicity study in dogs. There were also no maternal or developmental effects observed up to 350 mg/kg/day in a developmental study in rats and up to 266 mg/kg/day in a developmental study in mice. No parental or reproductive effects were observed in a reproductive toxicity study in rats. This same reproductive toxicity study reported labored breathing and weakness in offspring at the highest dose tested (1,020 mg/kg/day). However, since these effects occurred only at limit dose levels and there were no histopathological findings in the lungs, they are not considered relevant for risk assessment purposes. There was also no evidence of mutagenicity in the available studies and no structural alerts for carcinogenicity were found for malic acid. No evidence of neurotoxicity or immunotoxicity was observed in the available database.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.

The hazard profile of malic acid is adequately defined. Overall, malic acid is of low acute, subchronic, and developmental toxicity. No systemic toxicity is observed at doses that are relevant for risk assessment. Since signs of toxicity were not observed, no toxicological endpoints of concern or PODs were identified. Therefore, a qualitative risk assessment for malic acid can be performed.

1. Dietary exposure from drinking water, food and feed uses. In evaluating dietary exposure to malic acid, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from malic acid in food as follows:

Dietary exposure (food and drinking water) to malic acid may occur from eating foods treated with pesticide formulations containing this inert ingredient and drinking water containing runoff from soils containing the treated crops. Dietary exposure may also occur from non-pesticidal sources ( e.g., food additive uses and natural presence in fruits and wine). However, a quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Malic acid may be present in pesticide and non-pesticide products that may be used in and around the home. However, a quantitative residential exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found malic acid to share a common mechanism of toxicity with any other substances, and malic acid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that malic acid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

Based on an assessment of malic acid, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. Because there are no threshold effects associated with malic acid, EPA conducted a qualitative assessment. As part of that assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Because no toxicological endpoints of concern were identified, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to malic acid residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Therefore, an exemption from the requirement of a tolerance is established for residues of malic acid (CAS Reg. No. 6915-15-7) when used as an inert ingredient (buffering and stabilizing agent) in pesticide formulations applied to growing crops pre-harvest under 40 CFR 180.920.

This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

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

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0447 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 27, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0447, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-8792-03-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E8926) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.478 be amended by establishing tolerances for residues of the herbicide rimsulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide), in or on pomegranate at 0.01 parts per million (ppm) and tropical and subtropical, small fruit, edible peel, subgroup 23A at 0.01 ppm. There were no comments received in response to the notice of filing.

FFDCA section 408(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. FFDCA section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for rimsulfuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with rimsulfuron follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking and republishing the same sections is unnecessary. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a tolerance rulemaking for rimsulfuron in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to rimsulfuron and established tolerances for residues of that chemical. EPA is incorporating previously published sections from this rulemaking as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the Toxicological Profile of rimsulfuron, see Unit III.A of the February 12, 2018, final rulemaking (83 FR 5942) (FRL-9972-36).

Points of departure/Levels of concern. A summary of the toxicological endpoints for rimsulfuron used for human risk assessment is discussed in Unit III.B of the February 12, 2018, final rulemaking.

Exposure assessment. Much of the exposure assessment remains the same although updates have occurred to accommodate the exposures from the petitioned-for tolerances. These updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, please reference Unit III.C of the February 12, 2018, final rulemaking.

EPA's dietary exposure assessments have been updated to include the additional exposures from the new uses of rimsulfuron on pomegranate and tropical and subtropical, small fruit, edible peel, subgroup 23A. An unrefined chronic dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software incorporates 2005-2010 consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic assessment used tolerance level residues for all crops and assumed that 100% of the crops were treated with rimsulfuron. The Agency's default processing factors were used where available. An acute dietary exposure assessment was not conducted since there was no adverse effect observed for a single dose of rimsulfuron.

Dietary exposure from drinking water. The new uses do not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations in the chronic dietary assessment as identified in Unit III.C of the February 12, 2018, rulemaking.

From non-dietary exposure. There are no proposed residential uses at this time; however, there are existing residential uses on turf that have been previously assessed using current data and assumptions. For the residential assessment of the turf uses, EPA did not conduct a quantitative residential handler risk assessment. The end use label requires handlers to wear specific clothing (long-sleeve shirt and long pants) and chemical-resistant gloves, so EPA assumed the product is not for homeowner use. There is the potential for post-application dermal exposures; however, a residential post-application dermal exposure assessment was not conducted because no dermal hazard was identified in the rimsulfuron database. The quantifiable post-application residential risk estimates reflect incidental oral exposure to children 1 to less than 2 years old from hand-to-mouth exposure to turf treated with rimsulfuron. The margin of exposure (MOE) is 26,000, which is greater than the level of concern of 100 and is not of concern.

Cumulative effects from substances with a common mechanism of toxicity. In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. The agency has utilized this framework for rimsulfuron and determined that although rimsulfuron shares some chemical and/or toxicological characteristics ( e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for rimsulfuron and other pesticides and no further cumulative evaluation is necessary for rimsulfuron.

Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor (SF) from 10X to 1X for all risk scenarios. See Unit III.D. of the February 12, 2018, final rulemaking for a discussion of the Agency's rationale for that determination.

Aggregate risks and Determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

An acute dietary exposure assessment was not conducted since there was no adverse effect observed for a single dose of rimsulfuron. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 1.8% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure.

The short-term aggregate exposure assessment for children 1 to less than 2 years old includes dietary (food and drinking water) and incidental oral exposure from hand-to-mouth activities from post-application exposure to turf. The short-term aggregate risk estimate for children 1 to less than 2 years old is an MOE of 3,700, which is greater than the level of concern of 100 and is not of concern. Acute risks are not expected due to no adverse effect observed for a single dose of rimsulfuron; and chronic aggregate risks to adults and children are equivalent to the dietary (food and drinking water) risks for those respective assessments and are not of concern. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of intermediate-term risk is necessary. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, rimsulfuron is not expected to pose a cancer risk to humans.

Therefore, based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to rimsulfuron residues. More detailed information on this action can be found in the document “Rimsulfuron. Human Health Risk Assessment in Support of a Petition for the Establishment of Permanent Tolerances on Pomegranate and Tropical and Subtropical, Small Fruit, Edible Peel, Subgroup 23A” in docket ID No. EPA-HQ-OPP-2021-0447.

For a discussion of the available analytical enforcement method for various crops, see Unit IV.A of the February 12, 2018, rulemaking.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex has not established MRLs for residues of rimsulfuron in or on any commodity associated with this action.

Therefore, tolerances are established for residues of rimsulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide), in or on pomegranate at 0.01 ppm and tropical and subtropical, small fruit, edible peel, subgroup 23A at 0.01 ppm.

In addition, as a housekeeping measure, EPA is removing the tolerance for potato at 0.1 ppm, which expired on August 12, 2018, and has no effect at this time.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the CRA (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

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

I. Background and Statutory Authority

The purpose of the NIH LRP programs is to recruit and retain highly qualified health professionals as biomedical and behavioral researchers. The programs offer educational loan repayment for participants who agree, by written contract, to engage in qualifying domestic non-profit supported research at a qualifying non-NIH institution, or as an NIH employee for a minimum of two years (or three years for the Intramural LRP's general research subcategory).

On December 13, 2016, Congress enacted the 21st Century Cures Act, Public Law (Pub. L.) 114-255, Section 2022 of which amended the Public Health Service (PHS) Act to authorize the consolidation of National Institutes of Health Loan Repayment Programs (LRPs) into the Intramural Loan Repayment Program and the Extramural Loan Repayment Program.

The legislation also provides the NIH Director with the authority to establish or eliminate one or more subcategories of the LRPs to reflect workforce or scientific needs related to biomedical research. Thus, this statute allows for up to four subcategories for the Intramural Loan Repayment Program (General, Acquired Immunodeficiency Syndrome (AIDS), Clinical for Researchers from Disadvantaged Backgrounds, and one additional subcategory) and up to six subcategories for the Extramural Loan Repayment Program (Contraception & Infertility, Pediatric, Clinical, Health Disparities, Clinical for Researchers from Disadvantaged Backgrounds, and one additional subcategory).

Furthermore, the 21st Century Cures Act provides the NIH Director with direct authority to administer the NIH Loan Repayment Programs (formerly the duty of the Secretary, HHS).

Finally, the legislation authorizes NIH to raise its annual loan repayment amount to a maximum of $50,000, which reflects a change from the previous maximum annual loan repayment amount of $35,000.

The PHS Act, as amended, now contains sections 487A (Intramural loan repayment program; 42 U.S.C. 288-1) and 487B (Extramural loan repayment program; 42 U.S.C. 288-2), with the removal of previous sections 464z-5, 487C, 487E, and 487F by the 21st Century Cures Act. Sections 487A and 487B of the PHS Act authorize the NIH Director to enter into contracts with qualified health professionals under which such professionals agree to conduct research in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $50,000 of the principal and interest of the qualified educational loans of such professionals. In return for these loan repayments, applicants must agree to participate in qualifying research for an initial period of not less than two years (or a minimum of three years for the Intramural LRP's general research subcategory), as one of the following: (1) An NIH employee (for Intramural LRP), or (2) A health professional engaged in qualifying research supported by a domestic non-profit foundation, non-profit professional association, or other non-profit institution ( e.g., university), or a U.S. or other government agency (Federal, State or local).

HHS announced its intentions to initiate this rulemaking action in the notice of proposed rulemaking (NPRM) titled “National Institutes of Health Loan Repayment Programs” that it published in the Federal Register on March 8, 2022 (87 FR 12919-12923). The NPRM provided a sixty-day public comment period. The comment period ended May 9, 2022.

In the NPRM, we proposed updating the existing regulation for NIH LRPs codified at 42 CFR part 68, and titled “National Institutes of Health Loan Repayment Programs,” to reflect the changes in NIH LRPs that resulted from enactment of the 21st Century Cures Act.

Specifically, we proposed amending the authority citation by adding the United States Code (U.S.C.) citation 42 U.S.C. 216 and removing U.S.C. citations 42 U.S.C. 254o, 42 U.S. C288-3, 42 U.S.C.288-5, 42 U.S. C. 288-5a, 42 U.S.C. 288-6, and 42 U.S.C.285t-2.

We proposed amending § 68.1 by removing the references to sections 487C, 487E, 487F and 464z-5 of the Public Health Service Act (PHS Act), and references to U.S.C. citations 42 U.S.C. 288-3, 42 U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C. 288-6, and 42 U.S.C. 285t-2; and by revising the last sentence of the introductory narrative to indicate that the NIH Loan Repayment Programs include two separate programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers).

Additionally, we proposed amending paragraphs (a) and (b) by revising them and their respective subparagraphs in their entirety to reflect that there are currently two NIH LRPs, the Intramural LRP with up to four subcategories and the Extramural LRP with up to six subcategories.

We proposed amending § 68.2 by removing the term “Secretary,” adding the term “Research in Emerging Areas Critical to Human Health,” and revising the term “Nonprofit funding/support to read “Nonprofit research funding/support.” We further proposed amending § 68.2 by revising the definitions for “Debt threshold,” “Director,” “Educational expenses,” “Extramural LRP,” “Intramural LRP,” “Loan repayment programs,” “Participant,” “Program eligibility date,” “Qualified Educational Loans and Interest/Debt,” “Reasonable educational and living expenses,” “Repayable debt,” and “Waiver.”

We proposed amending § 68.5 by revising paragraph (d) to state that for the Extramural LRP only, individuals who receive any salary support or participate in research that receives funding support from a for-profit institution or organization, or Federal Government employees working more than 20 hours per week are ineligible to participate.

We proposed amending § 68.6 by removing the word “Secretary” and adding in its place the words “NIH Director.”

We further proposed amending § 68.7 by revising paragraph (d)(2)(iii) to state that for the minority health disparities subcategory, at least 50 percent of the contracts are required by statute to be for appropriately qualified health professionals who are members of a health disparity population.

We proposed amending § 68.8 by revising paragraph (a) to state that NIH may pay up to $50,000 per year of a participant's repayable debt rather than the previous $35,000 per year.

Additionally, we proposed amending § 68.12 by removing the word “Secretary” and adding the words “NIH Director” in its place.

We received a total of four public comments in response to the NPRM. Two of the comments were duplicates. We read the duplicates and considered them, but because they were not directly relevant to this rulemaking, they are not discussed.

A third commenter indicated that she agreed with the rule. Additionally, the commenter noted she appreciated the amendment of the language to address the Research in Emerging Areas Critical to Human Health and Nonprofit research funding/support as a focus of the important workforce needed to carry out this work. The commenter suggested that the challenge for organizations like NIH and nonprofits is attracting top talent to compete with the private biomedical research field. Finally, the commenter stated the education required and the work that is needed to improve the health of disadvantaged communities emphasize the importance of federal loan forgiveness programs for graduates who want to give their time and experience to public service. The commenter did not suggest any changes to what was proposed in the NPRM.

A fourth commenter stated that she agreed with the proposed change of having the NIH LRPs consolidated into two programs. The commenter also agreed that the NIH Director should be able to administer the NIH LRPs. However, the commenter disagreed with changing the loan repayment amount from a maximum of $35,000 per year to a maximum of $50, 000 per year. The commenter stated that the maximum loan amount should be increased on a smaller scale to reduce government spending. NIH has no discretion with respect to the loan repayment amount being increased to a maximum of $50,000 per year, because that amount has been established in statute with the enactment of the 21st Century Cures Act, Public Law (Pub. L.) 114-255. Therefore, we did not consider or adopt the suggested change.

Consequently, we did not make any changes to what we proposed in the previous NPRM in response to the four public comments received. Thus, the changes being made by this final rule are the same as the changes proposed in the previous NPRM except for the additional changes made to correct the terms “Extramural LRPs” and “Intramural LRPs” in § 68.2, Definitions, to read “Extramural LRP” and “Intramural LRP”, respectively. Each Program is a singular program with subcategories. Therefore, each term should be singular not plural. We made the changes necessary to correct this in the final rule.

We provide the following as public information.

We examined the impacts of the final rule under Executive Order (E.O.) 12866, Regulatory Planning and Review; E.O. 13563, Improving Regulation and Regulatory Review; E.O. 13132, Federalism; the Regulatory Flexibility Act (5 U.S.C. 601-612); and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

E.O. 12866 and E.O. 13563 direct Federal agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity) for all significant regulatory actions. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year). Based on our analysis, the rule does not constitute an economically significant regulatory action.

E.O. 13132, Federalism, requires Federal agencies to consult with State and local government officials in the development of regulatory policies with federalism implications. We reviewed the rule as required under the order and determined that it does not have any federalism implications. This rule will not have effect on the States or on the distribution of power and responsibilities among the various levels of government.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. For the purpose of this analysis, small entities include small business concerns as defined by the Small Business Administration (SBA), usually businesses with fewer than 500 employees. Applicants who are eligible to apply for the loan repayment awards are individuals, not small entities. This rule will not create a significant impact on a significant number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires Federal agencies to prepare a written statement which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal organizations, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation with base year of 1995) in any one year. The current inflation-adjusted statutory threshold for 2022 is approximately $165 million based on the Gross Domestic Product deflator. This rule will not result in a one-year expenditure that would meet or exceed that amount. Participation in the NIH loan repayment programs is voluntary and not mandated.

This rule does not contain any new information collection requirements that are subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). More specifically, § 68.6 is a reporting requirement, but the specifics of the burden are determined in the approved application forms used by the NIH Loan Repayment Programs and have been separately approved by OMB under OMB No. 0925-0361 (expires October 31, 2022). Additionally, §§ 68.3(c) and (e), 68.11(c), 68.14(c) and (d), and 68.16(a) are reporting requirements and/or recordkeeping requirements, but they also are covered under OMB No. 0925-0361.

The Federal Assistance Listings numbered programs affected by this rule are:

For reasons presented in the preamble, the Department of Health and Human Services amends 42 CFR part 68 as set forth below.

Background

VA published a proposed rule in the Federal Register at 86 FR 64132 on November 17, 2021, to amend the VAAR to implement and supplement the Federal Acquisition Regulation (FAR). VA provided a 60-day comment period for the public to respond to the proposed rule and submit comments. The public comment period closed on January 18, 2022. VA received ten comments from two respondents.

This rulemaking is issued under the authority of the Office of Federal Procurement Policy (OFPP) Act which provides the authority for an agency head to issue agency acquisition regulations that implement or supplement the FAR.

The VAAR has been revised to add new policy or regulatory requirements, to update existing policy, and to remove any redundant guidance where it may exist in affected parts, and to place guidance that is applicable only to VA's internal operating processes or procedures in the VA Acquisition Manual (VAAM).

This rule adopts as a final rule the proposed rule published in the Federal Register on November 17, 2021, except for revisions to respond to the public comments as discussed below, and other technical non-substantive changes to update terminology in accordance with FAR final rules and other minor administrative amendments as shown below.

The first respondent references two VA information technology and security publications and observed that as the field of technology grows, fraudulent activity rises and notes that the proposed rule provides a layer of uniform security. The respondent goes on to note that liquidated damages are instrumental.

VA appreciates the comment on the proposed rule. One of the VA Acquisition Regulation rewrite project objectives is to incorporate any new agency-specific regulations or policies to implement statutory and other requirements, to ensure VA can effectively execute its mission to serve Veterans. VA believes the regulation appropriately implements specific liquidated damages statutory requirements in the event of a data breach. The comments do not require the VA to make any revisions to the proposed rule. Therefore, VA is taking no action to revise the proposed rule based on these comments.

Another respondent recommends revising the proposed notification and reporting of security and privacy incidents from “within 1 hour of discovery to the contracting officer” to “notification of within 24 hours of identification” as being a more reasonable timeline.

VA appreciates the comment and has considered the respondent's suggestion. VA is required to ensure immediate notification in the event of discovery so that action can be initiated. VA has determined that waiting until 24 hours vs. the originally specified “within 1 hour of discovery” as set forth in the rule would potentially put Veteran's data at further risk. The one-hour notification requirement is consistent with existing VA policy that all contractors must currently comply with. In order to ensure VA continues to protect Veteran's data, the current reporting requirement is necessary. Therefore, VA is taking no action to revise the proposed rule based on these comments.

The same respondent requests that VA elaborate on the liquidated damages that are proposed for contracts that will be subject to the clause. The respondent asked, “How will such damages be assessed and enforced and is there potential for mitigation of any such damages?”

As stated in the preamble of the proposed rule, the VA Secretary is required by statute (38 U.S.C. 5725(a)-(c)) to ensure that if a contract is entered into for the performance of any Department function that requires access to sensitive personal information that VA shall include, as a condition of the contract, that a contractor shall not, directly or through an affiliate of the contractor, disclose such information to any other person unless the disclosure is lawful and is expressly permitted under the contract. This statute also requires that each such contract be subject to liquidated damages to be paid by the contractor to VA in the event of a data breach of any sensitive personal information processed or maintained by the contractor or any subcontractor under the contract. The liquidated damages collected will be used for the purpose of VA providing credit protection services. The clause that sets forth the requirement is found in the proposed rule at section 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs. The clause states that if the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach, the contractor shall, in place of actual damages, pay to the Government liquidated damages of [Contracting Officer inserts amount] per affected individual in order to cover costs related to the notification, data breach analysis and credit monitoring. The amount to be inserted by the contracting officer will be set forth in VA internal policy as the amount may change each year and would be inserted in the clause prior to contract award so contractors subject to the clause are aware. As stated in the clause, in the event the contractor provides payment of actual damages in an amount determined to be adequate by the contracting officer, the contracting officer may forgo collection of liquidated damages. Each situation will be handled by the contracting officer on a case-by-case basis under the terms and conditions of the clause as set forth in each contract.

The comments do not require VA to make any revisions to the proposed rule. Therefore, VA is taking no action to revise the rule based on these comments.

The respondent asks whether a contractor may defer to their own internal annual training programs already in place versus using VA furnished content.

VA has considered the respondent's request to permit a contractor to use their own training in lieu of VA-specific training. However, to comply with Federal policy and requirements, VA implementing directives and policy require VA organizational users (to include contractors, employees, subcontractors, and associates) and nonorganizational users to adhere to prescribed VA Privacy and Information Security Awareness and Rules of Behavior training. This training is the same training VA employees are required to take. Therefore, all contractors, contractor employees, subcontractors and associates are required to take the VA specific training and submit certificates when required by the contract where access to VA information, information systems, and VA sensitive information is required as set forth in the applicable clause(s) that are inserted in solicitations and contracts. The training is specific to VA requirements in order to protect VA information, VA sensitive information and VA information systems.

Therefore, VA is making no changes to the proposed rule as a result of this comment.

The respondent also requests VA provide more specific requirements for background screening.

Separately, specific requirements for background screening are set forth as applicable in each solicitation and contract. As this question is outside the scope of this proposed rule, VA is making no changes to the rule as a result of this comment.

The respondent asks if the definition of the initiation of a Business Associate Agreement (BAA) criteria differ from the HHS language?

To address the inquiry regarding the definition, VA refers the respondent to the definition of “Business Associate Agreement (BAA)” as set forth at VAAR 802.101. A Business Associate Agreement (BAA) means the agreement, as dictated by the Health Insurance Portability and Accountability Act of 1996 (HIAPA) Privacy Rule (45 CFR part 160), between the Veterans Health Administration (VHA) and a business associate, which must be entered into in addition to the underlying contract for services and before any release of protected health information (PHI) can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of VHA. VA applies the criteria as set forth in the HIPAA Privacy Rule.

In VAAR section 824.103-70, Protection of privacy—general requirements and procedures related to Business Associate Agreements, VA policy states that to ensure compliance with unique responsibilities to protect PHI, contractors performing under VA contracts subject to unique PHI and HIPAA shall comply with requirements and the clause prescribed at section 804.1903, 852.204-71, Information and Information Systems Security.

The respondent also inquires whether VA will require BAAs to be executed in exclusive support of this contract and held separate from the support of other organizational business?

To address the inquiry regarding the definition, VA refers the respondent to the definition of “Business Associate Agreement (BAA)” as set forth at VAAR section 802.101. A BAA means the agreement, as dictated by the HIPAA Privacy Rule (45 CFR part 160), between VHA and a business associate, which must be entered into in addition to the underlying contract for services and before any release of protected health information (PHI) can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of VHA. VA applies the criteria as set forth in the HIPAA Privacy Rule.

In VAAR section 824.103-70, Protection of privacy—general requirements and procedures related to Business Associate Agreements, VA policy states that to ensure compliance with unique responsibilities to protect protected health information PHI, contractors performing under VA contracts subject to unique PHI and HIPAA shall comply with requirements and the clause prescribed at section 804.1903, 852.204-71, Information and Information Systems Security.

To address the respondent's second inquiry whether VA will require BAAs to be executed in exclusive support of a contract, as stated at VAAR section 824.103-70 of the rule, paragraph (a), which describes HIPAA Business Associate Agreement requirements, providing that, under the HIPAA Privacy and Security Rules (see 45 CFR part 160), a covered entity (VHA) must have a satisfactory assurance that its protected health information will be safeguarded from misuse. To do so, a covered entity enters into a BAA with a contractor (now the business associate), which obligates the business associate to only use the covered entity's PHI for the purposes for which it was engaged, provide the same protections and safeguards as is required from the covered entity, and agree to the same disclosure restrictions to PHI that is required of the covered entity. This specific VA requirement is in concert with the specified HIPAA Privacy Rule (see 45 CFR part 160).

The public is also invited to see VA Directive 6066, Protected Health Information (PHI) and Business Associate Agreements Management, as referenced at paragraph (c). Contractors will be required to execute BAAs as required by the contract. Contractors should contact the cognizant contracting officer and contracting officer's representative, as required, for questions regarding BAAs which may have previously been executed and filed with the VHA (the only administration of the Department of Veterans Affairs that is a HIPAA covered entity under the HIPAA Privacy Rule).

The comments do not require the VA to make any revisions to the proposed rule. Therefore, VA is taking no action to revise the rule based on these comments.

The respondent requests that VA elaborate on the details of what would be expected to be included in the Information Technology Security Plan.

VA has considered the respondent's comment and is slightly editing the clause at 852.239-70, Security Requirements for Information Technology Resources, to ensure the requirement for a plan is understood by revising the title of the plan and its use, including in the clause at 852.239-73, Information System Hosting, Operation, Maintenance, or Use, both prescribed in VAAR part 839. The title of the required plan referenced in the clause at 852.239-70, Security Requirements for Information Technology Resources, is revised from “Information Technology Security Plan” to “Information System Security Plan” to better reflect the underlying content submittal requirements. In the clause at 852.239-70, paragraph (c) states that, generally, the plan shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of information technology resources developed, processed, or used under this contract. It should include implementation status, responsible entities, resources, and estimated completion dates. An “Information system security plan” means a formal document that provides an overview of the security requirements for an information system and describes the security controls in place or planned for meeting those requirements. Information system security plans may also include, but are not limited to, a compiled list of system characteristics or qualities required for system registration, and key security-related documents such as a risk assessment, Privacy Impact Assessment (PIA), system interconnection agreements, contingency plan, security configurations, configuration management plan, and incident response plan. The plan shall address the specific contract requirements regarding information system security and related support or services included in the contract, to include the performance work statement (PWS) or statement of work (SOW). The plan shall also comply with applicable Federal Laws that include, but are not limited to, 40 U.S.C. 11331, the Federal Information Security Modernization Act (FISMA) of 2014 and the E-Government Act of 2002. The plan shall meet information system security plan requirements (describing the security controls in place or planned for meeting those requirements) in accordance with Federal and VA policies and procedures, and as amended during the term of a contract, and include, but are not limited to the following:

(1) Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource;

(2) National Institute of Standards and Technology (NIST) Guidelines; and

(3) VA Directive 6500, VA Cybersecurity Program, and the directives and handbooks in the VA 6500 series related to VA information (including VA sensitive information and sensitive personal information and information systems security and privacy), as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, VA Handbook 6500.6, Contract Security; and VA Directive and Handbook 0710, Personnel Security and Suitability Program, which establishes VA's procedures, responsibilities, and processes for complying with current Federal law, Executive orders, policies, regulations, standards, and guidance for protecting VA information, information systems (see 802.101) security and privacy, and adhering to personnel security requirements when accessing VA information or information systems.

VA has updated the VAAR text prescribing the clause, and the clause at 852.239-70, Security Requirements for Information Technology Resources.

The respondent asks VA with respect to the clause at 852.239-73, Information System Hosting, Operation, Maintenance, or Use, to provide more details on the VA systems control procedures as well as what might be expected to be included in the PIA.

VA has considered the respondent's request to further elaborate on the requirement for a PIA. In order to provide clarity to the public, VA is incorporating non-substantive technical amendments to the clauses at 852.239-70, Security Requirements for Information Technology Resources, and 852.239-73, Information System Hosting, Operation, Maintenance, or Use, to clarify that when VA is referring to a “security plan” the requirement is for an “information system security plan.” VA has made the corresponding revisions to the clauses and applicable VAAR text where that term is included to clarify this. VA is also clarifying for the public via the clause at 852.239-70, paragraph (e), Security accreditation, that VA is referring to non-VA owned systems.

In the clause at 852.239-73, Information System Hosting, Operation, Maintenance, or Use, VA is also clarifying in paragraph (c), Collecting, processing, transmitting, and storing of VA sensitive information, that VA is referring to a broader category of VA sensitive information of which Personally Identifiable Information (PII) is a subset and has revised the clause at 852.239-73, Information System Hosting, Operation, Maintenance, or Use, to reflect “VA sensitive information” in lieu of “PII” in the paragraph to ensure clarity.

And, in paragraph (g), Disposal or return of electronic storage media on non-VA leased or non-VA owned IT equipment, VA has added a key specific reference to the National Institute of Standards (NIST) 800-88, Rev. 1, “Guidelines for Media Sanitization,” and VA Directive 6500, VA Cybersecurity Program, paragraph 2(b)(5), Media Sanitization, to provide the public more information on what electronic media sanitization requirements apply.

These technical revisions of the rule align the two clauses and ensures the public is aware that PII is considered a subset for VA sensitive information and the requirements for protecting and safeguarding the same are clearly identified and understood.

The respondent asks a final question with respect to the proposed clause at 852.239-74, Security Controls Compliance Testing, and specifically if VA can provide more details on the items to be included in a security control assessment. The respondent noted that they have concerns that it may be difficult to complete the assessment depending on the timing of any advance notification.

VA refers the public to more information on security control assessments that can be found in NIST SP 800-53A Rev. 5. The comments do not require the VA to make any revisions to the rule on the basis of the specific comment. However, VA is making one minor revision to the clause in the first sentence to provide clarity. The sentence is being revised from. . . . “VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the Contractor . . .” to “VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security and privacy controls implemented by the Contractor . . .”.

Based on the review of public comments and to provide clarity as discussed above under the analysis of public comments, VA is summarizing the technical revisions to address the comments as follows:

1. At section 839.106-70, the heading of the section is changed to “Information system security and privacy contract clauses,” in lieu of “Information technology security and privacy clauses.” And in paragraph (a), the heading for the clause at 852.239-71 is revised from “Information Technology Security Plan and Accreditation” to “Information System Security Plan and Accreditation.”

2. In the clause at 852.239-70, Security Requirements for Information Technology Resources, the following clarifying edits were made:

a. In paragraph (a), the definition for “Security plan” is revised slightly to now read “Information system security plan” and an unnecessary reference to “or an information security program and” is removed for clarity.

b. In paragraph (b), in the first sentence the phrase “information technology security” is revised to read “information system security . . .”.

c. In paragraph (c), the heading of the paragraph is revised to read “Information system security plan” in lieu of “Information technology security plan.” Other conforming edits are made to revise the use from “security plan” to read “information system security plan”, and to remove the term “technology” where not appropriate. The paragraph is also updated in the fifth sentence to remove the phrase “or qualities required for system registration” as unnecessary.

d. In paragraph (d), the required number of calendar days for submittal of an Information System Security Plan is increased from “30 days after contract award” to read “90 days after contract award.” This provides more time for contractors to accomplish the required submittal.

e. In paragraph (e), dealing with security accreditation, the phrase “information technology security accreditation” is revised to read “information system security accreditation” in the first sentence. It is also clarified by adding the phrase “for non-VA owned systems” to make this clear. And the second to last and the last sentence are edited to improve the flow of information.

f. In paragraph (f), the referenced “IT Security Plan” is revised to reflect the updated usage of “Information System Security Plan” as contained within the rest of the clause.

g. In paragraph (j), dealing with Government access, the phrase “information technology inspection” is revised to reflect “information system inspection” to reflect the more accurate terminology. And the word “technology” is removed in the last sentence after the word “information” so that it now reads “. . . information systems operated on behalf of VA), . . .”.

3. In the clause at 852.239-73, Information System Hosting, Operation, Maintenance, or Use, the following editorial revisions are made for clarity and to incorporate the appropriate use of the term “information system security plan” in lieu of “security plan.”

a. In paragraph (a), the definition for “Security plan” is revised slightly to now read “Information system security plan” and an unnecessary reference to “or an information security program and” is removed for clarity.

b. In paragraph (c), dealing with collecting, processing, transmitting, and storing of PII, the heading is revised to reflect “VA sensitive information” in lieu of PII as the more appropriate term to use that would encompass PII. The heading for this paragraph would now read “Collecting, processing, transmitting, and storing of VA sensitive information.” An unnecessary phrase “as determined by the VA Privacy Service” is removed. The phrase “Privacy Impact Assessment” is deleted, and the phrase “Information System Security Plan” is inserted in its place as the more accurate term. And the requirement that a Plan of Action and Milestones (POA&M) must be submitted and approved is expanded from just prior to “collection of PII” to prior to “collecting, processing, transmitting, and storing of VA sensitive information” to comply with requirements already described elsewhere in the rule.

c. In paragraph (g), concerning disposal or return of electronic storage media on non-VA leased or non-VA owned IT equipment, VA is adding the required specific references to the existing language as follows: “NIST 800-88, Rev. 1, “Guidelines for Media Sanitization,” and VA Directive 6500, VA Cybersecurity Program, paragraph 2(b)(5), Media Sanitization . . .”.

4. In the clause at 852.239-74, Security Controls Compliance Testing, VA is making a minor edit to revise the phrase “all of the security controls and privacy practices” to “all of the security and privacy controls” in the first sentence.

This rule makes 12 non-substantive changes to the rule to provide clarity, eliminate confusion, and to ensure compliance with the FAR. Specifically, VA is revising the term “commercial items” to reflect either “commercial products and commercial services” or “commercial products or commercial services” in alignment with FAR final rule, Federal Acquisition Regulation: Revision of Definition of “Commercial Item”, RIN 9000-AN76, effective December 6, 2021. There are 14 mentions of the legacy term “commercial items” that were identified in this rule's amendatory language in the following VAAR parts, subparts, and sections, to include headings as well as the underlying text. The legacy term “commercial items” was also referenced in two FAR clause references where the FAR heading has also been revised because of the referenced FAR final rule. The respective VAAR part 812 table of contents also has the legacy term “Commercial Item” and will also be updated with this final rule.

Accordingly, VA is revising the final rule to reflect the updated terminology in accordance with the FAR final rule and as reflected in the amendatory text as follows (items number 1-9 below):

1. At section 804.1902, Applicability, VA is revising the phrase in the section from “acquisition of commercial items” to “acquisition of commercial products or commercial services.”

2. At section 811.503-70, Contract clause, paragraph (b), VA is revising the phrase “in commercial items” to read “for commercial products or commercial services . . .”.

3. At section 811.503-70, Contract clause, paragraph (c), VA is revising the phrase “commercial items” to read “commercial products or commercial services . . .”.

4. Under part 812, Acquisition of Commercial Items, VA is revising the heading from “Acquisition of Commercial Items” to “Acquisition of Commercial Products and Commercial Services”.

5. At subpart 812.3, VA is revising the heading from “Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Items” to read “Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Products and Commercial Services.”

6. At section 812.301, VA is revising the heading from “Solicitation provisions and contract clauses for the acquisition of commercial items” to read “Solicitation provisions and contract clauses for the acquisition of commercial products and commercial services.”

7. Under section 812.301, at paragraphs (f)(1) and (2), VA is revising the heading to the FAR provision at 52.212-1 to read “Instruction to Offerors—Commercial Products and Commercial Services,” and the heading to the FAR provision at 52.212-2 to read “Evaluation—Commercial Products and Commercial Services.”

8. At section 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs, the following revisions are made:

a. In the Alternate I paragraph, the phrase, “commercial items” is revised to read “commercial products or commercial services,” and in paragraph (e) under Alternate I, the referenced heading for the FAR clause at 52.212-4 is revised to read “Contract Terms and Conditions—Commercial Products and Commercial Services.”

b. In the Alternate II paragraph, the phrase, “commercial items” is revised to read “commercial products or commercial services,” and in paragraph (e) under Alternate II, the referenced heading for the FAR clause at 52.212-4 is revised to read “Contract Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services).”

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866.

The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

This final rule includes provisions constituting a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that require approval by OMB. Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for review and approval, including all comments received on the proposed information collections and any changes made in response to comments. OMB has reviewed and assigned four new OMB Control Numbers, which are detailed below. In accordance with 5 CFR part 1320, the new OMB control numbers and the information collections are not approved at this time. OMB has up to 30 days to approve these information collections after the final rule publishes.

• OMB Control Number 2900-0895 for section 839.106-70, Information security and privacy clauses, and the VAAR clauses at 852.239-70, Security Requirements for Information Technology Resources, 852.239-72, Information System Design and Development, and 852.239-73, Information System Hosting, Operation, Maintenance or Use.

• OMB Control Number 2900-0900 for section 804.1970, Information security policy—contractor general responsibilities, and the VAAR clause at 852.204-71, Information and Information System Security.

• OMB Control Number 2900-0901 for section 811.503-70, Contract clause, and the VAAR clause at 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

• OMB Control Number 2900-0902 for section 812.301(f), Solicitation provisions and contract clauses for the acquisition of commercial products or commercial services, and the VAAR clauses at 852.212-71, Gray Market and Counterfeit Items, and 852.212-72, Gray Market and Counterfeit Items—Information Technology Maintenance Allowing Other-than-New Parts.

If OMB does not approve the collections of information as requested, VA will immediately remove the provisions containing a collection of information or take such other action as is directed by OMB.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The factual basis for this certification is based on the information set forth in this section. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

This rulemaking does not change VA's policy regarding small businesses and does not have a significant economic impact to individual businesses. The overall impact of the proposed rule would be of benefit to small businesses owned by Veterans or service-disabled Veterans as the VAAR is being updated to provide needed guidance to ensure VA's contractors properly protect and safeguard VA sensitive information, which includes Veteran's sensitive personal information. This rulemaking adds a new VAAR part concerning Acquisition of Information Technology that codifies information collection burdens. VA's requirement to collect the information is the result of existing requirements to ensure compliance across the Federal government and specifically when VA contractors, subcontractors, business associates and their employees require access to VA information (including VA sensitive information) or information systems. VA is merely adding existing and current regulatory requirements to the VAAR and placing guidance that is applicable only to VA's internal operation processes or procedures into a VA Acquisition Manual. VA estimates no substantial cost impact to individual businesses will result from these rule updates already required to be considered by both large and small businesses to receive an award from VA or another Federal agency. There are costs associated with this rulemaking pertaining to the codification of an information collection request in order to comply with VA's responsibilities under the Federal Information Security Modernization Act of 2014. Each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. By statute, VA is required to ensure that its contractors, subcontractors, business associates, and their employees operating under contracts at VA shall be subject to the same Federal laws, regulations, policies or procedures as VA and VA personnel. While this requirement adds some burden in annual costs and hours to firms already awarded and performing contracts at VA, the overall cost is considered de minimis, for either large or small contractors, in relation to the potential impact and harm to Veterans and VA information and information systems should a contractor not comply. Properly setting forth the requirements will provide clarity to the public and ensure appropriate safeguards are in place to ensure protection of VA's information (in particular VA sensitive personal information) and information systems. In total, this rulemaking does not change VA's policy regarding small businesses, does not have a substantial economic impact to individual businesses, and does not significantly increase or decrease costs small business were already required to bear when performing contracts which required the access, maintenance, process, or utilization of VA sensitive information or information systems.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal Governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This rule would have no such effect on State, local, and tribal Governments or on the private sector.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, approved this document on December 19, 2022, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set forth in the preamble, VA amends 48 CFR chapter 8 as follows:

The Pipeline and Hazardous Materials Safety Administration (PHMSA) published final rule HM-260B  1 to correct editorial errors and improve the clarity of certain provisions in PHMSA's program and procedural regulations and in the Hazardous Materials Regulations (HMR; 49 Code of Federal Regulations parts 171-180). The intended effect of the rulemaking was to enhance accuracy and reduce misunderstandings of the HMR. The changes in the final rule included numerous amendments to the § 172.101 Hazardous Materials Table (HMT). Unfortunately, the amendments to the table entries for various hazardous materials introduced new unintended errors that PHMSA is correcting in this notice. The unintended errors are summarized below.

UN2258, 1,2-Propylenediamine: In HM-260B, PHMSA removed special provision A6 from column (7) of the § 172.101 HMT for several hazardous materials including “UN2258, 1,2-Propylenediamine.” Special provision A6 was removed because it had been inadvertently added back to the § 172.101 HMT when making unrelated changes to entries in final rule HM-219C. 2 UN2258, 1,2-Propylenediamine is a Class 8 corrosive liquid material that also has a secondary Class 3 flammable hazard. Thus, in column (6) of the table, the codes “8” and “3” are specified for the hazard labels required for a package containing this material. However, in HM-260B, we inadvertently omitted reference to the “3” from column (6). The absence of the “3” will create uncertainty for shippers and carriers of “UN2258, 1,2-Propylenediamine” as to whether a Class 3 label is required on a package containing this material. To meet the original intent of HM-260B to enhance accuracy and reduce misunderstandings of the HMR, PHMSA is correcting this error in this notice. See Section III. Corrections.

Vessel stowage codes: In HM-260B, PHMSA also made several revisions to correct inadvertent omissions of vessel stowage codes from column (10B) to the § 172.101 HMT for the entries “UN1783, Hexamethylenediamine solution, 8, III,” “UN1788, Hydrobromic acid, with not more than 49 percent hydrobromic acid,” and “UN1740, Hydrogendifluoride, solid, n.o.s., 8, III.” Column (10B) assigns specific codes for the stowage and handling requirements for specific hazardous materials transported by vessel. In HM-219C, PHMSA had inadvertently omitted stowage code “52” for the Packing Group (PG) III entry for “Hexamethylenediamine solution” and stowage codes “53” and “58” for the PG III entry for “Hydrogendifluoride, solid, n.o.s,” when making unrelated changes to these entries to specify reference citations for authorized packaging exceptions.

Stowage code “52” means stow “separated from” acids. Stowage codes “53” and “58” mean stow “separated from” alkaline compounds and stow “separated from” cyanides, respectively. These stowage codes are important to ensure proper segregation between acids and both amines and cyanides. Amines react dangerously with acids and evolving heat, and the heat of reaction has the potential to generate corrosive vapors. Cyanides react with acids to generate toxic vapors. PHMSA attempted to add the respective stowage codes back to column (10B) under HM-260B but instead added the stowage codes to column (7), which assigns special provisions applicable to certain § 172.101 HMT entries. More specifically, stowage code “52” was added to both column (7) and column (10B) for “Hexamethylenediamine solution, II” and stowage codes “53” and “58” were added to column (7) and not column (10B) for “Hydrogendifluoride, solid, n.o.s., III.”

Readers may misinterpret unrelated special provisions as being applicable and that the stowage codes that were inadvertently omitted would not apply. For example, special provision “53” requires packages to display a subsidiary risk label “EXPLOSIVE” along with the subsidiary hazard indicated in the shipping description. If “53” were to remain in column (7) for the PG III entry of “Hexamethylenediamine solution”—which is a corrosive material that does not have an explosive hazard—persons would be mischaracterizing the hazard for the material.

Additionally, in final rule HM-215O, 3 PHMSA inadvertently omitted stowage codes “53” and “58” for the entry “UN1788, Hydrobromic acid, with not more than 49 percent hydrobromic acid.” PHMSA had made numerous changes to the stowage codes assigned to hazardous materials in the § 172.101 HMT for consistency with the International Maritime Dangerous Goods (IMDG) Code for regulation of hazardous material transported by vessel including for the companion entry “UN1788, Hydrobromic acid, with more than 49 percent hydrobromic acid.” The IMDG Code Dangerous Goods List has just one table entry for “UN1788, Hydrobromic acid,” but PHMSA splits it into two hazardous materials descriptions because of varying safety measures dependent on the mode of transport. For instance, “UN1788, Hydrobromic acid, with more than 49 percent hydrobromic acid,” is forbidden for transport by air. PHMSA attempted to add the respective stowage codes to column (10B) of the § 172.101 HMT to the “not more than” entry of UN1788 but inadvertently omitted the “not” from the hazardous materials description effectively making the changes apply to the “more than” entry of UN1788. PHMSA also inadvertently omitted stowage code “8” in the process. If these errors remain uncorrected, readers may misinterpret the provisions that apply to the “more than” entry as now applying to the “not more than” entry and that the missing stowage codes would not apply when transporting this material. To meet the intent of HM-260B to enhance accuracy and reduce misunderstandings of the HMR, PHMSA is correcting these errors in this notice. See Section III. Corrections.

Statutory authority for this correction notice is provided by the Federal Hazardous Materials Transportation Law (49 U.S.C. 5101 et seq. ). The Secretary delegated the authority granted in this law to the PHMSA Administrator at 49 CFR 1.97(b).

PHMSA finds it has good cause to make the corrections without notice and comment pursuant to Section 553(b) of the Administrative Procedure Act (APA, 5 U.S.C. 551, et seq. ). Section 553(b)(B) of the APA provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. As explained above, the changes to the text of the final rule document provided in this notice consist of corrections to preamble discussion of § 172.101 HMT and corrections to the regulatory text in the amendatory instruction for changes to § 172.101 HMT. The publication of this correction notice is needed to ensure the accuracy and reduce misunderstanding of unintended changes or omissions to § 172.101 HMT.

The January 26, 2023, effective date of the revisions contained in this notice is authorized under both Section 553(d)(1) and (3) of the APA. Section 553(d)(1) provides that a rule should take effect “not less than 30 days” after publication in the Federal Register except for “a substantive rule which grants or recognizes an exemption or relieves a restriction,” while Section 553(d)(3) allows for earlier effectiveness for good cause found by the agency and published within the rule. 5 U.S.C. 553(d)(1), (3). “The purpose of the thirty-day waiting period is to give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. F.C.C., 78 F.3d 620, 630 (D.C. Cir. 1996). Since this final rule has not yet taken effect, the impact on affected parties is minimal and such parties will not be adversely impacted by the shortened period before the correction becomes effective. The corrections in this notice accurately represent the intended changes to the § 172.101 HMT in the final rule and, in accordance with 5 U.S.C. 553(d)(1), are effective January 26, 2023. Moreover, PHMSA finds that good cause under Section 553(d)(3) supports making the revisions effective January 26, 2023, because the corrections contained in this notice are entirely consistent with the final rule—which itself was published on December 27, 2022—and helps promote accuracy and understanding of the § 172.101 HMT requirements prior to the January 26, 2023, effective date.

This notice has been evaluated in accordance with existing policies and procedures and is considered not significant under Executive Order 12866 (“Regulatory Planning and Review”) and DOT Order 2100.6A (“Rulemaking and Guidance Procedures”); therefore, this notice has not been reviewed by the Office of Management and Budget (OMB) under Executive Order 12866. PHMSA finds that the corrections in the notice (in all respects consistent with the final rule) neither impose incremental compliance costs nor adversely affect safety.

The Regulatory Flexibility Act (5 U.S.C. 601, et seq. ) requires agencies to review regulations to assess their impact on small entities unless the agency head certifies that a rulemaking will not have a significant economic impact on a substantial number of small entities including small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. The Regulatory Flexibility Act directs agencies to establish exceptions and differing compliance standards for small businesses when possible to do so and still meet the objectives of applicable regulatory statutes. Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”)  4 requires agencies to establish procedures and policies to promote compliance with the Regulatory Flexibility Act and to “thoroughly review draft rules to assess and take appropriate account of the potential impact” of the rules on small businesses, governmental jurisdictions, and small organizations. DOT posts its implementing guidance on a dedicated web page. 5

The final rule was developed in accordance with Executive Order 13272 and with DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act and ensure that potential impacts of draft rules on small entities are properly considered. There are no costs to small entities associated with the final rule. The final rule made non-substantive changes that do not impose new requirements, so there are no direct or indirect adverse economic impacts for small units of government, businesses, or other organizations. This notice similarly does not impose new requirements but makes corrections to errors in the final rule document in the amendments to the § 172.101 HMT that if left uncorrected would be inaccurate and cause misunderstanding by stakeholders as to what requirements apply. Consequently, PHMSA certifies that neither the final rule nor this notice has a significant economic impact on a substantial number of small entities.

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ), no person is required to respond to any information collection unless it has been approved by OMB and displays a valid OMB control number. Section 1320.8(d) of 5 CFR requires that PHMSA provide interested members of the public and affected agencies an opportunity to comment on information and recordkeeping requests. The corrections in this notice impose no new or revised information collection.

The Unfunded Mandates Reform Act of 1995 (UMRA; 2 U.S.C. 1501, et seq. ) requires agencies to assess the effects of federal regulatory actions on state, local, and tribal governments, and the private sector. For any final rule that includes a federal mandate that may result in the expenditure by state, local, and tribal governments, or by the private sector of $100 million or more in 1996 dollars in any given year, the agency must prepare, amongst other things, a written statement that qualitatively and quantitatively assesses the costs and benefits of the federal mandate. The final rule did not impose unfunded mandates under the UMRA and this notice to correct errors in the final rule document also does not impose unfunded mandates. It does not result in costs of $100 million or more in 1996 dollars to either state, local, or tribal governments, or to the private sector in any one year and is the least burdensome alternative that achieves the objective of the rule.

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), and implementing regulations by the Council on Environmental Quality (40 CFR part 1500) requires federal agencies to consider the consequences of federal actions and prepare a detailed statement on actions that significantly affect the quality of the human environment. DOT Order 5610.1C, “Procedures for Considering Environmental Impacts,” establishes departmental procedures for evaluating environmental impacts under NEPA and its implementing regulations. The purpose of the final rule was to introduce non-substantive changes that do not impose new requirements in order to improve accuracy and understanding of the HMR. The corrections to the final rule in this notice similarly do not impose new requirements. Therefore, PHMSA has determined that implementing this final rule will not significantly impact the quality of the human environment.

The final rule was analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”)  6 and its implementing Presidential Memorandum (“Preemption”). 7 Executive Order 13132 requires agencies to assure meaningful and timely input by state and local officials in the development of regulatory policies that may have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” The corrections in this notice are consistent with, and facilitate compliance with, the final rule, and do not have any substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government beyond what was accounted for in the final rule. It does not contain any provision that imposes any substantial direct compliance costs on state and local governments, nor any new provision that preempts state law. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

Executive Orders 12898 (“Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations”), 8 13985 (“Advancing Racial Equity and Support for Underserved Communities Through the Federal Government”), 9 13990 (“Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis”), 10 14008 (“Tackling the Climate Crisis at Home and Abroad”)  11 and DOT Order 5610.2C (“Department of Transportation Actions to Address Environmental Justice in Minority Populations and Low-Income Populations”) require DOT agencies to achieve environmental justice as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects of their programs, policies, and activities on minority populations, low-income populations, and other underserved and disadvantaged communities.

PHMSA evaluated the final rule under the above Executive Orders and DOT Order 5610.2C and did not expect the final rule to cause disproportionately high and adverse human health and environmental effects on minority, low-income, underserved, and other disadvantaged populations and communities. The final rule was facially neutral and national in scope; it was neither directed toward a particular population, region, or community, nor was it expected to adversely impact any particular population, region, or community. Since PHMSA did not expect the final rule to adversely affect the safe transportation of hazardous materials generally, PHMSA does not expect the corrections to the final rule in this notice to involve disproportionately high adverse risks for minority populations, low-income populations, or other underserved and other disadvantaged communities.

The final rule was analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”)  12 and DOT Order 5301.1 (“Department of Transportation Policies, Programs, and Procedures Affecting American Indians, Alaska Natives, and Tribes”). Because none of the corrections have Tribal implications or impose substantial direct compliance costs on Indian Tribal governments, the funding and consultation requirements of Executive Order 13175 do not apply.

Executive Order 13175 and DOT Order 5301.1 require DOT Operating Administrations to assure meaningful and timely input from Indian Tribal government representatives in the development of rules that significantly or uniquely affect tribal communities by imposing “substantial direct compliance costs” or “substantial direct effects” on such communities or the relationship and distribution of power between the Federal Government and Native American Tribes. PHMSA assessed the impact of this final rule and determined that it did not significantly or uniquely affect tribal communities or Native American Tribal governments. The changes to the HMR as written in the final rule are facially neutral and have broad, national scope. PHMSA therefore, expected the final rule not to affect tribal communities significantly or uniquely, much less impose substantial compliance costs on Native American Tribal governments or mandate tribal action. Because PHMSA expects the final rule will not adversely affect the safe transportation of hazardous materials generally, PHMSA does not expect it will entail disproportionately high adverse risks for tribal communities. For these reasons, PHMSA concluded the funding and consultation requirements of Executive Order 13175 and DOT Order 5301.1 do not apply. Similarly, PHMSA does not expect the corrections to the final rule in this notice to affect tribal communities significantly or uniquely, much less impose substantial compliance costs on Native American Tribal governments or mandate tribal action.

Under Executive Order 13609 (“Promoting International Regulatory Cooperation”), 13 agencies must consider whether the impacts associated with significant variations between domestic and international regulatory approaches are unnecessary or may impair the ability of American business to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The corrections to the final rule in this notice do not impact international trade.

The National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) directs federal agencies to use voluntary consensus standards in their regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specification of materials, test methods, or performance requirements) that are developed or adopted by voluntary consensus standard bodies. The corrections to the final rule do not invoke any voluntary consensus standards, so the National Technology Transfer and Advancement Act of 1995 is not applicable in this case.

PHMSA makes corrections to both the preamble and regulatory text of the final rule document. PHMSA is correcting the preamble discussion of changes to column (7) of the § 172.101 HMT by removing discussion of changes to the entries “UN1783, Hexamethylenediamine solution, 8, III,” and “UN1740, Hydrogendifluoride, solid, n.o.s., 8, III,” which misconstrue the intended vessel storage codes changes as special provision changes and correctly adds to the discussion of column (10B) changes as discussion of vessel stowage code changes for these materials. Additionally, PHMSA is correctly revising the § 172.101 HMT entries for the hazardous materials discussed above in Section I.

In FR Doc. 2022-26960, appearing on page 79752 in the Federal Register of Tuesday, December 27, 2022, the following corrections are made:

1. On page 79755, in the 3rd column, beginning at the bullet paragraphs starting with “For “UN1740”” and “For “UN1783””, the following are correctly removed:

• For “UN1740, Hydrogendifluoride, solid, n.o.s., 8, PG III,” PHMSA is correcting an error where special provisions 53 and 58 are missing from column 7.

• For “UN1783, Hexamethylenediamine solution, 8, PG III, PHMSA is correcting an error where special provision 52 is missing from column 7.

2. On page 79756, in the 2nd column at the end of the first paragraph and before the heading “Section 172.102,” the following is correctly added:

• In column (10B) for “UN1740, Hydrogendifluoride, solid, n.o.s., 8, PG III,” stowage codes “53” and “58” are missing. PHMSA inadvertently omitted these stowage codes when making changes to this entry in HM-219C to allow packaging exceptions. Stowage code “53” provision means stow “separated from” alkaline compounds and stowage code “58” provision means stow “separated from” cyanides. PHMSA is amending the HMT to add the stowage codes back to column (10B). This amendment will ensure that this material is properly stowed for safe vessel transport.

• In column (10B) for “UN1783, Hexamethylenediamine solution, 8, PG III,” stowage code “52” is missing. PHMSA inadvertently omitted this stowage code when making changes to this entry in HM-219C to allow packaging exceptions. Stowage code “52” provision means stow “separated from” acids. PHMSA is amending the HMT to add the stowage code back to column (10B). This amendment will ensure that this material is properly stowed for safe transport.

Why we need to publish a rule. Under the Act, a species may be removed from the Federal Lists of Endangered and Threatened Wildlife and Plants ( i.e., “delisted”) if it is determined that the species has recovered and no longer meets the definition of an endangered species or a threatened species. Delisting a species can only be completed by issuing a rule.

What this document does. This rule removes the SC Bell's sparrow ( Artemisiospiza belli clementeae ) (formerly known as the SC sage sparrow, Amphispiza belli clementeae ), SCI bush-mallow ( Malacothamnus clementinus ), SCI paintbrush ( Castilleja grisea ), SCI lotus ( Acmispon dendroideus var. traskiae ), and SCI larkspur ( Delphinium variegatum ssp. kinkiense ) from the Federal Lists of Endangered and Threatened Wildlife and Plants (Lists) based on the species' recovery.

The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species because of one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We must consider these same factors in delisting a species.

We have determined that the five SCI species are not in danger of extinction now nor are they likely to become so in the foreseeable future based on a comprehensive review of their status and listing factors. Specifically, our recent review indicated that the Navy's successful removal of nonnative herbivores (goats, sheep, pigs, cattle, mule deer) led to recovery of vegetation in areas of severely degraded habitat on SCI and to the recovery of these five species to the point that they no longer require protections under the Act. Accordingly, the species no longer meet the definition of endangered or threatened species under the Act.

We developed species status assessment (SSA) reports for the five species, in cooperation with an SSA team and the Navy. The SSA reports represent a compilation of the best scientific and commercial data available concerning the status of these species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.

Peer review and public comment. In each of the five respective SSAs, we evaluated the species' needs, current conditions, and future conditions to inform our May 5, 2021, proposed rule (86 FR 23882). We sought peer review from independent specialists and evaluated their comments to ensure that our determination is based on scientifically sound data, assumptions, and analyses. We considered all comments and information we received during the public comment period on the proposed delisting rule and the draft PDM plan when developing this final rule.

On May 5, 2021, we proposed to delist these five SCI species from the Federal Lists of Endangered and Threatened Wildlife and Plants (86 FR 23882). Please refer to that proposed rule for a detailed description of previous Federal actions concerning these species. The proposed rule and supplemental documents are provided at https://www.regulations.gov under Docket No. FWS-R8-ES-2020-0074.

On December 9, 2021, following the closing of the public comment period on the proposed rule and while this final rule was being drafted, we received from the U.S. Navy (hereafter, “Navy”) a draft description of the proposed action and alternatives for the San Clemente Island Training and Testing Environmental Analysis, which identified proposed changes in training activities and proposed designation of new training areas in habitat occupied by the five SCI species. In response to this new information, we coordinated with the Navy to identify appropriate avoidance and minimization measures, and the Navy reaffirmed commitment to incorporate minimization measures into future training activities (Golumbfskie-Jones 2022, in litt, p. 1).

We also refined the analysis of current and future conditions as presented in Version 1.0 of each of the SSAs in response to this new information by including the proposed training areas in the analysis and revising the anticipated erosion and adjacency impact zone at the periphery of assault vehicle maneuver areas (AVMA) and landing zones (LZs). In the proposed rule, under extreme conditions in the future scenarios, we considered that all plants in an entire watershed could be impacted by training if an AVMA occurred in the same watershed. As revised, we instead analyzed impacts to occur up to 500 feet around the areas, as 500 feet more accurately reflects the impacts of training that could extend beyond the boundaries of AVMAs and LZs based on observations of baseline conditions surrounding existing AVMAs and LZs and in consideration of the erosion control measures the Navy will continue to implement. Thus, incorporation of a 500-foot impact zone beyond the boundary of these areas provides a more biologically accurate assessment for future condition, compared to the proposed rule, where we assumed that all plants in the watershed would be lost.

The results of our analysis were incorporated into the respective SSAs, which are available as Version 1.1. Future condition of each species in Version 1.1 of each SSA was assessed using the same methodology as in the original SSAs, with the following expectations: (1) Future military training would be limited to the high-use training footprints identified in the SSA Version 1.1; (2) fire impacts to species considered would occur within the same areas of the island that experienced two or more fires during the period 2007-2018; (3) impacts within high-use training and frequent fire footprints would increase; and (4) impacts outside high-use training and frequent fire footprints would be minimal. No change in the fire footprint (beyond that contemplated in the original SSA) is considered because it is unlikely there will be changes in ignition sources or fire management, and thus future fire patterns should remain comparable to historical fire patterns. As described below, and with the exception of changes made as a result of Navy input, we made no substantive changes to this final rule based on comments received on our proposed rule by Federal and State partners, or based on comments received from the public during the public comment period.

In our May 5, 2021, proposed rule to delist the five SCI species (86 FR 23882), we requested that all interested parties submit written comments on the proposed delistings and our draft PDM plan by July 6, 2021. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposed delistings and draft PDM plan. A newspaper notice inviting general public comments was published in the San Diego Union-Tribune (major local newspaper) and also announced using online and social media sources. We received five comments from the public on the proposed rule, and we received no requests for a public hearing. While all of the commenters expressed general views that the five SCI species should remain listed under the Act, none provided substantive information that required changes to this final rule.

Below, we present a review of the taxonomy, life history, ecology, and overall status of the five SCI species, referencing data where appropriate from the SSAs that were finalized for each of the five species.

The five species addressed in this final rule are endemic to SCI, the southernmost island of the California Channel Islands, located 64 miles (mi) (103 kilometers (km)) west of San Diego, California. The island is approximately 56 square mi (145 square km, 36,073 acres (ac), or 14,598 hectares (ha)) (Junak and Wilken 1998, p. 2) and is long and narrow: 21 mi (34 km) long by 1.5 mi (2.4 km) wide at the north end, and 4 mi (6.4 km) wide at the south end (USFWS 1984, p. 5). The island consists of a relatively broad open plateau that slopes gently to the west. Conspicuous marine terraces line the western slope of the island, while steep escarpments drop precipitously to the rocky coastline on the eastern side along the southern 75 percent of its coastline. Many canyons, some of which are up to 500 feet (ft) (152 meters (m)) deep, dissect the southern part of the island. Mount Thirst, the highest point on the island, rises to approximately 1,965 ft (599 m) (Navy 2013a, p. 1.4).

SCI is located in a Mediterranean climatic region with a significant maritime influence. Average monthly temperatures range from 58 degrees Fahrenheit (°F) (14 degrees Celsius (°C)) to 66 °F (19 °C), with a monthly maximum temperature of 72 °F (22 °C) in August and a monthly minimum of 51 °F (10 °C) in December (Navy 2013a, p. 3.11). Average monthly relative humidity varies from 54 to 86 percent depending on location and time of year, and the island experiences dramatic fluctuations in annual rainfall, averaging 6.6 inches (in) (16.8 centimeters (cm)) (Navy 2013a, pp. 3.11, 3.13). Precipitation is received mainly from November through April, with little from May through October. In addition to precipitation, low-level stratiform clouds and fog drip during the typical dry season provide moisture to the SCI ecosystem (Navy 2013a, pp. 3.9, 3.13). The central plateau is characterized mainly by native and nonnative grassland communities. Marine terraces on the western side of the island support maritime desert scrub communities, and the steep eastern escarpment supports grassland and sagebrush communities. Deep canyons that incise both the east and the west sides of the island support limited canyon woodland communities.

A thorough review of the taxonomy, life history, and ecology of the SC Bell's sparrow is presented in the SSA report (USFWS 2022a). The SC Bell's sparrow ( Artemisiospiza belli clementeae; Chesser et al. 2012), formerly called the SC sage sparrow, is a non-migratory subspecies of Bell's sparrow endemic to SCI. It is a grayish-brown-colored sparrow with a small dark breast spot, complete white eye rings, and distinctive white and black malar stripes. It is approximately 5.1-5.9 in (13-15 cm) long, and weighs, on average, 0.59 ounces (16.8 grams) (Martin and Carlson 1998, p. 2; Turner et al. 2005, p. 27).

The SC Bell's sparrow was once close to extinction, with a low of 38 individual adults reported in 1984 (Hyde 1985, p. 30). The population was estimated to be 316 in 1981, 38 in 1984, and 294 in 1997 (Beaudry et al. 2003, pp. 1-2), based on transect surveys on the marine terraces of the west shore of the island. In the period 1999-2011, transect surveys continued predominantly in boxthorn habitat on the west shore, and population estimates ranged from 452 to 1,544 SC Bell's sparrows (USFWS 2022b, p. 27). As the native shrub habitat recovered following the removal of the nonnative grazing and browsing animals, the distribution of SC Bell's sparrow expanded on SCI (Meiman et al. 2019, pp. 2-4). Observations of Bell's sparrows in areas of the island outside the marine terraces on the west shore increased. In 2012, breeding season survey methodology was modified (Meiman et al. 2019, pp. 3-4) to include survey plots randomly distributed throughout the island. Using this approach, new plots are selected for survey each year. Implementation of this survey methodology resulted in an island-wide estimate of 2,267 Bells' sparrow territories (4,534 adult sparrows) in 2013. The population estimates ranged from 4,194 to 7,656 adult Bell's sparrows in the period 2013-2018 (USFWS 2022a, p. 25). While the SC Bell's sparrow is now distributed widely across the island (see figure 1, below), its density varies greatly spatially and among vegetation types. SC Bell's sparrows may be found in some habitat mapped as grasslands; however, many grassland areas do not support SC Bell's sparrows, likely due in part to the lack of shrub cover. Recent estimates of potential available habitat have increased from approximately 4,196 ha (10,369 ac) in 2009 (USFWS 2009, p. 8) to approximately 13,132 ha (32,449 ac) (Meiman et al. 2018, p. 5).

Boxthorn-dominated plant communities, particularly along the northwest shoreline and marine terraces, support high-quality habitat that provided refugia to the Bell's sparrow when the population was lower. Boxthorn habitat along the northwestern shoreline and marine territories remains densely populated, supporting a significant percentage of the SC Bell's sparrow population. This area is particularly important to the species. In addition, moderate to high population densities are also found in sagebrush and shrub habitat along the steep eastern slope. SC Bell's sparrows are present in significantly lower densities in mixed shrub, cactus, and grassland (grass/herb) habitats along the central plateau (Meiman et al. 2018, p. 18).

SC Bell's sparrows inhabit most plant communities on SCI, including maritime desert scrub in Lycium (boxthorn) phase, Opuntia (prickly pear) phase, and Cylindropuntia (cholla) phase; maritime sage scrub; canyon shrubland/woodland; and grasslands (USFWS 2022a, pp. 20-21). Within these plant communities, SC Bell's sparrows show an affinity for areas dominated by shrubs and cacti ( Opuntia sp.). SC Bell's sparrows demonstrate a positive association with structural shrub cover (Meiman et al. 2015, p. 33), as they typically use shrubs for nesting substrate and use the gaps between and area underneath shrubs for foraging. The abundance of shrubs, including boxthorn, has been positively correlated with sparrow density (Turner 2009, pp. 53-54). High grass cover has been correlated with lower sparrow densities and larger territory sizes, which may indicate that grasses are not likely important resources during the nesting season (Turner 2009, pp. 53-54).

The SC Bell's sparrow is a ground gleaner and eats available insects and spiders, and seeds taken from the ground and low vegetation. During the winter, SC Bell's sparrows feed on prickly pear and cholla cactus fruit and on moths (Hyde 1985, p. 24). The initiation of breeding activity and the length of the nesting season appear to be tied to precipitation patterns (Kaiser et al. 2007, pp. 48-49; Meiman et al. 2018, p. 36). Breeding activity usually peaks in March and April and lasts through late June or July. Clutch size ranges from one to five eggs, with asynchronous hatching after 12 to 13 days of incubation conducted mostly by the female (Martin and Carlson 1998, p. 9). SC Bell's sparrows can breed during their first year. A pair can produce multiple clutches, with some pairs producing multiple successful broods in favorable years (Martin and Carlson 1998, p. 9; Kaiser et al. 2008, p. 36). SC Bell's sparrows express site fidelity each nesting season, and juveniles disperse from the natal area during their first winter.

Amounts and distribution of rainfall affect the timing and extent of vegetation growth and flowering, which likely affects resource availability for SC Bell's sparrows. During drought years, SC Bell's sparrows may not reproduce at all, or a subset of the population may suppress breeding (Kaiser et al. 2007, p. iv; Stahl et al. 2010, p. 48; Meiman et al. 2019, p. 35), which can result in depressed populations following prolonged periods of severe drought. Less severe or shorter duration dry periods, however, do not appear to result in significant population changes, as evidenced by recent dry periods and relatively stable SC Bell's sparrow population estimates. SC Bell's sparrows appear to respond to favorable precipitation patterns and resulting conditions by producing multiple clutches, which typically drive population numbers up in years that follow “good” precipitation years (Kaiser et al. 2007, p. iv; Stahl et al. 2010, p. 50).

A thorough review of the taxonomy, life history, and ecology of the SCI bush-mallow is presented in the SSA report (USFWS 2022b). SCI bush-mallow ( Malacothamnus clementinus ) is a rounded shrub in the Malvaceae (mallow family) (Slotta 2012; 77 FR 29078, p. 29080, May 16, 2012). Plants are generally 2.3 to 3.3 ft (0.7 to 1 m) tall with numerous hairy branched stems arising from the base of the plant (Munz and Johnston 1924, p. 296; Munz 1959, pp. 122-125; Bates 1993, p. 752). Flowers are clustered in the uppermost leaf axils, forming interrupted spikes 3.9 to 7.9 in (10 to 20 cm) long (Munz 1959, p. 125). Flowers are bisexual and variously described as having pink or white and fading lavender petals (Munz and Johnston 1924, p. 296; Bates 1993, p. 752).

The historical range and distribution of SCI bush-mallow on SCI is unknown because botanical studies were not conducted on the island prior to the introduction of ungulates beginning in the 1800s (Kellogg and Kellogg 1994, p. 4). At the time of listing, one site at Lemon Tank Canyon on the eastern side of the island and two additional locations of two to three small plants in China Canyon on the southern end of the island were known (42 FR 40682, p. 40683, August 11, 1977; USFWS 1984, p. 48). Since listing, new locations of SCI bush-mallow have been discovered among the generally southwesterly facing coastal terraces and their associated escarpments in the southern and middle regions of SCI (Junak and Wilken 1998, pp. 1-416, Geographic Information System (GIS) data; Junak 2006, pp. 1-176, GIS data; Tierra Data Inc. 2008, pp. 1-24, appendices and GIS data; SERG 2010a and 2010b, GIS data). Most of the known locations occur throughout the southwestern region of the island. The main southern distribution of SCI bush-mallow is disconnected from the Lemon Tank Canyon locality by approximately 4 mi (6.4 km). Many of these new locations have been documented since feral mammals were removed, suggesting that plants may have reemerged from underground stems that survived grazing by feral herbivores (Junak 2006, pers. comm. in 77 FR 29078, p. 29086, May 16, 2012), although experts doubt that rhizomes would be able to store enough energy to sprout after a long period of dormancy without sending up shoots in the interim (Munson 2022, pers. comm.; Rebman 2019, pers. comm.; Morse 2020, pers. comm.).

The current abundance and distribution of SCI bush-mallow is estimated to total approximately 5,611 individuals at 222 locations occupying 15 watersheds (see figure 2, below) (USFWS 2022b, pp. 29-31). Because distinguishing genetically distinct individuals among groups of stems is difficult, counts or estimates of individuals have most often been used collectively to refer to both genetically distinct individuals (genets) and clones (ramets) (USFWS 2022b, p. 26). In the current estimate, individuals refer to individual plants and not necessarily to genetically distinct individuals, since the number of genetically distinct individuals is unknown. Because of access restrictions due to risk of unexploded ordnances, occurrences within areas subject to bombardment have not been assessed recently enough to be included in this estimate but are likely still extant.

SCI bush-mallow occurs in a variety of habitats on SCI. Historically, it was observed on rocky canyon walls and ridges, presumably because foraging goats did not browse those areas. Since removal of nonnative feral ungulates, SCI bush-mallow has been found at the base of escarpments between coastal terraces on the western side of the island within maritime cactus scrub (Navy 2002, pp. D-19, D-20), and it can also occur on low canyon benches and in rocky grasslands. Moisture that collects in rock crevices and at the base of canyon walls and escarpments may provide favorable conditions for this species (Junak 2006, pers. comm. in 77 FR 29078, p. 29094, May 16, 2012). Based on its habitat range on the island and the ease of cultivating the plant, SCI bush-mallow appears to tolerate a broad range of soil types (USFWS 1984, p. 50). It is often associated with maritime cactus scrub vegetation on coastal flats at the southwestern end of the island (Junak and Wilken 1998, p. 256).

SCI bush-mallow flowers in the spring and summer, typically from March to August (Kearney 1951, p. 115; California Native Plant Society 2011). It is generally thought that SCI bush-mallow is pollinated by insects; potential pollinators incidentally observed in the wild include wasps and butterflies (USFWS 2007c, p. 9). Although no specific pollinator for this species is known, the shape of the flowers suggest that it is not limited to a specific pollinator and instead can be pollinated by different pollinators (Muller and Junak 2011, p. 33).

While each plant can produce large numbers of seeds, recorded seed production in natural occurrences of SCI bush-mallow has been very low (Helenurm 1997, p. 51; Junak and Wilken 1998, p. 291; Helenurm 1999, p. 39). Germination rates in seed trials are also low, only 4 to 35 percent (Evans and Bohn 1987, p. 538; Junak and Wilken 1998, p. 291). Hypotheses for low seed set and germination rates include low pollinator visitation rates, reduced pollinator diversity, partial self-incompatibility ( i.e., plants need to be pollinated by a non-closely related individual), limited survey efforts, and that seed germination may be stimulated by fire (USFWS 2022b, pp. 22-23). However, it is difficult to determine the cause of the apparent low reproductive output noted, whether low reproductive output is still an issue currently, and whether fire assists germination.

SCI bush-mallow can reproduce vegetatively, or clonally, by sprouting from rhizomes (Evans and Bohn 1987, p. 538), as well as sexually by seeds, although sexual recruitment is likely low. The ability to spread vegetatively by underground rhizomes results in patches of spatially separate but genetically identical individuals (Evans and Bohn 1987, p. 538). Occurrences are likely a mix of both genetically unique individuals (genets) and clonal individuals (ramets) that are connected underground. Although difficult to discern between ramets and genets in the field, most groups of plants are composed of ramets from an unknown number of genets, consistent with other plant species exhibiting strong clonal growth. Although growth and spread of the population has been thought to be mostly clonal (Muller and Junak 2011, p. 50), evidence of sexual reproduction includes two seedlings identified in the field (by the presence of cotyledons) on a recently burned site in 2014 (Munson 2022, pers. comm.). While the distribution of SCI bush-mallow is much greater than was known at the time of listing, difficulty and confusion with discerning between ramets and genets and low reproductive output create uncertainty about whether it is reproducing sexually or only clonally.

Two different studies of population genetics have been conducted (Helenurm 1997; Helenurm 1999). These genetic assessments along with field observations indicate that overall genetic diversity is low, but there is some level of genetic diversity within and among patches of SCI bush-mallow ( i.e., based on these studies, not all individuals are clones in each area). However, due to the limitations of techniques, neither study is conclusive. Genetic diversity is presumed to have declined since the introduction of feral browsers and grazers, but we do not know historical or current levels of genetic diversity or normal rates of sexual versus asexual reproduction, so no comparisons can be made. Overall, genetic diversity within SCI bush-mallow is still very low compared with other island endemic plant taxa (Helenurm 1999, p. 40).

This species may be subject to drought stress to some extent (from 25 to 89 percent of individuals sampled), which may reduce flowering (Muller and Junak 2011, p. 58). This species may be drought deciduous as is a closely related species of bush-mallow, Malacothamnus fasciculatus, but there are no physiological studies to support this conjecture; the similar phenology of SCI bush-mallow and its habitat attributes support the suggestion (Muller and Junak 2011, p. 32).

Although no information is available regarding the fire tolerance of SCI bush-mallow, other species in the same genus ( e.g., Malacothamnus fremontii ) rapidly become established after fire (Rundel 1982, p. 86). Seed germination in other species in the genus is stimulated by fire, and there is evidence that fire may also have a positive effect on SCI bush-mallow (Keeley et al. 2005, p. 175). Because of its ability to resprout from rhizomes and the adaptation of other species in the genus to fire, it is thought that SCI bush-mallow is likely resistant to fire and that its seeds may even respond positively to fire (USFWS 2008b, p. 77).

A thorough review of the taxonomy, life history, and ecology of the SCI paintbrush is presented in the SSA report (USFWS 2022e).

SCI paintbrush ( Castilleja grisea ) is a highly branched perennial subshrub in the broomrape family (Orobanchaceae) endemic to SCI (Chuang and Heckard 1993, p. 1021) and is the only representative of the genus Castilleja found on the island (Helenurm et al. 2005, p. 1222). SCI paintbrush is typically 11.5 to 31.5 in (29 to 80 cm) in height and covered with dense white, wooly hairs. Most Castilleja species have bisexual flowers disposed in terminal spikes. The flowers of SCI paintbrush are yellow.

SCI paintbrush is thought to have been relatively common on SCI in the 1930s and subsequently declined as a result of unchecked grazing by introduced feral herbivores (Helenurm et al. 2005, p. 1222). The complete historical range of SCI paintbrush on SCI is unknown because botanical studies were not completed before the plant's decline. Herbarium records documented the species on the south and east sides of the island before the time of listing (California Consortium of Herbaria 2019, records for C. grisea ). By 1963, SCI paintbrush was reported as rare or occasional (Raven 1963, p. 337). Since the complete removal of feral ungulates from SCI by 1992, SCI paintbrush has been detected across the southern two-thirds of the island (Keegan et al. 1994, p. 58; Junak and Wilken 1998, p. 1-416, GIS data; Junak 2006, p. 1-176, GIS data; Tierra Data Inc. 2008, p. 1-24, appendices and GIS data; SERG 2010a and 2010b, GIS data). The current abundance and distribution of SCI paintbrush is estimated to comprise 601 locations totaling 42,104 individuals occupying 87 watersheds (see figure 3, below) (USFWS 2022e, pp. 27-29).

Over time, the range of SCI paintbrush has expanded, and it now occupies a broad range of habitats across the island. SCI paintbrush is often associated with two major vegetation types: Canyon woodland (which encompasses approximately 696 ac (282 ha)), and maritime desert scrub (which encompasses approximately 6,228 ac (2,520 ha)). Aspect varies widely, but generally plants are found on flats and steep rocky slopes from 0-70 degrees (CNDDB 2019; Navy 2017, p. 11-24; Vanderplank et al. 2019, p. 5), and the species is found almost exclusively on non-clay soils and rocky outcrops (Vanderplank et al. 2019, p. 5). SCI paintbrush can colonize disturbed areas, and the species likely has the potential for further range expansion on SCI (Navy 2008a, pp. 3.11-3.20; Vanderplank et al. 2019, p. 5).

All members of the genus Castilleja are considered hemiparasitic, meaning that its roots are capable of forming parasitic connections to roots of other plants (Heckard 1962, p. 27). Plants within the genus are capable of photosynthesis and can exist without a host, but they are able to derive water, nutrients, and photosynthates from a host plant if present (Heckard 1962, p. 25). Members of the genus Castilleja appear to form parasitic connections with a wide range of host plant species from a wide range of families (Heckard 1962, p. 28; Atsatt and Strong 1970, p. 280; Marvier 1996, p. 1399; Adler 2002, p. 2704; Adler 2003, p. 2086; Muller 2005, p. 4). Although studies to verify host-connections have not been done, numerous plant species are associated with SCI paintbrush (Junak and Wilken 1998, p. 82; Muller 2009, pers. comm., in 77 FR 29078, p. 29096, May 16, 2012). The generalist host-selection of C. grisea likely aided recovery of this species as the vegetation recovered following the removal of feral browsers and grazers (Muller and Junak 2011, pp. 16-17).

SCI paintbrush typically flowers between February and May, producing yellow bisexual flowers (Chuang and Heckard 1993, pp. 1016-1024; Navy 2013a, p. 3-203). SCI paintbrush is likely self-incompatible (unable to produce viable seed through self-fertilization), as observed in other species of the genus (Carpenter 1983, p. 218; Junak and Wilken 1998, p. 84). Results of a population genetic study were consistent with an outcrossing breeding system (Helenurm et al. 2005, p. 1225). SCI paintbrush is most closely related to, and shares floral traits with, other species in the genus primarily adapted for bee pollination (Chuang and Heckard 1991, p. 658), but both insect and hummingbird pollination of Castilleja have been reported (Grant 1994, p. 10409; Junak and Wilken 1998, p. 84).

Although the lifespan of SCI paintbrush is unknown, its larger stature and woodier habit (general appearance or growth form) suggest it may be longer lived, which would be consistent with an estimated lifespan of 5-15 years based on observations made during repeat visits to occupied sites (Munson 2022, pers. comm.). Based on life-history, the persistence of interbreeding groups of plants may depend upon frequent production of seed (Dunwiddie et al. 2001, p. 161) as no evidence of clonal growth has been found (Muller and Junak 2010, p. 42). Population growth is primarily by recruitment from existing populations from plants that emerged from the soil seedbank following removal of feral herbivores or from plants that survived those impacts (Muller and Junak 2010, p. 42). However, the increase in SCI paintbrush's range, along with the discovery of new individuals along trails or near buildings that people frequent (O'Connor 2022, pers. comm.), suggests that the establishment of new population centers may be relatively common. The degree of fire tolerance of SCI paintbrush is unknown. It is not specifically adapted to fire, but it is likely resilient to occasional fires and has been seen to persist in areas after fires, although severe fires can kill plants and reduce numbers of individuals in a location (Muller and Junak 2011, p. 16;; Tierra Data Inc. 2005, p. 80; Vanderplank et al. 2019, p. 13).

A thorough review of the taxonomy, life history, and ecology of the San Clemente Island lotus is presented in the SSA report (USFWS 2022d).

SCI lotus ( Acmispon dendroideus var. traskiae ) is a semi-woody, flowering subshrub in the legume or pea family (Fabaceae). It is endemic to SCI (Isely 1993, p. 619) and is one of five taxa in the genus Acmispon found on the island (Tierra Data Inc. 2005, p. C-8; Brouillet 2008, pp. 388-392).

SCI lotus is typically less than 4 ft (1.2 m) tall with slender erect green branches (Munz 1974, pp. 449-450; USFWS 1984, p. 59; Allan 1999, p. 82). Each leaf has three to five leaflets, each approximately 0.2 to 0.3 in (5 to 9 millimeters (mm)) long (USFWS 1984, p. 59; Allan 1999, p. 82). SCI lotus has small yellow flowers that are bisexual and arranged in one to five flowered clusters on stalks that arise from axils between the stem and leaf of terminal shoots (Junak and Wilken 1998, p. 256). Pistils are initially yellow, turning orange then red as the fruit matures (USFWS 1984, p. 59).

The 1977 listing rule mentioned that SCI lotus occurred at Wilson Cove on the north end of the island, but no other details were available (42 FR 40682, p. 40683, August 11, 1977). In the 1984 recovery plan, SCI lotus were restricted to six “populations” associated with rocky areas, with the largest number of plants growing in the Wilson Cove area (USFWS 1984, p. 59). Only a few herbarium specimens of SCI lotus exist, making historical distribution and condition difficult to assess. Based on herbarium records, California Natural Diversity Database (CNDDB) records, and the recovery plan, the historical range includes occurrences in the northern part of the island (Wilson Cove) down to the southern point (Pyramid Head). Since the final removal of all feral herbivores by 1992, the distribution of this taxon has steadily increased (77 FR 29078, p. 29110, May 16, 2012). By 1997, roughly 50 percent of documented occurrences of these plants were found in the vicinity of Wilson Cove, and by 2004, 75 percent of the distribution of this taxon was found beyond this area and extended to the southernmost part of the island (USFWS 2007b, pp. 4-5).

The most recent survey data show the distribution of SCI lotus spans the length of the island from Wilson Cove to the southern tip east of Pyramid Cove, approximately 19 mi (31 km) (Junak and Wilken 1998, p. 261; Junak 2006, Map A-C; Vanderplank et al. 2019, p. 27). The majority of locations tend to be clustered on north-facing slopes on the eastern side of the island (Vanderplank et al. 2019, p. 7). SCI lotus tends to occur in small groups of 10 to 50 individuals (Allan 1999, p. 84). The statuses of some historical locations are unknown because they occur in areas with restricted access, such as due to unexploded ordnances, or have not been surveyed in a long time. Based on repeated surveys within some watersheds, 15 previously occupied watersheds are no longer considered occupied (USFWS 2022d, p. 26). However, the overall number of watersheds in which SCI lotus is documented increased from 4 reported during 1980-1989 surveys, to 50 reported in the period 2010-2014 (USFWS 2022d, p. 21). Despite limitations of the survey data ( e.g., not all areas were surveyed during every survey period), the data indicate that the number of individuals and the range of SCI lotus have increased over time, and SCI lotus's current distribution is estimated to be 249 locations within 57 watersheds totaling 20,743 individuals (see figure 4, below) (USFWS 2022d, pp. 24-27).

SCI lotus establishes on north- and east-facing slopes and ridges at elevations ranging from 25 to 1,400 ft (7.6 to 463 m) and is found in canyon bottoms or along ridgelines (Junak 2006, p. 125). It appears to preferentially establish and grow somewhat colonially around rock outcrops and among large boulders situated in grassland areas and along the interface between grassland and maritime sage scrub (Allan 1999, p. 84; Navy 2002, p. D-9); SCI lotus also readily occupies disturbed sites and locations close to buildings, roads, and pipelines (Navy 2013b, p. 3-201). It occurs on well-drained soils where adequate soil moisture is available to the plant (Junak and Wilken 1998, p. 256; Navy 2002, p. D-9) and occurs mostly on clay to rocky soils (Vanderplank et al. 2018, p. 7). SCI lotus is generally associated with two habitat types on the island: canyon woodland supported on approximately 696 ac (282 ha) and maritime desert scrub along the northeastern escarpment supported on approximately 6,228 ac (2,520 ha) (Navy 2002, pp. 3.57, 3.58).

SCI lotus is short-lived, with a reported lifespan of less than 5 years (USFWS 2008b, p. 113); however, individuals near Wilson Cove have been observed to live longer than 6 years (Emily Howe 2017, pers. comm. in Vanderplank et al. 2018, p. 6). Like other legumes, the roots of plants in the genus Acmispon to which SCI lotus belongs are able to fix atmospheric nitrogen, making it available to plants in the form of ammonia, enriching the soil and making members of the genus Acmispon important post-fire colonizers (Sørensen and Sessitsch 2007 in Vanderplank et al. 2018, p. 4).

SCI lotus flowers between February and August, peaking from March to May (Junak and Wilken 1998, p. 256; USFWS 2008b, p. 113), with halictid bees (a family of small solitary bees that typically nest in the ground), bumblebees, and small beetles observed foraging on the flowers (Junak and Wilken 1998, p. 257; Allan 1999, pp. 64, 85). A sister taxon ( Acmispon glaber [syn. Lotus scoparius ]) flowers in response to available moisture from fog and precipitation, primarily winter rainfall (Vanderplank and Ezcurra 2015, p. 416), which may also be true of SCI lotus. The taxon is self-compatible, meaning it is capable of self-fertilization, and can self-pollinate (Allan 1999, pp. 85-86), but plants may also rely on insects for more effective pollination (Arroyo 1981, pp. 728-729).

On average, a single SCI lotus individual can produce approximately 36 to 64 flowering shoots, 118 to 144 flowers per shoot, and 4 to 6 seeds per fruit (Junak and Wilken 1998, p. 257). This information suggests that, under ideal conditions, an individual can produce a high volume of seeds (16,000 or more). Like most legumes, SCI lotus seeds require scarification (weakening or opening the seed coat to promote germination) or gradual seed coat degradation to germinate (Wall 2011, pers. comm. in 77 FR 29078, p. 29095, May 16, 2012). SCI lotus is thought to have high long-term survival in the seed bank. Germination rates for seed stored for 6 years dropped only from 80 percent to 76 percent; one seed lot displayed 65 percent germination after more than 30 years in storage (Cheryl Birker 2017, pers. comm. in Vanderplank et al. 2019, p. 6).

The majority (67 percent) of SCI lotus's genetic variability is found among, rather than within, occurrences (Allan 1999, p. 61). However, more recent genetic work (McGlaughlin et al. 2018, p. 754) has shown moderate levels of genetic diversity in the species, with gene flow between neighbor populations. The genetic diversity of SCI lotus is equal to or higher than that of the mainland variety of the same species, Acmispon dendroideus var. dendroideus, and SCI lotus also contains unique and highly divergent genotypes (Wallace et al. 2017, pp. 747-748). SCI lotus has hybridized with A. argophyllus var. argenteus in disturbed areas in Wilson Cove (Liston et al. 1990, pp. 239-240; Allan 1999, p. 86). Based on intermediate characteristics, the hybrid plants appear to be first generation (F1 generation) plants from a cross between the two varieties. It is not known whether these plants can produce viable seeds by backcrossing between the hybrids or with the putative parent plants (Allan 1999, p. 86).

The fire tolerance of SCI lotus is not well understood. Based on SCI lotus's growth characteristics and occurrence increases in areas affected by fire, and the fire adaptations of related taxa, SCI lotus may be resilient to at least occasional fire. Because it is short-lived and likely relies on its seed bank for recruitment, fire may benefit this taxon by opening up areas of bare ground for seedling germination (USFWS 2007b, p. 7). However, frequent fires could exceed its tolerance of fire severity and frequency and exhaust the seed bank in repeatedly burned areas (USFWS 2007b, p. 11; USFWS 2022d, pp. 20-21).

A thorough review of the taxonomy, life history, and ecology of the SCI larkspur is presented in the SSA report (USFWS 2022c). The SCI larkspur ( Delphinium variegatum ssp. kinkiense ) is an herbaceous perennial in the buttercup family (Ranunculaceae). It grows 6 to 33 in (14 to 85 cm) in height but generally is less than 20 in (50 cm) tall (Koontz and Warnock 2012, no pagination). The flowers are light blue to white in color and are bilaterally symmetrical with five petal-like sepals and four smaller petals. The uppermost sepal is a straight or downcurved spur that is characteristic for the genus.

SCI larkspur is one of two subspecies of Delphinium variegatum that occur exclusively on SCI, the other being Thorne's larkspur ( Delphinium variegatum ssp. thornei ). The island subspecies are currently distinguished primarily by flower color, with Thorne's larkspur generally having bright blue ( i.e., darker), slightly larger flowers than the SCI larkspur, which generally has white flowers, consistent with distinctions noted in earlier works (Dodd and Helenurm 2000, p. 125; Koontz and Warnock 2012, no pagination). SCI larkspur occurs mostly in the northern portion of the island, and Thorne's larkspur occurs in the southern portion of the island. However, in the middle of the island (and on the far southern end), the two flower colors coexist in many locations, with varying proportions of each color, and flower colors ranging from pure white to dark purple. While ambiguity of the subspecies classifications, mostly within the central areas of the island, has caused some confusion regarding true range and distribution, the currently accepted taxonomic treatment recognizes the two subspecies and is followed in our assessment.

The historical range and distribution of SCI larkspur on SCI is unknown because botanical studies were not completed before the plant's decline. The final listing rule (42 FR 40682; August 11, 1977) did not provide specific information regarding the SCI larkspur's distribution and abundance. The 1984 recovery plan noted that the subspecies occurred in six or seven locations (USFWS 1984, pp. 17, 35). The true range and distribution of SCI larkspur on SCI is somewhat unknown due to the ambiguity of the subspecies classifications, particularly in the central areas of the island where SCI larkspur and Thorne's larkspur co-occur, as do plants exhibiting characteristics intermediate between the two subspecies. While various delineations have been used to classify mixed occurrences (USFWS 2022c, p. 22), SCI larkspur is generally found mid-island on gentle slopes on the eastern side of the island, although the species has also been detected at higher elevations on the west side of the island (USFWS 2022c, p. 22). Since grazing pressure was removed on SCI, both subspecies of Delphinium variegatum have been noted to have expanded dramatically (O'Brien 2019, pers. comm.). The species' ability to go dormant also contributes to difficulties in determining population counts. The current distribution and abundance estimate of SCI larkspur is 18,956 individuals within 22 watersheds (see figure 5, below). Occupancy at two additional watersheds has been reported, but population counts are not available at these locations (USFWS 2022c, pp, v., 36).

SCI larkspur is found in a broad range of habitats within the same general vegetation types and is widespread across the island. SCI larkspur is generally found within mid- to high-elevation grasslands on the east side of the northern and central portions of the island where it occurs in clay, loam, and rocky soils with soil depths ranging from shallow to deep; however, it is more often associated with non-clay soils (Vanderplank et al., 2022.). Reported habitats have included coastal grasslands (Koontz and Warnock 2012, no pagination), as well as grassy slopes and benches, open grassy terraces, and chaparral and oak woods (Warnock 1993 in USFWS 2008a, p. 12). Currently, SCI larkspur occurs primarily on the east side of the island on gentle slopes with northern, northwestern, and eastern exposures. The higher elevation plateau supports grasslands dominated by the native perennial bunch-grasses interspersed with annual forbs while the mid- and lower-elevation grasslands tend to be less floristically diverse and dominated by introduced annual grasses. They are primarily found within vegetation communities dominated by Artemisia californica, nonnative grasslands, and Baccharis pilularis (Vanderplank et al., 2022.).

Flower production in Delphinium can be highly variable and may be dependent upon quite localized weather conditions (Lewis and Epling 1959, p. 512) and soil moisture (Inouye et al. 2002, pp. 545, 549). Plants may not flower until reaching 2 to 3 years of age ( e.g., Waser and Price 1985, p. 1727 in reference to D. nelsonii ).

SCI larkspur generally flowers from March to April (California Native Plant Society 2001, in USFWS 2008a, p. 3), but has been documented flowering from January to April (Koontz and Warnock 2012, no pagination). Blue and white flowered Delphinium species are largely pollinated by bumblebees (Waser and Price 1983, p. 343; Waddington 1981, p. 154). Several different species of pollinators have been observed visiting SCI larkspur (USFWS 2022c, p. 28; Junak and Wilken 1998, p. 120; Munson 2022, pers. comm.; SERG 2015b, p. 13). Given the spur-length of San Clemente Island larkspur, bumblebees or hummingbirds may be the primary pollinators (Jabbour et al. 2009, p. 814). Successful outcrossing within island populations indicates that pollination is effective; therefore, populations of pollinators are likely to be ample.

Like most other California larkspurs, SCI larkspur can survive below ground when conditions are unfavorable and may remain dormant and not appear above-ground for one or more years. The species begins to go dormant shortly after flowering, remaining dormant until early in the rainy season. Although we have no information on the lifespan of SCI larkspur, based on information regarding other species of larkspurs, it is likely that the subspecies is relatively long-lived (USFWS 2022c, p. 28). Because of the species' ability to go dormant, and additionally because flower production in Delphinium can be highly variable and may be dependent upon quite localized weather conditions, exact numbers of individuals are difficult to locate and count.

In comparison with other endemic plant species, Delphinium variegatum appears to be typical in its pattern of genetic diversity relative to its geographic range at both the population and taxon levels (Dodd and Helenurm 2002, p. 619). However, in comparison with other Delphinium, the genetic variation observed for the insular taxa of D. variegatum appears to be low. The data suggest that there is a higher level of gene flow among adjacent populations. If estimates of historical gene flow are indicative of current patterns, then gene flow among the 24 island populations studied appears to be high enough to prevent genetic differentiation among them. This finding is consistent with the general low level of genetic differentiation found among populations of other species in the genus Delphinium (Dodd and Helenurm 2002, pp. 619-620).

Little is known regarding the fire tolerance of SCI larkspur. However, its dormancy period (roughly May or June through November) and the fire season generally coincide (O'Connor 2022, pers. comm.; Navy 2009, p. 4.22). The possible benefits of fire to SCI larkspur include reduction in competitive shading and/or nutrient uptake, which would likely increase flowering and possibly visibility to pollinators.

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the Lists.

Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species, or to delist a species, is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.

There are many paths to accomplishing recovery of a species, and recovery may be achieved without all the criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the definition of an endangered species or a threatened species under the Act. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all guidance provided in a recovery plan.

In 1984, we published the Recovery Plan for the Endangered and Threatened Species of the California Channel Islands (recovery plan); it addresses the five species in this final rule, plus some additional species (USFWS 1984, entire). The recovery plan preceded the 1988 amendments to the Act outlining required elements of recovery plans. As such, the recovery plan does not include recovery criteria, but followed guidance in effect at the time it was finalized. Rather than including specific criteria for determining when threats have been removed or sufficiently minimized, the recovery plan identifies six objectives to achieve recovery of the Channel Island species. Given the threats in common to the species addressed, the recovery plan is broad in scope and focuses on restoration of habitats and ecosystem function. The six objectives identified in the recovery plan are:

• Objective 1: Identify present adverse impacts to biological resources and strive to eliminate them.

• Objective 2: Protect known resources from further degradation by: (a) Removing feral herbivores, carnivores, and selected exotic plant species; (b) controlling erosion in sensitive locations; and (c) directing military operations and adverse recreational uses away from biologically sensitive areas.

• Objective 3: Restore habitats by revegetation of disturbed areas using native species.

• Objective 4: Identify areas of San Clemente Island where habitat restoration and population increase of certain addressed taxa may be achieved through a careful survey of the island and research on habitat requirements of each taxon.

• Objective 5: Delist or downlist those taxa that achieve vigorous, self-sustaining population levels as the result of habitat stabilization, habitat restoration, and prevention or minimization of adverse human-related impacts.

• Objective 6: Monitor effectiveness of recovery effort by undertaking baseline quantitative studies and subsequent follow up work (USFWS 1984, pp. 106-107).

The Navy has taken a variety of recovery actions to achieve the recovery plan's objectives. These include:

• Removing all feral herbivores, which was achieved in 1992.

• Monitoring and control of the expansion of highly invasive, nonnative plant species on an ongoing basis since the 1990s (O'Connor 2022, pers. comm.).

• Implementing a nonnative wildlife program (nonnative predator management) initiated by the Navy in 1992 (USFWS 2008b, p. 172).

• Conducting and funding surveys, research, and monitoring to better understand the ecology and habitat requirements of sensitive species and monitoring their status and the effectiveness of recovery efforts.

• Conducting long-term vegetation monitoring studies.

• Conducting propagation and outplanting (transplant individuals from the greenhouse to vegetative communities) of non-listed native species through a contract with the San Diego State University Soil Ecology and Restoration Group (SERG) (Navy 2013a, p. 3-5). Although the restoration efforts were not specifically designed for the benefit of the species addressed in this final rule, restoration of the island's vegetation communities has helped to improve habitat suitability for the subject species by reducing the spread of invasive, nonnative plants and restoring ecological processes.

• Conducting annual reviews of fire management and fire occurrences, allowing for adaptive management to minimize the frequency and spread of fires. For example, in 2017, after a large fire that burned part of the eastern escarpment had seemingly gone out, the fire restarted the next day and response was therefore delayed. This occurrence prompted a change in how the Navy monitors fires that are thought to be extinguished (O'Connor 2022, pers. comm.).

• Addressing assault vehicle-related erosion through development of an erosion control plan for the AVMAs (Navy 2013b, entire). The Navy also incorporates erosion control measures into all site feasibility studies to minimize impacts from erosion and avoid impacts to listed species.

Contributions to meeting the recovery objectives include adoption and implementation of the SCI Integrated Natural Resources Management Plan (INRMP). The Navy adopted the SCI INRMP in 2002 (Navy 2002, entire) and updated it again in 2013 (Navy 2013a, entire). An INRMP is intended to guide installation commanders in managing their natural resources in a manner that is consistent with the sustainability of those resources, while ensuring continued support of the military mission (Navy 2002, p. 1-1). The INRMP identifies goals and objectives for specified management units and their natural resources, including measures to protect, monitor, restore, and manage special status species and their habitats. The Navy identifies and addresses threats to special status species during the INRMP planning process. If possible, threats are ameliorated, eliminated, or mitigated through this procedure.

The SCI INRMP outlines management actions for invasive species control island-wide, including near listed species; biosecurity protocols; restoration of sites that support sensitive plants; habitat enhancement for sensitive and listed species; fuel break installation to minimize fire spread; and fire suppression to protect endangered, threatened, and other priority species. The Navy also developed and implements specific plans for some management issues, including the SCI Wildland Fire Management Plan; Erosion Control Plan; and the Naval Auxiliary Landing Field San Clemente Island Biosecurity Plan. For additional details on the Navy's implementation of recovery efforts, see “Conservation Actions and Regulatory Mechanisms,” below.

Interim progress on achieving the recovery objectives resulted in improvements in the status of SCI paintbrush and SCI lotus such that our 2007 5-year reviews recommended reclassification (USFWS 2007a, p. 14; USFWS 2007b, p. 17), and both species were subsequently reclassified from endangered species to threatened species (78 FR 45406, July 26, 2013). We also recommended in our 2007 5-year review for SCI bush-mallow and 2008 5-year review for SCI larkspur that they be reclassified as threatened (USFWS 2007c, p. 22; USFWS 2008a, p. 26).

While the recovery plan did not include specific metrics, the plan's objectives have largely been achieved for these five species through removal of nonnative herbivores and subsequent recovery of native plant communities, and through restoration and management actions implemented by the Navy to improve habitat and control threats related to erosion, invasive species, fire, and land use. As a result of these actions, habitat has been sufficiently restored and managed on the island and supports self-sustaining populations for each of these five taxa.

Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for threatened and endangered species. In 2019, jointly with the National Marine Fisheries Service, the Service issued final rules that revised the regulations in 50 CFR parts 17 and 424 regarding how we add, remove, and reclassify threatened and endangered species and the criteria for designating listed species' critical habitat (84 FR 45020 and 84 FR 44752; August 27, 2019).

However, on July 5, 2022, the U.S. District Court for the Northern District of California vacated the 2019 regulations ( Center for Biological Diversity v. Haaland, No. 4:19-cv-05206-JST, Doc. 168 (N.D. Cal. July 5, 2022) ( CBD v. Haaland )), reinstating the regulations that were in effect before the effective date of the 2019 regulations as the law governing species classification and critical habitat decisions. Subsequently, on September 21, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit stayed the district court's July 5, 2022, order vacating the 2019 regulations until a pending motion for reconsideration before the district court is resolved (In re: Cattlemen's Ass'n, No. 22-70194). The effect of the stay is that the 2019 regulations are the governing law as of September 21, 2022.

Due to the continued uncertainty resulting from the ongoing litigation, we also undertook an analysis of whether this final rule would be different if we were to apply the pre-2019 regulations. That analysis, which we described in a separate memo in the decisional file and posted on https://www.regulations.gov, concluded that we would have reached the same proposal if we had applied the pre-2019 regulations because both before and after the 2019 regulations, the standard for whether a species warrants delisting has been, and will continue to be, whether the species meets the definition of an endangered species or a threatened species. Further, we concluded that our determination of the foreseeable future would be the same under the 2019 regulations as under the pre-2019 regulations.

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 requires that we determine whether any species is an “endangered species” or a “threatened species” because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects. We consider these same five factors in reclassifying a species from an endangered species to a threatened species or removing a species from the Lists (50 CFR 424.11(c) through (e)).

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term foreseeable future extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors. The SSAs estimated the future condition of each species at 20-30 years, and we use that timeframe as the foreseeable future in this rule.

The SSA reports document the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including assessments of the potential threats to the species. The SSA reports do not represent our decisions on whether any of the species should be delisted or reclassified under the Act. They do, however, provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. The following is a summary of the key results and conclusions from the SSA reports; the full SSA reports can be found at Docket No. FWS-R8-ES-2020-0074 on https://www.regulations.gov.

To assess species viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency supports the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, severe wildfire); and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate changes, successional changes to habitat). In general, the more resilient and redundant a species is and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decisions.

Below, we review the biological condition of the species and their resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

Each of the five SCI species occurs as a single population with no natural division in their ranges. However, for assessing species resilience and for monitoring and tracking the plant species in the future, we divided the species' ranges into watershed units to quantify threats across the range. Watersheds were suggested for use in delineation for monitoring purposes by the Navy (Vanderplank et al. 2019, pp. 6-7), as every point on the island can be easily assigned to a watershed, and watershed boundaries on SCI are not expected to change significantly during the 20- to 30-year timeframe of this analysis. These units are not meant to represent “populations” in a biological sense; rather, these units were designed to subdivide the species' ranges in a way that facilitates assessing and reporting the variation in current and future resilience across the range. In the SSAs for the plant species, we assessed the species' ability to withstand stochastic events in each watershed, and how these occupied watersheds contribute to the viability of the entire island population (the species). Note that this way of delineating analysis units within which to measure resiliency does not follow the methods used in the July 26, 2013, rule reclassifying SCI paintbrush and SCI lotus (78 FR 45406), and it is therefore not directly comparable. However, the watersheds that are represented correspond to the extant occurrences described in the July 26, 2013, reclassification rule (USFWS 2022d, pp. 82-85; USFWS 2022e, pp. 89-92).

To assess species resilience for SC Bell's sparrow, we followed the approach used in annual breeding season surveys. Annual breeding season surveys divide the island into eight vegetation strata, estimate the SC Bell's sparrow density in each strata, and extrapolate the density across the strata to obtain a population estimate for the strata. We assessed the resiliency of the subspecies within each of these strata in terms of the estimated population size, and combined the strata results to assess the resiliency of the subspecies. The vegetation strata do not represent “populations” in a biological sense; as with the plant species, these units subdivide the species' range in a way that facilitates assessing and reporting the variation in current and future resilience across the range.

Our SSA framework generally includes identifying the species' ecological requirements for survival and reproduction at the individual, population, and species levels. However, population-level and species-level needs, such as number of individuals or reproductive success necessary to maintain an occurrence, level of gene flow or dispersal, etc., are not well understood for any of the five species. Where information is lacking or incomplete, we make certain scientific assumptions based on principles of conservation biology to conduct our analyses. In each of the plant SSAs, we make the assumption that, for the plant species, higher numbers of individuals within a watershed correlate with greater resilience and, conversely, watersheds with fewer individuals or with only one occupied location within the watershed have lower resiliency. Similarly, for SC Bell's sparrow, our models in the SSA assume that density correlates with greater resilience, and that vegetative strata with greater densities have greater resilience.

We reviewed the potential risk factors ( i.e., threats, stressors) that could be affecting the five SCI species now and in the foreseeable future. In this final rule, we will discuss only those factors in detail that could meaningfully impact the status of the species. Those risks that are not known or unlikely to have effects on the status of the SCI species, such as disease or seed predation, are not discussed here, but are evaluated in the SSA reports. Many of the threats and risk factors are the same or similar for each of the species. Where the effects are expected to be similar, we present one discussion that applies to all species. Where the effects may be unique or different to one species, we address that species specifically. Many of the risk factors affect both habitat (quantity and quality) and individuals of the species (disturbance, injury, or mortality). The primary risk factors ( i.e., threats) affecting all the SCI species are: (1) Past, current, and future land use, including military training activities (Factors A and E from the Act); (2) erosion (Factor A); (3) invasive species (Factors A and E); (4) fire and fire management (Factors A and E); and (5) climate change (Factors A and E). Additional risk factors for some of the species include predation (Factor C), drought (Factors A and E), small population size (Factor E), and reduced genetic diversity (Factor E). Finally, we also reviewed the conservation efforts being undertaken for the species.

The current habitat conditions for listed species on SCI are partly the result of historical land use practices. SCI was used legally and illegally for sheep ranching, cattle ranching, goat grazing, and pig farming (77 FR 29078, p. 29093, May 16, 2012; Navy 2013a, p. 2-3). Goats and sheep were introduced early by the Europeans, and cattle, pigs, and mule deer were introduced in the 1950s and 1960s (Navy 2013a, p. 3-185). These nonnative herbivores greatly changed the vegetation of SCI and were the main cause of the SCI species' decline (42 FR 40682, p. 40683, August 11, 1977). Persistent grazing and browsing defoliated large areas of the island, and the animals' trampling caused trail proliferation, which exacerbated erosion, altering plant communities on SCI and leading to severe habitat degradation and loss of suitable habitat that likely curtailed the range of endemic plants and animals on the island. Grazing and ranching on the island also facilitated the introduction and spread of nonnative plants (Navy 2002, p. 3-31).

All nonnative ungulates were removed by 1992 (Keegan et al. 1994, p. 58; 77 FR 29078, p. 29093, May 16, 2012). Since then, the vegetation on SCI has rebounded, and habitat conditions have improved, leading to changes in the cover of native and nonnative plants on the island, further evidenced by the increases in endangered and threatened taxa since the feral animals were removed (Uyeda et al. 2019, pp. 6, 22, 30). While nonnative herbivores have been successfully removed and are no longer directly affecting native plant communities, continuing impacts include areas vulnerable to erosion that have not fully recovered, the presence of invasive species, and the interaction of nonnative grasses with fire. The past and continuing effects of erosion, invasive species, and fire are discussed further below.

SCI is owned by the Navy and is the primary maritime training area for the Pacific Fleet and Sea Air and Land Teams (77 FR 29078, May 16, 2012). The island also supports training by the Marine Corps, the Air Force, the Army, and other military organizations. As the westernmost training range in the eastern Pacific Basin, where training operations are performed prior to troop deployments, portions of the island receive intensive use by the military (Navy 2008a, p. 2.2).

Infrastructure, including runways, buildings, fuel distribution network, training facilities, berthing areas, and associated development, is concentrated at the northern half of the island. The remainder of the island supports scattered operations buildings, training facilities, an electrical distribution system, and Ridge Road running along the central plateau of the island. In addition to existing infrastructure, military exercises and training activities occur within designated training areas on the island and have the potential to affect the SCI species (see table 1, below). Altogether, 34.8 percent of the island's area is currently in one of these training areas, although training does not occur uniformly within each area. Military training activities can involve the movement of assault vehicles and troops over the landscape and can include live munitions fire, incendiary devices, demolitions, and bombardment.

The Shore Bombardment Area (SHOBA) occupies roughly the southern third of the island and encompasses approximately 13,824 ac (5,594 ha) (Navy 2008a, p. 2-7, Navy 2009, p. 2-4). Areas of intensive use within SHOBA include two Impact Areas and three Training Areas and Ranges (TARs). Impact Areas support naval gun firing, artillery firing, and air-to-ground bombing (Navy 2008a, p. 2-7; Navy 2013a, p. 2-8). Much of the remainder of SHOBA serves as a buffer around Impact Areas; thus, 59 percent of SHOBA is not within intensive training areas subject to direct training activities. Some areas, particularly the escarpment along the eastern coast, have limited training value because precipitous terrain hinders ground access.

Due to military training activities, land use has been considered a threat to listed species on SCI. Training and other land use activities have multiple potential impacts, including trampling or crushing individuals or groups of plants; disturbance of nesting birds or injury or mortality of nestlings; and habitat impacts including disturbances to soil and vegetation, spread of nonnative plant species, creation of road ruts and trails, compaction of soils, and fires (USFWS 2008b, pp. 96-99). Erosion, nonnative species, and fire are discussed separately from military training in this final rule.

The Navy is drafting an environmental assessment to evaluate future training areas, exercises, and frequency on SCI. Training frequency and intensity in existing training areas will increase in the future, and new training areas, including landing zones (LZs), AVMAs, and a new TAR may be established. Up to 19 new helicopter LZs may be designated, and we anticipate impacts associated with training could occur within about 500 feet of each LZ. Future training may include up to 13 new AVMAs, 6 of which overlap with existing training areas. We anticipate impacts associated with this training could occur within about 500 feet of each AVMA. Future training also includes one new TAR (TAR 23), which will be located on the northwestern shore of SCI, within significant high-quality boxthorn habitat that is proposed as an SCI Bell's Sparrow Management Area. For our analysis in this final rule, we assessed these additional training areas, the anticipated impacts, and the conservation measures the Navy will implement to ensure the viability of the five SCI species.

Purpose of the Sea Turtle Observer Requirement

Under the ESA, 16 U.S.C. 1531 et seq., NMFS has the responsibility to implement programs to conserve marine life listed as endangered or threatened. All sea turtles found in U.S. waters are listed as either endangered or threatened under the ESA. Kemp's ridley ( Lepidochelys kempii ), loggerhead ( Caretta caretta; North Pacific distinct population segment (DPS)), leatherback ( Dermochelys coriacea ), green ( Chelonia mydas; Central West Pacific and Central South Pacific DPSs) and hawksbill ( Eretmochelys imbricata ) sea turtles are listed as endangered. Loggerhead (Northwest Atlantic distinct population segment), green (North Atlantic, South Atlantic, Central North Pacific, and East Pacific DPSs), and olive ridley ( Lepidochelys olivacea ) sea turtles are listed as threatened, except for breeding colony populations of olive ridleys on the Pacific coast of Mexico, which are listed as endangered. Due to the inability to distinguish between populations of olive ridley turtles away from the nesting beach, NMFS considers these turtles endangered wherever they occur in U.S. Pacific waters. While some sea turtle populations have shown signs of recovery, many populations continue to decline.

Bycatch in fishing gear is the primary anthropogenic source of sea turtle injury and mortality in U.S. waters. Section 9 of the ESA prohibits the take (defined to include harassing, harming, pursuing, hunting, shooting, wounding, killing, trapping, capturing, or collecting or attempting to engage in any such conduct), including incidental take, of endangered sea turtles. Pursuant to section 4(d) of the ESA, NMFS has issued regulations extending the prohibition of take, with exceptions, to threatened sea turtles (50 CFR 223.205 and 223.206). Section 11 of the ESA provides for civil penalties and criminal penalties for anyone who knowingly violates the Act or a regulation issued to implement the ESA. NMFS may grant exceptions to the take prohibitions with an incidental take statement or an incidental take permit issued pursuant to ESA section 7 or 10, respectively. To do so, NMFS must determine the activity that will result in incidental take is not likely to jeopardize the continued existence of the affected listed species. For some Federal fisheries and most state fisheries, NMFS has not granted an exception for incidental takes of sea turtles primarily because we lack information about fishery-sea turtle interactions.

For most fisheries, the most effective way for NMFS to learn more about bycatch in order to implement the take prohibitions and prevent or minimize take is to place observers aboard fishing vessels. In 2007, NMFS issued a regulation (50 CFR 222.402) establishing procedures to annually identify, pursuant to specified criteria and after notice and opportunity for comment, those fisheries in which the agency intends to place observers (72 FR 43176; August 3, 2007). These regulations specify that NMFS may observe fisheries, commercial or recreational, operating in U.S. territorial waters, the U.S. exclusive economic zone (EEZ), or on the high seas or on vessels that are otherwise subject to the jurisdiction of the United States. Failure to comply with the requirements under these regulations may result in civil or criminal penalties under the ESA.

NMFS will pay the direct costs for vessels to carry the required observers. These include observer salary and insurance costs. NMFS may also evaluate other potential direct costs, should they arise. Once selected, a fishery will be required to carry observers, if requested, for a period of five years without further action by NMFS. This will enable NMFS to develop appropriate observer coverage and sampling protocols to investigate sea turtle bycatch, and to evaluate whether existing measures are minimizing or preventing bycatch.

NMFS uses information on sea turtle distribution and habitat use to inform the development of the final AD. A summary of this information was included in the proposed AD (87 FR 54948; September 8, 2022) and was considered in developing the final 2023 AD.

Pursuant to 50 CFR 222.402, NOAA's Assistant Administrator for Fisheries (AA), in consultation with Regional Administrators and Fisheries Science Center Directors, develops a proposed AD identifying which fisheries are required to carry observers, if requested, to monitor potential interactions with sea turtles. NMFS provided an opportunity for public comment on the proposed determination (87 FR 54948; September 8, 2022). The determination is informed by the best available scientific, commercial, or other information regarding sea turtle-fishery interactions; sea turtle distribution; sea turtle strandings; fishing techniques, gears used, target species, seasons and areas fished; and/or qualitative data from logbooks or fisher reports. Specifically, fisheries are identified on the AD based on the extent to which:

(1) The fishery operates in the same waters and at the same time as when sea turtles are present;

(2) The fishery operates at the same time or prior to elevated sea turtle strandings; or

(3) The fishery uses a gear or technique that is known or likely to result in incidental take of sea turtles based on documented or reported takes in the same or similar fisheries; and

(4) NMFS intends to monitor the fishery and anticipates that it will have the funds to do so.

The AA used the most recent version of the annually published Marine Mammal Protection Act (MMPA) List of Fisheries (LOF) as the comprehensive list of commercial fisheries for consideration. The LOF includes all known state and Federal commercial fisheries that occur in U.S. waters and on the high seas. However, in preparing the AD, we do not rely on the three-part MMPA LOF classification scheme. In addition, unlike the LOF, the AD may include recreational fisheries likely to interact with sea turtles based on the best available information.

NMFS consulted with appropriate state and Federal fisheries officials to identify which fisheries, both commercial and recreational, to consider. NMFS carefully considered all recommendations and information available for developing the AD. The AD is not an exhaustive or comprehensive list of all fisheries with documented or suspected sea turtle bycatch. NMFS will not include a fishery on the AD if that fishery does not meet the criteria for inclusion on the AD (50 CFR 222.402(a)).

For many fisheries, NMFS may already be addressing bycatch through another mechanism ( e.g., rulemaking to implement modifications to fishing gear and/or practices), may be observing the fishery under a separate statutory authority, or will consider including them in future ADs based on the four previously noted criteria (50 CFR 222.402(a)). The fisheries not included on the 2023 AD may still be observed by NMFS fisheries observers under different authorities ( e.g., MMPA, Magnuson-Stevens Fishery Conservation and Management Act (MSA)) than the ESA, if applicable.

NMFS publishes the final determination in the Federal Register and individuals permitted for each fishery identified on the AD will receive a written notification. NMFS will also notify state or territory agencies. Once included in the final determination, a fishery will remain eligible for observer coverage for a period of five years to enable the design of an appropriate sampling program and to ensure collection of sufficient scientific data for analysis. If NMFS determines a need for more than five years to obtain sufficient scientific data, NMFS will include the fishery in a subsequent proposed AD, prior to the end of the fifth year.

On the 2018 AD, NMFS identified two fisheries and required them to carry observers, if requested, through December 31, 2022. The 2020 AD identified four additional fisheries and required them to carry observers, if requested, through September 29, 2025. The fisheries included on the current AD are available at https://www.fisheries.noaa.gov/national/bycatch/sea-turtle-observer-requirement-annual-determination.

NMFS received 14 comment letters on the proposed AD (87 FR 54948; September 8, 2022). All commenters were members of the public. All commenters expressed general support of the regulation or fishery observer programs. All substantive comments are addressed below. Comments on issues outside the scope of the AD were noted but are not responded to in this final determination.

Comment 1: Twelve commenters expressed general support for the regulation.

Response: NMFS agrees and has included two fisheries on the 2023 AD to allow for increased data collection on sea turtle bycatch to accomplish the purposes of the regulation.

Comment 2: One commenter was supportive of the regulation but recommends NMFS include a fishery in the Pacific Ocean on the 2023 AD. The commenter noted that adding a Pacific fishery will allow NMFS to cover fisheries in the Atlantic, Pacific, and Gulf of Mexico.

Response: NMFS acknowledges that there are other fisheries, in addition to those included on the 2023 AD, that have the potential to incidentally take sea turtles. The 2023 AD is not meant to be a comprehensive list of fisheries that have sea turtle bycatch or fisheries that require monitoring, but rather a focused list, based on specific inclusion criteria, one of which is based on available funding (see Purpose of the Sea Turtle Observer Requirement section). NMFS is not including a Pacific fishery on the 2023 AD because none of the fisheries in the Pacific met all of the inclusion criteria.

Comment 3: A commenter was supportive of the regulation but raised concern over what NMFS' standards were for distributing and placing observers among fisheries on the AD. The proposed rule stated “That no individual person or vessel, or group of persons or vessels, be subject to inappropriate, excessive observer coverage.” The commenter questioned what would make observer coverage inappropriate or excessive.

Response: When using the AD authority to observe a fishery, NMFS will work within the current observer programs and follow the observer program's standards and observer placement design requirements. Pursuant to 50 CFR 222.404, NMFS will follow the standards for distributing and placing observers: (1) The requirement to obtain the best available scientific information; (2) The requirement that observers be assigned fairly and equitably among fisheries and among vessels in a fishery; (3) The requirement that no individual person or vessel, or group of persons or vessels, be subject to inappropriate, excessive observer coverage; and (4) The need to minimize costs and avoid duplication, where practicable. For example, Northeast Fisheries Observer Program (NEFOP) coverage is determined by an annual discard analysis and sea day allocation report required by the Standardized Bycatch Reporting Methodology (SBRM) Amendment. Trips are assigned based on effort. As there is no pre-trip notification requirement for these fleets, guidance is provided to the contract holder which estimates coverage based on that year's sea day schedule and prior years effort. There are regulations in the SBRM amendment and the contract that prevents individual vessels from being covered in a biased manner.

Comment 4: A commenter stated that the AD does not include information on how an observer program would be implemented for recreational fisheries from public piers. They noted that several fishing piers in the Gulf of Mexico have a high rate of sea turtle bycatch. The Loggerhead Marine Life Center in Florida has a responsible pier initiative program. The commenter stated that this data can provide information on sea turtle bycatch off piers and NMFS can use that information to use the AD for recreational fisheries occurring on piers.

Response: NMFS acknowledges that there are other fisheries (commercial and recreational), in addition to those included on the 2023 AD, that have the potential to take sea turtles. The 2023 AD is not meant to be a comprehensive list of fisheries that have sea turtle bycatch or fisheries that require monitoring, but rather a focused list, based on specific inclusion criteria, one of which is based on available funding (see Purpose of the Sea Turtle Observer Requirement section). NMFS is not including shore-based recreational fisheries on the 2023 AD because none of the fisheries met all of the inclusion criteria. NMFS and our partners (including those in the Sea Turtle Stranding and Salvage Network) are trying to learn more about how sea turtles interact with recreational fishing gear—see additional information on our Sea Turtle and Recreational Fishing website here: https://www.fisheries.noaa.gov/national/marine-life-distress/sea-turtles-and-recreational-fishing.

NMFS includes two fisheries in the Atlantic Ocean/Gulf of Mexico on the 2023 AD. The two fisheries, listed in Table 1, are the mid-Atlantic gillnet and Gulf of Mexico menhaden purse seine fisheries. These two fisheries were previously listed on the 2018 AD for a five-year period ending December 31, 2022. NMFS includes these fisheries pursuant to the criteria identified at 50 CFR 222.402(a)(1) for listing a fishery on the AD because sea turtles are known to occur in the same areas where the fishery operates, takes have been documented in this fishery, and NMFS intends to monitor this fishery.

NMFS used the 2022 MMPA LOF (87 FR 23122; April 19, 2022) as the comprehensive list of commercial fisheries to evaluate for fisheries to include on the AD. The fishery name, definition, and number of vessels/persons for fisheries listed in the AD are taken from the most recent MMPA LOF. Additionally, the fishery descriptions below include a particular fishery's current classification on the MMPA LOF ( i.e., Category I, II, or III); Category I and II fisheries are required to carry observers under the MMPA, if requested by NMFS. As noted previously, NMFS also has authority to observe fisheries in Federal waters under the MSA and collect sea turtle bycatch information. The AD authority will work within the current observer programs, and allow NMFS the flexibility to further consider sea turtle data collection needs when allocating observer resources.

A summary of information about the mid-Atlantic gillnet and Gulf of Mexico menhaden purse seine fisheries was included in the proposed AD (87 FR 54948; September 8, 2022) and was considered in developing the final 2023 AD.

As part of the 2023 AD, NMFS has included, to the extent practicable, information on the fisheries and gear types to observe, geographic and seasonal scope of coverage, and any other relevant information. NMFS intends to monitor the fisheries and anticipates that it will have the funds to support observer activities. After publication of the final determination, there will be a 30-day delay in the date of effectiveness for implementing observer coverage, see DATES.

The design of any observer program for fisheries identified through the AD process, including how observers will be allocated to individual vessels, will vary among fisheries, fishing sectors, gear types, and geographic regions, and will ultimately be determined by the individual NMFS Regional Office, Science Center, and/or observer program. Pursuant to 50 CFR 222.404, during the program design, NMFS will follow the standards below for distributing and placing observers among fisheries identified in the AD and among vessels in those fisheries:

(1) The requirement to obtain the best available scientific information;

(2) The requirement that observers be assigned fairly and equitably among fisheries and among vessels in a fishery;

(3) The requirement that no individual person or vessel, or group of persons or vessels, be subject to inappropriate, excessive observer coverage; and

(4) The need to minimize costs and avoid duplication, where practicable.

Vessels subject to observer coverage under the AD must comply with observer safety requirements specified in 50 CFR 600.725 and 600.746. Specifically, 50 CFR 600.746(c) requires vessels subject to observer coverage to provide adequate and safe conditions for carrying an observer and conditions that allow for operation of normal observer functions. To provide such conditions, a vessel must comply with the applicable regulations regarding observer accommodations (see 50 CFR parts 229, 300, 600, 622, 635, 648, 660, and 679) and possess a current United States Coast Guard (USCG) Commercial Fishing Vessel Safety Examination decal or a USCG certificate of examination. A vessel that fails to meet these requirements at the time an observer is to be deployed may be prohibited from fishing without observer coverage under 50 CFR 600.746(i). Observer programs designed or carried out in accordance with 50 CFR 222.404 are consistent with existing NOAA observer policies and applicable federal regulations, such as those under the Fair Labor and Standards Act (29 U.S.C. 201 et seq. ), the Service Contract Act (41 U.S.C. 351 et seq. ), and the Observer Health and Safety regulations (50 CFR part 600).

Additional information on observer programs in commercial fisheries is available on the NMFS National Observer Program's website: https://www.fisheries.noaa.gov/topic/fishery-observers.

The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. No comments were received on that certification, and no new information has been discovered to change that conclusion. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

This regulation contains existing collection-of-information (COI) requirements subject to the Paperwork Reduction Act and would not impose additional or new COI requirements. The information collection for the AD is approved under Office of Management and Budget (OMB) control number 0648-0593. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.

This regulation has been determined to be not significant for the purposes of Executive Order 12866.

In accordance with the Companion Manual for NOAA Administrative Order (NAO) 216-6A, NMFS determined that publishing the AD qualifies to be categorically excluded from further National Environmental Policy Act (NEPA) review, consistent with categories of activities identified in Categorical Exclusion G7 (“Preparation of policy directives, rules, regulations, and guidelines of an administrative, financial, legal, technical, or procedural nature, or for which the environmental effects are too broad, speculative or conjectural to lend themselves to meaningful analysis and will be subject later to the NEPA process, either collectively or on a case-by-case basis”) of the Companion Manual, and we have not identified any extraordinary circumstances listed in Chapter 4 of the Companion Manual for NAO 216-6A that would preclude application of this categorical exclusion. If NMFS takes a management action for a specific fishery, for example, requiring fishing gear modifications, NMFS would first prepare any environmental document specific to that action that is required under NEPA.

This regulation would not affect species listed as threatened or endangered under the ESA or their associated critical habitat. The impacts of numerous fisheries have been analyzed in various biological opinions, and this regulation would not affect the conclusions of those opinions. The inclusion of fisheries on the AD is not considered a management action that would adversely affect threatened or endangered species. If NMFS takes a management action, for example, requiring modifications to fishing gear and/or practices, NMFS would review the action for potential adverse effects to listed species under the ESA.

This regulation would have no adverse impacts on sea turtles, and information collected from observer programs may have a positive impact on sea turtles by improving knowledge of sea turtles and the fisheries interacting with sea turtles.

This regulation would not affect the land or water uses or natural resources of the coastal zone, as specified under section 307 of the Coastal Zone Management Act.